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chrisvoncsefalvay

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vaers-outcomes

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Rash, itchy and diffuse. Present on chest, arms, legs, palms of hands and neck. Clinically appears consistent with Varicella. Treated initially with steroids IM, however did not respond. Initiated treatment with antivirals. Response unclear at this time.

0No event

As of today I couldn't stop smelling smoke, except nobody in this house smokes. It's an unbearable live smoke smell that comes and goes. I've looked up "smoke smell, Pfizer." What came up was phantosmia.

0No event

fever 101.4, chills, cough, low energy, dull headache

0No event

Erythema, warmth, tenderness, swelling at injection site

0No event

This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.

0No event

On Friday morning, starting about 9am I felt extreme cold that could only be remedied by laying under three blankets in a 72 degree room, on Friday afternoon I spiked a fever of 101.5 that was successfully treated with Tylenol through the evening. Appetite suppressed through end of day Saturday.

0No event

Information has been received from a medical assistant referring to multiple patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of Gardasil 9 (lot # M003659, expiration date 20-SEP-2017) intramuscularly. Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.

0No event

Pt requested Pfizer Booster/Bivalent to be given, with other vaccines of TDaP and Flu. Pt was given Pedi Pfizer (5-11yo) dose, that was undiluted. AE was noted when counting waste of vaccine for day. Pfizer was called for advise of treatment or steps to be completed for Pt health concerns. Pfizer reported, "Pedi Pfizer Bivalent (5-11yo) dose undiluted , is same as Pfizer Bivalent 12 and up." No further treatment or steps should be taken.

0No event

patient presented to the Emergecy department complaints of 1 day of dyspnea and discomfort while breathing. Patient was found to have a D-Dimer of 10.6, a CT was performed finding filling defects seen within the distal R and L main pulmonary arteries. Additional pulmonary emboli extend into the segmental branches of the lingula and L lower lobe as well as into the right middle lobe and R lower lobe. additional pulmonary emboli are seen within the segmental branches. Mild pulmonary emboli are seen within the segmental branches within the left upper lung. elevated R heart pressures shown by compression of the left ventricle with enlargement of the right ventricle and bowing of the intervertebral septum into the left heart. Patient bolused with heparin and places on heparin drip. Elevated troponins

4HOSPITAL

Covid Arm - Raised rash that is sore and itchy on and around injection site. About the size of a playing card

0No event

Information has been received from a county health registered nurse concerning a 36 month old male who on 08-OCT-2001 was vaccinated with VARIVAX (Merck). On 27-APR-2001, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Merck). This is one of 28 reports received from the same source. No further information is available.

1ER_VISIT

Information has been received from a physician concerning a 5 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient developed breakthrough chickenpox in December 2006. No further information was provided. This is one of several reports received from the same source. Additional information is not expected.

0No event

This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age (gender unspecified). On 23-AUG-2013 the patient was vaccinated with an expired dose of M-M-R II lot # 670080/0402AA, exp. 16-MAR-2013. No adverse effects reported. Additional information has been requested.

0No event

pt recv vax; following day exp difficulty voiding & burning upon urination;f/u MD stated pt was dx w/ hematuria not related to vax;

0No event

This spontaneous report as received from a nurse refers to a currently 3 months old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in 2017, the patient was vaccinated with an improperly stored ROTATEQ lot # N013885 (dose was not provided). Data logger was not involved. No adverse effects were reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA012873: US-009507513-1712USA012874: US-009507513-1712USA012875: US-009507513-1712USA012876: US-009507513-1712USA012877: US-009507513-1712USA012878:

0No event

T. 99.8

0No event

1 week after my first dose, I was bed ridden from fatigue, body ache, head and neck pain, nausea, weakness and pain that I felt in my veins and bones, and slight dizziness and occasional warmth/fever. All symptoms relieved naturally 1 week later.

0No event

It attacked thoracic nerve and pain; couldn't use right arm for 2 years; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media. This case involves patient (unknown demographics) who experienced attacked thoracic nerve and pain (neuralgia) and couldn't use right arm for 2 years (mobility decreased), while he/she received vaccine INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious it attacked thoracic nerve and pain (neuralgia) and couldn't use right arm for 2 years (mobility decreased) (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was not reported. There will be no information available on the batch number for this case.

0No event

Day 8 after vaccine I developed a red rash directly under the injection site. The rash spread and now covers much of my upper left arm. It?s red, itchy, raised, and hot.

0No event

Patient received Varicella Vaccine on 8/6/08. He started to develop a rash on 8/7/08 and still has rash at present. He developed a generalized body rash; on his face, neck, chest, right leg, and left arm. Patient received the Varicella Vaccine in his left arm and mother noticed most of rash is on his Left arm. The mother estimates there are 50 lesions on his body. Patient saw a doctor on 8/8/08 and the doctor felt that Patient has chickenpox due to him receiving the Varicella Vaccine.

1ER_VISIT

Fever, Chills, Muscle Aches, Pounding headache, Fatigue, Malaise, Joint pain, stuffy nose, shortness of breathe, chest feel heavy, injections site pain (not red or swollen), sinus congestion, inner ear ache.

0No event

tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 (Lot number: EL0142) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glucose intolerance" (ongoing); "Hyperlipidemia" (ongoing); "Hypothyroid" (ongoing); "Acid Reflux" (ongoing). Concomitant medication(s) included: BIOTIN; CHOLECALCIFEROL; GINGER [ZINGIBER OFFICINALE]; LEVOTHYROXIN; METFORMIN; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; PREBIOTICS NOS;PROBIOTICS NOS. The following information was reported: TENDERNESS (non-serious), outcome "unknown", described as "tenderness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Nothing in her life has changed, medication, foods, nothing. She did have tenderness after the first injection, more than after the second or the booster. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None Follow-up attempts are completed. No further information is expected.

0No event

Vaccine error: Vaccine administered past its beyond use date. The vaccine stored in the freezer beyond the timeframe recommended by the manufacturer.

0No event

Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.

0No event

tested and the result showed positive; tested and the result showed positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 at 12:00 as dose 1, single (Lot number: EL3247) intramuscular, in left arm, on 12Apr2021 at 13:00 as dose 2, single (Lot number: EL3247) intramuscular, in right arm, as dose 3 (booster), single (Batch/Lot number: unknown) and on 05Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FH8027) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "recovered" and all described as "tested and the result showed positive". The events "tested and the result showed positive" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received 2 Pfizer Covid vaccines plus 2 Pfizer Covid boosters. The last booster was on 05Apr2022. About a month after that, she was with a friend who later tested positive for Covid, so when she started to feel symptoms, she tested herself, and the result showed that she too, was positive and categorize symptoms as being mild. The patient went to emergency room/department or urgent care. Treatment reported as IV fluids and Advil. Covid test type post vaccination was a Nasal Swab on 21May2022 (positive). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.

1ER_VISIT

This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were administered a dose of GARDASIL (dose, route, lot number and expiration date not reported) that was exposed to a temperature outside the prescribing information. The temperature excursions were not reported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.

0No event

Arm hurts; Still has some tightness when he bends it in; Not being able to move his leg/could not straighten it/could not bend it; kept on waking up/ not sleeping last night; Throbbing; Left knee started hurting so bad/agonizing pain, agonizing joint pain in his left knee he describes it as a banging pain in the knee for multiple hours; He could not walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), GAIT INABILITY (He could not walk), MUSCLE TIGHTNESS (Still has some tightness when he bends it in), MOBILITY DECREASED (Not being able to move his leg/could not straighten it/could not bend it) and INSOMNIA (kept on waking up/ not sleeping last night) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced GAIT INABILITY (He could not walk), MOBILITY DECREASED (Not being able to move his leg/could not straighten it/could not bend it), INSOMNIA (kept on waking up/ not sleeping last night), PAIN (Throbbing) and ARTHRALGIA (Left knee started hurting so bad/agonizing pain, agonizing joint pain in his left knee he describes it as a banging pain in the knee for multiple hours). On 09-Aug-2021, the patient experienced MUSCLE TIGHTNESS (Still has some tightness when he bends it in). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts). On 09-Aug-2021, GAIT INABILITY (He could not walk), MOBILITY DECREASED (Not being able to move his leg/could not straighten it/could not bend it), INSOMNIA (kept on waking up/ not sleeping last night), PAIN (Throbbing) and ARTHRALGIA (Left knee started hurting so bad/agonizing pain, agonizing joint pain in his left knee he describes it as a banging pain in the knee for multiple hours) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts) and MUSCLE TIGHTNESS (Still has some tightness when he bends it in) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Reporter Information and event added. On 09-Aug-2021: Event details added

0No event

wheezing same day as vaccine- albuterol hfa and prednisone dyspnea exacerbated over next several days leg deep venous thrombosis developed/diagnosed 11 days later

0No event

patient received expired dose of V AQTA; No adverse effects reported.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions and allergies were not provided. On 04-DEC-2019, the patient received an expired dose (expired product administered) of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis; lot number R030120 and expiration date 15-NOV-2019. Information about strength, dose, frequency and route of administration was not provided. No additional adverse effects were reported.

0No event

Itching, swelling, red, hot, burning, placed ice bag on swelling and took Benadryl.

0No event

Low grade fever for 6 days, dry cough, general fatigue. Anemia, enlarged lymph nodes.

0No event

Sleeplessness; Swelling of lymph glands; Feeling tired; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 09Mar2021 at 17:15, as a single dose for COVID-19 immunisation. The patient's medical history included degenerative joint disease, mild hearing loss, asthma, depression, anxiety, seasonal allergies, migraines and vertigo. The patient had no history of allergies to food, medications or any other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included ZOLOFT, joint support (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), VIT D (MANUFACTURER UNKNOWN), ZYRTEC and probi (MANUFACTURER UNKNOWN), all for unknown indications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021 at 16:00, the patient experienced sleeplessness (9 days so far), swelling of lymph glands which lasted for 3 days and feeling tired for 4 days. The patient did not receive any treatment for the reported events. The clinical outcome of the events sleeplessness was resolving; swollen lymph glands was resolved on 13Mar2021 and feeling tired was resolved on 14Mar2021. No follow-up attempts are needed. No further information is expected.

0No event

Was given Pediatric dose instead of adult dose.

0No event

This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter state that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration date not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 18 months old infant patient of unknown gender. On 19-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.

0No event

Pain in right arm, then, in a few days, sharp pain on my right side any time I took a deep breath: front, side, and back of chest area on right side!

0No event

Fever. Not herself x 2 days.. increased fussiness. Mother notes usually well mannered, now crying more. Pulling at ears last night, fever spike 101.5, 11:30pm last night. LEG PAIN, TREAT WITH IBUPROFEN. SEIZURES-SENT TO HOSPITAL.

1ER_VISIT

TC received by grandmother; states pt has a red swollen mark - on upper arm and a quarter sized bruise. Instructions given to monitor area/pt. Warm soak and seek medical attention if necessary.

0No event

Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-DEC-2014, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.

1ER_VISIT

No adverse effect reported; improperly stored vaccine in use; This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. The patient's pertinent medical history and drug reactions or allergies were not reported. The concomitant medication included sterile diluent which was reported to be stored properly. On 18-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dosage information, route of administration and anatomical location were unknown) (lot # R019237 with an expiry date of 04-JUL-2020 or lot # S005078 with an expiry date of 19-FEB-2021 as the nurse was not able to determine which lot was given to the patient) for prophylaxis (product storage error). No adverse effect reported. It was reported that the vaccine was exposed to a temperature of -14 degree Celsius (C) to -10 degree Celsius (-9.74 C) for an unknown time frame. There was no previous temperature excursion reported. Data logger was involved. The outcome of product storage error was unknown. No product quality complaint (PQC) was associated with this report.

0No event

Fever, fever blisters, malaise, achiness onset the morning after receiving the Zostavax injection.

0No event

very achy muscles, headache lasted over a week, tired

0No event

Urticaria, started ~10 days post vaccination treatment started with Benadryl on and off for a week, then adjusted by allergist to 10mg Zyrtec and 180mg Allegra daily for 3 weeks, Hives mostly subsided by February but a lingering neck rash/hive is still there four months post vaccination.

0No event

Initial report received from a health care professional on 31 October 2013. A 73-year-old female patient who had no illness at time of vaccination, no pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported, had received FLUZONE HD in left deltoid (lot number U4764AA) on 10 October 2013. On 10 October 2013, the patient had soreness around the injection site for 21 days. Looks ok externally, no redness, no bruising. If she lies on the side it hurts. Laboratory investigations were not reported. At the time of this report, the patient was recovered from the event. Documents held by sender: none

0No event

heavy chill for about two hours, with 101.4 fever. sore knee joints for two days

0No event

have been sick and not able to get second dose yet; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. Shingrix was discontinued. On an unknown date, the outcome of the sickness was not recovered/not resolved. It was unknown if the reporter considered the sickness to be related to Shingrix. Additional case details were reported as follows: The age at vaccination was not reported. The patient had been sick after 1st dose of Shingrix and not able to get the second shot. The patient asked do I have any immunity.

0No event

Beginning on 1/24, I had left thigh paresthesias. The next day on 1/25 I had entire left side of my body paresthesias of left leg, arm, trunk and face/head. I also had associated left lower lip asymmetry/droop - it resolved with smiling but was noted at rest. I went to the ED on 1/25/21 evening to be evaluated due to facial asymmetry and paresthesias and had a brain MRI and C spine MRI which did not show any abnormalities (no signs of multiple sclerosis, brain tumor, stroke, etc) on 1/26/21. Vitamin B12 levels were sent and Lyme titers were sent. Lyme was negative and vitamin B12 was ultimately seen to be in low normal range at 223 on 1/26/21. I continued to have paresthesias on both right and left sides of my body but no other development of weakness anywhere with exception of slight facial asymmetry. I had iron studies and tissue transglutaminase as well to screen for malabsorption, which was normal, except for mildly low ferritin 12 on 2/1. I started IM vitamin B12 injections for 4 weeks. I also had TSH, free T4, hepatitis C antibody on 2/1 to evaluate for other causes of paresthesias, which was negative, and lead testing on 3/17 which was normal. Due to symptoms persisting, I also had an EMG/NCS on 3/15 since symptoms were still present given concern for mild guillan-barre syndrome. This did not show results consistent with large fiber sensorimotor polyneuropathy such as guillan-barre syndrome. During this same time period, I began to have night sweats soaking through my pajamas and even the sheets of my bed on 2/10, 2/11, 2/24, 2/26, 3/9, 3/11 and 3/12. For these night sweats, I underwent a work-up as well with echocardiogram on 2/16 which was negative for endocarditis (showed incidental atrial septal aneurysm) and with LDH, uric acid, CRP, ESR, CBC and HIV testing that was all normal on 3/1. I had a chest x-ray on 3/12 and CPK, HFP, and FSH on 3/17 to evaluate for other causes of night sweats, which was all negative/normal. I had a CT abd/pelvis on 3/25 which was also reassuring against oncologic process. I had a bubble echo on 5/20 to ensure no PFO with atrial septal aneurysm, which was negative for PFO. Night sweats have improved, but I continue to have paresthesias that come and go.

1ER_VISIT

Redness, swelling, tingling, hot, cellulitis 1-3 days after injection Tx: Antibiotics, cool compresses, BENADRYL.

1ER_VISIT

Information has been received from a physician concerning an 11 week old who was vaccinated with a dose of ROTATEQ. About three weeks later the patient experienced a fever. Additional information has been requested.

0No event

Light Headed dizzy

0No event

Scab at injection site "like a smallpox scab", with redness

0No event

patient was given Janseen vaccine left arm. After giving vaccine, the pharmacist realized it had expired 5-25-2021. vaccine was given at 10 am 5-26-2021

0No event

Flu like symptoms; Sweaty; Tacky and does not feel good overall; Chills; Fatigue; Hip pain; Pain in ear; Pain in allover her left side; Arm pain; Throat pain; Did not feel quite herself; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel quite herself), EAR PAIN (Pain in ear), PAIN (Pain in allover her left side), PAIN IN EXTREMITY (Arm pain) and OROPHARYNGEAL PAIN (Throat pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 031L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concurrent medical conditions included Crohn's disease, Irritable bowel syndrome, Psoriasis, High cholesterol, Hypothyroidism, Fibromyalgia and Arthritis. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced FEELING ABNORMAL (Did not feel quite herself). On 14-Apr-2021, the patient experienced EAR PAIN (Pain in ear), PAIN (Pain in allover her left side), PAIN IN EXTREMITY (Arm pain), OROPHARYNGEAL PAIN (Throat pain) and ARTHRALGIA (Hip pain). On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweaty), FEELING ABNORMAL (Tacky and does not feel good overall), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (Did not feel quite herself), EAR PAIN (Pain in ear), PAIN (Pain in allover her left side), PAIN IN EXTREMITY (Arm pain), OROPHARYNGEAL PAIN (Throat pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweaty), FEELING ABNORMAL (Tacky and does not feel good overall), ARTHRALGIA (Hip pain), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided Concomitant medication list include infliximab infusion which was reported to be stopped 2 weeks before vaccination. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-079426 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-079426:Cross lin with Dose 1

0No event

Fatigue ,irritability,confusion, muscle spasms, tachycardia, dizziness, upon drifting off to sleep body will jolt gasp for air and heart racing, next day right leg was throbbing with moderate joint pain in ankle and knee, brain fog

0No event

Immediately after getting the first dose vaccine, I sat down and then I slumped over in seconds. I fell asleep and I could not wake up. I could not even speak and could not respond when they asked my name. It felt like an out of body experience and a feeling of impending doom. My blood pressure was elevated and when I came around later. I spoke to my Allergist later and he advised that if I get the second one I should be observed. The extreme exhaustion persisted for a week.

0No event

This case was reported by a nurse and described the occurrence of fever in a 2 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 9/10/03, the patient received an injection of Infanrix. Later that day, at an unspecified time post immunization, the patient's parents telephoned the physician to report that the patient was experiencing fever, malaise and an injection site reaction characterized by redness, swelling, and induration. The events resolved on an unspecified date prior to 9/17/03.

0No event

Patient c/o of upset stomach, being disoriented, states "balance was off" no fever. Mother notified student returned to class.

0No event

Patient was administered a 12+ Pfizer COVID vaccine dose at age 11.

0No event

Swelling at the injection site; Pain of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain of the arm) and VACCINATION SITE SWELLING (Swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038A21A) for COVID-19 immunisation. The patient's past medical history included No adverse event (no reported medical history). On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain of the arm). On 20-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain of the arm) and VACCINATION SITE SWELLING (Swelling at the injection site) had not resolved. Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

0No event

Patient woke up dizzy in the middle of the night. He has never been dizzy before. He said his head hurt and asked for a tylenol. He took one and walked back to his room. Before he made it to his room, he blacked out and fell to the ground. Thankfully he did not hit his head. He fell on carpet but we did not know he passed out. He was out for about 1 1/2 hours before he woke up, found himself on the floor, and came back to the room to let us know.

0No event

weakness; diarrhea; swelling; chills; high fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills) and PYREXIA (high fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills), PYREXIA (high fever) and VOMITING (vomiting). At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills), PYREXIA (high fever) and VOMITING (vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drug included Blood pressure medication. Patient reported that she began to feel better on 24-Mar-2021. Treatment medication was not reported.

0No event

Patient had 20-30 sec. fainting spell after receiving Hepatitis A and typhoid, episode post Hepatitis A.

0No event

Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 64-year-old patient (gender not reported), who was vaccinated with a dose of DAPTACEL (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because a 64-year-old patient received pediatric Daptacel. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.

0No event

Had the semi quantitative AB test. Showed positive response.; Had the semi quantitative AB test. Showed positive response.; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program. A 69-year-old (will be 70 on 05Apr2021) patient of unspecified gender received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot# unknown) via unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, patient had CLL and semi quantitative AB test that showed positive response. Patient would like to be in front of line for third shot. Patient was involved in CLL vaccine study with then CLL, getting the third shots that would provide useful information. The patient underwent lab test which included semi quantitative AB test with Positive result on an unspecified date. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

0No event

guest described feeling dizzy

0No event

Sore arm; injection site is very warm; Its like someone injected her with warm water; Headaches; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (injection site is very warm), FEELING HOT (Its like someone injected her with warm water), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swollen injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (injection site is very warm), FEELING HOT (Its like someone injected her with warm water), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swollen injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (injection site is very warm), FEELING HOT (Its like someone injected her with warm water), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swollen injection site) outcome was unknown. The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable. No concomitant medication was reported.

0No event

The pt experienced hives following vaccination. Treated with Benadryl. The pt recovered. Additional information has been requested.

0No event

Extreme full body weakness- Full body soreness Sore throat Headache Blurry vision Fever- lasted for 4 days- treated with lots of fluids Advil Tylenol. Slept as much as possible. 5th and 6th day sore throat bad headache. Missed 4 days of work

0No event

Fever 100.3 midway through day--took ibuprofen, fever broke about 4 hours after taking ibuprofen. Has not returned. Muscle aches--had pulled a muscle in my upper back/neck the night before. The pain was manageable early in the day, but became more intense as the evening went on. Today (the next day) it is manageable again. Fatigue for most of the day after the injection.

0No event

Within about 30 mins of getting the vaccine I felt a little dizzy/disoriented. This feeling passed within an hour. That night, 3/27 around 9 PM I began to feel cold as if I was running a fever and started having body aches. I did not take my temperature to see if I actually did have a fever. The symptoms lasted most of the night. The next day, 3/28 I had the flu-like symptoms again at night.

0No event

12/24/2020 generalized face tingling apprx. 10 minutes post vaccination. Administered diphenhydramine 25mg PO. Symptoms resolved within 5 minutes. VS stable. Observed for one hour and D/C'd in stable condition. 12/30/2020 F/U phone call. States "mild" H/A evening of 12/24/20 but no other sxs. Problems resolved.

0No event

No adverse effect. Patient potentially received Moderna COVAX 0.5 mL versus the correct dosage of Moderna COVAX 0.25 mL. The Moderna COVAX 6mos to 4yrs old is clearly labeled as ?0.25 mL single dose vial? however I did the investigation and found that the single dose vials we have on hand indeed have 0.5 mL inside of it.

0No event

Pulsing in my left foot

0No event

A couple hours after the immunization, patient reported that everything seemed very small (almost Alice in Wonderland Syndrome-like). Episode lasted for approx. 10 minutes Seen in clinic a few hours after that and had normal neurological exam and normal mentation for age. . Happened a few more times also with brief duration and complete resolution-total 5 episodes on day of flu vaccine. Reportedly had another episode a couple days later, then on e episode a week later than the last episode approx. 1 month later. Described seeing a castle or Jack in the bean stalk during one of the later episodes and also reportedly had one episode (recorded on video) where she was coloring outside the lines then when over, she could color inside the lines.

0No event

Slight itch, red rash around injection site, skin warm for 3 days (so far)

0No event

The site got very hot, painful and swollen. Proceeded to swell at the face, neck with painful burning sensation and painful bone structure all over the face with difficulty breathing.

0No event

expired vaccine administered

0No event

Experiencing severe headaches unable to sleep

0No event

received the Covid-19 vaccine. She reports symptoms of headache 10 minutes post vaccine administration. No other symptoms reported. VS as follows at 1235: BP 133/95, 96%113, O2: 97% 1240: BP 118/85, HR 89, O2 96% 1245: BP 124/88, HR 90, O2: 96% 1250: BP 115/75, HR 88, O2: 99% Pt has a hx of seizure and migraines. Pt observed for approximately 25 minutes and discharged home accompanied of her mother in stable condition. Pt reported improvement in symptoms

0No event

Flu like symptoms: body ache chills hot throat pain rash from wrist up to injection site

0No event

joint pain so bad I could't move - 24 hours after injection - facial swelling and inside of mouth swelling - m2 days after injection - extreme headache almost immediately after injection

0No event

her arm is still painful and unbearable; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Formulation: Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration in Right arm on 13Oct2021, as a Dose 3 (booster), Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received Dose 1 And Dose 2 of COVID-19 Vaccine (unknown manufacturer) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On an unspecified date in Oct2021, the patient arm was still painful and unbearable, and the patient queried if she could put ice or heat on the arm and was preparing to take ibuprofen. The patient also queried if she could be recommended for her painful arm with any treatment. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

0No event

Intense headache, starting at the back of my neck, chills, nausea, diarrhea, pain & swelling at injection site, and my whole body ached. Bedridden from Friday night until today, Sunday. Feeling better now, but weak

0No event

Fatigue; Chills; Headache; Arm Soreness; Dizzy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 11:45 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "Sinus" (unspecified if ongoing), notes: Other medications in two weeks: Sinus-Allergy; "Allergy" (unspecified if ongoing), notes: Other medications in two weeks: Sinus-Allergy. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, product=COVID 19, brand=Pfizer,, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=Mar/2021, dose number=1, administration time=11:45 AM, dose number=1, vaccine location=Left arm), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunisation, reaction(s): "Chills", "Fatigue", "Headache", "Arm Soreness". The following information was reported: FATIGUE (non-serious), outcome "recovered" (2021), described as "Fatigue"; CHILLS (non-serious), outcome "recovered" (2021), described as "Chills"; HEADACHE (non-serious), outcome "recovered" (2021), described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "Arm Soreness"; DIZZINESS (non-serious), outcome "recovered" (2021), described as "Dizzy". Therapeutic measures were not taken as a result of fatigue, chills, headache, pain in extremity, dizziness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

0No event

Area around site very hard and swollen.

0No event

Information has been received from a physician concerning a "23 year old female" with unknown medical history, who was vaccinated intramuscularly with a first dose of Gardasil (Lot # unknown). Subsequently on an unknown date, the patient experienced nausea and vomiting for two days and was diagnosed with fever (of 101 degrees) after receiving the first dose. Outcome reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. 02/17/2010 On 10-OCT-2007, the patient experienced nausea and vomiting and a fever of 101 x 2 days. The signs and symptoms went away without any problems. Unspecified medical attention sought. No product quality complaint was involved. Additional information is not expected.

0No event

Breakthrough case admission after 2 vaccines Janssen 5/7/21 lot# 205A21A; Moderna 12/21/21 lot# 032H21A

4HOSPITAL

redness at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received on 28th February 2019, refer case US2019098228). On 28th May 2019, the patient received the 2nd dose of Shingrix. On 28th May 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site swelling was recovering/resolving. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix. Additional details were provided as follows: The patient planned to follow-up with her physician. The reporter consented to follow-up.

0No event

Approximately 30 minutes after receiving his 2nd dose of the Pfizer COVID vaccine he had sudden onset of dizziness, nausea, and feeling flushed. He went to Emergency Department for treatment. He was discharged from the Emergency Department to home. On 1/12/21 he states nausea and dizziness gone. Slight headache. Feels better.

1ER_VISIT

p/vax pt devel pox;pt had multiple lesions on face, trunk & extremities;pt required a visit to MD office;it was also reported that vaccine failed;

1ER_VISIT

Within 30 days my blood pressure rose to 184/90. I was unaware that my blood pressure had risen, as i only had a constant headache and because I donate blood, I have my blood pressure checked every 60 days or so. I sought treatment from my physician and was placed on Losartan.

0No event

Patient complained of extreme arm pain for 3 weeks after shot. Went to doctor who said shot was not given in deltoid muscle. Patient was unable to explain where shot was given. She could not lift her arm for 3 weeks and says it is still not back to normal.

0No event

The day after receiving the Moderna booster injection, she began feeling tingling sensations in her feet and legs and legs sometimes feeling cold sensation. The tingling has persisted for more than 2 weeks, extending up to her thighs and buttocks and she has also felt tingling sensation in her chest wall and left arm. Symptoms are intermittent and bilateral. Symptoms have not resolved. Lab studied pending. She has been referred to neurology for consult

0No event

Facial and lip swelling with increased drooling 3-4 hours after vaccination. Seen in ER, given inhaled and oral steroids. Transferred. No further problems noted but kept overnight for observation. Given oral steroids on 7/29/06 and released. Diagnosis anaphylaxis to MMR/Varicella. 08/23/066-records received from hospital for DOS 7/28-7/29/06 DC DX: Allergic reaction to MMR and varicella Down's syndrome Symptoms: allergic reaction likely to vaccines that were administered day of admission. Lips swelling, horse voice and drooling. Treated in ER with prednisone, Benadryl and epi/decadron nebulizer. Stridor and wheezing reduced. Hospital course: continued on room air pulse Ox 96-100%, no respiratory distress and vitals stable. Admitted for observation and discharged. No labs or diagnostic testing performed.

2ER_VISIT, HOSPITAL

COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: 6n6205), in left arm and on 24Mar2021 as dose 2, single (Lot number: 6p7534) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 18Nov2021 as dose 3 (booster), single (Lot number: 031h21a), in left arm and on 29Jun2022 at 14:30 as dose 4 (booster), single (Lot number: 060a22a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Addisons disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: The patient had no known allergies. The patient took Hydrocortisone, Prednisone, omeprisol and Florinef in 2weeks (lot number for all products: Unknown). The patient took COVID 19 Treatment with Paxlovid (Treatment start date: 21Jul2022, Treatment start date: 26Jul2022, Lot number: unknown, Indication: Treatment of COVID-19).

0No event

Flat red patches over body lasting 3-4 days.

0No event

Patient received full COVID vaccine series on 3/9/2021 and 3/30/2021. Patient became symptomatic with COVID symptoms on 7/13/2021. Symptoms include mild productive cough, fatigue, muscle aches, decreased smell. patient was tested for COVID-19 on 7/20/2021 via RT-PCR which returned positive. Patient was offered monoclonal antibody therapy and declined. Patient was seen in Emergency SErvices on 7/23/2021 for increased nausea, vomiting and diarrhea and increasing lethargy. She received IV fluids and Zofran. Oxygen saturations in mid-90s on room air. Patient discharged home. Patient returned to emergency services on 7/24/2021 and found to be significantly hypoxic requiring supplemental oxygen via nasal cannula at 2 Liters. Patient was subsequently admitted to the hospital for additional treatment. Chest x-ray with bilateral patchy infiltrates, being trearted with dexamethason/remdesivir. Patient remains admitted to the hospital at the time of this report.

4HOSPITAL

Pt reports feeling shaky after receiving this injection of vaccine. EMT stayed with patient and spoke with her, offered her a cookie and some juice and patient reported feeling better, no concerns. Was sent home with her friend, who drove her to the clinic.

0No event

A 12-year-old patient came in with parent for booster dose. He was given the Pfizer pediatric formulation 0.2mL (10mcg/0.2ml). The error was noted while doing data entry. A health department nurse was consulted. She advised the patient be given 0.2mL of the Pfizer 12+ formulation (30 mcg/0.3mL) to get a full dose totaling 30mcg. Nurse and pharmacist apologized to the patient and parent. The second injection (0.2mL of the Pfizer 12+ formulation) given the same day. Patient monitored for another 15 minutes after the 2nd injection and did not have any reactions during the observation period.

0No event

Mononucleosis and Strep

1ER_VISIT

healthy pt made funny face, face turned red, appeared to be holding breath; mom determined not breathing, gave couple puffs, dialed 911; pulmonary artery & aorta w/fibromuscular thickening & stenosis; cardiomegaly; pulmonary congest & hem

3DIED