chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (dose administered after manufacturer date of expiry) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine/lot# batch/lot# 048L21A) for COVID-19 immunization. No medical history reported. On Jul 11, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 11, 2022, patient administered expired product (dose administered after manufacturer date of expiry). At the time of the report, administered expired product (dose administered after manufacturer date of expiry) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient administered the second booster dose. Vial thawed for the first time on Jul 11, 2022. The number of doses per vial: 3. On Jul 11, 2022, vial initially stored in the refrigerator. Vial did not undergo any temperature excursions. This case linked to MOD-2022-608564 (patient link).
Patient reported an allergic reaction to the vaccine with arm and elbow swelling as well as swelling at the injection site. Swelling has not resolved until now. She sought medical attention from PCP who advised that this was a vaccine related adverse event and instructed not to get the high-dose vaccine in the future.
Headache, Myalgia, pain, swelling & swollen lymph nodes to injection site
Pt was given 2nd dose, monitored x 15 min with no complaint of symptoms of rxn. Left clinic, and shortly after began having left-sided chest pain requiring ED visit approximately 5 hours after dose. Per ED notes, pt has hx HTN. Initial BP in ED 142/97. Dx is ED was CP r/o ACS. Pt was advised by ED MD to be admitted, however pt refused admission with a plan to f/u with her own cardiologist.  Pt ultimately left AMA from the ED.
itching got worse; rashes; maculae; papulae; possible allergy to the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration on 19Jan2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine includes the first dose of BNT162B2 on 29Dec2020 for covid-19 immunisation and experienced mild itching on an unspecified date. After initial dose, on an unspecified date the patient had some mild itching a week after. The patient suspect it was from the vaccine. The patient nevertheless completed the second dose and a week after that on an unspecified date the itching got worse with rashes then maculae and papulae. The patient went to see an allergist and he ruled possible allergy to the vaccine. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
blood - high cholesterol, numbness and tingling: in arms, depression - deep problems, energy: loss, pain (muscle and joints), pain (lower back), blood pressure: varies, fibromyalgia, etc  5/27/08 Reviewed VA medical records of 10/2004-05/2008. Records reveal patient experienced: hyperlipidemia, right arm & neck pain w/radiculopathy, low back pain (since 2003)w/radiculopathy, left shoulder dislocation while on active duty overseas 11/2003-7/2004. insomnia, obesity, recurrent tonsillitis & URI, GERD, depression, DJD, bilateral CTS, DDD, adjustment disorder w/mixed anxiety & depressed mood, hand fracture from fall, recurrent left shoulder subluxation, capsulloraphy w/adhesive capsulitis of left shoulder, HTN, HA, eye floaters, bilateral sacroilitis w/steroid injections, sciatica, trochanteric bursitis, right dequervain tenosynovitis, right epicondylitis.  1/11/2010 Arthritis, major depression, high blood pressure, high blood cholesterol, energy low levels, Myalagia mood; anxious, irritable, libido: loss, flu-like symptoms, sleep problems, weight gain, neck, rigid pain, legs, lower back, muscles and joint, back, right thumb radiating up through forearm, tens needed for pain, numbness and tingling fingers, leg, memory: trouble remembering recent information.
experienced a couple of allergic reactions after receiving both the first; difficulty swallowing water; difficulty breathing; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 58-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "experienced a couple of allergic reactions after receiving both the first"; DYSPHAGIA (non-serious), outcome "unknown", described as "difficulty swallowing water"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing".  Additional information: Caller stated that one patient (female, 58 years of age) experienced a couple of allergic reactions after receiving both the first and the second dose of the Pfizer-BioNTech COVID-19 Vaccine. Caller stated that these 58 years-old patients is supposed to receive Ruxience, but they are concerned that she experiences another allergic reaction like the one she had against Comirnaty. Caller would like if there were ingredients in common between these two products. Caller would like to know if there's information on what ingredients are the patients allergic to, in regard to the Pfizer COVID-19 vaccine.  The first time the patient had difficulty swallowing water and with the 2nd dose even after taking Benadryl she had difficulty breathing. Benadryl: not suspect on product. Caller stated even after taking Benadryl she had difficulty breathing.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200966459 Same patient/product, different dose/event (dose 2);
Patient fainted about 1 min after receiving his first dose. Pt was sitting in the chair next to parents and fainted and fell to the floor. Parents picked him up and placed him back in the chair. Pharmacist did not witness the fall, just heard the noise of pt hitting the ground. Pt looked pale and felt warm before Pedialyte was administered. Pharmacist gave pt Pedialyte and discussed options with mom. Mother stated she did not want anyone else called and since the pt started talking and gaining color after a few sips of Pedialyte, mother stated she just wants him observed. Pt was observed for 30 min and was able to walk and exit the pharmacy with parents without assistance.  Family left after about 45 min of observation.
PFIZER COVID VACCINE #3 GIVEN 9/23/21, LOT #30145BA; limited medical records received on pt; 2/22/22 pt to ED via EMS after hitting head during a fall; pt became unresponsive en route to hospital; intubated in ED; CT head showed right basal ganglia hemorrhage and right occipital hematoma; hypertensive bleed; CT chest showed bilateral pneumonia; positive COVID test; pt transferred to ICU; 5 days later pt passed away in the hospital
It has been 9 days post first dose and I have developed red marking at the injection site. It is warm to the touch and sore when touched.  Itchy as well.
p/recv vax pt the next day devel mild diarrhea; no further info available
Increased sleepyness for several hours after receiving vaccine. Then had brief seizure-like event -whole body shaking and face turning blue that lasted estimated less than 1 minute. Of note, patient also received Rotavirus vaccine and PREVNAR at the same time
swelling beginning next day-size of golf ball @ site of TD;painful in under arm area as well lasting 2 days;began 4MAY&5MAY;used ice pack;swelling gradually dec still sore on 7MAY96
I had sharp pain left side, I wasn't feeling good for 2 days. I did a virtual with doctor, she said it could be a heart attack, asked me to go the ER around Mar 4 or 5th 2021. Went to ER, asked to go to heart specialist. Stayed overnight. Did a treadmill test. Nausea and shoulder pain.
Rash on bilateral sides of neck with associated burning sensation and pain. Rash does not extend to front of neck over throat. Started to feel burning sensation three hours after injection. Erythema did not appear until Saturday, 10/16/2021. Today is Wednesday 10/20/2021 and burning, erythemic, painful skin is still present.
Pt. called and stated that evening of 11/19/08 she started having hoarseness and when she woke up on 11/20/08, she was hoarse and had a knot in her armpit. She also told me that her arm had been sore and Advil helped with soreness. Advised her to call family Doctor and to please call us back with what he told her.
Hospitalized for COVID 11/2/21 from positive test 10/26/2021.
Pt got vx, had breakthrough infection of shingles/Suspected vaccination failure; Breakthrough Infection of Shingles; Nerve damage; Surgery; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage and surgery. On an unknown date, the outcome of the vaccination failure, shingles, nerve damage and surgery were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The reporter considered the nerve damage and surgery to be unrelated to Shingrix.  Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: The case was reported by the patient. The patient had a breakthrough infection of shingles that was precipitated by surgery and nerve damage. The patient had surgery and nerve damage not due to shingles. The reporter consented to follow up. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Notified by Home Health Nurse 1/15/18 that patient had stuffy nose, low grade fever and slight cough post vaccine. Lungs clear.
This spontaneous report as received from a Grandparent consumer refers to his grandchild of unknown age. On an unspecified date, the patient was vaccinated with dose 3 GARDASIL, inj (dose, frequency, therapy route, product lot number were not provided). No other co-suspects were reported. No concomitant medications were reported. The vaccine was administered outside the prescribing information. The patient received the series every two months for the 3 doses. No adverse effect reported. The outcome of the patient received the third dose two months after the second one and no adverse effect reported was unknown. Additional information is not expected.
Swelling of armpit of injected arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Oct2021 12:00 (Lot number: FI-2593) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Batch/Lot No: en6202), administration date: 05Mar2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (dose 2, single, Batch/Lot No: ep7534), administration date: 26Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 25Oct2021, outcome "not recovered", described as "Swelling of armpit of injected arm". Therapeutic measures were not taken as a result of swelling.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected.
This case was reported by a physician via call center representative and described the occurrence of tiredness in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a year after receiving BEXSERO, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the tiredness to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional only provided limited information. No product or patient information provided. The healthcare professional stated BEXSERO was administered to the patient a few months back from the date of reporting and complained of feeling tired or exhausted for one week.
Swelling, redness, pain lt upper arm @ site of inject recvd 10JUN92;
Pts right arm, site of infection started aching the day following injection then on 8/2/04 left leg began to cramp and ache (thigh being the worst). General body aches also up to date 8/5/04. Right arm was better completely on 8/2/04.
1st dose pfizer vaccine was given to patient on 07/07/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window. We reached out to pt on 07/10/21 to get the 1st dose again. Patient will return to the pharmacy to repeat dose on 07/12/21.
Swelling to left hand dysphagia on Sunday 10/11/2009  11/17/09 Medica lrecords received for DOS 10/08-10/13  Final DX: Cellulitis of hand, except fingers and thumb. Weakness-generalized. Pressure Sore.   Left hand pain and swelling, increasing weakness.  Swelling. H/O CP. Xray neg. Pressure sores near gluteal cleft and hip.   ICD9 Codes: 682.9
Wrong dose given, pediatric dose for 5-11year olds given instead of adult dose 12years or older, after pre-screening done. Doctor on call was consulted and met with the mother and child, explained child was under dosed, but advised to come back in 3 weeks for second dosage with adult dose. Mother understood information and will comply by doctors orders.
Patient felt flushing across chest, sat down and symptoms resolved, patient then reported feeling sweaty and wanting to lie down. Patient was assisted onto the floor by staff. No Loss of consciousness. Patient transferred to ED for evaluation. Patient received IV fluids and 0.25 mg alprazolam.  Patient was discharged home from ED.
Experienced an injection site reaction that included redness about 3 inches both above and below the injection site; Experienced an injection site reaction that included swelling about 3 inches both above and below the injection site; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech covid-19 vaccine, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Jan2021 (at the age of 75-year-old), as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter called on behalf of her mom, who received the first dose of Pfizer-BioNTech COVID-19 vaccine last Monday, 25Jan2021. On an unknown date in 2021, the patient developed an injection site reaction that included redness and swelling about 3 inches both above and below the injection site. No other symptoms noted. It was asking whether the patient would receive the second dose or not. The outcome of both events was unknown.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Blister with water beneath surface in area where bandaid adhesive touched skin near immunization site accompanied by itching. Mom is taking to MD today.
mom stated pt had sz @ 530PM on 14AUG97;states had another sz;pt has f/u @ clinic;
CARDIOVASCULAR PROBLEMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced cardiovascular problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiovascular problems was not reported. This report was non-serious.
Fever (highest at time of report 100.8),  muscle pain, joint pain, nausea, chills
Fever between 100 and 102.3 degress F lasting for 2 days.
Extreme itching at site within 15 mins.  Fatigue within and headache with 1 hour.  2.5 hrs muscle spasms in chest while laying down and fever of 100.1.  3.5 hours skin hot, swollen and hard from elbow to shoulder.  4.5 hrs baseball size lump in same area. DAY 2 after vaccine headache entire day, redness hot to touch looks like sunburn in upper arm and very swollen still. Entire arm and hand and armpit and neck area very sore barely can function with affected arm low grade fever 100.3  DAY 3 redness like a sunburn hot to touch swollen now moved to elbow joint cannot barely bend elbow hand affected and hurt a great deal. temp is 99.9
No adverse effects reported; One dose of VAQTA was accidentally administered to the patient in place of Recombivax; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 08-NOV-2018, the nurse reported that one dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot # R013859 has been verified to be a valid lot number for hepatitis a vaccine, inactivated, expiration date reported and establish as 14-JUN-2019) (strength, dose, frequency and route of administration were not reported); was accidentally administered to patient in place of hepatitis b virus vaccine rhbsag (yeast) (RECOMBIVAX) (wrong product administered).         No adverse effects reported.
Nightmares; Rash in the upper left arm, then back and left ear, described it as veryitchy; inflammation of her left arm and and its lymph nodes; Tiredness; General malaise; Lack of sleep; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Lack of sleep), ASTHENIA (Weakness), NIGHTMARE (Nightmares), MALAISE (General malaise) and RASH PRURITIC (Rash in the upper left arm, then back and left ear, described it as veryitchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A or 051A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced INSOMNIA (Lack of sleep), ASTHENIA (Weakness), MALAISE (General malaise), LYMPHADENOPATHY (inflammation of her left arm and and its lymph nodes) and FATIGUE (Tiredness). On 27-Mar-2021, the patient experienced RASH PRURITIC (Rash in the upper left arm, then back and left ear, described it as veryitchy). On an unknown date, the patient experienced NIGHTMARE (Nightmares). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy rash, at an unspecified dose and frequency. On 30-Mar-2021, RASH PRURITIC (Rash in the upper left arm, then back and left ear, described it as veryitchy) had resolved. At the time of the report, INSOMNIA (Lack of sleep), ASTHENIA (Weakness), NIGHTMARE (Nightmares), MALAISE (General malaise), LYMPHADENOPATHY (inflammation of her left arm and and its lymph nodes) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non significant follow up received on 13 MAY 2021, Reporter information updated
Headache, Myalgia, Arthralgia, INJECTION SITE PAIN, WEAKNESS, HEADACHE, CHILLS, FATIGUE Narrative:
Redness, pain, swelling at the site (R) deltoid area, warm, tender, also rash all over body x 2 days, flesh colored bumps, worse on face and arms, similar to what patient had with food allergies.
The night of, I experienced the pretty standard symptoms I had a fever of 103 I had muscle aches, nausea, soreness, headache, throwing up, dizzy extreme fatigue. The next morning I started rotating Tylenol and ibuprofen, the fever broke around the 48-hour mark. However the nausea headache dizziness stuck around for 5 more days. Under the care of my doctor you know he encouraged me to report it to vares. Since I had prolonged side effects last 72 hours
When I first got the vaccine, I started to experience a weird feeling in my head. I came home from getting the vaccine and my head bothered me that whole day. I went to bed and woke up the next morning and woke up with pain from head to toe. That went on and progressed and I stayed in bed for 9 days. I wasn't getting better, so I went to the urgent care and there was a doctor there and she told me to go to the ER. She tested me for COVID-19, and it came back positive. She told me to go and went to the ER and after a few hours I was admitted. They took tests and things and reported to each other what was going on. Another doctor said I could take meds and go home, and another doctor said no because my kidneys were crashing. I stayed at the hospital for 8 days. I was invited to be put on the ventilator because my oxygen and breathing was really bad, but I declined. Then I went home and had to recuperate until I felt okay. Still have an ongoing cough to this day.  Another thing to note here, the day after I received my Johnson & Johnson vaccine was when it was recalled for safety issues. It was noted that there were some bad batches during this time. (Privacy), doctor was the healthcare professional at the urgent care I went to at urgent care.
Pt developed fullness about injection site on right anterior, lateral thigh with minimal redness (? secondary to Prevnar or HIB) per MD's note.
PAIN IN MY HIPS, LEGS, ARMS, NECK,  SHOULDERS, SO IT BECAME ALL OVER MY BODY; FATIGUE; This spontaneous report received from a patient concerned a 66 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included nerve pain.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. Concomitant medications included melatonin for sleeping problem. On 07-APR-2021, the subject experienced pain in my hips, legs, arms, neck, shoulders, so it became all over my body. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and pain in my hips, legs, arms, neck, shoulders, so it became all over my body. This report was non-serious.
right pulmonary embolus heparin drip pain below right rib cage in hospital 23 hours feel better mow