chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fainted within 30 seconds/Passed out completely after shot; Passed out completely after shot; Some intermittent light headedness and dizziness; Some intermittent light headedness and dizziness; Irritating; scary/ fearful; scary/ fearful; This is a spontaneous report from a contactable consumer (patient's mother).   An 18-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0169) at single dose, on 22Apr2021 at 17:30, for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were unknown. Patient's mother reported that her son fainted within 30 seconds of receiving the Pfizer vaccine 1st dose and since then he had experienced some intermittent light headedness and dizziness. He passed out completely after shot. Adverse events were described as following: "patient is due to get his second dose of the shot later this evening but is having periods of lightheadedness and dizziness. Patient's mother states that her son also feels like he is going to pass out. She states that this started 30 seconds after the first shot. Her son only passed out once, completely right after the shot, it was a bad experience. She's glad he actually wants the other one today, but he is concerned because he is still lightheaded and dizzy after 3 weeks. Patient's mother states that he has been trying to function, work, and live his life but its irritating to him and scary. The doctor suggested that he should get his second dose but her son is a little fearful". Physician Office Visit required. The patient did not recover from intermittent light headedness and dizziness, while clinical outcome of the other events was unknown.; Sender's Comments: Based on known drug safety profile and strong temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I had a large red circle around the area where the shot was given in my left arm and it was hard and swollen.  It appeared to be in the muscle.  The swelling hardness and redness started to decrease the evening of 1/23/2021.
A nurse reported that a 6 month old male received his 1st dose of Rota Shield, as well as, Hib and DTAP vaccines on 5/21/99. On 5/25/99, the infant developed diarrhea which resolved within 24 hours. Follow-up information received from the physician on 9/16/1999 stated that the infant received Rota Shield and ActHIB (PMC) on 5/21/99 and that the infant remained recovered.
This spontaneous report was received from a health care worker refers to unknown number of patients of unknown demographics. No relevant medical history of the patients were reported. On unknown dates the patients were vaccinated with VAQTA 25/0.5 (units unspecified) (dose, route of administration, lot number and expiry dates were not reported). No concomitant medications were reported. It was reported that unknown number of patients received improperly stored VAQTA on unknown dates. All vaccines were supported with in-house stability data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
First 2 Pfizer shots were fine. No unusual symptoms, just tired.   Booster was Moderna. Woke up in the middle of the night with a fever and feeling like all my bones were on fire. Random excruciating cramps all over my body. Lasted about 8 hours.   This was similar but less severe than a bad (paresis?) reaction I had to the flu shot in 2008.
My right upper arm, under my right arm and the side of my right breast was swollen and in pain for a few days.
pt recv vax & devel inj site rxn characterized by redness, swelling & soreness w/in 24hr of vax lot# 4978165;this is 1 of 4 pt from this facility to devel rxn;
Rash, 48 hours, post vax, small pin-point and pruritic, started on thighs and lower legs, behind knees, traveled to forearms, upper arms then to chest, above navel. Face, feet, hands and back were not involved. No fever. On 9/20/00, saw MD and treated with prednisone. Dx'd as viral. On 9/28/00, it was basically gone.
The site of my shot is still red; The site of my shot / sore.; The site of my shot is still / itchy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as an adult as per the vaccine indication. The patient received the vaccine. The patient experienced site of shot was still red, itchy and sore.
VACCINE ADMINISTERED AFTER THE 6 HOUR MARK AFTER FIRST PUNCTURE IN REFRIGERATED CONDITIONS; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned a 20 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 205A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced vaccine administered after the 6 hour mark after first puncture in refrigerated conditions. On 04-JUN-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine administered after the 6 hour mark after first puncture in refrigerated conditions and incorrect storage of drug was not reported. This report was non-serious.
I slept all day Sunday after the shot. I stayed home from work on Monday not feeling well and then Monday night my throat started hurts. It felt like strep throat and I could barely talk. I went to the hospital to be checked out and they tested me for Covid, the flu and strep throat. All came back negative. I still do not have a much of a voice and me lungs hurt. I have been coughing and spitting stuff up, but no fever. Went to the doctor again on Saturday April 4th and they said my lungs sound good and sent me home with some cough medicine. Still do not have much of a voice.
An eleven year old girl who was being treated with RabAvert for post-exposure therapy, experienced bronchitis, a swollen throat, lesions on her mouth and was hospitalized for pneumonia. A bat had landed on the girl and she had been advised to be treated for possible rabies.  The first dose of RabAvert was given in August 2002, and post-exposure therapy had been completed at the time of the events. Hepatitis B vaccine series was initiated 1 week after the last dose of RabAvert. Approximately 1 + 1/2 months after starting RabAvert, the patient developed bronchitis and was treated with oral medication (name unknown). However, her symptoms did not improve. She was hospitalized for pneumonia. At that time she had a swollen throat and lesions in her mouth. No further information was given. Additional information received on 10/15/02: The patient was hospitalized on 10/9/02. She was seen in her private physician's office for follow up on 10/14/02. A chest x-ray was done on that day, and all her symptoms had resolved. The physician determined that the events were not due to study medication.
Employee tested negative for varicella titer on pre-employment 10/28/04. Responded on 12/7/04 for Varivax series. Given 1st injection 12/7/04 R deltoid. Employee broke out with chicken pox on 12/20/04 on face, chest, back (scalp).
No physical adverse event-- pt previously vaccinated with Janssen Covid-19 vaccine; amidst cancer workup and anticipating need for surgery and chemotherapy.  Requested subsequent vaccination with Pfizer vaccine, agreed with propriety given anticipated immune suppression.  Dose #1 administered 8/5/21; dose #2 planned for 9/16/21 (two weeks s/p surgery and before chemo initiation)
After my son and daughter received this vaccine in November, my daughter and son both began to get a rash on their skin from their neck to their ankles. After a few weeks, my son's rash went away while my daughter's only got worse. We saw a family doctor who originally thought it was eczema. After no resolution, she referred my daughter to a dermatologist who took biopsies and said that most likely she had pityriasis lichenoides but that it could be lymphomatoid papulosis. We travelled to different doctors who treated the skin condition with a trial of methotrexate, UV therapy, and Triamcinolone. The rash resolved in most areas of her skin except a large patch on her right leg and a small patch on her left leg. Additional biopsies were taken in November 2016 and an official diagnosis of Mycosis Fungoides (a Cutaneous T-cell Lymphoma) was given. A follow-up with an oncologist was made in January of 2017 and the cancer was staged at 1A. Increased light therapy was ordered along with Imiquimod 5%. The patches are still present and she has to see a dermatologist every 3 months to monitor the areas.
Patient returned to pharmacy complaining arm felt swollen from shoulder to elbow. He says his arm area felt hard and sore. Physician notified. Dr. says common adverse, follow up Friday with MD if not better.
Patient received injection Influenza and Trumenba and had mere syncope episode in which he bumped his head on the wall the doctor was called into the room and patient was examined he had no bumps, cuts or bruising and the patient left office with no further incidents.
Acute onset of Nausea, dizziness, and fatigue about 40-45 minutes after vaccine given. Patient had similar symptoms to first dose but onset was the next day and symptoms lasted 5 days.
Cold hands, cold feet, throat pain, arm pain, migraine. He got better after taking a Benadryl and went to sleep. In the morning he still had symptoms as slight migraine and slight throat pain.
Patient presented initially to the ED with complaint of body aches, myalgias, 24 hours following second dose of the Moderna COVID-19 vaccination. Initial ED workup was unremarkable, including CBC, CMP, Troponin, CK, Magnesium, CXR and EKG. Her vitals were normal and she was subsequently discharged home with family. She then returned several hours later following a witnessed cardiac arrest. She was resuscitated and admitted to the ICU intubated and on multiple vasopressors in critical condition.
Information has been received from a physician concerning a 12 year old female with no pertinent medical history who on 10-JAN-2001 was vaccinated with the first dose of VARIVAX "standard dose" (Oka/Merck) and on 01-Oct-2007 was vaccinated with a second dose of VARIVAX (Oka/Merck). Subsequently the patient developed chickenpox lesions when she was exposed to chickenpox over a sleep over with her friends. The patient developed 4 lesions on her chest. 1 lesion on her stomach, and 4 lesions on her legs. She has no fever, but the lesions were itching. As of 30-APR-2008, the patient was recovering. The patient was sought medical attention at the physician's office. There was no product quality complaint. Additional information has been requested.
the MenCYW-135 liquid conjugate component were inadvertently mixed together; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number amva975a, expiry date 31-JUL-2024) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: the MenCYW-135 liquid conjugate component were inadvertently mixed together) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the inappropriate preparation of medication and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 06-Jul-2023 and 07-Jul-2023 The health care professional stated that when the Menveo vaccine 2 vials containing the MenCYW-135 liquid conjugate component were inadvertently mixed together (inappropriate reconstitution technique). The reporter examined that the caps and vials and realized that two of the liquid conjugate were in the package without the MenA lyophilized conjugate component (missing components - Injection -0050). The following questions were asked to access the scenario: there was no evidence of tampering upon receipt, the blister tray was correctly sealed, the product was stored (original box or vials removed and stored separately) as original box and the product was purchased directly from GlaxoSmithKline. As per content the suspect product did not need to be sent back to GlaxoSmithKline.   The reporter was advised to throw away the suspect product.   The GlaxoSmithKline will credit the wholesaler account. The adverse event and product quality complaint was shared the same case number. No adverse event information was reported. The reporter consented to follow-up. The Menveo vaccine 2 vials containing the MenCYW-135 liquid conjugate component were inadvertently mixed together, which led to inappropriate preparation of medication.
Patient reported a rash in her body that is been getting worse since the beginning of the year. The rash is now in her whole body. She saw a dermatologist on 1/14/22 that prescribed oral steroids and topical steroid. She was advised by dermatologist to come back in 2 weeks if no improvement. The rash is still present as of 1/15/22
03Nov95 pt recv 1 dose vax. Pt exposed to varicella virus 10Feb98. 21Feb98 pt devel "approx 100 chickenpox lesions all over her body. There was no fever".
Information has been received from a pharmacist referring to 4 newborns (numbered 161, 162, 163 and 164). Background: Since June 2015, there had been 1645 times (30 times each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 03-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable physician, through a Pfizer Sales Representative. A male patient was administered with PREVNAR 13 single dose unknown route on an unknown site at an unknown time on an unknown date. Anatomical location of the administration of the vaccine was unknown. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. An unknown date at an unknown time the patient had sore throat. It was unknown if the patient had any siblings. Relevant lab data was unknown. At the time of report it was unknown if the patient was taking pneumococcal 13-val conj vac. At the time of report the clinical outcome of the above mentioned event was unknown. The patient did provide information to the reporter regarding the reported adverse event with the use of the product. The reporter could confirm the occurrence of the events reported by the patient and was not willing to be contacted again by Pfizer for follow-up information on the reported adverse event. Follow-up attempts completed. No further information expected. Follow-up (04Ot2013): New information reported from a contactable physician includes: reporter informed by patient about the event; reporter confirmed the events reported by the patient; reporter not confirmed further contactability.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM ABOUT TWO INCHES BELOW WHERE NEEDLE INSERTED; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 138 pounds, and height was 68 inches. The patient's concurrent conditions included: multiple sclerosis (MS), rheumatoid arthritis (RA), osteoarthritis (OA), emphysema, non- alcoholic, and ex smoker, and other pre-existing medical conditions included: Patient had no known allergies and did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported,1 total, administered on 16-MAR-2021 (in the morning) to right arm for prophylactic vaccination. Concomitant medications included fingolimod hydrochloride, fluconazole, prazosin, prednisone, and sulfasalazine. The patient was taking more medicine but could not remember the name of rest of the medicines. On 17-MAR-2021, the patient experienced sore arm about two inches below where needle was inserted, it started the day after vaccination and lasted either a day or a day and half. On 25-AUG-2021, the patient had protein spike test done and the result came as "zero" antibodies (confirmed immunological vaccine failure). Patient's primary care physician (PCP) ordered the test, so they were aware of the results. Patient was willing to get a copy of the results from the test if required. Patient stated that, no expiration date was written on the vaccination card. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm about two inches below where needle inserted on 18-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191699 This case, from the same reporter is linked to 20210900277.; Sender's Comments: V0: 20210900383-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Hives by armpit of arm received shot.  Still have hives more than a week later.  Itchy periodically.
Patient denied symptoms during 15-minute required observation period.  When she got up from chair to pick up vaccination card, endorsed near-syncope and bilateral lower extremity weakness like "she felt she was walking in sand."  Denies visual symptoms, oral swelling, dyspnea, pruritis, nausea.  Patient sat back down and was attended to.  She was noticeably nervous (hand/leg shaking).  SpO2 99%, HR 62.  Patient endorses history of anxiety that is treated with beta blocker.  Patient felt back to her baseline after approximately 15 additional minutes of rest and sipping on water.  Trial of ambulation at that time with complete resolution of symptoms.  She was cleared to return to work with return precautions.
Patient noticed legs itching the evening after receiving vaccination, at night she felt a burning/tingling sensation and looked to see swelling and redness on back of calf on both legs. Patient presented to pharmacy on the following day; the rash that developed has a similar appearance of a shingles rash.
Before getting the flu shot, I was asked if I was allergic to Eggs, Gelatin or Latex. I've never been allergic before, so said no, and the shot was given. Shortly after- my face, tongue and lips started to tingle. I returned to employee health and told them what was happening and they said it sounded like I was having a slight reaction to the shot. Suggested either take Benedryl or if gets worse, go to Emergency. Opted for the Benedryl med and left work early because it made me sleepy. Returned to work the next day but went to Urgent Care that afternoon to be checked out. Face tingled for a day or so after the event.
PT began to have redness, itching and swelling at the injection site. The symptoms worsened over the first 48 hours. The symptoms began to lessen on the 3rd day and at that time the site was slightly red with a distinct red dot at injection point and red circle around the area. Itching had subsided as well.
Redness, swelling about 4-6 inches in diameter, and warmth at the injection site.
pt recv vax 4MAR96 & 13MAR96 pt devel a rash, achiness & arthralgia;no further details were provided;
Patient rec'd AFLURIA vac 10/2/13 said was swollen and oozed pus at site in April 2014, as of July still visible (2014) wound.
Day 1-2 Arm pain first 48 hours - subsided after 4 days  Day 1-3 Had feeling of chills (but not severe) - no fever  Day 2 Numbness and tingling on left side of face started 2 days after vaccine  Feeling of nerve sensitivity in arm up through neck and ear Day 5 acute chills - shakes in the night - could not stop shaking. Took acetemophofin  Day 6 today - still feeling shivers. Have taken Advil this morning
Reported to immunization staff by a physician. A mother refused vaccine due to a death the mother heard about.  All the information on this case at this time.  11/27/07 Reviewed autopsy report which states COD as Sepsis, blood culture positive for Klebsiella pneumoniae.