chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; chills; the area around the injection site is red and swollen; the area around the injection site is red and swollen; feverish; This is a spontaneous report received from a contactable consumer via medical information team. A female patient (Age: 66 unit: unspecified) received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration, on 31Jan2021 (Sunday), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unknown date, patient had reported being tired (on Monday) and having chills, Feverish, not today but that was for both two days, Monday and Tuesday. Patient had reported the area around the injection site is red, hot to the touch and swollen and wants to know how long this will last. Patient stated, "was it normal reaction to the injection to the vaccine, to the Pfizer COVID vaccine. "And they could tell her if it is okay, she thought it was but she just want to double check on that." Outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.
Patient was administered vaccine. Stood up to go sit in monitoring section. Sat down and immediately stated he didn't feel good. Patient stated he was dizzy and felt out of it. He started sweating. Patient denied closing of throat or any anaphylactic reaction. Patient later stated he blanked out and did not know where he was. EMT was called however patient did not go with as he felt  his symptoms relieved.
This patient is non-immune to rubella by titer. Ten days after a dose of MMR reports wide, red band across the top of her feet and both wrists, swollen fingers, joint stiffness. The patient did not present for treatment. She was seen 3 weeks later, still reports joint aches. The patient denies history of fever, rash or any other symptoms.
pt. recvd. vax & developed T-105 which resolved 2 days later,then recurred w/ rash consistent w/ MMR reaction & bilateral otitis media & sore throat.
Allergic response to Pfizer Covid Vaccine #1, resulting in immediate numbness and tingling in face and mouth, dry cough and tightness in throat. Hives present after 6 hours. Symptoms were controllable with benadryl for the first 6 hours, but became uncontrollable 6 hours after the vaccine. Patient went to Emergency Room to control symptoms.
Saturday AM around 5AM lt hand was swollen had a red hot burning sensation;couldn't get had closed together;it did let up a little pt soaked it;hand cont to hurt but did nl chores;ecchymosis @ inj site;
vaccinated with expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 22nd June 2022, the patient received Havrix. On 22nd June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments: The reporter stated that a patient was vaccinated with an expired dose of Havrix. The reporter gave consent to follow up. Additional Supportive Information: The patient received dose of Havrix which was already expired in 24th May 2022 which lead to Expired vaccine used.
Mother called stating patient C/O Shortness of breath, dizziness, nausea, fever, arm tenderness.
HEADACHE; LEFT ARM WAS WEAK AND LEGS WERE WEAK FOR A FEW MINUTES; EARS FELT CLOGGED; FELT A NOISE IN MY EARS; SHORTNESS OF BREATH; COULD NOT BREATHE THROUGH MY NOSE SO BREATHING THROUGH MY MOUTH; CHEST PAIN; NASAL CONGESTION; TOP OF MOUTH DRY AND RASPY; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 132 pounds, and height was 65 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced top of mouth dry and raspy. On 23-MAY-2021, the subject experienced nasal congestion. On 24-MAY-2021, the subject experienced chest pain. On 26-MAY-2021, the subject experienced shortness of breath. On 26-MAY-2021, the subject experienced felt a noise in my ears. On 27-MAY-2021, the subject experienced ears felt clogged. On 28-MAY-2021, the subject experienced left arm was weak and legs were weak for a few minutes. On an unspecified date, the subject experienced could not breathe through my nose so breathing through my mouth, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm was weak and legs were weak for a few minutes, was recovering from nasal congestion, top of mouth dry and raspy, and could not breathe through my nose so breathing through my mouth, had not recovered from chest pain, and headache, and the outcome of ears felt clogged, felt a noise in my ears and shortness of breath was not reported. This report was non-serious.
The patient came into the pharmacy for a routine Flu shot but suffered a sudden spike in her BP several minutes after. After careful observation and continued increases in her BP, we contacted the MD who recommended we call an ambulance for her. Other than the elevated BP and visible anxiety, the patient did not complain of other side effects.
Information has been received from a physician concerning a 37 month old male pt who was vaccinated with varicella virus vaccine live and he now has a full blown case of chickenpox. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
popular erythematous rash in patches, scattered from right shoulder down the right arm, with mild itching. no edema. no vesicles. no pain. no treatment required. suspicious for early shingles vs "covid arm." started on day 3 after vaccine, and worsened over next several days.
Then I got severe cardiac arrhythmias first time ever in my life. 20x PVC per minute. I still have it; after second dose really sick about 4 days.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Jan2021, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included hypothyroid. Concomitant medications were not reported. Past drug included morphine (known allergy: morphine). The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that after second dose she really sick about 4 days. Then she got severe cardiac arrhythmias first time ever in my life. 20x PVC per minute. She still had it on an unspecified date in Jan2021. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Patient reports that he began to feel ill immediately following his vaccination. He had a temperature recorded by his mother at 5pm and his temperature was 102.9. He was brought into the walk-in clinic for possible adverse reaction. A rapid strep test was positive in the clinic and the patient was treated for strep. It is possible that the vaccination coincided with bacterial infection. I feel his reaction was due to illness from strep bacteria and not caused from vaccine.  Mother comforted that the VAERS was filed.
2/24/21 about midnight I was not feeling well. I was having stomach pain. At 3:00am (2?25/21) i woke hot and stomach pain was worse. About 4:00am diarrhea started.  I never went back to sleep that day.  At 6:00am after a shower I notice a bump by my left clavicle.  I notice it was movement about the size of a nickel.  I called Dr. office, they agreed to see me in the afternoon.  At 3:30pm I saw Dr. said that it's lymph and I should keep an eye on it.  He recommends an ultra sound if not better in two weeks. Left shoulder is painful and it is a little hard to type, but not a big deal. 2/25/21 about 9:00pm I went to the bathroom I had a bright red bowels.   2?26/21 I am waiting for Dr. (she has been my stomach doctor for many years) to speak with her about the bloody bowel.  I will also call Dr. a message to keep her up
Head fullness (brain swelling?), plugged ears, temporary spatial hearing loss, persistent tinnitus
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose, frequency and indication unspecified). On an unknown date the patient inadvertently received ZOSTAVAX instead of VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Had a mild case of covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had a mild case of covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had a mild case of covid-19). At the time of the report, COVID-19 (Had a mild case of covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Had a mild case of Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information were reported.  Company comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious, AESI event of mild Covid-19. The event mild Covid-19 occurred after the unknown dose number of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event was unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-419667 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious, AESI event of mild Covid-19. The event mild Covid-19 occurred after the unknown dose number of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event was unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
03/2022 After 3rd dose notices illregularities in vision that came after extreme excersize. Halos and stars.   10/2022  Woke up with double vision this came and went over the course of the week. Optomitrist and Optomologist diagnosed dry eyes. Continued for months off and on.  02/2023 Diagnosed by neroligist MG Myasthenia Gravis. Ordered tests. Blood test positive ACHR+ result. Xray and CAT SCAN turned up negitive results for Thymoma or brain tumor. Prescribed Pyrostigmine in the office. 30 minutes immediate results to correct double vision.
Headache, Myalgia, NauseaVomiting, TIRED,FATIGUE,SOB Narrative:
Pt recvd vax 7MAR94 & pt was adm to hosp w/acute abdomen; 26APR94 dx w/nephrotic synd; addtl details are being requested;
Patient received covid vaccine at 1542. While sitting in observation, patient complained of a "heaviness" in her chest and used her rescue inhaler, 2 puffs at 1612. I offered to call EMS for her: however she refused, stated "I don't want to go to the Emergency Room". She also reacted to her first two doses of the Covid vaccine. 1615 patient took 50 mg of Benadryl that she brought with her to the clinic. 1616 patient was having difficulty breathing and heaviness was worse. Patient agreed for EMS to be called. 1617 EMS called and patient self administered her epi pen. 1618 Patient breathing easier and stated, "the heaviness is getting better". 1621 EMS arrived and took over care and monitoring of patient to transport to Emergency Department. Patients parents were with her at the clinic and were going to meet her at the Emergency Room.   Emergency Visit: Dr."This is a 46-year-old chief complaint allergic reaction.  46-year-old who apparently got her first Covid shot a while ago had some itching afterwards got her second 1 and had quite a bit itching took some Benadryl decided to get a booster shot now and when she did it today she said she started getting short of breath and feel like she her tongue was swelling so she gave herself an epi shot took some Benadryl and came in she denies any other complaints" Dr., "Please note patient is feeling much better I do think some of this was anxiety I explained to her to use her EpiPen she has an extra 1 I will send her home with some prednisone tell her to take Benadryl to I did not get any vaccinations with a Covid type in the future as this could cause a severe anaphylactic reaction" Prescription for Prednisone 80 mg po daily x5 days.  Medications received in the ED: ATIVAN, PEPCID, Solumedrol, Benadryl injection.
Arm in which I received the shot had a breakout of hives/welts (approx 8-10 sq inches) and was hot to the touch near the injection site for at least a week (started two weeks after the shot).  Eventually subsided and went away.
I received my first dose 8/30/2021. My next menstrual cycle started 9/15/2021 and has lasted 3 days longer since. I have an appt on 1/25/2022 and will speak to my doctor about this.
This spontaneous report has been received from a nurse referring to a patient of unknown age and unknown gender. Information of concurrent condition, pertinent medical history and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 04-JAN-2019, the patient was administered 1 dose of improperly stored VARIVAX (three lot numbers and expiration date (lot# R019235 with expiration date 04-JUL-2020, lot # R018932 with expiration date 02-JUL-2020 and lot # R013565 with expiration date 13-MAY-2020) were provided, but which lot was administered to the patient was unknown; strength, dose detail and route were not reported) for prophylaxis. Three lots of VARIVAX were exposed to temperature excursion of 6 Fahrenheit degree to 14 Fahrenheit degree for 3 hours, 15 Fahrenheit degree to 46 Fahrenheit degree for 5 hours and 30 minutes and 47 Fahrenheit degree to 77 Fahrenheit degree (also reported as 49.6 Fahrenheit degree) for 30 minutes. No previous temperature excursion. No adverse effects was reported. Data logger was not involved. This is one of the four reports from a same reporter. Sender's Comments: US-009507513-1902USA004204: US-009507513-1902USA004203: US-009507513-1902USA004205.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    This case was linked to MOD-2021-036812, MOD-2021-036813, MOD-2021-036769 (E2B Linked Report).; Sender's Comments:  MOD-2021-036813:same reporter, reporter's husband MOD-2021-036769:same reporter, reporter's husband's daughter MOD-2021-036812:same reporter, invalid case
Headache, Myalgia, Arthralgia, Fever, CHILLS, FATIGUE, STUFFY NOSE Narrative:
Chills, Headache, Myalgia, Arthralgia, Fatigue, Rash on forearms
3 1/2hr p/vax pt devel persistent irritability & dec screaming x 2hr, difficult to console, negative CBC & urine, nl behavior in 6hr;
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 08-MAR-2016, the patients were vaccinated with improperly stored VAQTA (lot # L045713 and expiry date 14-JAN-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 47.8F for 1 hour and 10 minutes. Previous temperature excursion: No. Data logger: Yes. Outcome: Supported. This is one of the several reports received from the same reporter. Additional information has been requested.
Arthralgia/arthritis; inflamation of joints; pain in joints, esp knees early AM & evening, also ankles, shoulder & back. 26OCT90 pt better but still has problem w/knealing; 28DEC90 All sx subsided by latter NOV90.
Approximately 6 weeks after 2nd dose of vaccine, right eye began constantly twitching.  Two weeks after twitching started, patient noticed nystagmus in both eyes.  Right pupil changes sizes when the left pupil does not.  Went to rheumatologist who said condition is rare with lupus so patient was referred to eye doctor.  Patient underwent full eye exam and was told that problem appeared to be neurologic.  Eye doctor referred patient to neuro ophthalmologist whom patient  has not yet seen.  Primary care physician also felt issue was neurological.  Concern for myasthenia gravis.
felt numbness everywhere/ I was numb for 6-8 months; serum sickness; allergic to something in the medication; don't feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, felt heat and it radiated down my arm and in my chest), administration date: Mar2021, for Covid-19 immunization, reaction(s): "felt heat". The following information was reported: HYPERSENSITIVITY (hospitalization) with onset 2021, outcome "unknown", described as "allergic to something in the medication"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "don't feel good"; HYPOAESTHESIA (hospitalization) with onset 2021, outcome "recovered", described as "felt numbness everywhere/ I was numb for 6-8 months"; SERUM SICKNESS (hospitalization) with onset 2021, outcome "unknown". The patient was hospitalized for hypoaesthesia, serum sickness, hypersensitivity (start date: 2021). The events "felt numbness everywhere/ i was numb for 6-8 months", "serum sickness" and "allergic to something in the medication" required physician office visit. Additional information: Patient stated that with the 2nd vaccine, around 3 weeks after first one (between Mar2021 to Apr2021), patient felt numbness everywhere for a few days it came and went. she ended up going to hospital on the 7th day. They said she was allergic to something in the medication. She went to several Doctors and her Rheumatologist said she had serum sickness, and it would take 6 months or longer to leave her system. She was numb for 6-8 months. She was going to so many doctors trying to figure out what to do. She felt like she was dying. She made a report about the reaction to the vaccine but Pfizer aren't making it easy because you already don't feel good yet are trying to navigate the forms and the email and the websites, She didn't follow up. She had been fine.   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-202201065248 same patient/drug, different doses and events;US-PFIZER INC-202201065250 same patient/drug, different doses and events;
5 1/2 x 4 1/2 cm reddened, warm to upper left arm. No treatment with RX.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 19-OCT-2012 09:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
O? 5/12/2021 there was some slight pain and itchiness.  The next day the area was a little red, itchy and swollen until Friday night 5/14/2021.  Saturday 5/15 until 5/17 the itchiness, swelling, and pain went away.  On Tuesday 5/18, I noticed the injection site becoming red again. On Thursday 5/20/21, the area around the injection site was swollen, again, red again, and itching.  It looked like a rash or a red splotch.  On Friday, the splotch got bigger and redder and had the same itching.  Today, 5/22/21, it looks the same and I will be seeking medical treatment tomorrow.
After 24 hours experienced fever of 102 and chills. Lasted less than 12 hours.  5 days after vaccine a red lesion appeared near the injection site.  It is itchy and a little sore
My temperature has gone up to 103 - 101 and my normal temp is about 97, extreme body aches where I van barely get out of bed.
Staff called from hospital and stated the patient came in complaining of headache since yesterday. She stated the patient said the only different was getting the PNEUMOVAX 23 immunization.
Lightheaded and dizzy 15 minutes after vaccination.  Assisted to cot legs elevated.  HR and BP within normal limits.  Stayed at the site for 30 minutes after dizziness started and was then able to leave the site with his mother to home without further dizziness.
(R) lateral thigh with 2 cm x 3 cm erythema and warm area.
Patient felt lightheaded and dizzy. Patient felt like he was going to faint. Patient stated that he had not eaten anything yet for the day. Patient felt fine after about 15 minutes.
This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccination in a 6-month-old male patient who received KINRIX (batch number DR294, expiry date September 2016). On 2nd October 2014, the patient received KINRIX .5 ml. On an unknown date, the dose was an unknown dose. On 2nd October 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the appropriate age at vaccination to be related to KINRIX. Additional information: KINRIX was given to a 6 month old baby. Meanwhile KINRIX is recommended for children between 4 to 6 years. No adverse event reported. No additional information was available. The case was closed.
Patient received a third Shingrix vaccine due to mix-up. Patient completed the series previously (11/13/2018 & 05/02/2019)
Felt like had the flu- gradually got worse and was admitted to hospital 10/10/2010