chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning a 20 month old male with no relevant medical history and no known allergies who in May 2002, was vaccinated with a dose of MMR II in the left leg. Concomitant therapy included Augmentin. On 5/31/02, the pt developed the "normal" fever for a few days after injection. By the fourth day, he was itching and developed a rash in the left leg at the injection site which spread over his left leg. The pt was seen by a physician and he received "scaby cream" Acticin. It was reported that the cream made the rash spread all over his body. Additional info has been requested.
Shingles outbreak, C7/8 dermatomes of the right UE/trunk
Pharmacist unknowingly pulled vaccine from package with a past beyond use date. Vaccine was administered to the patient 7 days past beyond use date. No reported adverse effects.
At the time of Injection, the patient had reported that they needed their 2nd dose of the Pfizer vaccine. They did not have their vaccination record with them and were quite adamant that they had received the Pfizer vaccine as their 1st dose.  The Vaccine was given to the patient, and they were instructed to bring in their card to be filled out the next day.  When they brought in their card it was noted that their 1st dose was in fact Moderna not Pfizer.
On Oct. 8 received Flu vaccine. On Oct 12, lost most hearing left ear. Diagnosed by ENT w/Idiopathic Sensorineural Sudden Hearing loss. Treated w cortisone, oral and intratympanic.
pt slept from 3-10PM; mom woke @ 7PM to given APAP; temp checked @ 10PM t102; @ 11PM t105; more APAP given-cool sponge bath-4AM t105 again APAP repeated-cool bath;
This spontaneous report as received from a other health professional refers to a 24 year old female patient. On 18-JUL-2017 the patient was vaccinated with GARDASIL 9 lot # M016193, subcutaneous in the left deltoid for prophylaxis. On JUL-2017 the patient experienced injection site mass. On 18-JUL-2017 the patient experienced incorrect route of drug administration. The outcome of injection site mass was reported as recovered/resolved. The outcome of incorrect route of drug administration is unknown. The reporter considered incorrect route of drug administration to be not related to GARDASIL 9. Additional information has been requested.
had the worst case of shingles ever/suspected vaccination failure; had the worst case of shingles ever; Pain; Scab; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the worst case of shingles ever/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had the worst case of shingles ever), scab (Verbatim: Scab) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported and the outcome of the scab was resolved (duration 21 days).   It was unknown if the reporter considered the vaccination failure, shingles, scab and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, scab and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 30-JUL-2023 This case was reported by patient via interactive digital media. The reporter reported that his/her mother got the vaccination and had the worst case of shingles ever. 21 days to scab over and ended up in ER twice because the pain was unbearable. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
pt rcvd vax; pt devel hives around neck; hives lasted for approx 1 day;
Developed shingles on 07/12/2021. Never had shingles before. Started at skin area around T-12 and followed rib cage all the way around to midline on stomach. Doctor ordered acyclovir.
Client came in for a Pfizer booster dose and received a pediatric Pfizer dose. Client then received a Pfizer booster dose.   The next day client reported a sore arm and a headache.
I received the vaccine this past Monday 29 Mar 2021, and tested positive; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer Sponsored Program . A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 29Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received the vaccine this past Monday (29Mar2021) and tested positive on an unspecified date in 2021, how did that affect her from getting her second dose, she asked. Any unaddressed medical questions were not referred or forwarded to Medical Information. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever, fatigue, body aches,  and  blisters on the inside of mouth
4 hours after shot, and lasting 5 days, strong metallic taste. On sixth day, numbness in legs and right arm. Lower back pain started on day  7 with difficulty walking.  Visited the emergency room at Hospital. MRI and CAT scans showed now clotting or stroke event.  Follow up with family doctor after developing Raynaud's syndrome.  Raynaud's Disease is now what I live with.
An investigator reported that a 2 month old male received his 1st dose of Prevnar on 10/17/02, at 1 month of age, as part of the Prevnar Post-Marketing Safety Surveillance Trial, "Post-Marketing Evaluation of Prevnar-Pneumococcal 7 Valent Conjugate Vaccine: Safety of Prevnar Administerred Cconcurrently with Routine Infanr Vaccinations at 2, 4, 6, and 12 to 15 months of Age." On 10/17/02, the infant also received Tripedia, Polio Vaccine, ActHIB, and Engerix B vaccines. On 11/6/02, 20 days post-immunization, the pt expired due to SIDS. Autopsy findings confirmed the cause of death as SIDS. Post-mortem total body x-rays revealed "no recent or healing fractures, bony malformations or projectiles." Toxicology results from a sample of heart blood were negative for ethanol and acetone. Per the autopsy report: "The presence of lymphocytic inflammatory infiltrates in many of the organs, especially the lungs and CNS, and the lymphoid hypertrophy noted in the GI tract, suggest a viral syndrome, which is considered coincidental. The clinical history and scene investigation do not reveal evidence of an overwhelming infection. The decedent was asystolic and apneic when encountered by paramedics." Both the investigator and the medical monitor assessed the SIDS as "not related" to the study vaccine. This report of a serious (OMIC), labeled event is being submitted in a 15-day time frame, as requested by FDA.
2- 2 1/2 inch sized red/hot painful swollen area at site  varicella vaccine starting on 8/1/09.  Ice was applied intermitently and by 8/3/09 area was no longer painful, redness/warmth were greatly decreased.
Patient came to the pharmacy and showed me a lump close to the area where she got her shot. I felt the lump it was hard. The center was harder than the surrounding area. The diameter was about 1.5 inches. Patient stated that it was not sore so she didn't know exactly when it started. She was guessing about 2-3 days ago. I advised patient if it gets worse in a day or two, then she should contact MD as well as the pharmacy.
PATIENT HAS DEVELOPED PAIN IN THE LEFT ARM FOLLOWING THE VACCINE. PATIENT WENT TO MD DID MRI BUT MD CANNOT VERIFY IF IT IS RELATED TO VACCINE OR NOT. BUT PATIENT HAS WATCHED ON TEVELESION A DOCUMENTARY SHOWING THIS COULD DEVELOP IN VACCINE WAS NOT ADMINISTERED PROPERLY AND CONTACTED THE PHARMACY.
I was having involuntary muscle movement in my arms, neck and legs while trying to sleep last night.  I've been up for approximately 4 hours and have not had any symptoms once I was awake and moving around.
Ear Infection; itching; ear ache; soreness in ear canal; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear Infection), PRURITUS (itching), EAR PAIN (ear ache) and MYALGIA (soreness in ear canal) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     no medical history information was reported.  Concomitant products included BUPROPIONE for Depression, SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced EAR INFECTION (Ear Infection), PRURITUS (itching), EAR PAIN (ear ache) and MYALGIA (soreness in ear canal). At the time of the report, EAR INFECTION (Ear Infection), PRURITUS (itching), EAR PAIN (ear ache) and MYALGIA (soreness in ear canal) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient described that ear infection, pruritus, myalgia, ear pain are common to her.   Reporter did not allow further contact
really bad arm pain for 4 days, couldn't move my arm, couldn't sleep on my left side arm, mild body aches
administered a dose of improperly stored VARIVAX; No adverse effects were reported; Information has been received from an office manager referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided.  On an unknown date, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R033656, expiration date was 20-NOV-2020; strength, dose and route were not reported) for prophylaxis. The vaccine had temperature excursion of the range 15 Fahrenheit (F) degree to 46 F degree (26 F degree) for 6 hours. There has no previous temperature excursion. The call was due to the digital data logger. No adverse effects were reported.  This is one of five reports which have the same reporter regarding different patients.; Sender's Comments:  US-009507513-1906USA002087: US-009507513-1906USA002088: US-009507513-1906USA002089: US-009507513-1906USA002090:
On Wednesday 12/6/17 less than 24 hours after receiving vaccines, patient fainted at home in the shower. Pt. was seen at Hospital ER, and referred to cardiology for evaluation and follow up.
sore arm; swelling; discoloration; red dots on legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SWELLING (swelling), VACCINATION SITE DISCOLOURATION (discoloration) and RASH ERYTHEMATOUS (red dots on legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), SWELLING (swelling), VACCINATION SITE DISCOLOURATION (discoloration) and RASH ERYTHEMATOUS (red dots on legs). At the time of the report, PAIN IN EXTREMITY (sore arm), SWELLING (swelling), VACCINATION SITE DISCOLOURATION (discoloration) and RASH ERYTHEMATOUS (red dots on legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This is a spontaneous report from a non-contactable consumer (patient). This consumer reported same PREVNAR 13 (batch number unknown), via an unspecified route of administration on an unspecified date (22Oct, year unspecified) at a single dose for immunization. Medical history included allergens (gluten, corn, dyes, animal-derived, other). The patient's concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine on 22Oct (year unspecified) and since then she feels awful, was horrible sick since. Patient heard that there was a formaldehyde and mercury in it. Patient also reported cold, cough, not feeling good, sneezing, her throat has been hurting, she has been sick, had chills and small fever, experienced arm red but no rash, all on an unspecified date. Patient stated that she did not want a vaccine, and stated that she was not happy and this was awful. Patient stated that she rarely get sick, that she did not take any medications. Patient stated that she notified a doctor about her symptoms but HCP did not really do anything about it, then she called her other doctor and was told by that HCP that they had the same symptoms after pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein vaccination. The outcome of the events experienced feels awful, horrible sick since, cold, cough, not feeling good, sneezing, throat has been hurting, chills, small fever, reported arm red but no rash was unknown. No follow-up attempts are possible, information on the batch number could not be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018449607 same reporter, suspect product, and events/ different patient.
RASH FROM FLAT AND DRY TO RAISED TO PURULENT OFF AND ON, 2 DAYS AFTER VACCINATION.  RUNNING A FEVER OFF AND ON.
approx 2min p/vax pt became weak, dizzy, clammy & nauseous;BP dropped 20-30mm, pulse rate dropped 20 points;episode lasted about 15min then BP & pulse went back up;LOC nl;
Left arm above elbow was numb, nose stuffy, cheeks and tongue swollen, salivary glands in front of ears swollen, headache Client took oral benadryl every 3 hours to relieve symptoms and rested in bed Total symptom duration: 2 days Symptoms mostly resolved by day of call on 1/20/2010
Oth complications following immunization, NEC, unit on 2016-06-19.
Expired Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix 720) (batch number ep47e, expiry date 06-FEB-2023) for prophylaxis.   On 18-MAR-2023, the patient received Havrix 720. On 18-MAR-2023, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-MAR-2023 The reporter reported that a patient received an expired dose on 18-Mar-2023. The reporter consented to follow up. At the time of reporting, the patient received an expired dose of Havrix, which led to expired vaccine used.
Swollen armpit on left side (same as injection) lymph node swollen to about the size of a tennis ball; Swollen armpit on left side (same as injection) lymph node swollen to about the size of a tennis ball; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient not pregnant received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 11Feb2021 13:30 (Lot Number: EL9261) as single dose (at age of 34-year-old) for covid-19 immunisation. Medical history was not reported. Concomitant medications included montelukast sodium (MONTELUKAST SODIUM), sertraline hydrochloride (ZOLOFT) and cetirizine hydrochloride (ALLERTEC). The patient previously took amoxicillin and experienced drug hypersensitivity. First dose of bnt162b2 (BNT162B2), was received via an unspecified route of administration, administered in Left arm on 19Jan2021 02:30 PM (Lot Number: EL8982) (at age of 34-year-old), for covid-19 immunisation. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient has not been tested for COVID-19 post vaccination. On 13Feb2021 02:00 AM patient experienced Swollen armpit on left side (same as injection) lymph node swollen to about the size of a tennis ball. Events resulted in Emergency room/department or urgent care. No treatment was received for the events. Patient had not recovered from the events, at the time of the report.  Follow-up attempts completed. No further information expected.
A report has been received from a Physician concerning a 3 year old, Female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received nasal FLUMIST Quadrivalent on 01-Oct-2013. Medical representative reported that patient got FLUMIST Quadrivalent then got the flu on 15-Dec-2013. The doctor told the Medirep that child was only minorly ill, but got better. The patient recovered from the event of patient got the flu / tested positive for flu on an unspecified date. The reporter considered the event to be non-serious.
About 3-5 minutes after getting the vaccine began experiencing a light headedness feeling. Took my blood pressure and it was a little high (140/95), I attributed this to anxiety but got home and my BP at home was down to about 120/76 about 1 hr. after. I laid down to sleep it off but could not sleep as about 1 hr. after trying to go to sleep I started to get a headache. After about 2 hours of battling it I decided to take a Extra Strength Tylenol which helped with the headache about 2 hrs later is was almost gone but the feeling of lightheadedness/dizziness was still there a bit worse than at the beginning. I slept it off and the next morning it was about 50 % better and by about noon it seemed to be 99% better. Today is Thursday ( on my 3rd day) and still feel a slight dizziness but I also have seasonal allergies which sometimes give me the same symptoms. I expect to be better soon.
This spontaneous report was received from a health care professional and refers to a pediatric patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-MAR-2018, the patient was inadvertently vaccinated with a dose of VAQTA injection, lot # N016805, expiry date 04-SEP-2018, intramuscularly (exact dose was not reported) for prophylaxis. No adverse effects were reported.
Hives difficulty breathing including cough within about 30 min. of the MMR vaccine. Treated in Emergency Room with epinephrine and "breathing treatment". Resolved.
Information was received from a pharmacist regarding a 55 year old female patient with hypertension, allergies (unspecified), and no drug reactions/allergies, who on 01-DEC-2014, was vaccinated with a single dose of ZOSTAVAX (lot # K012785, expiration date 28-NOV-2015), subcutaneously in the left upper arm. Concomitant therapies included FLONASE and SINGULAIR. On 03-DEC-2014, the patient called the pharmacy stating she had developed hard, red, painful bumps on her left arm and her face. She also developed a runny nose on 03-DEC-2014. No treatment was given. The outcome of the runny nose and the hard, red, painful bumps on her left arm and her face was reported as not recovered. No further information was provided. Additional information has been requested.
Patient given incorrect vaccine, was given Pfizer Pediatric Bivalent non diluted 0.3ml IM instead of Pfizer Bivalent Grey top. Patient has not experienced any signs or symptoms (fever, chills, injection site reactions) post vaccination
Pain where they administered the shot and fatigued the rest of the day and the next. At 3am the next day woke up with a fever of 102F, muscle pain, chills and a headache. 30 minutes later I vomited. Took Tylenol. Woke up at 10am with a fever of 100F, muscle pain, chills (not severe as earlier), headache (not as severe) and eye strain very severe. (I wear glasses but I?ve never had eye strain this severe)
Tenderness at site 1 hour after injection, large red circle around site 1 day after.
Since the shot, I've been sick more frequent than ever before.  I also am on month 8, almost 9, of coughing up globs of what's been identified as Candida.  5 doctors later no one knows how to fix me.
one week after shot I woke up to redness, swelling and itching with some pain around the site of the injection
Patient noticed the redness to arm at vaccine site the day after she got the vaccine, when she first woke up. She reports that area is tender, a little itchy,  hot. She also had expected symptoms including body ache, fatigue, headache, and fever. Physical Exam:  Left arm with red area 10x5 cm of erythema, induration centrally.  Flat fluid filled blister in center, 1x.04 cm. Tender to palpation, hot to touch.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/14/2021 and 5/5/2021. Presented to ED on 10/1/2021 with reports of loss of taste, dyspnea on exertion, and diarrhea consists of watery stools 3 times a days for the past 2-3 days. Patient reports drinking 5 of 8oz water bottles every day but is having very minimal urine production.  He reports associated lightheadedness, chills, non-productive cough, and decreased appetite. He was treated with Remdesivir, Tocilizumab, Decadron and supportive care. On 10/3/21 patient had a syncopal episode and became bradycardic. He went into cardiac arrest. CPR was initiated. Patient eventually expired.
This spontaneous report as received from a licensed practical nurse refers to a 7 month old patient (gender unknown) with unknown medical history or concurrent conditions. On 23-FEB-2011, the patient was administered ACTHIB and on 23-FEB-2011 the patient was administered the second dose of ACTHIB. On 01-AUG-2011, the patient was vaccinated with an unspecified HIB vaccine, before 12 months of age, which could have been PEDVAXHIB (vaccine interchange). All vaccines were administered. No adverse effects were reported. The outcome of interchange of vaccine products was unknown. Additional information is not expected since no permission to contact HCP was provided.
This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s  for prophylactic vaccination (Dose Number In Series 1: route of admin, frequency and batch number not reported) (unspecified manufacturer).   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination (Dose Number In Series 2). No concomitant medications were reported.   On 29-OCT-2021, the patient had expired lot number. (Dose Number In Series 2)  On 30-OCT-2021, the patient experienced headache and upset stomach.(Dose Number In Series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from headache, and upset stomach, and the outcome of expired lot number was not reported.  This report was non-serious.  This case, from the same reporter is linked to 20211061501.