chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 21 year old female who in her youth, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that on 04-AUG-2005 the patient failed to show seroconversion in a recent test. The patient had two titers drawn and both were equivocal. Unspecified medical attention was sought. No product quality complaint was involved No other information was provided.
Started with nausea, next day had joint pain, fatigue and nausea with diarrhea and fever of 101F. Day 3 had muscle pain, fatigue and severe diarrhea and fever of 100 F with acetaminophen started around the clock. Day 4 had migraine and nausea and diarrhea and fever of 100F. Day 5 has diarrhea throughout night approx every 30 minutes and extreme fatigue and headache. Symptoms have not yet subsided. One day 5 post vaccine.
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX. Concurrent medical conditions included asthma and hypertension. Concomitant products included SINGULAIR, Levothyroxine, valsartan, hydrochlorothiazide and metoprolol. On 2nd March 2018, the patient received SHINGRIX. On 2nd March 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In March 2018, the patient experienced injection site erythema and striae. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the injection site erythema and striae were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema and striae to be related to SHINGRIX. Additional details were provided as follows: The reporting physician stated that a patient who received SHINGRIX on 2nd March 2018 developed 15 to 16 blisters or vesicles on injection site over the weekend, which was most likely (according to physician) her non-dominant arm (left arm). The reporting physician stated symptoms were better today than yesterday. The physician stated he believed this was extremely likely to have been caused by SHINGRIX. The physician stated that medical intervention has included ADVIL or TYLENOL, and that the patient's other physician was considering prescribing VALTREX. The reporting physician did not have lot number or expiration date. But in follow up narrative they reported that, the patient presented to the physician's office after receiving dose 1 of SHINGRIX from another provider. Prior to being seen, she told the physician she had vesicles at the injection site. Upon further evaluation, the provider deems there are no vesicles but a large erythematous area with striae, at least 90 mm in diameter. The patient also believed that she was given the injection subcutaneously but had yet to confirm, which led to inappropriate route of vaccination. The health care professional follow up on his question about the adverse event noted in the prior. It was then that he informed to representative that the patient had just come in and left and she did not have vesicles, which were reported previously. Her adverse event seemed more in line with grade 3 injection site reactions. She also told the health care professional that she was almost certain she got the vaccine subcutaneously, but has yet to confirm, which led to incorrect route of drug administration. This case has been linked with US2018037473, reported by the same reporter.
Kind of vertigo; All of sudden she felt unbalanced; Like her head was heavy; she was holding onto things when she walked; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 15:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included visually handicapped and could not read her vaccine card; vertigo before, a year ago. There were no concomitant medications. The patient had her first COVID 19 vaccination, on 28Jan2021, about 3PM and she will get the booster on 22Feb2021, but it seemed like she had kind of vertigo on 29Jan2021, this just happened in the last hour, all of sudden she felt unbalanced, like her head was heavy, and she was holding onto things when she walked, She did call her primary doctor, he didn't think it had to do with the vaccine, so she thought to call and ask, she was fine, and then all of a sudden she started to get this kind of vertigo, he asked if her head was spinning, but it's not, it felt heavy and she has had vertigo before, a year ago, but she doesn't know. Her doctor told her to rest, so she was laying down, and when she lifted her head she could feel, it was not spinning, she knew she was not feeling balanced. When asked to clarify her question, states she wasn't sure this happening had anything to do with the vaccination, she called her primary care doctor and he thought it wasn't, had nothing to do with it, so she thought since she called, she would wait and talk to Pfizer in case, that other people have experienced the same thing. States she was hoping this agent could tell her it would go away in a little while, but her primary care doctor said it has nothing to do with it, but it may have to do with it, it was somewhat of a coincidence that was happened, and she was fine for 24 hours, all of a sudden she started to feel this whatever. States she did not need anything else at this time. Outcome of the event vertigo was not recovered and all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Allergic body rash since the second dose. It comes out 2-3 times per wk.
Patient administered the MCV4 powder mixed with sterile diluent instead of the MCV4 diluent. No adverse reactions noted, per mother when contacted. Will need revaccinated due to dose being non viable.
PATIENT HAD AN EPISODE OF SYNCOPY.  PATIENT HAS HAD SYNCOPY REACTION IN THE PAST TO NEEDLES.  EMT ON SITE MONITORED BLOOD PRESSURE AND PULSE.  THE PULSE REMAINED LOW (40'S) AND SO THE EMT'S TOOK PATIENT TO THE HOSPITAL.
The evening of the vaccine I noticed pulsatile tinnitus, which began as a low thudding sound in my head (with pulse). The next day the tone had changed to the high pitch, constant ringing of tinnitus. I also experienced persistent daily headaches for 8 days, which has resolved.   The tinnitus has not resolved and ranges in intensity from so loud I cannot listen it focus to background noise.
diagnosed with COVID; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (diagnosed with COVID) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced COVID-19 (diagnosed with COVID). At the time of the report, COVID-19 (diagnosed with COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-070732, US-MODERNATX, INC.-MOD-2021-068781 (E2B Linked Report).; Sender's Comments:  MOD21-070732:Patient mother cross linked case US-MODERNATX, INC.-MOD-2021-068781:Crossed linked
Woke up Monday, Nov. 16 with spasms of pain like lightening running down my entire body, numbness in hands and feet, so exhausted I could hardly stand, blood pressure spiked to 195/95 and ran in the high 180's until last week, and all my  joints were so "enflamed" I had a hard time moving. This has lasted to the present.
Small localized reaction (4.5cm) L arm Large localized reaction - with significant erythema, induration, warmth (13cm) on R arm
Patient reports issue for pneumonia and flu vaccine given each in opposite arms. Shortly after receiving vaccine, left arm hurt quite badly, was very swollen, and she could not use it well. Developed welts down to about the elbow. Between 08/20/2012 and 09/21/2012, patient has been seen in emergency room four times and received topical creams and a steroid shot from physician. Also has seen a dermatologist who put her on Z pak. Patient states had welts all over her body, especially on her thighs. Patient will see dermatologist on 09/25/2012 again. Left arm continues to be painful and difficult to use. Patient has no redness, swelling at site, or fever, but does continue to have "welts" on body.
Question about symptoms if things were related or not to vaccine. Pt with fever, vomiting, diarrhea, meningeal signs, photophobia, headaches, hospitalization.
pt recv vax 15SEP95 & APR96 pt was hosp as a result of cystic fibrosis;3APR96 while in hosp, pt exp a mild case of chicken pox w/3 vesicles;no further details were provided;
Autistic child: difficult infant who did not develope age appropriate speed. He was referred for evaluation at 2 years of age with ultimate dx of autism. Physician feels speech not present early and temporal association with vaccine. 60 day follow-up states the event was not due to vaccine.
significant red warm blotchy rash at injection site starting day 9.. progressed larger and larger and appeared to spread (non uniform circle) down arm..  warm and tender to touch. L underarm lymph node swollen. eventually slightly itchy
pt recv vax 24FEB98 & the following day pt devel gen hives;
He had extensive bruising on his right arm from the shoulder down to the elbow. He went to the hospital and said he could have a possible hematoma and informed him to tell us about the reaction.
Starting 2/18/2021 vaccination site got red and itchy and somewhat warm to touch.   A bit raised also .
Approximately 45 minutes after being discharged back to class from school based health clinic, patient returned back to health suite with nose bleed. His face mask and hands were covered with blood. The bleeding stopped spontaneously after about 5 minutes.
1 hrs p/receiving the flu vax pt devel a 3mm induration w/inc warmth @ the deltoid inject site; t99.4; pt required ER/MD visit; recovery occurred w/in 24 hrs;
Despite patient having long-standing history of ET, she had a completely normal CBC in August of 2020 and was maintained on the same dose of hydrea for more than 10 years. She was found to have an abrupt drop in both hemoglobin (13->9g/dl) and platelets (300s-- >104) 2 days after her 2nd vaccine.  Her hydrea dose was lowered and repeat blood work 1 month later demonstrated platelets of 64 and hemoglobin of 6.7.  patient was admitted to the hospital and was transfused 2 units of blood.  Bone marrow biopsy demonstrated 50% cellular marrow with grade three fibrosis consistent with Post-ET MF. No evidence of hemolysis, vitamin, or iron deficiency.  Spleen not enlarged.  Hydrea was stopped completely during admission.  Today's blood work (4/8/2021) demonstrates continued thrombocytopenia and anemia - platelets of 54 and hemoglobin of 7.5.
Kid received Havrix adult dose; Kid received Havrix adult dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 3-year-old male patient who received HAV (Havrix adult) (batch number NZ7JR, expiry date 17th June 2023) for prophylaxis.   On 31st October 2022, the patient received Havrix adult. On 31st October 2022, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 03-NOV-2022 Reporter's Comment: The reporter was registered medical assistant. The reporter reported that, a kid received Havrix adult dose by error. The reporter consented to follow up by email. Additional Supportive Information: The reporter reported that, a kid received Havrix adult dose by error, which led to accidental overdose and adult product administered to child.
Muscle soreness and weakness upon certain movements especially at night.  Extreme weakness in a week or so post injection for 4-5 days.  Has abated some but still limits movement.
On 6/21 patient reported to pharmacist : Patient said both arms were red around immunization site, which had subsided by this time. Her left side of her face is droopy and her arm is numb.
10/27/2021. 99% blood clot in main artery widow maker. I was able to get to the emergency room in time to get treatment , moved to hospital where stint was placed that same night.
Two weeks after receiving the vaccine my mother developed shingles, which was misdiagnossed as atopic dermatitis by the NP who sees her at her assisted living facility. Four days later, she had to be transferred by ambulance to the ER. Due to eye involvement, she was transferred to specific Hospital where she could be under the care of ophthalmologists. After a week in the hospital she was transferred to a rehab center where she developed Covid.
Longer than recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix  (1st dose received on 19th February 2023).   On 14-MAY-2023, the patient received the 2nd dose of Twinrix. On 14-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended Interval). The outcome of the drug dose administration interval too long 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: 24-JUL-2023 The Pharmacist would like to know how to proceed with the third dose. The reporter consented to follow up. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Circular erythematous blistering rash developed at the site of the injection about 2 cm in diameter
Very sore site of injection; Large red area at injection site.; Very warm to touch at injection site.; By 6:00 pm on day of injection was having pretty heavy diarrhea, this lasted about 3 days; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 08Dec2021 at 10:00 (Lot number: FW8027) at the age of 69 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high", notes: High blood pressure; "Irritable bowel syndrome", notes: IBS and "GERD"; (unspecified if ongoing). Concomitant medications included: AMLODIPINE; ESOMEPRAZOLE and VIT D. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6206, vaccine location: Left arm, administration time: 13:00), administration date: 19Mar2021, when the patient was 68 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0162, vaccine location: Left arm, administration time: 10:00), administration date: 10Apr2021, when the patient was 68 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 at 10:00, outcome "unknown", described as "Dose received: 3"; DIARRHOEA (non-serious) with onset 08Dec2021 at 18:00, outcome "recovered" (11Dec2021), described as "By 6:00 pm on day of injection was having pretty heavy diarrhea, this lasted about 3 days"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021 at 11:00, outcome "recovering", described as "Very sore site of injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 10Dec2021 at 11:00, outcome "not recovered", described as "Large red area at injection site"; VACCINATION SITE WARMTH (non-serious) with onset 10Dec2021 at 11:00, outcome "not recovered", described as "Very warm to touch at injection site". Therapeutic measures were not taken as a result of diarrhoea, vaccination site pain, vaccination site erythema and vaccination site warmth.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Fever, chills, aches, nausea. I had them for approximately 24-48 hours.
Around 8pm, legs achy, back sore, chills and low grade fever around 100.5 around 1130pm, severe body aches, malaise. Chills dissipated around 7am but body aches lingered along with fatigue for the rest of the day. Slight chills the night of 1/9. Feels better on 1/10. No body aches and no chills.
Felt a little bit dizzy; Felt pain going down arm into hand after Covid-19 vaccine injection; Covid-19 vaccine injection pain; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0164; Expiration date: unknown) via an unspecified route of administration on 23Apr2021 as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not any history and other Products. The caller reported that she and her daughter (patient) received the COVID-19 vaccine on 23Apr2021 and on same day caller reported that the patient experienced injection pain and felt a little bit dizzy within the first 15 minutes following the injection of the COVID-19 vaccine. Caller reported that the patient felt a pain going down her arm into her hand. Caller reported that the patient described the pain like a zing type of sensation. It was reported that both she and the patient were tested for COVID-19. Caller reported that the patient tested negative. She reported that she and the patient were going to get retested for COVID-19 today on 27Apr2021. Caller self-reported on adverse events. Caller had an MI inquiry, addressed on website and stated that her daughter was being a pill. The patient underwent lab tests and procedures which included SARS-COV-2 test which was negative on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 35 year old female dialysis patient who on approximately 08/21/2004 was vaccinated with a first 40 mcg dose of hepatitis b virus vaccine rHBsAg (yeast) subsequently the patient had arm shoulder and neck pain and stiffness. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
about 2 hours after shot my throat felt like it was closing and had a hard time swallowing.  lasted only until the next day.   Arm was sore.
Patient states that about a week later he noticed tightness and pain in the arm. When asked did he take anything for it such as ibuprofen or TYLENOL, he said no, he doesn't take those. Appearance of arm is smooth with no redness, bruising or any markings present. Patient stated pain was severe after holding phone for 45 minutes.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result; Negative, notes: Paxlovid rebound 3 days after first negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid from 13Jul2022 to 18Jul2022.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a physician, via a GSK representative, and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with CERVARIX, (GlaxoSmithKline). On an unspecified date the subject received 1st dose of CERVARIX (unknown route, unknown arm). At an unspecified time after vaccination with CERVARIX, the subject experienced swelling injection site and injection site redness. The subject's parent had reported an injection site reaction of large red circular swelling on their daughter's arm following the 1st dose of CERVARIX. At the time of reporting the events were resolved. The physician considered the events were possibly related to vaccination with CERVARIX.
Pain in shoulder immediately after injection, more than expected with a vaccine.  Severe shoulder pain, inability to flex left deltoid by day 3.  Reported to PCP on 11/10, still couldn't use arm.  Accidential flexing of the muscle caused severe pain, could not rollover/prop up on arms when in bed.  Dr said to take 2 Aleve in AM & 2 in PM and reevaluate the following week.   11/21 scheduled appointment for 11/22/22.  At appointment, diagnosed with deltoid tendinitis, received shoulder x-ray & 15 days of diclofenac  (75mg 2x.day).  Some improvement noticed w/in 3 days, but range of motion began to decline again after 10 days of medicine. Range of motion still limited and painful on 12/8/22.
I was exactly 32 weeks pregnant on the day of my Pfizer booster dose vaccination. 36 hours later I went into preterm labor and was hospitalized. Labor was able to be slowed down but I ended up having the baby at 32 weeks 5 days. He was 4lb 13oz.  I had been having contractions regularly prior to my booster dose, and was hospitalized for a night at exactly 31 weeks due to regular contractions that were able to be stopped completely with medications. 12 hours after receiving my booster shot I had muscle pains, nausea, chills, headache, and abdominal cramping that worsened at 24 hours and then turned into contractions at 36 hours.
- Vaccine Failure - patient with chicken pox, 50 - 100 lesions