chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Fatigue; Random jumps in blood pressure; BP is still very unstable; Random jumps in heart rate; heart rate jumps are worse; extreme heart rate jump; This is a spontaneous report from contactable consumer (patient). A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: TER8733), via an unspecified route of administration in left arm, on 06Apr2021 at 09:30 AM (at the age of 64 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included high cholesterol. The patient's concomitant medications included ezetimibe (ZETIA), colecalciferol (VITAMIN D), and ascorbic acid (VITAMIN C). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021 at 12:00 PM, the patient experienced nausea and fatigue related to random jumps in blood pressure (BP) and heart rate. After visits to physician and emergency room (ER), no other cause was found. The patient was put on losartan as treatment, but BP is still very unstable and heart rate jumps are worse (Apr2021). The patient cannot walk to bathroom without extreme heart rate jump, this was going on for weeks and not getting better. The patient assessed the events as non-serious. Since the vaccination, the patient has been tested for COVID-19 (nasal swab) on 16Apr2021 that was negative. The patient had not recovered from the events.
Legs like rubber; Hardly able to make from one room to another; Was always independent, able to take care of her home and drive, and since she received the second dose this is not happening; Very, very fatigued; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Legs like rubber), GAIT DISTURBANCE (Hardly able to make from one room to another), IMPAIRED WORK ABILITY (Was always independent, able to take care of her home and drive, and since she received the second dose this is not happening), FATIGUE (Very, very fatigued) and CHILLS (Chills) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Legs like rubber), GAIT DISTURBANCE (Hardly able to make from one room to another), IMPAIRED WORK ABILITY (Was always independent, able to take care of her home and drive, and since she received the second dose this is not happening), FATIGUE (Very, very fatigued) and CHILLS (Chills). At the time of the report, MUSCULAR WEAKNESS (Legs like rubber), GAIT DISTURBANCE (Hardly able to make from one room to another), IMPAIRED WORK ABILITY (Was always independent, able to take care of her home and drive, and since she received the second dose this is not happening), FATIGUE (Very, very fatigued) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.
My son had, DTAP, Polio, MMR, Flu, Varicella, He had a seizure later that evening and the following day.  Spent 2 nights in the hospital and was monitored by EEG and had an MRI done.
Information has been received for the Pregnancy Registry for HPV vaccine from a nurse concerning a 19 year old female patient who in June 2008, was vaccinated with the first dose of GARDASIL. Concomitant therapy included ADDERALL and PROZAC. The patient was pregnant when she was given the first dose of HPV vaccine in June 2008. Currently in approximately August 2008, the patient was having gall bladder problems, but no other symptoms reported. The patient's LMP was 02-FEB-2008 and EDD 08-NOV-2008. The patient sought medical attention. No further information is available.
07/22/2022 He came home from school feeling drowsy. The next day he had a fever, 99 and got up to 101, chills, nauseated, vomiting, head ache and lost his appetite. Sunday he was moping around. On Monday he was running a fever again and coughing. He tested negative for COVID, the Flu and Pneumonia at the doctor's office but was diagnosed with an upper respiratory infection. He was prescribed an antibiotic and medicine for cough. He is doing better today.
This spontaneous report as received from a 65 male consumer (reporting on himself). The patient did not have a pertinent medical history or drug reaction allergies. Around 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot #, and route not reported, 1 vaccine). Concomitant therapy was not reported). On 01-MAY-2014 shingles occurred on the right side of callers face and pain. The patient stated that he did not have the blisters, just the pain. He went to his doctor and the doctor said it was shingles even though there was not a rash. The patient was prescribed VALTREX with the stipulation to not take it until blisters occurred. Laboratory diagnostic studies were not performed. The outcome of shingles and pain was unknown. Additional information has been requested.
Within 15 minutes of receiving vaccination; I could feel heart palpitations and had to take deep breaths. My heart felt as if it was racing. I checked my Apple Watch and my resting heart rate was 156bpm. The nurse at the clinic than confirmed my heart rate as well as an elevated Blood Pressure. After remaining at the clinic for observation, my resting heart rate only dropped to 124bpm. At that time the nurse felt I should go to the ER for an evaluation. She escorted me to the ER where I was evaluated and released 5.5 hours later with nothing found. ER attending physician advised to get the 2nd dose but confirm with PCP. My PCP also advised to get the 2nd dose.
Drug interaction; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Drug interaction) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DRUG INTERACTION (Drug interaction). At the time of the report, DRUG INTERACTION (Drug interaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Reported that on an unknown date, the patient experienced Humira did not work well by itself. Moderna covid-19 vaccine (Elasomeran) was also considered suspect. Reported Causality for Drug ineffective (Humira did not work well by itself) for Moderna COVID-19 vaccine reported as Possible. It was unknown whether patient was enrolled in a COVID-19 vaccine trial. No treatment medication was reported.
Symptomatic of Sars-COV-2; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 12Apr2021 (age at vaccination 62-year-old) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she received first dose 12Apr2021 and 11 days later became symptomatic of Sars-COV-2 on 23Apr2021. She was tested on 27Apr2021. She was asking for recommendation on receiving second dose. The patient underwent lab tests and procedures which included sars-cov-2 test showed unknown results on 27Apr2021. The outcome of event was unknown.  Information on lot/batch number has been requested.
High-pitched cry with fever and irritable. Consoled after 12 hours. No erythema and normal neuro exam. Observation and supportive care. Dx: Antecedent viral syndrome.
Information has been received from a registered nurse concerning two patients who were vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #656262/1497F). Within three days after vaccination, the patients developed redness and papule. The papule was confirmed to be chickenpox. This is one of two reports received from the same source. Additional information has been requested.
Increased hear rate occurred approx 1 hour after receiving the vaccine, continued for 3-4 days
Tested positive for COVID-19; A spontaneous report was received from a consumer  regarding himself, an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed and hospitalized with COVID-19.  The patient's medical history was not included. It was stated that the patient takes other medications, however they were not identified.  On 21 January 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On an unspecified date, the patient reported that he went to the hospital and was admitted for COVID-19. Medications were given as treatment, but not identified. He states that he has no clue what it is, it was given to him at the hospital.   Consent to contact was provided.  Action taken with mRNA-1273 was not reported.  The outcome of the event, diagnosed COVID-19 positive after receiving the vaccine was considered unknown.; Reporter's Comments: This case concerns an 88-year-old male who was hospitalized with a serious unexpected event of COVID-19.  The event occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
3 hrs /p admin pt started /w high pitched 1 hr crying, T-100, for 1 hr. /P crying ceased very lethargic, listless, non responsive, wouldn't take milk, admitted 4Jan91, D/C 5Jan91
Patient was vaccinated  at 1435 pm and immediately upon vaccination patient noted hives going up her left forearm. This was the same arm of the vaccination. 50mg of Benadryl was administered orally at 1440 pm per our policy and procedures and patient continued to be monitored for adverse signs and symptoms. At 1505 RN noticed flushed face and  redness on neck. No shortness of breath was noted and speech was maintained. At 311 patient stated general feeling of racing heart. Vitals were taken. HR 80, BP 140/80, RR 14. EMT was notified and called  with a 1526 Arrival. Patient was transferred to Healthcare and call back at 1629 letting us know patient was stable.
This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration on an unspecified date to an unspecified date at single dose for immunization, SHINGRIX via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced a high unspecified active protein count when getting blood work done, after taking SHINGRIX and PREVNAR 13. The outcome of event was unknown.
little bit of pain in the arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date and had pain in her arm, refer case US2023AMR105508).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: little bit of pain in the arm). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR105508   Additional Information: GSK Receipt date: 31-JUL-2023 This case was reported by patient via interactive digital media. The patient stated that just two or three days of pain in the arm, that was all. The patient reported that he/she was fine with two doses, just a little bit of pain in the arm for about three days. Follow-up case was not provided as no contact details.; Sender's Comments:  US-GSK-US2023AMR105508:same patient
This case was reported by a pharmacist and described the occurrence of injection site redness in a 33-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On the morning of 12 November 2012 the subject received a dose of FLULAVAL (.1 ml, intradermal, left arm) and experienced inappropriate route of vaccination and vaccine underdose. FLULAVAL is indicated as a single dose of 0.5mL administered intramuscularly. On 12 November 2012 at 10:30, less than one day after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the event was unresolved. The pharmacist considered the event of injection site redness was probably related to vaccination with FLULAVAL. Follow up was received on 8 January 2013 from pharmacist. The pharmacist stated that she was a "poison specialist who was called by the nurse practitioner who administered the FLULAVAL." On 12 November 2012, the subject experienced injection site redness minutes after vaccination with FLULAVAL. On 12 November 2012, 39 minutes after vaccination with FLULAVAL, the injection site redness had resolved. The pharmacist stated "per the nurse practitioner who re-evaluated the patient, by 11:09 on 12 November 2012, the symptoms of redness had resolved. The patient had no induration at the injection site." The pharmacist did not consider the event to be serious.
Pt. states she 1st noticed redness at the site of the PNEUMOVAX injection around 7:00pm 11-16-10. On 11-17-10 it was the size of a nickel. This morning 11-18-10 it was bigger than a quarter measures 7 1/2cm x 6cm. No reaction at site of flu shot.
red & swollen @ inj site; swelling size in diameter=size of avocado;pt c/o very painful;referred to pvt MD:
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On 25-JUN-2012 the patient was vaccinated with GARDASIL dose 1 (reported as "Prevention of HPV"). On 30-JAN-2013 the patient received the second dose of GARDASIL. On 16-APR-2013 the patient was vaccinated with third dose of GARDASIL (which was considered inappropriate schedule of vaccine administration). Dose and route of administration were not provided. No adverse effect was reported. Additional information has been requested.
Mild headache upon waking up, progressively worsening throughout the day, mild lightheadedness, chills, low-grade fever, and  brain fog began at approx. 10:00 AM and gradually worsened as day progressed. Symptoms completely resolved as of 8:00 AM 1/10/2021.
I took my vaccine March 29 in pharmacy after that  I can?t go to work for the side effect  nauseas , dizzy and headache  , those   actually continue . The condition of the storage of the vaccine was not correct  , the  staff have more than 20 vaccine  accumulated. in a plastic bag inside the drawer without  fridge  I don?t know for how long time , they continue with this practice , the patient  take the shot in a small place and they prepare the  syringe before that  you seat  down in the place to take the shot .Thanks
2yr 11month old child given 3+yr Flu vaccine, no adverse effects noted.
Child stopped being verbal. Stopped showing emotion besides crying contantly. Stopped smiling, cooing, babbling.
Patient came back to office on 5/15/2014 reported after playing basketball on 5/12/2014 had noticed a knot where Varicella vaccine was given.  On 5/15/2014 at office visit, reported redness, swelling and knot. 3cm induration and 6cm redness. Doctor gave prescription of Augementin to treat.
Patient had problem several minutes after administering the vaccine. She felt that the trachea closed. We administered BENADRYL 25mg capsule.
COVID PNEUMONIA; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a consumer via a company representative via media article concerned a 58-year-old male. The patient's height, and weight were not reported. Patient had no existing condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that a fully vaccinated patient who died of COVID pneumonia. The patient was vaccinated in March. The patient had started a cough and ended when patient was ventilated. After more than a month of fighting COVID-19, a physician told that patient was no longer able to get oxygen. The physician cannot give him any more oxygen. Patient was 100 percent and had failed (suspected clinical vaccine failure).  On an unspecified date, the patient died from Covid pneumonia. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure was not reported and of Covid pneumonia was fatal. This report was serious (Death, and Life Threatening). This report was associated with a product quality complaint: 90000197223.; Sender's Comments: V0: 20211022931-Covid-19 vaccine ad26.cov2.s- Covid pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211022931-Covid-19 vaccine ad26.cov2.s- suspected clinical 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; Reported Cause(s) of Death: COVID PNEUMONIA
She is noted to have a nonproductive cough.  Temperature is 99.1.  O2 sat 93% on room air.  Nasopharyngeal swab showed Covid?19.  She was negative on 12/30.  She has been vaccinated and been given a booster prior to admission.  Possibility of monoclonal antibody treatment was considered, however given the omicron variant being most likely, this was deferred to infectious disease who recommended 3 days of remdesivir.
Soreness; Headache; This is a spontaneous report from a contactable Healthcare Professional reporting for herself.  A 53-years-old female patient received first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: ER5730, by intramuscular route in right arm, in Hospital, on 17Dec2020 at 08:45, at single dose for COVID-19 immunization. The patient had no known allergies and no relevant medical history. Concomitant medications were taken, but they were unspecified. On 17Dec2020 at 15:00 the patient experienced soreness and headache, both assessed as non-serious and resolved on an unknown date in Dec2020 without any treatment.
Patient who is status post Whipple procedure in February who presents to the emergency department due to increased abdominal distention and redness and warmth to an area around his incision. At this point the labs are ok-will attempt to treat with oral antibiotics. Pt instructed to return to ER for increased redness, fever, or chills etc. Hospitalization for a procedure- paracentesis. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
two patients (a 52-year-old man and a man in his 60s) were administered nonavalent HPV vaccine to potentially reduce the number of new skin cancers; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a male patient in his 60's.  The patient's concurrent conditions included immunosuppression, squamous cell carcinoma, basal cell carcinoma and liver transplant. The patient's medical history was not reported. Concomitant therapies included tacrolimus.  The patient had multiple keratinocyte carcinomas (KCs) after his liver transplant in 1995. He was treated with tacrolimus from 1995 to 2016. To potentially reduce the number of new skin cancers, the nonavalent human papillomavirus (HPV) vaccine (manufacturer) was administered intramuscularly at 0, 2, and 6-months (April, June, and October 2016) (off label use). Prior to the first intramuscular vaccine at month 0 (April 2015-April 2016), the patient was diagnosed with 9 new KCs (8 squamous cell carcinoma (SCCs) and 1 basal cell carcinoma (BCC)).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports derived from the literature article (cross referenced with MARRS # US-009507513-2205USA005371).  Literature Report: .; Sender's Comments:  US-009507513-2205USA005371:
Immediately flush, breathing rapid. Feeling of shock when you touch live electric wire's injection site throughout body.  Felt like passing out, nearly did.  Got laid down in Nurses office.
Vaccine was .05 cc injection; 12 hours later - chills, never had a true fever, fatigue, muscle aches, and a headache. That night I went to bed earlier - got 10 hours of sleep and felt worse then when I get sick. That lasted exactly 12 hours. By noon the following day, it had disappeared. Took Aleve. I returned to work the following day.
Left thigh with 3x4 inch red, warm and indurated area on left upper thigh with superficial scratch. Thigh noticeably swollen (1 1/2 -2 x diam of right thigh). No fever. Given Keflex 150mg PO TID x 10days.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored oral, ROTATEQ (lot # K009752 with expiration date of 15-APR-2016, dose and strength unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Client reports got really sick with pain in elbows, feet, hands, and knees right after vaccination on 04-16-21. He didn't think he could drive home, felt like he needed to stop at a friend's home, but did not make it home. Could barely walk and had a hard time getting out of bed the next day.  Reported he did get sick to stomach and had diarrhea on Saturday, did not have a fever.  Reports Sunday through Monday he felt better but still painful in his joints. He wanted to go to ER but his daughter told him to wait it out.
left thigh with swelling and mild erythema inferior to injection site. right thigh with small blister formation at injection site.