chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Hep A in left arm (HAVRIX) - immed felt tingling all the way down arm and arm felt "hot" no shortness of breath, no redness or swelling at site.
After the first two parts of the Moderna vaccine (3/5/2021 and 4/5/2021) and the booster (12/17/2021) I experienceda high level of pain at the injection site (left arm for all doses) beginning about 12 hours after the vaccine was administered and continuing for about 72 hours.  I typically have a high tolerance for pain; however, the injection site pain was strong enough that I had trouble sleeping and it hurt to move my arm at all.  Approximately 4 weeks after receiving the booser, I experienced a recurrence of the injection site pain - beginning on 1/16/2022 and continuing for about 72 hours.  I had not done any activities or anything out of the ordinary that would have caused the pain - it was the exact same as the pain experienced previously with the vaccines.
Sore Red arm in injection spot day 7 then day 9&10 muscle aches & chills.. The condition was mild and went away in 48 yours. No Doctor was contacted. Over the counter advil was taken.
41 year old male complained of possible allergic reation. Onsite EMS responded. Vitals BP 144/90 HR 86. Refused treatment and went home.
45 minutes after the shot, my lips started tingling. They went numb and it stayed for about ten days. I also had numbness in the soles of my feet that lasted for about two weeks. The day after the shot, I had the normal reaction. Fatigue, lowgrade fever for about 24 hours.   I spoke to my doctor about it, but did not go see anyone.
My mother received the 2nd Moderna shot and 1 month later, experienced blood clots in her right leg and in both of her lungs.  They were big clots in her lungs.  Had to go to ER.  Was admitted and diagnosed with the clots.  Was treated IV drip of Heparin.  Was released two days ago and will have to continue with Eliquis until further notice.
On 8/27/2015 patient received PREVNAR 13 then 6 days later on 9/2/2015 she got large red area, hot but not painful. It's two to three inches wide and four to five inches long. The redness is on anterior of arm but not medical where the injection site was. She started BENADRYL 25mg then 50mg QID. She saw doctor on 9/4/2015 ordered cephalexin 500mg, but doctor says not cellulitis. She only took three doses and stopped due to side effect. But redness was gone. We are not sure if reaction is related to PREVNAR 13 or not.
Patient is a 60 y.o.male with PMH DM2, HTN, dyslipidemia who presents to ED on 8/2/2021 for worsening SOB, weakness and dry cough at home. He reports fevers, chills and diarrhea. He initially came to the ED on 7/29/2021- he was not hypoxic so he was sent home. He then had worsening symptoms so returned. Rapid test positive int he ED 8/2/2021. CXR with progression of bilateral infiltrates. Admitted, provider consulted on 8/2/2021 for COVID PNA, acute resp failure, increasing O2 requirement. Hospital course: 8/2- admitted; Actemra. 8/3- Provider consulted, on heated high flow nasal cannula. 8/4- transfer to ICU status
feel a little weakness; my arm was swollen, painful for two days; my arm was swollen, painful for two days; initially being unable to urinate; This spontaneous case was reported by a patient and describes the occurrence of URINARY RETENTION (initially being unable to urinate) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: TYLENOL.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced URINARY RETENTION (initially being unable to urinate) (seriousness criterion medically significant). On 14-Apr-2021, the patient experienced ASTHENIA (feel a little weakness), VACCINATION SITE SWELLING (my arm was swollen, painful for two days) and VACCINATION SITE PAIN (my arm was swollen, painful for two days). On 13-Apr-2021, URINARY RETENTION (initially being unable to urinate) had resolved. On 16-Apr-2021, VACCINATION SITE SWELLING (my arm was swollen, painful for two days) and VACCINATION SITE PAIN (my arm was swollen, painful for two days) had resolved. At the time of the report, ASTHENIA (feel a little weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Historical medication included vitamins . she takes cholesterol medication, Tylenol and vitamins.  Patient was scheduled for second dose on 28-May-2021 Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt recieved Moderna COVID vaccine on 3/6/21@0930 & on 3/7/21 around 1200, pt developed stroke symptoms. Went to ER admitted. MRI demonstrates left parietal infarct - rt side weakness & slurred speech
Patient was lethargic and cranky after vaccine, lost appetite and started running a fever Tuesday evening. Wednesday morning after taking her temperature it was 102 degrees. TYLENOL did not reduce fever, but MOTRIN did. At night she would wake up every 45 minutes and cry 1-3 minutes and be inconsolable. Saturday afternoon she started to develop a rash, and after going to bed that night she awoke crying with the rash on her face raised and red. There was a big patch on her bottom as well. Her chest, stomach and back were covered but as severe. As of Tuesday evening her temperature had gone down, but is still not eating, lethargic, fussy, and clumsy. The rash is still on her face and resembles eczema.
Severe radiating pain (pain level of 8-9) in arm radiating up to shoulder and neck.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Patient developed a cough and fatigue on 7/31/21, about 4 days after vaccination. He was sleeping all day and had trouble getting himself out of his chair, which is abnormal for him. He also developed lower back pain. Patient self-treated back pain with acetaminophen and a heating pad with success.  Patient presented to our clinic on 8/2/21 with complaints of the above symptoms. Vitals and exam were unremarkable with the exception of redness in the ears and throat. Patient was subsequently tested for COVID - results pending.
allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 44-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-May-2009 that indicated no adverse events were reported through the medical clinic. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
15 days following vax, developed severe body, joint and muscle aches with fever approx 100 deg F. Lasted approx 4-5 days. Had redness, itching at vax site.
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (manuf unk) for prophylxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine (manuf unk) on 9/22/99. He also received hep B vaccine 10/10/95, 11/17/95 and 6/10/96; combination diphtheria and tetanus toxoids and pertussis/Haemophilus influenzae type B conjugate vaccine (DTP+ActHIB 11/17/95, 1/22/96, 3/18/96 and 3/20/97; Orimune 11/17/95, 1/22/96, 3/20/97 and 9/22/99; and MMR II 12/19/96 and 9/22/99. The subject's attorney alleged that "as a result of mercury in thimerosal-adultcreated infant that the subject received as an infant, he now suffers and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." The mercury poisoning in this report is considered medically serious (OMIC).
Large red, itchy, and hot red circle below the injection site- developed two days after vaccine. 9/12/21 9/13/21- itchiness increased, still hot and same size red circle. Difficulty breathing.
itchy rash all over body started 24 hours after vaccine and lasted a week.  resolved with benadryl, zyrtec.
Large area of redness under injection site, Hard swollen area under injection site, Pain, Once pain subsided it became very itchy. Ongoing
This is a spontaneous report from a contactable physician via Company Representative. The reporter reported for 4 patients. This is the first of four reports. An elderly male patient received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for cerebrovascular accident prophylaxis. The patient medical history and concomitant medications were not reported. The patient experienced bi-lateral pulmonary emboli on an unspecified date. The physician reported that 4 patients in his practice got the Pfizer COVID-19 vaccine and each developed Bilateral Pulmonary Emboli within a month of the vaccine. 3 of the 4 patients were male. 1 was female. All were age 70 or older. One male patient on this group was also on apixaban for atrial fibrillation and still developed pulmonary embolism. For apixaban, the reporter did not provide any causality assessments. The action taken in response to the event for apixaban was unknown. Outcome of the event was unknown.  This case was received via Pfizer Inc (Reference number: 202101406989) on 19-Oct-2021 and was forwarded to BMS on 22-Oct-2021. Based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-111615), license party for apixaban (ELIQUIS). BMS Medical Evaluation Comment: This patient had pulmonary embolism after receiving apixaban therapy. This patient was also vaccinated for COVID-19. Based on the limited information available regarding the therapy details, event onset date, action taken with the suspect and outcome of the event, it cannot be ascertained with the reasonable possibility that the apixaban could have contributed to the event pulmonary embolism.  Causality Assessment: ELIQUIS; Pulmonary embolism; Per Reporter = No Information; Per Company (Bristol-Myers Squibb) = Not Related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available the reported event is considered not related to suspect drugs.,Linked Report(s) : US-PFIZER INC-202101407018 Same reporter, different patient/event.;US-PFIZER INC-202101407019 Same reporter, different patient/event.;US-PFIZER INC-202101407020 Same reporter, different patient/event.
Patient states that about one week after vaccination she noticed a quarter size red spot on her arm in the area where she received vaccine. Patient reports that spot on arm was painful. patient reports that arm was sore shortly after vaccination but that soreness had resolved a couple days after vaccination until this spot appeared then pain returned. Patient is under the care of doctor. I advised patient to contact doctor to notify him of reaction and to let him advise her on how to treat reaction.
This spontaneous report has been received from a medical assistant and refers to a multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L046508, expiration date 17-MAY-2017 and lot # M006104, expiration date 01-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 9 hours. There were no previous excursions reported. Digital data logger was not involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA011799: US-009507513-1703USA011810:
Pt was nervous about getting the vaccine. Pt has a seizure type event (eyes rolled back, pt was shaking and then fainted). Pt had no recollection of adverse event when he regained consciousness. Emergency services was called.  Pt's BP, glucose and EKG was ok per EMS. EMS suspected that pt had an anxiety attack but additional information not available at this time.
Given influenza vaccine 11/19/07. Noted slight redness and warmth to injection site that evening. Reported to Employee Health on 11/21/07 after no improvement.
Pulmonary Embolism to right lower lobe - now on Eliquis 5mg twice daily. Was seen at urgent care and transferred to hospital.
very nauseous; chills; achy; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 15Mar2021 09:45 (Lot number: EN6206) at the age of 56 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Enlarged prostate" (ongoing); "Stevens Johnson syndrome" (unspecified if ongoing), notes: allergic to sulfa drugs; 10 years or 12 years prior; "allergic to sulfa drugs" (unspecified if ongoing), notes: developed Stevens Johnson syndrome, 10 years or 12 years prior. Concomitant medication included: CIALIS taken for prostatomegaly (ongoing). Vaccination history included: BNT162B2 (dose 1, Lot number: EN6198), administration date: 22Feb2021, when the patient was 56 years old, for COVID-19 immunisation; Shingrix vaccine (dose 1, a year prior), for immunisation, reaction: "not feeling well"; Shingrix vaccine (dose 2, a year prior), for immunisation, reaction: "not feeling well".The following information was reported: NAUSEA (non-serious) with onset 15Mar2021 16:00, outcome "not recovered", described as "very nauseous"; CHILLS (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 15Mar2021 16:00, outcome "recovered" (17Mar2021), described as "achy".No follow-up attempts are possible. No further information is expected.
Initial report received on 19 February 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 10-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance Study (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4131AA received on 23 March 2012, lot number C4182AA received on 25 May 2012, and lot number C4270AA received on 27 July 2012. (Routes and sites of administration not reported). The subject developed a cough on 01 December 2012, approximately 4 months after the last dose, and a paroxysmal cough without a whoop on 10 December 2012. The subject also developed cold like symptoms on 05 December 2012, posttussive vomiting, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 12 December 2012. Chest x-ray findings were unknown. Corrective treatments consisted of azithromycin starting on 12 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 22 January 2013, the subject's cough was not persisting. The duration of the cough was reported at that time as 32 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
PATIENT CAME IN FOR FLUCELVAX AND HEPLISAV-B.  AFTER SITTING DOWN AFTER ADMINISTRATION, HE RETURNED TO THE PHARMACY IN A FEW MINUTES AND SAID HE HAD A HARD TIME BREATHING.  WE SAT AND WAITED FOR A FEW MINUTES, AND IT ONLY WORSENED.  WE TOOK HIM BACK INTO OUR IMMUNIZATION ROOM AND THEN WAITED A FEW MORE MINUTES WHERE HE SAID HE CANNOT BREATHE.  AT THAT POINT I ADMINISTERED EPIPEN AND AFTER 5-10 MINUTES HE START TO FEEL RELIEF.  HE THEN WENT TO THE ER WHERE THEY CONTINUED TO ADMINISTER IV MEDS FOR HIS ALLERGIC REACTION AND MONITORING BEFORE HE WAS RELEASED, AND HE SAID HE FELT MUCH BETTER AFTER THE IV MEDS.  HE HAS BEEN FINE SINCE.
Excessive swelling in pt (L) arm. Localized to injection area only. Pt instructed to take 50 mg diphenhydramine and continue q 6 hours until swelling stops. Pt saw PA on 12/13 instructed to continue diphenhydramine. Arm still swollen with pain radiating from injection site.
Fever, seizure (grand mal) 01/16/04.  Shots 01/12/04 (DTAP, IPV, MMR, FluZone).  Nurse follow up on 06/18/04 states: "ADD: cough, runny nose, fussy, screaming."
Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; No other issues or concerns noted; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unknown date (reported as 20-MAY-2022), the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Note by Dr. 03/28/12. Became drowsy, achy, felt feverish. Slept most of the day and until 1pm the next day. Did not have fever when examined 3/28 tingling on bottom of his feet the next day - very mild.
PATIENT REPORTS BEGINNING AT ABOUT 11PM THE FOLLOWING SYMPTOMS: FELT AS IF GETTING A COLD, SEVERE HEADACHE, BP 141/91 AND PULSE 102BPM, TREMORS/SHAKING THAT LASTED 2 HOURS, EXCESSIVE URINATION, WEIGHT LOSS (5LB FROM ONSET TO "RECOVERY"), LACK OF APPETITE, FEELING OF SEVERE DEPRESSION, PINK SPLOTCHES IN VISION (PATIENT IS BLIND). SYMPTOMS SLOWLY STARTED TO WANE OVER TIME. HEADACHE RESOLVED ON 9/7 AND EXTREME MUSCLE SORENESS RESOLVED 9/10/19
This patient had urticaria to the face, seen within 1 hour of reaction at the pediatric clinic.
Fever, Chills, Anorexia, Arthralgias, Myalgias, Headache, Tenderness/Erythema/Warmth at the injection site Started the morning after vaccine was given Used Ice packs to the injection site, Tylenol with improvement in symptoms Improving by ~ 72 hours after onset
Initial report received from a health care professional in on 15 October 2014. A 28-year-old female patient, had received a dose of FLUZONE QIV vaccine (lot number: UI187AA, expiry date 30 Jun 2015, route and dose number not reported) in left deltoid on 02 October 2014. The patient had no illness at the time of vaccination. The patient did not receive any other vaccinations within 4 weeks of vaccination of FLUZONE QIV. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. On 02 October 2014 i.e. same day after vaccination patient had experienced pain at the administration site since patient received the vaccine and even today patient can't move her arm. Reporter advised to seek medical attention. Corrective treatment was not reported and no laboratory details. At the time of this report, patient outcome was not recovered. Documents held by sender: None. Followup information received from a health care professional on 21 January 2015. It was reported that no new information was provided to report.
G40.909 EPILEPSY, UNSPECIFIED 4/22/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE 4/22/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION R09.02 HYPOXIA 4/22/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION
Mother states client's left arm was red after injection from deltoid muscle to his elbow. Reports swelling upon awakening the next morning 8/3/07 from his muscle down to elbow. Continued to swell and on 8/4/07 states arm was twice the normal size. On 8/4/07, took client to ER. States MD squeezed left arm and pus came out the injection site. MD prescribed Keflex antibiotic.