chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an 8-week-old patient who on 28-AUG-2006 was vaccinated with an oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccine included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of Hib conj vaccine. "About two hours post vaccination", on 28-AUG-2006, the patient's parents indicated that the patient was crying excessively.  Subsequently, the patient recovered.  Unspecified medial attention was sought.  No product quality was involved.  No other information was provided.  The health professional also reported a second patient that had a similar experience following vaccination with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Additional information has been requested.
DIED; This spontaneous report received from a patient via a social media via a company representative concerned multiple patients of unknown race and ethnicity. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On17-NOV-2021, it was reported on that 3 patients died after being fully vaccinated. Reporter stated that "I know three who died. All fully vaxd". The cause of death was unknown. It was unknown if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.   This report was serious (Death).; Sender's Comments: V0: 20211142701-Covid-19 vaccine ad26.cov2.s-Died. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Approximately 90 minutes after vaccination, She developed severe vertigo and intractable nausea and vomiting.  EMS was called and she was taken to ED.
Body aches and fatigue began at 5:30 pm on day of injection. Chills and fever to 101.4 began about 11:30 pm on day of injection and lasted through 5:00 pm two days after injection (03/14/2021) along with body aches.  Fatigue lasted until 3/16/2021.  Arm still sore but getting better.
About 5 hours after receiving dose o 10/18/21, hives began on chest area and spread to stomach. Hives continued to spread through 10/26/21. Patient reports hives all over body.
Patient developed hives/whelps at vaccine sites as well as local erythema with in one minute of receiving vaccines, noted as allergy and will not administer further doses. Pt evaluated by physician in office and given 12.5mg benadryl P.O.-to continue as needed.
This spontaneous report was received from a health care worker refers to a male patient of unknown age. Patient medical history and current condition was not reported. On 05-MAY-2015 the patient was vaccinated with GARDASIL third dose, (Lot # K023432 and expiry date reported as 18-JUN-2016) of dose 0.5 ml via intramuscular route. Patient started therapy with the GARDASIL on 21-AUG-2014. On 5-MAY-2015 (reported as within 24 hours after receiving the third dose of GARDASIL on 5-MAY-2015) the patient experience low grade fever, headache, stomach ache and fatigue. No treatment was given to the patient. Product quality complaint was not reported. The outcome of the events was unknown. Causality assessment was not provided by the reporter. This is one of the two reports concerns siblings (1505USA005396). Additional information has been requested.
pt recvd vax 4JAN94 approx 12 hrs later awakened w/101-sore arm, red @ inject site; Today arm redder & diameter 2x3 min sl fever 99;
throat started to hurt when she swallow; sore throat; ear aches; feeling tired; not sleep well; cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 Immunisation. The following information was reported: EAR PAIN (non-serious) with onset 21Mar2021, outcome "recovering", described as "ear aches"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "feeling tired"; POOR QUALITY SLEEP (non-serious) with onset Mar2021, outcome "unknown", described as "not sleep well"; NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "cold"; ODYNOPHAGIA (non-serious) with onset 26Mar2021, outcome "unknown", described as "throat started to hurt when she swallow"; OROPHARYNGEAL PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "sore throat". Therapeutic measures were taken as a result of ear pain.  Additional information: It was reported that 5 days later the patient (age: 71; unit: unknown) experienced ear aches after she washed her hair for removing hair dye. She used some ear drops and it subsided. Patient was asking if this was a side effect or something else. Patient wanted to know information about booster shot after 2 doses of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
65-year-old male with past medical history of hypertension, hyperlipidemia, GERD, BPH, peripheral vascular disease, anxiety, diabetes mellitus on insulin, and end-stage renal disease on hemodialysis Tuesday/Thursday/Saturday presented to the emergency department complaints of worsening right testicular pain.  Patient reports that he was usual state of health until yesterday evening when he started having persistent nausea and vomiting and also had 1 episode of diarrhea.  Patient reports that he went to his primary care physician this morning and started having testicular pain therefore, requested that he come to the emergency department for further evaluation.           7/26/2021tested positive 8/7/2021 discharged Upon arrival to the emergency department, patient was found to have sepsis secondary to prostatitis and epididymo-orchitis.  Patient also noted to be incidentally positive for COVID-19.  CT abdomen consistent with severe prostatomegaly.  Reactive lymphadenopathy.  Ultrasound of the scrotum consistent with epididymo-orchitis. Chest x-ray was otherwise negative for any acute findings.  Patient was noted to have elevated troponin however, EKG independently reviewed and negative for any acute findings.  Also noted to have hypertensive urgency, leukocytosis, anemia, hyponatremia, hypochloremia, metabolic alkalosis, uremia, hyperglycemia, hyperproteinemia, elevated BNP, and elevated lipase.
Employee received the flu vaccine on 10/23/18 early in the am. When The employee returned to his home that evening he noticed swelling and slight pain. The morning of 10/24/18 he noticed bruising at the injection site and down his left upper arm.
1/2 hour after injection, area of insertion started to hurt and burn, then right side and then the butt area started hurting and then settled in the small of the back. No strength in right leg. Sent to Doctor. Pain until Sunday 1/16/05. Pt at work 1/18/05.
Swelling at site of injection on left upper thigh. Present for over 2 months.
"Strong headache", progressing to migraine overnight (over ~ 12-16 hours post vaccination); "Strong headache", progressing to migraine overnight (over ~ 12-16 hours post vaccination); This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 17:00 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Apr2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 04Nov2021 20:00, outcome "recovered" (Nov2021), MIGRAINE (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021) and all described as ""Strong headache", progressing to migraine overnight (over ~ 12-16 hours post vaccination)". Therapeutic measures were not taken as a result of headache, migraine.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
spotting; severe allergic reactions; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (spotting) and ALLERGY TO VACCINE (severe allergic reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (spotting) and ALLERGY TO VACCINE (severe allergic reactions). At the time of the report, VAGINAL HAEMORRHAGE (spotting) and ALLERGY TO VACCINE (severe allergic reactions) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was reported. Treatment medication was not provided.
Waited 15 min at the vaccine site immediately after vaccine. Driving home 15 min after waiting I had to pull over because my daughter needed to vomit.   Went the whole day vomiting  and also had diarrhea this went on for 6 days. Day seven and eight she was back to normal. She did miss school the whole time.
05feb90 pt vax hepta B.  pt ex dizziness, blurred vision, and weakness which resolved w/i several minutes.  pt ex. nausea which resolved w/i 30 min. mar90 pt vax 2nd hepta B. sx recurred and resolved similarly.
A Fib; This is a spontaneous report from a contactable consumer received via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient went into A Fib after receiving the vaccine. The patient was treated in the hospital and received a blood transfusion. The outcome of the event was unknown.  Information on lot/batch number should be obtained.
About 12:00 pm (shot received at 10:15am) I started to feel a tingling sensation from the tips of my ears and over the course of a few minutes it spread from my ears to my chin, the nerve that runs through my chin and ears has been tingling for almost an hour now. It isn't painful whatsoever, but it isn't a subtle reaction either. I also believe I may be able to feel the muscle under the chin but I'm unsure, it might just be fat haha.
(F) - 34 y.o. Note Creation:7/26/2022 Encounter Date:7/26/2022      History   Chief Complaint Patient presents with ? Vomiting During Pregnancy ? Generalized Body Aches ? Seizures     HPI  The patient is a 34 y.o. female G1 P0 at 21  w 4 d gestation, patient of Dr c/o having a grand mal seizure this am witnessed by FOB. Pt was unconscious for 20 seconds and was post-ictal afterwards. She has had a know seizure d/o since 2010 and sees Dr of Neurology. Her last seizure was 1 yr ago. When she became pregnant, she was not comfortable taking her medication (Keppra and Topamax) so she stopped it despite recommendations to continue with her medication. Pt states she has had N/V and body aches today. She denies vaginal bleeding or contractions. She reports good fetal movement. She denies fevers/chills, sore throat, nasal congestion, coughing or shortness of breath.     Past Medical History: Diagnosis Date ? Asthma   ? Seizure       Past Surgical History: Procedure Laterality Date ? HX CHOLECYSTECTOMY
This spontaneous report was received from a Medical Assistant, referring to an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA 25/0.5, for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported), instead of an adult dose. No adverse effects were reported for the patient.
Patient was able to get scheduled for an appointment at age 11.   No reaction at this time.  Vaccine just given prior to age 12 as recommended.
is a 66-year-old female who presents to the emergency room for evaluation of shortness of breath and low oxygen levels .  The patient was recently admitted to our hospital several times due to COVID 19 infection and pneumonia. She was initially diagnosed with COVID19 on July 12. Patient reports persistent shortness of breath.  Her shortness of breath is much worse with exertion. Patient reports that she has been given oxygen on August 29th.  She notes that her saturations were below 90% on home oxygen.  Patient denies any fever, chills, chest pain, hemoptysis, leg swelling, bleeding issues.
Pt recvd vax that noc mom went into room & pt shaking (generalized) while asleep; mom woke pt up; stated he was limp; t102; swelling of rt arm;
A bruise at injection site the size of a silver dollar appeared  8 days after injection. . No severe pain, just light discomfort  when pressed on . Nothing else
they contracted COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (they contracted COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (they contracted COVID-19). At the time of the report, COVID-19 (they contracted COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company Comment: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
pt recv vax 26APR96 & 7FEB97 during the 29th wk of pregnancy pt was exposed to chickenpox;a titer taken that same day indicated that pt failed to seroconvert;
blisters look more like chicken pox; rash / was on the patients hip / on feet, knees, buttocks, and few on elbow; new clusters developed / and in hair; blister starts as a red bump with a white center; the blister scabs over with a yellow cru; Extremely itchy; yellow crust; This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number JC453, expiry date 15th February 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 4th September 2020, the patient received the 2nd dose of Shingrix. On 5th September 2020, 1 days after receiving Shingrix and Shingrix, the patient experienced chickenpox, rash, rash follicular, blister, blister infected, pruritus and crust. On an unknown date, the outcome of the chickenpox, rash, rash follicular, blister, blister infected, pruritus and crust were unknown.   It was unknown if the reporter considered the chickenpox, rash, rash follicular, blister, blister infected, pruritus and crust to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After the second Shigrix injection, the patient developed a rash the next day.  The rash was not at the injection site. The first cluster was on the patients hip. 4 days later the original cluster had scabbed and were clearing up However, as they cleared up, new clusters developed on feet, knees, buttocks, and few on elbow and in hair. The blister starts as a red bump with a white center. After scratched, the blister scabs over with a yellow crust. Extremely itchy first 48 hours.  The reporter consent to follow up.
Patient did not show any adverse events from the incorrect Covid-19 vaccine as of 0800 on 4/6/22
Patient had an apneic episode with bradycardia at home. Was observed overnight in hospital and was fine. Ex 26 week preemie with chronic lung disease on oxygen.
Vaccine given after the adjusted use-by date but before the official expiration date. There was no adverse event per se, local health dept instructed us to file this report anyway.
pt stated that she requested both shots be given in the same arm. pt stated that she had a bruise on her arm from the previous day of running into a door frame. pt presented with a bruise on her arm and a dark purple spot to the bottom left of the bruise. pt had red, blotchy area around the purple spot. I asked the pt if she was bitten by something . she denies being bitten. the area in question is away from the injection site per the pt. she states that her arm is very sore. I advised the pt to take Benadryl to see if the redness would go away since it looked like an allergic reaction.  I followed up with the pt on sunday. pt stated that her arm was still sore and the redness was still there
Narrative: COVID infection following COVID vaccine series 01/05, Pfizer, dose #1 02/02, Pfizer, dose #2 07/25 COVID swab, result: detected non Facility 07/25 pt cc: fatigue, rhinorrhea exposure: wife 08/09 COVID swab, result: detected
Information has been received from a registered nurse concerning a 6-year-old female who on 28-May-1999 was vaccinated SC with a 0.5 ml first dose of varicella virus vaccine live. Concomitant vaccinations on the same day included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a third dose of HIB conj vaccine (OMP) (manufacturer unknown), a third dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, and a third dose of poliovirus vaccine inactivated (IPOL). On 15-Dec-2003, the patient developed breakthrough chickenpox with less than 50 lesions and a low grade fever. No diagnostic laboratory tests were performed. Unspecified medical attention was sought and a prescription drug was not required. It was noted that therapy with varicella virus vaccine live was "discontinued." A product complaint was not involved. Follow-up information including an "official shot record" was received from the registered nurse which indicated that on 15-Dec-2003 the patient developed a rash on her trunk and back which was noted to be "coming in crops." The patient had a slight fever and a runny nose. Lesions were present and one had a blister and one had a scab. The patient reported itching. The patient was instructed on varicella. The official shot record indicated that on the 11-Nov-1997 and 20-Jan-1998 the patient received a first and second dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) and on 06-Aug-2003 received a third 0.5 ml dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). On 20-Jan-1998 and 31-Mar-1998 the patient received a first and second dose of HIB conj vaccine (OMPC) (manufacturer unknown). On 20-Jan-1998, 31-Mar-1998, and 06-Aug-2003 the patient received at first, second, and fourth dose of poliovirus vaccine inactivated (IPOL). On 20-Jan-1998, 31-Mar-1998, and 06-Aug-2003, the patient received a first, second, and fourth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. On 06-Aug-2003 the patient received a second dose of measles mumps rubella vaccine and a first dose of hepatitis A virus vaccine inactivated (manufacturer unknown). Additional information has been requested.
Rash on arm (injection site) to (L) deltoid rash on (L) neck area.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient in his (or her) 70's with no pertinent medical history, drug reactions or allergies who on 01-JUL-2008 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). There was no concomitant medication. The reporter stated that she did not double check the vial and made the mistake. It was not product confusion. No adverse events reported. Follow-up information was received on 04-SEP-2008 from the C.M.A. concerning a 77 year old retired male who was administered a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). The reporter confirmed that no adverse event occurred. This is one of several reports from the same source. Additional information is not expected.