chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician, as part of a marketing research program refers to a female patient in her late 70's. There were no medical history, concurrent conditions and concomitant therapies. On an unknown date in the Spring 2009, the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose and route of administration not reported) at pharmacy. The patient developed immediate severe allergic reaction. She was taken to the emergency room (ER), where she received epinephrine. She recovered within hours from the onset of the adverse event (in the Spring 2009) and was never admitted to the hospital. Diagnostic tests assessing the patient's sensitivity to a variety of agents were performed subsequently by allergist in 2009 and demonstrated that the patient had severe allergy to gelatin. The reporter considered anaphylactic shock to be related to ZOSTAVAX and immediately life-threatening. Upon internal review anaphylactic shock was considered to be medically significant. Additional information has been requested.
This spontaneous report was received from a physician refers to a patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of VAQTA (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient might possibly have received dose 1 and dose 2 of VAQTA (dose, route and lot # not provided) separated by a 10 year period but this could not be confirmed at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
Anaphylactic/ type I/ reaction within 12 hours of vaccine Gardasil generalized urticaria, facial oedema.  10/16/07 Received ER medical records of 8/24/2007 which reveal patient experienced hives, swollen lips & face & itching all over.  Tx w/epi, IV steroids, IV antihistamine.  Improved & d/c to home FINAL DX: angioedema.
About 12 hours after the shot, patient became violently ill.  She had high fever 101-102 F with throbbing headache, chills, aches and violent vomiting all night long.  Of note, patient was positive for Covid 19 and sick for about 13 days with high fever in April of 2020 (almost a year before the shot)
pneumovax given 29MAy96, pt devel redness, swelling (12.4cm x 10cm) 2 days later, tx for cellulitis
Extreme fatigue in arm that shot was administered in; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 16:30 (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunization. No other medical history. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 04:00 PM (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications were not received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.: No Allergies to medications, food, or other products. On 27Mar2021 03:00 PM, the patient Extreme fatigue in arm that shot was administered in. The event was assessed as non-serious. No treatment received for the adverse event. Outcome of the event was recovered in Mar2021.  No follow-up attempts are needed. No further information is expected.
9-29-18 Started not feeling well-headache, chills. Double vision 9-29 and 10-1, 10-3 reported arm weakness. Fatigue started 9/30/18. Treatment: Ibuprofen (also: TRUMENBA and Flu: 9/21/17; presyncope, headache, fatigue, nausea, tingling (feet, fingers). 10/4/18: Symptoms almost fully resolved.
headache; fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The age group was not reported but was selected as adult as per vaccine indication.  The patient received dose of Shingrix  and experienced headache and fever.
One week later, site of injection became red, swollen and felt bruised, similar symptoms to a few hours after the shot but one week later, lasting for 3 days.
3/11/02 patient  diagnosed with moderate chicken pox (varicella) oubreak 14 months after varicella vaccine given
Localized itch at site of injection, reported by patient immediately after receiving injection. Had patient remain seated in waiting area. Rechecked her in about 15 minutes. Site was a little red (patient skin tan and red already) and small bump "slightly itchy". Called patient several times 7/17/15, no answer.
Received vaccine 1/6/21 approx. 2PM.   On 1/7/21, felt severe body aches & pains worsening throughout the day.  My right arm at injection site was sore, swollen, red & tender.  By 6PM, had fever of 101.7.  Took 3 maximum strength Tylenol to control fever.  Still had Temperature of 101.7 a few hours later & took more Tylenol.  Couldn?t stop shaking from fever.  Fever kept returning when Tylenol wore off.  Last fever was 101.4 on Friday  1/8 at 12PM.  Took Tylenol every 4 hours.  Still had severe body aches throughout entire day/nite of 1/8.  No fever Saturday 1/9 but still have body aches & pains.  Injection site still red, swollen, tender & sore.
Patient was given Pediatric dose of Hep B. Patient was revaccinated at a later date with Adult dose of Hep B.
1 week after, patient fell on an asleep leg.  Since then, despite no trauma to neck or head, has been persistently dizzy and unsteady.  Also chronic neck pain.
Vesicular rash on trunk 26 days after Immunization administration, rash non tender, pre eval.
This case was reported by a other health professional via call center representative and described the occurrence of erythema urticarial in a 17-month-old female patient who received KINRIX (batch number 4F49N, expiry date 13th November 2017). On an unknown date, the patient received KINRIX .5 ml. On an unknown date, less than a month after receiving KINRIX, the patient experienced erythema urticarial and inappropriate age at vaccine administration. On an unknown date, the outcome of the erythema urticarial and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the erythema urticarial to be related to KINRIX. Additional details were provided as follows: This case was reported by a medical assistant (MA). The patient received KINRIX at 17 months age, which led to an inappropriate age at vaccination. The patient also developed a red welt on her leg.
This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 the subject received a dose of FLULAVAL (details unknown). On either 4 or 5 October 2010, less than one week after vaccination with FLULAVAL, the subject experienced a 2-4 inch area of injection site tenderness, injection site redness and hotness at injection site. At the time of reporting the events were improved. The healthcare professional reported that she gave approximately 40 vaccinations to employees and has had 7 reports of a 2-4 inch area around the injection site that was tender, red and warmer than the surrounding skin. This is case 4 of 7 (see case IDs A0885121A, A0885268A, A0885269A, A0885271A - A0885273A for the other reports). The healthcare professional also reported an additional subject who experienced different adverse events following vaccination with FLULAVAL (see case ID A0885114A for more details). Follow-up information indicated that this subject was 29 years old at the time of events. No additional information was provided.
patient's sugars spiked by 40-60 points and sustained at elevated levels despite not eating any triggering foods; pregnant :Yes; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 at 04:15 (at the age of 40 years) as single dose in the left arm for COVID-19 immunization. Medical history included gestational diabetes and asthma. Last menstrual period was on 11Jun2020. Concomitant medications included pyridoxine hydrochloride (B6); doxylamine succinate (UNISOM [DOXYLAMINE SUCCINATE]); acetylsalicylic acid (BABY ASPIRIN); magnesium. The patient previously took methylprednisolone (MEDROL DOSEPAK) and had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient became pregnant while taking BNT162B2. The patient was 38 weeks pregnant at the onset of the event and was due to deliver on 01Apr2021. On 10Mar2021, the patient's sugars spiked by 40-60 points and sustained at elevated levels despite not eating any triggering foods. It was unknown if patient receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
administered with the vaccine at 13 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered with the vaccine at 13 years old) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered with the vaccine at 13 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered with the vaccine at 13 years old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. No concomitant treatment was reported.
Pretty severe dizziness, chills and nausea starting about 10 minutes after administration and lasting about 20 minutes. A second, milder wave occurred about an hour later.
Generalized hives beginning 30 hours after receiving vaccine. Patient took 50 mg Benadryl 12 hours after onset; recived 8 mg decadron IM, 25 mg Benadryl IM, and tapering course of po prednisone on 8/04/06.
Redness around the injection site; Swelling around the injection site; Soreness around the injection site; Bad itching around the injection site/ itches like crazy; Around the injection site, warm to touch; This is a spontaneous report from a non-contactable consumer or other non hcp. A 77-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 28Feb2021 14:15 as SINGLE DOSE for COVID-19 immunization. Medical history included atrial fibrillation, hypertension (high blood pressure), blood cholesterol increased, hypertension; all from an unknown date and unknown if ongoing. Concomitant medications included apixaban (ELIQUIS), metoprolol, atorvastatin and diazepam (DIAZEPAM) taken for an unspecified indication, start and stop date were not reported. The patient previously administered Bactrim and Iodine experienced allergy for both. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 07Feb2021 14:15 as SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 07Mar2021 05:00 exactly 7 days from the 2nd dose of Pfizer, the patient experienced redness, swelling, soreness and bad itching around the injection site, warm to touch, itches like crazy. The patient stated that she did not experience fever and chills. When I received the second vaccine, the volunteer nurse was irritable and wanting to get it over with. I am not sure if she was new or not. A man walked by and talked and she got very irritated to the point she said she was giving me my shot whether I was ready or not. I did not know the man and just wanted the shot. That shot she gave me hurt and bruised. Now 7 days later I have a big red area a few inches in diameter around the injection site. The events were assessed as non-serious. The patient had a telemedicine visit with the local urgent care. Therapeutic measures included Hydrocortisone cream for the itching, Zyrtec once a day, and maybe Tylenol for any pain or if patient develop a fever, recommended outlining the red area to see if it spreads. Outcome of the events were reported as Unknown at this time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Head ache started at 10:20am took Tylenol. At 12:15 i still have a headache.  If head ache continues i will take more medications.
Breakthrough COVID-19 infection positively diagnosed with an at-home antigen test  on 11/7/2021 and confirmed with a PCR test on 11/8/2021.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot# unspecified) on 12-MAY-2009. It was reported that the patient is in the office for the second dose of GARDASIL (lot# unspecified) late at time of the report on 30-AUG-2012. The patient was not experiencing any known symptoms. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Patient received Moderna Vaccine on Friday 4/16/2021 12:00pm in dialysis clinic.  Over the weekend family called and left a message stating that patient CTB on Friday 4/16/2021 around 8pm.
Covid 19 vaccination provided by patients work (unknown manufacturer) via phone visit pt reports starting Saturday positive swelling in face, hands and feet, reports improvement in swelling at this time. Positive full body aches, fever, significant fatigue and shortness of breath
After taking the second vaccine she had the typical reactions for 24 hrs, then she was fine. At her last OB appt on the Nov 19th her baby heartbeat was strong and fine and mom blood pressure became a little high. A few days later she didn't feel her baby move anymore. She went to the OB and they couldn't feel the baby heartbeat and the dr confirm fetal death. On Nov. 20th she was in her 39th week of pregnancy and she delivered a stillborn male. The baby was due on Nov 24th 2021 and had no prior complications before taking the 2nd vaccine, she had a completely normal healthy pregnancy.
Storage and handling excursion- Patient was given a dose of pfizer vaccine past BUD time of 6 hours- with labeled expiration time of 3:00PM of 8/11/2021 dose was given at 4:34PM . No adverse event was reported, no additional dose was given.
Generalized rash over arms and legs "itching" and slight edema around mouth. Sent to ED MD and given epinephrine and prednisone pack. Released. On date of report to employee health, denied any symptoms.
This spontaneous case was reported by a nurse and describes the occurrence of ATRIAL FIBRILLATION (she was having heart palpitations, then diagnosis her with AFIB) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter once. On 14-Apr-2022, the patient experienced ATRIAL FIBRILLATION (she was having heart palpitations, then diagnosis her with AFIB) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in April 2022 due to ATRIAL FIBRILLATION. At the time of the report, ATRIAL FIBRILLATION (she was having heart palpitations, then diagnosis her with AFIB) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ATRIAL FIBRILLATION (she was having heart palpitations, then diagnosis her with AFIB) to be related. No concomitant medication details were provided.  Patient went to emergency room because she was having heart palpitations. 4th dose, patient stated that she had irregular heart beat and was hospitalized for observation. She was kept over night for observation, then diagnosis with AFIB. No treatment medication details were provided. Company comment: This is a spontaneous case concerning a 76-year-old female patient with no medical history reported who experienced the unexpected and serious (hospitalization and medically significant) AESI atrial fibrillation the same day a dose of mRNA-1273 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. Patient went to ER because she was having heart palpitations. She was kept overnight for observation and was then diagnosed AFIB. Patient´s age remains as a contributory risk factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 76-year-old female patient with no medical history reported who experienced the unexpected and serious (hospitalization and medically significant) AESI atrial fibrillation the same day a dose of mRNA-1273 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. Patient went to ER because she was having heart palpitations. She was kept overnight for observation and was then diagnosed AFIB. Patient´s age remains as a contributory risk factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
pain in right lower extremity few hours  after first and second vaccine. pain then returned and was diagnosed with Right lower extremity DVT
A company sales representative reported that a child received an injection of Prevnar and the next day, developed a "cold." As of the date of this report, no further info was available.
She had her COVID 19 shots, but she doesn't know how many she had. She would guess they were all Pfizer/tested positive for COVID; She had her COVID 19 shots, but she doesn't know how many she had. She would guess they were all Pfizer/tested positive for COVID; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had her COVID 19 shots, but she doesn't know how many she had. She would guess they were all Pfizer/tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: The patient reported that her age was probably close to 60. She stated that she had diarrhea so bad that she had permanently discontinued to taking treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 (BNT162B2 NOS) and the reported events drug ineffective, COVID-19.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M041181 and expiration date 31-MAY-2018 and lot # M038728 and expiration date 25-APR-2018 (dose and frequency were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 34 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005381: US-009507513-1709USA005380: US-009507513-1709USA005382: US-009507513-1709USA002048.
Patient stated her arm swelled and was red. When patient mentioned she had a reaction today upon examination of her arm there was no redness or swelling visible
Allergic reaction, Pruritic Rash, BENADRYL. Kenalog injection. H1 & H2 inhibitors
Arm pain after second dose; 1st dose in June2021 and 2nd dose in October2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain after second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in June2021 and 2nd dose in October2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Gout.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Arm pain after second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in June2021 and 2nd dose in October2021). At the time of the report, PAIN IN EXTREMITY (Arm pain after second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in June2021 and 2nd dose in October2021) outcome was unknown.            Patient Date of Birth was reported.  Concomitant medications include high blood pressure medication and gout medication.  No Treatment information was reported.   This case was linked to MOD-2022-539147, MOD-2022-539162 (Patient Link).   Reporter did not allow further contact
This case was reported by a healthcare professional and described the occurrence of allergic reaction in a female subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Diphtheria tetanus acellular pertussis, manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of Diphtheria tetanus acellular pertussis (unknown). At an unspecified time after vaccination with Diphtheria tetanus acellular pertussis, the subject experienced an allergic reaction. At the time of reporting the outcome of the event was unspecified.