chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Less than 3 weeks after receiving DTP vaccine, my daughter had at least one episode of seizure activity. Since then, she has had multiple seizures and multiple types of seizures including grand Mal requiring emergency lifesaving treatment. She has taken antiepileptic medication since infancy, daily. She had had hydrocephalus known since birth and VP shunt placed 6/23/94 for hydrocephalus.  Annual follow up on 03/31/04: "Pt did not recover from adverse events.  Seizure disorder, Encephalopathy/organic brain syndrome, ADD, cerebral palsy, communication disorder, other learning disabilities associated with the brain injury. "
Chills, vomiting, headache after 30 hours of receiving COVID-19 Vaccine
Pneumonia; received his first dose of the Pfizer COVID-19 vaccine on 22March2021 and then was diagnosed with COVID-19; received his first dose of the Pfizer COVID-19 vaccine on 22March2021 and then was diagnosed with COVID-19; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on 22Mar2021 as 1st dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Mar2021, the patient received first dose of the Pfizer COVID-19 vaccine and then was diagnosed with COVID-19. On 04April2021, the patient was hospitalized. The patient also developed Pneumonia, The patient received Remdesivir treatment and the patient was doing well now. The outcome of the events were resolved on an unspecified date.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the information currently available and close temporal association the lack of efficacy of the vaccine BNT162B2, the causal association of the reported events COVID-19 and pneumonia with the usage of the vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
shingles across his head and face/diagnosed with herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 02-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered severe, painful and debilitating shingles across his head and face. The patient was diagnosed with herpes zoster and underwent extensive medical treatment. The patient has permanent scarring on his head and occasional itching above his eyes to this day. These injuries and medical treatment were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster was not recovered and causal relationship was assessed as related.   The lawyer considered the event herpes zoster to be disability.
Very shortly after my injection on 3/7/21 (within 1-3 days after injection is when I first noticed) I have had a high pitch, steady (not pulsating) ringing in my head. It doesn't seem to favor either ear, just the sound is consistent in my head. It has not gone away, it is every day - all day.
pt recvd vax & arm where vax given was red; inflamed & warm to touch from inject site to elbow;
He got his vaccine, then he waited for the 15 minutes, and went back home.  That day he had a headache, but nothing serious or concerning.  It has been a whole weak and nothing major changed.  Since yesterday he has what they described in the beginning, depression in the left side of his heart, shortness of breath and rapid heart beat.  He has not called his doctor or gone to the ER.  He now has BP monitor and it has been morning, while on the phone he did his BP and it was 147/102.  This is a little bit lower than it has been.  Oxygen level right now is 98, BPM 97.
feel the side effects/effects of the booster last; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (feel the side effects/effects of the booster last) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (feel the side effects/effects of the booster last). At the time of the report, VACCINATION COMPLICATION (feel the side effects/effects of the booster last) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Afebrile: ~34 lesions trunk area (x5-6d) itchy.  Low grade temperature.
Starting with 1st shot, noticed the increased psychological effects stated in the medical records. Not recovered.
Acute interstitial pneumonia with significantly elevated CRP -  occurred 3 days following vaccine administration.  Steroid responsive.  BAL negative for expanded infectious workup.  No other constitutional symptoms of note.
I received the shot on 7/29 and immediately had a terrible headache and had to wear sunglass inside the light was painful. On Friday 7/30 I experienced calf numbness which continued throughout the weekend. On 7/31 I woke up in the middle of the night in a sweat and felt numbness in my calves and had a migrane. The morning of 8/1 I woke up feeling awful. I got up to get my daughter out of her crib and fainted while walking to her room. The remainder of the day I felt awful.
This spontaneous report was received from a physician, concerning a 1 year old patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was inadvertently vaccinated with GARDASIL 9 1 dose, for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA011516.
Patient vomited 4 minutes after being vaccinated.  She reports that she has menstrual cramps today and not feeling well to start.  She also reports that she gets very nervous with vaccination.  Patient vomited/gagged about 4 times.  Also complained of sweating.  Reports no other symptoms and symptoms resolved after 20 minutes.  Patient reports that she has similar symptoms with blood draws.
Dizziness resolved in 20 minutes. Shortness of breath treated with Albuterol inhaler resolved in 20 minutes.
Hospitalized 09/20/2021; COVID-19 positive 09/20/2021; fully vaccinated  DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: a 85 y.o. female with past medical history significant for HTN, HPL, diet controlled DM 2, OA. She presented to the ED due to the above complaints.  Patient states she started feeling unwell about 9 days ago. Since that time she has been experiencing generalized weakness, poor appetite, and fevers. More recently she has developed shortness of breath which has been progressing as well as cough.  She is vaccinated against COVID. Upon arrival to the ED, patient was AF but hypoxic. She is currently on 2L of supplemental oxygen. Basic labs were obtained and significant for + COVID PCR. CTA thorax was obtained and was negative for PE but did demonstrate scattered groundglass opacities throughout both lungs suggestive of atypical infection. She was treated with Decadron 6 mg daily for 4 days.  Which she will continue for 6 more days.  She was not a candidate for remdesivir, due to she was symptomatic >10 days.  She should stay in isolation until she finish her Decadron. Initially she required oxygen support, but by the time of discharge she was in her home.
This serious spontaneous case, initially received from pharmacist on 29-Oct-2018, concerns a male patient of an unspecified age. Since an unspecified date, the patient was on chemotherapy. On an unspecified date, the patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number and expiry date: not reported]. On an unspecified date, after vaccination, the patient had large, swollen lymph nodes under his arm. It was reported that the patient would receive a steroid injection as a treatment. At the time of this report, the outcome of the event was not reported. This case: 201805077 was cross-linked to case: 201805075 due to same reporter.
Patient had intussusception 6/22/14 and had exploratory laparotomy surgery on 6/23/14.
Headache, Myalgia, NauseaVomiting, WHOLE ARM OF INJECTION SIDE, INJECTION SITE PAIN Narrative:
Malaise and decreased libido, began about 2 hours post vax, and lasted approximately 12 hours.
PATIENT HAD PFIZER VACCINE ON 01/06/2021, 01/27/2021, AND TESTED POSITIVE TO COVID
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO. On 5th March 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 5th March 2018, unknown after receiving BEXSERO, the patient experienced vaccine administered at inappropriate site. In March 2018, the patient experienced injection site pain (serious criteria disability), fever (serious criteria disability) and injected limb mobility decreased (serious criteria disability). The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the injection site pain, fever and injected limb mobility decreased to be probably related to BEXSERO. Additional details were provided as follows: Field representative was reporting on behalf of healthcare professional. The Patient was teenager, specific date of birth or age was unknown. The age at vaccination was not reported. Injection site reaction was described as pain. There was pain present at time of BEXSERO injection, and then the pain woke her at 3 am on the morning following injection. The patient could not use her arm due to pain. The patient also experienced a fever of 101 degree F which had now resolved. Events were managed with TYLENOL and ibuprofen. The reporter also mentioned that the injection was given high on the arm, which led to inappropriate site of administration. He felt as though it might had been above the deltoid. The healthcare professional was not treating physician, he was patient's father. Treating physician unknown by field representative. Field representative planned to forward healthcare professional questions onto MSL, so MSL may also submit adverse event details to Agency.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 13-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event; ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes administered to the patient: yes with no reported adverse event; Initial information was received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 18 months old male patient who reported that ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event and ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes administered to the patient: yes with no reported adverse event after receiving ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2023, the patient received a dose of 0.5 ml of suspect ipv (VERO) (Suspension for injection) (lot V1A021M, Expiry date :27-Feb-2024) (strength was unknown) via intramuscular route in unknown administration site for Immunization and developed a non-serious event of ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event (product storage error) and ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes administered to the patient: yes with no reported adverse event (poor quality product administered) (latency : same day) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event and was Unknown for the event ipol (opened) exposed to a temperature excursion.accidentally left the refrigerator door open too long. low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes administered to the patient: yes with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Right eye bleed. Blood spots over my torso/trunk. Happened after the first dose but I thought it was random. Same thing right eye bleed with pain. Bloody spots over my torso/trunk. Both developed over 48 hours after the dose. Saturday I developed a high fever, severe malaise and arm pain at the injection site. I most most concerned about my eye and the bloody spots over my trunk.  Patient received first Pfizer dose on 11/19/21 lot # FE3590.
horrible hot flashes; night sweats; menopause; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: HOT FLUSH (non-serious), outcome "unknown", described as "horrible hot flashes"; NIGHT SWEATS (non-serious), outcome "unknown"; MENOPAUSE (non-serious), outcome "unknown".  Additional Information- Patient received two Covid vaccines a year ago and had horrible hot flashes and night sweats since. Patient was 65 and through menopause, was also through with night sweats. she would like to know if there was anything she could do to made it stop. She was miserable asked for help.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Significant fever, nausea, dizziness, trouble walking, sweating, inability to care for self/child
Parent states patient seen at ER on 9/5/08 1am. Parent states right leg was hard, red and swollen. Patient given oral steroids at ER.
temperature 103, HR 130; 11pm-6 am, HR elevated from 12/14- until 2/16 ( 48 hours post injection
Systemic: non-allergic rash, see details-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient vomiting about ~30 minutes after receiving vaccine and arrived at store showing rash (non-raised, light red spots on left hand) ~7 hours post administration (no other sx's), referred to urgent care immediately
Watery non-bloody diarrhea, fever to 101.8 deg F, Cephalaud to caudal red dotting rash.
Did not have cold - healthy before on 10/26/15 48 hours after shot given 10/26/15, I developed sudden extreme congestion choking wheezing for 3 days. Mucous was so viscous it would not come out - at times it could be pulled out in one long 24 inches string without breaking with bristles of toothbrush scraping the throat.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # L007558, expiration date 10-NOV-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 40, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication was reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case( Same reporter)
30 hrs post inject had a resp failure & was put on a respirator; no other organs involved; severe eosinophilia, lung biopsy showed eosinophilic infiltration; tx w/pred & improved & removed from ventilator on 18NOV92; will do skin testing i;
The pt experienced a fever of 104 within 24 hours post vax that lasted 12 hours.
Patient complained about headache then next day stated she had diarrhea and vomiting 11/6/12 then store asst. director stated patient went to hospital 11/09/12 and patient stated she has Guillain Barre syndrome. We at the pharmacy have not confirmed from patient or hospital yet on diagnosis.
I felt fine the day of the vaccine but I woke up at 3:45 AM.  I was so cold that I was shaking, I ached all over.  When I got up my temperature was 102 and in stayed between 101.5 and just over 102 for about 30 hours.  I also had cold like symptoms, a cough and diarrhea.  It wasn't until 48 hours after the shot that my temperature was normal.