chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Less than 24 hours after the shot I began experiencing unexpected and unusually heavy menstrual feeding and cramps.
Anxiety week after first, confusion, sweats.; Anxiety week after first, confusion, sweats.; Anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 (Lot number: ER8732) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hep B inactive" (unspecified if ongoing), notes: Hep B inactive, Hep c cured, Genital Herpes, Gastroparesis, IBS, arthritis; "Hep c cured" (unspecified if ongoing); "Genital Herpes" (unspecified if ongoing); "gastroparisis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; XANAX; OMEPRAZOLE; PEG3350. Past drug history included: Steriods for Known allergies, reaction(s): "Allergy", notes: steriods, Codeine, ciprofloxacin drugs; Codeine for Known allergies, reaction(s): "Allergy"; Ciprofloxacin for Known allergies, reaction(s): "Allergy". The following information was reported: CONFUSIONAL STATE (non-serious), HYPERHIDROSIS (non-serious) all with onset 13Apr2021 07:00, outcome "not recovered" and all described as "Anxiety week after first, confusion, sweats."; ANXIETY (non-serious) with onset 13Apr2021 07:00, outcome "not recovered", described as "Anxiety". It was unknown if therapeutic measures were taken as a result of confusional state, hyperhidrosis, anxiety.  Additional information: The recent COVID-19 vaccine was administered in School or Student Health Clinic. 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, has the patient does not test for COVID-19. The patient did not take other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: grapefruit size redness/swelling of arm
he woke up with delay onset of rash on his arm. It was pretty large, 3 inches by 2 inches of a rash where the injection site was; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE RASH (he woke up with delay onset of rash on his arm. It was pretty large, 3 inches by 2 inches of a rash where the injection site was) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced VACCINATION SITE RASH (he woke up with delay onset of rash on his arm. It was pretty large, 3 inches by 2 inches of a rash where the injection site was). At the time of the report, VACCINATION SITE RASH (he woke up with delay onset of rash on his arm. It was pretty large, 3 inches by 2 inches of a rash where the injection site was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not on any concomitant medication.  Patient received first dose of the pediatric Moderna COVID-19 vaccine. Rash was not raised. It was reported that no pain from the rash.  Batch/Lot number and expiration date was unknown.  Patient did not received any treatment.
Body ache; Pain bones; Fever; Feeling tired; chills; Headache; Sore arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), BONE PAIN (Pain bones), PYREXIA (Fever), FATIGUE (Feeling tired) and CHILLS (chills) in a 45-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.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Body ache), BONE PAIN (Pain bones), PYREXIA (Fever), FATIGUE (Feeling tired), CHILLS (chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm injection site). At the time of the report, PAIN (Body ache), BONE PAIN (Pain bones), PYREXIA (Fever), FATIGUE (Feeling tired), CHILLS (chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported   This case was linked to MOD-2021-037299 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: As per the TCR Report received on 12-May-2021 has denial for further follow up and to contact the patient.
Painful Red Rash/Bruise the size of a softball on R Arm at spot of injection site. Rash was noticed morning of the 29th, but arm started to feel sore the night before. No current treatment is being done.
This case was reported by a healthcare professional and described the occurrence of facial rash in a 9-month-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 25 June 2008 at 09:45 the subject received 3rd dose of ENGERIX B at 0.5 ml in the left thigh. On 26 June 2008, 1 day after vaccination with ENGERIX B, the subject experienced facial rash, abdominal rash and back rash (systemic reaction). The healthcare professional considered the events were clinically significant (or requiring intervention) as treatment with BENADRYL and AVEENO bath were recommended. It was not reported that the subject actually received these treatments. On an unspecified date in June 2008, the events resolved. The healthcare professional considered the events were probably related to vaccination with ENGERIX B.
Patient received 1st dose over 2 years ago didn´t get the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 26-APR-2022 Reporter's Comments: The pharmacist stated that a patient received the first dose of Shingrix over 2 years ago and would like to know if she needs to restart the series. The health care professional did not have date of birth at this time. The reporter consented to follow up via postal. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.
Redness and swelling at injection site.  Treatment: Benadryl & Tylenol.
This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 4-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 29th November 2016, the patient received KINRIX (intramuscular) 0.5 ml. On an unknown date, less than a week after receiving KINRIX, the patient experienced injection site warmth, injection site swelling, injection site pain and injection site redness. On an unknown date, the outcome of the injection site warmth, injection site swelling, injection site pain and injection site redness were unknown. The reporter considered the injection site warmth, injection site swelling, injection site pain and injection site redness to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to health department. At 13.9 hours, the patient received a dose of KINRIX on her right arm. On the same day, the patient concomitantly received MMRV (non-GSK) vaccine on her left thigh. The batch number reported for MMRV was M026879 with expiry date as 27th November 2017. On 1st December 2016, reporter brought the patient back to see physician because her upper right arm was red, warm, swollen and was hurting. The redness was up to the size of the patient's palm. The physician was also notified about this situation. Further details were unable to obtain. The reporter's call was transferred to Medical Information (MI). The reporter also reported similar adverse events for 4 other children (see cases US2016180181, US2016180183, US2016180270 and US2016180187) that received the same lot of KINRIX vaccine.
Vaccine 1-unusual headache x 4 days-rizitriptan-relieved . Vaccinine 2- same unusual headache x 2 days plus. neck muscle pain , limited range of motion, heat compress and stretching-still  not resolved
fever; This spontaneous report was received from a lawyer, regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (# US-009507513-1704USA010973), and refers to female patient of unknown age. The patient smoked cigarettes for 15 years. Her concurrent conditions included chronic obstructive pulmonary disease (COPD), methicillin-resistant Staphylococcus aureus (MRSA) and emphysema. The patient's medical history included chickenpox and shingles. On an unknown date in 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient got fever. The outcome of the event was unknown. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided. This is one of two cases concerning the same patient.; Sender's Comments:  US-009507513-1704USA010973:
Case number PHEH2014US004803 is an initial spontaneous report received from a medical assistant on 06 Mar 2014: This report refers to an adolescent male patient. He was given only the MenCYW-135 component of MENVEO (batch number: X13051) intramuscularly without being reconstituted with MenA on 04 Mar 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
sick; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for three patients. This is the first of three reports.   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization on an unknown date. The patient (a CCU RN (nurse)) called in sick the following day after receiving the 2nd dose of the vaccine on an unknown date. The outcome of the event sick was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021039442 Same reporter, same product, same event, different patients;US-PFIZER INC-2021039440 Same reporter, same product, same event, different patients
Painful, swollen red, hot to touch noticed vaccine 1-2 hours after receiving vaccine.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: The patient grandfather reported for the patient that she got very sick from the vaccine.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101281144 same reporter, different patient
pt fainted within 5 mins after shot. Head hit the floor. Instucted pt to lay down and feet up at least 15-30 mins or until feeling better. Pt can sit up after 20 mins and requested protein bar bc he was in the middle of intermetten fasting (no eating for 18 hours and eating within the 6 hours). Blood pressure 141/87 with pulse 75. Pt felt fine , forehead not hurting unless touch the area .
On 05/03/2001 the patient experienced redness and warmth at the injection site. The patient went to the local emergency room and was treated with antibiotics. Additional information has been requested.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 51-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at that time. It was reported that no adverse reactions were reported.  No treatment information was reported.
7NOV98 respiratory arrest taken to hosp;no prior problems noted-child was nl & appeared healthy day of vax;no prev events noted;
High fever (still have) Sweats  (comes and goes) Shivering (stopped) Nausea (still have)
My symptoms were a lot of coughing, body aches, and low-grade fever. These symptoms lasted for several days. I tested positive for COVID-19 on March 1, 2023. I spoke with the doctor on day 3 of my symptoms and received PAXLOVID.
From 1am to 5:30am - High fever 102+ degrees, delirium, fast breathing, chills, shortness of breath, weakness, slight nausea Since then weakness, fatigue, loss of appetite, fog brain.   It felt as if I had an adrenal crisis as opposed to a fluish feeling.  There were no activities or events that day that would cause an adrenal crisis like this, especially in the middle of the night. .   Due to the delirium, I didn?t realize I was sick.  At 5:30, was conscious and chills had stopped.  I took 500mg of  Tylenol and fever broke.  Today I am weak and mostly bedridden.    fatigue, loss of appetite
whole body sever itching.  Scratched shin raw, back had hives, abdomen continues to sporadically itch.  Never experienced  itching of this nature this before.  MUCH BETTER, but not fully resolved.   (My Mother had same response to her second Moderna COVID19)
Pt developed a red rash on his face on 6/27/13 and by 6/28/13 they had spead all over his body.
Mom states pt had bumps on chest 1Feb91,/p recvd immun. Rash moved to arms &stomach was pink & looked like goose bumps, on the 7th got more rash-had been in sun 2 days before &got rash around neck, all over x/ legs & face. MD felt unrelated
Patient reports left shoulder pain that possibly started after receiving second dose of the  Moderna vaccine.  She reports left shoulder pain started several months ago and believes possibly around the time after receiving vaccine to left arm.
States feeling clammy, BP elevated during first 15 minutes of observation post vaccination, all other VS normal.  Kept in observation until blood pressure down and no longer symptomatic, no further incident reported.
received a 0.50 ml  BOOSTER dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (received a 0.50 ml  BOOSTER dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (2nd dose) and PFIZER BIONTECH COVID-19 VACCINE (1st dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 18-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (received a 0.50 ml  BOOSTER dose). At the time of the report, ACCIDENTAL OVERDOSE (received a 0.50 ml  BOOSTER dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.  It was reported that patient received a 0.50 ml BOOSTER dose instead of a 0.25ml booster dose because of a administration error.
Redness about 2 inches wide, slightly raised, and itchy. Soreness for 2 days after injection.  Soreness stopped after 2 days. Redness and itchiness continued to day 9 after injection.  Day 10, still have redness but no longer itchy.
developed fever, chills, hedACHE, AND MARKED , initial symptoms resolved except for fatigue, the developed sever Poly Tendonitis until i was unable to walk, I was then started on metotrexate and predisone, tendonisits resolved, hey i got boster dose and subsequently developed Shortness of breath, and Arrythmia (Apcs) the shortness of breath got worse to the point that after waliking 4 blockd I was gasping for air, I was taken off Methotrexate and predisone  but continue to hove arrythmia and shortness of breadth anf v=chest wall pain A year ago i was healthy waling 3 miles a day up and down hills, but am unable to do this now.
Alzheimer disease; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 85-year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "subdural hematoma", start date: 2019 (unspecified if ongoing); "cognitive age-related impairment", start date: 2017 (ongoing). The patient's concomitant medications were not reported.Alzheimer disease The following information was reported: DEMENTIA ALZHEIMER'S TYPE (medically significant), outcome "unknown", described as "Alzheimer disease". The patient's daughter went part-time for work around 2015 because that is when she started to realize that her mother (the patient) couldn't do her pill box or do stuff like that anymore. The daughter started to accompany her mother to all of her doctor's appointments. At that point is when she noticed it but she thinks it started even prior to that. They did testing and at first it showed just cognitive age related impairment on that initial testing in 2017 and then they did testing again in Mar2021 or so and that showed definite change. They also did a functional MRI that showed loss of volume in regions that are pretty commonly associated with Alzheimer's. Her mother is on donepezil (ARICEPT) to try and help with that, she is on the max dose of 10 BID. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: loss of volume in regions. Therapeutic measures were taken as a result of dementia alzheimer's type.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on available information and known safety  profile the reported "Alzheimer disease"  is an intercurrent medical condition and is unrelated to  bnt162b2.  Case will be reassessed if additional information is received.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200133054 same patient, different dose (2)/ events;US-PFIZER INC-202200149139 same patient, different doses (1,2,3)/events;US-PFIZER INC-202200221790 same patient, different dose (3)/events
Syncope, lightheadedness. Observation had him walk and he fainted while walking. Ate Crepes for breakfast, lunch he had chips and a small cup of water.