chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Everytime I have had one of the injections, I had chest pain and heart palpitations. Starts right after I have the shot and continue for days. But I could feel my stomach hurting after the shot, maybe 3 hours later, I didn't eat anything until 6 hours later. And then after I ate,  a cake mix muffin, then within 30 mins or so, my stomach started bubbling really bad, went to the bathroom. Last night I went about 6-7-8 times. I thought It was over until I got up this morining and I had diahrea again. It wasnt making me throw up. I have ibs, so I usually suffer from constipation. Thats how I know it's the vaccine.  I usually suffer from high blood pressure, from the 4 vaccines I received, my blood pressure would get high. The 2nd shot, my bp got extreamly high, and I had to go to the er. But last night my bp was 105/67.  This was around 2am.
Due to language barrier, vaccine was administered to an 8 year old. Mom was asked multiple time  if this is the child name which she answered yes, she was told to verify all info and sign for consent which she did ( which we later found out she just signed someone else form and did not understand anything asked). Patient arm was punctured but retracted as soon as  we  figured it out. Cannot determine exactly how much was injected ( but not full dose of 0.3ml)
Patient was administered with expired vaccine.; One day before the vial was used for administration, it was initially stored in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine.) and PRODUCT STORAGE ERROR (One day before the vial was used for administration, it was initially stored in the refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 067F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine.) and PRODUCT STORAGE ERROR (One day before the vial was used for administration, it was initially stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine.) and PRODUCT STORAGE ERROR (One day before the vial was used for administration, it was initially stored in the refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the number of doses/vials used were unknown and the number of doses were administered to unknown number of patients on 5 separate days after the manufacturer date of expiry from 5 different vials.  The date(s) of administration of vaccine were reported as 18 Apr 2022, 25 Apr 2022, 26 Apr 2022, 16 May 2022 and 17 May 2022.The vial hadn't undergo any temperature excursions.  No treatment medication were reported.
This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), BRADYCARDIA (Developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose) and HAEMORRHAGE (Found herself in blood) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included AFib. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HAEMORRHAGE (Found herself in blood) (seriousness criterion medically significant), FALL (Fell down  and  hit the pole) and HEART RATE DECREASED (Heart rate was low/heart rate of 45 to 50 pulse per minute after the first dose). On an unknown date, the patient experienced BRADYCARDIA (Developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose) (seriousness criterion medically significant) and CHEST DISCOMFORT (feeling of tightness in her chest). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), BRADYCARDIA (Developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose), HAEMORRHAGE (Found herself in blood), FALL (Fell down  and  hit the pole), HEART RATE DECREASED (Heart rate was low/heart rate of 45 to 50 pulse per minute after the first dose) and CHEST DISCOMFORT (feeling of tightness in her chest) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: low (Low) Low heart rate below 50.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As per report patient went to a cardiologist where he performed several tests and everything came normal and could not figure out the cause for patient's low heart rate.  No treatment medication information provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of atrial fibrillation (A Fib) and use of concomitant medication acetylsalicylic acid could probably be contributory factors to the events.   This case was linked to MOD-2021-300180 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of atrial fibrillation (A Fib) and use of concomitant medication acetylsalicylic acid could probably be contributory factors to the events.
Shoulder joint was very sore; different from usual muscle soreness from previous shots.  Limited shoulder mobility with onset of soreness.  Unable to fully move the shoulder joint without pain. It was noticed later that day that the injection point (where the little spot of blood and bandaid was) was located at the top of shoulder at the joint.
Shingles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) 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) UNKNOWN. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       NO CONCOMITANT AND TREATMENT DRUGS WERE USED.
Day of injection: Sore arm at injection site, but extended length of the arm for the next three days. Hurt to even lift arm or lay on it. Day after injection: Pain on same side as injection from left ear all the way down left leg, headache, drowsiness, body aches. Slept about 12 hours that night.
pt recvd vax; arm became swollen, red, painful,itched;swelling & redness disappeared over 10-14 days; pain & tenderness still present especially w/ movements in arms;
8 days after the vaccine was received injection site became tender to touch, visibly swollen and red.  redness and swelling approximately 5 inches in circumference. Some itching currently not severe. Notified my PCP via email.
10/6 - vaccine given. 10/14 - mother notice "red spot" at injection site. Measure 30 mm x 12 mm.
Case number PHEH2016US023411 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 29-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the right arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Fever of 101 Severe body aches Severe Joint pain Headache Breathing difficulty
beginning 6 or 7 days p/vax devel sl lethargy, t99.4, rhinorrhea followed by 3-4 day course of breaking out in vesicular erythematous based rash which itched & scabbed over approx 50-75 lesions total; appeared to be a mild case of chickenpo
CLIENT REPORTS SHE STARTED EXPERIENCING PAIN,TENDERNESS AND SWELLING UNDER HER RIGHT ARMPIT AREAS ONE DAY AFTER RECEIVING A MENINGICOCCAL VACCINE IN HER RIGHT DELTOID MUSCLE ON 06/27/07.
Onset of chills the evening of the injection.  The following day, approximately 21 hours after injection developed worsening aches and chills.  Fatigue started around 1400 the day after injection (2/19/21).  That evening diarrhea, nausea and vomiting progressed.  Debilitating nausea occurred all day on 2/20/21.  Diarrhea remained until 2/22/21.
Headache; Got extremely ill; His arm hurt for days; Shortness of breath; He had chills; Fever; Was sleeping like a vampire / didn't wake up until 07:00PM to 08:00PM at night; No appetite; Felt chest pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 29Oct2021 03:00 (Lot number: FD0809) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (hospitalization) with onset Oct2021, outcome "unknown", described as "His arm hurt for days"; DYSPNOEA (hospitalization) with onset Oct2021, outcome "unknown", described as "Shortness of breath"; CHILLS (hospitalization) with onset Oct2021, outcome "unknown", described as "He had chills"; PYREXIA (hospitalization) with onset Oct2021, outcome "unknown", described as "Fever"; SLEEP DISORDER (hospitalization) with onset Oct2021, outcome "unknown", described as "Was sleeping like a vampire / didn't wake up until 07:00PM to 08:00PM at night"; DECREASED APPETITE (hospitalization) with onset Oct2021, outcome "unknown", described as "No appetite"; CHEST PAIN (hospitalization) with onset Oct2021, outcome "unknown", described as "Felt chest pains"; HEADACHE (hospitalization) with onset 30Oct2021 03:00, outcome "unknown", described as "Headache"; ILLNESS (hospitalization) with onset Oct2021, outcome "unknown", described as "Got extremely ill". The patient was hospitalized for pain in extremity (start date: 31Oct2021). Therapeutic measures were taken as a result of pain in extremity, sleep disorder, headache.  Clinical course: Patient says his arm hurt for days after the shot and for treatment he put ice on it. He says he was put into the hospital 31Oct2021 as a result of that injection and went home a couple hours later. He says the hospital gave him meds for the headache he had had for four days. He says at first he tried to take Motrin for the headache but that didn't do nothing, and the hospital gave him something then told him to take Tylenol from now on, which he took over the counter extra strength for the dose. he was in perfect health before he got the vaccine.  No follow-up attempts are possible. No further information is expected.
Patient dreamt she was having a stroke around midnight (estimated) the night of her vaccine. Woke with LUE/LLE weakness and facial droop. Did not immediately report, but after persistent symptoms presented to ED 3/10 for evaluation. MRI showed early infarct right frontal lobe in setting of extensive chronic ischemic small vessel disease throughout the periventricular and subcortical white matter. MRA head/neck negative. EKG: NSR
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 03-APR-2018 the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N005274, expiry date: 03-APR-2018) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (59.6 degree Fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA005621; US-009507513-1804USA005625; US-009507513-1804USA005629; US-009507513-1804USA005628; US-009507513-1804USA005624; US-009507513-1804USA005623; US-009507513-1804USA005626; US-009507513-1804USA005630; US-009507513-1804USA005627; US-009507513-1804USA005622.
When getting the injection, at the end of it, when the provider pulled out the needle, some of the vacine came out as well and dripped/ ran down my arm to my elbow. I remarked on it, as did she.  She saw it happen and was aware of it,  it was clearly a surprise to her.   When the vacine drops ran down my arm to my elbow, administer expressed dismay, and took her fingers and ran them over the drips, back up my arm to the injection site, and patted it , saying something like that should have gone in there. And then expressed, some kind of exclamation of surprise.  Of the  - oh my -, or -whoopise- variety.  All of which made me think it was unusual and not right.  Then she said nothing.   Patted it up with a tissue.   I asked, about what had happened, and she said something to the effect that she thought I had gotten enough, and was covered.  If I had had more presence of mind at the time I should have asked to speak with a supervisor.  Since the dose is small, I don?t know how many drops can spill and someone is still covered ?  and what follow up protocol is for my situation, if there is any ?
I started with low-grade fever and chills about 12h after receiving my second dose of the Pfizer covid19 vaccine. Chills lasted for about 15min, they were of moderate intensity. Then I had low grade fever, body ache and tiredness for the entire next day (01/08/2021); it was bad enough to interfere with my regular activities of work and childcare. I ended up taking the day off. On the following day (01/09/2021), I woke up fully restored.
Discovered 3 swollen lymph nodes on neck, behind left ear. Put warm compress on affected area. As of 04/24/2017, lymph nodes are still swollen.
itching; Skin eruption; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and RASH (Skin eruption) in a female patient of an unknown age 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 PRURITUS (itching) and RASH (Skin eruption). At the time of the report, PRURITUS (itching) and RASH (Skin eruption) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pfizer COVID19 vaccinations given on 5/5/21 and 5/26/2021.  Patients last menstrual period 4/27/2021 prior to pregnancy.  Spontaneous abortion/miscarriage at 7 weeks gestation on 6/24/21.
Red, erythematous, rash over entire area of vaccine. Was warm to touch, patient did not receive medical attention. Patient was also fevered and fatigued for a few days following Pneumovax administration.
VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATER AFTERNOON.
No additional adverse event reported; The patient was vaccinated with improperly stored PROQUAD; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On an unspecified date, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rHA(Lot# U010746 and expiration date 03-OCT-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). On 09-DEC-2021, the vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius for 0 hours 10 minutes and 0 seconds and minus 10 degree Celsius to 8 degree Celsius (7.4 Celsius) for 8 hours 20 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided.
Case number PHEH2016US023462, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 25-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscularly into left arm on 16 Feb 2016. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense malaise for 24 hours followed by 2.5 days of fatigue
I woke up the morning of  April 24 with a swollen injection site. It?s painful and red. It was fine after. It didn?t swell up until almost 10 days later.
Next day evening mom noticed right arm hot to touch, red and swollen, palm size spot. Left arm red and swollen size of quarter. ER visit same night. TX: Benadryl and ice pack. R resolved 3-5d, L resolved 10d.
10:00 am received vaccine @ medical center right side of mouth felt strange on the way home. 13:00 pm right side of mouth continued to feel strange.  Looked in mirror and noticed uneven smile, right side of mouth drooping.   13:35 pm messaged my primary care MD.  And called Nurse triage. 14:00 pm Nurse triage advised me to go the emergency room ASAP. 15:00 pm @ Emergency room.  Stroke code called, labs, CT, MRI completed.  Diagnosis Bell's palsy.  Went home with steroid and anti-viral.   Symptoms are improving.
Chills and fever. It was only 99 and later in the day it was 99.5 and nausea. Weakness.
Has itchy rash on forearms and front of legs @ one week after the immunization, and presented to the pharmacy 11/10/15.
During bath mom noted rash all over-called Dr. and he told her to use BENADRYL prn 10/29/09.
mouth, eye twitching-shoulder numb, arm and hand twitching, rt side body twitching, muscle spasms
Shaking chills with low grade fever and dry heaves (vomiting). Also loss of appetite and general malaise.
mild rash around the injection site; This is a spontaneous report from a non-contactable consumer.  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration in 2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In 2020 (five days after vaccination), the patient experienced mild rash around the injection site.  Outcome of the event as unknown.  Information about lot/batch number cannot be obtained. No further information is expected.
received a shipment of fluzone high dose quadrivalent on 16oct2023 that was shipped out on 12oct2023 and vaccines were out of the stability range with no reported adverse event; clinic already had given 4 doses of the vaccine out of stability with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 66 years old female patient who was administered the Influenza Quadrival A-B High Dose HV vaccine [Fluzone High-Dose Quadrivalent] which were out of stability due to reporter received a shipment on 16Oct2023 that was shipped out on 12Oct2023 and vaccines were out of the stability range with no reported adverse event no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Oct-2023, the patient received 0.7 ml dose (frequency: once; strength: high dose) of suspect Influenza Quadrival A-B High Dose HV vaccine of lot number: U8162BA and expiry: 30-Jun-2024 (formulation: not reported) via intramuscular route in the left deltoid for immunization.  On an unknown date, it was reported that a shipment of Influenza Quadrival A-B High Dose HV vaccine was received on 16Oct2023 that was shipped out on 12Oct2023 and vaccines were out of the stability range with no reported adverse event (product storage error) (unknown latency).  On 16-Oct-2023, the patient was already administered Influenza Quadrival A-B High Dose HV vaccine out of stability with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Reproducible joint pains following receipt of Anthrax vaccines 1-6. He also reports experiencing intermittent joint pain following receipt of each of his previous Anthrax shots. The pain affects his hands, neck, back, hips, knees, and ankles, primarily on his right side. The onset of joint pain usually occurred within 8-12 hours of vaccine receipt and lasted about 3-4 days. The pain is described as a dull aching. He rates the pain intensity level ranging from 3 to 5/10. He denies any joint swelling, redness or warmth and has not limited his activities significantly. He self treats with Motrin or Advil when pain occurs. Now, he experiences joint pains at least 5 times per month. He does not recall experiencing fatigue and headaches following previous Anthrax vaccines. He denies experiencing any unusual or prolonged reactions at previous vaccination sites, and specifically denies significant swelling, redness, tenderness, nodules and itching. Symptom: Joint Pain, multiple joints