chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse. A 94-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient experienced low-grade fever at night-time, diarrhea, fatigued and not feeling well. Caller stated her mother is scheduled to get the second dose of the Pfizer-BioNTech COVID-19 vaccine tomorrow. She received her 1st dose 3 weeks ago. She explained her mother has been experiencing either "stomach flu or COVID-19" symptoms since the last 3 days. She specified her mother has "low-grade fever at nighttime, diarrhea and is kind of fatigued." She asked if her mother should get the second dose of the vaccine tomorrow. Reporter emphasize that Her mother's symptoms not related to the first dose. The outcome of the events unknown. No follow-up attempts possible. Information about lot/batch number cannot been obtained.
Information has been received from a  physician concerning a male who "more than a year ago" was vaccinated with varicella virus vaccine live. The physician reported that the pt was seen recently and had presented with a mild case of chicken pox. Additional info has been requested.
Narrative: Employee presented to Occ health for COVID bivalent booster. She was administered COVID Pfizer monovalent vaccine instead of COVID Pfizer bivalent vaccine.
just a little sore arm normal injection, left arm very sore; Fatigue; Walking anxiety attack/Anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: EW0178) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 20Aug2021, outcome "recovered" (21Aug2021), described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset 21Aug2021, outcome "recovering", described as "just a little sore arm normal injection, left arm very sore"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Walking anxiety attack/Anxiety". Therapeutic measures were not taken as a result of fatigue, pain in extremity, anxiety.  Additional information: Caller states he just got his first shot and he has to wait 21 days before the next one, and so far it has been fine, just a little sore arm normal injection, left arm very sore, and a little fatigue the first day but nothing out of the ordinary. He reported that he has anxiety, he was a walking anxiety attack. Patient had no relevant family history and no relevant tests done. Patient did not had any AE prior to vaccination and had no medication prior Vaccinations (within 4 weeks). Any AE(s) did  not require a visit to emergency Room or physician office.  No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 51-year-old female patient who received SHINGRIX (batch number 7447A, expiry date 25th April 2020) for prophylaxis. On 17th April 2019, the patient received SHINGRIX (subcutaneous) .5 ml. In April 2019, less than a day after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), skin warm, redness, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the cellulitis, skin warm, redness and swelling were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the cellulitis, skin warm, redness and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the lateral posterior left arm via subcutaneously, which led to intramuscular formulation administered by other route. The patient was reacted to the dose. The patient called the next day to report their reaction and then was seen at the time of reporting and was being treated for cellulitis.
Pain at Injection Site; Fever of 101.5; Chills; Shaking; Headache; Burning Eyes; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, chills, tremor, headache and burning in eyes. On 25th September 2020, the outcome of the injection site pain, fever, chills, tremor, headache and burning in eyes were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, tremor, headache and burning in eyes to be related to Shingrix.  Additional details were reported as follows: On 24th September 2020, less than a day after vaccination, patient experienced chills, shaking, fever of 101.5, pain at injection site, burning eyes, and a headache. Till the time of reporting, the patient had no symptoms and patient wanted to know if he should get the next injection. Reporter was provided with the Medical Disclaimer and was encouraged to see his physician and also provided the information in content, including the PI. The reporter consented to follow-up.
The patient had a seizure; back arched, eyes rolled back in head, arms went rigid, she made moaning sounds and has no memory of the event. She was very hot and pale and could barely walk.
4hr p/vax pt had 30sec apneic episode& turned blue;had high pitched cry & listlessness;hosp overnoc for monitoring, begun on pred;temp only sl elevated responded to around the clock APAP;
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a female pt who experienced extra dose of Prevnar and antibody result abnormal.  The pt received a dose on an unspecified date. Relevant medical history was not provided.  Indication for Prevnar was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day.  Concomitant medications were not reported.  The pt experienced extra dose of Prevnar (accidental overdose) and antibody result abnormal (antibody NOS abnormal).
I went back to the doctor for a follow on my blood work after I had my second booster. He ran a complete blood panel work up on my blood that came back showing that my white blood count was extremely low as well as my platelet. These numbers are low enough that I should be in the hospital. He prescribed Prednisone for 30 days. I will be doing blood work every two weeks to monitor my white blood count and platelets.
Erythema, edema, pain...(5 X 3.5 cm.) right deltoid. "Hive like lesion on injection site."
patient's inside of mouth felt hot day after vaccine and within a couple days has felt like sores inside. patient unsure if from vaccine or from shrimp and sauce she ate that night of vaccine, but occasionally eats shrimp. she is trying Benadryl to see if that helps - informed patient to call 911 if swelling of throat, mouth, tongue and/or shortness of breath occur. (patient not currently having these symptoms)
23 Feb 2021: event: fainting spell, nausea, no prior warning 26 Feb 2021: doctor visit, fitted with heart monitor 1 March 2021: Doctor visit, readout of heart monitor showed no anomaly. 16 Mar 2021: event: fainting spell, nausea, no prior warning 30 Mar 2021: event: passed out in shower, EMT called, rushed to Medical Center, admitted to ICU 31 Mar 2021: treatment: pacemaker installed circa 1000 AM,  2 Apr 2021: released from Hospital xxx
sore throat; coughing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and COUGH (coughing) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and COUGH (coughing). The patient was treated with DEXTROMETHORPHAN POLISTIREX (ROBITUSSIN 12 HOUR COUGH RELIEF) for Sore throat and Cough, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, chills, nausea, diarrhea, vomiting started at 10 am the following morning. Another 12 hours and still having above-mentioned symptoms bit also one instance of passing out
Swelling and pain and hardness of right arm. Swelling is travelling down arm. there is a definite demarcation of swelling. Ibuprofen for swelling and pain. Pt reports no fever, chills or other SX.
Injection site - swollen arm  Muscle aches Joint pain Tingling in toes/fingernails Metal taste in mouth
Sur with 16-20 Erythema pustule on left arm around recent tattoo. Symptoms can decrease with time.
Site swelling and redness to the Upper Left Arm (back of arm). Ibuprofen was given to child by his parent along with using cool compresses to injection site. The injection was given at 10:45am.
"Rash", "warm feeling" and "feel of sore on touch" on the arm at injection site.
patient said arm has been sore since getting vaccine, however the arm does not hurt at injection site but only as patient moves arm backwards
A lot of arm pain for the next day, it was inflamed, hot and red. I put arnica ointment on many times and it got better, but the next week it flared up again and the pain in my arm has intensified.
Approximately 3-5 minutes after receiving the vaccine, while sitting down, the patient's eyes rolled to the back of her head and she began involuntarily jerking.  The episode lasted less than 5 seconds (approximately 3 seconds per the patient's mom who witnessed the event).  When she regained consciousness, she was alert and aware of her surroundings, but did report some drowsiness.  She reported no difficulty breathing.  EMS evaluated the patient for a potential seizure, however they deemed she likely experienced vasovagal syncope.  The patient was stable and did not have to be transported to the hospital via EMS.
This was patient's second dose vaccine. It should have been Pfizer, as her first vaccine administered was Pfizer. Pt is also 16 years old, which is not age approved for Moderna.
Muscle aches, chest pain, SOB, visual disturbances, arthralgias. Treated with fluids, OTC NSAID's
On days 8 what appeared to be a mosquito was noticed at the injection site. Within a day it spread into a larger patch. Two days later even larger but flatter and no longer itching.  Four days later it?s much faded.
One hour after administration became lightheaded with mild headache.  5 hours later developed itchy chest, neck , and back with joint pains and chills  The next morning noted a rash on chest and back with itching. The aches and chills had resolved  After taking Claritin x2 , the rash began to dissipate and completely resolve by 1/23.  No other symptoms
This spontaneous report was received from an office manager concerning a 14 year old patient of an unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 21-DEC-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot number M032650, dose, route and expiration date were not reported) and on 28-DEC-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot number M032650, dose, route and expiration date were not reported) for prophylaxis. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Female friends describing missed periods/menopause symptoms.; Female friends describing missed periods/menopause symptoms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult 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: MENOPAUSE (non-serious), AMENORRHOEA (non-serious), outcome "unknown" and all described as "Female friends describing missed periods/menopause symptoms."  Additional information: Description of Event: Female friends describing missed periods/menopause symptoms. Age group 40-50.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I'm experiencing muscle and joint pain on the right side arm and hands. On the left side inside muscle of the arm. Pain in right leg that is severe knee joint and the muscle behind the knee. Left leg pain in joint and muscle. Prescribed Ibuprofen 600mg that is not helping.
3 days after injection he began with arthralgias & arthritic stiffness.  This progressed to overt inflammatory arthritis of hands/knees/buttocks.  Work up CR-P elevated at 5.88, ESR neg, Lyme neg, CMP neg, CBC neg.  Condition resolved with steroid treatment x 3 wks.
Patient given peds third dose of Engerix-B 0.5 mL instead of adult 1 mL dose.
Pt complained of warmth and itching at injection site. Redness and swelling noted.
A large red around the inject site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A large red around the inject site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (A large red around the inject site). At the time of the report, VACCINATION SITE ERYTHEMA (A large red around the inject site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Experienced dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Experienced dizziness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Experienced dizziness). At the time of the report, DIZZINESS (Experienced dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reporter by the reporter.   Reporter did not allow further contact
Swollen/raised area about 3? diameter, red and irritated, persistently itchy like a cluster of mosquito bites.
10 min after Flu shot. Pt. began to feel "hot, dizzy and shaky". Itching at vaccination site. Pt symptoms intermittent with same intensity and rapid HR.
pt recvd vax & 2 days p/vax exp hives on the head & neck; tx Pred;
The pt developed a rash after the 1st shot. Used over-the-counter ointments. Had a very bad rash after with arthus, sleeplessness, joint pain, loss of weight and  questionable heart condition. I went to 10 doctors with no results. I used everything on the market and prescription drugs with no results. (Had 2nd Lymerix on 9/13/99). *Follow-up report on 01/29/03: PT states, "I have lyme disease and arthritis in ankles, knees, hipe and wrists. I now need a cane to walk. MD's said stay off ladders, roofs, no crawing. I have fell in bath tub got cracked ribs also fell at work. I still have fatigue, headaches, back pain, loss of balance. I had no history of lyme disease or any symptoms prior to the Lymerix shots I have been o antibiotic therapy for almost a year 4000 pills. Also anti-inflammatory medications. I believe this has affected my immune system. I had a whilte blood count of over 15400 - should be 400-600 need more room.
Started with headache, body aches and nausea. Treated with acetaminophen 500 mg q6h until symptoms subsided at around 10am on 10/07/2016.
Urticaria Started Day After Vaccine. Received Medrol Dose Pak, Famotidine And Benadryl from ER
The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.; No adverse reaction; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse reaction) 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 (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse reaction) 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 reaction) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) No concomitant medications were reported.  It was reported that, nurses had no Standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults. It was reported that approximately 100 patients were administered an invalid dose  0.25 ml instead of 0.5 ml of the Moderna COVID-19 bivalent booster.  No treatment details were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 67 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203), on 18Mar2021 as dose 2, single (Lot number: ER2613), on 04Nov2021 as dose 3 (booster), single (Lot number: FF2590) and on 29Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication(s) included: BUPROPION; CITALOPRAM; GLUCOSAMINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (27Sep2022) Positive, notes: Rebound COVID 4 days after last dose. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in case numbers 2014SA071241, 2014SA071253, 2014SA071262, 2014SA071266, and 2014SA071268. A 12-year old patient (gender and date of birth not reported) received ADACEL and/or DAPTACEL and subsequently developed a mild cough and tested positive for pertussis (positive PCR). According to the reporter, there was currently a pertussis outbreak in the county where the patient resided. Lot numbers, dates of vaccination, and event onset dates, and outcome were not reported. Additional documents held by sender: None.
Really really dizzy, kind of like dehydrated; Really really dizzy, kind of like dehydrated; Having difficulty breathing; Heart rate jumped up at rest; Can barely get out of the car; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Really really dizzy, kind of like dehydrated), DEHYDRATION (Really really dizzy, kind of like dehydrated), DYSPNOEA (Having difficulty breathing), HEART RATE INCREASED (Heart rate jumped up at rest) and ASTHENIA (Can barely get out of the car) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Congestive heart failure, COPD and Atrial fibrillation.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Really really dizzy, kind of like dehydrated), DEHYDRATION (Really really dizzy, kind of like dehydrated), DYSPNOEA (Having difficulty breathing), HEART RATE INCREASED (Heart rate jumped up at rest) and ASTHENIA (Can barely get out of the car). At the time of the report, DIZZINESS (Really really dizzy, kind of like dehydrated), DEHYDRATION (Really really dizzy, kind of like dehydrated), DYSPNOEA (Having difficulty breathing), HEART RATE INCREASED (Heart rate jumped up at rest) and ASTHENIA (Can barely get out of the car) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Heart rate: 100 (High) 100 beats at rest.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: updated the outcome of Event(s) from (unknown to Resolved/Recovered)