chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TOPAMAX; LYRICA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), 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 tested positive for COVID-19 on an unspecified date. It was reported that the patient needed to take monoclonal antibodies (bamlanivimab (MANUFACTURER UNKNOWN)) before the second dose. However, the patient tested positive after the first dose and so the pharmacist was questioning if it is okay for the patient to take the antibodies before the second dose. The patient underwent lab tests and procedures, which included COVID-19 test: positive on an unspecified date. The clinical outcome of tested positive for COVID-19 was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: Limited information precludes a medically meaningful assessment of the case.  Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Fatigue within hours of vaccination. Slept through the afternoon and late into the next day. Shivering while in bed with sweatshirt, sweatpants, multiple blankets and room temperature of 75.  Swollen lymph node in the armpit of the arm I got the vaccination in (about golf ball size with soreness over the next 2-3 days). Dizziness over the next few days following vaccination. Foggy thinking and trouble focusing in the week or more following vaccination.
on 11/17/21 Pt got J&J shot at 1135 became light headed and dizzy came over to ems. Ems placed pt on stretcher and hooked up ecg at 1146 pt was in normal sinus rhythm, 157/104 bp, 81 hr, 100% spo2 room air. Pt skin appeared hot, clammy, flushed. Pt was given 50mg PO of Benadryl at 1148 due to pt throat being red and a possible allergic reactrion. Pt blood pressure continued to rise up to 181/122. At 1156 Pt heart rhythm changed from normal sinus rhythm to atrial flutter 6:1 and heart rate was bouncing around from 126- 212. Pt remained axo x4. No LOC. Pt began to feel palpitations in her chest and hands became cold. Pt had tremors at this point. Pt was very anxious. Fast ED was done and was negative. Care was transferred and they transported pt to Hospital ER.
Red Hot swollen Lump on Arm lasted for a little over 24 hours and had some skin flaking.
SHORTNESS OF BREATH; COULDN'T WALK; COLD; CAN'T COMPREHEND/THINK; FEELS DEPRESSED; ANGRY; CRYING; NOT FEELING WELL; MUSCLE WEAKNESS; THROWING UP; SORE THROAT; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and she is pretty healthy, very athletic and has not been ill in the last 20 years.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2021, the subject experienced throwing up. On 24-APR-2021, the subject experienced sore throat. On 24-APR-2021, the subject experienced muscle weakness. On an unspecified date, the subject experienced shortness of breath, couldn't walk, cold, can't comprehend/think, feels depressed, angry, crying, and not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle weakness, throwing up, and sore throat, and the outcome of shortness of breath, not feeling well, couldn't walk, cold, can't comprehend/think, angry, crying and feels depressed was not reported. This report was non-serious.
Narrative:  Patient is 75 y/o male who presented to the ER on 12/7/21 with cough, fever, body aches, and shortness of breath for the 5 days. Emesis after coughing. Diagnosed with COVID-19 3 days ago at an outside facility and presented to the ER on 12/5/21 feeling worse. Oxygen saturations at home and ER were less than 90% on room air. Transaminitis/acute hepatitis suspected to be secondary to COVID infection. Admitted and treated with dexamethasone (12/7-12/17) and remdesivir (12/7-12/12). Discharged 12/25/21. Vaccinated with Janssen one dose vaccine on 3/30/21 at a facility. Second "booster dose" on 11/30/21 through the health care facility. PMH: OSA, CAD, and emphysema.
Fever (greater than 101 degrees), chills, headache, aches in the exterior part of both ear, soreness at injection site; used aspirin to relieve pain.  Almost cleared up by 4/15/2021, except for sharp pain in exterior ears.
pt recvd vax 8JUN95 & 18JUN95 pt broke out w/pox;devel about 6 to 10 lesions per day for 19 days;pt recovered;No further details were provided;
Large, painful red splotch at injection site. Red splotch is almost the size of my hand.
This is a spontaneous report from a contactable consumer. A 76-year-old female patient received PREVNAR 13, via an unspecified route of administration in the left arm on 08Sep2016 at 9:00 am or 10:00 am at 0.5 ml single dose for immunization. Medical history included high cholesterol, Hashimoto's disease, type 2 diabetes, knee replacement (Both knees done 19 years ago), hip replacement (Left hip replaced 7 years ago; Right hip replaced 5 years ago); all on unknown dates. Concomitant medications included ongoing LIPITOR 20 mg daily since 1999, metformin 500 mg, 2x/day ongoing since 2008, and SYNTHROID 137 ug, 1x/day ongoing since 1990. The patient also received aspirin, ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide, (PRESERVISION AREDS 2), triamterene / hydrochlorothiazide (75/50mg), KEFLEX 500 mg capsule oral, 1 capsule, three times a day, for 7 days, and prednisone (50 mg tablet) oral, 1 tablet every day, with food, for 5 days. The patient previously received a pneumococcal vaccine for immunisation on an unknown date about 8-9 years ago. She stated that many years ago had a reaction to a product made with duck eggs. On 10Sep2016, the patient reported arm was red and had very warm area on arm, in an area about 6 inches. She was diagnosed an allergic reaction with cellulitis of left upper arm. She received unspecified treatment and recovered.
Day 14 after shot, 2/11/2020, evening intense itching just below the admin site (still visible w/small bruise) and noticed a warm, red, raised welt. Approximately 3in top (shoulder) to bottom and 2 inches left to right. Skin feels taut and the swelling feels slightly hard under the skin.
I woke up and was really tired and really sore - body aches and at the injection site; that lasted most of the day until evening. I got a fever around 100.0 and I took Tylenol. The fever went away within 30 min. I started getting chills and sweats. I took my temperature and it was normal but I was still getting chills and sweats. That went through the night. I was still tired and had the soreness in body and at injection site. When I had the chills, I was shivering and shaking (not just feeling chilled.)  June 4th, 2021 - is my due date; my history of pregnancy - first pregnancy and it's been normal so far.
hospitalized 9/17/21 with Acute hypoxic respiratory failure due to Covid 19 Pneumonia.
AFTER 15 MINUTES OF VACCINE ADMINISTRATION THE PATIENT BEGAN CONVULSING.
low grade fever; This is a spontaneous report from a contactable Physician reported patient. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch number/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history included endometriosis from an unknown date. The patient's concomitant medications were not reported. On an unspecified date, the patient had a constant low grade fever 2 weeks out of getting the first dose of the Pfizer vaccine. The patient had no other medical issues other than endometriosis. The patient had been seen in urgent care and has had multiple negative tests for COVID and everything had been negative on an unspecified date. The caller asked if there were any reports of long term low grade fevers. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D10A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Oct-2020 and the estimated date of delivery was 24-Jul-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound foetal: normal (normal) Normal. On an unknown date, Amniocentesis: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   past pregnancy details: Live birth, full term pregnancy on Aug-2018.
pt recvd vax; grandma noticed rash over face 4 hr after vax then hives all over body; difficulty in breathing; seen at hosp er; recvd IV & DPH; severe anaphylus;
worse side effects; side effects; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (worse side effects), ADVERSE REACTION (side effects) and FATIGUE (tiredness) in a male 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 ADVERSE REACTION (worse side effects), ADVERSE REACTION (side effects) and FATIGUE (tiredness). At the time of the report, ADVERSE REACTION (worse side effects), ADVERSE REACTION (side effects) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I have had a headache since the day after I got my booster (dose #3). Dose # 2 was 4/2021
Fever, body aches, fatigue, dehydration. Started about 30 hours after injection.  Acute symptoms lasted about 12-18 hours.
Pt states she heard or "felt"  a popping ( I as the pharmacist do not recall hearing a popping) she states that she felt as if her nose was then about to bleed (this was not communicated the day of) Pt states she had chills the following tuesday (3 days later) and her arm began to swell. Pt also receives a bone marrow shot in the same arm. at presentation on friday 9/20 patient does not present with swelling, some slight redness however her skin turgor and condition of skin makes most of her skin appear dry brittle and slighlty red. Pt denies pain, limited motion, and appears to be doing fine. she states she just wanted us to know that she had a reaction. she did inform her md. I instructed her to talk with her doctor next year as to whether or not she should receive the vaccine. Pt is not angered at the pharmacy and or immunizer just wanted us to know.
the nurse after injecting the first shot said it is empty and drew one more dose and gave another; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the nurse after injecting the first shot said it is empty and drew one more dose and gave another) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for Blood pressure.    On 06-May-2021 at 9:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the nurse after injecting the first shot said it is empty and drew one more dose and gave another). On 06-May-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (the nurse after injecting the first shot said it is empty and drew one more dose and gave another) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Patient did not experienced any side effects after getting the doses.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional reporter details, Event verbatim updated,additional information added.
Pfizer-BioNTech Covid-19 Vaccine EUA. I had vomiting, body aches, headaches, blurry vision, fever, taste was funny, tired, chills, sweats, constipated.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Mar2023 at 12:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 05Sep2023 to 09Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
18-24 hours after injection, large amount of redness, swelling and induration at injection site left deltoid. No fever or malaise.  Treated with Benadryl oral antibiotics to cover for possible infection.
DULL/TENDER PAIN/SENSATION SLIGHTLY BELOW THE NAVEL; This spontaneous report received from a patient concerned a 73 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced dull/tender pain/sensation slightly below the navel. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dull/tender pain/sensation slightly below the navel. This report was non-serious.
PATIENT EXPERIENCED DIZZINESS AFTER 2ND COVID SHOT. MOTHER WAS PRESENT. HAD HIM PUT HIS HEAD BETWEEN HIS LEGS, MONITORED BLOOD PRESSURE, ICE PACK ON THE BACK OF HIS NECK. HE STARTED TO FEEL BETTER. SINCE HE WAS IMPROVING WE LET HIM STAY IN THE CLINIC ROOM WITH A TECH MONITORING UNTIL HE COULD STAND BACK UP. GAVE HIM A JUICE AS WELL FOR WHEN HE WAS FEELING BETTER. PATIENT FULLY RECOVERED AND WAS FINE PRIOR TO LEAVING THE STORE.
Pt experienced injection site reaction characterized by redness and heat, 4cm circular area. Resolved after 48 hours.
Itching, swelling, hard/swollen-started 1week after dose and increased symptoms through today (48 hours of symptoms)
Aches all over body and low grade fever, extreme soreness in arm of vaccination, took Aleve at 2:00 AM and fever subsided, still extremely sore...feel sick to my stomach...why such a bad reaction to this shot???
Patient had a dizzy spell, fainted twice for about 15 seconds each. appeared to have seizure like activity. Called 911 for furthur assistance. Patient was pale and cyanotic, became alert by the time paramedics got to the site.
redness, swelling, itching at site of vaccine. on 9/5 redness has gotten larger than before.
Redness at injection site and extending above and below. (L deltoid) body aches, chills, general malaise.
Moderna COVID-19 Vaccine EUA Patient report: I was vaccinated 12/28/2020. I had very mild face itching the day after the vaccine that could have easily been to something else since I am a highly allergic person anyway. On 1/5/2020 I developing itching, bruising, welts, heat and slightly hard (firm but still a little squishy) around the injection site. Approximately 3in x 2in.  She did not feel it was cellulitis as she was familiar with this but will continue to monitor for progression of symptoms.
Pt recvd Hep B vax & exp an unspecified allergic reaction; No further details were provided;
received 1st dose of shingrix / get a case of hives / still have hives (mild); This case was reported by a consumer via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2020, the patient received the 1st dose of Shingrix. In November 2020, less than 3 weeks after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   The reporter considered the hives to be unrelated to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the vaccine and not long after, seemed to get a case of hives. The patient stated that he/she still had hives (mild) 6 weeks later. The patient wanted to know if it was possible that he/she might have a mild case of shingles from the vaccine or a reaction. The patient did not associate it with the vaccine. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253665:Dupliacte case US-GLAXOSMITHKLINE-US2020AMR253498:Dupliacte case
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 22-OCT-2012 03:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 25-SEP-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.