chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19/COVID-19 rapid test positive; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19/COVID-19 rapid test positive) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     Concurrent medical conditions included Bronchiectasis (Bilat bronchiectasis) and Drug allergy. Concomitant products included MEDROXYPROGESTERONE, ESTRADIOL, LEVALBUTEROL [LEVOSALBUTAMOL] and IPRATROPIUM for an unknown indication.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19/COVID-19 rapid test positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/COVID-19 rapid test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: positive (Positive) positive COVID-19 test. On 19-May-2022, SARS-CoV-2 test: positive (Positive) Covid-19 rapid test 19 May 2022 positive. On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive PCR test 22 May 2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient began Paxlovid 14 May 2022, 1 day after starting symptoms, day of positive COVID-19 test. All doses completed, no missed doses. Mild course of symptoms largely improved by end of course (19 May 2022). Covid-19 rapid test 19 May 2022 positive. New symptoms 21 May 2022 increased fatigue. Positive PCR test 22 May 2022. New sinus/respiratory congestion reported on 23 May 2022 was ongoing as on 25 May 2022.   Company comment: This is a spontaneous case reported by a nurse. A 65-year-old female patient, with no relevant medical history, experienced non serious event of COVID-19  approximately 5 months after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. The patient was treated with Paxlovid, symptoms largely improved. New symptoms of fatigue and sinus/respiratory congestion started after ending treatment; SARS-CoV-2 test remained positive after all doses completed. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case reported by a nurse. A 65-year-old female patient, with no relevant medical history, experienced non serious event of COVID-19  approximately 5 months after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. The patient was treated with Paxlovid, symptoms largely improved. New symptoms of fatigue and sinus/respiratory congestion started after ending treatment; SARS-CoV-2 test remained positive after all doses completed. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Drug allergy (Rash); This spontaneous report was received from an unspecified type of reporter via Pfizer concerning a patient of unspecified age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, the patient was vaccinated with a pneumococcal vaccine (pneumococcal Vaccine, Polyvalent (23-valent) or pneumococcal 15v conj vaccine (CRM197)) (manufacturer unknown) (as prophylaxis, no more vaccination details were provided).   On an unspecified date, the patient presented a drug allergy presented as a rash (drug eruption). The outcome of the event was not provided.  The causality assessment between the event and the suspect vaccine was related.
Dizziness, Headache, SkinRash, Rash, diaphoretic Narrative:
Information has been received from a 74 years old male patient with high blood pressure, high cholesterol and drug allergies to penicillin and other unspecified medications. In late November 2014, the patient was vaccinated with ZOSTAVAX, 1 dose 0.65 ml, (lot#, expiration date, dose and route not reported). Concomitant therapies were not reported. The patient reported that he became ill a few days before Veterans Day in January 2015 (date unspecified). The illness that the patient experienced was an elevated blood pressure, severe headache and a rash on the right side near the hip area. The patient became ill again on 10-MAR-2015. The patient stated that this last illness included stomach troubles of him vomiting and being sick for several days. The wound on the patient's leg "bled a little bit" had soreness and painful to the touch (date unspecified). The patient had not recovered from the events Treatment of triamcinolone acetonide cream and other unspecified medications were given to the events. Blood work and other unspecified diagnostics were performed (results unknown). The patient went to ER but was not admitted tot he hospital. The causality was not provided. Additional information has been requested.
pt recv vax 31MAR98 & no rxn noted until 1APR98-local rxn redness & tenderness @ site;reaction size 50x65mm;
Symptoms began about 4 hours after shot.  Vaccination site became sore and pink in color.  Started feeling warm. Began to cough. Nose started to run with a watery clear colored liquid. Eyes started oozing a thick whitish color substance like I had pink eye.  Cough was very wet. I'm not sure if my throat began to swell or if it was just clogged with mucus.  I started having difficulty breathing and began to panic somewhat.  I started drinking as much cold water as I could. I took 2 Aleve PMs and tried to calm myself down.  I put drops in my eyes to help clear the gunk. I had my phone ready to call 911 but breathing got easier.  I put Vicks vapor rub under my nose and went to bed.  I got up several times during the night to wipe my eyes with a warm wet washcloth as I was afraid my eyes would be glued together by the next morning if I did not.  The symptoms were gone by the next morning.  I was exhausted so I stayed in bed until 11am.   I was still a little foggy in the brain the next day and tired today.
Heavy menstrual cycle with blood clots, bright red color, extreme cramping in pelvic area as well as shooting pain in both legs. Started on 5/13 with heavy cramping, cycle started on 5/16. Bled two days longer than normal. Still experiencing cramping on 5/20/21
Woke up at 2:00am after falling asleep around 12:00am. Experiencing feverish feelings with no fever (98.0). Nausea also began around this time. Took a zofran 8mg at 2:30am, didn?t really experience any relief. Then suddenly had to vomit (mostly bile) at 3:00am. Feeling slightly nauseous after vomiting but better than before.
The patient's father called us at 630pm on 11/29/21 and reported that the patient had a lump in his left armpit.  Per his father, the patient noticed the lump in the left armpit on the afternoon of 11/28/21. The states that it is a pain level of 3/10, but no other symptoms.  Patient's father was advised to seek medical care for the patient for follow up.
8/13, Patient called to ER and stated that Sx, chills since 8/1. The last day worked was 7/23. Son was point of contact. Vaccinated.
Swollen throat, gradually spreading from throat to palate, difficult to swallow, beginning immediately after leaving pharmacy. Stopped at ambulance station. Treated with IV SOLU-MEDROL and BENADRYL. Discharged home around 4:30pm.
Hives - started 12 hours after vaccines. Started on Benadryl then Zyrtec and Zaretia 24 hours later.
Headache, Myalgia, Arthralgia, Fever, chills, fatigue, diarrhea  Narrative: Employee received vaccine on 01/04/2021 and did not experience  symptoms until the following day. On 01/05/2021, employee began experiencing  fever (100 F), chills, headache, joint and muscle aches, fatigue, and diarrhea. Of  note, employee reports attended a football game on 12/26/2020.  Reports using Dayquil and Nyquil currently for symptoms. Symptoms have not yet  resolved.
Developed Extreme Tinnitus 4 days after getting the first dose of the COVID 19 Vaccine.  The day it happened I was working at my desk and I slumped over and had completely no control over my balance.  I had to hold on to walls to keep standing up straight.  I was barely able to drive myself home, the next day I went to an ENT where I was prescribed Steroids, but that did not help.  Since this time I have had constant ringing in my ears, balance problems, horrible nausea.  I have good days and bad, but all of these conditions still exist today almost 2 years later.
The day after receiving my booster shot of the Moderna vaccine, I developed a severe migraine. From that point on for about the next month, I struggled with headaches and migraines continually. While I don't believe the booster continued to be the cause of the migraine/headaches after the initial one on 11/18/21, I do believe it triggered the series. After about a month or so of dealing with it, I saw my primary care physician. She proscribed me a 5 day dose of a steroid to stop the migraines. The steroid certainly helped, but it took another few weeks for me to feel regularly free of the headaches/migraines.
pt was in Hospital 10/10 - 10/15/21 with c/o back pain due to fecal impaction; also found to be positive for COVID but was asymptomatic; pt had a recent family exposure; fecal impaction treated and pt was dc'd to home; DNR/DNI; per death certificate, pt died in the home with Diastolic Heart Failure and HTN being the causes of death; COVID 19 infection 6 wks prior was listed as a condition contributing to death
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 57-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no Known allergies. There were no concomitant medications (Other medication in 2 weeks reported as no). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 23Sep2022 to 28Sep2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
pt recv vax 16OCT97 & that same day pt devel an erythematous macular papular rash on chest;pt devel pruritis all over body & diffuse myalgia & arthralgia on legs & arms;
Had stroke; Has loss of vision in right eye; Has headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had stroke), BLINDNESS (Has loss of vision in right eye) and HEADACHE (Has headaches) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (Has loss of vision in right eye) (seriousness criteria hospitalization and medically significant) and HEADACHE (Has headaches) (seriousness criterion hospitalization). The patient was hospitalized on 21-Jun-2021 due to BLINDNESS, CEREBROVASCULAR ACCIDENT and HEADACHE. At the time of the report, CEREBROVASCULAR ACCIDENT (Had stroke), BLINDNESS (Has loss of vision in right eye) and HEADACHE (Has headaches) outcome was unknown.            No concomitant medication information was provided by the reporter. Treatment information was unknown.  It was reported that the patient experienced stroke 3 days after receiving the 2nd dose of the vaccine. He was hospitalized on 21Jun2021. Patient also had headaches and loss of vision in right eye, and both started the day of stroke.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe headache/normal headache; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache/normal headache) and PYREXIA (slight fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (History of migraines). Concomitant products included TOPIRAMATE (TOPAMAX) for Migraine prophylaxis, ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (Severe headache/normal headache) and PYREXIA (slight fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 14-Apr-2021, HEADACHE (Severe headache/normal headache) had resolved. At the time of the report, PYREXIA (slight fever) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
Persistent redness right deltoid area (area of injection) more than 72 hours after injection; Redness tracks to right axilla; swelling and fullness in right axilla; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Oct2021 14:15 (Lot number: 301358) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NAPROXEN. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL9269, prev dose lot unknown: False,, prev dose administrator route: intramuscular, prev dose administration date: 05Feb2021, prev dose dose number:2, prev dose vaccine location:Right, arm.), administration date: 05Feb2021, when the patient was 59 years old, for Covid-19 immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL3248, prev dose lot unknown: False,, prev dose administrator route: Intramusular, prev dose administration date: 15Jan2021, prev dose dose number 1, prev dose vaccine location: Right arm.), administration date: 15Jan2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 03Oct2021 02:30, outcome "not recovered", described as "Persistent redness right deltoid area (area of injection) more than 72 hours after injection"; ERYTHEMA (non-serious) with onset 03Oct2021 02:30, outcome "not recovered", described as "Redness tracks to right axilla"; SWELLING (non-serious) with onset 03Oct2021 02:30, outcome "not recovered", described as "swelling and fullness in right axilla". Therapeutic measures were not taken as a result of vaccination site erythema, erythema, swelling.  Additional information: No known allergies, Post vaccination patient was not tested for COVID. Prior to vaccination patient had no COVID. Patient had no other medical history. Facility type Vaccine: Pharmacy or Drug Store. If other vaccine in four weeks: No  No follow-up attempts are possible. No further information is expected.  Follow-Up (13Oct2021): Follow-up attempts are completed. No further information is expected.
No adverse effects; Received one dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 20-JUN-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA), lot # R035227 (expiry date: 01-JAN-2020) for prophylaxis (strength, anatomical location and route were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F)/ 9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009510: US-009507513-1906USA009082: US-009507513-1906USA009509: US-009507513-1906USA009522:
Immediate temporary euphoria, severe exacerbation of chronic lumbar pain within two hours, tinnitus, mild peripheral neuropathy of fingertips, burning eyes that have lasted 7 days, general aches and pains that have continued for 7 days. The problems come, go, and then return.  The euphoria was just once immediately after  the injection.  Some problems with diarrhea that come and go.
After vaccination this nurse realized the client was 17 years old, and Moderna is to be administered to clients aged 18 and over.  Client was monitored for thirty minutes with no signs or symptoms of adverse reaction. Client reported feeling "fine". This nurse's supervisor, and medical director, were notified. This nurse was advised to report this incident to VAERS
Patient was in Observation area.  Witnessed by RN fainting and sliding to floor.  Other RNS and Paramedic immediately at her side.  Initially groggy but came alert and oriented quickly.  Initially Bradycardic and hypotensive.  IV started and  immediate improvement. History of vasovagal episode with blood draws.  Denied injuries or discomfort. Sent by ambulance
About 6 hours after vaccine was administered patient had a lot of pain to the injection site.  She noticed there was a large lump and the area was hot to touch.  She applied an ice pack and took ibuprofen.  She woke up today and felt like it had improved but still had swelling and redness.  Area measured 8cm X 5.5cm
Ridge under the injection; Rashes under the injection site; Muscle bulge a little; This case was reported by a consumer and described the occurrence of injection site induration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site induration, injection site rash and muscle swelling. On an unknown date, the outcome of the injection site induration, injection site rash and muscle swelling were recovered/resolved.   It was unknown if the reporter considered the injection site induration, injection site rash and muscle swelling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR181753   Additional Information: GSK Receipt Date: 05 DEC 2022 Reporter's comment: The reporter stated that the patient had side effects with both shorts of Shingrix. The reporter stated that the patient had muscle bulge a little, creating a ridge under the injection site which lasted for 3 to 4 days The patient developed two small rashes about a half inch under the injection site. One the size of a half dollar or a little larger. The other one is smaller the size of a quarter which lasted for 1 to 2 days. This case is linked with US2022AMR181753 same reporter, same patient second dose.; Sender's Comments:  US-GSK-US2022AMR181753:Same reporter
This spontaneous report as received from a licensed practical nurse refers to a currently 29 year old female patient with allergy to DEMEROL and DARVOCET. The patient received RECOMBIVAX HB on 08-JUL-1996, 20-AUG-1996, and on 14-JAN-1997, respectively (doses, routes and lot numbers not specified). On 21-JUN-2013, the patient was found to have a low hepatitis B antibody titer (blood titer test was performed). As a result, the patient was restarted on the RECOMBIVAX HB vaccination series. However, on 08-JUL-2013, this adult patient was given a pediatric dose of RECOMBIVAX HB in error. The patient's present status was unspecified. The outcome of adverse events was not reported. The relatedness for RECOMBIVAX HB and adverse event was not reported. Additional information has been requested.
No adverse effects reported. No additional AE.; HBP calling to report post expiry dose of MMR II.  No adverse effects reported.  No additional AE.  No PQC. LOT U031359  Exp. 10/7/2023; This spontaneous report was received from offiece manager and refers to a 12-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-OCT-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, single dose, lot #U031359, expiration date: 07-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Severe pain, dizziness, allergic reaction. ER gave her IV pain med, steroid and BENADRYL. She was dismissed and states no other pain or problems. Pt states pharmacist gave her a partial injection and then he got a 2nd syringe, squeezed some out and injected her again same arm.
This case was reported by a physician, via a GSK representative, and described the occurrence of hepatitis B positive in a child subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included elevated liver enzymes and sexually transmitted disease. On unspecified dates, as an infant, the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (details unknown). At an unknown time after vaccination with Hepatitis B vaccine, the subject experienced hepatitis B positive. The physician reported that four subject's, all children from the same family, were vaccinated with the hepatitis B vaccine series (unknown manufacturer) as infants, and as the children are now older (unknown ages) two of the children have tested positive for hepatitis B, and two of the other children were tested as having no immunity/no protection. This is case 2 of 4 (see case IDs A0938693A, A0939315A, A0939316A for details of the other reports).