chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling and numbness in my face and my left arm and shoulder.  The doctor thought is was a stroke so I went to the hospital for a CAT scan and an MRI.  I did not have a stroke.  The tingling and numbness lasted for about 6 hours
Patient had sudden onset of sweats and lightheadedness while at work.  She was sent home, proceeded to have 1 episode of vomiting and then rested.  Feeling completely fine after resting.
At minute 9 post-administration of vaccine, patient experienced rapid onset numbness at tongue and roof of mouth. 30 seconds post-onset numbness began to become less severe. Numbness currently (~48 hours after administration) intermittent and resolves completely upon patient taking 25 to 50 mg Benadryl.
Patient reports a hard lump in the left arm - surrounded by red, itchy skin. This has been over the last 12 days since receiving injection and was told it was cellulitis by her nurse. Patient instructed to use a hot pack on her arm by nurse and this has been helping.
Swelling at the injection site, it is hard and warm and about the size of the palm of my hand.  It has lasted through the day since I noticed it this morning.  It is also sore muscle pain in my right arm where the swelling is.  I emailed my doctors office to inquire what I should do.
Woke up about 1 a.m. and was scratching my wrist.  I got up and turned on the light.  My hands were sort of a splotchy red (more red than not...) and itched, especially the wrist of my left hand.   My fingers were a bit puffy, but not swollen.  I ran my hands under cold water and used a hand cream.  They still itched a bit, but were better.  I waited a bit and reapplied hand cream.  I was tired and fell back asleep about 1:30 a.m.  When I woke up about 7 a.m., my hands were fine and there was no itching.  I have been fine since (altho I experienced the tiredness others have mentioned).
significant fatigue after she received her second dose of shingrix vaccine; This serious case was reported by a physician via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: significant fatigue after she received her second dose of shingrix vaccine) (serious criteria other: As per reporter). The outcome of the fatigue was not reported.   The reporter considered the fatigue to be related to Shingrix.     The company considered the fatigue to be related to Shingrix.   Additional Information: GSK Receipt date: 11-AUG-2023 A physician reported that his wife (patient) had significant fatigue after she received her second dose of Shingrix vaccine.  Physician believed it was related to immunization with Shingrix. The reporter did not agree to follow up from GSK.
36 hours of significant flu like symptoms: fever, chills, muscle pain, nausea, cough
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; Vaccines initially stored in the refrigerator on 19-Jan-2022 but was given beyond 30 days use by date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccines initially stored in the refrigerator on 19-Jan-2022 but was given beyond 30 days use by date) and POOR QUALITY PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022 at 9:16 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines initially stored in the refrigerator on 19-Jan-2022 but was given beyond 30 days use by date). On 03-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, PRODUCT STORAGE ERROR (Vaccines initially stored in the refrigerator on 19-Jan-2022 but was given beyond 30 days use by date) and POOR QUALITY PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that patient took 1st dose on 26-Feb-2021 and second dose on 26-Mar-2021. No treatments were reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up received updated Non-significant information
pt recv vax 3JUL97 & 26SEP97 pt devel chickenpox some of which were scattered;pt eval by Md who noted that the exact amount was unk;pt devel a rash, papules & vesicles on the legs, arms, face & head;DPH given;
I experienced had a positive Covid test on 01-12-2021.  My symptoms were nasal congestion.  I do not have no symptoms today.
Dizziness, Headache, Arthralgia, Fever, chills, fatigue, hot flashes  Narrative:  Other Relevant History:
This case was reported by a nurse via call center representative and described the occurrence of fever in a 17-year-old female patient who received Bexsero (batch number ABX6C1AA, expiry date 30th August 2019) for prophylaxis. On 23rd August 2018, the patient received Bexsero. On 23rd August 2018, less than a day after receiving Bexsero, the patient experienced fever, headache, general body pain and photophobia. On an unknown date, the outcome of the fever, headache, general body pain and photophobia were recovered/resolved. It was unknown if the reporter considered the fever, headache, general body pain and photophobia to be related to Bexsero. Additional information received as follows: The healthcare professional reported that the patient experienced a fever (102 degree fahrenheit), light sensitivity, headache, and body aches which were started in the afternoon of vaccination day and resolved within 48 hours.
No additional AE/PQC.; HCP calling to report GARDASIL 9 was inadvertently administered after it's expiration date. HCP reports the vaccine had no previous temperature excursions. No side effects reported with the administered dose. No additional AE/PQC.; This spontaneous report was received from Other Health Professional and refers to a 19-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-AUG-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #U008316, expiration date: 15-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 16-AUG-2023, HCP called to report GARDASIL 9 was inadvertently administered after it's expiration date. HCP reports the vaccine had no previous temperature excursions. No side effects reported with the administered dose. No additional AE/PQC.
pt recv vax 6NOV95 & devel swelling the size of an orange,@ inj site;no other details were available as of the reporting date;
Muscle pain; severe muscle spasms in his legs; Trouble walking around house; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number was not known), first dose via intramuscular route of administration, administered in Arm Left on 03Mar2021 (At the age of 59 year) as DOSE 1, SINGLE for covid-19 immunization. Medical history included arthritis (Verbatim: Arthritis started 5 years ago), degenerative bone disease (started at least 5 years ago, been on pain medications) and hepatic cirrhosis (diagnosed 11 years ago, Quit drinking at that time) from an unknown date and unknown if ongoing. Concomitant medication(s) included oxycodone (10mg/325mg) taken One tablet every 6 hour for pain, start and stop date were not reported. No Prior Vaccinations (within 4 weeks) and no other vaccinations within four weeks. On 04Mar2021 14:30 the patient experienced muscle pain, severe muscle spasms in his legs and trouble walking around house on an unspecified date of 2021. The patient underwent lab tests and procedures which included CBC and Comprehensive metabolic panel found to be with no result on unspecified date. Patient for Treatment involved a shot in the ER after 19 hours, but he doesn't know what that was. He was also given 30 pills of Methocarban. There was no hospitalization involved for patient. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021750210 same reporter, same drug/event, different patient
My son showed me his rash on his leg (at site of injection) and said his rash matched mine (I was having an allergic reaction on my hand at the time).  His rash looked pretty bad, covering the entire upper thigh.  I called the phone nurse at the pediatrician's office to ask about both my reaction and his rash.  The phone nurse scheduled an appointment for my son to be seen the next day at the doctor's office.  We went to his appointment the next day and the doctor we saw said that she wasn't sure if it was an adverse event or if it was an infection of some sort. She prescribed antibiotics to be sure to clear it up in case of infection.  The rash was about 18 cm in length and about 6 cm in width on the upper left thigh.
Initial case received from a consumer on 27 June 2011. A male patient, who was 36 years old at the time of the report, received an influenza vaccine (manufacturer and lot not reported) approximately 2 years ago. He reacted adversely to the event, and noted that his immunity had gone "down a lot" since vaccination. He was subsequently exposed to large groups of children, many of whom had symptoms of coughing, and also became ill. He presented to his physician with struggle of breath and redness of eyes, and was diagnosed with pertussis. Treatment included Z-PAK. Outcome was not reported.
Multiple family members; grabbed wrong dose for patient. Noted right after injection. Gave adult Pfizer to 9-year-old when should have administered pediatric dose. No adverse reaction noted.
Patient presented to ED with shortness of breath and fever. Came to facility after rehab reported him having a low grade fever and ill appearing. Patient was admitted on 9/18/21, has been on nasal cannula 2L since admittance.
This spontaneous report as received from a pharmacist via company representative refers to a 60 year old female patient. Pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX VIAL (dose, lot # and Expiry date were unknown) subcutaneously. On an unknown date, the patient experienced redness, swelling and the skin area being heated at the injection site. The patient spoke to the pharmacist for medical attention. The patient received treatment for the events. On an unknown date, the outcome of the events were reported as recovered/resolved. The reporter did not assess the causality between the events and the suspect therapy. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse refers to a 37 years adult female patient. The nurse reported that the patient who might have received M-M-R II (lot # unspecified), (route, dose and location unspecified) as a child. The patient underwent lab to titer for measles, mumps and rubella, which showed the patient had a negative titer for measles. Additional information is not expected.
Within less than 24 hours of the first dose of the Moderna Covid vaccine I experienced a fever (up to 102 at one point), chills, body aches and extreme fatigue.  Also severe pain at the injection site. These symptoms lasted less than 24 hours. Was expecting this from the second dose, not the first. My husband received his first dose at the same time I did and did not have the same side effects except for the arm pain.
This spontaneous report as received from a pharmacist via a company representative refers to a 14 year old female patient. On 02-JAN-2014 the patient was vaccinated with GARDASIL (dose, frequency, route and lot number were not provided) dose 1. On 02-JAN-2014 the patient passed out and vomited after receiving the injection. No treatment was given. After further observation the patient left the office. The outcome of passed out and vomited was reported as recovered/resolved. The relatedness was not provided. Upon internal review the event passed out was assessed as medically significant. Additional information has been requested.
Headache, extreme fatigue, body aches, diarrhea X 48 hours
an expired dose of Menactra was administered to the patient, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 17 year old female patient who was administered an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was not pregnant.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 03-Sep-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6208AD, expiry date 08-Jul-2020, vial) once via unknown route in the left deltoid for prophylactic vaccination.  It was reported that the clinician may vaccinate right away and another clinician wanted to wait on her second dose of Varicella in a month.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event 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 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.
Whenever I had prior flu shots I experienced flu-like symptoms within hours of the shot. This time I experienced shortness of breath around 6:00 - 6:30 p.m. I could not catch my breath so my husband took me to Urgent Care. When I got to Urgent Care a doctor advised me that he thought I could have a blood clot, possible heart issues, or a reaction to the flu shot I had a couple of hours earlier. He recommended that I go to hospital as the hospital could do tests and provide faster test/lab results. My husband drove me to ER. They too thought I had a blood clot or a heart attack. They noted my HD FLUZONE vaccination received earlier that day as a reaction to that shot was also a possibility. They ran numerous EKGs, blood work (D-dimer; Troponin) gave me a heparin via IV, gave me a nitroglycerin). They monitored my blood pressure, I wore a heart monitor, and they monitored low oxygen levels. The ER doctor admitted me to the hospital. At 3:30 a.m. Dr. came to my room to examine me. At 6:00 a.m. a nurse took blood, and performed vitals. They scheduled me for an 8:15 a.m. nuclear stress test which took 3 hours. After 2:30 p.m. or so the cardiologist who read my stress test posted results online so Dr stopped by to tell me the results and to discharge me on 10-3-14. The heart attack and/or blood clot issues were ruled out, leaving the possibility of an adverse reaction to the flu shot.
Information has been received from a medical assistant concerning a female (age not reported) who (approximately one month ago) in approximately November 2006, was vaccinated with Gardasil (yeast). On 04 Dec 2006, the patient just now experienced redness and swelling at what the patient believes is the injection site. The patient had not yet been seen at the office at the time of the reporting. The outcome of the event was unknown. Additional information has been requested. Additional information was received from the medical assistant. On 04-DEC-2006, the patient reported redness and puffiness at the site. On 11-DEC-2006, the patient was examined by the physician. The area inflamed was similar than one half inch diameter. The patient was given antibiotics for one week. No diagnostic tests were performed. On an unspecified date, the patient recovered. No additional information is expected.
Patient received Moderna 1st dose on 4/6/2021 and then was administered Pfizer as her second dose vaccine. Patient did not have her vaccination card with her. Patient does not remember discussing with nurse "which vaccine" she was there to receive although patient scheduled a Pfizer vaccine in our health portal. No adverse side affects noted, patient is doing well. Instructed to not get anymore Covid vaccines per CDC guidelines and to call us if she has any adverse reactions.
1/24/2023 In the evening participant lost sense of taste and smell.  Tested with an At Home COVID-19 Test, positive.  1/25, televisit with PCP who proscribed Paxlovid, and to treat symptomatically.  1/27 taste started to come back, 1/28 smell started coming back too.  By 1/31 everything returned to normal.
This is a spontaneous report from a noncontactable consumer (patient). A 27-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0126), at the age of 27, via an unspecified route of administration, left arm, on Apr 15, 2021, at 09:00, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included Descovy (emtricitabine-tenofovir alafenamide fumarate) from an unknown date for unknown indication. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, unknown site, on an unknown date, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 15, 2021, at 18:15, patient experienced chills, aches and fatigue. No therapeutic measures taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergency visit. Since the vaccination, patient has not tested for COVID-19. The outcome of chills, aches and fatigue: recovering (at the time of report). No follow-up attempts possible. No further information expected.
Metallic taste with food; Terrible smell; This spontaneous case was reported by a physician and describes the occurrence of DYSGEUSIA (Metallic taste with food) and PAROSMIA (Terrible smell) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, CANDESARTAN and PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DYSGEUSIA (Metallic taste with food) (seriousness criterion disability) and PAROSMIA (Terrible smell) (seriousness criterion disability). At the time of the report, DYSGEUSIA (Metallic taste with food) had not resolved and PAROSMIA (Terrible smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Did not test positive for Covid at that time.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not take any medications to treat symptoms.  The patient was still experiencing the lingering metallic taste and was concerned about that. The patient reports it as disabling and depressing.  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, use of concomitant medication sumatriptan (usually prescribed for migraine) could probably be a contributory factor.; 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, use of concomitant medication sumatriptan (usually prescribed for migraine) could probably be a contributory factor.
Cold sweats, fever, fatigue, headache, aches, chills, nausea
Patient started to complain of itching over entire body and rt arm where injections were given. Arm began to swell and turn bright red, he was crying saying his arm hurt really bad and very itchy and hot to touch, skin was very hard. Swelling was significant. Gave him 1tsp Benadryl (CVS brand). Itching subsided, pain and swelling did not. Continued Benadryl every 4hrs as instructed by pediatrician. Day 2 swelling continues.
pt presents to ED with c/o SOB and cough x 10days; tested positive for COVID 5 days ago; COVID test is still positive; O2 sats in the 60s%; O2 supplementation given (90% saturation with O2); given Decadron and ABX in ED; admitted; COVID pneumonia; ARF; acute renal failure; COPD; transferred to Hospital; intubated; given Baricitinib and albuteral inhaler; Pt had a PEA without a BP; CPR performed and pt achieved ROSC; family then changed code status to DNR; pt lost pulse again and expired in the hospital
Information as received from a nurse referring to multiple different unspecified patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with GARDASIL (lot#, expiration date, strength, dose and route unknown). There was no concomitant medication reported. After being administered GARDASIL, the patients experienced feeling faint. The outcome of the event was unknown. The causality between this event and GARDASIL was unknown. This is one of several reports received from the same reporter. Additional information has been requested.