chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Jan 2, 2023 I started having a sore throat and a bad headache and I had a fever 102.1 and I still have a fever it broke but it came back, and I lost my taste and smell and super, super tired and I feel really bad. I called my doctors office and my doctor said that he thinks that the medication that I am taking interfere with the vaccine. So, I am still fighting COVID. My body is feeling better, but I still have a fever and I have a sore throat.
I had an incidence of Syncopal episode. In May of 2021 I was at work and I was very dizzy, pale and weak. I visited my doctor and after testing they couldn't find anything wrong. I have seen a Cardiologist and Neurologist. All tests were negative. I have had several more episodes on 06/07/2021 and 06/19/2021. There has not been any explanation.
I was called to see a patient who was here for vaccines only after she had a reaction. Historical report to me was from the nurse in attendance,  and less so from the mother of patient and patient's  two brothers who were in the room.  patient received only HPV vaccine, was noted to become pale, then shake with seizure-like movements and then had near-syncope episode. Still responding, but slowly. Diaphoretic.
5 minutes post vaccination, the patient was sitting down and went unconscious. Patient remained sitting at all times during this encounter. A nurse on site talked to him and attempted to rouse him. After a few minutes of being unsuccessful in keeping him awake/aware, paramedics were called to the site. Patient would wake for a few seconds and then go unconscious again. When paramedics arrived, patient was able to remain awake. No treatment was administered. Patient did not have to be taken in an ambulance.
82 y/o female, PMHx of CA, DM, HTN, hyperlipidemia, IBS, osteoporosis, RLS, seizure disorder, bladder prolapse, and diverticulitis admitted for altered mental status, elevated blood pressure, nausea and shaking, on 6/22/21. Pt tested positive for Covid, but did not exhibit symptoms except may fever. Pt has chronic ulcers on bilateral toe with purulent drainage, undergoing wound care. Toe ulcers found to be source of infection. Was put on clindamycin, Flagyl, and vancomycin (but developed allergic reaction to vancomycin). Pt was discharged to home on 6/23/21.
flushing Narrative:  Pt received Pfizer COVID vaccine and reported feeling dizzy with red face and flushed. Pt was lightheaded and warm to the touch with redness in the face increasing over time. VS stable. Pt was sent to ER at 11:55am, stable and discharged to home at 1pm. Pt reported feeling well the next day and is scheduled for repeat dose on 01/31/2021.
Sudden onset of vitiligo/vitiligo on torso and legs/hands cotton white, snow white/not dissipated at all/white splotches here and there; This spontaneous case was reported by a consumer and describes the occurrence of VITILIGO (Sudden onset of vitiligo/vitiligo on torso and legs/hands cotton white, snow white/not dissipated at all/white splotches here and there) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VITILIGO (Sudden onset of vitiligo/vitiligo on torso and legs/hands cotton white, snow white/not dissipated at all/white splotches here and there). At the time of the report, VITILIGO (Sudden onset of vitiligo/vitiligo on torso and legs/hands cotton white, snow white/not dissipated at all/white splotches here and there) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported. No treatment was reported Patient had 2nd dose administered on 12-Mar-2021: 016M20A. Booster dose administered on 19-Jan-2022: 013F21A
Body aches, fatigue, cough, runny nose, sore throat, congestion Narrative:
Passed out; she lost control of bladder; Blood pressure low; A spontaneous report was received from a consumer concerning a 53-years-old, female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out (loss of consciousness) and lost control of bladder (urinary incontinence) and blood pressure low(hypotension).  Patient's past medical history included, low blood pressure. It was normally on the lower end. She had fainted 10-15 times in her life. The patient was going through menopause and had been having hot flashes. Products known to have been used by patient with in past two weeks  included bupropion hydrochloride and vitamins nos.  On 02-Mar-2021, 5-7 minutes before the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010A21A or 010AZ1A illegible), intramuscularly in left arm  for prophylaxis of COVID-19 infection.   On 02-Mar-2021, the patient passed out. She lost control of bladder. They took her into room, her blood pressure went low and passed out, they got her blood pressure back up she came around in a couple minutes. They called 911 but no ambulance came. When the patient felt good enough to leave, then they sent them home. She felt effects for rest of day, but felt normal the next day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The events of passed out (loss of consciousness) and lost control of bladder (urinary incontinence), blood pressure low(hypotension) resolved on 03-Mar-2021.; Reporter'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.
Trochleitis, peripheral neuropathy, migraines, eye pain, loss of depth perception.  Went to an optometrist on 12/31 and Medical Center Emergency room on 12/31.  After doing a CR scan and ruling out a stroke and aneurysm, was referred to a retina specialist, neurologist and neuro opthamologist.
Feeling lightheaded, extreme weakness, & fatigue. Short of breath and shaky. Stated before 1st Covid vaccination walked 2-3 miles a day in 30 minutes and skied several times a week. Become weak after first vaccination. But since 2nd Covid vaccination can't even go up or down the stairs without heart pounding and having to rest at the bottom/top. It has been 4 weeks and client states weakness and fatigue is not lessening but getting worse. Stated called PCP. PCP wanted client to wait 4 weeks before coming in. Stated the main thing the PCP would do would be to draw blood.
He received vaccine on 3/10 and on 3/12 was admitted to hospital with a brain bleed. his INR was 10 However he had INR done 3/2/21 and it was 2.5. Dr not sure if related to vaccine or not He underwent surgery on 3/13 and was in hospital 43 days
This spontaneous report received from a patient via a company representative concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 14:25 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced headache. On 11-JUN-2021, the subject experienced could not think, confused. On 11-JUN-2021, the subject experienced vomit. On 11-JUN-2021, the subject experienced cough. On 11-JUN-2021, the subject experienced lack of air. On 11-JUN-2021, the subject experienced heavy sweating. On 11-JUN-2021, the subject experienced extreme pain in his legs (described as the worst of any workout he has ever done in his life). On 11-JUN-2021, the subject experienced chills. On 11-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: salbutamol. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not think, confused, vomit, cough, lack of air, heavy sweating, extreme pain in his legs (described as the worst of any workout he has ever done in his life), chills, fever, and headache on 12-JUN-2021. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Approximately one week after receiving 1st dose I developed cellulitis.  It was sore the day after as expected and had a couple of itchy days but nothing that I thought was abnormal.  It started on Tuesday, 1/12/21 as a small outbreak of hives/welts (with intense burning and itching) at the injection site and progressed by doubling and possibly tripling in size over the course of the next couple of days.  It produced a red, swollen and warm spot on my arm at the injection site.  On 1/14/21, I saw my Primary Care physician and was prescribed an antibiotic for treatment.
Complete hearing loss in three days and partially recovered. Still has had PO steroid 7 dys. No severe sensory-neural hearing loss.
I noticed my feet swelling a couple day after, then I was very tired but I thought it was my monthly cycle, then I was so tired that I couldn't walk up the stairs. Now each time I take a step I have to stop to rest before I take another step, I am out of breath. I have nausea, and feel like I want to throw up after  eat, I did not relate the symptoms that it could be related to the vaccine at first and did not go to the doctor. I have headaches and very tired. And now it's getting worse and I cannot walk.
patient was received an expired vaccine/ no AE; patient was administered vaccine during pregnent/ no AE; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (Reference number- 00768515) and transmitted to Sanofi on 14-Sep-2021.   This case involves a 31-year-old female patient who administered an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event (expired product administered) during her pregnancy (Maternal exposure during pregnancy).  Gestation period at onset was 10 weeks.  Data regarding this pregnancy were received prospectively for example before pregnancy outcome was unknown.   The date of last menstrual period was 06-Jul-2021.  The estimated due date is 12-Apr-2022.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 14-Sep-2021, the patient received a 0.5 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ702AA and expiry date 30-Jun-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "4 patients in her office on 14SEP2021 received vaccinations of FLUZONE QIV NP that expired on 30JUN2021. Caller asked for information on how to proceed and whether or not these doses should be re-administered".  It was a case of actual medication error due to Expired vaccine used and Maternal exposure during pregnancy (latency was on same day).  Relevant prenatal testing after exposure was not reported.  At the time of reporting, patient had no adverse event.  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.
Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021); Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)). On 20-Sep-2021, PRODUCT STORAGE ERROR (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-326226, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received contains significant information. Race and Ethnicity information were updated. Vaccination facility information and both dose details were updated.
COVID vaccine breakthrough case. Pfizer 3/18/2021 (no lot #), 4/8/21 EW0150, 11/23/2021 FH8027 and bivalent 9/19/2022 FJ2524
Missed second dose time window; Positive COVID Test; began to feel tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose time window), SARS-COV-2 CARRIER (Positive COVID Test) and FATIGUE (began to feel tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), ETODOLAC, OMEPRAZOLE, METFORMIN, INSULIN GLARGINE (LANTUS), LEVOTHYROXINE, CLARITHROMYCIN (CLAVIX), ATENOLOL, ISOSORBIDE MONONITRATE and LIRAGLUTIDE (VICTOZA) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced SARS-COV-2 CARRIER (Positive COVID Test) and FATIGUE (began to feel tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose time window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose time window) had resolved and SARS-COV-2 CARRIER (Positive COVID Test) and FATIGUE (began to feel tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, SARS-CoV-2 test: positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Treatment for Covid-19 included, intravenous (IV) Bamlanivimab. No medical history was provided.; 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, SARS-Cov2 carrier and fatigue, a causal relationship cannot be excluded.  This report also refers to a case of product dose omission issue for mRNA-1273, lot # 031L20A.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from an investigator regarding a 4 month old male participant in a study who expired due to SIDS. At 2 months of age, the participant received the first dose on 11/05/2005. The participant also received the first dose of Infanrix (diphtheria, tetanus toxoid, acellular pertussis vaccine), the first dose of Engerix B (hepatitis b vaccine) and the first dose of Act-Hib (haemophilus b conjugate vaccine (tetanus) on 11/05/2002. Medical history: Patient was of full term gestation, had been in good health and was taking no medication. Indication for Prevnar was immunization. Product was administered on 11/05/2005. Dose regimen was 1 dose intramuscular. Concomitant therapy included Infanrix, Engerix b, Act Hib and Polio vaccine (poliomyelitis vaccine inactivated. On Jan 08 2003, 64 days post immunization, the patient expired due to SIDS (sudden infant death syndrome). The mother reported the child was found lying on his back with his head to the left, unresponsive. Emergency services were summoned. The patient was found pulseless and apneic, death was determined to be present at 0750 hours. The reported cause of death autopsy, as per coroner, was SIDS. Toxicologic test results blood negative for common drugs and chemicals was done on 01/30/2003. The investigator(s) and medical monitor(S) considered sudden infant death syndrome not related to the study product.
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. On or about 28-JUN-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 20-MAY-2014, the patient was treated in hospital, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 68 year old female patient who had a thiomersal allergy and hypertension. Concomitant medications included lisinopril, zolpidem and nitroglycerin ointment. On the 08-Jan-2015, the patient received AFLURIA injection (batch number (TS0007) via the intramuscular route in the left arm. She had also received a PNEUMOVAX immunisation (batch number not reported) at her doctor's office before going into the pharmacy. On the 09-Jan-2015, the patient developed a rash on her face and eyes. There was no irritation at the injection site. The patient filled a prescription for fluorometholone ointment from an ophthalmologist. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported that the patient attended the Emergency Room.
diagnosed with cancer; Caller received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, and is scheduled to receive the second dose on Sunday, 11Apr2021. Caller mentioned that she was recently diagnosed with cancer.; This is a spontaneous report received from a contactable female consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;( solution for injection, Lot number unknown, expiration date: unknown) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date patient was diagnosed with cancer and would need an implant- a port in the chest for IV access. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, and is scheduled to receive the second dose on Sunday 11Apr2021. The outcome of event was unknown.  Information on Lot/Batch number has been requested
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 30-year-old female patient received BNT162b2 (BNT162B2), on 15Dec2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: The patient is treated for Covid-19 with paxlovid from 02feb2023 to 07Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 16NOV96 & 26NOV96 pt exp 5 lesions & mild fever for 1/2 of 1 days;
Left arm became swollen and red, itchy rash developed and persisted for 7 days.
Post vaccination feeling of breath doom, walking to door to get fresh air. Syncope, fell to floor. No head injury. Post vaccination syncope, brief generalized tonic-clonic movement followed by emesis. Blood glucose 114, BP 120/80, HR90, O2 Sat 96%.
Flu shot was administered at around 4:30pm. The luer-lok needle was not screwed on tightly prior to administration which caused some of the vaccine to leak out, resulting in an incomplete dose. Patient has not reported any symptoms before leaving the pharmacy.
Numbness and tingling in left arm, possibly related to site of injection - also states developing bumps at extremity of left hand.
Within 36 hours of 2nd vaccine , he had a massive stroke. Could not  speak or move right side.
the child suffered a seizure and was admitted to the hospital; This spontaneous report was received from the patient's mother and refers to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-OCT-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).  On 23-OCT-2022, the patient experienced a seizure and was admitted to the hospital. The patient was intubated for two days while on oxygen. Treatment also included unspecified steroids and antibiotics. On an unknown date in October 2022, the patient was discharged from the hospital. At the time of reporting, the patient had not recovered from the event of seizure.   The causal relationship between the seizure and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  Upon internal review, the event seizure was determined to be medically significant. The reporter considered the event seizure to be life threatening.
I was diagnosed as having had a stroke - acute/subacute infarction involving the superior medial aspect of the right cerebellum