chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My only symptoms to the vaccine was a sore arm and headache. In May my symptoms started with scratchy throat, slight cough. I thought it was from going through our belongings as we had just had a house fire. On Friday we went to an outdoor carnival, I did wear my mask, but by that evening I was coughing more and was very tired. I slept the entire day Saturday and that is not like me at all. Sunday, I had a terrible cough, body aches and pains, stuffy and runny nose, could not breathe. I took a home COVID-19 test thinking it would come back negative but it came back positive in under a minute. I got worried because I have had Pleurisy, I called my doctor and had a telehealth appointment. I was prescribed a five day course of antiviral medication that I started as soon as I picked them up from the pharmacy that Monday. My symptoms were tolerable during the day. The nights I had to take nighttime THERAFLU to tame the cough so that I could sleep.
Patient started to feel faint 10 minutes after getting vaccine. She was breathing but very weak and started to look pale. Called 911 at 12:35. EMT's on scene at 12:45. EMT's did full scan of her. wanted her to go to hospital Patient refused to go. Signed form refusing hospital care.
A non-serious spontaneous report of felt odd (like head in fishbowl, unable to concentrate), headache, constant runny nose, sore throat and stuffy nose/ fully congested has been received from a consumer concerning a 39-year-old female patient, subsequent to FLUMIST. The patient's past medical history includes migraine treated with cefuroxime. The patient had acquired H1N1 from her five year-old son in Nov-2009. She had experienced hallucinations, could not walk, had extreme pain in joints and was put on budesonide+formoterol for a year. The patient received 0.2 ml FLUMIST on 10-Nov-2010 nasally for Influenza. Within one hour post vaccination, the patient developed headache and took cefuroxime. The headache resolved. In the evening of 10-Nov-2010, the patient developed constant runny nose. On 11-Nov-2010, the patient had a stuffed nose and felt odd (like her head was in a fishbowl and unable to concentrate). On 12-Nov-2010, the patient woke up fully congested and with a sore throat. The symptoms were not resolved. The outcome of the events felt odd (like head in fishbowl, unable to concentrate), headache, constant runny nose, sore throat and stuffy nose/ fully congested was not recovered while the headache was resolved.
Clot blood; Lots of other conditions; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot blood) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Clot blood) (seriousness criterion medically significant) and IMMUNISATION REACTION (Lots of other conditions). At the time of the report, THROMBOSIS (Clot blood) and IMMUNISATION REACTION (Lots of other conditions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of thrombosis and an unexpected, non-serious event. The events occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient had a blood clot and 'lots of other conditions' (unspecified). No further details were provided. The outcomes of the events were unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of thrombosis and an unexpected, non-serious event. The events occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient had a blood clot and 'lots of other conditions' (unspecified). No further details were provided. The outcomes of the events were unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Injection on left bicep Was slightly itchy with minimal redness through 07/01/2016 Took off pajama shirt at 11:30 AM 07/02/2016 to reveal appearance Swelling dark red warm to touch size of his entire bicep Itchy, highly bothersome prescribed OTC Benadryl and a prescription. He was given a total of 6 injections in one day in the 2 in each bicep and one in the thigh. One was chicken pox.
5/14/07 Left upper extremity - 1 x 1cm erythema circumferal immunizations, fatigue 24 hours, left axillary lymph node, left arm pain - heaviness. Robust reaction tx with Cipro 500mg BID x 10 days - 5/16/07 erythema, fatigue sxs - resolve.
fatigue; headache; body ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2021 at 15:00 as dose 2, single (Lot number: EM8729) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "irregular/rapid heartbeat" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL oral taken for heart rate irregular, start date: 2000 (ongoing); ATORVASTATIN oral taken for blood cholesterol increased, start date: 2000 (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Date: 18Mar2021, Time: 14:30 PM, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8727), administration date: 18Mar2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), 1 year 9 months 9 days 9 hrs after the suspect product(s) administration, outcome "recovered"; HEADACHE (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "body ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported, the patient had headache, body aches for about 4-6 hours after dose 2 upon waking the next morning. Relevant Tests include Lumira Dx SARS-COV-2 RRA on 19Jan2023, Result: Positive. Specific relevant test for Thromboembolic events with Thrombocytopenia was None. Lack of effect details: No lack of effect - product reduced disease/symptoms to expected level. Adverse event includes headache, body aches, fatigue on 18Jan2023. Seriousness criteria was reported as Not serious. AE outcome was Recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300136129 same reporter/pt, different dose/event;US-PFIZER INC-202300033779 same reporter/pt, different dose/event;
Few minutes after inj with Gardasil pt's mother reported that pt feels dizzy, looks pale and had stiffening of UE and LE. NO L.O.C, no seizures, Pt was observed 20 minutes and discharged in good condition.
PATIENT DEVELOPED HIGH FEVERS 101.5-103 FOR 2 DAYS THAT STARTED 10 DAYS AFTER SHOTS WERE ADMINISTERED.  OTHER THAN FEVERS AND POOR APPETITE, HE HAD NO OTHER SYMPTOMS. FEVERS RESOLVED AFTER 2 DAYS.
3-4 hours after onset of vaccines, she dev. (L) arm pain, stiffness. Followed by pain into neck, headaches, several body aches, poor appetite, fatigue, dizziness.
Patient became dizzy, lightheaded, pale, diaphoretic and hypotensive approx. 5 minutes after receiving vaccine. Also c/o nausea without vomiting.
Coronary artery bypass grafting x4 on pump. The patient's oxygen was weaned to room air. He progressed well with physical and occupational therapy and was stable to be discharged to home with family support on POD #3.  Hospital admission was within 6 weeks of receiving the COVID vaccine.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine (intramuscular). On an unknown date, unknown after receiving dTpa vaccine, the patient experienced fever and limbs stiffness. On an unknown date, the outcome of the fever and limbs stiffness were unknown. It was unknown if the reporter considered the fever and limbs stiffness to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that his sister and their two kids had a Tdap (unknown date; unknown manufacturer) and experienced the side effects. The caller reported that she was not close to her sister or their kids and had no further information to report. This case has been linked to the case US2018074039 and US2018074038, reported by the same reporter.
47 y/o F presented to Covid Vax Clinic on 11/10/21 for side effects after 2nd Covid Vax dose received on 11/09/21 Lot Number 30145BA.  C/o about 2-inch spot with redness, swelling, soreness on LT arm. Pt also c/o some difficulty moving LT arm. Injection site appears to be out of IM deltoid range.  Pt states that sx have worsened w/in last 24 hours. Denies any other sx, severe pain, or numbness. Pt denied needing any ER/urgent care transport at this time or after receiving 2nd dose.  Pt received 1st dose of Pfizer Vaccine on 10/18/21 Lot Number 30145BA. Pt reports taking 1 day off after to recover from cold like sx which she believes were caused by initial dose.
Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old patient (gender not reported) who received a dose of MENACTRA lot U5839AA via unknown route in the left arm and ADACEL lot U5898AA via unknown route in the left arm on 20 Jul 2018 instead of fifth dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) lot number not reported via unknown route and a dose of PROQUAD lot number not reported via unknown route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered as patient received MENACTRA and ADACEL, however vaccinations were intended to be the 5th dose of DTaP and first dose of PROQUAD. It was unknown if the patient experienced any adverse event or not. 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. Documents held by sender: None.
Family MD called to report seeing pt today for F/U from ER visit on 10/22/18 after pt received FLUZONE HD and PSV23 at our pharmacy. Pt's reported pain level at ER was "20 on scale 1-10."  Per pt, she has had 3 subsequent courses of NSAIDS/steroids trying to relieve pain from injection site. "Was in tremendous pain X 1 month, tolerable now but still has some pain." Pt is getting MRI scheduled.
A pharmacist (also reported as physician) reported she heard from an unknown source that in October 2011, there were a patient who developed unspecified reactions post vaccination with ZOSTAVAX (Merck) (Lot # and route not reported) and the "flu" vaccine (manufacturer and name unspecified). The patient's reactions were so severe that led to the emergency room. At the time of the report, patient's outcome was unknown. Follow up information was received from the registered pharmacist concerning the 72 year old male patient who at 12:30 PM on 26-SEP-2011 was vaccinated with his first dose of ZOSTAVAX (Merck) (Lot# 670754/0621AA, "Exp Date: 24-JUL-2012") by SC route and his second dose of FLUZONE (Lot# UH2152AA, "Exp Date: 03-APR-2012") (was vaccinate the 1 dose prior years) in a pharmacy. The pharmacist stated that the patient was given vaccine at 12:30 PM on 26-SEP-2011 and adverse reaction started at 17:00 PM on 26-SEP-2011. The patient experienced cough, wheezing, chest tightness, dropping in blood pressure, losing of color in face and shortness of breath. The patient required emergency room and 1 day hospitalization. Electrocardiogram (EKG), chest x-ray, heart attack work-up and blood pressure monitoring were performed with unknown results. Attempts are being made to verify the existence of an identifiable patient. This is one of several reported received from the same source. No further information is available.
After 3 hours after the booster, I started feeling dizziness, lightheaded, difficulty speaking and double vision. My husband took me to emergency facility. I experienced the memory loss. I didn't remember the way how we travel there, how we made a decision to do it and I didn't remember the conversation we had during this time. I still don't remember the first minutes at ER. The memory  and the symptoms went back to normal after about 1 hour since the beginning of incident.
I received my 1st booster shot on 02/10/2022 my adverse event started on 02/23/2022. I tested positive on 02/25/2022. On Wednesday the 02/24/2022 I had a itchy throat. 02/25/2022 I was sneezing, my taste bud was gone, I was coughing. On Sat I had extreme fatigue along with fever. I emailed my doc, they said to stop taking some of my recent medications. They told me to take Tylenol and take cough medication (benzonatate) 3-4 days till I started feeling better by next Wednesday I was fine. COVID home test on Friday 02/26/2022.
Pregnant patient was given Flumist. She did not have nay symptoms after   the administration. Incidetn reported to patient's OB GYN.
Starting 01/16/2021 (within 24 hours of the vaccine) I had a running fever, my joints ached and hurt (shoulders, elbows and knees) as if someone was stabbing me with a knife directly into the joints and I had body aches. These symptoms lasted for almost 3 days then they resolved. Within 2 days of receiving the vaccine, the distal joint of my left thumb became extremely swollen (2x the size of the right one) which lasted for about 2 weeks. Ever since then, it will randomly swell. Also, I get random pains in between my right elbow and hand (severe aching) since my first shot.  Also, I get random sharp joint pains in my knees and ankles.
pt was given a moderna booster, dose was incorrect for a booster (0.5ml given) and pt not eligible for Moderna booster based on age.
on 8/10/21 patient presented to ED with cough, fever, shortness of breath, diarrhea, headache, and nausea for about 3 days, pt was sent home and returned to ED on 8/12/21, needing dialysis
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received Comvax and Dtap in right thigh site of Dtap immediately swelled to 1 1/2 inch by 1 1/2 inch. No discoloration, pt immediately very fussy. Possibly SQ in pt initiated with Ice and Motrin immediately.
Sleeping a lot more; More tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping a lot more) and FATIGUE (More tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Relapsing multiple sclerosis, Depression and Anxiety. Concomitant products included OCRELIZUMAB (OCREVUS), PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), OXAZEPAM, VITAMIN D3 and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced HYPERSOMNIA (Sleeping a lot more) and FATIGUE (More tired). At the time of the report, HYPERSOMNIA (Sleeping a lot more) and FATIGUE (More tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  treatment medications were reported
G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 5/21/2022 ANEMIA G62.9 NEUROPATHY 1/20/2022 ANEMIA I95.9 HYPOTENSION 7/6/2022 ANEMIA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/12/2022 ANEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 5/21/2022 ELEVATED LIVER FUNCTION TEST G62.9 NEUROPATHY 1/20/2022 ELEVATED LIVER FUNCTION TEST I95.9 HYPOTENSION 7/6/2022 ELEVATED LIVER FUNCTION TEST J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/12/2022 ELEVATED LIVER FUNCTION TEST G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 5/21/2022 CHOLANGIOCARCINOMA G62.9 NEUROPATHY 1/20/2022 CHOLANGIOCARCINOMA I95.9 HYPOTENSION 7/6/2022 CHOLANGIOCARCINOMA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/12/2022 CHOLANGIOCARCINOMA
I had a stroke; This is a spontaneous report from a non-contactable Nurse. A 61-years-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3302), via an unspecified route of administration in left arm on 02Feb2021 at single dose for Covid-19 immunisation in hospital. Medical history included hypothyroid. Patient is not pregnant. Concomitant medication included levothyroxine, trazodone, famotidine (PEPCID), cyanocobalamin (VITAMIN B 12). The patient previously took codeine and experienced drug hypersensitivity. Historical vaccination included BNT162B2(lot number:EL3248) on 12Jan2021, in left arm, first dose. No other vaccine in four weeks. No Covid prior vaccination. The patient stated I don't know if it was a result of the Covid shot. But I don't have any comorbidities and I had a stroke on to four which was two days after the shot on 04Feb2021 09:30 with outcome of recovering (as reported). AE result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (2 days), disability or permanent damage. The patient underwent lab tests and procedures which included Nasal Swab, Covid test result: negative.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Despite insufficient clinical information provided, by close temporal relationship and absence of factors which may provide an alternative cause, the company deems there is a reasonable possibility that the reported stroke is related to the suspect drug Comirnaty. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt did not experience an adverse reaction.  I am reporting that He received his 2nd dose 45 days from the 1st dose instead of 60-180 days.  I am not sure how this will affect the effectiveness of the vaccine.  It was recommended that I do report through VAERS
body aches; chills; pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant), MYALGIA (body aches) and CHILLS (chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 0-30L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Nov-2020 and the estimated date of delivery was 04-Sep-2021. On 24-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On 22-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (body aches) and CHILLS (chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, MYALGIA (body aches) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Fatigue, fever, minor nausea for over 24 hours. Vaccine occured Saturday at 11:30AM and beginning of symptoms were noticeable around 10 am the following day (Sunday).
A mother reported that her son received tetanus vaccine at 13 months of age, following a cut on his finger. Since that time, she noticed that her son's language skills decreased significantly. A dx of autism was made. Autism was considered "Medically Important". This child experienced petit mal convulsions following receipt of Hib-Titer and Acel-Imune vaccines at 2 months of age. The reporter inquired about the thimerosal content of the vaccines. See related HQ2269010MAY2002. The follow up states the pediatrician indicated that the child was admitted to the hospital for seizure activity. He was seen by a neurologist. Neurological exam and EEG were normal, but it was recommended that the child not receive pertussis in the future. On 5/9/02, a mother reported that her son received tetanus vaccine (manuf unk) at 13 months of age following a cut on his finger. Since that time, she noticed that her son's language skills decreased significantly. A diagnosis of autism was made. Autism was considered medically important (OMIC). The reporter inquired about the thimerosal content of the vaccine.