chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Toes started having purple blothces; little minor achy; A spontaneous report was received from a consumer concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain (little minor achy) and skin discoloration ( toes started having purple blotches,looks like covid toe).  The patient's medical history was not provided. Concomitant medications reported were Vitamin pill, Omeprazole for drug use for unknown indication.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) through unknown route in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced little minor achy. On 18 Feb 2021, the patient experienced toes that started having purple blotches and she stated it looks like Covid toe.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Dyspnea on exertion. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Mom states patient had seizure in the parking lot (siting in car), following the administration of immunizations. Mom called 911 and the patient was taken to a local ER for treatment, CT, scan, EKG, and lab work. Mom reports all work up so far has been negative. Patient had a doctors appointment this morning and is scheduled for a EEG later today, 8/7/2018. Patient does not have a history of seizures.
Throat felt like a knot on it side and hot; Throat felt like a knot on it side and hot; This is a spontaneous report from a contactable other healthcare professional.  A 43-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine) lot no: EJ1685, intramuscular on 22Dec2020 11:45 at a single dose for COVID-19 immunization in the hospital. The patient's medical history was not reported. Concomitant medications included birth control, thyroid meds, stomach meds. No other vaccines were administered in four weeks. On 22Dec2020 12:00, the patient experienced throat felt like a knot on it side and hot. The patient recovered from the events. on 22Dec2020 12:00. The events were reported as non-serious. The patient did not receive treatment for the events.
Severe asthma attack - unable to breathe - fast heart rate - dizziness - wheezing.
Headache started around 430 pm on 12/29. Woke at 3am on 12/30 with 102.7 temp. Sweats. Soreness to left arm
Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 13-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   Reporter did not allow further contact
Shot given 3 days prior to presentation with erythema extending beyond elbow with complaints of pruritus. Denies paresthesia/ weakness; nor constitutanol symptoms.
This is a spontaneous report from a contactable Physician (Internal medicine via a Pfizer sales representative). A 73-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot # S5T635, Expiry Date 30Oct2018, NDC # unknown) intramuscular at 0.5 ml, single into left arm on 07Nov2017 for immunisation for prevention of pneumococcal pneumonia. The patient medical history and concomitant medications were not reported. The patient came back into the office complaining of swelling and a lump on her left arm on 11Nov2017. She was treated with BENADRYL and CLOBETASOL on 11Nov2017.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The medical assistant reported that a patient was inadvertently administered a dose of VARIVAX (lot # M003441 with expiration date: 19-JAN-2018) instead of an intended dose of ZOSTAVAX on 27-JUL-2016. The medical assistant reported that the nurse who administered the VARIVAX mistakenly thought VARIVAX was for prevention of shingles. No adverse effect reported. No product quality complaint was involved. No additional information provided. Additional information has been requested.
The day after injection, c/o severe headache, neck hurting and difficult to move. Went to ER- MRI was ok. Since then having joint and muscle pain. Also c/o vision changes. Seeing family Dr. for follow-up.
fever >101, chills, aches, severe site pain; lasted for about 7 hours
Has been in bed all day; Aches; Nausea; Fever of 101.4; This spontaneous case was reported by a nurse and describes the occurrence of BEDRIDDEN (Has been in bed all day), MYALGIA (Aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.4) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (Has been in bed all day), MYALGIA (Aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.4). At the time of the report, BEDRIDDEN (Has been in bed all day), MYALGIA (Aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (High) Fever of 101.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-303445, MOD-2021-303415 (Patient Link).
Pt recvd 3 doses of Engerix-B & almost immediately p/vax of 3rd dose pt exp a severe rxn that included bronchospasm, hypotension, & SOB; pt was resuscitated & Epi was given; events considered to be life threatening;
excruciating pain for 2-3 days (head to toe in muscles and joints) severe fatigue for 2-3 days upset stomach and nausea for a few hours  numbness in face  heart fluttering and weakness
Red, itching, hot r/arm 1/2 hour post shot. Over a course of 1 hour redness, itching, burning spread to neck, shoulder.  Benadryl was given. No difficulty breathing noted. By the time MD saw the pt, the symptoms were resolved, approx. 2hrs.
Paresthesia of the left foot. Feels like water flushing over the outer aspect of dorsal foot. Occurs about every half hour for the last day and a half. Mild headache grade 1/10.
Person to be vaccinated reported to have a history or forming keloid scars. No symptoms reported within 15 minutes of observation.
Shingles in genital area. Famciclovir 1500 mg daily for 10 days was prescribed.
administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly dose of VAQTA (lot # R006210 exp date 22-APR-2019) (dose and route not reported). There was a data logger issue. The temperature of excursion was 47 °F to 77 °F (47.3 °F) for a time frame of 5 minutes. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1809USA009046: US-009507513-1809USA009096: US-009507513-1809USA009097: US-009507513-1809USA009099.
9 wks post vax, devel fever. Treated with Ceftriaxone. Fever abated. Mild neutropenia abated by 6/96. No firm dx. Possible "benign neutropenia of childhood."
Surgery last Monday; This spontaneous case was reported by a patient and describes the occurrence of SURGERY (Surgery last Monday) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SURGERY (Surgery last Monday). At the time of the report, SURGERY (Surgery last Monday) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications was not provided.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 27-SEP-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
When I woke up I could not move or speak, my eyes could not even move, my wife tried to speak to me and see what is wrong with me, and I could not respond, slowly my eyes started to open a little bit, and then my mouth opened a little bit but I still could not speak, then my finger moved a little bit, but still could not move very much, had to use the bathroom but could not move myself to go to the bathroom. My wife thought I was playing and put water on me, but I could not move, a little while later I was able to move my arm and my wife helped me to the bathroom, and then sat me on the couch however I still could not move. After about two hours, I started to began to walk and move slowly on my ow. I also had a headache and a low fever the whole day, but by the next day everything was back to normal and I am fine.
High fever - normally 97.6^F, fever 103.3^F; severe headache; lethargic to the point of severe exhaustion - no energy to walk more than 5 steps; central, focal chest pain/pressure at base of the heart/lower sternum that lasted approximately 20hrs, associated mild wheezing/SOB for the last 10 hrs or so of that window.  No appetite for 3 days following vaccination.   Chest pain/pressure and shortness of breath resolved after ~20 hrs. Headache resolved within 5 days. Fever resolved within 3 days. Fatigue and lethargic resolved within approximately 1 week.
Systemic: Bell's Palsy-Severe, Additional Details: back pain, guillain barre
"I" began tinnitus in "my" right ear and dizziness.; "I" began tinnitus in "my" right ear and dizziness.; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Apr2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 10Apr2021, the day after her second dose of the vaccine, the patient experienced tinnitus in her right ear and dizziness. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus in her right ear and dizziness was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, itching on arm started 1 day after vaccine given; seen 4 days after vaccine with 2 inch area redness, induration, tenderness around vaccine site.
Sudden onset of nausea and immediate vomiting of small aomunt, felt a wave of lightheadedness which passed and then recurred after a few minutes.  Also felt chills which persisted for 45 minutes.  Blood pressure and HR stable.   Due to these symptoms, employee health required that patient will be COVID tested
Information was received from a registered nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. It was reported the multiple patients were administered improperly stored VARIVAX (lot # L013827, expired on 21-APR-2017) (dose and route unknown) on multiple dates. The vaccines were previously exposed under 22.2 F for 4 hours and 25 minutes, and was exposed under 8.3 F for 50 minutes this time. Data logger was involved. No adverse effects were reported. Additional information has been requested.
PARTIAL DOSE INJECTED; CHILLS; FELT SICK; MUSCLES PAIN; FEVER; This spontaneous report received from a consumer concerned a 32 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced partial dose injected. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced felt sick. On 26-MAR-2021, the subject experienced muscles pain. On 26-MAR-2021, the subject experienced fever. On 14-APR-2021, Laboratory data included: COVID-19 antibody test positive (NR: not provided) 21, and COVID-19 virus test negative (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, felt sick, muscles pain, and fever on 28-MAR-2021, and the outcome of partial dose injected was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist via a company representative, refers to unspecified patients. On an unknown dates, the patients were vaccinated with ZOSTAVAX (dose, lot number and expiration date were not reported). No concomitant medications were reported. On an unknown dates, the patients experienced approximately four-inch ring or red spot around the injection site that occurred one to two days, after patients received ZOSTAVAX. The pharmacist had told patients to use BENADRYL and to follow-up with physician if no improvement. The patient sought medical attention via calling a pharmacist. Outcome and relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 at 16:00 as dose 1, single (Lot number: EU00152), in left arm and on 07May2021 at 16:00 as dose 2, single (Lot number: EU000182) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN, start date: 03Jan2017; NORT, start date: 03Jan2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 of Paxlovid. Treatment start date was 23Aug2022 and stop date was 24Aug2022 of lot number G06840  Clinical course: The patient had no known allergies.  No follow-up attempts were possible. No further information was expected.
Patient received his first dose of Pfizer vaccine via IM in left arm. Patient was waiting in the waiting area post Covid vaccine accompanied by his father when his vision started to become blurry. As patient was raising his hand for assistance, he lost consciousness  for a couple seconds and hit his head on the wall behind him while remaining in his chair. RN stat was called. Vital signs were taken with blood pressure low. Patient visibly diaphoretic. 911 called at 518. Patient transferred from wheelchair onto stretcher via patients father. Patient has no history of allergies or on medications at this time. When paramedics arrived, patient stated feeling better. Ortho static vital signs taken. Blood sugar checked via paramedics and was 98. Patient stating vision is back to normal. IV fluids started for patient via paramedics. Patient was then transferred via ambulance out of clinic at 1745.
Stinging, burning pain in lower buttocks. I have had previous outbreaks of shingles. During my last attack, (Jan. 2007), I was taking Acyclovir when I Received a shot of ZOSTAVAX. Reaction was so severe I had to be admitted at a later date under emergency conditions for 7 days. 8/15/07-records received-DC Summary for DOS 5/3-5/9/07-DC DX: Acute ileitis. Chronic low back pain. Atrial fibrillation. On a chronic anticoagulation. Presented with C/O diarrhea for 7 days. Dehydrated with low potassium levels. Low back pain with numbness in bilateral legs upon sitting. Neurology consult 5/15/07-buttock pain and shingle. Patient may have cauda equina syndrome or neuropathy. Neurology consult 8/8/07-Reflexes absent at ankles but equal and symmetric with bilateral down going toes. Gait and station is normal. Impression:postherpetic neuralgia. Follow-up Report: PSN - Pt. has another attack of shingles. PSN - Post syndrome neuropathy.
I tested positive showing I had contracted the COVID virus recently with fever and sickness for 3 days; I tested positive showing I had contracted the COVID virus recently with fever and sickness for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "I tested positive showing I had contracted the COVID virus recently with fever and sickness for 3 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: After having 3 Pfizer COVID vaccines, I tested positive showing I had contracted the COVID virus recently with fever and sickness for 3 days which I am now over. My question is, how is this possible after getting these vaccines.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.