chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; headache; nausea; vomiting; diarrhea; exhaustion; full body aches; muscle pain; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a non-contactable consumer or other non hcp (patient) . A 26-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration, administered in left arm on 24Mar2021 15:00 (Age at vaccination: 26 Years) (not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation.The patient medical history was not reported. The patient previously took codeine and experienced allergy. (Allergies to medications, food, or other products was reported as Codeine). Concomitant medication included desvenlafaxine taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, headache, nausea, vomiting, diarrhea, exhaustion, full body aches body aches and muscle pain on 25Mar2021 01:00. The outcome of events was recovering. No treatment was given to the patient. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  Information on the lot/batch number has been requested.
Sixth dose of vaccine administered from vial when authorized for only 5 doses per vial.
Gave the 5-11 year old Pfizer vaccine instead of 12 and older. Called Pfizer and they recommended giving another .3 cc of the 12 and older vaccine. Came back 5/26/22 at 4 pm for next dose
This initial spontaneous report was received from a physician via a company representative reporting that one of her patients told her of another patient of unknown age and gender whose pertinent medical history, concomitant medications or concurrent conditions were not described. The reporter stated that on an unknown date, the patient was vaccinated with a dose of an unspecified vaccine; GARDASIL or GARDASIL 9 injection (dose, route, lot# and expiration date were not provided). On an unknown date, the patient began getting headaches and sought medical attention at a Neurologist who told that the vaccine GARDASIL or GARDASIL 9 had also caused a brain tumor. Product quality complaint (PQC) was involved. At the time of the report, the outcome of the event was unknown. The reporter causality between the event to the suspect therapies was not reported. Additional information has been requested.
Site where given was swollen for 3 days and I still have a large black and blue mark since April 9th.
SEVERE CHILLS;  SEVERE BODY PAIN; FEVER; NAUSEA; LASTED 18 HRS. FATIGUE NEXT 3 HRS/ TOOK ZOFRAN, MOTRIN AND TYLENOL TO RELIEVE SYMPTOMS.
It was reported the patient had a severe allergic reaction to the Pfizer shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "It was reported the patient had a severe allergic reaction to the Pfizer shot".  Additional Information: On 16Aug2022, it was reported that a patient started treatment on an unspecified date with Pfizer-BioNTech COVID-19 vaccine at an unspecified dose, frequency and indication. It was reported the patient had a severe allergic reaction to the Pfizer shot and has been told not to get an mRNA vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse, concerning an adult female patient with no pertinent medical history, who on unknown dates was vaccinated with the first and second doses of VARIVAX (Merck) (routes and lot numbers not provided). On an unknown date, a varicella antibody titer test was performed, and the result was negative. The patient's outcome was unknown at the time of reporting. The patient sought medical attention via office visit. No further information is available.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        Action taken with mRNA-1273 in response to the events was not applicable No treatment information and concomitant medications were provided   This case was linked to MOD-2021-213355, MOD-2021-213355 (Patient Link).
arm pain, redness, pain at injections site, burning pain that extends from chest wall into mid axillary line up through inner upper arm. Pink rash to legs, feels like pins and needles to her legs.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-MAR-2010, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-AUG-2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving 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 was unknown. Causality assessment was related. Additional information has been requested.
Fever peaking at 102 and persisting for around 72 hours, chills, sweating, severe fatigue, severe tightness/aching through neck and shoulders, significant swelling/tenderness in left armpit.
This spontaneous report as received from a physician via field representative regarding himself. The patients age, concurrent conditions and relevant medical history was not reported. On an unspecified date in June 2014 (reported as one month back) the patient was vaccinated with ZOSTAVAX (dose, frequency, and route unspecified). The physician who was the patient reported that after being vaccinated his arm swoll up really really bad and it stun and burned for a week. The field representative stated that the patient was fully recovered now. The causality of the events with ZOSTAVAX was not reported. Product quality issue was not involved. Additional information has been requested.
fever; body malaise; Body aches; muscles hurt; sharp eye pain/If she turns her eyes to the right or to the left; chills; This is a spontaneous report from a contactable consumer. A 24-year-old female patient (daughter) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at 18:00 on 17Dec2020 at single dose for COVID-19 immunization. Medical history included asthma and anxiety. Concomitant medication included sertraline hydrochloride (ZOLOFT) for anxiety. The patient experienced fever, body malaise, body aches, muscles hurt, sharp eye pain/if she turned her eyes to the right or to the left, and chills on 18Dec2020. At time of reporting, the outcome of events was not recovered.
PATIENT CALLED PHARMACY ON 2/28/23 AND EXPLAINED THROUGH A INTERPRETOR THAT SHE STARTED HAVING CHEST PAIN AND " HEART PAIN" 20 MINUTES AFTER RECEIVING THE VACCINE.  SHE STATED THAT SHE IS STILL EXPERIENCING CHEST DISCOMFORT AND HAD CALLED HER PHYSICIAN. HER DOCTOR TOLD HER TO CALL THE PHARMACY BACK OR GO TO A LOCAL HOSPITAL. WE ADVISED PATIENT TO SEEK MEDICAL ATTENTION SINCE IT HAS BEEN 8 DAYS SINCE THE VACCINE AND SHE IS STILL HAVING PROBLEMS .
Pain on back; Pain on hips; Headache; Generalized pain on body; Pain on arm; Pain on neck; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN IN EXTREMITY (Pain on arm), BACK PAIN (Pain on back), ARTHRALGIA (Pain on hips) and NECK PAIN (Pain on neck) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #037A7LB) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE and (unspecified)                                                  Spray for seasonal allergies for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced NECK PAIN (Pain on neck). On 09-May-2021, the patient experienced HEADACHE (Headache), PAIN IN EXTREMITY (Pain on arm), BACK PAIN (Pain on back), ARTHRALGIA (Pain on hips) and MYALGIA (Generalized pain on body). At the time of the report, HEADACHE (Headache), PAIN IN EXTREMITY (Pain on arm), BACK PAIN (Pain on back), ARTHRALGIA (Pain on hips), NECK PAIN (Pain on neck) and MYALGIA (Generalized pain on body) outcome was unknown. Not Provided      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.   This case was linked to US-MODERNATX, INC.-MOD-2021-114441 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114441:First Dose Case
On patient's left upper arm Area noted of approximately 4 cm in diameter, with a white dot and hole where needle entered. It was raised, scaly like in touch, and extremely hard and hot to the touch. Patient also had vomiting throughout the early morning and into afternoon.
Approximately 5 minutes after receiving first dose of Pfizer COVID vaccine, patient had syncopal episode with brief seizure activity noted
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 27-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
pain and numbness in L armVS 133/84-120/76, AP 73-63 O2 sat 96%, T 99.3 RR 20 assessed by provider. Symtoms lasted injection sit, itching and cramping of l arm Narrative:
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The agency consulted with public health and environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The agency is working with public health on a compliance improvement plan and has been reinstated vaccination privileges.
UNKNOWN CAUSE OF DEATH; ELEVATED HEART RATE; HYPER RESPIRATIONS; FLU LIKE SYMPTOMS; MENTAL CONFUSION; WEAKNESS WORSENED; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included the patient did not had medical and underlying condition and was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The patient was not taking any concomitant medications. On 03-APR-2021, the patient experienced elevated heart rate, hyper respiration, flu like symptoms including chills, weakness, fatigue, cough; the patient also had mental confusion and nausea. He was called in urgent care centre and they treated him with over the counter medications, Tylenol (paracetamol). On 16-APR-2021, the patient died due unknown cause. The daughter stated that she was taking him to emergency room the day he passed away. It was unknown if the autopsy was performed. The cause of death was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on 16-APR-2021, had not recovered from mental confusion, and the outcome of weakness worsened, elevated heart rate, hyper respirations and flu like symptoms was not reported. This report was serious (Death).; Sender's Comments: 20210439259-COVID-19 VACCINE AD26.COV2.S -Unknown Cause Of Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt. given PREVNAR 13 lot # G32487 0.5 ml IM Rt DLT on 8/22/2013. She called on 8/23 and reported redness - adv BENADRYL, ice, TYLENOL. Call back if not better. On 8/26, she presented w/ 16x9 area of redness, hot, tender.
645PM mom returned to clinic stated that pt started coughing, wheezing, tightness in throat, puffy eyes (5PM only visible sx @ clinic was eye puffiness)audible wheezing heard by stethoscope;epi given;
Break Through Menstrual Bleeding - I am post menopausal and have not had a period for approximately 2 years.    I also within 8 hours started experiencing a sharp stabbing pain in my left upper back that has not subsided.
Changes in menstrual cycle - the period wasn't supposed to start for another 7-10 days but it started on 31May2021; Two days after my 2nd vaccination and heavier flows noticed as well; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ENOM) via an unspecified route of administration, administered in Left arm on 29May2021 at 15:00 as Dose 2,Single for COVID-19 immunization. The patient's medical history included none. Other Medical history- No.Concomitant medications(received within 2 weeks of vaccination) included amoxicillin (AMOXICILLIN) taken for an unspecified indication from 29May2021 to an unspecified stop date. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient hasn't been tested for COVID-19. On 31May2021 at 16:00,the patient experienced changes in menstrual cycle - the period wasn't supposed to start for another 7-10 days but it started two days after my 2nd vaccination and heavier flows noticed as well. No treatment was received. No prolonged hospitalization. The outcome for the events was Unknown.  Follow-up attempts are completed. No further information is expected.
Lost feeling in both legs; Little dizziness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Lost feeling in both legs) and DIZZINESS (Little dizziness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS & MINERALS PLUS LUTEIN, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and GABAPENTIN for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced HYPOAESTHESIA (Lost feeling in both legs) and DIZZINESS (Little dizziness). On 23-Apr-2021, HYPOAESTHESIA (Lost feeling in both legs) and DIZZINESS (Little dizziness) had 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 information was reported.
low grade fever; cough; headache; sore throat; tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from a sales representative.  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 28Nov2021 (Batch/Lot number: unknown) at the age of 5 years as dose 2, single and administration date 07Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "tested positive for Covid-19"; PYREXIA (medically significant), outcome "unknown", described as "low grade fever"; COUGH (medically significant), outcome "unknown", described as "cough"; HEADACHE (medically significant), outcome "unknown", described as "headache"; OROPHARYNGEAL PAIN (medically significant), outcome "unknown", described as "sore throat". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) low grade; sars-cov-2 test: (12Jan2022) positive. Description of Event: patient was vaccinated with his first dose on 07Nov2021 and completed the series on 28Nov2021. He has tested positive for Covid-19 on 12Jan2022 His symptoms include low grade fever, cough, headache and sore throat.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
w/in 2-3 days p/vax pt had shoulder pain; however, had no inject site react; neuro consult was obtained EMG done 10NOV93 dx lt ulnar neuropathy; pt lost grip in lt hand 15NOV
Within 24 hours of receiving vaccine: nausea, fever, chills,  headache & fatigue.  The following 24 hours up to 48 hours, on/off headaches & fatigue.  Day 3, 4/11/2021 @ 1 p.m. I experienced a black out for about 2 seconds.  The first sensation was total dizziness and then everything went gray.  I fell into the wall but not down to the floor.  After that I felt normal.  Day 4, I inexplicably dozed off for a split second while driving.
2 days p/vax rt deltoid edematous, red & warm & pain increasing w/edema, brought to emergency dept by parent;tx ATB & dx of cellulitis;
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long-standing health conditions was reported as unknown.     On 21-Feb-2022 at 3:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Feb-2022 at 3:54 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination or at the time of the adverse event were reported as unknown. Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown. No concomitant medications were provided by reporter. On 21-Feb-2022 at 15:54:35, patient received an expired booster dose.Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment medications were provided by reporter.
Aprx 12 hours subsequent to vaccine, developed chills, low grade fever, throat pain, deep muscle pain, headache and nausea. Symptoms lasted for 24 hours and then began to subside.
BODY ACHES; CHILLS; SORE THROAT; DIZZINESS; TIGHTNESS OF CHEST; HIGH FEVER; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate asthma, allergies, and reactions to medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced high fever, body aches, chills, sore throat, dizziness, and tightness of chest. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, body aches, chills, sore throat, dizziness and tightness of chest was not reported. This report was non-serious.
FLUZONE Influenza vaccine administered 10/25/12. Today client reports to PH agency pain at site, numbness, tingling at fingers. Difficult to pick up arm and raise arm to dress. Pain with moving arm. Site (L) deltoid. Pain started 10/26/12. No treatment sought. Patient will contact clinic today.