chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt fine 15 minutes after the injection they looked after me to make sure I was ok I went into work like normal but around 9:00 I started feeling sick to my stomach I waited it out because my shift ended at 11 I drank lots of fluids but around 1am that morning I got really dizzy and tried my best to rest but my body just wouldn?t let me i finally dozed off somewhere between 2 in the morning and woke up around 3:45  with this rash and and shortness of breathe I couldn?t stop itching so I stayed in a hot bath constantly running and draining hot water to ease my skin off after about a few hours things started to feel a little better a kept taking Benadryl and constantly kept lotion to keep my skin moist It felt so dry It was painful but I had to work through it the only thing that has not went away is the chest pains and the mystery cramps I have in my stomach from time to time it?s time for me to take my second dose but I?m scared and I was reading on the CDC website if I had an reaction to contact you I have been to the ER since I do not have a primary care doctor but due to the amount of people their and the wait times and the worrying of being in a hospital during this time I never got a chance to see a doctor I can take deep breathes but when I breathe out it flutters as well I?m trying to give all the information I have Had to work through this and keep going day by day but the chest pains now are really starting to scare me from reading what?s on the CDC website
Given FLUMIST w/reported history of egg allergy - Pt observed for 30 minutes and released w/no symptoms.
11/4/08  Optic Neuropathy leading to severe loss of vision right eye.  Treated with high dose IV steroids with no benefit.  5/4/09 Received Optho Clinic consult of 12/30/2008. FINAL DX: AION right eye(anterior ischemis optic neuritis) Records reveal patient experienced sudden painless vision loss right eye on 11/2.  Exam revealed disc edema.  5/11/09 Received OPH office records DOS 11/4/08-12/1/09. FINAL DX: Anterior Ischemic Optic Neuropathy - Right Eye Patient noticed spot and pain in right eye.  Central vision loss. Right eye fundus elevation with telangiectatic vessels.   4/28/09 Received PCP medical records of 11/17/08-4/6/09. FINAL DX: ischemic optic neuropathy Records reveal patient experienced unilateral vision loss.  Had been diagnosed by outside MD & had PICC line placed for high dose steroids x 5 days.  Unilateral blindness remained despite steroids & was continued on oral antibiotics & steroids w/o resolution.  1/2/09 tripped & fell w/pain on right shoulder & ribs.  Dx w/rotator cuff bursitis & tx w/PT & meds. 5/12/10 Monocular blindness.
a nurse forgot to mix the sterile diluent with the "shingles" vaccine and administered only the sterile diluent to a patient today; a nurse forgot to mix the sterile diluent with the "shingles" vaccine and administered only the sterile diluent to a patient today; patient did not receive complete dose from initial attempt.; This spontaneous report has received from a medical assistant, referring to a 56 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.  On 09-SEP-2020, the reporter stated that a nurse forgot to mix the sterile diluent (manufacture unknown) (1 dose, strength, route, indication, lot number and expiration date were unknown) with the shingles vaccine and administered only the sterile diluent (manufacture unknown) to the patient (single component of a two-component product administered and product preparation error), instead of the vaccine itself. Upon probing, the reporter was referring to zoster vaccine live (ZOSTAVAX) (1 dose, strength, route, lot number and expiration date were unknown) vaccine for prophylaxis, and today was meant to be first shot of shingles vaccine. The reporter would like to know if it was okay to administer zoster vaccine live (ZOSTAVAX) since patient did not receive complete dose from initial attempt (accidental underdose).
Information has been received from a male consumer who on an unspecified date was vaccinated with a dose of PNEUMOVAX (manufacturer unknown). The consumer indicated that he had received "a pneumonia vaccine once a year since it first came out, I don't know the name of the vaccine but it begins with a 'p'". The consumer also reported that he developed diabetes after he started getting vaccinated yearly and was hospitalized for diabetes in May of 1990. At the time of the report, the patient's status was unknown. Additional information has been requested.
Patient received Pfizer covid vaccine 6 hours and 51 minutes after the vaccine had been reconstituted. Patient has not had any side effects, however, CDC has advised that she will need an additional dose. Waiting for more guidance from CDC as to when to administer another dose.
Cardiac arrest, found unattended at home.  Per hospital, had massive MI.  Treated in ER/hospital.  Passed away following morning.
Post vax, the pt experienced heart block. Pt subsequently had a pacemaker inserted. FU information confirms that the pt had had lyme disease and was subsequently found to have third degree heart block that was incidentally found when he was being treated for a broken are. This case has been deleted as no AE has been identified.
sore arm; This spontaneous report was received from a lawyer and a female patient who approximately in 2000, was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown), for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).       On an unknown date, the patient experienced sore arm (pain in extremity).    The outcome of pain in extremity was unknown.  Causality assessment was not provided.    Subsequently the patient was vaccinated with zoster vaccine live(ZOSTAVAX) which caused shingles (captured in MARRS 2004USA001156).; Sender's Comments:  US-009507513-2004USA001156: US-009507513-2012USA004280:
I receive a Pfizer Covid booster shot at approximately 12:15 pm on 12/30/2021 in my left arm. On 12/31/2021, I began to have a severe burning pain in my left arm, left shoulder, neck and head. The pain intensified upon movement, even small movements made it worse. It was somewhat alleviated by a warm shower but would return within 15 minutes of leaving the shower. the pain lasted about 18 hours.
02/07/22 presents to ED for "Psychiatric Problem". PMHx of "ADHD, Suicidal Attempts"
Gave shot at 11:10am, pt returned at 12pm stating her lips and tongue were tingling. Pain and soreness in left arm-pain moved down arm. No SOB, difficulty breathing, no visible swelling or redness at injection site. Pt observed for ~30 min, gave 2 TYLENOL ex str. No further problems reported.
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned multiple patients. 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: 1805029, expiry: 25-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Initial unsolicited report received from Consumer on 26-Oct-2015. This case involves a patient (age and gender was not provided) who was vaccinated with a dose of INFLUENZA VACCINE (Trivalent Flu Vaccine) (Manufacturer: unknown, batch number, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient had experienced potential adverse event. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
Got flu like systems the following day and each day felt weaker with headache and ear and neck pain thought flu ignored. Then felt worse went to urgent care tested negative for corona virus. Seen by dr on site.12/12/21.  Double ear infection. Home with antibiotics, got worse. Face extreme pain went to ER at hospital due to left side face dropping and speech slurring was diagnosed with double ear infection and Bell Palsy on 3/14/2021.
pt recv vax 30APR97 & exp raised rash w/itchy welts which moved from one part of the body to another;consulted a MD & was treated w/zirtec, but the rash still persisted a month later;
Axillary lymphadenopathy. Swollen gland under right armpit. went to the Urgent care on the second day of the swelling. went away completely after 4 days
p/vax pt had trouble breathing & a heavy feeling in chest; advised checking w/MD before getting any more immun
slight headache; Her nose is a little runny; ache in her right thigh above her knee; did not sleep well; vomited; nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included platelet count increased and migraine. Concomitant products included fluoride.   On 6th October 2020 12:30, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced pain and sleeplessness. On 7th October 2020, the patient experienced headache and runny nose. In October 2020, the patient experienced vomiting and nausea. On an unknown date, the outcome of the vomiting, nausea and pain were recovered/resolved and the outcome of the headache and runny nose were not recovered/not resolved and the outcome of the sleeplessness was unknown.   It was unknown if the reporter considered the vomiting, nausea, headache, runny nose, pain and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine at 12:30 PM and at 7.15, 18hrs 45min after had nausea this morning and vomited. The patient did not sleep well and had an ache in her right thigh above her knee.  The patient had a slight headache and was prone to migraines, but the headache was not a migraine type and nose was a little runny and had a fluoride treatment at the dentist. The reporter did not consent to follow up.
extreme muscle spams in both legs unable to walk went to ER twice and was administered steriods, norco, vallium  time course 2 days
Information has been received from a nurse concerning a (approx) 15 year old female who was vaccinated (date, route and site not reported) with the 1st dose of GARDASIL vaccine (yeast) (lot # not reported). Concomitant therapy included influenza virus vaccine (manufacturer unknown). The patient complained of numbness in her hands and feet after receiving GARDASIL vaccine (yeast). The patient reported that the numbness  was on and off. Patient received unspecified medical attention. At the time of this report,  patient's outcome was unknown. Additional information has been requested. Information has been received from a physician concerning a 15 year old female patient who on 20-NOV-2007, was vaccinated IM in to the left deltoid with a first dose of HPV vaccince. On 21-NOV-2007 one day after the vaccination, the patient experienced intermittent numbness and tingling in her hands and feet. It was reported that it would last a few minutes and it occurred 4 to 5 times per day. The patient then went on to develop a cough and cold. On 26-NOV-2007, the patient was daignosed with mononucleosis. Laboratory disgnostic studies performed included serum Epstein-Barr virus early antigen immunoglobulin M antinbody test and serum Epstein-Barr capsid antigen immunoglobulin G antibody test which were reported as positive. Within 5 days, the patient recovered from intermittent numbness in hands and feet. Subsequently, the patient recovered from mononucleosis, cough and cold. No product quality complaint was involved.
Redness, heat, swelling to injection site.  Treated with Benadryl as needed and given prescription for Keflex, one tsp tid x 10 days.
Slightly below low grade fever at 99.2F on 12/23/20 @ 1:15 s/p COVID-19 vaccine received on 12/21/20 @ 14:43. Acetaminophen 650mg administered once on 12/23/20 @1:15 with resolution of symptoms by morning 12/23/20 @ 7:30. Fever ACETAMINOPHEN 650 MG ONCE
This spontaneous report was received from a physician referring to an 11 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date in May 2017 (reported as "last week"), the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not provided). Other suspect vaccine administered on the same date included diphtheria toxoid(+) pertussis acellular vaccine (unspecified)(+) tetanus toxoid (TDAP) (dose, route of administration, lot number and expiration date were not provided), also for prophylaxis. On an unknown date in May 2017, the patient had complaints of dizziness after receiving the vaccines and then she had a seizure that lasted for 30 seconds. In addition, her face went blank and her legs and arms were stiff. The physician also reported that the patient's vital signs were stable, so they kept her for two hours for observation, at which time she vomited (vomiting). The outcome of the events was unknown at the time of this report. Causality relationship between the events seizure and vomiting with and GARDASIL 9 and diphtheria toxoid(+) pertussis acellular vaccine (unspecified)(+) tetanus toxoid (TDAP) was not reported. Upon internal review, the event seizure was determined to be medically significant. No product quality complaint was involved. Additional information has been requested.
Muscle twitching; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (Muscle twitching) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu shot (Flu shot one week before bivalent booster); for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Flu shot and Moderna COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Muscle twitching). At the time of the report, MUSCLE TWITCHING (Muscle twitching) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient states that took the Moderna bivalent booster last fall. After 4-5 weeks. patient noticed muscle twitching. It got worse. Patient took the bivalent COVID booster a week after getting FluZone (flu shot). patient was not sure if it was too close together. Patient does not think a flu shot could do that because patient had so many flu shots over the years. The patient states that took 5 Moderna shots before getting the Moderna bivalent booster. patient got the Moderna bivalent booster on the same day.  No treatment medications were reported.   This case was linked to MOD-2023-707976 (Patient Link).
Meets vital records criteria: Cardiovascular disease, recent COVID-19. Pt was discovered in a state of decomposition by law enforcement conducting a welfare check requested by a family member on the afternoon of 11/13/21. Record shows pt was fully vaccinated
Held their breath and turned blue; Held their breath and turned blue; This spontaneous report was received from a physician via company representative referring to multiple female infant patients of an unknown age. The patient's concurrent condition included rotavirus immunization. The patient's medical history, historical drugs, drug allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, oral for prophylaxis and rotavirus immunization. On an unknown date, infant patients held their breath (breath holding) and turned blue (cyanosis) during administration of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Physician reported that, this issue spontaneously resolved after administration was completed and also reported to field employee that this issue occurred more often in unspecified male infants, though it was clarified that both unspecified male infants and unspecified female infants may have been involved. Physician no longer administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to any patients due to the issue, and instead administered ROTARIX (manufactured by GlaxoSmithKline), and reported that no patients have experienced the same issue with ROTARIX. It was not clarified if this meant any patients who experienced the issue with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) completed their rotavirus vaccination series with ROTARIX. The outcome of breath holding, and cyanosis was reported as recovered. The causality of the events was related with respect to suspect therapy rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.
Began with urticarial rash including swelling, began to become irritable and rash got worse 1/23-1/27. Went to ER and Dx with allergic reaction. Saw allergist, Dx with viral infection. Seen in office 1/27 dx with pharyngitis- given zithromax. 1/29 seen in ER dx with ? given Amox (? with rash) - to see 10 but rash disappeared along with fever.
Info has been received from a physician concerning a 17 month old male pt who on 1/28/05 was vaccinated with varicella virus vaccine live. On 6/29/05, the pt experienced a mild case of breakthrough chicken pox. It was noted that he was afebrile. There was no product quality complaint reported. The pt is recovering. Follow-up info received from the physician reported that there are no additional details regarding the adverse event or pt's outcome. The pt sought unspecified medical attention. No additional info is expected.
Daughter woke up trembling but could not move or yell out for help. Also felt fatigued, headache, and for the past year is still suffering since vaccination.
Pt received vaccine at 10:52AM. At 1PM had pain, fever, and swelling in arm. Patient taken to hospital via ambulance. Patient was admitted. CBC showed elevated WBC. Ultrasound showed fluid around bursa sac. As of time of report, patient is still hospitalized.
Patient was admitted to hospital from home for pneumonia. She was vaccinated on day of discharge to a skilled nursing facility. She proceeded to stay ill & did not recover from her illness. She was admitted to hospital 1/12/20 for sepsis and multifocal pneumonia. She cardiac arrested during hospital stay
Red, swollen at both sites of injection was unable to walk. X rays and blood work was taken 10/28/2005 at 4:50 pm.
got last year I got so sick from I was in the hospital for 2 weeks; Initial information received on 09-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp via Social media.  This case involves an unknown age and gender patient who reported got last year I got so sick from I was in the hospital for 2 weeks, while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient reported no and he/she will never do it again, the one he/she got last year he/she got so sick from was in the hospital for 2 weeks (illness) (unknown latency). The patient was hospitalized for this event during 14 days.  Action taken: Not applicable   It was not reported if the patient received a corrective treatment for the event (got last year I got so sick from I was in the hospital for 2 weeks).  At time of reporting, the outcome was Unknown for the event got last year i got so sick from i was in the hospital for 2 weeks.; Sender's Comments: Sanofi company comment dated 17-Jan-2022: This case concerns a patient who had hospitalization, after treated with Influenza vaccine. The time to onset is compatible with the role of the vaccine. However the lack of information regarding past drugs, relevant medical history, concurrent conditions, demographics, personal history, therapy details, latency and concomitant medications precludes a comprehensive assessment of this case. Based upon the reported information, the role of the vaccine cannot be assessed.
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 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 3 (booster), single (Lot number: gh9702) at the age of 44 years, in left arm 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 included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Dilantin, reaction(s): "Known allergies: dilantin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid on 13Feb2023 to 16Feb2023.
PT reported to the primary care clinic about an hour after his 2nd dose of Moderna vaccine and stated he was having chest pain and palpitations. EKG and vitals obtained pt evaluated and transported to local ER via EMS.
Pain/swelling in my armpit on the same side of my body as where the shot was given
This spontaneous report as received from a nurse refers to an unspecified number of patients. The patient's medical histories were not reported. In February 2015 (reported as between 17-FEB-2015 and 25-FEB-2015), the patients received improperly stored doses of GARDASIL, 0.5 ml, intramuscularly (lot # and site of administration were not reported). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) and HEADACHE (Headache) in a female patient of an unknown age 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 PAIN (Body aches) and HEADACHE (Headache). At the time of the report, PAIN (Body aches) and HEADACHE (Headache) had resolved.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-057065 (Patient Link).   Reporter did not allow further contact