chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had all vaccines and boosters for Covid. We had Covid in July; had all vaccines and boosters for Covid. We had Covid in July; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "had all vaccines and boosters for Covid. We had Covid in July". Clinical course: Patient had have all vaccines and boosters for Covid and had Covid in July.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5/BNT16B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300151904 Same event, same vaccine different patient;
nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9365) via an unspecified route of administration in the right arm on 15Feb2021 12:00 AM at single dose for covid-19 immunisation. Medical history included allergy to bees and wasps. The patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin and olmesartan medoxomil. The patient previously received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 12:00 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the  second dose, the patient experienced headache, fatigue, upset stomach and nearly vomiting, chills, nearly fainting and new mouth sores, painful arm on 15Feb2021 13:15. No treatment was received for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovered in Feb2021.
Have had Shingles 2 times already. Woke up this morning feeling like I have the flu-achy body and hurts to move.
FRI 9/14- FATIGUED, NOT QUITE RIGHT. SAT 9/15- SLIGHT HEADACHE, TIRED. SUN 9/16- VOMITING, HEADACHE, STAYED IN BED ALL DAY-UNKNOWN IF I HAD A FEVER. MONDAY 3AM 9/17 - SEIZURE, STIFF BODY-SHAKING- AUDITORY DISTURBANCE -INABILTY TO WILLFULLY MOVE MY BODY. TUES 6:00AM, SHORT SLIGHT EVENT JUST INVOLUNTARY SHAKING, NO AUDITORY DISTURBANCE.
8 days after the injection (3/18/2021) the injection site became swollen, feverish, sore followed by a rash that traveled from the sight down near the elbow and half way around the arm. Ice packs, localized topical medication or allergy meds did not ease the arm.  On the 25th of March the reaction remains. Dr. office now prescribing oral steroids. Covid arm reaction lasting longer than it should. Painful.
Patient is a 45 y.o. male with history of glioblastoma s/p craniotomy currently on chemotherapy and DVT/PE on Eliquis who presented to hospital 8/28/2023 for weakness, fever with Tmax of 101 at home, and cough found to be COVID positive. His hospital course was complicated by deconditioning with recommendations for IPR. Given progressive weakness which was occurring prior to admission, neuro oncology recommended repeat brain MRI which showed progression of disease. Radiation oncology was consulted, who did not recommend radiation. Neuro-oncology then recommended hospice as there are no chemotherapeutic options. He was initiated on a steroid taper followed by daily decadron. He was discharged to IPR on 9/6 and will determine if he would like to pursue hospice outpatient.
Discharge Provider:  Primary Care Physician at Discharge:  MD  Admission Date: 1/13/2023  PRESENTING PROBLEM: Lung abnormality [J98.4] Acute on chronic respiratory failure [J96.20]   HOSPITAL COURSE: Patient was a 73 y.o. male who is s/p bilateral lung transplant 7/25/18 for IPF, complicated by MDS with pancytopenia, systolic and diastolic heart failure (currently compensated), CAD s/p CABG, then stent (7/2022), atrial flutter. He had COVID-19 infection 12/2022 which was not treated. He presented on 1/13/2023 with worsening respiratory symptoms (dyspnea, cough, wheezing, increased work of breathing, mild desaturation and 1 L drop in home spirometry), CT showing bilateral nodular pulmonary infiltrates. He underwent bronchoscopy 1/13/22 and was admitted to the lung transplant service for IV antibiotics and ID consultation.    During bronchoscopy he had bloody secretions on initial bronch, hemoptysis and worsening infiltrates post bronchoscopy. Bronchoscopy with negative bacterial cutlures, empiric abx stopped 1/17.  CXR worsening,  ECHO obtained and EF down to 30%, previously 60%,  with basal to mid anterolateral and apical segments severely hypokinetic, moderate MR. BNP over 37,000. Heart failure team were consulted. 1/18 RHC with Swan placement demonstrated biventricular failure- lasix and Milrinone gtt started per AHF team. 1/21 CT thorax with worsening perihilar infiltrates. Course further complicated by worsening AKI for which nephrology was consulted.  Underwent RHC 1/30 on milrinone 0.1, with low filling pressures and normal CO.  Milrinone was weaned off.     He had worsening respiratory failure 2/1 and didn't tolerate attempts at BiPAP even with Precedex gtt.  He had worsening mental status with ABG showing only hypoxemia.  CT head without new acute abnormality. Ct thorax showed extensive bilateral ground-glass opacities, worse from prior study.  GOC discussion with wife, daughter, and son at bedside with concern for need for intubation.  They decided to transition to comfort care.  At 1745, he passed away   Per Lung Transplant team request, a limited chest autopsy was requested.  Family consented.   Date of Death: 2/2/23 Time of Death:  5:45 PM Preliminary Cause of Death: Acute respiratory failure
Daughter received Gardisil vaccine along with other vaccines. No adverse reaction to needle puncture. Nurse commented patient was very relaxed. But, patient fainted approximately 5 minutes after receving vaccines. Blood pressure dropped and skin was clammy. Treatment was nurse practioner checked patient. Fainting was not identified on doctor handout sheet of possible side effects.
This non-valid spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, patients were vaccinated with improperly stored doses of ROTATEQ (dose, units, frequency and route not reported) (lot # N005626 and expiration date: 26-NOV-2018), GARDASIL 9 (dose, units, frequency and route not reported) (lot # N020353 and expiration date: 28-APR-2020) and RECOMBIVAX HB (dose, units, frequency and route not reported) (lot # M022077; expiration date: 10-MAR-2019 and lot# M010212; expiration date: 02-JAN-2019) at an unknown temperature for an unknown time frame. It was unknown whether temperature excursion had occurred previously or not. Data logger was involved. No product quality complaint involved. This is a non-valid spontaneous report due to lack of patient identifiers. Follow-up information was received from the medical assistant on 08-MAR-2018. The temperature excursion ranged between 0 degrees Celsius (°C) to 1°C on an unknown date for a time frame of 214 hours and exact temperature and time below 0°C (-0.4°C) for 4 hours and 30 minutes. Follow-up information was received from the medical assistant on 12-MAR-2018. All vaccines had multiple excursions starting on 18-JAN-2018 until 01-MAR-2018. GARDASIL 9 was exposed to 0 C to 1 C (1.2) for total of 8 hours and 10 minutes prior to being administered from 18-JAN-2018 until 29-JAN-2018, it continued with excursions until 01-MAR-2018 with total time: excursion below 0 C (-0.4 C) for 4 h 30 min which occurred after 29-JAN-2018 and that the total time at 0 C to 1 C was for 214 h. This is a non-valid due to lack of patient identifiers. Follow-up information was received from the medical assistant on 12-MAR-2018. Who stated that one patient total received on 29-JAN-2018, a dose of improperly stored GARDASIL 9 with lot #M040412 exp date 30-JUN-2019.
Pt recvd vax on 22SEP92 & later that day pt devel an pruritic erythematous rash over lower legs & trunk & a sl temp;
This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
major rash on arm; redness on arm; swelling on arm; itchiness on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (major rash on arm), VACCINATION SITE ERYTHEMA (redness on arm), VACCINATION SITE SWELLING (swelling on arm) and VACCINATION SITE PRURITUS (itchiness on arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE RASH (major rash on arm), VACCINATION SITE ERYTHEMA (redness on arm), VACCINATION SITE SWELLING (swelling on arm) and VACCINATION SITE PRURITUS (itchiness on arm). At the time of the report, VACCINATION SITE RASH (major rash on arm), VACCINATION SITE ERYTHEMA (redness on arm), VACCINATION SITE SWELLING (swelling on arm) and VACCINATION SITE PRURITUS (itchiness on arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-362071 (Patient Link).
22 x 12cm erythema, induration, warmth rt proximal ant leg;
Rash started 7 days after administration, rash covered both upper arms..  Rash has persisted for 3 weeks, and is currently still active.
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) 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.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-740880 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740880:Same reporter
Irritability and excessive crying x 24 hours. Tx with Tylenol Q 4 hrs x 24 hours and Benadryl BID x 2 doses
I had my lab work done in July 2021 and my LDL had increased by 30 points.  My sister just had her lab work completed and her LDL went from 79 to 156.   I received the  Pfizer vaccine, 1st dose 2/2/21, 2nd dose 2/23/21.
We received from a health care professional the following information on 29 NOV 2007: A 55-year-old female patient born on 29 SEP 1952, was vaccinated with Fluvirin (batch no. 81274) i.m. on an unspecified date. The patient had stroke after getting flu vaccine. She got tingling and numbness in the same arm as the vaccine was given right after vaccination. The patient was hospitalised (dates are unknown).
Red and swollen underarm muscle with pain traveling up and down to below the elbow and into the lymph nodes of the arm.
Large painful welt at injection site. Welt is approximately 3" long by 2" wide. Today is 10/28; the welt is the same size and is painful enough to preclude side sleeping.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 04-JAN-2016, the patient was vaccinated with improperly stored GARDASIL 120Y, 0.5ml, administered intramuscularly (with lot # K008931 and expiry date of 04-MAR-2017). However, no adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected since the reporter did not wish further contact.
Pt is here for 2nd dose of covid vaccine. Mother states pt developed rash on B arms and neck 5 days after initial dose on 07/08/22. Mother spoke to Dr after days of onset. Advised by Dr not to administer vaccine due to reaction. No difficulty breathing or trouble swallowing.
Tdap and MENVEO was given in L arm on Mon 8-21 in the afternoon. Mom brought child in on Wed 8-23 in the afternoon with L arm red, swollen and warm to touch with the area of redness 8"x12" surrounding the injection sites. Mom reports that the redness and swelling began on Tues am and progressively got worse with the area of redness spreading and the swelling becoming significant enough to bring child in for a evaluation.
Fatigue; headaches; muscle aches; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Aug2021 (Lot number: FC3181) at the age of 24 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product COVID 19, Brand: Pfizer, Lot number: FA7485, Lot unknown: False, Administration date: 30Jul2021, Dose number: 1), administration date: 30Jul2021, when the patient was 24 years old, for Covid-19 Immunisation. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "Fatigue"; HEADACHE (non-serious), outcome "not recovered", described as "headaches"; MYALGIA (non-serious), outcome "not recovered", described as "muscle aches"; NAUSEA (non-serious), outcome "not recovered", described as "nausea". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, nausea.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not had any known allergy.  No follow-up attempts are possible. No further information is expected.
Initially only normal symptoms for 36 hours of fever, body aches, chills, shivers. Once those cleared, vision became blurry. Thought I was tired so went to bed. Woke up the next morning (Monday) to severe dizziness, nausea, vomiting, blurred vision. Went to ER and was diagnosed with Benign Paroxysmal Positional Vertigo. Was given Zofran and prescription strength Meclizine and sent home. Spent two days sleeping it off. Better on second day but still slightly dizzy. Much better on third day. I had never had Vertigo prior to this.
Subsequently, she was found to be pregnant. LMP was 03/15/1999. Expected delivery date is 12/20/1999. F/U was received which indicated the request for follow up was fowarded to obstetrician. F/U received from RN. During pregnancy the pt took a prenatal vitamin and iron supplement. Pt experienced an upper respiratory infection during the pregnancy. Preterm labor was experienced. On Jan. 17, 2000 at 42 weeks gestation the pt gave birth to a normal healthy male. Birth wgt was 7 lb 14 oz. Follow up provided no additional data. No further information is available.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 07Jun2021; CARVEDILOL, start date: 07Jun2021; ATORVASTATIN, start date: 17Oct2022; SPIRONOLACTONE, start date: 17Oct2022. Past drug history included: Sulfasalazine, start date: 10Aug1989; Azathioprine, start date: 20Jul2006. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered"; COVID-19 (medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken from 25Feb2023 to 01Mar2023 as treatment of COVID-19  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300103048 same patient, different drug/event.;
pt recvd vax & t104.5 & remained that high until next am when dec to 103; mom cont to give APAP; pt fussy, wined-no shrill cry; pt not seen by MD;
Was given MMRV Proquad, which is not indicated for under 4 years old.
did not feel well; This case was reported by a consumer via call center representative and described the occurrence of malaise in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Caller reports that she received her first Shingrix shot 2 weeks after a flu shot, she did not feel very well after her first Shingrix shot.  On 2nd June 2020, the patient received 2nd dose of Shingrix. The reporter did not consent to follow up
An unspecified rash developed on the chest, stomach and back; unspecified red bumps developed under the right armpit; redness developed at the right at the right deltoid; This spontaneous report was received from a nurse via a company representative and refers to a male patient of unknown age. The patient's pertinent medical history, concomitant medications and previous drug reactions/allergies were not reported.  On 16-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), in the right deltoid lot # R027576, expiration date was not reported, but upon lot validation process established as 23-JUN-2020 (strength, dose and route of administration were not reported); diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid lot# 92T7J in the right deltoid (strength, dose, route of administration and expiration date were not reported) and meningococcal acyw conj vaccine (carrier unspecified) lot# AMV AZ06A (strength, dose, route of administration, anatomical location and expiration date were not reported) all three for prophylaxis.   In July 2020, the patient developed an unspecified rash on the chest, stomach and back, unspecified red bumps under the right armpit and redness at the right deltoid. The reporter stated that an unspecified parent notified the medical practice but no treatment was provided.  At the reporting time, the patient did not recover from the events. The causality assessment was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027576; expirationdate: 23-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Patient tested positive on 04/20/2021 via PCR. Upon arriving to hospice care, patient tested positive via rapid on 04/29/2021. She died in hospice care on 05/01/2021.
post menopausal bleeding - continuing occasional involuntary incontinence leakage for about 10 days
Fainted; low pulse oxygen level; Fainted; low pulse oxygen level; This is a spontaneous report from a contactable consumer. A 54-year-old, nonpregnant, female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 at a health clinic facility, via an unspecified route of administration, administered in left arm on 25Apr2021 11:45 AM (age at vaccination: 54 years; Batch/Lot Number: ER8736) as single dose for COVID-19 immunization. Medical history was reported as none and patient had no known allergies. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination patient had not been tested for COVID-19. The patient experienced fainted; low pulse oxygen level on 25Apr2021 11:45 am. No treatment was given. Patient recovered on an unspecified date from fainted; low pulse oxygen level.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent conditions and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions but, no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.