chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date vaccine date on 04Jan2021; Day 6 -10 migraines hit; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 23:30 on 04Jan2021 at single dose for COVID-19 immunization and other vaccine same date vaccine date on 04Jan2021 on left arm. Medical history included allergies to penicillin, allergy to bananas, wheat (patient do eat products w wheat), dairy; Melanoma 3rd degree 1987 & 2005, allergies, sinus surgery resolved problems. Concomitant medication included venlafaxine, omeprazole, bupropion hydrochloride (WELLBUTRIN). It was reported that patient had no other vaccine in four weeks. The patient previously took ampicillin and experienced drug allergy. No issues until middle of night of first injection. The patient experienced intense pain in left injection arm; fever; could not sleep, other aches all over on 05Jan2021. Used ice packs & Motrin. Fever left after two days. Intense pain continued. 5th day switched to heating pad & took 2 tablets of Tylenol every 6 hours. Called patient's doctor on days 6 & 8. Suggested patient alternate Tylenol & Motrin every 6 or 8 hours. Day 6 -10 migraines hit. The outcome of event fever was recovered on 07Jan2021. The outcome of events migraine and Product use for unapproved combination was unknown. The outcome of rest events was not recovered.  Information on the LOT/Batch number has been requested.
Nausea; Fatigue; Dizziness; Vertigo; Chills; Night sweats; Throat itchy; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 13:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), ascorbic acid (VITAMIN C), multi-vitamins (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. 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. On 20May2021 at 19:00 the patient experienced all sick symptoms nausea, fatigue, dizziness, vertigo, chills, night sweats and throat itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, fatigue, dizziness, vertigo, chills, night sweats and throat itchy was recovering at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21May2021 at 13:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reported at 6/21/17 at 11:15AM by patient to employee: achy, nausea, unable to eat, sore joints and muscles, chills.
I tested positive for COVID July 16, 2021, at that time I lost my sense of smell. About a month later I regained complete normalcy of my sense of smell. On October 22, 2021 I received my first Pfizer vaccination. On or about October 25, 2021, items that once smelled unfavorably  began to smell distorted and  ?garlicky? which is the best way I can  explain it. My feces, underarms and whenever I would experience flatulence they all had the same smell. I?ve had to have family members smell the same items and they keep telling me the that it smells like regular stinky feces not garlic. I?ve been self conscious and quite embarrassed that I?m walking around smelling like garlic to others when in actuality it?s only effecting me. I believe I am experiencing Phantosmia as well as parosmia.  I also experienced joint pain in my left pointer finger after the vaccine which the pain had subsided after a few days.  As of today, I am still experiencing distorted smell issues. I currently have a doctors visit scheduled however it isn?t until November 8, 2021.
HPV Vaccine - Incorrect interval between doses. Patient had stated this was second dose but this was the third dose.
Mother states that infant started crying once home and lasted for 4 hours.  Infant quieted to sleep for approx. 20 minutes and then awoke again and screamed for additional 2 hours.  Right thigh was reddened/swollen and hard.  All symptoms were gone and baby was "back to normal" by the next day.
COVID-19; Fever; Pain; got sick; he did not feel well; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported 2 reports for herself and her husband. This is the 2nd of 2 reports and refers for her husband. A 74-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# unclear,  E or FU4176), via an unspecified route of administration, on 28Jan2021, at single dose, for COVID-19 immunisation. Medical history included blood pressure high and non-alcoholic fatty liver. Concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on 05Feb2021 with outcome of unknown, fever (non-serious) on 05Feb2021 with outcome of unknown, pain (non-serious) on 05Feb2021 with outcome of unknown, got sick (non-serious) on 29Jan2021 with outcome of unknown, he did not feel well (non-serious) on 29Jan2021 with outcome of unknown. The patient got sick on the very next day and he did not feel well and each day he got worse and worse until his wife had to take him to the emergency room on 05Feb2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 05Feb2021. Therapeutic measures were taken as a result of the events and included treatment with Tylenol.
headache; Bumps at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Bumps at injection site) and HEADACHE (headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE MASS (Bumps at injection site). On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). At the time of the report, INJECTION SITE MASS (Bumps at injection site) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-076398 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076398:1st dose case
Pt noticed this morning that above her injection site on her left deltoid area she had redness and warmth.  Pt has a scar on left deltoid area and redness went along horizontally on her arm.  There also was some warmth to that area.
Information has been received from a female consumer, who was also the patient, who on an unspecified date was vaccinated with a dose of GARDASIL. The patient reported that a huge bump appeared on the injection site after she received the dose. The outcome was unknown. The patient did not seek medical attention. No further information is available.
Having issues that she is unable to dress, wash, pulling up covers etc.  This is gotten to a very difficult situation and excruciating pain.  Started 9.26.22 when got shot.  With talking about it noted that it was high in shoulder that it was given.  It was sore right away but thought that was the norm.  Noted that it worsened on 9.29.22 and elevated to this stance at this time
after recv vax in 9/97 pt on 3/98 lab evaluation revealed lack of seroconversion (igG0.44)
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) (batch number- 011J20A) No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Stiffened joints, feeling sick about 3 hours after injection, led to passing out in bed only to become aware of exceedingly loud whooshing sounds in ears, unable to move, fearing something would burst in my head (blood vessels?). Passed out again, awoke sometime next day. Reported reactions to my doctors at the usual 6 month appointments, in July and August of 2021. Eye doctor did find hemorraghes on my retinas, but thought might indicate diabetes. Primary care doctor did annual bloodwork showing no diabetes; suggested might be from high blood pressure. Latest eye doctor appointment, December 2021, found hemorraghes are now gone.  Have not got booster.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EJ1686), in right arm and on 28Jan2021 as dose 2, single (Lot number: EL9261) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lung nodules and being monitored for sarcoidosis or lymphoma" (unspecified if ongoing), notes: Other medical history: Lung nodules and being monitored for sarcoidosis or lymphoma; "Lung nodules and being monitored for sarcoidosis or lymphoma" (unspecified if ongoing), notes: Other medical history: Lung nodules and being monitored for sarcoidosis or lymphoma; "Lung nodules and being monitored for sarcoidosis or lymphoma" (unspecified if ongoing), notes: Other medical history: Lung nodules and being monitored for sarcoidosis or lymphoma; "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
like a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (like a cold) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Penicillin allergy. Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) for Osteoporosis.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced NASOPHARYNGITIS (like a cold). At the time of the report, NASOPHARYNGITIS (like a cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Coronavirus test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
Pt well at time of administration of immunizations. Began vomiting approx 4 hrs after imm. given, then not feeding well, then became somewhat irritable. Taken to ER by parents about 14 hrs after imm. given. No fever. Diagnosed with Paroxysmal atrial tachycardia, and shock. Adenosine IV administered in ER as directed per Ped cardiologist. Transported via air to medical center. 4/20/07 Received med record for 4/13/07 which includes vax lot numbers which confirms VAERS report.  5/25/07 Received hospital medical records which reveal patient experienced SVT unresponsive to treatment & multiple bouts of emesis prior to being seen at outlying facility.  Blood c/s done & given IV antibiotics prior to transfer.  On admit, heart rate was 210-217 & was hypothermic w/poor perfusion.  He was grunting w/O2 sats of 85 & was started on O2 & then intubated for unstable cardiac condition.  Multiple cardiac meds & multiple cardioversions were done before he was able to be converted to NSR.  ID consult did not feel SVT was due to pertussis vaccine & continued on IV antibiotics.  Was transferred again to higher level of care.  6/8/07 Received 3rd hospital medical records which reveal patient admitted 4/15-4/19/07 to peds cardiology ICU.  Prior to admit, patient experienced increased sleepiness & persistent vomiting.  Seen at outlying ER & PICU & found to have wide complex tachycardia resistant to multiple drug therapies.  Intubated.  Attempts at cardioversion were unsuccessful.  Rhythm slowed decreased s/p sodium bicarb & was started on esmolol & transferred to another hospital.  Able to be successfully extubated day after admission & weaned to RA.  Was in same rhythm but able to be successfully converted with meds.  Remained in stable condition, diet advanced & changed to oral meds.  D/C to home on propranolol  FINAL DX: Supraventricular tachycardia & atrial septal defect.  1/1/10 follow up - after the episode reported above, patient was diagnosed by ped. cardiologist with junctional ectopic tachycardia. he is controlled with amiodarone. he has had additional tachycardia episodes but none related to further immunizations- he has been kept current on his immunizations.
This spontaneous report as received from a nurse, refers to currently 13 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of R001262 and an expiration date of 10-NOV-2001; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following potential temperature excursion: Unknown temperature for 1 day. Reportedly, there had been no previous temperature excusions and the aformentioned one were not identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.
Syncopal episode resulting in 911 response. Pt became lightheaded then lost consciousness for approximately 30 seconds. Pt did not fall and no trauma was sustained. She was taken to a private recovery area where she was placed in trendellenburg?s. Vitals signs monitored every 5 minutes. Upon EMS arrival, pt was assessed with findings unremarkable. Pt refused transport by EMS and was released from the clinic after she displayed no symptoms for 10 minutes.
Found out last Friday that she is pregnant; This is a spontaneous report from contactable consumer (patient) via Pfizer Sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 12Apr2021 as dose 1 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient was pregnant at time of vaccination. Patient withheld got the 1st dose of Covid-19 vaccine last 12Apr2021 and her 2nd dose schedule will be tomorrow (03May2021); however, she just recently found out last Friday that she was pregnant in Apr2021, and she wanted to know if she can still continue to take the 2nd dose. The outcome of event was unknown.  Follow up needed, further information has been requested.
acute pericarditis; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 23Dec2020 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if other vaccines were given in four weeks and unknown if patient had Covid prior vaccination. The patient experienced acute pericarditis on 24Dec2020. Clinical course as follows: Doctor colleagues at the institution admitted (at Emergency room/department or urgent care) and treated a patient with acute pericarditis who received his first dose of Pfizer SARS-CoV-2 EUA vaccine on 23Dec2020. The physician (reporter) considered the event as non-serious. The outcome of the event was recovering.  Information about batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event acute pericarditis cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
c/o itching and dizziness.  25mg PO Benadryl given.  Observed for 30 minutes and then went back to work.  Stated symptoms improved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in right arm and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) negative, notes: testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever off at least 100° over the course of the night; could barely sleep.  Ended about 9:30 AM the next morning after taking Advil.  Also a sore arm at site of injection that persists currently.
Extreme nausea, which triggered gallbladder attack. Resulting in hospitalization for emergency gallbladder removal.
sweating; itching palms; elevated HR; headache that lasted 24 hrs; fatigue; foggy feeling that also lasted 24 hrs; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685) intramuscular on right arm on 19Dec2020 14:45 at single dose for COVID-19 immunization. Medical history included DM type 2, irritable bowel syndrome, restless legs syndrome, insomnia. Other unspecified concomitant medications received in two weeks. The patient previously took thiomersal and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020, within 10 minutes of the reaction she experienced sweating and itching palms with elevated HR. Within 1 hr of the vaccine she had a headache that lasted 24 hrs with fatigue and a foggy feeling that also lasted 24 hrs. No treatment received for events. Events outcome was recovered.  No follow-up attempts are possible. No further information is expected.
Janssen Covid-19 Vaccine EUA .   Crawling skin, seems to get worse after a shower or temperature change.  It has been going on since I received the J & J vaccine in September 2021.   It involves the arms, legs, spine and head.
On 2/14/2019 patient received PPSV23 at another facility. On 9/14/21 patient received same vaccine. Series was administered incorrectly.
Aplastic anemia. Post Lymerix vax, the pt experienced low red blood cells and was dx with aplastic anemia. This case is SB medically serious. The information received on 03/17/2000 provides no further information. Additional information has been requested.
severe muscle pain in both upper arms followed by bilateral loss of arms and legs movement...transfered to a hospital and treated as a stroke victim for one day...MRI showed severe swelling of the spinal cord between C4-6. treated with prednisone and released from hospital for neuro surgeon and neurology follow up...10 weeks later diagnosed as transverse myelitis
Information has been received from a 61 year old female with no pertinent medical history or allergy reaction who in November 2007, was vaccinated with ZOSTAVAX. There was no concomitant medication. In May 2008, the patient experienced shingles. As of 13-AUG-2008, the patient has not recovered. The patient did not seek medical attention. No further information is available.
One day after receiving vaccines, patient developed swelling at injection site of left arm and a macular rash of the face.
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; CYANOCOBALAMIN (VIT B12) at an unspecified dose and frequency and ASCORBIC ACID (VIT C) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   This case was linked to US-MODERNATX, INC.-MOD-2021-089253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089253:1st Dose