chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus started in October of 2021.  The tinnitus is a constant ringing that never stops (i.e. 24/7).
Hospitalization 1/21/22-1/24/22 weakness, body aches, dizziness, cough, rectal bleeding, decreased appetite, dehydration
Development of Pityriasis Rosea 6 weeks after receiving second vaccine; skin issue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2021 (Lot number: EL3247) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALEVE. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". Vaccination history included: Bnt162b2 (Previous Dose Product: COVID-19, Previous Dose brand = Pfizer BionTech, Dose Number: 1, Batch/Lot No: EK5730, Vaccine Location : Arm Right), administration date: 18Dec2020, when the patient was 53 years old, for Covid-19 immunization, reaction(s): "Covid". The following information was reported: PITYRIASIS ROSEA (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Development of Pityriasis Rosea 6 weeks after receiving second vaccine"; SKIN DISORDER (non-serious) with onset 01Mar2021, outcome "not recovered", described as "skin issue". The events "development of pityriasis rosea 6 weeks after receiving second vaccine" and "skin issue" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2020) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of pityriasis rosea, skin disorder.  Additional information: Patient did not receive other vaccine in four weeks. Patient reported no covid prior vaccination. Patient reported covid tested post vaccination. Steroids. Antibiotics, and steroid creams were taken as treatment received for the events.  No follow-up attempts are possible. No further information is expected.
patient complaining of itchy rash over large portion of body, no trouble breathing. Recommended taking diphenhydramine which was showing benefit in resolving symptoms of itch. Also recommended hydrocortisone cream to intense itching areas for short period of time if needed
Gave Moderna vaccine to a 16-year old patient.  EUA has only approved Moderna vaccine to be used in those 18+.
Within 5 minutes post vax, the pt's stomach was upset, legs were weak, saw a yellow outline around everything, became yellow, and experienced dizziness. Within 5 hours we noticed a rash developing around his upper thighs. Over the next 24 hours, it spread onto his torso and arms. Seemed to get worse on day 3, then proceeded to disappear.
Eight days after the vaccination, right upper arm was swollen, red, irritated, itchy, and warm to the touch.
01/25/2021 Around 6 hours after my vaccination, I started having chills, had heartburn, and tossed and turned all night. The next morning, my temperature was over 103. I took TYLENOL and figured I felt lousy because my fever was so high. I did not contact my doctor. The symptoms did not resolve until 28 hours later. 1/27/2021 I babysat and the next day I was exhausted. On 1/29/21 I felt fine.
intense arm pain; severe chills; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (intense arm pain) and CHILLS (severe chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (intense arm pain) and CHILLS (severe chills). At the time of the report, VACCINATION SITE PAIN (intense arm pain) and CHILLS (severe chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 18 year old female patient with no pertinent medical history, drug reactions or allergies. The patient's history of previous pregnancies and live births was not reported. The patient was vaccinated with dose 1 and dose 2 of GARDASIL (lot #, dose and route not reported) one year ago (approximately in 2011). No other co-suspects were reported. There were no concomitant medications. Subsequently, the patient became pregnant with an approximate LMP of April 2011. It was reported that the patient delivered a healthy infant without complications in January 2012. On 24-aug-2012, patient was in the office to receive the third dose of vaccine. Additional information has been requested.
She stated she is sicker than a dog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She stated she is sicker than a dog".  Additional information: The reporter stated that she received a Pfizer Covid vaccine booster dose and was having a reaction. She stated she was sicker than a dog. She wants to know what she should do about her reaction to manage it. She was going to follow up with treating hcp for medical advice. The reporter was provided with response: Pfizer was unable to make treatment recommendations and was referred to treating hcp/vaccinator and/or local Emergency Dept. Doctor/healthcare provider was in the best position to advise about the appropriate action to take as doctor/healthcare provider are most familiar with medical condition, clinical history, how treatment has been conducted and any relevant information to specific case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NAUSUA BEGAN AT 3:30 - QUICKLY FOLLOWED BY FEVER, CHILLS, HOT COLD FLASHES AND VOMITING. DIARRHEA ALSO.   VOMITING WAS SEVERE UNTIL 6:30 PM WHEN I FINALLY FELL ASLEEP. FATIGUE.
Facial erythema/edema, mild respiratory distress. Vitals wnl.
Initial report was received from a consumer, who was also the patient, on 29 February 2012. A 76-year-old female patient had received an injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc. (lot number, route and site not reported) on 25 September 2011. Ever since the shot, the patient had been sick, had pneumonia and had been coughing. The patient felt like she was incapacitated. Medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Per Mom, later that day started wtih ongoing explosive diarrhea, then suddenly became nonresponsive, had blue lips, but then did become responsive again and restart crying. Mom called EMS, states pulse ox was 70s when EMTs arrived, went via ambulance to hospital. Being evaluated in ED, vitals are good, no more diarrhea, feeding well. Initial dx is BRUE, possibly related to vaccines she had earlier today.
This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 54-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. The patient's past medical history included shingles. Previously administered products included acyclovir (patient was on acyclovir for recurring shingles). On 1st April 2018, the patient received the 1st dose of SHINGRIX. On 10th June 2018, the patient received the 2nd dose of SHINGRIX. On 12th November 2018, 225 days after receiving SHINGRIX and 155 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient did not have shingles when she received SHINGRIX. The patient was reportedly not on acyclovir for the second dose, but she might have been on it for the first dose. The patient had since developed shingles again and started taking acyclovir again yesterday. The reporter had consented to follow up. This case was considered as suspected vaccination failure as a primary vaccination schedule and confirmatory laboratory test were not reported.
Redness, swelling , pain. Onset 7 days following 6inx2.5in
substantially higher blood sugar levels; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (substantially higher blood sugar levels) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (His blood sugar levels increased since he received  the vaccine.).   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (substantially higher blood sugar levels). At the time of the report, BLOOD GLUCOSE INCREASED (substantially higher blood sugar levels) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment medication were not provided.  Patient mentioned of having high blood sugar level after first dose.
getting sick; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (getting sick) and COVID-19 (tested positive for COVID-19) in a  patient of an unknown age and gender 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (getting sick) and COVID-19 (tested positive for COVID-19). At the time of the report, ILLNESS (getting sick) outcome was unknown and COVID-19 (tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Patient queried when will he be able to get his Moderna booster dose.  No concomitant medications details were reported. No treatment information details were reported. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with unknown medical history, who experienced the unexpected, non-serious authority event of COVID-19. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. There is no available information regarding clinical course and treatment medication. COVID-19 virus test was initially positive; however, recently, patient had a negative result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: Follow up received on 24 Jan 2022 added No New Information; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with unknown medical history, who experienced the unexpected, non-serious authority event of COVID-19. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. There is no available information regarding clinical course and treatment medication. COVID-19 virus test was initially positive; however, recently, patient had a negative result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Wicked diarrhea about 4or 5 hours after; stomach off for 24 hours Mild headache day one, stronger headache day 2 Achy day 2
3 Doses administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12 hours post puncture) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 012M20A and 025A21A) for COVID-19 vaccination.     Concomitant products included COLCHICINE, DENOSUMAB (PROLIA), FESOTERODINE FUMARATE (TOVIAZ), LISINOPRIL, OMEPRAZOLE, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX), RIVAROXABAN (XARELTO), HYDROCODONE, PARACETAMOL (TYLENOL [PARACETAMOL]) and METOPROLOL for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12(US) hours post puncture). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12(US) hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported by the reporter.  No treatment medication was reported.  Date the vial initially stored in the refrigerator was 14 Jan 2022 Date and time vial first punctured was 19Jan2022, 8:40am The vial did not undergo any temperature excursions. The vial was stored in fridge post puncture. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was only for drawing doses.   This case was linked to MOD-2022-458470, MOD-2022-458516 (Patient Link).
Significant swelling, entire upper arm, Fever with Tmax 101/8 recorded, Apparent cellulitis per ED
Pfizer Dose 1 4/22/21 (EN6201) Pfizer Dose 2 5/13/22 (ER9735) COVID Positive 1/16/22  1/15/22: A 44-year-old female with past medical history of schizoaffective disorder and borderline personality comes to ED complaining of low back pain.  Patient states pain started couple of days ago, low back pain, nonradiating. Patient is not a great historian, tox very less and only on repeated questioning, probably secondary to schizoaffective disorder.  Denies cough or shortness of breath.  Feels nauseous but no vomiting.  Denies abdominal pain on diarrhea or constipation.  Denies dysuria or hematuria or frequency of urination.   In the ED, her temperature was 101.3° F, pressures, responded to fluid bolus.  Blood work significant for hypokalemia and mild metabolic acidosis, no leukocytosis.  Alcohol level negative.  Drug screen negative.   CT abdomen pelvis done in the ED reported possible colitis involving hepatic flexure of the colon.  Patient is given IV ceftriaxone and metronidazole in the ED.  ED physician did not want to discharge the patient as he was not sure that the patient will be compliant taking antibiotics as outpatient.  1/19/22: Patient is a 44-year-old female with past medical history of schizoaffective disorder, borderline personality comes into the ED complaining of low back pain with started a couple of days prior to admission, along with fever mild metabolic acidosis and hypokalemia.  She was admitted to observe a shin service started on antibiotics, IV fluids and analgesics.  Imaging demonstrated no evidence for PE though some concerns for possible minimal infiltrate versus atelectasis, CT abdomen negative for acute etiology. Patient did test positive for COVID-19 and spiked fevers however she did not require supplemental oxygen.  For p.o. intake improved and pain was controlled she was tolerating this without any issues.  She also received antibiotics prophylactically it was transition to oral antibiotics, ascorbic acid, a Tessalon, zinc, to complete empiric course-- though suspect possible infiltrate and fevers related to COVID-19.  Blood cultures were collected and were negative for 48 hours patient was afebrile for more than 24 hours.  Blood pressures monitor on review seem to run baseline low/low normal patient otherwise asymptomatic. Patient had very flat affect sometimes refusing treatment, often irritable.  Behavioral Health was consulted, advised to continue her home medications of conveyed the and Remeron.  Discussed with Dr. Recommended patient be continued on this regimen on disposition and no ongoing reason for behavioral health admission, can follow up further as outpatient with establish providers.  All ED and RTC precautions were provided, COVID-19 quarantined precautions provided to patient.  She endorses understanding and agreement with plan as outlined. Follow-up with PCP within 7 days of discharge, follow-up with behavioral health provider as discussed.
Pt had brief seizure with convulsions which lasted approximately 30-40 seconds immediately following administration of 2nd dose of GARDASIL vaccine in our office today.
Per mother inflammation of left deltoid area started on 3/18/04 around noon no other symptoms just large & hot.
This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # K025006 with expiration date 22-JUL-2017, (dose and route of administration were not provided). Concomitant medications was not reported. No adverse effects reported. Third excursion for PEDVAXHIB: Temperature/time: 34.7F for 15 minutes. Previous excursion: 34.4F for 30 minutes plus 48F for 8 hours. This is one of several reports received from the same source. Additional information has been requested.
Severe chest pain for 3-4 hours.  Occasional chest pain for 1-2 weeks after.
pink oval rash approx 3.5 in long X 2 in wide w/white ring around it; the shot was administered about halfway up on the back side of my arm, only subcutaneously, not intramuscular.; immediate pain; fatigue; arm really still hurt; she wasn't getting oxygen; This is a spontaneous report from a contactable consumer.A 62-years-old female patient received first dose of bnt162b2 (BNT162B2), subcutaneous, administered in Arm Left on 04Feb2021 14:45 (Batch/Lot Number: EN9581) (at the age of 62-years-old) as dose 1, single for covid-19 immunization. Medical history included mitral valve prolapse, intermittent jaw pain, drug hypersensitivity (sulfa). Concomitant medications included calcium (CALCIUM) and multivitamin.  There was no other vaccine in four weeks. The patient did not had Covid prior vaccination and did not test for Covid post vaccination. On 04Feb2021 at 15:00, the patient experienced immediate pain, fatigue and Inappropriate route of vaccination and on 05Feb2021, the patient experienced pink oval rash approx. 3.5 in long X 2 in wide w/white ring around it, arm really still hurt and wasn't getting oxygen. It was reported that first, the shot was administered about halfway up on the back side of her arm, only subcutaneously, not intramuscular. (Wore a very short sleeve shirt, so wrongly placed shot was not due to clothing issue). Had immediate pain that felt unusual as it didn't stop after shot was given. Drove to designated parking area to wait required 15-30 min. After a few minutes she removed mask as it seemed like she wasn't getting oxygen, but she thought maybe feeling that a shot given improperly was causing her stress. Wasn't wheezing, do not have asthma, etc. Did some deep breathing and after a minute or so, felt breathing returned to normal. Stuck around for a half hour or so just to make sure, but her arm really still hurt. Very tired that evening. Also first evening the painful area expanded. Following day had pink oval rash approx. 3.5 in long X 2 in wide w/white ring around it. More pain & very tired that day. Next day rash turned red, pain to touch. Tired to day 3. Rash for 18+ days but receded. The events were not treated. On 04Feb2021, the patient recovered from difficulty breathing and was recovering from other all events.  Follow-up attempts completed. No further information expected.
Had the vaccine and I still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself or himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated that he or she had the vaccine and still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
One week after 1st shot experienced blurred vision then in subsequent days had head pressure and slight headaches.  Headaches were behind the eyes mainly with pressure on the sides of the head.  Developed Tinnitus with ringing in both ears constantly.  Headaches have gotten less but Tinnitus is constant.  Still today, 26 days after the vaccine my Tinnitus is there.  No prior history of Tinnitus or any other medical condition.
Developed chickenpox on 4/6/98, unknown length of illness. Developed chickenpox again on 1/22/01. Supportive care.
pt recvd vax;next day devel inc temp. 3-4days later, devel measles-type rash on torso,legs,arms,face; red/blotchy macular rash,lasted 1 wk, achy all over. rash reappeared.
moderate redness, itching and mild swelling about 3 inches in diameter around left deltoid that appeared 8 days after vaccine injection. Took Tylenol and left alone. Gradually improved and slowly resolved over next few days
Injection site reactions: Pain, tenderness, swelling of the lymph nodes in the same arm as the injection  General:  fatigue, headache, muscle pain, joint pain, chills