chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a 23-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-MAR-2019, the patient was inadvertently vaccinated with an expired dose of M-M-R II, subcutaneously in right arm, lot # N009799, expiry date: 24-MAR-2019 (dose was not provided) for prophylaxis. No adverse effects were reported.
Arm  has  red swollen ring around the injection site  with a fever a week after getting the vaccine.   I also had this reaction the day of the vaccine but it went away and now a week later it is back.  Not sure if I should be concerned or if this is normal.
Bloody nose 8 hours post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old female patient (not pregnant) received BNT162B2 (COMIRNATY), administered in arm left, administration date 11Nov2021 19:45 (Lot number: FK5618) at the age of 10 years as dose 1 (tris), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EPISTAXIS (non-serious) with onset 12Nov2021 03:30, outcome "recovered" (Nov2021), described as "Bloody nose 8 hours post vaccination". Therapeutic measures were not taken as a result of epistaxis.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. . The patient did not receive any other vaccines within four weeks prior to the vaccination. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, reported as multiple unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, anatomical location, lot# and expiration date were not reported). Administered doses of RECOMBIVAX HB experienced temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes on an unknown date. Temperature was logged with a data logger, and there were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
warm erythematous area approx 6.5 x 4cm lt deltoid w/swelling;painful to touch;
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was subdural hematoma.
Left arm shoulder pain and severe nausea began about 12 hours afer vaccine and lasted for approx another 16 hours; Left arm shoulder pain and severe nausea began about 12 hours afer vaccine and lasted for approx another 16 hours; Severe Burning from neck, through arm, and down side immediately after injection lasting about 20 minutes; Left arm shoulder pain and severe nausea began about 12 hours afer vaccine and lasted for approx another 16 hours; This is a spontaneous report from a contactable other health care professional, the patient.  A non-pregnant 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283), intramuscular  in the left arm on 20Jan2021 at 09:30 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included hydroxyzine pamoate and multivitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 20Jan2021 at 09:30 AM, the patient experienced severe burning from neck, through arm, and down side immediately after injection lasting about 20 minutes. Left arm shoulder pain and severe nausea began about 12 hours after vaccine and lasted for approximately another 16 hours. The events were reported as non-serious. The patient did not receive any treatment for the events. The clinical outcome of severe burning from neck, through arm, and down side immediately after injection lasting about 20 minutes, Left arm shoulder pain and severe nausea began about 12 hours after vaccine and lasted for approximately another 16 hours was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Vomiting; On the lower back, on the side where she got the injection/hurts right now; Completely lost her appetite; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), VACCINATION SITE PAIN (On the lower back, on the side where she got the injection/hurts right now) and DECREASED APPETITE (Completely lost her appetite) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 045A21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting), VACCINATION SITE PAIN (On the lower back, on the side where she got the injection/hurts right now) and DECREASED APPETITE (Completely lost her appetite). At the time of the report, VOMITING (Vomiting), VACCINATION SITE PAIN (On the lower back, on the side where she got the injection/hurts right now) and DECREASED APPETITE (Completely lost her appetite) outcome was unknown.            No Concomitants and Treatment medication were reported.
Mother called to report pt began the following s/s at 9pm same day as vaccine. Arm hurt significantly ice applied 3a significant body shakes, chills, sweating temp 98 degrees F - 100.8 F taken throughout night. 3:30 a ADVIL taken arm hurt more. Approx 4:30 am s/s subsided and pt fell asleep no s/s since.
patient experienced high fever, rash, warm to touch redness and swollen arm patient went to minor emergency and received antibiotics and steriods presented to pharmacy 4 days after showed signs of improvement but still had pain and some redness and swelling
slight headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EH9899, unknown expiration), intramuscularly on left arm, on 06Jan2021 at 09:00, at single dose, for COVID-19 immunization.  Medical history included penicillin allergy. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), fenofibrate (FENOFIBRATE), atorvastatin, and indapamide (INDAPAMID).  On 06Jan2021 at 10:00 AM, the patient experienced sore arm and slight headache that last one day (07Jan2021). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID post vaccination.  No treatment was received for the events. It was unknown if the patient received any other vaccines within 4 weeks prior to COVID vaccine. The patient recovered from the events on 07Jan2021. The events were assessed as non-serious.
Tonic-clonic sz lasting 1-2 min; no fever; sz occurred while nursing; exam in office p/sz by MD-nl exam;
No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 4 years old. On 29-FEB-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2008USA013494: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2003USA007542: US-009507513-2008USA013488: US-009507513-2008USA013490:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 at 17:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (12May2022) Positive, notes: started testing positive on rapid test again 5 days after finishing Paxlovid. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & 5min post vax exp a sz which lasted 60seconds;An ER or MD visit was required;resolved w/o tx;
Shot administered on 4/5/01 to left thigh. Parents report visit to urgent care on 4/6/01. Seen in office on 4/7/01. Had a fever of 102F. Left thigh with a softball size swelling, erythematous, non-tender area, noted by MD.
patient hasn't yet received dose 2.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 1st May 2023 with batch number 79S54 and expiry date 4th April 2025).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: patient hasn't yet received dose 2.). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-OCT-2023 Registered nurse (RN) reported patient had not yet received dose 2. Lot and expiration date were for dose 1, since 2 had not been given yet. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination.
Pneumonia; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A male patient of unspecified age (Age: 63; Unit: Unknown) received the first dose and second dose of BNT162B2, via unspecified routes of administration on unspecified dates at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After receiving both vaccines, patient still got pneumonia and he had seen many elderly died from pneumonia even after receiving the vaccine. Outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded.  The case will be reassessed should additional information become 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.
terrible diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (terrible diarrhea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIARRHOEA (terrible diarrhea). On 08-Mar-2021, DIARRHOEA (terrible diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   No treatment medication reported
First vaccination no issues or SE reported. Second immunization was fine for first few days. About 5 days ago, patient reports that the site of injection became red, hot to the touch, hard to the touch, and itches. Patient reports no fever. Patient is out of town and does not want to see an md. Advised patient if became worse or did not improve to contact md.
report my side effects from my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report my side effects from my vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report my side effects from my vaccine). At the time of the report, VACCINATION COMPLICATION (report my side effects from my vaccine) outcome was unknown.            No Concomitant medication information was reported. No Treatment medications were provided.   Reporter did not allow further contact
Presented w/ SOB, body aches, fever, diagnosed Covid + on 10/24/21.  Admitted to Icu, requring HFNC/BIPAP and Tx w/ steroids, Remdesivir, IVF.
The patient also received the second dose of vaccine 18 days after the first dose.; pain and swelling at injection site; pain and swelling at injection site; low grade fever (99.5 degrees Fahrenheit); chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 08Feb2021, at 16:00 (Lot Number: EM9810, at the age of 27 years old) as dose 2, single for COVID-19 immunisation. The patient has no known allergies and no other medical history. She was not pregnant at the time of report. Concomitant medications included meloxicam. She did not receive any other vaccine in four weeks prior to vaccination. The patient previously received first dose of BNT162B2, administered in the left arm on 21Jan2021, at 13:30 (Lot Number: EL3246, at the age of 27 years old) for COVID-19 immunisation and experienced pain and swelling at injection site for 36 hours. On an unspecified date in 2021, the patient experienced pain and swelling at injection site, low grade fever (99.5 degrees Fahrenheit), chills, body aches, headache, nausea, and fatigue for approximately 24 hours. The patient also received the second dose of vaccine 18 days after the first dose. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
The day after receiving vaccine, patient experiences a mild headache that becomes gradually worse.  Patient treated with ketorolac, celecoxib, carisoprodol, acetaminophen.  Headache in the frontal location.   No light sensitivity, No thunderclap onset.  Patient is treated with diphenhydramine, metoclopramide, and ondansetron with good effect. Patient observed in ER then discharged home.
Period symptoms worsened after shot - heavier flow, more severe PMS, lower back pain, etc.
Severe arm infection; chest palpitations; This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (Severe arm infection) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced LOCALISED INFECTION (Severe arm infection) (seriousness criterion medically significant) and PALPITATIONS (chest palpitations). At the time of the report, LOCALISED INFECTION (Severe arm infection) and PALPITATIONS (chest palpitations) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.  Company Comment: Very limited information regarding these events have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested.
Had colonoscopy 4/26/21 with removal of two 4-mm polyps from descending colon and cecum with cold forceps. Developed hematochezia 5/2/21. Syncopal event while driving 5/6/21 resulting in MVA. Initial platelet count 142K (baseline 112-129K), dropping as low as 96K on 5/8/21. Required transfusion of 3 units PRBC, 1 unit FFP. Had CTA abdomen 5/6/21 with active extravasation from hepatic flexure/transverse colon requiring coiling.
This spontaneous report was received from a medical assistant, and refers to a 12 month old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided. On 15-NOV-2018, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # N025570 with an expiration date in 13-DEC-2018), for prophylaxis, instead of a dose of VARIVAX. No adverse effect reported.
At start of visit - pt had a Tdap - about 10 mins. Into the visit, the pt became acutely SOB and diaphoretic.  We layed him down, he became unconscious with a thready pulse, no bp and no Pulse ox - he had spont. respirations. Pt was given one epi pen, nasal O2 and he gradually responded over about 10 mins.  First bp recorded was 60/42.  Pulse ox came up to 95% on 15L nasal O2. EMS WAS CALLED. PATIENT WAS SENT TO THE ER FOR FURTHER EVALUATION.
Information has been received from a healthcare worker and a 71 year old male physician with benign prostatic hyperplasia, hypothyroidism, hypertension, arteriosclerosis and asthma who on 06-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of zoster vaccine live. Concomitant therapy included levothyroxine Na (SYNTHROID), verapamil HCl (VERAPAMIL SR), montelukast sodium, morniflumate (FLOMAX), clopidogrel bisulfate, aspirin,  benazepril HCl, atorvastatin calcium (LIPITOR), valsartan (DIOVAN), omeprazole (PRILOSEC), fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and cisplatin (+) cyclophosphamide (+) doxorubicin hydrochloride (+) prednisone "CAPPRA". On 07-MAR-2007 "the next day" he experienced aching in his left lateral thigh area. On 08-MAR-2007 the patient developed a red vesicular rash in the L1-L3 dermatome distribution which was reported to be shingles. The outbreak was on the lower back, left thigh and left groin. His physician prescribed famcyclovir 500 mg three times per day, oxycodone and eszopiclone (LUNESTA) and was planning continued follow-up. At the time of the report the patient had not recovered. There was no product quality complaint. No further information is available.