chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer/biontech, Vaccine dose number=2/ brand other=Moderna, Vaccine dose number=3; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 12Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), on 25Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 06Oct2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "arrythmia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "obstructive sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Sulfa, reaction(s): "Known allergies: sulfa". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Nov2021, outcome "recovering", described as "Vaccine brand=Pfizer/biontech, Vaccine dose number=2/ brand other=Moderna, Vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Oct2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2023) Positive, notes: Tested positive for COVID in urgent care clinic 19Oct2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid from 19Oct2023 to 23Oct2023. Initial onset of symptoms: 18Oct2023. Tested positive for COVID in urgent care clinic 19Oct2023. Started Paxlovid: 19Oct2023, felt much better, almost completely well for 3-4 days.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering interchange of vaccine, the contributory role of company suspect drug BNT162b2 to all the reported events DRUG INEFFECTIVE and COVID-19  cannot be excluded completely.,Linked Report(s) : US-PFIZER INC-202300352919 Same patient, different drug, different event;
Increase redness spreading, no pain, mild heat to ant.  surface of upper (L) arm around inj. site no induration, no nodule- Tx: Benadryl Ttsp prn Q6-8h.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 10-SEP-2014, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # J012377 exp date 03-OCT-2015 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7C from  13-MAY-2014 to 10-SEP-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
This case was reported by a nurse via sales rep and described the occurrence of adverse event in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The field representative called to report adverse events that three different patients experienced on SHINGRIX as reported to her by the nurse. The field representative did not know any information in regards to demographics and what adverse events patient experienced, but knew that the patient experienced side effects from SHINGRIX vaccine. No further details were provided as far as what kind of adverse event the patient experienced. The field representative had very limited information. Attempted to call nurse twice to get further information on the events but was not able to reach her. She also stated that nurse had reported the event to VAERS. This was 1 of 3 cases, reported by the same reporter.
Pneumovax site was painful after injection. Extremely painful 3 hours after injection. Very large local reaction 9" area of redness: 4' x 2.5" inch raised reddened area around injection site. Pain shoulder to mid humorous. Fatigue, diaphoresis, headache, site warm to touch. Symptoms resolving after first day.
DizzinesS; stumbling; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (DizzinesS), GAIT DISTURBANCE (stumbling) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included TRAZODONE, Olosetram and DULOXETINE for an unknown indication, LEVOTHYROXINE.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (DizzinesS), GAIT DISTURBANCE (stumbling) and CHILLS (chills). At the time of the report, DIZZINESS (DizzinesS), GAIT DISTURBANCE (stumbling) and CHILLS (chills) outcome was unknown. Not Provided          Treatment details not included.The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable
Received Heplisav-B as A Booster 1 Year Ago and 2nd Dose Heplisav-B Administered; Received Heplisav-B as A Booster 1 Year Ago and 2nd Dose Heplisav-B Administered; Initial report received on 14-Aug-2023  A consumer in the reported that he, a male (age, race, and ethnicity not provided), was vaccinated for hepatitis B as a child, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as a "booster dose" one year ago (2022), and had the second dose of HEPLISAV-B on 13 Aug 2023.  No relevant medical history, concomitant medications, or allergies at the time of vaccination were reported.  On an unspecified date, when the patient was a child, he was vaccinated for hepatitis B (no details provided).  One year ago (date not specified), the patient received the first dose of HEPLISAV-B (no details reported) as a "booster dose."  On 13-Aug-2023, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported).  No additional information was provided as the patient was in a hurry to go to work.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Vomiting, Fever, Migraines, Muscle Aches & Pains
got sicker than hell; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional Information: GSK Receipt Date:22-JUL-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got sicker than hell from it, but he/she was told that was better than getting shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 28-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications were reported. Treatment for the event included loperamide hydrochloride and bismuth subsalicylate.   Reporter did not allow further contact
Day of inj Flu and MMRV slight redness and warm. 2/20/14 symptoms worsened - guardian states pt was feverish and decreased appetite along with large welts. Appears pt was not brought into clinic until 300 pm 2/21/14.
This spontaneous report was received from a Licensed Practical Nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L016428 with expiration date of 30-JUL-2017; lot # L018351 with expiration date of 11-AUG-2017; lot # L048237 with expiration date of 08-MAY-2017 and lot # L026602 with expiration date of 19-OCT-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was stated by the reporter, that the vaccine was exposed to a temperature excursion of 9 degrees C for 35 minutes. The vaccine has not been exposed to any previous temperature excursion and a data logger was stated. Furthermore, no adverse events were reported due to GARDASIL 9 and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
vomiting-12 hr p/vax;vomiting >24hr;inc BP, inc temp @ home;no fever in clinic
PATIENT DESCRIBED DIZZINESS, BLURRY VISION, LIGHTHEADEDNESS. PASSED OUT AND WAS HELPED INTO A CHAIR. LOSS OF MUSCLE TONE AND STARTED SLUMPING OVER. FELT HOT IN FACE AND ARM. WAS GIVEN COLD WATER AND PEANUT BUTTER CRACKERS TO EAT. PATIENT REPORTED NOT EATING ANYTHING ALL DAY. EMS CALLED AND PATIENT WAS CHECKED OUT. VITAL WERE NORMAL. WAS PICKED UP BY FAMILY MEMBER AND TAKEN TO AN EMERGENCY FACILITY FOR FURTHER CHECK-UP. APROXIMATE TIME OF INTERVENTION: 40 MIN
Vx administered less than an inch apart; This case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 9-week-old male patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL) (PEDVAXHIB) (batch number W021182, expiry date 27th February 2025) for prophylaxis.   On 17th January 2023, the patient received Infanrix, Infanrix Pre-Filled Syringe Device and PEDVAXHIB. On 17th January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site 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: 23 Jan 2023 Reporters comment: Medical assistant reported that the patient received a dose of Infanrix and a dose of Pedvaxhib at the same anatomic site, with less than one inch between each dose.  The reporter consented to follow up. Additional supportive information: As patient received both the vaccine on same application site which led to Vaccine administered at inappropriate site. Note: Pedvaxhib also kept as co-suspect as it was received at same site with Infanrix.
Moderna COVID?19 Vaccine  Right arm pain and pain, tenderness and swelling of the lymph nodes within right under arm and down the side.
Pt recvd vax 24APR77 & pt devel convuls & was hospitalized; suffered severe brain damage & cont to have sz until death on 1NOV89;
Information has been received from a pharmacist referring to a 63 years old male patient with hypertension. The patient had no drug reactions/allergies. On 06-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX, lot # L021608, expiration date 09-OCT-2016 (dose was not reported) subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown). On 07-OCT-2015, the patient developed mild swelling, redness with a size of a palm and warmth at the injection site and weakness below the injection within 24 hours after vaccination. The patient visited the pharmacy on 08-OCT-2015. No treatment was given for the adverse events and no lab diagnostic studies were performed. Outcome of the events was not recovered. The causality was not reported. Additional information has been requested.
Information has been received from a physician concerning an 81 year old female who on 08-APR-2008 was vaccinated with "regular dose" of VARIVAX (Merck) instead of ZOSTAVAX (Merck) for prevention of shingles. This was a medical error by the medical assistant. The physician reported that the medical assistant thought VARIVAX (Merck) and ZOSTAVAX (Merck) were the same thing. The patient was not experiencing any known symptoms. It was unknown if the patient sought medical attention. Additional information has been requested.
Seriousness criteria: Other-Medically Significant Initial report received from a health care provider on 31 August 2007. A 42-year-old female patient with a medical history of a penicillin allergy, had received an intramuscular left deltoid injection of Fluzone SV 2007-2008, lot number U2436AA on 30 August 2007 and 15 minutes later, she complained of slight tightness in her throat. During assessment, the patients blood pressure was 120/80. The patient received corrective treatment with 25mg Benadryl administered orally five minutes after the event began. No further treatment was reported and the duration of the event had not been provided. The patient had received a prior dose of Fluzone in November 2006 however no information about prior adverse events after receipt of Fluzone had been provided. According to the reporter, the patient had recovered from the event. Follow-up information was received from the health professional on 26 November 2007. The patient's symptoms resolved within 15 to 20 minutes of Benadryl administration, and no additional treatment was necessary. No adverse events had been reported by the patient following previous dose of Fluzone. Per the reporter, the final diagnosis was "anaphylactic reaction". Due to the information received in the follow-up report, this case has been upgraded to serious.
Lethargy, decreased appetite, excessive sleepiness, no talking, no intelligible communication, no eye contact, no "play" interest, coordination problems, very sensitive to sound, severe decrease in mental ability, severe neurological decline, difficulty walking, difficulty with balance, memory loss, loss of developmental milestones previously met. This is NOT MY CHILD!!!
Swelling of mouth 4 hours after vaccine.  Swelling took 3 days to go down.
Patient states she exhibited dizziness and blurred vision. Patient was given orange juice and symptoms were resolved.
I have had redness,  itching, and swelling at injection site starting approximately 1/7/2020.  This happens daily (sporadically), is self limiting,  and seems worsened by being hot.
severe body aches; joint pain; chills; headache; nausea; diarrhea; This is spontaneous report from a contactable nurse (patient). A 47-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL3249), via an unspecified route of administration on 09Jan2021 11:15 at single dose at right arm for covid-19 immunization. Medical history included mild asthma, known allergies: latex, peanuts from an unknown date and unknown if ongoing, and the patient was diagnosed with COVID-19 prior to vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. Since the vaccination, patient had not been tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EH9899) at single dose at right arm on 19Dec2020 11:15 am for covid-19 immunization. About 12 hours after the vaccination patient had severe body aches, joint pain, chills, headache, nausea, diarrhea on 09Jan2021 09:00 PM. All symptoms lasted from 12-16 hours, except the diarrhea lasted about 20 hours. Outcome of all events was recovered on 10Jan2021. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.
Information regarding ORIMUNE vaccine was received from an attorney regarding a male patient who developed mesothelioma and subsequently expired. The decedent received a dose of ORIMUNE vaccine on an unspecified date. Relevant medical history was not provided. Indication for ORIMUNE vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. It is alleged that the decedent's exposure to asbestos and asbestos-containing products and the Simian virus 40 contained within the polio vaccine, caused severe and permanent injury to the decedent, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. It is further alleged that on or about 9/02, the decedent was diagnosed with mesothelioma and subsequently expired on 6/15/03. The cause of death was reported as mesothelioma. No additional informatin was available at the time of this report.
Migraine headache, nausea, vomiting,  diarrhea,  muscle aches, fever of over 101 but under 102 - all happened the day after the 2nd dose.  He felt a little better for a few days but still struggled with nausea, some vomiting and diarrhea (and weight loss).  It's been a month and at this point the nausea is limited to the morning.
Initial information has been received from a licensed practical nurse and a physician and follow up information was received from a registered nurse, concerning a 74 year old retired male with hypertension, coronary artery disease, hyperlipidema and chronic obstructive pulmonary disease who on 06-NOV-2006, was vaccinated intramuscularly in the right deltoid with a second dose of Pneumovax 23 (Lot# 651406/0620F).  Concomitant vaccination intramuscularly into the left deltoid a dose of influenza virus vaccine (unspecified) (Lot # 70618).  The licensed practical nurse reported that on 06-NOV-2006 the patient developed a local reaction after vaccination with Pneumovax 23.  His whole upper arm became red, warm and swollen to the elbow.  The physician diagnosed symptoms as cellulitis of right arm.  Unspecified antibiotics were prescribed.  It was also noted that his previous vaccination with Pneumovax 23 was given on 12-NOV-2001.  The registered nurse reported that the patient developed swelling and soreness at the injection site.  It was painful to move his right arm.  The area was red and warm to touch.  His body temperature was 97.2, blood pressure was 140/70, pulse 80 and respirations 20. After 2 days, symptoms began to improve.  By the third day (08-NOV-2006), the patient had recovered.  There was no product quality complaint involved.  There were no other adverse events noted by the patient.  Additional information is not expected.
This spontaneous report was received from a medical assistant regarding unknown number of patients (age and gender not provided). No medical history and concurrent conditions were reported. On an unknown date the patients was vaccinated with incorrectly stored (incorrectly stored product) M-M-R II. Concomitant medication were not reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Covid (3rd dose) and Flu 1st dose) were given to the wrong patient. This patient received both of these vaccines on (9/9/22) and were accidentally administered to him again today (9/14/22). Shots were supposed to be administered to patient's brother.
The vaccine lot number B looks like an 8. This has resulted in charting incorrect lot occasionally by administering staff.
8:00 PM cough, headache, chills, fever, fatigue, nausea, hands felt numb and eyes crusted shut with a granular substance described by patient as "tasting like potassium".  Symptoms lasted a little over 24 hours.  No treatment was done.
This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant therapies were not reported. On an unknown date, the patient might have vaccinated with an improperly stored dose of VARIVAX (dose not reported) lot # L043620 (expiration date 02-NOV-2017) for prophylaxis. According to the reporter, the dose of VARIVAX was exposed to the following temperature excursion: -14 Celsius (C) degrees to -10 C (time frame: 6 hours and 15 minutes). A digital data logger was involved. No adverse effect was reported.