chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second Dose with Engerix; Initial Report Received on 26-Aug-2022.  A pharmacist  reported that a 20 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient received the second dose with Engerix.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route and site not reported) at another pharmacy location. The information regarding the initial HEPLISAV-B dose was reported as unknown.  On 24-Aug-2022, an unspecified number of days after having been vaccinated with HEPLISAV-B, the patient received a dose with Engerix (Lot # 337TC, expiration date 29-Mar-2024, NDC# not provided).   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Fever; Fatigue; Body ache; Very rapid heartbeat (approx. 120-130 bpm when resting); Severe chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". Vaccination history included: Bnt162b2 (dose number=1,, vaccine location: Left arm), administration date: 21Mar2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Severe chills", "Fever", "Fatigue", "Body ache". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Severe chills"; PYREXIA (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Fever"; FATIGUE (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Fatigue"; PAIN (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Body ache"; HEART RATE INCREASED (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Very rapid heartbeat (approx. 120-130 bpm when resting)". The events "severe chills", "fever", "fatigue", "body ache" and "very rapid heartbeat (approx. 120-130 bpm when resting)" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a licensed practical nurse referring to an unknown number of unspecified patients of unknown age and gender. Concurrent condition, historical condition and concomitant therapy were not reported. On unknown dates starting on or after 24-JUN-2016, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L033690, expiration date 14-JUN-2018; dose and route were unknown). The vaccines were stored under 32F for 4 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Plantar fascitis; Arthritis in both feet; Stiffness; Limitations in movement; Decreased range of motion of shoulder with some discomfort.; Multiple joint pains; Malaise; Painful shoulder; Nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), PLANTAR FASCIITIS (Plantar fascitis), ARTHRITIS (Arthritis in both feet), MUSCULOSKELETAL STIFFNESS (Stiffness) and HYPOKINESIA (Limitations in movement) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: shingrix vaccine (Past history to vaccine and present and reported to Glaxo Smith Kline) on 21-Jun-2018. Past adverse reactions to the above products included Polymyalgia rheumatica with shingrix vaccine. Concomitant products included SIMVASTATIN, LEVOTHYROXINE, PREDNISONE, ACETAMINOPHEN, BUSPIRONE and CHLORTHALIDONE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced MALAISE (Malaise), ARTHRALGIA (Painful shoulder), NAUSEA (Nausea) and HEADACHE (headache). On an unknown date, the patient experienced PLANTAR FASCIITIS (Plantar fascitis), ARTHRITIS (Arthritis in both feet), MUSCULOSKELETAL STIFFNESS (Stiffness), HYPOKINESIA (Limitations in movement), MUSCULOSKELETAL DISCOMFORT (Decreased range of motion of shoulder with some discomfort.) and ARTHRALGIA (Multiple joint pains). On 12-Feb-2021, MALAISE (Malaise), NAUSEA (Nausea) and HEADACHE (headache) had resolved. On 26-Feb-2021, ARTHRALGIA (Painful shoulder) was resolving. At the time of the report, PLANTAR FASCIITIS (Plantar fascitis), ARTHRITIS (Arthritis in both feet), MUSCULOSKELETAL STIFFNESS (Stiffness), HYPOKINESIA (Limitations in movement), MUSCULOSKELETAL DISCOMFORT (Decreased range of motion of shoulder with some discomfort.) and ARTHRALGIA (Multiple joint pains) outcome was unknown.            Polymyalgia rheumatica was severe in both hands and wrists.  Patient took cold-compress as concomitant medication.  No treatment medication was reported by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Patient demographics, concomitant medications, second dose details and new events were updated.
muscle pain/muscle pain started in forearm, creeping; Joint pain, shoulder, arm, and elbow area; Joint pain, shoulder, arm, and elbow area; This is a spontaneous report from a contactable consumer or other non hcp (patient).    A 65-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN2605), via an unspecified route of administration on 26Feb2021 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 65 years). Medical history included ongoing diabetes mellitus Verbatim: Diabetic diagnosed over 10 years ago/Reports he is on diabetic medications. Concomitant medications were not reported. The patient experienced muscle pain/muscle pain started in forearm, creeping on 02Mar2021, joint pain, shoulder, arm, and elbow area on an unspecified date in 2021. The patient was not treated for the events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
5 episodes of severe vomiting; Running diarrhea; Slight fever; A spontaneous report was received from a physician assistant on 19APR2023 regarding a 20-year-old male patient who had "5 episodes of severe vomiting" (PT: Vomiting), "running diarrhea" (PT: Diarrhoea) and "slight fever" (PT: Pyrexia) following the administration of Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical/surgical history, concomitant medications, or known allergies were reported as none.   On 17APR2023, Monday afternoon the patient received the first dose of Vivotif and felt completely fine on Monday and Tuesday. However, on 19APR2023 morning, about 40 hours after the first dose, the patient had five episodes of severe vomiting, a bit of running diarrhea and a slight fever. It was reported that there was a possibility of the patient being infected with viral illness in the household as his roommate who was not taking Vivotif had some vomiting and diarrhea yesterday evening (18APR2023).  Reportedly, the patient did not receive any treatment for the reported events and was doing well.  The patient recovered from the event "5 episodes of severe vomiting" on an unknown date in APR2023 while he was recovering from the events of "running diarrhea" and "slight fever".  The action taken with Vivotif with respect to the reported events was unknown.  No additional information was provided.  Based on the information available in the document three individual case safety reports 23000151 (patient-1), 23000152 (patient-2) and 22000250 (patient-3) were created and cross-linked in the database.  Company comment: It was reported that a consumer took Vivotif for immunisation and he had 5 episodes of severe vomiting (vomiting), running diarrhea (diarrhoea) and slight fever (pyrexia). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting, diarrhoea and pyrexia is assessed as possible (confounded by viral illness). The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif for immunisation and he had 5 episodes of severe vomiting (vomiting), running diarrhea (diarrhoea) and slight fever (pyrexia). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting, diarrhoea and pyrexia is assessed as possible (confounded by viral illness). The case is considered non serious as per medical assessment. 23000151:Linked case (Patient 1) 22000250:Linked case (Patient 3)
Pt immunized then 24 hours later noted swollen, red thigh above knee (distal to injection site and not at all involving injection site). Did not have any pain in leg. Had low fever (100 degrees). Taken to ER with WBC=16,900 and given IV clinda then PO clinda x 10 d for presumed cellulitis. Pt c/o itching of leg. Within 48 hours-72 hours fully recovered. No previous vaccine rxns. Had influenza like illness about 2 wks prior and rv'd TAMIFLU. Had seasonal FLUMIST 6-7 wks earlier.
Diarrhea, fatigue, chills, throat constriction, swelling of tongue (slurred speech) shortness of breath.
Patient said she developed blister rash on her face under her eye - she visited a physician & was prescribed Valacyclovir.
Redness an inch or two below the injection site. Slightly sore, itchy, warm. Showed up a couple days after the vaccination, and is almost gone 5 days after vaccination. (Saw a much larger/hotter/itchier red spot after my 2nd dose in March.)
This case was reported by a physician via a GSK representative and described the occurrence of red spot at injection site in a 4-year-old female subject who was vaccinated with (KINRIX, GlaxoSmithKline). On 16 April 2009 the subject received 1st dose of KINRIX (0.5 ml, unknown route, unknown arm). At an unknown time later that day (16 April 2009), after vaccination with KINRIX, the subject experienced an injection site reaction with a red spot at the injection site that was warm to touch, which increased in size to approximately the size "of a half dollar". The red spot then turned brown. The spot has remained "about the same size", but has lightened in color. The time frame from the change in colors was unknown at the time of reporting. At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with KINRIX.
Patient reported losing complete hearing in her right ear on 5/14/2021. She went to the Dr who prescribed amoxicillin and said it looked ok but was giving amoxicillin just in case. Patients hearing did not return and is currently 100% deaf in her right ear since 2 days after her first dose of Moderna COVID vaccine.
temperature runs colder although feels hotter; pain at injection site came back; Diarrhea; Injection site pain; shivering feeling like freezing; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BODY TEMPERATURE DECREASED (temperature runs colder although feels hotter), CHILLS (shivering feeling like freezing), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE PAIN (pain at injection site came back) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Cholecystectomy and Heart valve operation (The patient has an artificial heart valve). Concomitant products included WARFARIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (shivering feeling like freezing). On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 22-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On 23-Feb-2021, the patient experienced BODY TEMPERATURE DECREASED (temperature runs colder although feels hotter) and VACCINATION SITE PAIN (pain at injection site came back). At the time of the report, DIARRHOEA (Diarrhea), BODY TEMPERATURE DECREASED (temperature runs colder although feels hotter), CHILLS (shivering feeling like freezing) and VACCINATION SITE PAIN (pain at injection site came back) outcome was unknown and VACCINATION SITE PAIN (Injection site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 94.1f to 96 f (abnormal) Temperature tends to run colder although they feel hotter.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Dad calling 11/5/2021 stating child had a frontal headache the day after the vaccine 10/6/2021 and lasted till 10/10/2021. Patient was not evaluated in clinic nor family called during active symptoms
she developed hives on her right arm, but received shot in theleft arm.Now she has some on her arms and face.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 30-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered in left arm, on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered anatomical location not reported, on an unspecified date as dose 1, single for COVID-19 immunization. The patient stated she received second dose about an hour and ten minutes ago, about twenty minutes ago she developed hives on her right arm (on unspecified date). The patient stated but she received the dose in the left arm. The patient stated now she has some on her arms and face (on unspecified date). The patient stated she had no reaction with the first dose. The patient asked is this a side effect of the vaccine. The patient asked can she take a BENDADRYL. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL3249), in right arm, on 31Mar2021 as dose 2, single (Lot number: EH9899), in left arm and on 03Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 67 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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) Negative, notes: 2 days post tx - tested negative x2; (Jul2022) Positive, notes: retested 3 days post paxlovid=positive; (19Jul2022) Positive, notes: retested 19Jul still positive. Therapeutic measures were taken as a result of covid-19, drug ineffective with paxlovid started on 08Jul2022 and stop date 13Jul2022.  Clinical course: Patient did received other medications in two weeks. Paxlovid rebound, took 5 days of Paxlovid. (08Jul-13Jul) 2 days post tx-tested negative x2; then increase rhinorrhea, like water dripping; fatigue, cough, headaches; retested 3 days post paxlovid: positive, isolated again, continue to have rhinorrhea and fatigue and watery stools x 1 day; retested 19Jul still positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
his spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Adult patient received Pediatric Booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR7479B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Adult patient received Pediatric Booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Adult patient received Pediatric Booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         This case contains information for the 2nd of 3 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Treatment Medication use information was not provided by reporter.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored on cooler 1 , on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM : 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  On 15-Apr-2021, Excursion time was 09 AM, temp was 34, total doses given for the day was 188, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vial was moved to clinic. Vaccine BUD date was 09-May-2021.  Vials only punctured right before administration.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Moderna COVID-19 Vaccine EUA I had a skin rash occur one week after receiving the vaccine. It started as a small red area on my left arm and spread to a large, warm, itchy, red area on my left arm just under the vaccination site. I saw my primary physician who surmised it was likely a reaction to the COVID-19 vaccine due to no other issues present and blood work did not show abnormalities to suggest an underlying infection. I was provided a prescription for a topical steroid to decrease redness and itchiness, which was effective after a few applications. I then saw an immunologist to check in regarding safety for receiving the second dose of the vaccine, where I was told not enough data was available to determine a 2nd dose would be contraindicated based on my reaction to the first vaccine.
Received MMR vaccine on 01/05/2006, on 01/23/2006 pain erythema, itching at site of vaccine - seen in clinic.  Diagnosed with Cellulitis.
pain, redness, and swelling at site of injection. joint and muscle pain. extreme tiredness and weakness . headache. intense shivering. fever, hallucinations. loss of breath  my 1st shot only resulted in a mildly painful arm, the 2nd shot was much more problematic.
The vial with expiration 1/31/24 was taken out of freezer with a 10-week expiration of 11/30/22, so the dose was expired by 12 days. The patient does not report any issues, but per CDC recommendation, will be revaccinated 1/9/23.
This spontaneous report as received from a pharmacist refers to a 20 year old female patient. On 14-MAR-2013 the patient was vaccinated with VARIVAX dose 1 (lot number, dose, frequency not provided). The pharmacist reported that at the time of the report the patient had not yet received her second dose. No adverse event was reported. Additional information has been requested.