chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional via a sales representative and described the occurrence of alanine aminotransferase increased in a 56-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). In January 2011 the subject received unspecified dose of HAVRIX 1440 (unknown). In April 2011, approximately 3 months after vaccination with HAVRIX 1440, the subject experienced alanine aminotransferase increased and increased gamma-glutamyl transferase. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
fatigue; body aches; headache; pain at injection site; Received third dose of comirnaty vaccine on 04Nov in left deltoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 04Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization; Bnt162b2 (Dose:2), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 04Nov2021, outcome "not recovered", described as "fatigue"; PAIN (non-serious) with onset 04Nov2021, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 04Nov2021, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 04Nov2021, outcome "not recovered", described as "pain at injection site"; IMMUNISATION (non-serious) with onset 04Nov2021, outcome "unknown", described as "Received third dose of comirnaty vaccine on 04Nov in left deltoid".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TOOK TWO DOSES CONSECUTIVELY; This spontaneous case report (PVX2019-2399) was received from a pharmacist on 19-Sep-2019. It described a female consumer who "took two doses consecutively" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took first two doses of Vivotif in a row. The doses were taken on 17-Sep-2019 and 18-Sep-2019, respectively.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two doses consecutively" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses consecutively" was considered as not applicable.
Headache, Myalgia, UrticariPruritus, erythema at vaccine site Narrative:
Localized rash flare up in his groin area; More tired than usual; Felt soreness in the arm; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt soreness in the arm), PRURITUS (Itchy), RASH (Localized rash flare up in his groin area) and FATIGUE (More tired than usual) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.   Concurrent medical conditions included Skin rash (The patient had a couple of rashes) and Athlete's foot.  On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Felt soreness in the arm), PRURITUS (Itchy) and FATIGUE (More tired than usual). On an unknown date, the patient experienced RASH (Localized rash flare up in his groin area). The patient was treated with TERBINAFINE HYDROCHLORIDE (LAMISIL [TERBINAFINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 17-Mar-2021, PAIN IN EXTREMITY (Felt soreness in the arm) and FATIGUE (More tired than usual) had resolved. At the time of the report, PRURITUS (Itchy) and RASH (Localized rash flare up in his groin area) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  It was reported that the next day he felt soreness in the arm, more tired than usual and a localized rash flare up in his groin area, it is also itchy. The soreness and tiredness went away the next day. He put Lamisil on the rash but it does not seem to be affective. The patient had a skin rash for the last couple of years and athletes foot so he said it could be a coincidence.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07-May-2021 contains information regarding reporter mail address.
swollen/sensitive lymph node in armpit near injection site, slight dizziness the following day (ongoing at this time)
FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, penicillin allergy, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031,expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 10:00 in left deltoid for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.8 F. On 20-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: METOPROLOL; ESOMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid from 12May2022 to 17May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Petechiae; blister with blood underneath behind her knee; bruiseon abdomen and right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PETECHIAE (Petechiae), BLISTER (blister with blood underneath behind her knee) and CONTUSION (bruiseon abdomen and right arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20a and 012l20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, 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 experienced PETECHIAE (Petechiae), BLISTER (blister with blood underneath behind her knee) and CONTUSION (bruiseon abdomen and right arm). At the time of the report, PETECHIAE (Petechiae), BLISTER (blister with blood underneath behind her knee) and CONTUSION (bruiseon abdomen and right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication  was not provided. Treatment information was not provided.
Chills, two days Hot flashes, two days Nausea, two days Vomiting, three hours Fatigue, seven days Brain fog, three months Headache, two days Extreme headache, three hours
Sick with a cough; Sick/started to feel sick; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Sick with a cough) and MALAISE (Sick/started to feel sick) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006MNA) 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) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced COUGH (Sick with a cough) and MALAISE (Sick/started to feel sick). At the time of the report, COUGH (Sick with a cough) and MALAISE (Sick/started to feel sick) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received on 18-MAY-2021.Date of birth and outcome was updated.
Deep, excruciating pain from shoulder to tips of fingers. Could not touch or move arm due to stiffness and pain.
accidently administered a dose from last year Fluzone quadrivalent that expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Pharmacist via Medical Information  (Reference number- 00822705) and transmitted to Sanofi on 21-Oct-2021 in a specific country.  This case involves a 65-year-old male patient who was accidentally vaccinated with a 0.5 mL (once) dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] from last year (lot UJ432AA and expiry date 30-Jun-2021) via intramuscular route in the right deltoid on 21-Oct-2021 for prophylactic vaccination (expired product administered).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  It was reported "Pharmacist wants to know is there anything she should warn the patient about side effect wise and do we have any recommendation as far as revaccination? Caller states that after a patient left she realized that and the patient is not experiencing any side effects."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I started to experiencing itchiness at the site of the injection on Friday January 15th along with firmness around the site of the injections. On January 19th my arm now has a rash around the injection area that is approximately 6inches in diameter.
SEVERE REDNESS AND SWELLING IN THE ARM THE INJECTION WAS ADMINISTERED WITHIN 12 HOURS OF ADMINISTRATION.
Pt was contacted on Tuesday afternoon regarding routine labs and reported that he received the Adacel vaccine on Friday 2/28/20. On Saturday 2/29/20 patient reported that he noted a fever of 101 with associated chills. Patient denied any redness, swelling or pain in the injection site beyond what he endorses as normal post injection soreness. Pt denied  any symptoms of illness, including upper respiratory symptoms, rash, or other symptoms of general illness. Pt denied that anyone else in his household is ill. Pt reported that his symptoms have resolved, denied any further fevers or chills, and denied the need for follow up at this time. Pt was informed that a report would be made regarding the vaccine reaction and was agreeable.
After receiving the vaccine, my psoriasis started to spread to my entire body. My legs and arms are completely covered in sore and after seeing multiple dermatologists, allergists and my doctor- there is no cure as of yet. None of my lesions after subsided and they continue to spread.
- Involuntary movement - Slurred speech - Inability to speak  - Inability to walk, talk, feed self (can't function on own anymore) - Temporary memory loss  - Migraines  - Inability recognize family and friends - Feelings sometimes went away in certain parts of the body - Numbness and much more
Pt. returned to clinic 20-30 after immunization. Injection site Left arm with 1 inch erythema/itching and slight wheezing. Pt. given 50mg BENADRYL PO, followed by ATROVENT nebulizer Rx. VS BP 124/68, HR 84, R 16. Pt. reports feeling better, left arm erythema decreased. Pt. released to home with instructions to go to ED with further wheezing/SOB. Returned to ED for admission 6/28/12 at 1023 PM. Pt. c/o reoccurrence wheezing. Admitted and released 6/29/12. Hospitalization included nebulizer Rx and prednisone.
Employee states sitting in class & started feeling flushed, SOB, hives, right eye blurred vision, & dizzy approximately one hour post Hepatitis B #3 vaccine. Employee states went to ED where treated.
Patient was given vaccine on 9/23 and vaccine expired 9/21, the previous day.
Rashes face like chemical peel and red on fire, eyes itchy, red line waistline and bra line, neck and chest are red.  Pt. had Covid in Oct. 2020, blood drawn showed no anti-bodies 3 weeks prior the vaccine.
but his liver had inflammation; jaundiced; dark urine; He did not receive second injection of the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS (but his liver had inflammation) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (He did not receive second injection of the moderna vaccine). On 30-Mar-2021, the patient experienced CHROMATURIA (dark urine). On 01-Apr-2021, the patient experienced JAUNDICE (jaundiced). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEPATITIS (but his liver had inflammation) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date for Liver inflammation, at an unspecified dose and frequency. On 27-Mar-2021, PRODUCT DOSE OMISSION ISSUE (He did not receive second injection of the moderna vaccine) had resolved. At the time of the report, HEPATITIS (but his liver had inflammation), CHROMATURIA (dark urine) and JAUNDICE (jaundiced) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Biopsy liver: (abnormal) cancer free but liver had inflammation.. On 06-Apr-2021, Blood bilirubin: 36 (High) 36. On an unknown date, Blood bilirubin: 26 (Inconclusive) 26.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. On 30-Mar-2021, patient stated that his urine was getting dark and two days later, he started looking jaundiced. Patient saw the doctor on 06-Apr-2021. He was started on 20mg per day of prednisone. Company comment: Very limited information regarding this event has been provided at this time. Further information has been  requested. This is also a case of a 83 year old male who missed dose as a result of experienced illness.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been  requested. This is also a case of a 83 year old male who missed dose as a result of experienced illness.
Within 5 minutes of vaccine left arm felt heavy and numb. Pt kept extra 15 minutes. Heavy feelin and numbness resolved prior to leaving with her husband.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Pain at day at injection time, overnight knot form hardened red swoll area and painful. Lasted 4 day until relief. Hardened red area still present but going down and less pain.
This spontaneous report as received from a physician refers to a 23 year old male patient. On 06-JUL-2010 the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route and indication unknown). The patient received the second dose of GARDASIL late (date, dose and route unspecified). No adverse effects reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 30-SEP-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Drug Not Reported). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown, and expiry: unknown) dose was not reported, 1 total, administered on 02-APR-2021 to left arm for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  On SEP-2022, the patient experienced confirmed clinical vaccination failure (dose number in series 1). The patient additionally received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered on 01-NOV-2021 to left arm for an unspecified indication.  On SEP-2022, the patient experienced Fatigue, coughing, sneezing, fever returned lost taste, smell, and confirmed covid-19 infection. On 01-NOV-2021, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2).  The patient received unspecified medication from pfizer from 08-SEP-2022 to 13-SEP-2022 for treatment of COVID-19. Treatment was stop on 13-SEP-2022. On 16-SEP-2022, Laboratory data included: COVID-19 virus test Negative. On 19-SEP-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000253685. Sender's Comments: V0:20220959719-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients received ROTATEQ (Lot number: L033543, Expiry date: 30-MAY-2017) (dose, frequency were not reported) which was improperly stored.  No adverse effects reported. Causality assessment was not reported for the events.  This is one of the several reports received from the same reporter. Follow-up information has been received via telephone call from a medical assistant on 20-DEC-2016. The medical assistant reported that she would see if their IT department would be able to run a listing and if able, the medical assistant would fax the listing in. Additional information has been requested. Narrative was updated.; Sender's Comments: US-009507513-1610USA012464: US-009507513-1610USA012470: US-009507513-1610USA012469: US-009507513-1610USA012471:, MERCK 1610USA012472:Mfr number.
I gave this client a .5 cc injection of air accidentally (see previous form). In the follow-up call I made to the mother 5 days after the event on 10-1-12 she stated both girls who had received the IM injection developed a rash in armpits and abdomen 4 days afterwards. She took them to the pediatrician who didn't know the etiology; Rx'd cortisone cream and ZYRTEC. Mother gave oatmeal baths.
PT developed sever generalyzed rash with occasional bullae formation- rash seemed to be slowly improving until often second vaccination- Rash then became severe with multiple bullae- biopsy bullous pemphigoid
Suddenly I became very dizzy. I contacted my primary, Dr. and she sent me to the ER and ordered stroke protocol tests. The ER doctor determined that I have vertigo and referred me to my ENT. My ENT has ordered an audiology test and a tilt table test. I have them scheduled, but have not yet taken them. I also began having severe tinnitus.
encephalitis is reported in a pt who recvd flu vax; day p/flu vax pt became lethargic, was unable to ambulate & didn't recognize family; Pt seen in ER dx of encephalitis;