chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called in to complain about  severe soreness in her arm as well as tingling in her hands and feet. She received the vaccine on 1/11/19 but starting experiencing the tingling on 1/13/19. She states it started in her hands and has progressed to her feet. She stated this is not her first time receiving a flu vaccine but is worried that the symptoms she is experiencing is GBS. She was counseled to take tylenol or advil to help with the soreness in her arm and to contact her doctor if the symptoms do not improve.
the patient was scheduled for 2nd dose of Bexsero but was given MENQUADFI instead with no reported adverse event; Initial information received on 12-May-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 17 years old male patient who was scheduled for 2nd dose of bexsero, but was given menquadfi instead with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical treatment included Menactra in 2016. The patient's past medical history, vaccination(s) and family history were not provided. Concomitant medications included Meningococcal Vaccine B Rfhbp/Nada/Nhba Omv (Bexsero) for Immunisation.  In April 2022, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine lot number not reported (dose number: one) (strength, dose, route, administration site, expiry date and formulation: unknown). On 11-May-2022 he also received 0.5 ml of the same vaccine lot U6821AA via intramuscular route in the left arm (strength, expiry date and formulation: unknown) both for immunization.  On 11-MAY-2022, the patient developed a non-serious event the patient was scheduled for 2nd dose of bexsero but was given menquadfi instead with no reported adverse event (wrong product administered) (latency: same day) following the administration of meningococcal A-C-Y-W135 (t conj) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (wrong product administered).  At time of reporting, the outcome was Unknown for the event the wrong product administered.   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.
This case was reported by a nurse via sales rep and described the occurrence of cold sweat in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of cold sweat (1st dose received on an unknown date, refer case US2019GSK064951). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cold sweat and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the cold sweat and influenza-like symptoms were unknown. It was unknown if the reporter considered the cold sweat and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter said the patient was administered with 2nd dose at the appropriate time. The patient displayed similar but less severe symptoms. The reporter did not agree to follow up from GSK.
Pt had a syncopal ? seizure event the following morning where she felt cramping in her legs and fell to the floor and started shaking.  Evaluated in the ER and later was discharged as ok.  Event ruled as syncopal with possible seizure.  To follow up with neurology.
20 minutes after the first dose of the covid moderna vaccine I felt tightness in my jaw and then my mouth, tongue and jaw felt numb like as if I had novacane. This has never happened to me before. This lasted for about 15 minutes before returning to normal
2 hrs p/vax turned pale, cyanotic, limp improved immed p/given oxygen;
There was not an adverse reaction but reporting that this dose was given after the recommended 31 day storage parameter on 11/2/2021 vs 11/01/2021
Burning in arm almost instantly. Mom said that she had a fever (100.5), body aches, headache, stomachache  and pain in the arm. Mom gave Motrin and Benadryl. Patient said Motrin did nothing and Benadryl just made her tried.  She has missed 2 days of school because the pain was so severe.  Doing better today but the arm pain is still an issue. Coming in tomorrow to let the Doctor take a look at the arm.
administering FLUBLOK QIV post excursion of 30.4F with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 60-years-old male patient who was administered influenza quadrivalent recombinant vaccine [Flublok QIV] post excursion of 30.4 f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2023, the patient received 0.5 mL dose of suspect influenza quadrivalent recombinant vaccine (formulation unknown) (Strength: Standard; Frequency: Once) (batch number: U8058BA; expiry date: 31-May-2024) via intramuscular route in the deltoid nos (not otherwise specified) for Immunization, post excursion of 30.4f with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   No additional information at the time of call, caller declined follow-up.  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.; Sender's Comments:  US-SA-2023SA284378:
This is a non-serious case from a consumer in the USA who developed chest congestion after receiving FLUMIST. The reporter did not provide causality between events and FLUMIST administration. Approximately 30 minutes after receiving FLUMIST on 11/11/04, a 48 year old male developed chest congestion and started coughing. The patient reports sleeping all day and stay awake only 6-8 hours a day. The patient also experienced wheezing, weakness, and a dry nasal cavity. He has not gone to the doctor as of yet. All events are ongoing but at the time of the report, he says he is feeling better. The patient's medical history is unremarkable.
22 patients vaccinated using old vial from 03/12/21; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/12/21) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/12/21). On 09-Mar-2021, EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/12/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-207548, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258704, MOD-2021-258706, MOD-2021-258660.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up received, updated patient identifiers and demographics. On 01-Jul-2021: Follow up received added contact details. Added HCP  requested for followup and querying about revaccination procedure. On 01-Jul-2021: Follow-up received, no new information was updated.
Covid infection in Dec.; Covid infection in Dec.; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 06Oct2022 as dose 1, single; AMLODIPINE; METOPROLOL; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening) all with onset Dec2022, outcome "recovering" and all described as "Covid infection in Dec. ". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 10 day(s)). The event "covid infection in dec. " required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Unknwon results, notes: Covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A causal relationship to the suspect drugs cannot be excluded for events lack of efficacy and COVID-19. This case will be reassessed upon receipt of additional information. 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.,Linked Report(s) : US-PFIZER INC-202300085695 similar report from the same reporter;US-PFIZER INC-202300085696 similar report from the same reporter;US-PFIZER INC-202300085697 similar report from the same reporter;
COVID test date: 13Jan2022, COVID test result: Positive; COVID test date: 13Jan2022, COVID test result: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Jan2021 (Lot number: EL3248) as dose 2, single and administered in arm left, administration date 29Dec2020 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: TIROSINT; JUNEL; VITAMIN D [COLECALCIFEROL]; PANTOPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jan2022, outcome "unknown" and all described as "COVID test date: 13Jan2022, COVID test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Jan2022) positive. Clinical course:No prior vaccination within 4 weeks. No covid-19 prior vaccination.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Patient began to feel flu-like symptoms (fever, aches, chills) on Monday evening (10/22/12) then on Tuesday (10/23/12) morning patient's arm where shots were administered was swollen, hot and had red streaks. Patient went to see primary care physician Tuesday afternoon and the physician determined the area was infected and prescribed Keflex antibiotics for the patient. Spoke to patient Wednesday morning and patient is feeling better and swelling in arm has gone down.
Information has been received from a physician concerning a 19 year old female who in approximately 2009 was vaccinated with a 0.5 ml second dose of GARDASIL (no lot number provided).  "Few weeks ago", after vaccination, the patient experienced tingling and numbness.  One or two days later, unspecified medical attention was sought and she was diagnosed with Bell's palsy.  At the time of the report, as 14-JAN-2009, the patient was being treated with steroids.  Upon internal review, Bell's palsy was determined to be an other important medical event.  Additional information has been requested.
Dizzy; Tired; Weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 10:30 (Lot number: ER8732) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus", start date: 2000 (ongoing), notes: Verbatim: Diabetes; "Hypertension", start date: 2000 (ongoing), notes: Verbatim: Hypertension; "Spinal cord injury", start date: 2018 (unspecified if ongoing), notes: Verbatim: Injury to C6 and C7, Caller states that she had a fall in 2018 and suffered an injury to C6 and C7 on her spinal cord.States that her hands are still weak related to this.; "Arthritis" (ongoing), notes: Verbatim: Arthritis; "Fall", start date: 2018 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 01Apr2021, outcome "recovering", described as "Dizzy"; FATIGUE (non-serious) with onset 01Apr2021, outcome "recovering", described as "Tired"; ASTHENIA (non-serious) with onset 01Apr2021, outcome "recovering", described as "Weakness".  Additional Information:  Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations was none. Patient's Medical History (Including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests were none .The patient had a fall in 2018 and suffered an injury to C6 and C7 on her spinal cord. Stated that her hands are still weak related to this. patient was supposed to return for her second one on 14 Apr 2021.She didn't even felt when she got the shot and that her arm wasn't sore like she's read a lot of people's have been. There was no history of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient did not taken Prior Vaccinations within 4 weeks.The patient has not been taken additional Vaccines Administered on Same Date of the Pfizer Suspect.   No follow-up attempts are possible. No further information is expected.
arm hurts; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported arm hurts on 12Jan2021. The event outcome was recovering. No treatment for AE. No COVID prior vaccination; no COVID tested post vaccination.    No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of adverse event (experienced after receiving 1st dose, refer linked case US2018GSK195620). In October 2018, the patient received the 2nd dose of Shingrix. In October 2018, 1 day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: This case was reported by an Office Manager. The age at vaccination was not reported. Last Thursday before the date of reporting, the patient received Shingrix. On Friday after receiving Shingrix, the patient did not have any of the symptoms that she had the last time other than her arm hurt. The reporter agreed to receive follow up. This case has been linked with the case US2018GSK111832, reported by same reporter.
Patient received pediatric dose of Hepatitis B. instead of adult dose.  Give Hepatitis B adult dose in 8 weeks.
Unbreakable fever of 99 - 100 ... took advil & tylenol ... lasted 3 days             Cramping in leg and feet first night only Severe body aches all over my entire body 2 full days                                              Severe headache with pressure against my eyes 2 full days Nausea on 2nd evening only                                                                                                     Injection site was high frontal left shoulder ... I felt like a severe bumble bee sting on both my shoulders.  Pain was across my back & chest, my neck, and down into my arm pits.  Glands in my neck swelled.  2 full days .... 6 days later, my left arm pit is still sore and swollen.
Swollen, red, hot, inflamed at site. Neck rash/reddness.
Felt uncomfortable in the evening after being given immunization injection. Had difficulty sleeping. Injection site is hot, red, swollen (area is approximately 11x3 cm.). Have felt generally uncomfortable. Never had a reaction to flu shot before this.
Moderna COVID-19 Vaccine EUA  Sore throat about 3 hours after shot  continuing to next day so far.
mild tiredness; Received full third dose and not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild tiredness) and ACCIDENTAL OVERDOSE (Received full third dose and not immunocompromised) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Received full third dose and not immunocompromised). On an unknown date, the patient experienced FATIGUE (mild tiredness). On 31-Aug-2021, ACCIDENTAL OVERDOSE (Received full third dose and not immunocompromised) had resolved. At the time of the report, FATIGUE (mild tiredness) outcome was unknown.            No concomitant medications was provided. No treatment medications was provided.
Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included CALCIUM and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
This spontaneous report received from a patient concerned a 62 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis (Non-infectious intermediate, posterior and Panuveitis). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, first dose (1 in 1 once) administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 62 years old. No concomitant medications were reported. The patient received non-company suspect drugs adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported, Citrate free, administered for ankylosing spondylitis non-infectious intermediate, posterior and Panuveitis. On an unspecified date, the patient experienced seven blood clots in leg (thrombosis leg), flare up from stress, swelling in knee joints, condition aggravated, sensitivity after injection in stomach (Injection site hypersensitivity), knee pain, and injection site burns/stings and had an area of pain (Injection site pain). On JAN-2022 (date unspecified), the patient experienced Covid-19 which was coded as suspected Covid-19 infection and suspected clinical vaccination failure. On 09-JUN-2022, Laboratory data included: Magnetic resonance imaging result was unknown. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from suspected Covid-19 infection on 2022 (date unspecified), was recovering from seven blood clots in leg, condition aggravated, and sensitivity after injection in stomach, had not recovered from injection site burns/stings and had an area of pain, and knee pain, and the outcome of flare up from stress, swelling in knee joints and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested. Sender's Comments: V0: 20220639689- COVID-19 VACCINE AD26.COV2.S- SEVEN BLOOD CLOTS IN LEG. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220639689-COVID-19 VACCINE AD26.COV2.S-SUSPECTED 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.