chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe rash extendind from right shoulder, across chest and to the left shoulder. Also rash spots on both hands and inbetween index fingers and middle fingers. Patient states it came up about one month after the vaccine. States it itches, but does not give a burning sensation. Doctor is treating with Valcyclovir 1 gram by mouth twice a day for 7 days.
A consumer report has been received. The report concerns an 11 year old, male consumer, who received FLUMIST Quadrivalent (intranasal), 0.2 milliliters, during Oct-2015. Concomitant medications included GARDASIL and prednisone. The patient experienced felt dizzy, poison oak and headache. The outcome of the event of felt dizzy, poison oak and headache was unknown. The report was considered to be non-serious.
knocked out and just slept for the next two days; covid-19; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (knocked out and just slept for the next two days) and COVID-19 (covid-19) in a 5-decade-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Fever in January 2020, Chills in January 2020, Cough in January 2020, Ache in January 2020, Mucus discharge (required antibiotic to clear up) in January 2020 and Feeling unwell (very sudden, mysterious something) in January 2020.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (knocked out and just slept for the next two days) and COVID-19 (covid-19). At the time of the report, HYPERSOMNIA (knocked out and just slept for the next two days) had resolved and COVID-19 (covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Company comment: This is a spontaneous case concerning a 5-decade-old patient of an unknown gender with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 6 months after the second dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Patient experienced mild symptoms without hospitalization. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Concomitant product use was not provided by the reporter.  It was reported that patient was doubly vaccinated over 6 months ago, but not boosted.  Patient had tons of snot for the first two days and a cough caused by that. Ptaient was knocked out and just slept for the next two days, with a headache and body aches then just tired the day after.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a 5-decade-old patient of an unknown gender with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 6 months after the second dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Patient experienced mild symptoms without hospitalization. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Intense burning sensation on right thigh, followed by rash on 7/12/10.
Fever 103; Chills; Fatigue; Muscle aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Jan2021 (Lot number: EL3248) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE (ongoing); ZOLOFT (ongoing). Vaccination history included: Bnt162b2 (First Dose, Site and Route of injection:, Route of administration: Intramuscular, Batch/Lot number: EK5730), administration date: 24Dec2020, when the patient was 50 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever 103"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Muscle aches". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical information: The patient consider that Pfizer product had a causal effect to the adverse event. Specific relevant test for thromboembolic events with thrombocytopenia were none.  Follow-up attempts are completed. No further information is expected.
reaction started w/ nasal ddrip, sore throat. By Tuesday, Nov. 2nd, reaction had turned into severe double ear infection and sinus infection.
a 1 year old patient received an injection of QUADRACEL, no AE; Initial information received on 11-Aug-2021 regarding an unsolicited valid non-serious case from a other health professional and consumer/ non health care professional via Global Media Information (under reference 00719583).  This case involves a 1 years old male patient who received an injection of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included a dose of MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 04-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (total, lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration (same day latency).   It was reported that "Caller states that a fifteen month old patient received an injection of QUADRACEL in her office on 04-Aug-2021. Caller asked what Sanofi's recommendation was in this situation."  At time of reporting, the outcome was unknown for the reported event.  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.  There will be no information on the batch number for this case.
Information has been received from a licensed practical nurse concerning a patient who in the last month (approximately in September 2009) was vaccinated intramuscularly with 0.5 ml of PNEUMOVAX 23 (Lot # 663126/0464Y). According to the reporter, in the "same day as vaccination or the following day", the patient developed as injection site reaction. The affected area was red, painful and very hot. The patient recovered on an unspecified date. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Got the shots and then got shingles / Suspected vaccination failure; Got the shots and then got shingles.; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient got the shingles shots and then got shingles. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
1st 3 days extreme sore bright red swollen arm. Went away.  On day 5, noticed hard knot forming at injection site. Day 8, the red swollen arm returned and twice the size.  Other things to note: extreme diarrhea, headaches, body aches, nausea, severe anxiety and depression unlike I had in 30 years. Totally unexpected and not situational. Dr. Said might be vaccine related and to report.
Aprox 8 minuted after receiving the vaccine, I noticed prickling (pins and needles) starting to occur on my forehead, then including the nose as well. I felt numbness at the tip of my nose. I took my glasses off and my vision was blurry. I felt weak (almost faint), I felt a chill running through my arms and lightheaded. I was able to get the attention of the person monitoring us in the 15 minute wait area and she took me to the side to a nurse and EMS person was stated. I felt almost that feeling when they start an IV up (that weakness). My blood pressure remained relatively constant the times they checked it though I did feel a racing heart at moments. In about 30 minutes the obvious pins and needles was starting
This is a serious observational study case initially received on 26-Nov-2018, concerning a 34-year-old adult, female, pregnant subject of body weight 120 lbs, height 64 inches and body mass index (BMI) 20.6, enrolled in V130_11OB, a prospective observational safety study. The subject's obstetrical history included one full term live birth and one preterm live birth. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal/paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The pregnancy status of the subject was collected, and no pregnancy complications were noted. The subject's last menstrual period date was 03-Sep-2018. The gestational age of the subject was 05 weeks. The concomitant medications included CITRANAL ASSURE (300mg, daily [qd], orally) for healthy pregnancy and MAKENA, dose: 275 mg, once a week as needed via subcutaneous route to reduce the risk of preterm birth. On 11-Oct-2018, the pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252232, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication (explicitly considered as exposure during pregnancy). On 10-Nov-2018, the subject started treatment at gestational age 9.7 weeks with simethicone (80 mg, as needed, orally) for gas. On 27-Nov-2018, after administration of study vaccine, the subject underwent first trimester screening and risk of Down syndrome was identified. On an unknown date, the subject experienced gas. The subject's estimated date of delivery was reported as 10-Jun-2019. Significant follow-up received from other health professional on 13-Dec-2018: Concomitant medication (MAKENA) was added in the product tab. The event (Down's syndrome) was added in the event tab. The case was upgraded from non-serious to serious. The narrative was amended accordingly. Reporter's Comments: A 34-year-old female pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD at 05 weeks of gestational age (explicitly coded as vaccine exposure during pregnancy) and experienced gas. The company assessed the causality of the event vaccine exposure during pregnancy as not related to suspect vaccine, considering the special case scenario. The causality of the event gas was assessed as unassessable due to lack of information regarding onset latency. The event Down syndrome risk identified on first trimester screen was assessed as not related to suspect vaccine, as there are no known biological mechanism due to vaccination and progressive age of the mother appears to be plausible cause of the event. The company assessed the case as serious (medically significant).
Red skin, rash, swelling and pain. Treatment: patient started BENADRYL and was advised to continue BENADRYL for few more doses and also advised to take ADVIL/Ibuprofen. Feeling a lot better.
Approximately 2:30 9/13 received DTaP, MMR , IPV. Woke up 9/15 with redness to left arm. Came to our office. Diagnosed with local reaction.
had my booster shot last Friday; woke up with severe pain in my lower back and in my sciatica; woke up with severe pain in my lower back and in my sciatica; in excruciating pain; Can't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 14Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose number 1 and 2), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Jan2022, outcome "unknown", described as "had my booster shot last Friday"; BACK PAIN (non-serious), SCIATICA (non-serious) all with onset Jan2022, outcome "unknown" and all described as "woke up with severe pain in my lower back and in my sciatica"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "in excruciating pain"; GAIT INABILITY (non-serious) with onset Jan2022, outcome "unknown", described as "Can't walk". The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: I just had my booster shot last Friday and now I have the worst side effect. Had to call EMS just to get me out of bed. They told me they have seen alot of this with the booster shot.
left arm swollen, red, pain, pictures were taken by parents and relayed to office for assessment. The red area was the size of a baseball in diameter, swelling was hard to assess based on the picture. Pt was seen in Urgent Care 8/16/19, was advised to use ice pack and give Tylenol or ibuprofen. Father called on 8/20/19 concerned about appearance. Another picture was received from parents. Dr assessed stating it appeared it was healing, redness was gone but peeling appearance around the edge of the initial redness noted the first day. Advised to moisturize by applying aquaphor or petroleum jelly
Rash on thigh. Given Benadryl 12.5mg IM.
Extreme fatigue beginning day 5 with extreme chest pain accompanied by sharp pain radiating beside left shoulder blade and left arm. Some jaw pain and nausea.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient did a blood work 2 weeks after taking the vaccine for the purpose of donating blood yet, she had no antibodies to the covid19 virus (suspected immunological vaccine failure.) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210411516-COVID-19 VACCINE AD26.COV2.S -Suspected Immunological Vaccine Failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than; administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than) and PRODUCT STORAGE ERROR (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than) and PRODUCT STORAGE ERROR (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than) and PRODUCT STORAGE ERROR (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No adverse events were experienced by the patient.
got a little slow after the shot; This is a spontaneous report received from a non-contactable reporter (consumer) for a Pfizer sponsored program. The reporter is the parent.  A 15 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administration date 22Dec2021 (Batch/Lot number: unknown) at the age of 15 years as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL IMPAIRMENT (medically significant) with onset 22Dec2021, outcome "unknown", described as "got a little slow after the shot". The patient had the shot yesterday and got a little slow after the shot. The patient's parent asked if it's a side effect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Pfizer Clinical Trials Contact Center. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm.  It was reported that patient interested in participating in this study since patient took rituximab and do not seem to have any spike protein antibodies, despite having two shots of the Pfizer vaccine in Mar2021 and Apr2021 of this year. Had a sore arm with both shots, felt tired and cold after second shot. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
pain in her stomach; This is a spontaneous report from a non-contactable consumer (patient's daughter). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration on 01Apr2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 for COVID-19 immunization (Brand: Pfizer biotech, Vaccine name: COVID 19, Dose: 1). The patient's concomitant medications were not reported. Patient got the Pfizer COVID vaccine, first dose on 11Mar2021, second dose on 01Apr2021, she started experiencing pain in her stomach. Pain in her stomach started 3 weeks ago on 06Apr2021 (reported as approximately five days after the second dose). The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient (Pt) developed skin rash that first started on March 30, Tues in the calf area of left lower leg. It was like little spots and red and there was a burning sensation in the rash area like on fire and was more significant in the evenings between 6 pm to about 9 pm for three days. Pt saw the doctor on April 2nd by when the rash was on both legs and spread to more area and now was more like a broader area/blotch flared up and red. Pt was using corticosteroid cream prior to the visit but no relief. Pt was prescribed Triamcinolone cream to apply twice a day & told it was contact dermatitis. Patient did not start any new detergents, soaps or foods when the rash started.