chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/21/04 Sore throat, abdominal pain, low grade fever. 10/22/04 Sore throat, abdominal pain, vomiting, petechial rash on legs. 10/23/04 Joint pain, purpuric rash; hospitalized at hospital. Henoch-Schonlein Purpura. Also seen in ED on 10/22/04.
Patient was given J&J vaccine 25 hours after vial had been punctured. The vial remained in the refrigerator. We followed CDC guidance to call manufacturer who did not provide clear guidance.  The health department advised NOT to revaccinate.
Pt mother stated that her leg was red and was itching a lot. Parent requested to bring child in for evaluation but declined.
Swollen itchy eyelids. Some throat irritation. Temp 97.1, P 88, B/P 112/74, Resp. 18. Decadron 40mg IM stat. Allegra 60mg daily x 10. Prednisone 10mg bid.
11:30 the night of vaccination I was woken up by my girlfriend because I had soaked the bed from night sweats. Nauseous but no fever. Was restless all night long. Began running fever about 0830 the next morning. Fever was consistently above 103 for 1-2 days. Fever peaked at 105 and I went to urgent clinic. Urgent clinic doctor prescribed steroid cocktail and symptoms subsided completely subsided within two hours.
hives; This is a spontaneous report from a contactable other healthcare professional. A 31-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the left arm on 31Jul2021 (batch/lot number and expiry date unknown) at 31 years of age as dose 1, single for covid-19 immunization in pharmacy or drug store facility. Medical history included anxiety, depression, recently postpartum, sulfa allergies. The patient was not diagnosed with COVID-19, prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Aug2021, the patient experienced hives. The event was reported non-serious. The event resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The patient received antihistamines and prednisone as treatment due to the event. The outcome of the event was recovering.  The lot number for bnt162b2, was not provided and will be requested during follow up.
25 minutes after administration of IPV and Hep A, patients whole body got stiffened.  No tonic/clonic convulsions.  Confused for 20-30 seconds.  Whole body lasted about 30 seconds.  Patient completely back to normal and wanted to act per mom.  Comment: Asked reporter to send original by mail since this fax is hard to read.
Severe shaking, headache, fever, nausea, exhaustion lasted for 3 days and still felt ill, but improved, on the 4th day.
Arm soreness, body aches, headache, fever of 99.6, fatigue
pt recvd vax & broke out in scattered hives in patches of legs & arms; no fever or pruritus but mom called MD who said it was from vax;
Patient presented to clinic two days after receiving influenze vaccination. Patient has a 9cm diameter erythema area around injection site to left arm.
Minor headache; This is a spontaneous report from a contactable other health professional, the patient. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 10:30 (Batch/Lot Number: EN6205) (at the age of 32-year-old) as 1st dose, single dose for covid-19 immunisation. Medical history included none and no known allergies. Concomitant medication(s) included omega-3 fatty acids; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) both taken for an unspecified indication, start and stop date were not reported and multivitamin (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Mar2021 17:15, the patient experienced minor headache. Therapeutic measures were taken as a result of event and included treatment with Advil at 2x 200mg. The outcome of the event was recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
sz, sl fever 15-16 hr p/flu shot; had hx of other sz problems;
Pain in arm. Been 2 weeks and getting worse.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 17Mar2021 at 16:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hereditary angio edema type 3, something similar to Parkinson's, very light asthma, penicillin allergy, and some unspecified fruits allergy. The patient did not receive concomitant medications. The patient previously received naproxen sodium (ALEVE), MOTRIN (composition unknown) both for an unknown indication and experienced drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced pain in arm. It was reported that it had been 2 weeks and was getting worse. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event pain in arm. The clinical outcome of the event pain in arm was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt is a 37 yo female who reported fatigue and drowsiness 5 mins after getting the Moderna vaccine.  Pt. did not report the effect until after 15 mins.  Monitored pt for extra 15 mins.  Gave pt a cup of water.   Pt here with a family member.  Pt was discharged after being monitored for a total of 30 mins.  Pt states that she is "fine".  Denied any fatigue or drowsiness.  Pt was advised to go to closest E.R if symptoms resumes.
Information has been received from a health worker referring to unspecified number of unspecified patients. On 11-MAR-2016, the vaccine of RECOMBIVAX HB had been previously excursion on -1.1 Celsius degrees for 3 hours and 45 minutes. On 12-MAR-2016, the vaccine had been previously excursion on -0.9 Celsius degrees for 10 hours and 31 minutes. On 13-MAR-2016, the vaccine had been previously excursion on -1.2 Celsius degrees for 12 hours and 4 minutes. On 14-MAR-2016, the vaccine had been previously excursion on -1.1 Celsius degrees for 12 hours and 38 minutes. On 15-MAR-2016, the vaccine had been previously excursion on -0.7 Celsius degrees for 10 hours and 54 minutes. On 16-MAR-2016, the vaccine had been previously excursion on -0.4 Celsius degrees for 4 hours and 39 minutes. On unknown dates in 2016, the patients were vaccinated with incorrectly stored RECOMBIVAX HB (dose and route were unknown, lot #: L027733, expiry date: 13-SEP-2017). No adverse events were reported. Additional information has been requested.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies or concomitant medications were not reported. On an unspecified date, the patient may have been vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, frequency and route were not reported) lot # M022077 with expiration date of 10-MAR-2019, for prophylaxis. No adverse effects were reported. The temperature excursion of the RECOMBIVAX HB was between 32 F and 36 F, for a time frame of 72 hours. No previous temperature incursion was reported and no data logger was involved. No product quality complaint was involved (PQC).  This is one of several reports received from the same reporter.   Additional information has been requested.; Sender's Comments:  US-009507513-1702USA010330: US-009507513-1702USA010334:
Patient vaccinated on Friday. On Saturday, the injection site was warm and hard. On Sunday, the injection site was red. Adverse reaction is now starting to dissipate.
healthy adult developed unexplained weight loss from 160 to 130 within 3 months of first Covid vaccine, serious symptoms seemed to accelerate after booster dose.  Sought diagnosis.  Diagnosed as LADA, adult onset Type 1.5 diabetes.  Tested positive for autoimmune beta cell antibodies.  Now insulin dependent.  no known Type 1 diabetes in family.
Very tired; chills; fever; Received dose 4; Received dose 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FF2589) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 05Apr2022 at 11:00, outcome "unknown" and all described as "Received dose 4"; FATIGUE (non-serious) with onset 06Apr2022 at 05:00, outcome "recovered" (Apr2022), described as "Very tired"; CHILLS (non-serious) with onset 06Apr2022 at 05:00, outcome "recovered" (Apr2022); PYREXIA (non-serious) with onset 06Apr2022 at 05:00, outcome "recovered" (Apr2022), described as "fever". Therapeutic measures were not taken as a result of fatigue, chills, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies.   Follow-Up: Follow-up attempts are completed. No further information is expected.
Fever over 105, chills, cough, soar throat. aches and pain for 2 days. Led patient to go to the ER on monday  4/12. MD found blood clot at that point. No treatment was given patient was told to follow up with her PCP.  Did not go to PCP as yet.
worsening migraines since receiving her first Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of migraine aggravated in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine.   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced migraine aggravated. On an unknown date, the outcome of the migraine aggravated was not recovered/not resolved.   It was unknown if the reporter considered the migraine aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced worsening migraines since receiving her 1st Shingrix vaccine. The reporter did not consent to follow up.
pt recvd vax & 4 hts later exp rash to legs & face anxiety & premature ventricular contractions which lasted 4 days;
About 2 weeks after receiving the Moderna Booster, I developed a hive like rash that comes and goes within minutes. The rash effects my arms, legs, trunk, scalp, ears. I break out in hives on very specific parts of my body and the hives resemble a streak like formation with red, itchy raised welts. My PCP prescribed me a steroid pack to start today as the rash has not resolved for over a week now and she feels it is strongly related to a reaction from the booster.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tender to touch on the injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 VACCINATION SITE PAIN (tender to touch on the injection site). At the time of the report, VACCINATION SITE PAIN (tender to touch on the injection site) outcome was unknown. Not Provided.
Approximately 2 hours after receiving the flu shot I began to have severe pain in my left arm at the injection site. This pain still hasn't gone away. It is affecting my daily life, it wakes me up at night, it limits my activities of daily living and my performance at my job.
No  adverse affects. Patient given Additional dose of Pfizer  after receiving  Moderna primary series for 1st and second doses. Patient requested to mix nd match to increase efficacy. Patient received Pfizer adult dose 0.3 ml as Additional dose. Patient has not received a Booster dose yet.
Patient reports swollen eyes, nausea, and felt like her tongue was swelling a few hours after receiving the vaccine. No hospitalization required. Patients eyes were swollen the next day when she came into the pharmacy.  She took an antihistamine this morning.
When our facility received the Covid - 19 vaccine, I spoke with Dept. of Health and was told that the exp. date for the vaccine was 9 months from the mfg. date on the box. Which made the exp. date 5/31/22. On 5/20/22  at the Dept. of Health contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 4/29/22. Thus, we unknowingly gave exp. vaccine to patient.  Patient tolerated vaccine well, no adverse effects have been reported.
Fever 101 & recurrent sz needed IV Phenobabital to stop sz & hospitalization for further management of sz & hyponatremia;
pt recvd vax;was lethargic,irritable,loss of appetite;T 102 PO;apap given, pt awoke from sleep,irritable; T 103;inc T over the week end;abdo pain,dec appetite;to see MD;
Administered Novartis H1N1 (4 yrs and older) vaccine 0.25mL IM, right deltoid. Should have given Sanofi Pasteur H1N1 (6 mo and older) 0.25 mL IM. No signs or symptoms distress noted.
pt recv vax 15AUG95 & 8PM that noc pt felt warm- on 16AUG woke up w/a fever of 103;c/o h/a, nausea & lethargic;no c/o soreness @ inj site;
Blood clots in lungs; This is a solicited report from a non-Pfizer sponsored program, from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (BMS) (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-087002), license party for apixaban.  This 71-year-old female patient was involved in a patient support program. The patient received APIXABAN. The report describes a case of PULMONARY THROMBOSIS (Blood clots in lungs). Co-suspect products included tozinameran (Pfizer Biontech Covid-19 Vaccine) for an unknown indication. On an unknown date, the patient started APIXABAN (unknown route), (unspecified dose and frequency). On an unknown date, the patient experienced PULMONARY THROMBOSIS (seriousness criterion medically significant). The action taken with APIXABAN(Unknown) was unknown. At the time of the report, PULMONARY THROMBOSIS outcome was unknown. The patient took Pfizer Covid Vaccine and developed blood clots in lungs. For APIXABAN(Unknown), the reporter did not provide any causality assessments. The primary reporter was non-health professional. The indication for apixaban was unknown. Follow-up is unable to be performed.  The reporter's assessment of the causal relationship of the event with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Agency medical evaluation comment: This patient had pulmonary thrombosis after receiving apixaban therapy along with co-suspect Covid-19 vaccine. Based on the limited information available regarding event details, relevant medical history, therapy details and indication, it cannot be ascertained with reasonable possibility that the suspect therapy contributed to the reported event.  Causality Assessment: The event thrombosis pulmonary was not related to apixaban per company (Bristol-Myers Squibb) and was no information per reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Pending the clinical course, temporal association, and relevant medical history, the company does not attribute the event pulmonary thrombosis to Pfizer suspected drug bnt162b2. The event is considered unrelated to apixaban by assessment.
Vaccine administered after 2 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received on 29-sep-2021 and has non significant information
Information has been received from a Registered Nurse (R.N.) concerning a 16 year old female patient with no pertinent medical history, who on "07 June or 08 June 2010", was vaccinated with a first dose of GARDASIL (Lot# unknown). The nurse reported that "after receiving the first dose of GARDASIL on 07 June or 08 June 2010, the patient passed out. Was also stated that the patient felt lightheaded so they laid her down and then on 07 June or 08 June 2010 the patient recovered". The patient sought unspecified medical attention. Additional information has been requested.
No adverse effects reported; improperly stored doses of PEDVAX HIB; This spontaneous report has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On unknown dates from September 2018 to October 2018, the patients were vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # N031492 and expiration date 31-MAY-2020, route, strength, dose and frequency were not reported) for prophylaxis. No adverse effects were reported.        The temperature excursion was 36 Fahrenheit to 46 Fahrenheit for 1 day, 6 hours and 33 minutes. Previous temperature excursion was 47 Fahrenheit to 77 Fahrenheit for 2 hours and 12 minutes. The call was because of a data logger.  Follow up information was received from the reporting physician on 24-MAY-2019 via an inbound call. It was reported that all telephone attempts to obtain follow-up information have been unsuccessful.
Chills, fever over 102.1 for 5 hours, extreme burning sensation in stomach, cramps in stomach for over 24 hours. Extreme fatigue for over 24 hours. Pain, soreness, and raised area at injection site.
Headache, body ache, itchy eyes and face, chills (no fever), extreme menstrual cramps labor pains or terrible menstrual pains - I was not on my period when vaccinated)
Got flu vaccine 10/28/08 @ 3pm.  Around 5 pm, felt nauseated; around 7:30 felt achy all over, especially shoulders and back.  Then had chills and shakiness, vomited 5-6 times. that evening.  Weak but much better next day did not go to physician.
This spontaneous report as received from a nurse practitioner via company representative refers to a 23 year old female patient. The patient's medical history and concurrent conditions were not provided. On an unspecified date, the patient started therapy with GARDASIL (intramuscularly, dose, frequency, lot/batch # were not provided). The patient was a virgin when she completed the GARDASIL shot series (on unspecified date, in approximately 2007). On an unspecified day, in approximately 2011, abnormal paps started. It was reported that in 2014, the patient had low grade for type 18. The patient was tested positive for HPV for type 18 in 2015 on an unspecified date (she had high grade for type 18), even though the patient completed GARDASIL shot series at age of 16. The test came back with cervical intraepithelial neoplasia (CIN) 2 and 3 on an unspecified date. The patient had a colposcopy on 27-APR-2015, the result was not provided. The patient was scheduled to have loop electrosurgical excision (LEEP) procedure on unspecified date. The outcome of the events was reported as not recovered. The outcome of drug ineffective was unknown. The relatedness between GARDASIL and the events was not reported. Additional information has been requested.
7 days p/vax pt devel chickenpox that consisted of cluster & pustules that were scabbing over.