chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They've tested positive on Covid-19 last 14Feb2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients. This is the 2nd of 2 reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 11Feb2021 (Lot number and expiration date was not reported) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient reported they've tested positive on covid-19 on 14Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Feb2021. The 2nd dose will be scheduled on 04Mar2021. They are asking if they still need to take the 2nd dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021214002 different patient, same event and drug.
Pain behind eyes; Headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Pain behind eyes), HEADACHE (Headaches) and NAUSEA (nausea) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057620A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), OXYBUTYNIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced EYE PAIN (Pain behind eyes), HEADACHE (Headaches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, EYE PAIN (Pain behind eyes), HEADACHE (Headaches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient reported pain to workplace nurse the day after vaccination. Stated the pain kept him from being able to sleep that night. Patient was counseled to try a pain reliever such as ibuprofen or TYLENOL to see if that helped as injection site pain is a common side effect for the first day or two after vaccination. Patient was counseled to seek medical attention if pain lasted longer than that. On 10/23/2018 pt. reported that he still had pain at the injection site and pain with active range of motion. He can lift arm at chest level but has a lot of pain if he tries to go above that. On 10/30/18 pt. still has pain at injection site when he touches it, but he's not having pain all down his arm anymore. He feels like pain has moved because now it hurts him more in the front of his shoulder but only at night. He wakes up due to the pain. He does get relief by taking ibuprofen. Patient rates pain as 4/10. He states he doesn't notice it much during the day, just at night. Patient was again referred to his doctor for evaluation.
Roughly 6 hours later, I came down with a fever of 101, chills, sweats, shivering, body aches, and a horrible headache.
tender and sore injection site, unable to use injection arm. Severe diarrhea, vomiting, body and muscle aches, migraines, nausea from approximately 9 am following day throughout post injection day 5
Toughness; A rash that develop in chest, shoulder and mainly in chin, jaw and ear and somewhat on the face; Felt mild flushing (like a warm and flushing through the body); This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Felt mild flushing (like a warm and flushing through the body)), UNEVALUABLE EVENT (Toughness) and RASH (A rash that develop in chest, shoulder and mainly in chin, jaw and ear and somewhat on the face) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa) and Drug allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), LETROZOLE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced FLUSHING (Felt mild flushing (like a warm and flushing through the body)). On 08-Jan-2021, the patient experienced UNEVALUABLE EVENT (Toughness) and RASH (A rash that develop in chest, shoulder and mainly in chin, jaw and ear and somewhat on the face). At the time of the report, FLUSHING (Felt mild flushing (like a warm and flushing through the body)), UNEVALUABLE EVENT (Toughness) and RASH (A rash that develop in chest, shoulder and mainly in chin, jaw and ear and somewhat on the face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient developed syncope approx. 10 min  after receiving the vaccine and felt like he could vomit.  EMS was called and he refused to go to hospital.
Patient came in for a 1 month office visit on 10.7.21, patient was due for Hep A, Mennigococcal, and Tdap vaccines. Patient was given Hep A, Mennigococcal, and Dtap vaccines. It was discovered today, 10.15.21 that she was given the wrong vaccine (Dtap instead of Tdap), I first contacted the health department and they informed me patient would need the correct vaccine charted, I spoke to our VFC rep, and she informed me that is not the case, I will need to make a medication error report per Health center's policy and make a report to VAERS. That the patient was just given a stronger dose of diptheria than that is required for patients age. The tetanus part of either vaccine, Tdap or Dtap is the same strength/concentration, so patient is still covered. I informed pateint's mother of the incident. RN
Approximately 5 minutes after receiving vaccination patient fell out of chair onto floor and was breathing but unresponsive to pharmacist.  Patient opened eyes and was fully alert with in a couple of minutes of passing out.  Patient waited for another 30 minutes, had someone come pick him up, and stated he felt fine.
BREAKTHROUGH COVID 19 INFECTION. MILD URI SX DX ON DAY 2 OF ILLNESS. REGEN-COV OFFERED BUT HAS NOT BEEN ADMINISTERED AS OF DATE OF REPORT
Pt recvd vax 9AM on 20AUG92 pt began crying 12:30PM; this was a high pitched cry that lasted for 2 hrs; mom could not console pt; pt felt warm;
No adverse event.  Patient was administered Covid-19 vaccine on 6/8/2022 and the vaccine expired on 6/3/2022.  Scheduled for revaccination.
Have been taking flu shots for at least 31 years. This time I developed heart arrythmia, PVCs, pounding in my chest and carotids. had an urgent visit to the PCP with vitals, lab work and heart tracing/telemetry reported as normal. Now 2 months later, I am beginning to feel well. I believe the flu shot caused all this. I will either not take the shot in the future or will request the low dose vaccine if I can talk myself into it.
Patient having shortness of breath, then co-worker noted silver dollar size localized red circle at injection site. Shortness of breath worsened, went to ER, treated with zantac, prednisone and albuterol. Discharged home. Next day reports redness on arm diminishing, but now has rash to face.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with doses of (Oka/Merck) VARIVAX, (dose, frequency, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was filled. Follow up information has been received from 07-APR-2015, it was reported that the freezer in which the vaccines were stored went through "an auto defrost". There were no adverse events. On the same day 07-APR-2015, follow-up information has been received from Healthcare worker who provided patients' identifiers. This report refers to a 4 year old patient, who on 27-FEB-2015, was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, 0.5 ml (route was not reported), lot number as K011801, exp. date: 21-AUG-2016. This is one of several reports received from the same source. Additional informatiton has been requested.
Swelling of hands, feet, and some of face. When I saw the pt  her face had resolved but her hands and feet were slightly swollen. Her hands were swollen to the point where her rings were tight and her feet were swollen to the extent that her shoes were tight but she was able to wear them. I saw her 3 days after her vaccine
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 32-year-old female subject who was vaccinated with FluLaval vaccine during an unspecified trimester of pregnancy. The subject's medical history included "a tattoo just above the injection site". On 06 November 2006 the subject received unspecified dose of FluLaval at an unspecified injection site. On or after 06 November 2006 and on or before 08 November 2006, less than one week after vaccination with FluLaval, the subject experienced injection site redness. The reporter noted that the subject has a tattoo just above the injection site. The healthcare professional reported that the subject was pregnant at the time of the FluLaval administration. The trimester of pregnancy, date of last menstrual period and estimated date of delivery were not reported. At the time of initial reporting, 08 November 2006, the injection site redness was ongoing. The healthcare professional considered the injection site redness to probably be related to vaccination with FluLaval.  Follow-up information was received from the reporter on 02 March 2007.  The subject's medical history included one previous pregnancy that resulted in spontaneous loss.  Concurrent medication included prenatal vitamins (Duet with DHA) one soft gel tablet daily beginning 29 March 2006.  There was no evidence of a defect from a prenatal test.  This was a normal conception.  On 29 November 2006, at 18 weeks and six days of gestation, the subject gave birth via normal vaginal delivery to a female who weighed seven pounds, three ounces, was 21 and a half inches in length, and had a head circumference of 12 and a half inches.  No birth defects were noted.  Follow up information was received on 05 March 2007 via a reporting nurse, who noted that the subject was 27 years old and was vaccinated during the third trimester of pregancy at an employer's health clinic.  The subject's last menstrual period prior to vaccination was 02 March 2006.  On 06 November 2006, the subject received 0.5 cc of FLULAVAL (intramuscular) in the left deltoid.  The subject had a tattoo "just below" the injection site.  Two days after vaccination with FLULAVAL, on 08 November 2006, the subject developed an area of redness at the injection site that was approximately "one and three-quarters inches wide by three-quarters inches".  The patient did not complain of itching or burning, and the injection site was checked by the nurse daily until the redness resolved completely on 15 November 2006.  In the nurse's opinion, the injection site redness was related to vaccination with FLULAVAL.
This spontaneous report received from a pharmacist regarding patients of unknown demographics. The pharmacist reported a temperature excursion which resulted in GARDASIL, (lot number and expiry date were unspecified), injection for VAQTA (lot number and expiry date were unspecified) and RECOMBIVAX HB (lot number and expiry date were unspecified) being not supported. The reporter stated that there was a potential that the unsupported products might have been administered post excursion, but he was not sure and did not currently have any additional information to provide. Concomitant medication was unspecified. No adverse effects provided by patients. No product quality complaint involved. Additional information has been requested.
Next morning from vax he woke up with excruciating pain in left arm, screaming at top of lungs, crying hysterically, curled up in a fetal position, could not move or use the arm at all. Could not go to school. The area where vaccine was given was mottled light colored mottling. Very slight swelling. Called his pediatrician that morning and was told to take Advil and ice it. The severe event subsided gradually in next 24 hours. After about 2 weeks he mentioned that his vaccine site still hurts rated 6/10 at times. Then he did not talk about it for like a month, then he brings it up again stating his arm pain never quite went away since the vaccine. Then here recently, he started complaining of 6/10 pain daily, worse at night. His left arm feels heavy and fatigues on activity such as coloring or shading in colors. His left arm hurts and fatigues when he has to write on the whiteboard at school. He said the pain and weakness, when it comes is starting to depress him as he fears it is permanent. Now I am concerned, since he brings it up daily. I will be scheduling a doctor appointment for an assessment. He also complains of tenderness at the injection site.
Approx 30 mins after rcving vaccines patient became itchy all over body, eyes red and watery and skin red. Patient given 50 mg BENADRYL and stabilized, no add'l SE.
My Mom took it and still got it/Suspected vaccination failure; Got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My Mom took it and still got it/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's children via interactive digital media. The patient took shingles shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Fever and lethargy. Reported 102 degrees fever per mom. No fever at 12/16/13 visit.
Trigeminal Neuralgia; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration in Arm Left on 24Feb2021 at 09:30(at the age of 43 years old) as 2nd dose, single dose for covid-19 immunisation at Health Clinic. Medical history was none. Known allergies was none. Other vaccine received in four weeks included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration in Arm Left on 03Feb2021 as first dose, single dose for covid-19 immunisation. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication. The patient was not tested covid prior to vaccination. On 25Feb2021 at 20:00 the patient experienced trigeminal neuralgia. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Reporter reported as, "Doctor suspects a diagnosis of Trigeminal Neuralgia. Referred to a neurologist for confirmation and treatment plan". Therapeutic measures were taken as a result of trigeminal neuralgia. Treatment received as, medication to help with inflammation and pain. The patient was not tested for covid post vaccination. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Took a blood test / there were / no antibodies to Hep B (low titers); but no antibodies to Hep B (low titers); This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 67-year-old male patient who received HAB (Twinrix) (batch number 9RT94, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) (batch number 3PP42, expiry date 16th March 2022) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) (batch number H4A37, expiry date 18th October 2021) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2020, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 17th September 2019, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 17th August 2019, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 26th March 2021, 405 days after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 556 days after receiving Twinrix and Twinrix Pre-Filled Syringe Device and 587 days after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced therapy non-responder and hepatitis b antibody negative. On an unknown date, the outcome of the therapy non-responder and hepatitis b antibody negative were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The caller was patient himself. On 26th March 2021, the caller reports his HCP took a blood test and reported there were antibodies to Hep A, but no antibodies to Hep B (low titers), which led to therapy non-responder and hepatitis b antibody negative. The caller does not give permission to contact HCP. The reporter did not consent to follow up.
mom states rash began shortly p/vax given;below site of inj lt deltoid muscle;rash was gone next AM but reappeared that afternoon;
Presented to office 10/12/07 complaining of severe left shoulder pain which started around 10/6.  Blisters on arm appeared 10/8 in dermatomal pattern.  Diagnosis:  shingles.  Treated with Valtrex 1000mg tid for 7 days and pain medication.
Client and Mom left after immunization, a few minutes later came back to clinic. Mom stated pt started coughing and Mom noticed client had redness to throat and chest area. SOB noted. Oxygen per 6 liter per mask. Benadryl 25 mg IM to left thigh. Epinephrine 0.2 ml to left arm SQ. Tourniquet to left and right arm 5 minutes each then release. 911 called, taken to hospital.
Pt experienced HA, chills, vomiting, hot flashes, fever, for approx 2 days. Now (?) HA Exam unremarkable, Symptomatic (?), Fluids, pain meds.
Patient presented to the ED on 8/30/2021 with shortness of breath that started the previous day.   Prior to admission, she was on chronic steroids (prednisone 10 mg daily) for COPD.  She was also on CPAP at night prior to admission, but on room air during the day.  Upon admit to ED, she was started on 3L of oxygen, increased steroids, and remdesivir x 5 days.  She was also started on antibiotics due to concern for bacterial infection given history of COPD and multiple antibiotic courses in the previous 5 months.  She was eventually weaned off oxygen during the day and discharged home.
PAIN, WEAKNESS, NUMBNESS & TINGLING FROM WAIST DOWN TO LOWER EXTREMITIES. PROGRESSED TO PARALYSIS FOR 48 HOURS.  GRADUALLY REGAINED NORMAL FEELING.  6/10/08 Received d/c summary from hospital. FINAL DX: lower extremity pain/weakness; inflammation left shoulder injection site. Record reveals patient improved significantly by day after admission & was able to ambulate w/o difficulty & only slight thigh discomfort.  Patient was d/c to home with f/u by neuro./ss  4/11/08 Reviewed hospital medical records of 2/12-2/14/2008. FINAL DX: none stated.  No d/c summary available.  Admit dx: possible GBS. Records reveal patient experienced pain in bilateral thighs, difficulty walking, extreme fatigue, paresthesias of LEs & weakness starting approx 3-4 hours after vaccination.  Seen at Urgent Care facility & referred to hospital.  Then admitted to ICU until able to be transferred to higher level of care.  Neuro exam on admit WNL w/good reflexes & sensation.
30 minutes post vaccine, pt had c/o throat fullness. Pt states that she has a history of allergies to various things that will cause a ''pinchy tight throat'' but allergy medication has always cleared it in the past.  Pt was given 1 25mg pill of Benadryl at 10:57am.   BP at 11:00am 145/80. Pt was kept for observation on cot for 30 minutes.   BP at 11:26 128/78.   11:30 Pt left clinic ambulatory, stating throat felt better and had no distress. 02/04/2021 telephone call to patient for follow up. Pt states that she feels fine but that she took a second Benadryl at home 6 hours after the vaccine because ''throat still didn't feel quite normal''.
Myasthenia gravis; This is a literature report.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "sinus tachycardia" (unspecified if ongoing); "multiple hospitalizations" (unspecified if ongoing); "hospitalized" (unspecified if ongoing), notes: twice. The patient's concomitant medications were not reported. The following information was reported: MYASTHENIA GRAVIS (hospitalization, medically significant, life threatening), 48 hrs after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Antibody test: negative; negative; Anti-muscle specific kinase antibody: negative; Computerised tomogram head: unrevealing; Computerised tomogram thorax: normal; Electromyogram: demonstrating moderate-to-severe electrical decrem, notes: ents in extremity and bulbar muscles; Serology test: negative, notes: MG; Spinal X-ray: unrevealing. Therapeutic measures were taken as a result of myasthenia gravis.; Sender's Comments: Based on the available reported information, the causal association between the event myasthenia gravis and the suspect drug BNT162B2 cannot be excluded. 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.