chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy Type Sensory Reaction; 4 day she developed the shingles; She was so sick; she developed Spots on her chin and cheek leftover from the shingles; This is a spontaneous report from a contactable consumer (patients mother) or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on an unspecified date as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Mar2021, the patient underwent quantitative antibody lab tests included sars-cov-2 antibody after the first shot and the count results were 77.74 milliliters. Patient mother wanted to know how safe her daughter was because she could not get a second one as her doctors had told her she could not take the second dose. Patient never had Covid which reporter thanked God. Reporter stated that somebody had to have some data. 132 needed to donate convalescent plasma. On 23Jan2021, the patient experienced Bell's Palsy Type Sensory Reaction (always serious event) and 4 day she developed Spots on her chin and cheek leftover from the shingles. The events were considered as medically significant events. Reporter stated that she had an appt today with the dermatologist. They gave her almost like a bleaching thing and something for the itch. Patient mother stated that she had such a horrible, horrible reaction. The shingles and the way she reacted reporter thought she should have good antibodies. She was so sick the first 3 days and the 4 day she developed the shingles, bells palsy type reaction. Reporter got a table of all the companies that do the IGG testing and had gone to 7 doctors, 3 MRIs, 2 neurologists, her brain, cervical trigeminal nerve infectious disease and ophthalmologist. She further stated that there were other people getting these bells palsy type reactions. It was reported that they are all 27 (Patient) came out of it and patient left with spots on her face and her mother was grateful that she did not had nerve paralysis. Further reported that patient never had chickenpox. She was the first age group that got Varicella before kindergarten. She never got chicken pox so to get shingles and never had chicken pox, only 22% of the population gets that. 78% of the people that get the vaccine did not get shingles. But yet her antibodies for the varicella zoster was off the roof after the vaccine. IT was over 3000 and her face was proof of it. The outcome of Bell's Palsy Type Sensory Reaction was recovered on unspecified date and rest events was reported as unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Discharge Provider: MD  Primary Care Provider : DO    Admission Date: 6/13/2022 Discharge Date: 6/18/2022   Admitting Diagnoses: COVID-19  CONDITION ON DISCHARGE: Stable and improved. Home Health Care Svc    HOSPITAL COURSE:   Presented with malaise and fever and shortness of breation. Acute exacerbation or systolic heart failure with reduced ejection fraction, precipitated by covid.   Responded to diuresis and fluid restriction oxygen requirements reduced very quickly. Cough is an issue His baseline Creatinine is unknown, appears to be around 1.0 He had an AKI (cr 1.6) this admission (present on admission) that resolved with treatment. DM worsened by steroids. Recent vertebral fracture. He has history of gout and BPH.
Patient received a 3rd dose of Moderna vaccine on 09/01/2021. Patient passed away on 09/11/2021 from cardiac arrest.
Hep B Energix B Vaccination given, order clearly stated Pt. due for Hep A #2
Swelling with large knot under skin , shot site has red rash on top and painful. Chills and fever started around 5.00 pm through the night . dull headache . body aches.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no medical history and no prior pregnancies who on 22-MAY-2009 was vaccinated with the first dose of GARDASIL. On approximately 06-MAY-2009, the patient became pregnant, the patient was unsure of her LMP. On 24-JUN-2009, an ultrasound was performed for dating. The results showed the baby was 7 weeks and 6 days old, within normal limits. On 29-MAY-2009 the patient experienced headache and received MOTRIN 200mg daily for treatment. The LMP was on approximately 02-MAY-2009 and the estimated delivery date was on 04-FEB-2010. Follow-up information has been received from a physician via an Outcome Pregnancy Questionnaire. It was reported that the patient was vaccinated on 23-MAY-2009 (previously reported as 22-MAY-2009).  The patient was on therapy with prenatal vitamin since 29-JUN-2009 daily. On approximately 10-JUL-2009, the patient experienced Urinary tract infection (UTI) and vaginitis monilial. From 10-JUL-2009 to 18-JUL-2009, the patient was on therapy with MACROBID twice a day, for 7 days, for the treatment with UTI. On 10-JUL-2009, the patient was on therapy with TERAZOL, every night at bedtime for 7 days, for the treatment with vaginitis monilial. On 13-NOV-2009, the patient was vaccinated with a H1N1. It was reported that the patient had low risk for Down's syndrome, "occult 83" and Trisomy 18. The mom had a quad screen which was reported to be normal. On 26-JAN-2010, at 38 weeks of gestation, the patient delivered a normal male baby weighing 3093gram. The baby's birth length was 20 inches. The Apgar score is 9/9.The baby had no congenital anomalies or other complications/abnormalities. Additional information has been requested.
11/30/01 malaise , lightheaded, 12/1/01  no change, 12/2/01 stated slight cough,  12/4-12/6/01 hoarseness, chest congestion started 12/4 & cough productive (yellow-green) no F/U lump on neck since 12/6 R knee twisted in bed 12/6 better now. apparently better today. Treated for URI and released.
Diagnosed with Covid/tested positive for Covid on 30Mar2021 after receiving first dose of the Covid vaccine on 10Mar2021; Diagnosed with Covid/tested positive for Covid on 30Mar2021 after receiving first dose of the Covid vaccine on 10Mar2021; This is a spontaneous report received from a Pfizer Sponsored Program from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 10Mar2021 10:00 (Lot Number: ER2613) as SINGLE DOSE (at the age of 55-years-old) for covid-19 immunization.  The patient's medical history and concomitant medication were not reported. The patient did not receive prior vaccinations within 4 weeks.. The patient was diagnosed with Covid on 30March2021. She tested positive for Covid on 30Mar2021 after receiving first dose of the Covid vaccine on 10Mar2021. She was scheduled to receive her second Pfizer Covid 19 vaccine on 10April2021. She honestly thought it was allergies but she just wanted to be certain because she was supposed to go out of town for the weekend. She has not had another test. She was told not to come back for a repeat test. She has no symptoms and she is beyond her quarantine. She wants to make sure it is okay to get the second dose. The events did not require a visit to the emergency room. She went to the urgent care center. Treatment included she took over the counter medication; ibuprofen (ADVIL), guaifenesin (MUCINEX) and NetiPot. The patient underwent lab tests and procedures which included covid-19: positive on 30Mar2021.  Outcome of the events was unknown.
I started getting symptoms of UTI - I was treated with an antibiotic starting on 4/28/2021 - for five days. And then a few days later, it came back after I finished the antibiotic. I started on another antibiotic on May 8th. That took care of it. But after I finished with it, on May 19th, I had a fever that continued until May 24th. A urinalysis showed it wasn't UTI. No treatment.
Nine days after MMR vaccination the pt notes swollen glands, behind ears and posterior neck. 13 days after ?. 14 days after, the pt developed tightness and stiffness of elbows and knees.
I ended up having an adverse reaction to the shot per the ER provider. My body was trying fight it. I ended up not being able to breathe Sat, Sun, Mon and Tuesday. All with flu-like symptoms. Yesterday decided after calling off work Mon and Tuesday to go to the ER to see if they could help give me something to breathe. After 2 chest x-rays for pneumonia, nasal swabs for the flu, it all came up negative. Diagnosis: Bronchospasm, swollen lymph nodes. Treatment while in ER: Albuterol 5 mg once, ipratropium (ATROVENT) 0.02%, ketrolac (TORADOL) 60 mg, dexamethasone (DECADRON) 10 mg.
administered an expired Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ADXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 5th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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 patient inadvertently received an expired dose of Bexsero, which led to expired vaccine used. The reporter inquired if the patient needed to repeat the dose. The reporter did not consent to follow-up.
anxiety; hives; itching; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (age: 45; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced symptoms of hives, itching and anxiety on Dec2020. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Multiple pustules at site of inoculation spreading to Pt's neck, chest and arms. Sore throat with minimal exudate on (R) tonsil, difficulty swallowing, mild fever, rhinorhea. Anterior cervical lymph node TTP. Lung sounds clear bilat.
RASH; This spontaneous report received from a patient concerned a male 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: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported. On an unspecified date, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious.
they have given adacel to a patient instead of daptacel with no reported adverse event; they have given adacel to a patient instead of daptacel with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient and it was reported they have given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] to the patient instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-JUN-2023, they have given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] Suspension for injection(batch/lot number: 2CA18C1; expiry date: 29-Nov-2024; frequency= once; Strength = Standard) via intramuscular route in the left arm for prophylactic vaccination (immunization) to the patient instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] Suspension for injection with no reported adverse event (wrong product administered) (product dose omission issue) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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-2023SA191728:01662712
Hives like rash at day 3-4D, Fever day 5, Joint and muscle pain debilitating by day 5, Admitted to hospital 10-28-08. WBC 32,000, ESR 70 - 124, CRP 7.3.   1/26/09 Reiceived hospital medical records for 10/28-10/31/2008. FINAL DX: not available on d/c summary available Records reveal patient experienced migratory joint pain, fever & migrating pruritic rash.  Had recent strep throat.  Tx w/IV antibiotics, NSAIDS & antihistamines.  Improved by d/c to home on continued oral PCN & w/outpatient cardio & rheum consults.  2/3/09 Received Rheum & ID consults. Rheum consult of 11/14/2008: FINAL DX: arthritis, carditis, fever, ?Still's disease Records reveal patient exp (+)GABS 10/26 after rash developed on 10/24.  Rash has waxed & waned since.  Remained on PCN & NSAID.  Exam revealed swollen wrists w/decreased ROM.  Labs & x-rays ordered.   Patient was being f/u by cardio.  ID consult of 11/18/2008: FINAL DX: fever, arthritis, rheumatic fever doubtful Records reveal review of extensive medical records w/o definitive diagnosis.  Referred back to cardio & rheum clinics.
Patient received first dose of covid vaccine after having received treatment for covid-19 with antibodies and convalescent plasma on Dec. 28th, 2020. This is 89 days apart which is outside the guidance of the EUA. Vaccine administration was approved by Dr.
Around 5 a.m. the next morning, woke up with a fever. The highest the fever got was 101. Took Tylenol every 4 hours and fever remained 99. Woke up today, 4-9 with a really upset stomach and fever is still running 99
Approx. 12 hrs after immunization - fever 104, shaking chills, lethargy lasted about 12 hrs then improved.
Previously submitted- E# 730721 Updating with pt death 12/18/2021 :  Principal Problem:   Pneumonia Due To COVID-19
This spontaneous report as received from a non-healthcare professional concerning a 2 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 18-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N021720 with expiration date: 10-AUG-2019 (dosing details and route of administration was not reported), for prophylaxis. The sterile diluent (lot# R002715 with expiration date: 20-FEB-2020), used for reconstitution of the VARIVAX, was stored at the proper temperatures. No adverse effects were reported. The storage temperature was minus (-) 9 degrees Centigrade (C) to 8 degrees C for 8 minutes (multiple excursion). There was no previous temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter.
Myalgia, Arthralgia, painful/itching at injections site, fatigue Narrative:
symptoms of Bell´s Palsy; This case was reported by a other health professional via sales rep and described the occurrence of bell's palsy in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2019, the patient received the 1st dose of Shingrix. On 22nd January 2019, 4 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix at pharmacy. The patient had symptoms of Bell's Palsy. On 24th January 2019, the patient had a visit. The provider did not have a record of the vaccine's lot number and the patient has not visited or communicated with the office since the last visit.  No more information was known about the adverse events duration or outcome. The reporter did not give consent to follow up.
pt recv vax 20SEP96 & 4 to 5 wk later pt devel 3 dots located on ankle, knee & upper leg;
Sore arm at site of injection, lasting for 3 days Severe headache on the day after injection, lasting for 6+ hours Muscle pain/fatigue/nausea on the day after the injection, lasting 24 hours Two days after the injection, a mild headache, mild nausea lasting for 8 hours Two days after the injection, mild fatigue lasting for 24 hours
p/vax pt began to feel temp by 8:30PM temp, h/a & upset stomach;APAP & to bed 10PM up at 8:00 T102.5 more APAP slept until 3PM when woke w/T103.2;
I had upper respiratory infection few days after the vaccination date that lasted for 2 weeks. The infection was moderate in severity that I had to take a week off from work but I did not go to hospital. Then after 3-4 wks post vaccination (the third week of June) I started abdominal pain and diarrhea that was severe enough to cause me dehydration and hypotension. Till now (July 4-2021) I still have bouts of diarrhea and postprandial pain. I lost 6 pounds in the past 3 wks because I am avoiding food. I did go to hospital and I am being managed symptomatically at home.
This spontaneous report as received from a physician via a company representative refers to two or three patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the doses of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for the prevention of shingles. On unknown dates, the patients experienced a mild case of shingles. The outcome of mild case of shingles was unknown. The relatedness between the mild case of shingles and ZOSTAVAX was not provided. Additional information has been requested.
lung cancer; This is a spontaneous report from a contactable consumer or other non hcp.     A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3246), via an unspecified route of administration, administered in Arm Right on 27Jan2021 (at the age of 67-year-old) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included ongoing asthma (Verbatim: Asthma allergy), non-tobacco user (second hand smoke from her parents). There were no concomitant medications.  Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3246, Expiry date: unknown), via unspecified route of administration on 08Jan2021 (at the age of 67-year-old) in left arm for COVID-19 immunization. The patient experienced lung cancer on 19Feb2021.  The patient underwent lab tests and procedures which included CT Scan (computerised tomogram): unknown results (calcium score). Patient completed her Pfizer Covid 19 vaccine series in January. Patient developed lung cancer in February, has surgery with part of lung removed and reports being immunocompromised. unable to assess causality of developing cancer after receiving Pfizer Covid 19 vaccine series. Patient got her first two Pfizer COVID vaccines. She has questions about a booster and if she needs to get it.She was diagnosed with lung cancer after the vaccine. Her cancer was an incidental finding. It was lung cancer, and they took part of her lung out. Caller did not have a prescribing doctor. She got it at the hospital incase of a reaction. She got it at the (name). Her surgery was the 23Mar2021 to remove the cancer. She is sure its not related to the vaccine because it was right after. Her cancer was stage 1b. Therapeutic measures were taken with surgery on 23Mar2021 as a result of lung cancer. The outcome of event was recovered on unspecified date.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
About 5 minutes after receiving the vaccine I felt a rush of numbness/tingling/cold starting from my feet that worked it's way up to my head. Once the feeling got to my chest my HR increased.  Some SOA, suspected due to feeling of panic.  Feeling passed after about 3 minutes but kept coming back in waves about every 10-15 minutes.  Took Benadryl 25 mg at about 2:30 to see if it would help, symptoms calmed down at about 4:00.  The following morning on 1/30, the immediate symptoms had gone away.   By 1/30 evening, starting developing  constant numbness to BLE below knee. As of today, 2/4.  The numbness is still present.
First 24-48 hours: Riggers, 102 temp, myalgias, fatigue, tachycardia 2-4 days: Diarrhea, low grade temps, myalgias, fatigue and tachycardia  Day 6: new onset of hives all over body, in addition to fatigue and diarrhea
PATIENT was inadvertently given rotarix Intra muscular  , instead of orally
Left artificial knee swelled up; left knee caused pain; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP6955) via an unspecified route of administration in the right arm on 27Mar2021 at 14:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included naproxen (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN), all from unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route in the left arm on 07Mar2021 at 09:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 16:00, two hours after vaccine, the patient experienced left knee (artificial knee, six years ago in great shape), swelled up and pain that continued six days later use crutches on and off at the time of reporting, was improving every day. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event left knee swelled up and pain were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.