chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for an unknown indication.    No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient experienced VOMITING (Vomiting) (seriousness criterion hospitalization). At the time of the report, VOMITING (Vomiting) outcome was unknown.            No concomitant medications were reported. The patient had her covid booster dose and was hospitalized due to vomiting. On 15-Sep-2021, patient received booster dose of Moderna COVID-19 Vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of IMBRUVICA as per reporter for event vomiting was no reasonable possibility. No treatment medications were reported. 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.  Company comment-This spontaneous case concerns an elderly  female patient of unspecified age with no medical history reported, who experienced the unexpected serious (hospitalization) event of Vomiting on an unknown date after third dose of mRNA-1273 vaccination. Patient had received 1st and 2nd doses of same vaccine at an interval of one month and third dose six months later. Patient was hospitalized due to vomiting after booster dose. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns an elderly  female patient of unspecified age with no medical history reported, who experienced the unexpected serious (hospitalization) event of Vomiting on an unknown date after third dose of mRNA-1273 vaccination. Patient had received 1st and 2nd doses of same vaccine at an interval of one month and third dose six months later. Patient was hospitalized due to vomiting after booster dose. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
No adverse event. Patient was only 15 at the time of the injection and Moderna is only approved for 18 and older and we were advised to complete a VAERS form regardless of whether an adverse event occurred.
parents re port that sometime following immun the pt cried cont for 12 hrs; pt was evaluated by ER;
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 10-NOV-2012 19:36, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
feeling itching and redness on the same arm as injection was given; feeling itching and redness on the same arm as injection was given; feeling itching and redness on the same arm as injection was given; feeling itching and redness on the same arm as injection was given; This is a spontaneous report from a contactable 86-year-old female consumer reported that she received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EN5318), via an unspecified route of administration on 30Jan2021 at single dose in deltoid left for covid-19 immunization. The patient medical history and concomitant medications were reported. On 07Feb2021, she experienced feeling itching and redness on the same arm as injection was given and the injection was on the left side in the shoulder area. The patient took an allergy tablet and it put her to sleep and she took Benadryl, and it helped the itching, but it put her to sleep too. The outcome of the events was resolving.
Pt's son and primary caregiver noted  "rash" on 12/4. He had last changed her pajamas on 12/2 and had not noted the rash at that time. After NP exam on 12/5/22, pt diagnosed with severe case of herpes zoster to T6/T7 dermatome on the right side (beneath right breast around to the back) and likely vasculitis (discrete rash to entire body including neck, face, and pubis, sparing only palms of hands and soles of feet).
Breakthrough COVID-19 case.  8/22/21: Patient arrived at the ER due to nausea, decreased appetite, SOB, cough. Patient tested positive for COVID on 8/22/2021.  Diagnosed and treated for acute hypoxic respiratory failure and viral pneumonia due to Covid 19. Improved and discharged on 8/27/21. Note: patient previously vaccinated with Pfizer COVID-19 vaccines: first dose Pfizer vaccine on 3/31/2021 Lot # ER8735 and the second dose on 4/21/2021 Lot # ER8731.
Pfizer lot #FJ6369 with temp excursion. Reported to Pfizer company an ok'd for use. Instructed by their staff to report each dose given in this system.
Red, raised, hot area 4" x 2", distal left upper arm with another red, raised, hot area, 1 3/4" x 1 3/4" around injection site.
After she went to bed she felt like she might have had a slight bit of swelling in the lower lip area and upon awaking in the morning she noticed her whole face was puffy.  No problems with swallowing, speaking, reading, no chest pain, or shortness of breath.  She called Dr's. office and she was brought into the clinic for an appointment.  Dr. prescribed a Medrol dose pak, told her to take Claritin, Allegra or Zyrtec and also Ranitidine daily to help with the reaction.  If she noticed any difficulty with breathing or symptoms get worse she was directed to go directly to the Emergency Room.
I was approached by LVN and RN who informed me that they had both vaccinated the same patient at different times.  Each nurse had documentation that each had administered 0.1mL Jynneos (Lot #: FDP00013) ID to the same patient.  Both nurses stated that Pt sat down at their table to be vaccinated with a card showing that he had not received any previous Jynneos doses.  Each nurse vaccinated  the Pt, documented everything in Epic, then approached me at approximately 1215 hours when they found the problem.  Pt has not be able to be reached; phone call was attempted multiple times, but each time disconnected without voicemail availability.
Few small, flat, red spots on arms, trunk and legs.  Not itchy. Employee saw his PCP and dermatologist. Today spots are increased in number and itchy.  Employee will call and obtain a clearance from dermatologist to work.
PA reporting a dose of TENIVAC was inadvertently administered to a 4 month old, with no Adverse Event; Initial information received on 25-Jan-2022 regarding an unsolicited valid  non-serious case received from health professional.  This case involves a physician assistant (pa) reporting a dose of tenivac was inadvertently administered to a 4 month old, with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT  with Standard strength (unknown: formulation) at dose 0.5mL once via intramuscular route in the left thigh (lot U6831AA, expiry date: 25-Jan-2022) for Immunization.  On 25-JAN-2022 (latency same day), the patient developed a non-serious pa reporting a dose of tenivac was inadvertently administered to a 4 month old, with no ae (product administered to patient of inappropriate age) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  At time of reporting, the outcome was Unknown for the event pa reporting a dose of tenivac was inadvertently administered to a 4 month old, with no adverse 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.
On 9/17/03 @ 1pm administered Hepatitis B Vaccine(2nd series dose #2). On 10/1/03 the patient reported experiencing flu like symptoms approx 4-5 hours after receiving the vaccine on 9/17/03. His symptoms consisted of body aches, fever 101.0, & fatigue. Symptoms lasted approx 2 days. Symptoms treated with advil and rest. However, not sure how long his fever lasted because he only checked it at the onset of his symptoms. Please note: The Hepatitis B Vaccine Series was being repeated because the patient had an equivocal titer 3 months after completing the first series. Patient states his symptoms were severe and therefore has declined to complete the vaccine series at this time.  Vaccination Record:  1st Series  Hepatitis B Vaccine dose #1 given 8/21/02 Hepatitis B Vaccine dose #2 given 10/8/02 Hepatitis B Vaccine dose #3 given 3/31/03  HBSAB titer 7/2/03 Equivocal  2nd series  Hepatitis B Vaccine dose #1 given 8/13/03 Hepatitis B Vaccine dose #2 given 9/17/03
day one   3 hours after vaccine   dizziness, headache, fatigue.   day 2   migraine, vomiting, photophobia, nausea w/vomiting, fatigue and muscle aches.   two episodes of facial, arm and leg numbness, top of head hurt to touch, ear and teeth sensitivity only on right side.  Day 3  migraine, nausea, photophobia, fatigue, decreased vision due to swelling of cornea.   Day 4  tiredness, symptoms diminishing, right eye blurriness, cotton wool spot right eye retina up to current, getting smaller in picture taken at eye Doctor as of 2/3/21.  right side tooth sensitivity and ear ache to date.
Pt. received Tdap on 4/4/13 came back to clinic with complaint of full arm edema, (+) FROM, slight redness at deltoid.
DARK SKIN CANCER RASH/LICHEN PLANUS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-NOV-2021, Laboratory data included: Biopsy (NR: not provided) lichen planus. On an unspecified date, the patient experienced dark skin cancer rash/lichen planus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dark skin cancer rash/lichen planus. This report was non-serious.
I had chest pain and some SOB when I walked around. These lasted for about 3 days. I went to the ER on Nov 18th. They did chest x-ray, normal results. They also did blood work, normal results. They told it was a reaction to the vaccine.
BODY ACHES; MIGRAINE; RESTLESS IN BED; SHAKING CHILLS; FEVER; This spontaneous report received from a patient concerned a patient 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, migraine, restless in bed, shaking chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, and the outcome of shaking chills, body aches, fever and restless in bed was not reported. This report was non-serious. This case, from the same reporter is linked to 20210436881.
Doses administered past 30 day beyond use date; doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) and PRODUCT STORAGE ERROR (Doses administered past 30 day beyond use date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) and PRODUCT STORAGE ERROR (Doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. 16 patients were administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period. Dates of administration were 3-MAY-2022, 4-MAY-2022, 9-MAY-2022, 11-MAY-2022, 17-MAY-2022, and 20-MAY-2022. Treatment medication was not reported.
Patient is a 32-year-old female new patient 5 months post partum & currently breastfeeding, with seasonal and perennial allergic rhinitis and history of childhood asthma, referred by the emergency department to discuss anaphylaxis like reaction to the Johnson Johnson COVID-19 vaccination on 4/28/21.  She received her vaccine around 2:00 p.m. She began developing itchiness in her palms/soles of feet and scalp that quickly developed into a a welt like rash about 3-1/2 hours after receiving the vaccine while on a walk with her husband; this was shortly followed by facial swelling over her right eye.  They made it home and she got in a cold shower to cool down, became dizzy, started seeing spots and had difficulty breathing. Her husband called EMS and she was hypotensive when they arrived.  She was given 2 doses of epinephrine (0.2 mg each per ED note) and a dose of Benadryl which helped. Shortly after the 2nd dose, she began having difficulty swallowing, maintaining the ability to breathe through her nose. She was given a 3rd dose of epinephrine and transferred to the ED; during transport an IV was started with an epinephrine drip. She was seen at Emergency Department; she was given IV fluids, solu medrol, tryptase level and had a normal EKG.  She was discharged with an epi pen prescription. Tryptase is still pending at the time of her visit. She started a new prenatal vitamin at 11 am 4/28/21. Otherwise, she reports no new foods, medications or topical products. She did eat before going on a walk, pepper jack cheese, wheat thins, and black bean hummus. She is pretty sure she was not stung by a bee prior to onset of symptoms yesterday.   Interestingly she reports recent urticarial episodes that occurred in February of 2021. These occurred when she was visiting her in-laws and occurred in the middle of the night, 2 nights in a row during the middle of her visit.  She has never had hives previously.  She reports no family history of hives or anaphylaxis.  She reports no use of new topical products or medications.
One month after vaccines, hospitalized with pneumonia and paralysis waist down. Physical therapy in rehab. center for 4 weeks; continue home therapy for 6 weeks. (10/10/11 vaccine date)
Client presented for 1st dose Moderna Covid Vaccination.  She was vaccinated without incident.  Observation area reported that as client walked into observation area she fainted and was caught by staff.  no injuries noted or complaint of pain.  BP 100/60 P 54. Client lain down. Provided juice, water and crackers.  Client left after 45 minutes stating she felt "fine."
None.  Pt. received PEDIARIX and RECOMBIVAX HB (single dose) on 11-12-08
Developed left arm pain and swelling after 1st vaccine in left shoulder. Persisted longer than previous reactions. Found to have blood clot in left brachial vein on 4/15/21 on ultrasound after evaluation by me
Pt was scheduled for second dose of Pfizer (peds) on 12/11/2021. She was accidentally given an adult dose of Pfizer instead. No known adverse effects.
renal failure & post infect glomerulonephritis exp by pt who recvd flu vax;
mom noted swelling, redness;seen by MD noted large 5x4inch area on lt thigh w/some induration? reaction vs infect started on Cefzil 250 BID x 5 days;
From OHS: Lymph nodes, pain in shoulder, lumps in groin area, is not sure if it is related. Noticed these symptoms since the injection. Did have a fever after the vaccine. Second dose was almost 2 weeks prior. Patient received #2 1/21. Had fever, fatigue, HA x24-48 hours post vaccine that have resolved.  Localized injection site pain and induration L deltoid have decreased. PMH: R rotator cuff tear with surgical repair 2/2020.  Since 1/27, c/o severe pain in R shoulder radiating to right neck w/ possible muscle spasms.  Patient feels pain is localized to the trapezius muscle. Denies numbness, tingling, weakness in RUE. Patient spoke w/ PCP yesterday and was prescribed Flexeril. Patient has taken Flexeril without relief of pain. PCP rec MRI if no resolution of R shoulder symptoms. Patient has appt with Ortho surgeon 2/9. Rec patient f/u with PCP for medical management and try to get sooner appt with Ortho if possible. Denies f/c, chest pain, SOB, cough, fatigue, diarrhea, ansomia, sinus congestion, rhinorrhea, sneezing.
Fever up to 104.3F Taken Orally from the date of vaccination to 2 days later. Children's Tylenol was given.
Stomach and sternum pain fatigue vomiting lots of vomiting and has had vomiting everyday 3-4 sometime 10 times a day ever since for the past 2 years she has been to multiple hospitals and doctors and specialist she has been put on several different medications that do not calm it down she carries a bucket around at school she missed more days from school then she went all dr excused because that's how many times I have had to take her to the doctor and nothing is helping her she was a very healthy athletic girl that didn't miss school until a few days after she received the injection she has been fatigued and sick every single day since we did not finish the injections because I new that what made her sick I took her back to the same dr a few days later and told them that's what made her sick and they said it couldn't have and no one told me that I could report it and I no they didn't report it because they said I was wrong but Im not wrong I know what made my child sick Im very worried about my daughter and I want someone to give her something that reverses the injection right away because its ruining my daughters life I want someone to call me and tell me what Im supposed to do to help her now.
6 months post shingles vaccine, I began to feel multiple pain issues - sharp pain at bottom of buttock/top of thigh, burning in both shins, tingling in one foot, pain in abdomen and genitals. Weakness lasted for 5 months. I have recovered from weakness but pain persists. Spine MRIs negative. Blood tests and lumbar puncture show acute inflamation.  Neurologist believes I had a viral infection in my spinal cord. Pain is being treated with lyrica.
17 year old daughter received the first dose of the vaccine; Soreness in arm; Slight headache; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the first dose of the vaccine), VACCINATION SITE PAIN (Soreness in arm) and HEADACHE (Slight headache) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the first dose of the vaccine), VACCINATION SITE PAIN (Soreness in arm) and HEADACHE (Slight headache). On 14-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the first dose of the vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness in arm) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment was provided.
None- vaccine given 17 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (batch number- ER8732) on 29-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 17 days post expiry) 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 information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Patient received monovalent COVID vaccine as a booster when direction is to give only bivalent vaccines as a booster. No adverse reactions occurred.
Upon arrival for second dose of Moderna Covid19 vaccine patient reported a rash at injection site that appeared one week after injection (injection date was 6/2/21), the rash went away after a few days. She was told by the immunizing pharmacy to report back if this occurred again. Patient called 6/4 (2 days after her second vaccine) to report a rash at injection site and a swollen/painful lymph node in the armpit of the injected arm.
Patient was not old enough to receive the flu shot and was given by mistake. Patients physician spoke with parents and assured them no harm would come from vaccination. No treatment at this time.