chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case client was in attendance at Vaccine clinic on 3/3/2021.  After receiving the vaccine the client went into the monitoring area staffed by local EMTs.  She verbalized that she was having nausea and dizziness in waves, the EMTs gave her some juice and crackers, which did not resolve the issue.  Client verbalized that while being monitored her blood pressure was taken and was 200/100.  She denies any past/current health issues, takes no medication and has NKDA.  She was never had a reaction to vaccines in the past.  Client verbalized the feelings of nausea and dizziness occurred within 5 -10 minutes of receiving the vaccine.  She was transported via squad to the local hospital due to her blood pressure continued to rise.  During transport she reports a BP of 224/120.  Case client was monitored in the ED for approximately 2-3 hours and reports was given no medications or fluids, just monitored.  Her BP returned to a level that the hospital felt comfortable releasing her to go home.  This PHN followed up with the client the next day - on 3/4/2021 case client verbalized she went ahead and took the day off of work to rest, only complaint was a sore arm.  Nausea and dizziness has resolved, and denies any headache or chest discomfort. PHN encouraged client to go to her follow up appointment with doctor as scheduled and they should discuss together the risks and benefits of  receiving 2nd dose of the COVID Vaccine.  Case client verbalized understanding and declined any questions or concerns.  Case client received Moderna COVID19 Vaccine Lot #30A21A.
COVID Vaccine breakthrough case. Pfizer 4/3/21 EL3249, 2/10/21 EM9810 and boosted 10/25/21 EW0150 and 7/19/22 FP7139.
pt seen on 28JUN96 AM & given vax;pt devel small separate rose pink spots on upper thigh area bilat
Patient felt light-headed about 15 minutes after shot. She stood up and fell. A gentleman caught her so she wasn't injured. She said she was hot. She said her heart wasn't racing. I took her pulse and it was normal.
Noticed tingling in palm of left hand shortly after receiving vaccine.  There was pain radiating down left arm, numbness of fingers and weakness in left hand.  These synptoms continued into 10/15/2010 with additional fingers swelling, the veins in the left arm were bulging.  These symptoms continued 10/16/2010 and 10/17/2010 the symptoms subsided Monday 1018/2010. the patient didn't seek any medical treatment due to the inability to pay the co-pay.
After the date of application of the vaccine, I took an ibuprofen pill, which was the first reaction of knowing that she had anaphylaxis, later, I took an ADVIL pill, which gave me the same reaction, which before the vaccination was never present. The 2 times I took those medications and went to the Emergency Room in which I was administered epinephrine. I couldn't or had no help knowing what caused me to become allergic to these medications, yet on 6/20/22 I went to the Emergency Room again for shrimp. The truth is that this time it was something more serious to the point of paying attention and asking for help for my condition, which I really know was after I had been given the vaccine.
I had a sore arm and brain fog (really couldn?t think effectively for 4 days after my vaccine.)
Swelling at the vaccine site at upper left arm. Bruised feeling at site. Approximately 4 hours after the injection. General achiness and malaise this morning
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Malaise) and HEADACHE (Headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) injection for an unknown indication.    No Medical History information was reported.   On 29-Oct-2021, the patient started INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On 29-Oct-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021 at 8:00 AM, the patient experienced VACCINATION COMPLICATION (Malaise) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION COMPLICATION (Malaise) and HEADACHE (Headache) to be possibly related.    No treatment drugs were reported. No concomitants were reported.   This case was linked to MOD-2021-370379 (Patient Link).
pt brought to ED 11/23/21 after multiple falls at home; increasing SOB (on O2 2L via NC at home) with slightly productive cough; 11/23/21 pt test negative for COVID; has UTI; right middle lobe pneumonia; given ABX; 11/27/21 pt tested positive for COVID; using O2 supplement; pt became pulseless and expired in the hospital
Chills, fever of 101.7, nausea, fatigue , body aches. lasted for 24 hours
This child had a rash on her head (pustular lesions), face, arms,and trunk. Her face was swollen, low grade temp 98.5 (ax), itching. Onset this AM. Given a prescription for Atarax and recommended Aveeno baths.
Telephone call from parent - reports child c/o pain left arm + shoulder since vaccine on 1/13/2009 to day of call 1/16/09 - Parent reports relief with Tylenol. 1/20/09 - called parent  this am child fully recovered 0 pain.
This spontaneous report was received from office manager regarding a 6 month old female patient. The patient had no medical history, concomitant medications and drug reactions/allergies. On 17-FEB-2016, the patient was vaccinated with a dose of VAQTA, 0.5 ml, intramuscularly, lot # L015460, expiry date: 13-APR-2017, instead of RECOMBIVAX HB due to a clerical error. The patient did not seek medical attention. No treatment was given and no lab studies were performed. The nurse who administered the vaccine was no longer practicing at facility so the reporter was unable to verify it the two products were confused. They did not realize the error had been made until 16-AUG-2016. It was not specified how they caught the error. No product quality complaint (PQC) involved. Additional information has been requested.
IMMUNE SYSTEM HAD FALLEN AND DID NOT RESPOND AS WELL; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (IMMUNE SYSTEM HAD FALLEN AND DID NOT RESPOND AS WELL) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 26-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNODEFICIENCY (IMMUNE SYSTEM HAD FALLEN AND DID NOT RESPOND AS WELL) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (IMMUNE SYSTEM HAD FALLEN AND DID NOT RESPOND AS WELL) had not resolved.            No concomitant medications were reported.  The daily dose of Moderna COVID-19 Vaccine was given as (1 in 1 Once).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for the event of IMMUNE SYSTEM HAD FALLEN AND DID NOT RESPOND AS WELL with HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB)was not provided.  No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning an elderly female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Immunodeficiency, which occurred on an unknown date after a dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab (Humira) for unknown indication. Patient reported immune system had fallen and did not respond as well. At the time of the report, the event had not resolved.. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning an elderly female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Immunodeficiency, which occurred on an unknown date after a dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab (Humira) for unknown indication. Patient reported immune system had fallen and did not respond as well. At the time of the report, the event had not resolved.. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Tested positive/COVID 19 (fever and sore throat); intestinal issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 18:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 19Sep2023, outcome "unknown", described as "Tested positive/COVID 19 (fever and sore throat)"; GASTROINTESTINAL DISORDER (non-serious) with onset 19Sep2023, outcome "unknown", described as "intestinal issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19, gastrointestinal disorder. Additional information: Had covid vaccine on Monday 18Sep2023. On Tuesday 19Sep2023 began fever and sore throat plus intestinal issues, tested positive. Took Paxlovid for next five days (19Sep2023 to 23Sep2023). Better on 29Sep2023. Symptoms (fever, intestinal issues) returned today 30Sep2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Vaccinated 02/05/21  reports felling unwell though no specific symptoms until  02/13/21 developed red rash on forehead and eye swelling.  02/21 Reports blister and gum swelling and shortly later developed abdominal cramping and diarrhea 5-6 times.  Felt shaking and nauseous. Went to the ER treated with IV fluids, ativan and zofran. Improved. Headache 02/22/21 resolved following day. Feels now back to normal 02/23 since receiving the vaccine.
TIGHTNESS IN THROAT; DRY TONGUE; DRY COUGH; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-APR-2021, the subject experienced tightness in throat. On 10-APR-2021, the subject experienced dry tongue. On 10-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tightness in throat, dry tongue, and dry cough. This report was non-serious.
Dizzy, full body sweat, temporary loss of hearing and sight. Symptoms came on 1 minute after injection and lasted for 20 minutes. Lingering ringing and dizziness 24 hours after.
Patient is a 3y 10m old boy with history of ashtma/RAD as per mother's history, asthmatic, he is healthy. 10/23/09 at around 4-4:30pm-received his 1st H1N1 flu shot-left thigh and seasonal flu shot-right thigh. 10/24/2009 at around 3pm-mom noted that he is limping more on the left leg. Mom was thinking that probably the injection sites were bothering him. Limping got progressively worse. 10/30/2009- does not stand up nor walk anymore needs to hold on to the wall to get his toys, drags his feet at times. 11/3/09- seen at the clinic and appears well physical exam-normal limit tap tendon reflexes except for some weakness of lower extremities- probably gait, seems to fall and needs to be supported at times. Denies any fever; URI symptoms, vomiting disorder, dypenia drainage this entire period. Patient was admitted to hospital for further work-up. 12/11/09 DC Summary and hospital records received for DOS 11/03-11/07-09 Pt. presents with weakness and pain in both lower extremities one day after flu vaccinations in both extremities. Neuro consult , lumbar puncture, physical therapy and occupational therapy consults obtained. Improvement  in mobility and walking on discharge. DC Dx: Right lower leg weakness resolving.
pt diaphoretic w/pallor & feeling faint 3-5 mins p/vax; hypotensive, drowsy & nauseated; given Epi, DPH & taken to ER by rescue squad-pt examined & released;
Developed localized pruritic induration and erythema to distal arm and elbow, approximately 5 days after Anthrax #2 injection. Rash location separate from injection site.
ADMINISTERED VACCINE AFTER IT WAS AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS BUT LESS THAN 6 HOURS; This spontaneous report received from a pharmacist concerned a 25 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 023A21A expiry: 23-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced administered vaccine after it was at room temperature for more than 2 hours but less than 6 hours. The action taken with covid-19 vaccine  was not applicable. The outcome of administered vaccine after it was at room temperature for more than 2 hours but less than 6 hours was not reported. This report was non-serious.
diarrhea; felt all over crappy; weakness; fatigue; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FEELING ABNORMAL (felt all over crappy), ASTHENIA (weakness), FATIGUE (fatigue) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C(2/Z)1A -cllr unsure of letters) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported by the reporter.  Concomitant products included LOSARTAN, SPIRONOLACTONE, ATENOLOL and ROSUVASTATIN for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), FEELING ABNORMAL (felt all over crappy), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), FEELING ABNORMAL (felt all over crappy), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) 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 treatment information were provided.   This case was linked to MOD-2021-240538 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Fallow up received and contains no new information.
15 minutes after shot, felt high for about an hour; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (15 minutes after shot, felt high for about an hour) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced EUPHORIC MOOD (15 minutes after shot, felt high for about an hour). At the time of the report, EUPHORIC MOOD (15 minutes after shot, felt high for about an hour) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication or treatment information was provided.   Reporter did not allow further contact
I took at home test and tested positive for COVID-19. I had sinus and chest congestion. I also had fever, coughing, headache, and diarrhea. My doctor prescribed me Paxlovid and my symptoms lasted for a couple weeks.
he experienced atrial fibrillation; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete but manufacturer unknown), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "he experienced atrial fibrillation". Clinical course: It was reported that the patient was healthy. After the patient took the Bivalent booster dose he experienced atrial fibrillation.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the reported event atrial fibrillation 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.
Incorrect vaccine given to patient. Pt received IPOL and Pentacel which has IPV as well. Pt received duplicate vaccine administration.
Patient being vaccinated with a dose that expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 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.   On 15th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Twinrix and Twinrix 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the registered nurse. The reporter stated that, the patient was vaccinated with a dose of expired Twinrix vaccine, which led to expired vaccine used. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
5 days after injection noted onset of L sided facial pain along distribution of trigeminal nerve. progressive severe pain, and then on day 11 post vaccination blisters formed. diagnosed with herpes zoster (shingles) of the trigeminal nerve.
Patient is 32.6 weeks pregnant, she received adacel on 09/06/2019 and previous dose  of Adacel was on 08/19/2019. Estimated due date 10/30/19.
ADMINISTRATIVE ERROR.  PATIENT WANTED SHINGRIX VACCINE. SHE CAME WITH 3 KIDS THAT WANTED FLU VACCINE.  WHEN FAMILY WALKED INTO THE IMMUNIZATION ROOM, PHARMACIST VERIFIED WITH HER THAT ENTIRE FAMILY IS GETTING FLU SHOT.  SHE CONFIRMED.  AFTER FLU SHOT ADMINISTARATION SHE SAID THAT SHE WANTED SHINGRIX SHOT AND THAT SHE CONFIRMED IT INORRECTLY BECAUSE KIDS WERE ARGUING AT THE TIME WHO WILL GET FIRST SHOT.  ADMINISTERED CORRECT SHINGRIX VACCINE IN SAME LEFT DELTOID.  ADVISED PATIENT TO WAIT 15 MINUTES NEAR PHARMACY TO OBSERVE FOR ANY ADVERSE EVENTS.  NONE WERE OBSERVED. SHE LEFT.
No adverse event; 9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date).    It was reported that patient received other vaccine 4 weeks prior to covid-19 vaccine.   Concomitant product use was not provided by the reporter.  It was reported that The Pharmacist had a CDC site visit on 16-May-2023 where it was determined that 9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date. The vaccine was delivered to the hospital on 20-Sep-2022. 5 Patients received the vaccine on 14-Nov-2022, 2 patients received the vaccine on 15-Nov-2022 and the other 2 patients received the vaccine 22-Dec-2022.  Treatment information was not provided.  This case contains information about patient 7th out of 9 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-725025 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725025:Master case
patient was given past time of preparation, expired at 3 AM and was injected at 10 AM