chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness; Chills; Headache; Muscle pain; Joint pain; Fever; Nausea; Feeling unwell; Decreased appetite; Diarrhoea; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Oct2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease, high blood pressure (HBP), back surgery, cancer, arthritis and chronic pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included hydrochlorothiazide (HTZ) (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIPINE), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously took pethidine hydrochloride (DEMEROL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date at 08:00 and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number; UNKNOWN) via an unspecified route of administration in the left arm on 12Feb2021 at 08:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 19:00, the patient experienced tiredness, chills, headache, muscle pain, joint pain, fever, nausea, feeling unwell, decreased appetite and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tiredness, chills, headache, muscle pain, joint pain, fever, nausea, feeling unwell, decreased appetite, and diarrhea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Woke up at night with severe nausea and vomiting (one episode).  Woke up again later in the night attempting to vomit but dry heaving. Felt feverish, chills, decreased appetite for following 2 days.  Missed work due to feeling unwell, but was able to eat and drink without emesis.
I had fever and chill the whole day on the next day of the vaccination (01/12/2021).  It started in the early morning.  I took 500mg of Tylenol twice on that day to stop the fever.  I had upset stomach on the following day(01/13/2021).  I didn't take anything for that, just drank more water.  I had back shoulder pain on the next day after the stomach upset(01/14/2021).  I tried warm pack and pain patch.  One symptom a day and it was last the whole day.  It took three days for the symptoms to go away.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-DEC-2015 at 00:41, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.4 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Two loose bowel movements/diarrhea; Nausea; large area of redness; aches; itching/terrible itching; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching/terrible itching), PAIN IN EXTREMITY (sore arm), DIARRHOEA (Two loose bowel movements/diarrhea), ERYTHEMA (large area of redness) and MYALGIA (aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010921A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Animal bite (Bitten by rabbit at the age of 6). Previously administered products included for an unreported indication: RABIES (states that she was bitten by a rabbit skunk that had rabies when she was 6 years old).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (itching/terrible itching), PAIN IN EXTREMITY (sore arm) and MYALGIA (aches). On 01-Apr-2021, the patient experienced ERYTHEMA (large area of redness). On 02-Apr-2021, the patient experienced NAUSEA (Nausea). On 03-Apr-2021, the patient experienced DIARRHOEA (Two loose bowel movements/diarrhea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1/3 of a benadryl pill. At the time of the report, PRURITUS (itching/terrible itching), PAIN IN EXTREMITY (sore arm), DIARRHOEA (Two loose bowel movements/diarrhea), ERYTHEMA (large area of redness), MYALGIA (aches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No new information was provided in follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-Jun-2021 contains no new information.
Pt has had intermittent intensity of numbness but still has from and normal strength in (R) deltoid where pt was given Hep A.
caller says that fluzone hd was given to patient instead of flublok with no reported adverse event; Initial information was received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA294386(CLUSTER).  This case involves 61 years old female patient who reported that caller says that influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] was given to patient instead of influenza quadrivalent recombinant vaccine [Flublok] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Sep-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot UT8104BA, Expiry date : 30-Jun-2024, Frequency : once, formulation, strength was unknown) via intramuscular route in the left arm for Immunization and influenza quadrivalent recombinant vaccine (dosage, formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  . On 21-Sep-2023 the patient reported that caller says that fluzone hd was given to patient instead of flublok with no reported adverse event (wrong product administered) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event caller says that fluzone hd was given to patient instead of flublok with no reported 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.
I woke up feeling like I had the flu, I ached all over and thought I actually caught the flu. I waited a few days but it didn't go away. I went to the doctor. I felt better in about 6 days.
Covid19 breakthrough. 1st vaccine received on 11/05/2021 while pt in jail. 40 y/o presents to ED with overdose.  Roomates found pt unresponsive and performed CPR.  Upon arrival, EMS found pt apneic with pulse and administered mult doses of Narcan on route to hospital.  Pt vomited.  Room air sat 76% and pt placed on 15 L NRB.  CXR consistent with aspiration.  Started on IV ABX.
Pt became unresponsive and appeared to be having a seizure and then she became conscious again and vomited. Pt was sent via ambulance to the ER for further evaluation.
Tinnitus, began immediately after dose 2 and still have it more than a year later.
it was rpt fr MD concerning pt w/history of neg varicella titers on  2separate occasions in 95 & in 1996 & on 22jan99 pt began to devel vesicular lesions which devel in a unilateral dermatomal distr, moderate pain & dx w/herpes zoster
Injection site burning hot to touch; Pain up to the neck; Stinging when receiving vaccination; Itchy; Red patch at injection site; Painful; Red patch at injection site; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Injection site burning hot to touch), NECK PAIN (Pain up to the neck), PAIN (Stinging when receiving vaccination), VACCINATION SITE PRURITUS (Itchy) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (ESCITALOPRAM AL) for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE WARMTH (Injection site burning hot to touch), NECK PAIN (Pain up to the neck), PAIN (Stinging when receiving vaccination), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Red patch at injection site), VACCINATION SITE PAIN (Painful) and VACCINATION SITE ERYTHEMA (Red patch at injection site). The patient was treated with HYDROXYZINE at a dose of 25 mg and CYCLOBENZAPRINE at a dose of 10 mg. At the time of the report, INJECTION SITE WARMTH (Injection site burning hot to touch), NECK PAIN (Pain up to the neck), PAIN (Stinging when receiving vaccination), VACCINATION SITE PRURITUS (Itchy), HEADACHE (Headache), VACCINATION SITE RASH (Red patch at injection site), VACCINATION SITE PAIN (Painful) and VACCINATION SITE ERYTHEMA (Red patch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.   About 3 days later, the patient noticed a red patch at the injection site that became itchy, painful, and also burned. She felt pain up to the neck and injection site was burning hot to touch. She reports stinging when receiving vaccination. Reported that doctor thinks it was injected to nerves.
tightening of my chest and throat, wheezing, swelling and irritation in back of tongue and lips, rash/ skin bloching on face and chest bilaterally, injection site swelling and redness.
1st arm pain and slight fever, body aches. At this time, fever of 101.8 with excedrin, severe fatigue, arm pain, and body aches, especially spine and joint pain. It feels like I took another covid shot. I have slept for 5 hours today and i will go back to sleep as soon as i finish. Higher fever started at 1100.
Pt was mixing a new vial of smallpox when the syringe was removed from the vial some of the liquid squirted into her face.
Passed out; Chills during the night; Weak/weakness; Fever in the morning; Nausea; fatigue; dose 1 on 16Feb2021 15:00 and dose 2 on 05Mar2021 15:00; dose 1 on 16Feb2021 15:00 and dose 2 on 05Mar2021 15:00; This is a spontaneous report from a contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 (lot number EN6200) on 16Feb2021 15:00 and dose 2 (Lot Number: EN6198) on 05Mar2021 15:00 both via an unspecified route of administration in arm left as single dose for COVID-19 immunisation. Medical history included allergy to Thimerosal. The patient was not pregnant at the time of vaccination. Concomitant medication received within 2 weeks of vaccination included estradiol (ESTRADIOL TRANSDERMAL) 0.05 mg per day, Multivitamin and colecalciferol (D3 5000). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Symptoms after the second vaccine on 06Mar2021 04:00 included chills during the night, weak, fever in the morning, fatigue. Took 2 extra strength Tylenol at 9:00 am, back to bed. Up at 12:00 pm and overwhelmed with weakness, nausea, passed out, when she woke up she was laying on the floor. She did not know how long she was out, but she did not think it was more than 5-10 minutes. No treatment was received for the adverse event. The outcome of events chills, weakness, nausea, passed out, fever and fatigue was recovered, other events was unknown.
Mother reported to office on 02/12/04 that child had fever 105.5 per ear thermometer on the evening of 02/10/04 after immunizations that day.  On 02/13/03 continued with temperature 101.1 rect, not drinking/eating well, had nasal congestion and pharyngitis.
oN Sunday, January 10  I started having chills and fever around 12:30 pm.  My  fever got up to 101. I took aspirin and fever went away.  I experienced symptoms for about 4 fours.  I have been fine since then.
SWELLING OF THE FACE; This spontaneous report received from a consumer concerned a 68 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-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced swelling of the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the face. This report was non-serious.
Patient was administered Pfizer vaccine on 1/16/2021 and then was administered Moderna vaccine on 02/09/2021. Patient believes she received Pfizer for second dose of COVID vaccine when she came to the pharmacy on 10/12/2021 to receive a COVID booster vaccine. However, records show that patient received Moderna on Immunization Consent Form. Pharmacist was told by her Pharmacy District Manager, to give Pfizer for the COVID booster vaccine since she started with Pfizer for the first dose and to fill out a VAERS and incident report with pharmacy.
Patient developed urticaria within an hour of leaving our office. Was given oral anti-histamine when family called back for advice. No further progression that evening but woke up with hives in other places. Rechecked in office on 5/19 with urticaria noted to extremities and face. No oral mucosa or airway involvement. Was also seen evening of 5/19 at local ER due to concern with possible lip swelling.
Initial misuse report received from a healthcare professional on 19 March 2013. A patient (No information was provided regarding the patient) was administered expired dose of MENOMUNE vaccine. No adverse event was reported. List of documents held by sender: none.
patient received pediatric dose of 0.2ml.  should have been given adult dose of 0.3ml
Patient inadvertently received Moderna as second dose when it should have been Pfizer.  Patient responded yes when he asked if he was there for his second Moderna shot.  Several quality checks have been implemented, but we still missed it. Pfizer 1st shot - Lot# EJ1686 on 1/5/2021 Moderna 2nd shot - Lot# 025J20A on 1/27/2021
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 18-MAY-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M043306, expiration date: 24-APR-2018) diluted with sterile diluent (manufacturer unknown) (route of administration and frequency were unspecified) for prophylaxis. No adverse effects were reported.  The vaccine was exposed to a temperature range between 6 and 14 Fahrenheit degrees, for a timeframe of 1 hour and 15 minutes. There were no previous temperature excursions or a data logger involved. No product quality complaint was reported. Additional information has been requested.
Swelling is still there under her arm; Arm was sore; Extra dose administered; Off-label; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, Batch/Lot Number: 30130BA), Solution for injection, via an unspecified route of administration, administered in Arm Right on 14Sep2021 between 10:30 and 11 am (age at vaccination 64-year-old) as single dose for covid-19 immunisation. Medical history included Blood pressure high and may be little obesity. Concomitant medication included lisinopril taken for hypertension 30 mg once a day, carvedilol taken for hypertension 25 mg once a day and amlodipine taken for hypertension 5 mg a day. Patient did not receive any other vaccine within four weeks of receiving Pfizer vaccine. No additional vaccines were administered on same date of the Pfizer suspect. Patient received her first dose of the Pfizer COVID vaccine was on 07Mar2021 (batch lot number: EN6206) administered in her right arm and received her second dose of the Pfizer COVID vaccine was administered on 30Mar2021, (batch lot number EP7533) administered into her right arm for covid-19 immunisation. On 14Sep2021, patient received extra dose which was off label. On 15Sep2021, her arm was sore and had swelling and was puffy under her armpit. As per the report, patient received her booster dose of the Pfizer BioNTech Covid 19 vaccine on 14Sep2021. Yesterday her arm was sore and had swelling and was puffy under her armpit. It was staying about the same but the swelling was still there under her arm today. No relevant test was performed. Patient did not visit to emergency room or physician office due to adverse events. At the time of this report, the outcome of swelling was still there under her arm was not recovered and other events was unknown.
Dizzy; First dose 8-Feb-21 and second dose 16-Mar-21; Rash after getting second dose COVID-19 dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), RASH (Rash after getting second dose COVID-19 dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 8-Feb-21 and second dose 16-Mar-21) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, 1st injection (1 in 1 Once). On 13-Apr-2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, 2nd injection. In March 2021, the patient experienced RASH (Rash after getting second dose COVID-19 dose). On 16-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 8-Feb-21 and second dose 16-Mar-21). In 2022, the patient experienced DIZZINESS (Dizzy). In 2022, DIZZINESS (Dizzy) had resolved. At the time of the report, RASH (Rash after getting second dose COVID-19 dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 8-Feb-21 and second dose 16-Mar-21) outcome was unknown.      Formulation for HUMIRA was reported as Solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality with HUMIRA for event dizziness was reasonable possibility.  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.
Mother called @ 10 am 6/24/09 to say pt had large reddened area on R upper arm ~ about 4" in triangular shape - indurated and sensitive to touch. Center of reddened area appears fluid filled. Has had moderate fever since evening of 6/22.
Patient selected that he is immunocompromised or have a heath condition that causes a week immune system,. He was supposed to receive a 3rd dose of Moderna (0.5ml) but instead he was given a booster (0.25 ml)
Moderna vial was first punctured on 2/3/22 6 pm (room temp) and was to expire at 6 am on 2/4/22. Patient recevied an adminstration of booster dose from this vial at noon on 2/4/22
pain during the injection, described by him as a 6 on a scale from 1-10 (10 being th worst); This spontaneous report was received from a patient's mother who is a company representative and refers to a 12-year-old male patient. His medical history, concurrent conditions and concomitant therapies details were not reported.  On 20-OCT-2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On the same date, the patient experienced pain during the injection, described by him as a 6 on a scale from 1-10 (10 being the worst), which resolved 5 minutes post injection.   The causal relationship between the event and suspected vaccine was not reported.
Soreness at site of injection - 6/17/09 2hrs. Body ache and joint pains 6/18/09. High fever.
Seizure like activity, not responsive to verbal stimulus, loss of eye contact, lethargic, uncontrollably crying, diagnosis of global developmental delay and autism at 18 months.
Reaction to IPV, DTaP, HBV L thigh. presence of small ystic lesion on thigh. Pediarix was used on to immunize the pt.
Big itchy rash at injection site; Injection site hot to touch; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Big itchy rash at injection site), VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE PRURITUS (itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE RASH (Big itchy rash at injection site), VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE RASH (Big itchy rash at injection site), VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.