chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered the vaccine from a vial that was initially stored in the refrigerator on 01-Jun-2022/Dose administered after 30-day Use By Date; Administered the vaccine from a vial that was initially stored in the refrigerator on 01-Jun-2022/Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine from a vial that was initially stored in the refrigerator on 01-Jun-2022/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was initially stored in the refrigerator on 01-Jun-2022/Dose administered after 30-day Use By Date) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 067F21A and 067F21A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other products. The patient had no medical history related to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. The patient had not received any other vaccine within 1 month prior to administration of Moderna COVID-19 vaccine. It was unknown whether the patient was ever tested positive or diagnosed with COVID-19 or not.    On 09-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine from a vial that was initially stored in the refrigerator on 01-Jun-2022/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was initially stored in the refrigerator on 01-Jun-2022/Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine from a vial that was initially stored in the refrigerator on 01-Jun-2022/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was initially stored in the refrigerator on 01-Jun-2022/Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The date on which the vial was initially stored in the refrigerator was 01-Jun-2022. The patient was administered from a vial that was open on 01-Jun-2022 to the patient.  On 27-Jul-2022, the patient received first booster dose of Moderna COVID-19 Vaccine.  The vial had not undergone any temperature excursion.  The patient did not experience a similar event in the past and the adverse event did not cause the patient to seek medical care.  No treatment medications were reported.
pain in the neck/pain down her neck on her right side; hard for her to move it from side to side; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246; NDC number: Unknown; Expiry Date: Unknown) from an intramuscular route of administration via left arm on 02Feb2021 as single dose for covid-19 immunisation. Patient's medical history included ear ache in right ear and cold. She explained she did have an ear ache in right ear, she figured she must have had a cold. She was using ear drops and it just sort of went away. She clarified this was prior to the vaccine. It started over a week or 10 days ago, she guesses. She doesn't recall. She believes the ear ache was cleared by Tuesday before receiving the vaccine. The patient was received unknown concomitant medications. No other vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient experienced pain in the neck that makes it hard for her to move it from side to side and pain down her neck on her right side on 04Feb2021. The patient had the first COVID-19 shot last Tuesday evening and everything was fine. Probably on Thursday she started getting pain down her back, clarified as her neck, on her right side. Like, she can't hardly turn her head left or right without turning her whole body. Patient declined to include a healthcare professional for the report. She confirms she started having pain in her neck on the right side. She clarifies she had an ultrasound last Friday because they were concerned with her liver. They called that night and that was fine. However, Friday morning when she went in for that appointment, she really didn't have any pain in her neck. Therefore, it had to have been after. It must have actually started either Friday night or Saturday. Caller explains she paid no attention to the pain until yesterday so she thought she would call today. She was not sure about vaccination time stated had a 7 o'clock appointment, so maybe by 7:30-7:45PM. The outcome of events was reported as not recovered.
3-4d p/vax devel h/a assoc w/twitching of rt eye, followed by tingling parasthesia of rt arm;also had mild exacerb of asthma;
Moderna 5/6/21, 6/3/21. Positive on 1/12/23
Initial unsolicited report received from a consumer on 15 July 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of (Dtap) (batch number, route and site of administration were not reported) on unspecified date 11 years ago. On unspecified date after vaccination, the patient had an extreme reaction. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 15-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiation date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient reports lots of redness on lower extremities. event occurred around a week post-vaccination, and has lasted for 2-3 days so far. She states no swelling, not warm to touch, no irritation, and no itching. She reports feeling fine besides the redness on her legs.
Narrative: Pt reported no adverse effects from first dose on 02/11/2021, and said it was a delayed onset.
Patient experienced severe flu like symptoms to the point he was "unable to do much of anything." Patient is an MD, and took Acetaminophen for his discomfort. These symptoms lasted for 3 days.
Rash appeared from both wrists to about half of the arm. It doesn't hurt or itchy.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the left arm on 19Apr2021 at 15:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease and penicillin allergy. 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, losartan potassium (LOSARTAN/HCTZ) and thiamazole (METHIMAZOLE) for an unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 22Mar2021 at 15:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 22Apr2021, the patient experienced rash which appeared from both wrists to about half of the arm. It didn't hurt or itchy. The clinical outcome of the event rash appeared from both wrists to about half of the arm. It didn't hurt or itchy was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
UTI; This is a spontaneous report from a Pfizer sponsored program. The contactable male consumer reported for himself that: an unspecified age of male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via unspecified route of administration on 21Feb2021 as a SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Approximately on an unknown date in 2021, the patient he was diagnosed with UTI and will take antibiotics. The patient supposed to received second dose tomorrow (past 21 days). He enquired that, if it was ok to take antibiotics. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Patient has bruised area on lower area of upper left arm near elbow several inches from where her COVID vaccine was administered that began to appear 2-3 days after vaccination.  Area is bruised and dry with a small fold of skin covering the bruise (looks like you could tear off the skin like when you get a small cut and the skin is loose).  Patient's skin appeared dry in general but did not have any other areas where skin was loose or dead like it is near the site.  Patient reports area is painful to touch as well.  Per patient it has not worsened since she first noticed it but it has not healed.  Advised patient to monitor and seek care if area worsens. In addition patient reported being extreme dizziness and brain fog during the same timeframe and could not walk without support.
Painful, swollen lymph glands in left axilla & at site of injection swelling, redness & skin hot to touch. Approximate area on upper left arm 4 inches x 6 inches.
suspected vaccination failure; still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient was reporter's sister. The age at vaccination was not reported. The patient got the vaccine but she still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Muffled sound in the right ear, accompanied with light dizziness and sensitivity to sound in the right ear.
Both injections, feeling absolute crap; This case was reported by a other health professional via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (received 1st dose on an unknown date, refer case: US2021AMR222515).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the shingles vaccine. The shingles vaccine injections made the patient feeling absolute crap for a few days. The patient stated that it was much better than getting shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR222515:Same reporter.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: en5318), in right arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 43 years, in right arm, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Jul2022 as dose 4 (booster), single (Lot number: 006M21A) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "recovering" and all described as "tested positive for Covid-19". The event "tested positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: tested positive for Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 1/2 hours  after vaccination, developed swollen itchy eyelids (bilateral, upper & lower). Applied warm compresses, took Benadryl with relief of symptoms.  No difficulty breathing.  Took one more Benadryl 4 hours later prior to bedtime.
Copious amounts of nasal drainage, coughing, with copious amounts of sputum and tightness in chest. Treated with 0.3 epinephrine SQ; Benadryl 25 MG PO. Sent to Emergency Room.
Moderna COVID-19 Vaccine EUA dose given 57 days after BUD for refrigeration
Diarrhea  Narrative:  Abdominal cramping and watery diarrhea starting 2/9/2021 lasting until 2/19/2021. Did not require additional medical care, but patient was unable to work/carry on daily activities for approx 10 days following vaccination. Immodium provided moderate benefit but did not resolve diarrhea.  Other Relevant History:
PFIZER-BIONTECH COVID-19 VACCINE EUA.  Patient received vaccination on 2/10/21.  No adverse reactions reported following vaccination.  Patient had unplanned weight loss x 1 month of 14.1% and 6 month loss of 20.8% according to nursing nutrition notes. HT: 60in Wt 122lb. Patient died on 2/12/21.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAQUENIL S; LEVOTHYROXINE. Past drug history included: Minocycline, reaction(s): "known allergies: Minocycline", notes: known allergies: Minocycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received Anti-viral treatment of Paxlovid from 06Jul2022 to 11Jul2022 for the Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the drug's known safety profile, a possible contribution of the drug to the Drug ineffective and COVID-19 cannot be excluded.
Hypersensitivity reaction; Local tching/pruritus; hives at injection site/broke out in a rash and hives at the injection site.; Local Redness/erythema; rash at injection site/broke out in a rash and hives at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE PRURITUS (Local tching/pruritus), VACCINATION SITE URTICARIA (hives at injection site/broke out in a rash and hives at the injection site.), VACCINATION SITE ERYTHEMA (Local Redness/erythema) and VACCINATION SITE RASH (rash at injection site/broke out in a rash and hives at the injection site.) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Cefazolin - Asthma) since 2014, Sulfonamide allergy (Sulfa antibiotics - Rash), Allergy to intravenous contrast media (Iodine IV contrast - Asthma), Allergy to antibiotic (Gentamicin - Irritation), Allergy to vaccine, Osteoarthritis since 1984, Migraine headache since 1966 and Scoliosis. Concomitant products included AMLODIPINE from 2019 to an unknown date for Blood pressure management, TAMOXIFEN from 2014 to an unknown date for Chemoprophylaxis NOS, CICLOSPORIN (RESTASIS) for Dry eye, RANITIDINE from an unknown date to May 2021 for Esophageal reflux, MINOXIDIL for Hair loss, CIMETIDINE and TEMAZEPAM for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE PRURITUS (Local tching/pruritus) and VACCINATION SITE ERYTHEMA (Local Redness/erythema). an unknown date, the patient experienced VACCINATION SITE URTICARIA (hives at injection site/broke out in a rash and hives at the injection site.) and VACCINATION SITE RASH (rash at injection site/broke out in a rash and hives at the injection site.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE PRURITUS (Local tching/pruritus), VACCINATION SITE URTICARIA (hives at injection site/broke out in a rash and hives at the injection site.), VACCINATION SITE ERYTHEMA (Local Redness/erythema) and VACCINATION SITE RASH (rash at injection site/broke out in a rash and hives at the injection site.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: No specific follow-up information recorded. On 28-Jun-2021: Follow-up information received on 28 Jun 2021 included no new information.
Vaccination  site is swollen, red, and feels hot.   The site is approximately a 3 inch circle.
pt had fever, chills, disorientation, lethargy for 2-3 days following vax
10: PM Chilled hands and feet Overnight developed debilitating body aches, Headache Fatigue - slept for most of 24 hours. Resolved by evening 2/7. Total event lasted maybe 44 hours Treatment:  1 naproxin after 24 hours.
ADMINISTERED AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 54 year old male. 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 not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administered an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered an expired vaccine was not reported. This report was non-serious.
reoccurring gout; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Medical Information Team.  A 70 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown", described as "reoccurring gout".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. states after receiving the 2nd dose of Phizer 05/05/2021, started experiencing bruising around the injection site 05/08/2021, drowsiness, fatigue, eye fluttering, and hoarseness. All symptoms subsides within a week's time but hoarseness still continues on/off.
Information has been received from a physician concerning a 3-4 yr old pt who was vaccinated with a dose of varicella virus vaccine live (date unspecified). Subsequently, the pt was seen in the physician's office with a varicella-like rash <50 lesions. No further information was given. No product quality complaint was involved. Additional information has been requested.
This spontaneous report has been received from a Medical assistant and refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M040138, expiration date 28-SEP-2018 (dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measured a temperature of 8.6 Fahrenheit (F) for a total time frame of 20 minutes. The sterile diluent used to reconstitute vaccines was properly stored. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Discovered upon processing paperwork into system that patient was given Pfizer Bivalent as their 1st and 2nd dose (primary series)
Approximate 3 inch cirular red ?hot? spot  approximately 6 inches down from shot injection site in left arm. Starting around 3 pm  on Saturday after shot was given at 11 am on previous Wed. 04/14/2021.