chrisvoncsefalvay/vaers-outcomes huggingface dataset:
13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613), via an unspecified route of administration, administered in arm left on 28Mar2021 at 12:00 as single dose for COVID-19 immunization. Medical history included breast cancer from 2013 and blood cholesterol increased. The patient had allergy to sulfa. The patient previously received first dose of bnt162b2 (lot number: EN6202), in left arm on 07Mar2021 at 15:30 as single doses for COVID-19 immunization. Concomitant medication(s) (received within 2 weeks of vaccination) included atorvastatin, colecalciferol (VITAMIN D [COLECALCIFEROL]), ascorbic acid, betaine hydrochloride, boric acid, calcium carbonate, calcium citrate, calcium lactate, calcium pantothenate, calcium phosphate, citric acid, colecalciferol, copper gluconate, cyanocobalamin, folic acid, fumaric acid, magnesium aspartate, magnesium oxide, malic acid, manganese aspartate, menaquinone-7, nicotinamide, oxogluric acid, phytomenadione, pyridoxine hydrochloride, riboflavin, silicon dioxide, sodium molybdate, sodium selenite, strontium chloride, succinic acid, thiamine, zinc picolinate (OSTEOPRIME ULTRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 29Mar2021 at 03:00, the patient experienced 13 hours after receiving second dose, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage. The patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information expected.
red spot around vaccination area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot around vaccination area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red spot around vaccination area). At the time of the report, VACCINATION SITE ERYTHEMA (red spot around vaccination area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient developed severe swelling and redness of sublingual papilla 2 days after getting Rota Teq and Prevnar 13 immunizations.
Pain started day of shot....lasted 1 week Left arm hot. Inflamed area grew to 6" down and almost totally surrounding
At home, I blacked out and fell against a door frame. I was immediately sent to hospital. My doctors are still testing me to determine the cause of the blackout one day after receiving flu vaccine.
They couldn't control my blood pressure; Pain; This is a spontaneous report from a contactable consumer. This 37-year-old female consumer (patient) reported for herself.   A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported; Expiration Date: 10Jun2021), intramuscular route of administration, administered in arm left on 28May2021 16:30 (age at the time of vaccination was 37-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included GERD (gastro oesophageal reflux disease). The patient previously took Atenolol 100 mg/daily for blood pressure. Concomitant medications included omeprazole (OMEPRAZOLE) taken at a dose of 20mg for gastro oesophageal reflux disease. On an unspecified date, the patient stated that she wanted to report that she had a reaction to the vaccine, and she do not know how to report it. I had to go to the emergency room, and I ended up with porosity (Not clarified) and then they could not control my blood pressure and then I had a reaction to the medication (Un-specified medication) that they gave me to control either my blood pressure or the porosity (Not clarified). The patient also experienced pain from an unspecified date. Treatment medication included Benadryl and some steroid for the event blood pressure and pain pills for the event pain. The patient underwent lab tests and procedures on an unspecified date which included blood test reported as normal. The patient further stated that she does not know they were checking for everything. They were checking for blood clot, they were checking for heart enzyme, they were checking for heart attack, they were checking for just to make sure that I was ok, and I did not have anything going out with my heart. The patient also stated, "it's gone better, they gave me some steroid medication. I had to take Benadryl, I had to take some steroid and I had to take they gave me like a pain pill and as long as I can control the pain, I don't have to take anymore steroids." The patient was recovering from the events.   Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021696974 Pfizer
She recently developed flu-like symptoms and had a positive COVID-19 test. Fever, headache and nasal congestion are her symptoms; She recently developed flu-like symptoms and had a positive COVID-19 test. Fever, headache and nasal congestion are her symptoms; This is a spontaneous report from a non-contactable consumer (patient) received via a company representative. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date as dose 1, single and  via an unspecified route of administration on 01Mar2021 at the age of 52 years (Lot number and Expiry dates was not reported for both doses) as dose 2, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. It was reported, she recently (at the time of report) developed flu-like symptoms and had a positive COVID-19 test on an unspecified date. Fever, headache, and nasal congestion were reported as her symptoms. Treatment for the event was not reported. Outcome for the event was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Being quarantine by my employer; Have symptoms of COVID; I have COVID; Being quarantine by my employer; Have symptoms of COVID; I have COVID; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EK9231) via an unspecified route of administration on an unspecified date in Jan2021 as DOSE 2, SINGLE and received dose 1 (Lot number: EJ1685) via an unspecified route of administration on an unspecified date in Dec2020 as DOSE 1, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, being quarantined by my employer, had symptoms of COVID, I had COVID on an unspecified date in 2021.  Well, I was calling because I wanted some information about the I guess the booster vaccine for people that are immune compromised. I would like information about the third injection for the pfizer COVID vaccine for the people that are immune compromised. The reason I was asking is because I had my first shot in december and my second in january and I was now being quarantined by my employer because I had symptoms of COVID. The outcome of the events was unknown at the time of this report.  Further probing could not be done as the consumer was unwilling to share any further information, hence limited information available over the call.
COVID-19; AWFUL BODY ACHES/PAIN; SINUS ISSUE; HOARSE VOICE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimotos disease, and penicillin allergy. 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 15-JAN-2021 13:00 for covid-19 prophylaxis. Age at time of vaccination 49 years old. The batch number was not reported and has been requested. Concomitant medications included levothyroxine, omeprazole, and pramipexole.  On 30-JUL-2022, the patient experienced awful body aches/pain, sinus issue, and hoarse voice. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from awful body aches/pain, sinus issue, and hoarse voice, and the outcome of covid-19 was not reported. This report was non-serious.
inadvertently vaccinated with an expired dose of ACT-HIB with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender 9 patients who were inadvertently vaccinated with an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In 2017, the 9 patients were inadvertently vaccinated with an expired dose of dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ289AA, expiry date- 05-SEP-2016) (with an unknown dosage and strength) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Reportedly, Caller requested guidance on how to proceed.   Caller declined to provide an e-mail address and would not give any further patient information.   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.
No additional adverse symptoms reported; 15-month old patient was inadvertently administered an additional dose of MMR II; This spontaneous report has been received from a physician, referring to a 15 months old patient. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.     In November 2019 (reported as 3 months ago), the patient was initially vaccinated one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, frequency, lot# and expiration date were unknown) subcutaneously for prophylaxis at the 12-month well-check visit. On 25-FEB-2020, the patient was inadvertently vaccinated an additional dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, frequency, lot# and expiration date were unknown) subcutaneously for prophylaxis for their 15-month check-up (inappropriate schedule of product administration). No additional adverse symptoms were reported.
I tested positive for Covid on 28Aug2023; I tested positive for Covid on 28Aug2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 69-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Aug2023, outcome "unknown" and all described as "I tested positive for Covid on 28Aug2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2023) Positive.   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.
little soreness; flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had never been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Environmental allergy (Environmental allergies) and Blood pressure abnormal.  On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included medication for blood pressure. Treatment medication was not reported.   This case was linked to MOD-2022-540074, MOD-2022-540077, MOD-2022-540079 (Patient Link).   Reporter did not allow further contact
COVID+ 21Jul2022 with symp- severe h/a,throat congestion/cough; COVID+ 21Jul2022 with symp- severe h/a,throat congestion/cough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8030), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; OLMESARTAN. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022 at 03:00, outcome "recovered" (10Aug2022) and all described as "COVID+ 21Jul2022 with symp- severe h/a,throat congestion/cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: rapidly dark purple positive Covid test; (21Jul2022) Positive; (28Jul2022) Positive; (10Aug2022) Negative; (11Aug2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 21Jul2022 to 25Jul2022. Clinical course: COVID+ 21Jul2022 with symptoms- severe h/a, throat congestion/cough- began paxlovid. Ended pax 25Jul22- symp improved/NOT gone. At home test 28Jul2022 very slight pos. 30Jul2022 marked increase in illness- nasal congestion, inc. throat congestion/cough. Test: rapidly dark purple positive Covid test. No further treatment- negative Covid test finally 10Aug2022 and 11Aug2022.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2021 as dose 1, single (Lot number: Ew0177), in right arm and on 05Jul2021 as dose 2, single (Lot number: Ew0196) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rather not say . I do have asthma though" (unspecified if ongoing). Concomitant medication(s) included: TRELEGY; NORETHINDRONE [NORETHISTERONE ACETATE]. Past drug history included: Keflex, reaction(s): "known allergies: Keflex"; Minocycline, reaction(s): "known allergies: minocycline"; Aspirin, reaction(s): "Known allergies: aspirin"; Percocet, reaction(s): "Known allergies: Percocet"; Iodine, reaction(s): "Known allergies: iodine"; Cephalosporin, reaction(s): "Known allergies: Cephalosporin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (11Dec2022) Negative, notes: Tested negative 11Dec or 12Dec after treatment; (12Dec2022) Negative, notes: Tested negative 11Dec or 12Dec after treatment; (15Dec2022) Positive, notes: I thought I had flu but checked again for COVID on 15Dec evening and it came out positive . Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patent received Trelegy and Norethindrone as other medication in 2 weeks. Patent received Paxlovid as treatment for COVID 19. Treatment start date: 05Dec2022 and Treatment stop date: 10Dec2022. Patient had a virtual doctor apt on 16Dec2022.
This spontaneous case was reported by a non-health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use by date 13Oct2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use by date 13Oct2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use by date 13Oct2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication information was reported. The vaccine was received at the clinic on 13Sep2022. The vaccine beyond use by date was reported as 13Oct2022. No treatment information was provided.
Pt. had a Fluarix quadrivalent vaccine in  October 2022 and accidentally received an additional Fluarix quadrivalent vaccine on 12/15/22.  Pt. reported mild fever the evening of 12/15/22 and had no other symptoms since then to this date (12/21/22)
Flu like symptoms; feeling awful; . Body aches; fatigue; vaccination site pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 14:00(at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, graves' disease and depression. The patient had no known allergy. Concomitant medications included losartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), thyroid (MANUFACTURER UNKNOWN) and paroxetine hydrochloride (PAXIL) from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 1400 the patient experienced injection site hurt and on 31Mar2021 at 07:00 the patient experienced flu like symptoms, body ache and fatigue (so that the patient couldn't work) and feeling awful to sit up in bed was painful for the patient. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient included treatment with ADVIL for the adverse events and slept the entire day. The clinical outcome of the events of flu like symptoms, body ache, fatigue, injection site hurt and feeling awful was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Narrative:  COVID infection following COVID vaccine series 0707, Moderna, dose #1 (non-agency facility) 02/06, Moderna, dose #2 (agency facility) 11/24 SARS-COV-2 Variant Sequencing result: pending 11/24 stool staple results: + campylobacter, e coli, 11/24 COVID swab, result: detected 11/24 pt cc: diarrhea, exposure: unknown 12/03 pt admit to ED cc: diarrhea dx: diarrheal illness subacute, acute kidney injury LOS: 1 day 12/03 CXR impression: Normal portable chest.