chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting; no energy; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Feb2021 11:00 as SINGLE DOSE for covid-19 immunisation. Medical history included cancer from an unknown date and unknown if ongoing and Patient had no known allergies. There were no concomitant medications. Patient had no other vaccine in four weeks and no other medications in two weeks. Patient had no covid prior vaccination and no covid tested post vaccination. On 27Feb2021 12:00 AM, the patient experienced vomiting and no energy. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore arm; sick for four days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ILLNESS (sick for four days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history reported.).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and ILLNESS (sick for four days). At the time of the report, PAIN IN EXTREMITY (Sore arm) and ILLNESS (sick for four days) outcome was unknown. Not provided      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.   Concomitant medication details were not reported by the reporter. Treatment medication was not reported by the reporter.
Information has been received from a medical assistant concerning her 9 year old daughter who on an unspecified date was vaccinated with a second dose of GARDASIL vaccine (yeast). Concomitant therapy included "several other vaccines on the same day" (therapy unspecified). Subsequently on an unspecified date, the patient experienced rash on her face and neck after she received her second GARDASIL vaccine (yeast). Unspecified medical attention was sought. No details were provided regarding the rash and any treatment that was required. Subsequently on an unspecified date, the patient fully recovered from rash on her face and neck. No product quality complaint was involved. Additional information has been requested.
During the evening & night of the shot, I experienced flu like symptoms (fever & chills, fatigue, sore arm). The next day, the fever & chills & fatigue subsided but for the next two weeks, I have experienced muscle soreness in many areas of my abdomen & back. Over the counter pain patches &  pain relief (naproxen) helps at times.  I am surprised that I still experience pain & discomfort two weeks after my first shot. My second shot is scheduled for 4/21/21. I am not looking forward to it but I know it is required.
Woke up in the middle of the night with abdominal cramping and a bad headache.  As the day went on i was tired and achy.  By late afternoon I had chills and fever.  My breathing, smell or taste were not affected, but I had all the other reactions I was told to possibly expect the day after mu second shot.  However, I was having them 2 weeks after my second shot.  My fever broke during Wednesday night and I felt fine on Thursday
Day after vaccine admini - allergic reaction, sterile abscess. Red, swollen, hot to touch arm.
7"30 p.m. on day of vaccination (2-26-21) my arm where I got the shot (left) began to hurt.  Today is March 13th the arm still hurts not just at the injection site but the pain throbs throughout the arm and it is hard to carry/pick up items.  It's not life threatening but I don't understand why it is still hurting  Also I wonder if when I get my second vaccine next Friday, March 19, 2021, if I should get it in my right arm.
Dry, swollen, chapped, cracked lips; Dry, swollen, chapped, cracked lips; Dry, swollen, chapped, cracked lips; dry mouth; numbness of upper gums in mouth; This is a spontaneous report from a non-contactable consumer (patient). This report was received via a sales representative.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE and via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced dry, swollen, chapped, cracked lips, dry mouth, numbness of upper gums in mouth. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
fever; pain on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the left arm) and PYREXIA (fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included Symbicort inhaler, albuterol, nebulizer (4 treatments per day), cardiovil, lisonopril, FUROSEMIDE and Hydroziline for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on the left arm). On 18-Aug-2021, the patient experienced PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (pain on the left arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     This case was linked to MOD-2021-307413, MOD-2021-307468. Treatment information was not reported.
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with PROQUAD (lot #: M011664 with expiration date: 08-SEP-2017) (dose, dosage schedule and anatomical location were not reported), subcutaneously, for prophylaxis. The vaccine had been stored at a temperature excursion of 5-14 °F for 19 hours (digital data logger) with no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
I had a real bright blinding light then a spiderweb effect. I got a bad headache that came along with it. I could barely see and I had to put on sunglasses when I got home. My doctor found a hematoma behind my eye that was about to detach my retina. When the pressure got bad in the eye I would get a nose bleed and the pressure would feel better. I am still sensitive to light until this day.
PER MOM: THE SITE IS RED, HOT, AND HARD. PER MD: MOM WAS INSTRUCTED TO APPLY WARM COMPRESSES AND GIVE MOTRIN FOR DISCOMFORT. FOLLOW UP IF DEVELOPS FEVER OR STREAKING.
immobility in left arm; Headache through the night; Intermittent pain in right ear; Difficulty sleeping; Lethargy; Nausea leading to a single vomit; Nausea leading to a single vomit; temperature of 101 degrees fahrenheit; Chills; Rash covering entire trunk of body the following evening; This is a spontaneous report from a contactable consumer. This 58-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 11:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation .  Medical history included   from an unknown date and unknown if ongoing.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)  dose 1  05Apr2021, administered at 11:15 AM on left arm.  There were no concomitant medications and no other vaccine in four weeks. It was reported that on 27Apr2021 at 12:00 AM, the patient experienced headache through the night, intermittent pain in right ear, difficulty sleeping, lethargy, nausea leading to a single vomit, temperature of 101 degrees Fahrenheit, chills immobility in left arm, rash covering entire trunk of body the following evening. The outcome of the events was recovered on unknown date. Therapeutic measures were taken as a result of events included Ibuprofen. Patient had no covid infection or tested positive for covid prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Large edema and redness around injection site; Large edema and redness around injection site; Hardening of skin around the injection site; Pain upon palpation; Spontaneous report received on 17FEB2020.  A male consumer reported that he developed large edema and redness around injection site (PT: Injection site oedema/Injection site erythema), had hardening of skin around the injection site (PT: Injection site induration), and pain upon palpation (PT: Injection site pain) following the immunisation with BioThrax (anthrax vaccine adsorbed). On 13FEB2020 at 09:00 am, he received BioThrax via intramuscular route in right arm. On 14FEB2020 at 09:00 am, he developed large edema and redness around injection site (approximately 3 inches in diameter); his skin became hard around the injection site (approximately 1 inch in diameter) and he had pain upon palpation. The symptoms were not resolved at the time of report.  Concurrent condition included pet allergies, Schmorl's node and sleep apnea.  Company Comment: A consumer received BioThrax vaccination via intramuscular route on his right arm, and on the next day he developed injection site edema, injection site erythema, injection site induration, and injection site pain. These events have not resolved at the time of the report. Local injection site reactions like edema, erythema, induration and pain could happen after receiving BioThrax.  Given the temporal relationship and biologic plausibility, causality of all these events is assessed as related.; Sender's Comments: Company Comment: A consumer received BioThrax vaccination via intramuscular route on his right arm, and on the next day he developed injection site edema, injection site erythema, injection site induration, and injection site pain. These events have not resolved at the time of the report. Local injection site reactions like edema, erythema, induration and pain could happen after receiving BioThrax.  Given the temporal relationship and biologic plausibility, causality of all these events is assessed as related.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "restless legs syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asparagus, reaction(s): "Drug Allergy: Asparagus". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient used Paxlovid as treatment from 04Sep2023 to 09Sep2023.   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.
Shot location sore, very aching & tired, cold chilling couldn?t get warm,  followed by fevers hot feeling. Woke up to 2nd day back to normal.
Pt feels fatigue, fever, chills, and is having trouble concentrating.  PT claims that fatigue is just as bad, aches that are not severe, and is still having trouble concentrating. Took two advils the first day whcih helped with chills and aches, other than that nothing
Information has been received from a consumer concerning a 23 year old female who on 03-JUN-2008 was vaccinated with GARDASIL vaccine (yeast), she reports that she developed hives at the injection site after her second dose of GARDASIL vaccine (yeast) on 04-AUG-2008. The patient did not seek medical attention. The patient's hives at injection site persisted. Concomitant therapy included ACCUTANE. No further information available.
Woke up tired with feelings of a sinus infection, sore throat, headaches and cold chills. Took a rapid covid test and it was positive
No adverse event; Expired covid vaccine that was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired covid vaccine that was administered) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015B22A) for COVID-19 prophylaxis.     Patient had no allergies nor notable health conditions.     On 17-Feb-2023 at 8:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Feb-2023 at 8:30 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired covid vaccine that was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired covid vaccine that was administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired covid vaccine that was administered).    No concomitant medications was reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient does not had any adverse events. No treatment drug details was reported.
Pt had indicated on the form that she wanted a COVID shot, however, at the clinic, I recall being told that none of the employees had signed up for a COVID shot. Therefore, I administered a flu shot to the patient in place of the COVID shot.
IM H1N1 Adm, 1 1/2 hrs later developed rash on arms, blotchy rash on upper back & chest, no itching. States she developed this blotchy rash when she gets "hot" BP 120/90 no shortness of breath lungs clear.
a big loss of appetite for a few days; indigestion/stomach bug; nausea; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection and Lot Number: EL3247), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as single dose for COVID-19 immunization. Medical history included chronic Lyme disease and autoimmune issues. Concomitant medication included lamotrigine (LAMICTAL), lithium, retinol and clindamycin. On an unspecified date it was reported as patient was not sure if these symptoms are related to vaccine. After 5 days of first vaccine shot the patient experienced a big loss of appetite for a few days, followed by mild stomach bug symptoms for 10 days, indigestion and nausea on an unspecified date. The seriousness of the events was reported as non-serious. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
FEVER; This spontaneous report received from a health care professional concerned a 19 year old male. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
I have been coughing, diarrhea and drainage, It has lasted a week since Thanksgiving.
SLE flare up; pressure went up; Face got red; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received BNT162B2 (Batch/Lot Number: EN6205; Expiration Date: Jun2021), intramuscular, administered in Deltoid Left arm on 14Mar2021 11:30 as dose 2, single for COVID-19 immunisation.  Medical history included systemic lupus erythematosus from 2011, intestinal blockage from Jul2019 to Sep2019 (had surgery to repair intestinal damaged septum; Hospital 1 month, ICU 10 days), diverticulitis from Sep2020. Concomitant medications included ongoing metoprolol succinate for heart beat from 2014; ezetimibe for cholesterol from 2020; pantoprazole for stomach from 2019; and 2 weeks prior to 2nd dose for a week, she took metronidazole; dicyclomine and ciprofloxacin for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number 21Feb2021, intramuscular, in left arm, as single dose for COVID-19 immunization and the patient experienced on and off diverticulitis flare up, SLE flare up, red face, BP high, Burning sensation in Face and trembling. On an unspecified date, after second dose of vaccine, her pressure went up, face got red but not bad as before (when he had after first dose) and also reported that she had a minor flare up from her lupus.  The patient underwent lab tests and procedures which included on Nov2020, colonoscopy had done and found polyps, diverticulitis causing wall of descending loop to inflame, and took COVID test where result was negative, on Mar2021 her electrocardiogram showed normal , where HDL was 75 mg/dl, and LDL was 225 mg/dl. The events resulted in physician office visit. The patient was put on antibiotics for diverticulitis flare up. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
BUMPS ON BACK STARTED 1 DAY POST VACCINATION; BUMPS ON RIGHT BREAST STARTED RECENTLY.  RIGHT BREAST IS NOW SORE. PATIENT IS GOING TO CALL THE COVID HOTLINE.
Swelling on the skin of the chest, arms and leg the day after the injection lasting until the next day.  Tingling in the mouth for about an hour and a half on the same day.
Patient received the vaccine and was completely fine immediately following. We walked around the store, conversed, and 10-12 minutes after injection he had syncope and generalized tonic clonic seizure for minutes. We were transported 911 to Hospital ED where he had normal labs, normal brain MRI, and consultation with Peds Neuro. He was post-ictal for 30+ minutes to follow the incident. He has secondary trauma to his R temporal and occipital bones and likely a mild concussion resulting from the fall.
The patient received the Pfizer COVID-19 vaccine on 3/10/21 and 4/5/21. They tested positive for COVID-19 via the SOFIA antigen COVID-19 test on 5/29/21. The patient was exhibiting the following symptoms at the time of testing: fatigue, loss of taste and smell, headache, and body aches.
Admitted 5/26 from outside facility for GI bleed, cardiac arrest and severe sepsis. COVID+. Treated with tocilizumab, vit C, vit D, alinia, zinc. Family opted for comfort care and W/D life support. Expired 6/5.
Follow up information received from the nurse provided clarification of the date of vaccination administration and onset of symptoms, and treatment received. A nurse reported that a 32 year old female received a dose of Flumist nasal solution on 8/28/03. Medical history includes smoker, seasonal allergies and drug hypersensitivity to codeine and Biaxin. Indication for Flumist was immunization. Product was administered on 8/28/03. Dose regimen was 0.5mL. Concomitant medications were not reported. On 9/4/03, 1 week post immunization, the patient developed cough, sore throat, and burning in sinus. She was seen by her family physician, and treated for a sinus infection with amoxicillin.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown), on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: PAROXETINE, start date: 01Jun1998; ATORVASTATIN, start date: 01Jan2005, stop date: 13Sep2022; LISINOPRIL, start date: 01Apr2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2022) negative; (21Sep2022) negative; (24Sep2022) strongly positive; (13Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: COVID positive anthem test on 13Sep2022. Symptoms started on 12Sep2022 and resolved on 21Sep2022. COVID negative antigen test x2 separated by 12 hours on 21Sep2022. Started having cough, congestion, mild myalgias 23Sep2022. Antigen test strongly positive 24Sep2022. Suspecting rebound case. Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 13Sep2022, treatment stop date: 18Sep2022, indication: 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: The reported COVID-19 positive after four doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.