chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Positive; COVID Positive; Dose Number:3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 (Lot number: FL3197) at the age of 44 years as dose 3 (booster), single, administered in arm right, administration date 28Apr2021 (Lot number: EW0176) as dose 2, single and administered in arm right, administration date 06Apr2021 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 15Dec2021, outcome "unknown", described as "Dose Number:3"; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 29Dec2021, outcome "recovered" and all described as "COVID Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. Therapeutic measures were not taken as a result of covid-19.  Additional information: The patient did not have any other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Weak; Felt depleted like she had been hit by a truck / it took everything out of me; sickness.; Not sleeping; Hives; Itching; This case was reported by a consumer via call center representative and described the occurrence of hives in a 38-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 947BS, expiry date 30th June 2020) for prophylaxis.   Previously administered products included Flu vaccine (had flu shot and did not had a problem previously). Concurrent medical conditions included shellfish allergy and iodine allergy.   On 1st October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced weakness, exhaustion and sickness. In October 2019, the patient experienced hives, generalized pruritus and insomnia. On 22nd October 2019, the outcome of the weakness, insomnia, exhaustion and sickness were recovered/resolved. On an unknown date, the outcome of the hives and generalized pruritus were recovered/resolved.   It was unknown if the reporter considered the hives, generalized pruritus, weakness, insomnia, exhaustion and sickness to be related to Fluarix Quadrivalent 2019-2020 season.Additional details were provided as follows: The reporter was the patient. The patient received dose of Fluarix Quadrivalent 2019-2020 season in left deltoid at the pharmacy. Less than 3 weeks, the patient experienced hives, generalized pruritus and insomnia.  The patient at 1st stated that, 24 hours later got sick, but later stated that in the afternoon on the day of vaccination, started feeling symptoms. The patient felt depleted like she had been hit by a truck. The patient did not go to the work on thursday 3rd October 2019 and Friday, 4th October 2019. The patient reported that not sleeping because of itching all over the body,  The patient had hives and itching for 4 days. By saturday 5th October, the patient was not fully recovered. On 22nd October 2019, the patient called to GlaxosmithKline response center and stated that, all events were recovered. The reporter consented to follow up.
The day after the injection I was sore and the arm was bruised, purplish color, and hot to the touch. And this morning I got very itchy around the vaccine site and its still red and hard to the touch, like there was a lump under the skin.  The bruise has faded a little but its not getting much better. Medical provider called to recommend benadryl and tylenol, and keep a warm pack on it, and also to seek help if it has not improved over the weekend.
diarrhea; slowing of my bowels; loss of appetite; a lot of inflammation, inflamed intestinal tissue; GI Intestinal trouble; stoma is inflamed and it is like a volcano; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "colitis" (unspecified if ongoing); "ileostomy" (unspecified if ongoing), notes: Has had for 40 some years. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; GASTROINTESTINAL MOTILITY DISORDER (non-serious), outcome "unknown", described as "slowing of my bowels"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; GASTROINTESTINAL INFLAMMATION (non-serious), outcome "unknown", described as "a lot of inflammation, inflamed intestinal tissue"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "GI Intestinal trouble"; STOMA SITE INFLAMMATION (non-serious), outcome "unknown", described as "stoma is inflamed and it is like a volcano".  Additional information: She received her first Pfizer shot 1 week ago on Wednesday and that by Friday and last night she changed her appliance and noticed a lot of inflammation, inflamed intestinal tissue. She was not sure if the vaccine had caused some GI intestinal trouble. She wanted to know if inflammation in the intestinal area was a side effect. She was concerned that her stoma was inflamed and it was like a volcano. She just changed it yesterday and had side effects starting on Friday with her stomach. She doesn't know if she could get second shot if that would inflame it even worse in terms of a blockage or something. She has had this a lot of years and normally, she knew what she needed to do. This was different.   No follow up attempts are possible. No further information is expected.
Sight has gotten worse; Hearing is worse; Taste is weird; Normal cough; Tested positive for COVID a few days after vaccination; Felt  so sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for COVID a few days after vaccination), MALAISE (Felt  so sick), COUGH (Normal cough), VISUAL IMPAIRMENT (Sight has gotten worse), HYPOACUSIS (Hearing is worse) and TASTE DISORDER (Taste is weird) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced COVID-19 (Tested positive for COVID a few days after vaccination) (seriousness criterion hospitalization). On 18-Jan-2021, the patient experienced MALAISE (Felt  so sick) (seriousness criterion hospitalization) and COUGH (Normal cough) (seriousness criterion hospitalization). In February 2021, the patient experienced VISUAL IMPAIRMENT (Sight has gotten worse) (seriousness criterion hospitalization), HYPOACUSIS (Hearing is worse) (seriousness criterion hospitalization) and TASTE DISORDER (Taste is weird) (seriousness criterion hospitalization). The patient was hospitalized from 18-Jan-2021 to 01-Feb-2021 due to MALAISE. At the time of the report, COVID-19 (Tested positive for COVID a few days after vaccination), MALAISE (Felt  so sick), COUGH (Normal cough), VISUAL IMPAIRMENT (Sight has gotten worse), HYPOACUSIS (Hearing is worse) and TASTE DISORDER (Taste is weird) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Treatment information was not provided.  Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-064065 (Linked Report).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested. US-MODERNATX, INC.-MOD-2021-064065:serious_case
COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a positive COVID-19 test on 06Feb2021. The clinical outcome of the event positive COVID-19 test was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
t101-102 29MAR96; 31MAR 4 days w/rash took pt to ER for dx APAP for inc temp;
This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to a female patient of unknown age. Pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, strength, vaccination site, dose number, # lot, expiry date unspecified) during her pregnancy (exposure during pregnancy). Product quality complaint was not reported. No further information was provided. Additional information is not expected as the reporter did not wish further contact.
A non-serious spontaneous report of administration to a 58 year-old female was received from a Registered Nurse concerning a 58 year-old patient. A 58 year-old was given FLUMIST by mistake. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses in PNEUMOVAX 23 immunization series, lot number L014876, expiration date: 13-JAN-2017 and lot number M005287, expiration date: 08-OCT-2017, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a clinical medical assistant refers to an unknown number of patients of unknown age and gender. Since on 05-DEC-2014, the patients were vaccinated with M-M-R II (dose, frequency and lot number unknown), subcutaneously, and VARIVAX (Merck) (dose, frequency and lot number unknown), subcutaneously. No adverse effects reported. Additional information has been requested.
Redness from top of arm to elbow, area hard per pt. Not visualized by writer. Used ice to area, redness better but does have discomfort with use.
PATIENT RECEVIED THE VACCINE ON 5/2/18. PATIENT STARTED TO HAVE NORMAL RASH AROUND THE NECK AND BELOW THE BREAST ON SUNDAY, 5/6/18. ADVISED PATIENT TO GO SEE HER PRIMARY CARE DOCTOR OR URGENT CARE RIGHT AWAY. PATIENT STATED SHE WILL BE SEEING HER DOCTOR ON FRIDAY 5/11/18.
Please verify dose, typical MFG recommendation for 1-2 years old is 75-80mg/dose (this is 128mg/dose). Thank you!
Pt had vasovagal reaction and emesis immediately post vaccine admin. NO ALLERGY to vaccine. Okay to receive 2nd dose.  At 1:37PM, 6 min post receiving vaccine, patient told mom that he felt lightheaded and was having pain at injection site left arm. Rn assessed immediately and pt reported feeling "sick".  He drank few sips of water. MD called to bedside. I assessed pt at 1:39PM, pt sitting chair, elevated his legs onto the footrests of wheelchair sitting in front of pt.  +Facial and lip pallor,  and   complaining of nausea followed by 1 episode NBNB emesis consisting of what he ate for lunch 1 hour prior. Pt immediately reported feeling better post emesis. Lips appeared pink. Pt brought to triage area, lay supine on stretcher with legs elevated. Nausea and "lightheaded" sensation resolved prior to lying down. BP improved post emesis from 75/39 to 84/46 at 1:48 PM. Stayed lying down for 5 minutes after which time pt wanted to sit up.  Upon sitting BP and HR increased 96/64 and 69, stable with no nausea or lightheadedness, only remaining  sx "slightly weak". drank 12 oz apple juice and ate 2 graham crackers without any further emesis or symptoms. Observed for 15 more minutes and was ambulating without return of symptoms, discharged home with mom and brother with instructions to seek medical care if symptoms return.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 019B21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 3:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 3:57 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Nov-2021 at 2:45 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  The reported condition of the vial was not frozen.  Dose taken on 27 Feb 2021 with batch number 014M20A underwent multiple temperature excursion on 27 Feb 2021 from 33 to 35 degrees Fahrenheit from 09AM to 05 PM. Vaccine was moved to fridge on 24 Feb 2021 and Best Use Date for the vaccine was 26 Mar 2021. Product moved to clinic on 27 Feb 2021. Age of the patient at the time of vaccination was 69.90 years.  Dose taken on 27 Mar 2021 with batch number 019B21A underwent temperature excursion twice on 27 Mar 2021 till 35 degrees Fahrenheit at 09AM and 10 AM. Vaccine was moved to fridge on 23 Mar 2021 and Beyond Use Date for the vaccine was 22 Apr 2021. Product moved to clinic on 27 Mar 2021. Age of the patient at the time of vaccination was 69.97 years.  Dose taken on 03 Nov 2021 with batch number 035C21A underwent temperature excursion on 03 Nov 2021 till 35 degrees Fahrenheit at 10 AM. Vaccine was moved to fridge on 05 Oct 2021 and Best Use Date for the vaccine was 05 Nov 2021. Product moved to clinic on 03 Nov 2021. Age of the patient at the time of vaccination was 70.58 years.  No treatment medication reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
both arms slightly sore; off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose number unknown (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 25Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 25Oct2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 25Oct2022, outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "both arms slightly sore".  Additional information: Patient received Covid booster Bivalent. He and his wife both got the Covid vaccine 2 days ago and got the flu shot. It was the Covid booster, the new booster. Reporter and wife went to (PRIVACY) pharmacy 2 days ago and got the flu shot in the right arm and Covid booster in the left arm. The following day, both of reporter arms were slightly sore but he had no problems. Reporter clarified that Reporter and wife had the flu shot and Covid booster at same time. Reporter states that he had no rash like his wife but his arms are a little sore, slightly but, there was nothing red. Reporter declined to complete report on this experience. He states to document that he had both vaccines from the same batch number and he does not have any red rash. Reason for no lot number: of Flu shot: Complainant does not have the product with them at the time of call.  No follow-up attempts are possible. No further information is expected.
No additional AEs; an expired dose of V AQT A was inadvertently administered today 20 JAN 2021; This spontaneous report was received from a registered nurse who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  20-JAN-2021, the patient was vaccinated with a single expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot number S034296 was confirmed to be valid; expiration date 09-JAN-2021; dose, route of administration, anatomical location and strength were not provided) for prophylaxis. The patient did not experienced additional adverse events. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034296; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Patient states pain at injection site on 11/15/19 has not significantly decreased since injection. Bruise and swelling was present within 24 hours after shot and has subsided significantly. This is the patient's first 65+ flu dose.
Information has been received from a physician concerning a 2 month old white female with viral congestion and no fever who on 27-DEC-2006 was vaccinated with rotavirus vaccine (human-bovine) 1 cc PO as a first time dose (Lot # 655405/1113F). The nurse reported the infant of a diabetic mother had some nasal congestion at the time of immunization but no fevers at the time of immunization. On 04-JAN-2007 the patient returned to the clinic with a three day history of not sleeping, fussiness and batting at her ears (onset 01-JAN-2006). The nurse reported the infant was diagnosed with left acute otitis media and was treated with good resolution. The nurse noted that the patient did not develop otitis media after her four month immunization. The infant recovered on 10-JAN-2007. Additional information has been requested.
7PM 21DEC90 temp 103; irritability; admitted to Hosp;
PREMATURE VENTRICULAR CONTRACTIONS (PACEMAKER),FATIGUE,HEADACHE, SORETHROAT Narrative:  60 yo male with no known problem list at the agency, usually sees a non-agency provider reported fatigue, sore throat, headache and PVC's (pt has a pacemaker/defibrillator) on 3/22/2021 (when he was getting his second dose of covid19 vaccine). Symptoms resolved after 2 days with no intervention.
Cold, cough, fever, aches, headache, fatigue (next day). Went into severe bronchial infection within days.
pt recv vax & stated that pt had been back @ school x 10min when eyes began to swell along w/lips;advised to take pt immed to ER;pt went to ER & given DPH;
Pt. C/O (R) arm pain at injection site and entire upper arm w/erythema.
Pt. states after receiving the 2nd dose of Moderna 04/15/2021, started to experience swelling in the face and neck 07/05/2021 and believes he has been suffering from Gilliam Bar syndrome. ER visit 07/09/2021 recommended injection of Prednisone and Benadryl, fluids. Neurologist visit recommended. Still experiencing buzzing sensation throughout the body.
numbness/paresthesias to left upper arm. This then progressed to numbness that radiated down left arm and into left 4th and 5th fingers.; numbness/paresthesias to left upper arm. This then progressed to numbness that radiated down left arm and into left 4th and 5th fingers.; The left side of my face also felt numb; This is a spontaneous report from a contactable consumer (patient) or other healthcare professional.   A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Mar2021 16:30 (at the age of 35-year-old) as dose 2, single for COVID-19 immunisation.  Medical history included chronic allergies and environmental allergies from unknown date unknown if ongoing. Patient had no known drug allergies. Concomitant medications included drospirenone, ethinylestradiol (LORYNA); meloxicam (MOBIC); loratadine (CLARITIN); budesonide, formoterol fumarate (SYMBICORT); montelukast sodium (SINGULAIR) all taken for unspecified indication start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration, administered in left arm on 12Feb2021 13:30 (at the age of 35-year-old) as dose 1 single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. Approximately 15 minutes after receiving the second dose of Pfizer vaccine in her left arm on 05Mar2021 16:45, patient experienced numbness/paresthesias to left upper arm. This then progressed to numbness that radiated down left arm and into left 4th and 5th fingers. The left side of her face also felt numb.  patient did not received any treatment for adverse event. Not all fingers were numb, just ulnar distribution. No drooping or motor deficits. Symptoms lasted less than 10 minutes. Outcome of the events was resolved on 05Mar2021.  No follow-up attempts are possible. No further information is expected.