chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19/nausea, extreme diarrhea with bleeding, rash, (bad taste), fainting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:  Maybe PEG" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Jul2022, outcome "recovered" (06Jul2022), described as "Treatment of COVID-19"; SUSPECTED COVID-19 (medically significant) with onset 03Jul2022, outcome "recovered" (06Jul2022), described as "Treatment of COVID-19/nausea, extreme diarrhea with bleeding, rash, (bad taste), fainting". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient received Paxlovid from 03Jul2022 to 05Jul2022 of Covid-19.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Sudden hearing loss in both ears.  According to ENT and audiologist, the loss is almost profound.  A hearing test from a year ago shows normal hearing.  Hearing aids are now necessary
This spontaneous case was reported by a nurse and describes the occurrence of DIARRHEA (Diarrhea), ILLNESS (Was sick), PYREXIA (Fever (101°F)), CHILLS (Chills) and MYALGIA (Aching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced DIARRHEA (Diarrhea), ILLNESS (Was sick), PYREXIA (Fever (101°F)), CHILLS (Chills), MYALGIA (Aching) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 24-Aug-2021, DIARRHEA (Diarrhea), ILLNESS (Was sick), PYREXIA (Fever (101°F)), CHILLS (Chills), MYALGIA (Aching) and VOMITING (Vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, Body temperature: 101 f (High) Fever (max 101°F). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. It was reported that patient had to stay an extra 24hs fever-free for being able to go back to work. This case was linked to MOD-2021-326947.
8/26/2020 -pt presented to local ER due to L knee swelling and rash on shins and refusing to bear weight. Mom also presented to ER due to lice infestation at daycare. Pt given Permethrin and Xray of knee done , dc'd home. follow up appt in office , pt 's rash progressed to red blotchy lesions on buttocks,  and thigh, bumpy, also noted to have R foot swollen and L hand swelling. No fevers. No diarrhea or bloody stools. No abdominal pain. urinating fine. Presumed dx' of HSP given. Rec supportive care and to f.u after weekend- 3 days later with urine specimen.  Pt presented to Local ER again on 8/30/2020 due to rash spreading to face, and scrotal swelling noted with blister formation on lesions on leg, Derm consulted in ER, poss of EM raised,  Blood tests including Mycoplasma and HSV titers drawn.  Followed up here on 8/31/2020- swelling on both hands noted, but previous swelling and scrotal swelling had subsided. Petechial and purpuric lesions as well as bullae noted on legs. No real target lesions. For diagnosis, complement levels, IGA coats and derm referral ordered   Pt seen by Derm on 9/1/2020. agreed with  HSP diagnosis.  Last visit prior to this report was on 9/8/2020. Rash resolved from face  and buttocks, and bullae had resolved.  No swelling of extremities noted. Still with petechia on feet and purpuric lesion on LE's.  Has f/u scheduled on 9/22/2020- awaiting f/u urinalysis as well
Temp 100.8 (ax), 3 hrs p/ immun & began shaking went limp & had loss of color. P/ 1 hr child was fine. Taken to MD, temp 103 at night given tylenol.
Extremely heavy and painful menstruation one week after shot. It was abnormal for me to be that heavy with flow and to even have cramps, let alone that strong.
swelling redness itching pain in the arm hardness on site of injection 2-19-21
Red bump developed where the second dose of Moderna vaccine was injected. Bump is about two inches long. Bump is tender; painful when pressure is applied. Bump was noticed around 12 PM  on 5/28/21. Bump can be itchy.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # reported as L009205, expiration date 17-MAR-2017; lot # L007224, expiration date 03-MAR-2017) (route and dose were not provided) which had temperature excursion. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Dizziness, fatigue, extreme tiredness, and the day after head ache and extremely sore arm.
at 2m of age gave shots, pt immediately cried for 1/2 sec dad picked him up then imm. went in to a deep sleep for 40 min, only response to painful stimuli. Eyes rolling in back of head - same exact thing happened at 4 mos of age.
Vaccines were stored in the fridge since 13-Oct-2022 and administered on 14-Nov-2022; No adverse event; Administration error: 4 patients administered with Moderna bivalent beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13-Oct-2022 and administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13-Oct-2022 and administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event). On 14-Nov-2022, EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13-Oct-2022 and administered on 14-Nov-2022) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13-Oct-2022 and administered on 14-Nov-2022).    Concomitant product use was not provided by the reporter.  It was reported that, vial size was 2.5ml.  Vial was initially stored in refrigerator on 13-Oct-2022. The vial had not undergone temperature excursion. No AEs were reported.  No treatment medications were reported.  This case contains information for one patient out of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-673345, US-MODERNATX, INC.-MOD-2022-673344, US-MODERNATX, INC.-MOD-2022-673303 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673344:Same reporter US-MODERNATX, INC.-MOD-2022-673345:Same reporter US-MODERNATX, INC.-MOD-2022-673303:Same reporter
full pinky finger as well as the ringer finger from the top knuckle up (finger-tip section) on right hand were tingly and numb; full pinky finger as well as the ringer finger from the top knuckle up (finger-tip section) on right hand were tingly and numb; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 29Apr2021 at 15:30 (at the age of 29-year-old)  as a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 07Apr2021 at 12:00 (at the age of 29-year-old) as a single dose for COVID-19 immunization. The patient did not receive any medication within two weeks of vaccination. 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 30Apr2021, the patient experienced tingling and numbness. Its reported that patient noticed the day after the 2nd dose, that full pinky finger as well as the ringer finger from the top knuckle up (finger-tip section) on right hand were tingly and numb. She kept trying to wiggle them to get more blood into them, but it continued to feel the way your foot does when it falls asleep. On (05/04/2021), it feels like the same feeling had come down right below the knuckle in the large portion of hand (bottom knuckle) from pinky, and a down to the 2nd knuckle in ring finger. The clinical outcome of the events of tingling and numbness was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
After first and second dose, they felt sore for two days or three but not bad; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (After first and second dose, they felt sore for two days or three but not bad) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020b21a and 022m20a) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (After first and second dose, they felt sore for two days or three but not bad). At the time of the report, MYALGIA (After first and second dose, they felt sore for two days or three but not bad) had resolved.            Concomitant products include cholesterol medicine. No treatment information was provided.   This case was linked to MOD-2022-510135, MOD-2022-510207 (Patient Link).
A report from a pharmacist concerns a 16 year old female. No relevant history, concomitant disease, or concomitant medications were reported. On 31-Oct-2013, the patient received FLUMIST QUADRIVALENT (intranasal). The reporting pharmacist, who was the patient's neighbor, reported that the patient had FLUMIST QUADRIVALENT on 31-Oct-2013 and on 06-Dec-2013 was admitted to the hospital with vasculitis. The outcome of the vasculitis was unknown. The reporter assessed the vasculitis to be serious by the criterion of hospitalization.
EXCRUCIATING PAIN GOING UP TO THE SHOULDER AND NECK AND THEN DOWN AGAIN; A Nurse Practitioner thought it was SIRVA caused by; A spontaneous report was received from a Consumer concerning a 90-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced excruciating pain going up to the shoulder and neck and then down again and Nurse Practitioner thought it was SIRVA caused by the needle going in too far.  The patient's medical history included high blood pressure and allergic to tramadol/acetaminphen. Concomitant medications reported were Digoxin, Apixaban and Doxazosin.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the event excruciating pain going up to the shoulder and neck and then down again and Nurse Practitioner thought it was SIRVA caused by the needle going in too far.  Treatment details included Tramadol / Acetaminophen and Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), excruciating pain going up to the shoulder and neck and then down again and Nurse Practitioner thought it was SIRVA caused by the needle going in too far were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial report was received from a health care professional on 18 June 2012. This reporter reported another adverse event which was captured in case number 2012-06240. A 58-year-old female patient had received a dose one intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C3989AA, on 08 May 2012. On 09 May 2012 (also reported as 22 May 2012), the patient experienced redness, swelling, heat and itchiness at the injection site. The doctor determined it was cellulitis but no defining culture was obtained. The patient was treated with KEFLEX 500mg twice daily (BID) for seven days. The patient had no illness at the time of vaccination and a past medical history of migraines, anxiety, depression, gastroesophageal reflux disease (GERD), seasonal allergies, osteopenia and vitamin D and vitamin B12 deficiencies. No additional information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
bleeding at time of injection. At 7:30 pm today (same day as vaccine) noticed a large bruise developing. bruise is easily a 2 inch x 2 inch circle/oval centered on injection site. Arm is getting sore, but no worse than flu shot. bruise is blue, will probably be one of those ugly ones that matures into dark purple, then green, and yellow as it heals. not treatment yet. just was surprised by the bruising, especially the size.
Diarrhea; however caller's 3 prior doses were the Moderna COVID-19 vaccine.; 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 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Feb2023 at 14:00 as dose 4 (booster), single (Lot number: GJ3270) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 2), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 3), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Feb2023, outcome "unknown", described as "however caller's 3 prior doses were the Moderna COVID-19 vaccine."; DIARRHOEA (non-serious) with onset 16Feb2023 at 04:00, outcome "unknown", described as "Diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea  Additional information: No other conditions, investigations, other products. Initially stated calling because caller got the 4th shot, whatever the shot is called, and is experiencing some diarrhea. Calling Pfizer because caller is looking to get disposable panties for only a couple of days for discomfort and is looking for a recommendation for women's bowel incontinence or diarrhea. Patient weight: Probably 150ish pounds. Started around 4PM then at 4AM got up with uncontrollable diarrhea. Since 4AM hasn't done anything, is in bed, that is why caller thought caller may have a product around just in case diarrhea does come back.Upon attempting to clarify specific product name, caller stated it is either the Pfizer BioNTech COVID-19 vaccine mRNA, but caller thinks the last dose, 4th shot, caller got was the bivalent, is that the latest one, Caller then located vaccination card and clarified and confirmed caller received the Pfizer COVID-19 vaccine bivalent for caller's 4th dose. Confirmed this was caller's 4th dose total. 3 prior doses were the Moderna COVID-19 vaccine. Stated does caller have to go for a 2nd dose. Was on and off about whether caller was going to take the vaccine or not, then caller's sister had Covid so caller ended up getting the vaccine. Anatomical Site of injection: Left upper shoulder. Patient has no Current or recent cancer (including blood cancers such as Hodgkin's disease, leukemias, and myelomas); Advanced or untreated HIV infection; Use of medications that suppress the immune system (e.g., high-dose corticosteroids, cyclosporine, methotrexate, azathioprine, and biologic therapies like rituximab and etanercept). Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None.
Injection site very sore Nausea  Fatigue Chills Body aches Back pain
Patient received vaccine on Monday and reports feeling fine until Friday when she noticed redness around the injection site and itching.
Autistic symptoms; later diagnosed with PDD (pervasive developmental disorder, which is on the low end of the spectrum for autism).
temperature monitor log that the fridge temp went down to -6 Celsius/ Engerix-B that was in that fridge; This case was reported by a other health professional via sales rep and described the occurrence of incorrect storage of drug in a neonate male patient who received HBV (Engerix B) for prophylaxis.   On June 2021, the patient received Engerix B. On June 2021, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The newborn baby was administered Engerix-B, and since that time, reporter had seen on refrigerator temperature monitor log that the fridge temperature went down to minus 6 Celsius on 24th May 2021. Then it went right back up to normal temp it looks more like reporter system had an issue, not the fridge. The reporter temperatures are taken every 15 minute and it was just one time point that dipped down to the minus 6 degrees. The newborn baby got a dose of the Engerix-B that was in that fridge and he has not had any adverse reactions from the vaccine, which led to Incorrect storage of drug. The reporter consent to follow up.
immed p/vax pt devel an inj site rxn characterized by an orange-sized area of redness & swelling;the rxn abated w/in 24hr;
Immediately after administration at 3:25 pm patients face/lips began to swell Auvi - Q administered in left thigh by Dr in the office. Reaction occured in our office after vaccine administered
Similar to prior reactions, muscle and joint pain, nausea, headache... I took Percocet, Benadryl and Ibuprofen... eventually it got a little better, but It took me days to get over these symptoms completely.
This spontaneous report as received from a consumer refers to a currently 12 year old female patient who was not pregnant. On an unknown date the patient was vaccinated with second dose in the series of GARDASIL intramuscular (dose, strength and site of administration not reported). On an unknown date in December 2013 (reported as sometime last week) the patient experienced headaches, numbness and muscle aches. No treatment was given. The advising physician told the patient to visit a psychiatrist. The outcome of numbness, muscle aches and headaches was reported as not recovered/not resolved. The relatedness between GARDASIL and events was not reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age. No concurrent condition was reported. No historical medication was reported. Approximately in 2014, the patient was vaccinated with GARDASIL lot # J009243, 0.5 ml, intramusular. No concomitant medication was reported. Nurse stated that an unspecified number of patients received (unspecified doses in series) GARDASIL that was stored at 47F for 120 hours. Nurse also reported that temperature issue occurred on 29-JUN-2014 through 03-JUL-2014 so doses administered somewhere after 04-JUL-2014 and 23-SEP-2014. No adverse effects reported. The outcome of GARDASIL stored at 47f for 120 hours was unknown. No PQC involved. This is one of the several reports. Additional information has been requested.
REDNESS AT AND 3 INCHES AROUND INJECTION SITE. SLIGHT SWELLING AND WARM TO THE TOUCH
Sore shot Site  Red, swollen shot site  Swollen arm  Numb fingers in arm with shot  Tight and sore neck  Body aches  Chills  Sweats Diarrhea  Nausea
Patient received the Covid-19 vaccine. She vomited 15 minutes after receiving the first dose. Patient brought back into the room and was lying down on continuous monitoring.  Mother unsure if it was due to something she had for breakfast. Patient denies any difficulty breathing, swelling, or hives. Patient's heart rate remained in 70-80s and sating in 100%. Dr. notified. Patient was monitored for 45 minutes total. Advised mother what to monitor for and when to seek assistance.
Bell's palsy on the right side of face. Right eye cannot close, lips have no strength, loss of taste 3 days after vaccine
1-2AM fever 104-convuls ambulance called hospitalized adm for observation discharged 25FEB93; pt was adm mouth to mouth prior to ambulance arrival;
45 mins p/recvd vax pt returned w/generalized urticaria; many wheals & flares;
RUNNY NOSE ON DAY 3, SORE THROAT ON DAY 4, O2 SAT 87% ON DAY 5 AND WENT TO URGENT CARE. NO FEVER.
Left leg/thigh redness 4"x2.5" area warm/edema.