chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had vaccine about 10:15 am,about an hour after I developed a headache,arm began to get sore,nothing unusual then.As the night progressed,headache became worse and had chills,slight nausea.Couldn't sleep had to urinate a couple of times during the early am hours,took temp in the am early was 100 at that point. By 5 am felt like I had a severe UTI,frequency,urgency,urethral spasm after voiding.Then by 6am,had hematuria. I emailed my PCP at 7:30 am,I dropped off a urine sample locally.My doctor called in nitrofurintonin prescription for 5 days,100mg   2x per day. Still had headache chills off and on and my arm was very sore. Drank a lot of fluids,took tylenol 650mg,Still had nausea.   By later that day hematuria wasn't visible  anymore to me. Two mornings later,my PCP emailed me with a copy of my urinalysis report,also saying that there was zero bacterial growth.
pt recv vax 17SEP95 & learned that pt was pregnant (LMP November 1995);22DEC95 had a miscarriage;
Arm hurts horrible; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccines with an associated reaction of pain in extremity (received Covid vaccine on an unknown date in an unknown arm).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had received the first dose in an unknown arm. The reporter stated that his/her arm hurts horrible with the vaccine, it hurt just as much with the covid vaccines. The reporter was going for the second dose. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Information has been received from a lawyer regarding a case in litigation concerning a 61 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-APR-2015, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. In May 2015, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself and economic losses. Additional information has been requested.
pt recv vax 22JAN96 & pt devel an inj site rxn, characterized by redness, swelling, pain & a tingling feeling in arm;
This spontaneous report has been received from a medical assistant and refers to a 4-year-old patient of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 11-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M041083, expiration date 04-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. The reporter also stated that she had a printed report of the patients who received vaccines that had undergone the temperature excursion. The report included vaccine name, date given lot number and the name, gender and birth date of patient. This is one of several reports received from the same reporter. This is an amended report as corrected. This report was previously submitted with the incorrect Worldwide unique case identification number "US-009507513-1705USA005093", and this new follow-up submission is to provide the correct identification number "US-009507513-1706USA003936". "US-009507513-1705USA005093" is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique identification number. Additional information is not expected as all relevant correspondence has already been received. Sender's Comments: US-009507513-1705USA005086: US-009507513-1705USA005094: US-009507513-1706USA003934: US-009507513-1706USA003935: US-009507513-1705USA005093: US-009507513-1706USA003937.
This spontaneous report was received from a physician regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated an improperly stored doses of GARDASIL (dose and route were not reported, lot #L040459 with expiration date 06-APR-2017 or lot # K008931 with expiration date 04-MAR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
right arm pain; tiredness; nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, tiredness and nausea. On an unknown date, the outcome of the pain in arm, tiredness and nausea were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the right arm. On the same day, the patient received Pneumonia vaccine on the left arm. The patient stated that she had right arm pain with nausea and tiredness which lasted for 4 to 5 days. These symptoms had completely resolved at the time of reporting. The reporter consented to follow up.
UNSTABLE ANGINA 12/8/2022  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Approximately three days after vaccine, I experienced a blood clot.  This caused  an acute ischemic stroke in my left frontal lobe, resulting in muscle weakness and partial loss of use in my right leg.
Within 5 min, pt experienced nausea, dizziness. Completely collapsed limply within 10 min. With help, checked for breathing, checked pupils. Revived quickly. Pupils were pinpoint after event & pt still nauseated & dizzy. Transported EMS to hospital.
c/o fever (did not take temp), chills & dizziness;took a Motrin;felt better in 1 1/2-2hrs;(pt was reluctant to report, but did so on advice of daughter who works @ hlth dept
sore arm; patient was pregnant at time of vaccination.; This is a spontaneous report from a contactable consumer (patient) communicated to a sales representative. This consumer reported information for mother. This is a maternal report.   A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), first dose on 09Apr2021 12:30 (Lot number: ER8729) as dose 1 single and second dose on 02May2021 11:00 (lot number: EW0172) (age at vaccination 37-year-old) as dose 2 single both intramuscularly administered in left arm for COVID-19 Immunisation at Pharmacy/drug store. The patient was pregnant at time of vaccination of 23 weeks and pregnancy due date was 29Aug2021. No other vaccine in four weeks. The patient medical history not reported. The patient's concomitant medications were not received within 2 weeks of vaccination. The patient was pregnant at time of vaccination on 09Apr2021 and sore arm on 02May2021. No covid prior vaccination. No covid tested post vaccination. Treatment was not received for event sore arm. The outcome of event pain in arm recovered in 2021 and other event was unknown.  Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
Patient stated experiencing discomfort on left arm (injection site) for extended period of time. Initial doctor visit was made and the follow us required according to the patient.
I did not have an adverse reaction to the vaccine. In 01/2023 I noticed that I was not feeling well and feeling weak. I contacted my doctor, and I was diagnosed as anemic.  I take Vitamin B12 daily and I am drinking more water. My iron level is within normal range. I don't eat meat. I have meet with a dietician and I am on a meal plan.
Rapid heartbeat; Soreness on her injection arm that last for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat) and VACCINATION SITE PAIN (Soreness on her injection arm that last for a couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat) and VACCINATION SITE PAIN (Soreness on her injection arm that last for a couple of days). At the time of the report, HEART RATE INCREASED (Rapid heartbeat) and VACCINATION SITE PAIN (Soreness on her injection arm that last for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs and Treatment details, if any, not provided.
felt hot all over & wheezing about 7-8 mins p/vax fainted in elevator; brought back to office & given Adrenalin inject & improved; taken to hosp cont to improve over 2-3 hrs;
Uncontrollable and constant diarrhea; Both legs to knees severely swollen with retention of fluid; bloating in his stomach/constant bloating in stomach; Both legs to knees severely swollen with retention of fluid; Has no appetite; Sleepy all the time; Feels very cold and shaky; Feels very cold and shaky; Vaccine changed his taste of foods; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Uncontrollable and constant diarrhea), PERIPHERAL SWELLING (Both legs to knees severely swollen with retention of fluid), ABDOMINAL DISTENSION (bloating in his stomach/constant bloating in stomach), FLUID RETENTION (Both legs to knees severely swollen with retention of fluid) and DECREASED APPETITE (Has no appetite) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Uncontrollable and constant diarrhea), PERIPHERAL SWELLING (Both legs to knees severely swollen with retention of fluid), ABDOMINAL DISTENSION (bloating in his stomach/constant bloating in stomach), FLUID RETENTION (Both legs to knees severely swollen with retention of fluid), DECREASED APPETITE (Has no appetite), SOMNOLENCE (Sleepy all the time), FEELING COLD (Feels very cold and shaky), TREMOR (Feels very cold and shaky) and TASTE DISORDER (Vaccine changed his taste of foods). At the time of the report, DIARRHOEA (Uncontrollable and constant diarrhea), PERIPHERAL SWELLING (Both legs to knees severely swollen with retention of fluid), ABDOMINAL DISTENSION (bloating in his stomach/constant bloating in stomach), FLUID RETENTION (Both legs to knees severely swollen with retention of fluid), DECREASED APPETITE (Has no appetite), SOMNOLENCE (Sleepy all the time), FEELING COLD (Feels very cold and shaky), TREMOR (Feels very cold and shaky) and TASTE DISORDER (Vaccine changed his taste of foods) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
In less than 24 hours of receiving the vaccine, I experienced cold chills, body aches and soreness.  I went to bed and had to sleep for more then 12 hours to relieve the symptoms I was experiencing.  In less than 48 hours all the symptoms have cleared.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 17:00 as dose 4 (booster), single (Lot number: GJ2524) at the age of 57 years, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL, start date: 31Dec2022, stop date: 04Jan2023; NYQUIL, start date: 31Dec2022, stop date: 04Jan2023. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Symptoms came back and started testing positive again. No known allergies.  No follow-up attempts are possible. No further information is expected.
Tired the next morning, dizzy, flushed, 101.6 fever. Body pain, H/A. Felt like she would pass out, weak. Sore arm couldn't move it. Solid red circle at inj site.
Headache, Extreme Fatigue, Chills, Body Aches, Flushing of Face, Itching at Injection Site
Pt vax w/ 3rd hepta B on 16Jul90.  HBsAB test showed titer of 3.0RU.
Redness and pain at site of injection. Symptoms resolved within 2-3 days. Patient cancelled appointment due to resolution of symptoms.
Blisters on his hand and feet; it was all red; blisters are on fire/hand feels like burn; hot all the time; itching is coming back and forth; irritation; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters on his hand and feet), ERYTHEMA (it was all red), BURNING SENSATION (blisters are on fire/hand feels like burn), FEELING HOT (hot all the time) and PRURITUS (itching is coming back and forth) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLISTER (Blisters on his hand and feet), ERYTHEMA (it was all red), BURNING SENSATION (blisters are on fire/hand feels like burn), FEELING HOT (hot all the time), PRURITUS (itching is coming back and forth) and SKIN IRRITATION (irritation). The patient was treated with BETAMETHASONE DIPROPIONATE (BETAMETHASONE DIPROPIONATE CREAM) ongoing since an unknown date for Adverse event, at a dose of 0.05%; SILVER SULFADIAZINE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of cream and pills. At the time of the report, BLISTER (Blisters on his hand and feet), ERYTHEMA (it was all red), BURNING SENSATION (blisters are on fire/hand feels like burn), FEELING HOT (hot all the time), PRURITUS (itching is coming back and forth) and SKIN IRRITATION (irritation) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported.   This case was linked to MOD-2021-321355 (Patient Link).
Past store has got an outbreak case after getting second shot of Pfizer COVID-19 Vaccine; Past store has got an outbreak case after getting second shot of Pfizer COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Past store has got an outbreak case after getting second shot of Pfizer COVID-19 Vaccine".  Additional information: Medical enquiry information was reported. Transferring agent stated, "he had a consumer on the other line. He said that their past store on their charge after getting Pfizer COVID-19 Vaccine, he got an outbreak case. The concern was their past store had got an outbreak case after getting second shot of Pfizer COVID-19 Vaccine and he had also some questions regarding for yearly vaccine of COVID-19. The agent already answered his question about clinical trials.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
4cm Red-firm-warm to touch Rx for Augmentin Tsp BID x 10days.
The patient has dementia; patient received bnt162b2 as DOSE 3 (BOOSTER); Inappropriate dose of Vaccine administered; This is a spontaneous report from a Pfizer sponsored Program via contactable pharmacist.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine include COVID-19 Vaccine, Batch/Lot Number: Not reported via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and as DOSE 2, SINGLE both for covid-19 immunization (Primary Immunization series complete but unknown manufacturer). On an unspecified date, the patient has dementia, patient received bnt162b2 as DOSE 3 (BOOSTER) and had an Inappropriate dose of Vaccine administered. The reporter explains that they did a booster dose clinic yesterday and the patient had a copy of the card. The patient has dementia. The niece of the patient contacted them sharing that the patient had gotten the booster the week prior somewhere else and didn't tell anyone at the facility. The reporter wanted to know if there was anything the patient needs to look for or be aware of for the patient. The patient received 2 doses of the covid 19 booster vaccine and It was clarified the patient has gotten 4 doses total. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events (dementia, Booster, Incorrect dose administered) and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Woke in the morning on 2-4-2021 with diaphoresis, SOB and pain and swelling at the injection site with 8- 10 cm area of induration. He used his inhaler without improvement. Diminished breath sounds and tachypnea O2sat 96%
Headache lasting greater than 1 week, extreme fatigue and vaginal bleeding. Normally no headaches and very regular cycle
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021 at 1:21 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. No treatment medications were provided.
local erythema and raised skin at site of injection measuring 5x4x1cm, non tender, mild warmth to site. No pain, loss sensation, no  loss strength, no LAD axilla or chest, normal ROM, no tenderness to this site. NO constitutional symptoms and the patient was unaware of a local skin reaction.
pt c/o redness @ site, swelling & pain @ site;pt also c/o skin peeling & itching @ site of inj
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 prefilled syringes lot # reported as M98916 with expiry date: 17-SEP-2016 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 32.97 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursion reports. 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.