chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse, referring to a 34 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications and medical history were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA lot # N005274 for prophylaxis. No adverse effects were reported and no product quality complaint (PQC) was involved.
I had a sore arm a couple hours later.  Approximately 2- 2 1/2 hours after the injection the right side of my face started tingling, not completely numb but mild numbness.  The feeling is similar to Novacane wearing off from dental work.  Around 8 p.m. while laying down, my lips tingled for awhile.  As on 10 a.m. on 2/12/2021 I still have mild tingling in my right side of face and upper lip area on the right side.  I have had mild chills.
Hashimoto's thyroiditis diagnosis 11 months after vaccine. PCOS diagnosis 1.5 years after vaccine.
This spontaneous report as received from an other health professional refers to patients of unknown age and gender. In August 2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M040423 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA001288: US-009507513-1709USA001289: US-009507513-1709USA001230: US-009507513-1709USA001045:
Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive", which was also reported as "Vaccinated Family members in same household also positive after a Covid exposure on 28Nov2021. 12 vaccinated family members now covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101733546 same reporter/drug/event with different patient.
3 days after my vaccination, on 02/15/2021, extreme fatigue and mild headache. The ongoing issue of the diarrhea from the Moderna dose 1. About a week after, the fatigue was getting so bad that the doctor and I realized that my heart rate was lowering. The doctor had me stop taking the losartan, but within a month my BP started getting too high. She put me back on the losartan, but my heart rate was still too low. My resting heart rate has dropped so low that I just want to fall asleep at work. I always feel so fatigue and the results to the EKG, echocardiogram and heart monitor results have been normal, but my heart rate keeps falling so low that I just want to fall asleep even when I'm active. My dr. can't figure out why my heart rate is so low and why I am so tired. My sleep specialist checks my report on my CPap and tells me nothing has changed, the results are fine. I have not recovered from my AE, I was not so fatigue, and I still have the diarrhea, and my heart rate was not so low prior to the Moderna dose 1 and the Moderna dose 2 just intensified it.
Patient experienced redness and swelling at injection site. Mother reached out to doctor via phone and sent pictures.
Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient; Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 066821A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson Vaccine (lot number was 066H21A, expiration date was 02-Apr-2022 and first dose) on 25-Jun-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson Vaccine.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment details was provided.  The date on which the vial was moved from freezer to refrigerator was 3-Mar-2022. Maximum or minimum temperatures reached at the storage condition, as applicable were 49 degrees Fahrenheit and 37.7 degrees Fahrenheit respectively. The vial was stored in refrigerator and was in refrigerated storage condition at the time of the excursion. Vials were not visualized and the proposed desired use by date of the vial was given as 16-Mar-2022. The nurse reported no adverse reactions or side effects to the vaccine.
Allergy around the vaccine area, swollen, warm and itchy. It hurts when I touch it, and the reaction was a week after getting the vaccine.  The reaction looks like allergic reaction.  I took Claritin  and applied hydrocortisone cream to the area
TIA ~ found slumped in chair, aphasic, unable to stand. sent to local hospital emergency room
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 at 12:00 as dose 3 (booster),single (Lot number: Ff2589), in right arm and on 21May2022 at 12:00 as dose 4 (booster), single (Lot number: Fm9992) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (15Jul2022) positive; (20Jul2022) Negative; (28Jul2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication within 2 weeks. Patient received COVID 19 Treatment of paxlovid from 15Jul2022 to 20Jul2022. There was no Known allergies.  No follow-up attempts are possible. No further information is expected.
Sat 5-5-07 fever 101 AX, Sun 5-6-07 fever 103.8 AX, fussy
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit (8.611111111 degrees Celsius), the second lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit (15.5 degrees Celsius), the third lasting for 24 hours, with the highest recorded temperature of 64.8 degrees Fahrenheit (18.222222222 degrees Celsius), the fourth lasting for 48 hours, with the highest recorded temperature of 48.2 degrees Fahrenheit (9 degrees Celsius), the fifth lasting for 24 hours, with the highest recorded temperature of 48.1 degrees Fahrenheit (8.944444444 degrees Celsius), the sixth lasting for 48 hours, with the highest recorded temperature of 46.4 degrees Fahrenheit (8 degrees Celsius), the seventh lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit (8.444444444 degrees Celsius), the eighth lasting for 24 hours, with the highest recorded temperature of 46.2 degrees Fahrenheit (7.888888889 degrees Celsius), the ninth lasting for 72 hours, with the highest recorded temperature of 46.3 degrees Fahrenheit (7.944444444 degrees Celsius), the tenth lasting for 24 hours, with the highest recorded temperature of 46.6 degrees Fahrenheit (8.111111111 degrees Celsius) and the eleventh lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit (8.222222222 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 25-AUG-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Administered by Facility. Unable to retrieve lot numbers. Only injection dates were provided. 80-year-old male who was in the high care living center connected to the hospital here.  Patient recently in the emergency room for acute kidney injury.  Patient receiving fluids as of yesterday.  Reviewing patient's history and laboratories patient with a left lower lobe infiltrate on chest x-ray on 14 January 2022.  Patient brought over to the emergency room today because patient is hypotensive and weak with increasing oxygen demand.  Patient complaining of some mild back pain earlier no back pain now.  Denies nausea or vomiting denies abdominal pain.  Denies trauma fall or injury.  Patient brought over for further evaluation secondary to hypotension
Information has been received from a registered pharmacist concerning a male patient who on 21-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck), subcutaneously (dose and lot number not provided). The pharmacist informed that on 21-MAR-2011, the patient experienced pain at the injection site that had lasted since the injection was given on 21-MAR-2011. The patient did not seek medical attention. At the time of the report, the adverse event did no improve. The patient's outcome was unknown. Additional information has been requested.
Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium
Pt states that following vaccine administration her arm/shoulder became very sore and has remained sore since. She states it is very painful to move her shoulder.
Papilledema, pseudotumor with benign intracerebral hypertension, optic nerve edema 10/08/08-records received for DOS 7/21/08-Assessment:Papilledema with enlarged physiologic blind spots and episodes of visual dimming. Classic for pseudotumor cerebri. Occasional occipital nuchal headaches for past two months. C/O vision very dim and dark for about 10 seconds for past month.
internal head tremors; Tinnitus; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus) and HEAD TITUBATION (internal head tremors) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced TINNITUS (Tinnitus) (seriousness criterion medically significant) and HEAD TITUBATION (internal head tremors) (seriousness criterion hospitalization). The patient was hospitalized on sometime in March 2021 due to HEAD TITUBATION. At the time of the report, TINNITUS (Tinnitus) and HEAD TITUBATION (internal head tremors) had not resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment for the event included psychiatric medications and vitamin D.  Concomitant medication use was not reported. Treatment details were not provided for the events (Tinnitus, head titubation) experienced after the 1st dose.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event (tinnitus, head titubation), a causal relationship cannot be excluded.   This case was linked to (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (tinnitus, head titubation), a causal relationship cannot be excluded.
vasodilation; dropped BP/blood pressure drops; diaphoretic; tingling in arms/legs/Tingling all over; chills/Chilled; Hypotensive; This is a spontaneous report from a contactable nurse(patient). A female patient of an unspecified age received BNT162B2 (lot number: EH9899, expiration date: Mar2021), via an unspecified route of administration, on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history included shellfish and the seafood allergy. Concomitant medications were not reported. The patient had the vaccine now about an hour and half or may be two hours ago and within 20 minutes on 22Dec2020. The patient apparently became diaphoretic and hypotensive and 80 Systolic and the patient was tingling all over and chilled. They tried to call the paramedics and tried to bring the patient to ER. The patient stated she had similar reaction to some degree having taken some shellfish and the seafood allergy. Her blood pressure dropped, she supposed it's histamine release kind of drop her pressure. The patient was wondering, was this something that because it was in her system, was she going to continually keep having this episodic or is that just the one time.  The patient reported that she had a reaction similar to her seafood allergy reaction: histamine release, vasodilation, dropped BP, 20 mins after vaccine, became diaphoretic, systolic BP in 80s, had tingling in arms/legs and chills. The patient stated that she sat in the ER for about an hour and was fine after that. The outcome of the events was recovered on 22Dec2020.
sore arm; pain into her left breast; so cold that thought she was going to went in shock/teeth was cold; redness in her face; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BREAST PAIN (pain into her left breast), FEELING COLD (so cold that thought she was going to went in shock/teeth was cold), ERYTHEMA (redness in her face) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Apple allergy- itching, throat close up and problem with the tongue), Fruit allergy (Peach allergy-itching, throat close up and problem with the tongue), Allergy to nuts (Itching, throat close up and problem with the tongue) and Food allergy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 8:00 AM, 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 PAIN IN EXTREMITY (sore arm), BREAST PAIN (pain into her left breast), FEELING COLD (so cold that thought she was going to went in shock/teeth was cold), ERYTHEMA (redness in her face) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), BREAST PAIN (pain into her left breast) and CHILLS (chills) outcome was unknown, FEELING COLD (so cold that thought she was going to went in shock/teeth was cold) was resolving and ERYTHEMA (redness in her face) had resolved. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported.  The action taken with mRNA-1273 in response to the event was not applicable.
I have gotten an overdose of the Pfizer vaccine 3/2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (medically significant), described as "I have gotten an overdose of the Pfizer vaccine 3/2".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client's Mother stated that after client received Menactra vaccine on 12/14/2019, she developed "pimples" that did not itch for 24 hours. Mother stated she did not return to the clinic to report this because the rash disappeared the next day
lightheadedness; headache; vision changes; increased respirations; This is a spontaneous report from a non-contactable healthcare professional. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EN6205, Expiration date was not reported), intramuscularly on an unspecified date (at the age of 51-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included asthma (often triggered by stress and does have albuterol inhaler on hand) from an unknown date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced lightheadedness, headache, vision changes and increased respirations. It was reported that during the 15-minute waiting period after the injection, the patient began to experience lightheadedness, headache, vision changes and increased respirations. The patient denied rash, hives, difficulty swallowing, wheezing, throat tightness and hoarseness. The patient has a history of asthma often triggered by stress and does have albuterol inhaler on hand but has not used today. The patient denied frequent use of albuterol inhaler. Treatment included was water and TYLENOL 1000mg. The followup response to treatment was good. The patient's symptoms all resolved prior to discharge. The patient's O2 remained 99-100%, denied difficulties breathing and respirations decreased while she was in the bay. The patient was discharged, stable to go home and for follow up with PCP. The outcome of the events was recovered.  No follow-up attempts are possible. No further information expected.
The day of the vaccination patient felt weakness in both lower legs around 5:00 PM. Went to Hospital ER. By this time she felt tingling in her arms and legs and hands. ER had no explanation as to what was causing this. They felt there was a chance it could be the flu vaccine. They did do a CT scan of the lumbar spine and found spinal stenosis in her back according to her. She continues to feel fatigue and lightheadedness with a headache on and off.
Pt. Had vasovagal response right after.  Patient was laid down to floor, legs were elevated, pt. felt better, A&Ox3. Transferred pt. To wheel chair, had another vasovagal for 4secods, recovered quickly, emesis pouch was provided , no emesis. had another vasovagal for 3 seconds, quickly pt. laid down to floor. Legs elevated. Ice pack was placed behind neck. Pt. Stayed on floor for  10 mins., recovered, &oX3. Father at site present whole time. Pt. was moved to observation after  She was stable to wait in observation area for 15-30 minutes.
Received their first dose in march but never got a second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received their first dose in march but never got a second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received their first dose in march but never got a second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received their first dose in march but never got a second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Pt arm is warm to touch and red. No c/o pain received shot on 10-24-12 (shingles vacc.) came in on 10-25-12 with presentation of arm. Advised to use cool compress to area and take TYLENOL. Called patient at lunch time stated she was doing fine and that her arm was getting better.
On 5/15/2019 after immunization around 9pm, patient experienced side effects of body aches. Next day 5/16/2019 around 3pm, patient experienced fever, nausea, more body ache. Patient went to urgent care that day due to symptoms. Patient said urgent care physician mentioned symptoms could be related to Shingrix immunization. On 5/17/2019, patient noticed some symptoms are subsiding, but still feeling very tired. On 5/22/2019, patient revisited urgent care, this time she was diagnosed with bronchitis.