chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; A low grade fever; And exhaustion,following her covid vaccination, she states the symptoms only lasted a day; This is a spontaneous report from a contactable consumer (herself) via Pfizer sponsored program. A 61-years-old non pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; Tofacitinib citrate (XELJANZ), oral from Apr2020 (Batch/Lot number was not reported) to an unspecified date, at 5 mg, 2x/day for psoriatic arthropathy. No known allergies and medical history was reported. Concomitant medications included olmesartan medoxomil; rosuvastatin calcium (CRESTOR); omeprazole; vitamin d [vitamin d nos]; tramadol hcl and meloxicam (MOBIC) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient experienced in 2021 body aches, a low grade fever, and exhaustion, following her covid vaccination, she stated the symptoms only lasted a day on Feb/Mar 2021. No treatment measures were taken as result of events. The clinical outcome of the events were recovered in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
10 minutes following shot pt became pale sweaty, not feeling well. Weak & tired on exam she was pale, sweaty, pulse rapid BP OK. Pt was given water & lied down. BENADRYL given by mouth. 15 minutes later, feeling better sent home w/ normal vitals. 2 hr later patient doing OK per phone call to mom.
This case was reported by a pharmacist via call center representative and described the occurrence of eye disorder in a 68-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 16th April 2018 13:00, the patient received the 1st dose of SHINGRIX. On 16th April 2018, 15 min after receiving SHINGRIX, the patient experienced eye disorder. On an unknown date, the outcome of the eye disorder was not recovered/not resolved. The reporter considered the eye disorder to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient received SHINGRIX dose and developed a black dot on the left eye about 15 minutes after the injection.
Pt c/o slight SOB, dry mouth, dizziness after 2nd dose of Pfizer. RN & NP assessed VS (BP 147/87; HR 114, AOx4) afebrile, no SOB or trouble swallowing. Pt has history of anemia & taking iron supplements. Pt felt similar after 1st dose. RN & NP reassessed vital signs (BP 127/79; HR 99). Pt denied SOB, verbalized sx resolution. D/C to home with steady gait
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Suffered from Bell's palsy; This is a spontaneous report received from a non-contactable consumer from medical information team for a Pfizer sponsored program.  A 89 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "Suffered from Bell's palsy". The patient got the first COVID shot and suffered from Bell's palsy and three doctors told her that it was because of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 10/23/98; on same day pt exp malaise, sore LA, decreased movement LA, redness & swelling LA w/ itching; tx=Benadryl & antibiotics
Pain in chest area and middle back as evening progressed pain spead into sides and abdomin area.Had muscle spasms. hurt so bad couldn't lay daown or sit.could not apply presure to any midrif area. I took a couple of doses of Advil and about 10:00 pm I finally was able to rest.
hair loss; extreme fatigue; Spiked a fever of 102.9 less than 24 hrs after; extreme shortness of breath; coughing; bronchitis; O2 levels dropped to 90 at times; diagnosed with COVID; auto immune disease; This is a spontaneous report from a contactable Other HCP (patient).  A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 (Batch/Lot Number: EW0158) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination. Known allergies: NKDA; no food allergies; seasonal allergies. Concomitant medications included losartan potassium (LOSARTIN) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had spiked a fever of 102.9 less than 24 hrs after; was diagnosed with COVID 4 days later; had extreme shortness of breath and coughing; bronchitis; O2 levels dropped to 90 at times; fever for ten days; cough lasted for several weeks; now the patient had hair loss and extreme fatigue. DR was concerned that patient may have an auto immune disease now and now patient having bloodwork done to test for this (unknown results); still have shortness of breath some days and require an inhaler when that happens. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient underwent lab tests and procedures which included body temperature: 102.9 on 14Apr2021, oxygen saturation: dropped to 90 at times on 14Apr2021, sars-cov-2 test: covid on 17Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19 (as reported).  Therapeutic measures were taken as a result of the events and included administration of steroids. The patient was considered recovered with sequelae from the events on an unspecified date in 2021.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event autoimmune disorder 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.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that an unspecified number of patients received unspecified doses of improperly stored ROTATEQ, product lot# K007246, expiry date: 17-MAR-2016. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events were unknown. This is one of the several reports from the same source. Additional information has been requested.
Got her menstrual period and this is her 15 days with blood clot and heavy period; Got her menstrual period and this is her 15 days with blood clot and heavy period; Her CBC labs came back low; She can be anemic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Dec2021 09:00 (Lot number: FK5127) at the age of 10 years as dose 2 (tris), single for covid-19 immunisation. No covid prior vaccination. Relevant medical history included: "Asthma" (unspecified if ongoing); "Otitis media" (unspecified if ongoing). The patient took concomitant medications. No other vaccine in four weeks. There was other medications in two weeks. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 15Nov2021, when the patient was 10 years old, for COVID-19 Immunization, reaction(s): "After the vaccine she got covid". The following information was reported: HEAVY MENSTRUAL BLEEDING (serious), Menstrual irregular(serious) all with onset 17Dec2021 10:00, outcome "not recovered" and all described as "Got her menstrual period and this is her 15 days with blood clot and heavy period"; FULL BLOOD COUNT DECREASED (serious) with onset 17Dec2021 10:00, outcome "not recovered", described as "Her CBC labs came back low"; ANAEMIA (serious) with onset 17Dec2021 10:00, outcome "not recovered", described as "She can be anemic". The events "got her menstrual period and this is her 15 days with blood clot and heavy period", "got her menstrual period and this is her 15 days with blood clot and heavy period", "got her menstrual period and this is her 15 days with blood clot and heavy period", "her cbc labs came back low" and "she can be anemic" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: full blood count: (17Dec2021) came back low; sars-cov-2 test: (01Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of Menstrual irregular, heavy menstrual bleeding, full blood count decreased, anaemia. The patient was asthmatic, after the vaccine she got covid and she never got it in almost 2 years. A month after the vaccine she got her menstrual period and this is her 15 days with blood clot and heavy period from the first day. Her CBC labs came back low and she can be anemic now if i dont give her all the medications.
10 minutes after vaccination, patient syncopized.  His BP was low and he was tachycardic.  20 min after vaccines administered, patient with fine maculopapular rash on body.  Benadryl and decadron given.  He slowly recovered over the course of an hour.  The next day, he started complaining of tingling sensations first in his legs, then in his right arm.  The leg tingling resolved but arm tingling waxed and waned for the next few days.  He never lost feeling or had weakness.  No bowel or bladder concerns.  Neuro exam and reflexes remained normal
Mom stated child "screamed" for 8 hrs day of vaccine & off & on the next day. Child did not have BM for 4 days after vaccines & only then with infant suppository. C/O lethargy for several days after vaccines. Mom states she is a "medic" and did not take child to ER or PCP, child has temp of 101 degrees.  Advised mom to take child to PCP for further evaluation of condition and recommendation of further vaccines.
Patient experienced vomiting, chills, fever, fatigue and rash at the injection site a few hours after the injection.
Left forearm went and still is completely numb. Only 10% use of my Left hand. I have seen my primary care doctor and got a perscription for steroids. There has been no improvement since 11/29. im scheduled to see a neurologist on 12/28
Information has been received from  a register nurse (R.N) concerning to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant  therapies were not provided. On 31-MAR-2017, the patient was vaccinated with GARDASIL which had lot number L039066 and  expiration date on 19-MAR-2017, administrated intramuscularly for prophylaxis (dose, dosage number and anatomical location were not provided). The Patient was not expericiencing symptoms. There was no temperature excursion reporter. Product quality complaints were not involved. Additional information has been requested.
Had nausea and headache that began the day after shot. Headache continued for a week, then went away for a couple days.  Headache, nausea, and hot flashes came back Sunday 4/11 and are much worse than initial bout.  Headache has not responded to any treatment including all OTC pain relievers,  imitrex, tramadol, OTC allergy treatments.
Patient complained of itchiness. He had large hives covering from the groin to mid thigh to the back of the leg, extending down to the knees and some calf area. There are somehives on the arm as well. Took him to Urgent Care  Rx: Medrol 4 mg 21 pack. Instructed to take in the morning if symptoms don't improve overnight. Benadryl only that night.Next morning reaction includes the truck of thebody (back and chest). Patient is started on the Medrol with Benadryl. It inmproves but returns and more lesions are appearing including the face, neck , ears, fingers, knees. Taken again back to Urgent Care. He is given Benadryl 50 mg IM. Some reactions improve but he continues to have lesions appear and  disappear over the next 2 days. Also Friday morning his eyeball is red and swollen around the eyelid. The redness goes away and through the day lesion come and go. Lesion still as of this morning appear on his ankle. The lesions are hot to the touch and intensely itchy for patient. He continues to feel fatigue today and through the last 5 days. There are numerous pictures of the lesions.
Immed post injection, large amt of pain. Continued with pain x3 weeks. Pain with lifting & raising arm but not at rest.
Patient fell from a chair, he was found in prone position. Upon assessment patient did not respond to verbal commands, 911 was then called. After approximate five seconds patient was verbal and moving. He was coherent to person, place, time, and situation. Patients vitals post syncope episode were T. 98.2 R. 22 P. 96 B/P 131/71 spo2 96% on room air
she started itching everywhere; had hives; she also had massive diarrhea.; Her injection site was also extremely painful/Injection site really sore and hurtful; She also had vision blurriness/Vision affected a little; shortness of breath; redness and spots; quite uncomfortable; This is a spontaneous report received from a contactable consumer (patient, self-reported) via medical information team. A 67-year-old female patient BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EW0183 and expiry date was not reported), via an unspecified route of administration in arm right, on 11May2021 at 12:45 PM (age at vaccination: 67 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11May2021, the patient experienced she started itching everywhere, had hives, she also had massive diarrhoea, her injection site was also extremely painful/injection site really sore and hurtful, she also had vision blurriness/vision affected a little, shortness of breath, redness and spots, quite uncomfortable. Clinical course was reported as female patient who received her 1st dose of the vaccine yesterday. within 2 hours after the injection the patient had itching everywhere and had hives. This proceeded to continue to the night, where she also had massive diarrhoea. Reportedly the patient injection site was also extremely painful, which made her quite uncomfortable. She also had vision blurriness and shortness of breath. The patient also stated that the itchiness was still there, but it was nothing like it was be-fore. The redness and spots have diminished but she was still itching to death. The patient also stated that they are better than last night but still ongoing. Reportedly the patient did not want to get the injection, but her family suggested it. The patient also stated that she has some health problems. No further information provided by the patient. Reportedly the patient just wanted to report her information that she was concerned about getting the second shot. States that she has multiple allergies, does not specify. Reported that that she spoke with her allergist before the first shot, and they told her to get the injection. Reportedly the patient was wondering if she should get the second injection. The clinical outcome of the event she started itching everywhere was not recovered, and other event redness and spots was recovered, and other events was recovering.  No follow-up attempts are needed. No further information is expected.
Started feeling unwell several days after shot.  Chills fever soaked bed sheets and had to call in sick from work.  Did telehealth visit with primary who recommended Covid test which came back negative.  Primary advised going to Hospital emergency room for tests-she has been in hospital with pnemonia for 14 days and is now in ICU. Drs treating with high dose steroids, antibiotics and high dose oxygen.  She is not recovering.
Information has been received from a mother and a physician concerning a 38 month old female child with no allergies and a history of premature delivery who on 07/19/1999 was vaccinated SC with a first dose of varicella vaccine. There was no illness at the time of vaccination. Concomitant medications included Tylenol, and Motrin. Subsequently, the pt developed a fever of 104 deg F and 'she has chicken pox." Follow-up from the physician indicated that the pt developed "varicella naturally acquired May 30-June 2001." The mother reported that the fever was so high that the chid was hallucinating at night. It was reported that the pt recovered "within days of incident." Unspecified medical attention was sought. No furhter info is available.
Had a lump for a week that was hot and swollen; Had a lump for a week that was hot and swollen; Had a lump for a week that was hot and swollen; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender started received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient had a lump for a week that was hot and swollen. Outcome of the events was unknown.  Information on the batch number has been requested.
Never have had abnormal periods. Always lasting 28-32 days. They are now 17-20 days since April
02:45 PM walking , dizzy, rapid heart rate, mild chest pain. Directed to ER in hospital, CT Chest -- normal, EKG -- normal, Lab test-- normal. Xray Chest results --  basilar atelectasis, Hyperinflation of lungs. Blood pressure 171/109. No treatment given in ER -- f/u with PCP 12/18/20.  08:00PM nausea, headache, vomit 1x. 10:00PM fever 104.00;  Tylenol extra strength dose. 12/17/20 6:00am temp 99.00, Tylenol dose extra strength; body aches, fatigue, mild headache.
None, but vaccine is for 65+ and the patient is 64.5 YO!
Papular rash on all four extremities, had not resolved by assessment on 9/29/2022.
I felt a little sick tired and achy the night of 9/18 and went to bed. Ten minutes after waking up I went into V-tach and then V-fib, passed out and my ICD shocked me back. There was no warning or any symptoms. This has never happened before. A few hours later I followed up at Emergency room.
Tdap given on 12/26/06. Pt received Tdap 5/16/06, Td 6/16/06. Should have received Td on 12/26/06.  Follow-up states no known adverse event occurred - Td should have been given. Tdap vaccine type BOOSTRIX, GSK - Lot# AC52B012AA.
a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 27-NOV-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # 1637642 with expiration date 28-MAY-2022) via an unknown route for prophylaxis (product storage error). The administered dose experienced a temperature excursion for unknown time. It was reported that there were previous temperature excursions. The temperature excursions were detected by a data logger.  This is one of the three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2012USA003160: US-009507513-2012USA003525: