chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STROKE; DIZZINESS; BLURRY VISION; MIGRAINES; This spontaneous report received from a patient concerned an adult male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient had optimal body weight, lifestyle and diet. The patient had no history of heart or other health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, dose 1 administered on 08-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. Following vaccination with covid-19 vaccine ad26.cov2.s on an unspecified date in APR-2021, the patient suffered from dizziness, blurry vision and migraines for three weeks. On 28-APR-2021, the patient had a stroke which affected right side and speech which was diagnosed by a cardiologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, blurry vision, and migraines, and the outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20230152916- Stroke-The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Mom relates infant became expressively irritable and crying post receiving a DTaP. Child was not like this prior to this immunization. Child has not slept well either, symptoms have perssited x 2 wks. Suggest no further DTP.
Upper deltoid to elbow swollen and hot to the touch the evening of 10/22/03.  Area of reddness and swelling 4"x2" today 10-24-03 client states she is much better today.  Able to move arm today, client has been taking asprin for dicomfort instead of ibuprophen.
Second Dose had severe debilitating migraine headache 12hrs after dose with severe nausea and vomiting through 72hrs following dose.; with severe nausea and vomiting; with severe nausea and vomiting; Experienced severe muscle pain during 12-30hrs post dose with temp 101; Experienced severe muscle pain during 12-30hrs post dose with temp 101; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 52-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0182, Expiry date: not reported), via an unspecified route of administration in left arm on 28May2021, at 13:00 (at age of 52-years-old) as dose 2, single for covid-19 immunization. Medical history Gilbert's syndrome, Rosacea, irritable bowel syndrome from unknown date unknown if ongoing. Concomitant medication(s) included omeprazole taken for an unspecified indication, start and stop date were not reported; multivitamins [vitamins nos] taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamides for drug hypersensitivity, cephalexine for drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0170, Expiry date: not reported), via an unspecified route of administration in left arm on 07May2021, at 14:00 as dose 1, single for covid-19 immunization and experienced moderate migraine, nausea and vomiting. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 29May2021 at 07:00, patient experienced second dose had severe debilitating migraine headache 12hrs after dose with severe nausea and vomiting through 72hrs following dose, severe muscle pain during 12-30hrs post dose with temp 101, which eased off with only migraine and nausea remaining through 72hrs. The patient underwent lab tests and procedures which included body temperature: 101 on May2021. The patient received treatment headache and anti-nausea meds over the counter. Therapeutic measures were taken as a result for all the events. The events recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Fully vaccinated with Pfizer. Tested positive on 01/03/2022 upon arrival to Medical Center. Expired after arrival on 01/03/2022.
Started with 100.6 fever at 3am- 10pm following day 5/15/21  along with stomach ache, nausea and headache  5/16/21 right underarm lymph node began slightly.  Dark yellow pee, once.  5/17/21 - woke up with swollen lymph nodes, underarms and left side neck, right arm lymph node, painful.
Pregnancy hx: currently pregnant, 1 prior pregnancy resulting in live birth EDD for current pregnancy: 7/2/2021 ADEs: likely robust immune response. Extreme fatigue, pounding headache, and reduced appetite X 36 hours. Onset about 6 hours after immunization. Also had very sore deltoid at site if immunization. No fever / rash / swelling. Symptoms relieved with APAP.
Arm soreness; fever 99-102 over 24hrs; body ache; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 09:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; AMLODIPINE; LOSARTAN; XANAX. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline"; Celebrex, reaction(s): "Known allergies: Celebrex". Vaccination history included: Covid-19 vaccine (Dose 3 (Booster), unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series completed, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Oct2022 at 19:00, outcome "recovering", described as "Arm soreness"; PAIN (non-serious) with onset 11Oct2022 at 19:00, outcome "recovering", described as "body ache"; CHILLS (non-serious) with onset 11Oct2022 at 19:00, outcome "recovering"; PYREXIA (non-serious) with onset 11Oct2022 at 19:00, outcome "recovering", described as "fever 99-102 over 24hrs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pyrexia, pain, chills. Additional information: The patient had no other vaccine in four weeks. The patient had no covid prior vaccination and was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Pt developed myocarditis. Symptoms developed on  27 April.  Smallpox vaccination given on 19 Apr 09.  5/28/09 Medical records received DOS 4/27/09 to 5/21/09. FINAL DIAGNOSIS: Acute Myocarditis, chest pain, anxiety disorder (NOS). Post vaccination dx of acute myocarditis. Now c/o of periodic episodes of chest pain, pain shoots down left arm, vomiting.  6/12/09 Medical records received DOS 4/27/09 to 6/1/09. FINAL DIAGNOSIS: Myocarditis/pericarditis, anxiety disorder (NOS). Post vaccination c/o chest pain, sharp pain L arm, vomiting. Vaccinia right deltoid normal red reaction. Lightheadedness, headache. Paroxysmal nocturnal dyspnea. Bradycardia. Chest tightness, pressure.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient was seated at the post vaccination area on a bar stool provided by the store when she felt light headed and fainted.  Upon falling off the bar stool she hit her head on a water fountain located next to her.  Her ankle was also tangled within the constructs of the chair and was broken upon falling. 911 had to called for assistance and she was taken away.
Local erythema and edema at site of injection associated with supraclavicular adenopathy draining limb of injection site and animal bite.
Woke up to site of injection swollen, red, and warm, muscles stiff, unable to lift or move arm without severe pain/blacking out.  Lower back pain later in the day, followed by joint pain, aches, chills and fever.  Non-responsive to NSAIDs.  By the next day, on 12//23/2016, no improvement at injection site, and non-itchy rash had developed over entire chest region.
Red, swollen size of softball, hard and warm to touch. Limping when walks. Tylenol and ice to thigh.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX. In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756559A, A0756561A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA); AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA); AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Information has been received from a male physician who in the 1980's was vaccinated with a dose of varicella virus vaccine live. In the 1980's, the physician was involved in varicella research and was vaccinated with varicella virus vaccine live as an adult. A titer was drawn during the research was positive for varicella, however, all other commercial titers drawn there after were negative. The physician had treated women with natural varicella and never developed chickenpox. On 6/1/04, the physician had a commercial titer drawn and the results was negative. Unspecified medical attention was sought. Subsequently, on 6/1/04, the physician was re-vaccinated. A product quality complaint was not involved. The physician mentioned his son (WAES0406USA01257) and a friend of his son (WAES0406USA01258) who were both vaccinated with varicella virus vaccine live and subsequently developed chicken pox. Additional information has been requested.
get shingles; Rash; Second dose later than 2-6 month; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced shingles, rash and drug dose administration interval too long. On an unknown date, the outcome of the shingles, rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: The pharmacist reported that sometimes the patients received their second dose later than the recommended 2-6 month time frame. The reporter indicated there were patients who broke out in shingles rash a few months after the second dose, in patients who received second dose per recommended schedule, as well as the patients who received second dose late. The pharmacist did not had any patient specific information at time of reporting, just stated that it had happened to several patients. The reporter consent to follow up. The case was linked with case US2022123774, reported by same reporter. Additional Supportive Information: The patients received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.; Sender's Comments:  US-GSK-US2022123774:Same reporter
severe body pain from torso down, shortness  of breath, chest tightness, 87% on room air today, torso to feet burning sensations, faiacl "heaviness" , bilateral arm pruritic pain, difficulty making decisions at work today ,  gray lips during triage call lead to 911 disposition,
Patient was told to stay in the area for at least 15 minutes after vaccination.  She eventually came up to the counter and said she was feeling light headed and that she felt like her chest and neck were tight but she was not having trouble breathing.  She was asked to remain seated and the pharmacist sat with her and discussed her symptoms.  The patient felt clammy and reported tightness in her neck but no restriction to breathing.  Patient was given benadyl as a precaution to try to minimize any possible allergic reaction and she remained in the lobby for roughly 45 minutes.  After further discussion the patient felt like she was not improving but not getting any worse but agreed to have paramedics called to the scene for further assessment.  Patient actually walked outside to the ambulance where she was taken over care by the paramedics.
This spontaneous report was received from a healthcare worker and refers to an unspecified amount of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date in June 2015, the patients received VAQTA (pediatric and adult) strength 25/0.5 (units not provided) (lot #, expiration date, dose and route of administration were not reported) that was improperly stored on unspecified dates between 10-JUN-2015 through 22-JUN-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt here CMA from well child ck. Declines HPV #2 states had HPV #1. Within 24 hrs developed nausea, vomiting, lasting 7 days. Admin 10/7/10 during well child.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MALAISE (Malaise), ILLNESS (got really sick for booster dose), HEADACHE (Headache) and VOMITING (Vomited) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Keratosis, Fractured vertebra, White coat hypertension and Fall. Concurrent medical conditions included Lyme disease, Drug allergy (Allergy to sulfa drugs) and Relapsing-remitting multiple sclerosis. Concomitant products included Duloxetine; Losartan Potassium; Methotrexate; Zinc; Oxycodone; Vitamin D3 for an unknown indication. On 19-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), MALAISE (Malaise), ILLNESS (got really sick for booster dose), HEADACHE (Headache) and VOMITING (Vomited). At the time of the report, ASTHENIA (Weakness), MALAISE (Malaise), ILLNESS (got really sick for booster dose), HEADACHE (Headache) and VOMITING (Vomited) outcome was unknown. No treatment information was provided by the reporter.
5 hours after administration: muscular soreness at injection site; 10 hours after administration: Hot and cold flashes, caused poor sleep, muscular soreness persisted; 14 hours after: hot and cold flashes & muscular soreness persisted, headache, fatigue : treated with ibuprofen, rest, liquids; 24 hours after: upset/queasy stomach, and headache, fatigue, muscular soreness persisted : treated with ibuprofen, rest, liquids; 30 hours after: headache, fatigue, muscular soreness persisted : treated with ibuprofen, rest, liquids; 40 hours after: headache, muscular soreness persisted for 2 additional days : treated with ibuprofen.
I'm not sure of vaccine description.  2021 combo of for eggbased influenza vaccines given at pharmacy standard dose, not high one as sensitive and only 70. Next day site sore as expected.  Unexpected dime sized sore darkened spot mid way down left inside arm on little finger side.  NOT a bruise.  Lasted one week. Sat, Oct 9 after carrying usual heavy groceries left shoulder very sore esp outer area of shot and behind that, got worse over next several days.  Saw chiropractor Mon, Oct 11 who evaluated and recommended rest, ice.  Movement still restricted and area sore.
Information has been received from the physician's office and other health professional concerning a 61 year old female patient with "immunocompromised" immune system disorder and with CELEBREX, AGGRENOX, sulfonamide and statin allergy who was advised on 04-DEC-2009 (also reported in December 2009) at 11:30 was vaccinated subcutaneously with the first 0.65 ml dose of ZOSTAVAX (Merck) (Lot number 665293/1175Y). Concomitant medication included: prescribed VALTREX during office visit. It was reported that the patient still had shingles. On 14-OCT-2010 the patient was treated for shingles. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Bell's Palsy (left side of face paralysis); This is a spontaneous report from a contactable healthcare professional (patient).  A 35-year-old female patient received the 2nd dose (at the age of 35-year-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL8982), via an unspecified route of administration on the left arm on 05Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient had no known allergies and medical history reported as none. There were no concomitant medications. The patient was not pregnant (including the time of vaccination). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL1283), via an unspecified route of administration on the left arm on 15Jan2021 09:30 (at the age of 35-year-old) for COVID-19 immunization.  The patient developed Bell's Palsy (left side of face paralysis) on Friday afternoon 19Feb2021 (2 weeks after second dose of the vaccine). The patient went to the doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care due to the event (which was considered as serious disability or permanent damage). The emergency room (ER) doctor prescribed valacyclovir and prednisone. Outcome of the event was not recovered.; Sender's Comments: Based on temporal relationship and known drug safety profiles, a possible contributory role of suspect drug cannot be excluded for the reported event Bell's Palsy.  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.
Information has been received from an administrator referring to an unspecified number of patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of GARDASIL 9 (lot # K026246 with expired date on 28-JAN-2017, dose and route were unknown) which were post temperature excursion. No concomitant medication was reported. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Redness/rash around injection site, itching around injection site, headache, and potential low grade fever.
Case number PHEH2014US003835 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown)) at a dose of 0.5 ml on an undetermined date in JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration.  Following an internal review on 18 AUG 2014 of the data received on 21 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Sore arm after first shot; This is a spontaneous report from a non-contactable consumer, the patient reported for himself/herself.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported/not available), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was stated that, on an unspecified date, the patient experienced sore arm after first shot. The event was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, had not been tested for COVID-19. The outcome of the event was reported as recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful and tender area in armpit of the arm that got the shot. Assuming lymph node swollen and tender.
High fever for 3 days, extreme fatigue, muscle aches, chills, nausea.
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), on 22Jun2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6203; Expiration date: 30Jun2021), administration date: 20Feb2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EP6955; Expiration date: 30Jun2021), administration date: 13Mar2021, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FC3183), administration date: 25Sep2021, for COVID-19 Immunization. The following information was reported: SKIN HYPERPIGMENTATION (non-serious) with onset 25Jun2022, outcome "not recovered", described as "my upper lip got dark and still was hyperpigmentation". No follow-up attempts are possible. No further information is expected.