chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ALLERGIC REACTION; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566.
No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 16-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 0 hours 10 minutes 0 seconds, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.   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: 1687291; expirationdate: 11-SEP-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-009507513-2104USA002451: US-009507513-2104USA002494: US-009507513-2104USA002492: US-009507513-2104USA002495: US-009507513-2104USA002490: US-009507513-2104USA002491:
Received 1st SHINGRIX 8/9/18 and 2nd dose on 11/14/18. Developed shingles around 10/27/18 - very painful. Cleared up with VALTREX and Prednisone but returned on 12/6/19. Had shingles outbreak after both immunizations.
Pt c/o generalised achiness & jt pains 2 days after inj Tdap. No local reaction at site of injection. Temp = 99.4 F. S/S subsided after a few days.
bursitis; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA348246.  This case involves two patient (unknown demography) who experienced bursitis (bursitis), while they received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the two patients developed a non-serious bursitis (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was bursitis.  It was not reported if the patients received a corrective treatment.  The event outcome is reported as Unknown for bursitis.  Information on the batch number was requested.
pt recv vax 9SEP97 & 24NOV97 pt was seen by MD w/a classic case of shingles;It was reported that pt had grouped vesicles along C4-C5 dermatome extending down rt arm & back;pt has no known hx of immunosuppresion or hx of exposure to varicell
The patient did not experience any adverse effect. The pediatric  dose was given to an adult instead of the adult Hep B.
Rash on face, neck, and chest (lighter on abdomen) As of today, 6 days and is improving.
Information has been received from a registered nurse concerning a child whose grandparents were vaccinated with a dose of Zostavax on an unspecified date. The patient was in contact with the grandparents several days after they were vaccinated. The patient developed pustules after the contact. A product quality complaint was involved. Additional information has been requested.
severe palpitations, sinus tachycardia to the 140's requiring admission to hospital  also: fever, nausea, generalized weakness  Occurring day after receiving booster
pt recvd vax & following the 2nd inject was a little under the weather; w/3rd dose had burning & stinging; exp severe migraines & projectile vomiting (unable to eat), was very tired & listless;
Shortness of breath; Tested positive to COVID; Tested positive to COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Lung disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "Tested positive to COVID"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive. Caller mentioned her daughter tested positive to COVID in a over the counter test that she took on Saturday 15Jan2022. Caller mentioned she was exposed to her on Friday 14Jan2022. Caller asked how long should she quarantine for since the dates were always changing. Caller stated she had no symptoms, but shortness of breath, however she specified that she had a lung disease and this was not a new symptom for her.  Follow-up attempts have been completed and no further information is expected.
RECEIVED A JANSSEN COVID-19 VACCINE THAT THE TEMPERATURE OF THE FRIDGE HAD GONE UP TO 46.9 F FOR 17 MINUTES; INCORRECTLY STORED VACCINE ADMINISTERED; VACCINE STORED OUTSIDE OF THE ACCEPTABLE LIMITS; This spontaneous report received from a health care professional concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: 27-APR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 03-DEC-2021, the patient experienced received a janssen covid-19 vaccine that the temperature of the fridge had gone up to 46.9 f for 17 minutes, incorrectly stored vaccine administered, and vaccine stored outside of the acceptable limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received a janssen covid-19 vaccine that the temperature of the fridge had gone up to 46.9 f for 17 minutes, incorrectly stored vaccine administered and vaccine stored outside of the acceptable limits was not reported. This report was non-serious. This case, from the same reporter is linked to 20220121547.
Blood clots developed in the 3 arteries in my lower right leg, cutting off all blood flow below my ankle.  Extreme pain in my calf, my foot immediately lost its color and no pulses could be detected in my ankle or foot.  Rushed to ER by ambulance.  Vascular surgeon diagnosed it as simultaneous arterial thrombosis in the posterior tibial artery, anterior tibial artery, and fibular artery of the lower right leg.  Admitted to the ICU, treatment was heparin drip for 3 days until all 3 clots cleared and all foot pulses were detectable.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions and allergies provided. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL (lot# K011562, expiration date 08-APR-2017, doses, routes and sites of administration were not reported). No adverse events were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Hives on shoulders and back. Treated symptoms with 50mg of Benadryl at 9:00p on 11/30/21
I began having heart palpitations and shortness of breath about a week after the second Covid injection.  Over the next three weeks, the palpitations and shortness of breath became more pronounced.  On April 9, 2021 I had one period of approximately 5 minutes duration when my heart skipped every other beat - believed to have been PVCs.  About one week later I had one short duration of tachycardia (240 bpm) that lasted for about 5 to 10 seconds.
My arm is a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer unknown), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm is a little sore".  Additional information: Patient reported about receiving booster shot yesterday. Patients arm was little sore. Patient reported to had good days and bad days while on Xeljanz. Patient was prescribed Xeljanz XR 11 mg tablets.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
EXTREMELY extremely WEAK. - he had to use wheelchair to move, and fell off chair.  nausea, insomnia.  I could not move him and had to call fire deparment.  They said his extreme weakness was concerning and took him by ambulance to hospital.
Patient described having a rash and some swelling at the injection site in her right arm. She said she always experienced a mild fever and chills. She stated that she self-treated with TYLENOL and BENADRYL and her symptoms subsided.
Caller recently got COVID19 from someone at work; there are 3 people with heart problems who have gotten booster dose of the vaccine in the same house; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: EW0161, Date of administration: 09Apr2021), for COVID-19 immunization; Bnt162b2 (DOSE:2, Date of administration: 30Apr2021, Lot number: EW0167), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "booster"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "Caller recently got COVID19 from someone at work"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "there are 3 people with heart problems who have gotten booster dose of the vaccine in the same house". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: Patient mother wants to inform that Her son got both doses of the vaccine and now has Covid. He took a test yesterday, and on the bottom line was pink and purple, and the top line was pink so that means he has Covid. States that on 23Nov2021, a 20 year old that her son works with got Covid. Her son and other  people at work, including , and since then several people and their families who have not had the vaccines have gotten Covid, her son did get both doses of the vaccine but he did not have time to get the booster because he did not meet the age group requirements. Her son has notified his boss that he has Covid. Patient is just tired and achy right now, so it's not too bad. States that his boss closed down the shop because a couple more people have gotten it. Caller wants to know if she should notify his doctor that he has Covid? Also states that there are 3 others living in the house with him, and they have heart problems. The others in the home have had the booster already,Declined email address to provide.  Her son started having symptoms of Covid on 26Nov2021, he was very tired and cold. He took a Covid test on 29Nov2021, and it was positive for Covid. No History of all previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines Administered on Same Date of the Pfizer Suspect was reported, Adverse Event, No AE(s) require a visit to Emergency Room was reported, no Physician Office visit reported, no Prior Vaccinations (within 4 weeks) was reported, no AE(s) following prior vaccinations was reported. no Family Medical History Relevant to AE was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9/16/18 Went to pharmacy. Shindrex vaccine was given on upper left arm. Within 1 hour after, I felt puffiness, redness and hardness on injection sight & to the left of injection sight. The pharmacy stated that it will go away after 3 days. It did start going away with in that time frame. Around 9/17/18 I felt a burning pain started from the left middle finger all the way up my left arm and up to my neck. On 9/18/18 I felt burning pain and tingling in both arms. The next night on 9/19/18 I felt the same burning pain and tingling and could not sleep for 3 nights in a row, I continued to have swelling in my fingers, stiffness and pain, and sometimes unable to close my hands. At night the pain is so severe that I have to get out of bed and either take pain medication, stretch, massage and drink nettle tea, tart cherry etc, in an attempt to relieve the pain. The pain is still a daily intermittent occurrence but worse at night, on the injection sight and in both arms. Mostly in the right hand and weakness in both hands. I  can not sleep most nights. Sometimes I can feel pain throughout my body.
Chattering chills that bothered her all the night; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chattering chills that bothered her all the night) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced CHILLS (Chattering chills that bothered her all the night). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at a dose of UNK dosage form. At the time of the report, CHILLS (Chattering chills that bothered her all the night) outcome was unknown.            No concomitant medications were reported.
On tehe day of Shingrix vaccine, 12/5/22, patient experienced normal pain at injection site, and at night, fevers, nigh sweats, chills. Patient took ibuprofen that evening.  Patient developed a painful dermatomal rash on left breast on December 8, 2022, which was 3 days after 2nd dose of Shingrix vaccine. Patient described a pins and needles, burning sensation, occasional shock like sensation, hypersensitivty.  Patient took ibuprofen and acetaminophen for pain. She saw her physician on Decemebr 12, 2022 and physician was able to collect fluid from vesicle. Sent for Culture and PCR. PCR came back positive for VZV.
Initial and follow-up information has been received from a licensed practical nurse concerning a 17 year old, female student, with penicillin allergy, whose reported weight was 132 pounds and whose reported height was 65 inches with no illness at the time of vaccination who on 07-MAR-2007 at 4:00 p.m., the patient was vaccinated, intramuscularly into the left deltoid muscle with the first dose GARDASIL (Lot # 654389/0961F). It was reported that on 07-MAR-2007 the patient became nauseated, lightheaded, sweaty with anxiety and felt like her throat was swelling shut. It was reported that the patient had no respiratory distress. She was treated with a cool rag applied to her head and was laid down, given water to drink and within 5 minutes, she was fine. The patient recovered that day. On 23-MAY-2007, at 4:30 p.m., the patient was vaccinated, intramuscularly into the right deltoid muscle with the second dose of GARDASIL (Lot # "616867/0243D"). It was reported that on 23-MAY-2007, the patient became nauseated, lightheaded, and sweaty with anxiety and felt like her throat was swelling shut. It was reported that the patient had no respiratory distress. She was treated with a cool rag applied to her head and was laid down, given water to drink and within 5 minutes, she was fine. The patient recovered that day. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additional information is not expected.
Bladder infection; Fever; Chills; Headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CYSTITIS (Bladder infection), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CYSTITIS (Bladder infection), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CYSTITIS (Bladder infection), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided
Rash break out. Went to Dr on 10/18/2011. Received 2 shots and put on steroids for 7 days.
Pt returned to office one day later with left upper arm red, swollen, warm to touch, and painful. Afebrile.
Patient experienced redness and swelling; Patient experienced redness and swelling; This is a spontaneous report from contactable other health professional via Pfizer Sales Representative. A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot CD0412. Exp Jan2022), via an unspecified route of administration on 20Feb2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced redness and swelling on 21Feb2020 with outcome of recovered in Feb2020.
pt recvd vax; T 102 w/ generalized sz < 1 min w/ sl cyanosis;
Extremely painful enlarged lymph nodes under right arm. Remain painful 11days later. It is about the size of a baseball.
Information has been received from a health professional concerning a 6 year old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
Narrative: Patient received two doses of covid vaccine. Patient was in LTC/hospice for end stage dementia. No further evaluation of death noted. Reporting per facility instructions.
At around 9:30 am on 9/1/2017 mother noted "red  blotches all over body  his body from head to toe. "States he was "alittle irritable." States the rash is "bad" on his stomach looks like big mosquito bites. Also states that he has scratches on his legs like he had been scratching.
This spontaneous report as received from a healthcare worker refers to a unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot #K014548, 27-AUG-2016. No adverse effects were reported. Temperature 31 Fahrenheit for 712 hours and it was administered. There was no temperature excursion. Additional information has been requested.
Patient said around 45 minutes after receiving high-dose flu shot, he had uncontrollable chills.  The chills then came back 4 hours around 9:00 pm upon going to bed.  The chills lasted for about 3 hours, and he thinks he had a fever.  The chills were uncontrollable and he didnt know what was happening.  All pt could do was lay down in bed.  However, after the chills went away he was fine.  The next day, he just felt tired, but no other signs or symptoms of illness.
chest pains; irregular heartbeat; difficulties with her vision; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After injection, the patient suffered chest pains, irregular heartbeat and difficulties with her vision (onset dates unknown). As a result of her symptoms, the patient presented to a medical provider in her state. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.    Chest pains, irregular heartbeat and difficulties with her vision were considered to be disabling.
Patient stated symptoms of Multiple sclerosis progressed after moderna vaccine. She was still on Mayzent when this occurred.