chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADR's were MUCH less this second time; were given subQ; divided the 2nd shot into multiple smaller injections; This case was reported by a pharmacist via call center representative and described the occurrence of adverse drug reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction, intramuscular formulation administered by other route and wrong technique in product usage process. On an unknown date, the outcome of the adverse drug reaction, intramuscular formulation administered by other route and wrong technique in product usage process were unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, the patient received 2nd dose of Shingrix divided into multiple smaller injections that were given subcutaneously, which led to intramuscular formulation administered by other route and wrong technique in product usage process. The reporter stated that, the patient had much less adverse drug reaction after 2nd dose of Shingrix vaccination. This was 1 of 2 linked cases, reported by same reporter for same patient. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020151914:same reporter
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 71-year-old female patient who received SHINGRIX (batch number 4X733, expiry date 8th March 2021) for prophylaxis. On 28th March 2019, the SHINGRIX in left arm and a few days after, she started developing a rash on left ear and neck. After treatment from her provider she received acyclovir. No definite diagnosis of Shingles was reported. No additional details were provided.
headache; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ5352) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain".  Additional Information: Injection site pain and headache following COVID-19 bivalent booster. There was no underlying conditions or concomitant medications. Event took place after use of product.  Follow-up attempts are completed. No further information is expected.
Stroke; She has trouble getting the right words some times; This is a spontaneous report from a contactable consumer (patient's grandson). A 68-year-old female patient received BNT162B2 (COMIRNATY, solution for injection; Lot number and expiry date: unknown) via an unspecified route of administration, administered in left arm on an unspecified date in Apr2021(at the age of 68-year-old) as dose 2, single for COVID-19 immunisation. Medical history included diabetes diagnosed 15-20 years ago and unknown if it was ongoing. Concomitant medication was not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection; Lot number and expiry date: unknown) via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for COVID-19 immunisation. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No other Vaccines Administered on Same Date of the Pfizer Suspect and no other vaccine administered within 4 weeks prior Vaccinations. It was reported that on an unspecified date in Apr2021 patient was diagnosed with stroke after receiving the second dose the Pfizer COVID-19 vaccine (3 days later). Age at time of onset of reaction/event: 68 years. Reporter was calling on behalf of his grandmother as she was having trouble getting the words right sometimes on an unspecified date in Apr2021. Reporter had to accompany the patient as she was hospitalized due to some complications after her medical diagnosis from an unknown date and subject was discharged on an unknown date. This happened after she took the second Pfizer vaccine. Reporter wanted to get compensating for the medical bills and injuries due to Pfizer COVID-19 vaccine. Lab test and procedures included blood test: unknown result on an unspecified date. The event Stroke was reported as serious. Adverse events required a visit to: Emergency Room and Physician Office. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Patient received a 3rd dose of SHINGRIX vaccine. Dates of vaccine 5/21/2021, 1/15/2021 , 10/8/2020.
1st of 5 known seizures was an hour after the injection, the 2nd was 2 1/2 hours after the injection, the 3rd was  5 hours after the injection, the 4th was 22 hours after the injection the following day, the 5th was 40 hours after the injection. These seizures were different in nature.  His muscles and body tightened heavily for up to 2 minutes, he turned blue and was combative. Muscle spasms for up to 10 minutes after seizure.  Aggressively hyper focused and moving around unaware of reality for 20-30 minutes.
Superficial thrombosis; Redness in her leg 3 days after her second shot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in her leg 3 days after her second shot) and THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombosis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced ERYTHEMA (Redness in her leg 3 days after her second shot). On an unknown date, the patient experienced THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombosis). At the time of the report, ERYTHEMA (Redness in her leg 3 days after her second shot) and THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombosis) outcome was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.
Patient said arm swelled some and she couldnt move her arm up or down. She went to doctor.
Headache, Myalgia, Arthralgia, UrticariaPruritus, Sloughing, Angina, TINGLING BOTTOM LIP/TONGUE,SORE THROAT, INTENSE FATIGUE,PEELING OF SKIN ON BOTTOM LIP Narrative:
Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. In 2014 the patient was inoculated with ZOSTAVAX vaccine by a physician for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014 the patient was treated by a physician at a medical clinic for onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Fast heart rate for 5 days. Went to ER, chest Xray, IV Fluid, and anxiety meds given. DID NOT have anxiety.
Recurring herpetic type rash on foot. No pain or pruritus, never had before.
Bilateral discoloration of the thumbs. Pt denies any symptoms associated with discoloration. Pt states discoloration has been the same, has not gone down or increased in size.
Heart disease myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: 3330 BA) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid Prior vaccination: Yes. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ew 0175, Location of injection: Arm Left), administration date: 26Apr2021, when the patient was 38-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Er 8733, Location of injection: Arm Left), administration date: 02Apr2021, when the patient was 38-year-old, for Covid-19 Immunization. The following information was reported: MYOCARDITIS (medically significant) with onset 22Dec2021, outcome "not recovered", described as "Heart disease myocarditis". The event "heart disease myocarditis" required physician office visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (Dec2021) Heart disease myocarditis; Nasopharyngeal swab: (14Apr2022) Negative. Therapeutic measures were taken as a result of myocarditis.  Clinical course: The patient has not taken any vaccines in four weeks. The patient has not taken any other medication in two weeks. The patient was not tested covid post vaccination.
forceful vomiting 3 times 30 minutes after vaccination, no site swelling or redness
The single dose syringe malfunctioned, resulting in a partial dose being administered.  The pharmacist contacted Sanofi, who advised her to re-vaccinate in the opposite arm.  The patient has had persistent pain in the erroneous arm to the point of difficulty in lifting and moving the joint.
Temperature 101, Shivers, headache, body ache. Lasted about 36 hours. It also spiked up my fasting sugar level in the 190 range for a few days and it is slowly coming down over a period of 2 weeks.
Fever, fussiness on quarter sized area of papular rash on right thigh at site of varicella vaccine starting 8-9 days after vaccines.
The next day following injection started noticing an itch and red breakout on arm that was injected. Over the past several days it spread down to inside of elbow then moved back up to original spot and got thickened and sometimes hot with more itch. Now it is moving back down arm and periodically very itchy.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant therapies, concurrent conditions or medical histories provided. On an unknown dates, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # L005299, expiration date 17-FEB-2017 or lot # L007225, expiration date 03-MAR-2017, route and dose were not reported) that were exposed to temperatures outside of the recommended range. There were no adverse effects reported. Additional information has been requested.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/11/21 and 4/10/21. Presented to ED from clinic c/o Covid sxs and COVID+ on 1/27/22.  Admitted for acute respiratory failure 2/2 Covid PNA. Tx'd w/steroids and O2. O2 requirements increased, requested DNAR/COT status on 1/30/22. O2 requirements continued to increase. Transitioned to comfort care, expired 2/10/22. Pt was transitioned to comfort care. Treated with decadron,ceftriaxone, piperacilin/tazobactam. Pt expired on 2/09/22.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date in June 2016 (reported as on unspecified date since last week), the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 lot # L040181, expiration date 18-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33.5 degrees Fahrenheit for 28 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
)6/25/2008 Vaccine appt: infant was given at 10:10 am 80 mg of equate acetaminophen PO lot #8BK0321 exp 04/10, at 10:15 infant was given vaccines,at the time of vaccination infant was Nad resp unlabored no rash noted at 10:30 red blotches appeared developing into a hive appearing rash no other sx, 10:45 resp unlabored clear lungs Nad Hive rash present 7.5 mg of benadryl given IM 11:00 sx resolving, 12:00 symptoms resolved infant sleeping 12:05 edema noted in infants fingers and rash appearing again, referred to emergency room for evaluation, infant was given prednisone sx resolved and was dismissed to home, Tylenol was given to infant by mom at 2:00 pm no adverse reation occurred Follow up with mom by phone the next day infant was doing well no further problems except diarrhea evening of 06/25/2008
Pt said that almost exactly 1 week after vaccination she noticed tingling and numbness all over body. It got better as time went on; became less intense and focused to only hands and sometimes feet. Still after 6 months post-vaccination she still has numbness in mostly right hand and sometimes feet.  She has not sought and treatment or medical advice as of yet.
Mom states pt had shots approx 9AM & noticed pt feeling very hot @ 11AM; Took temp 105.0 R, blue around mouth w/jerking for 1hr-was taken to ER & put in tepid water; MD felt pt probbly had inc temp a/shot given;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 03-SEP-2014 the patient was vaccinated with a third dose of GARDASIL (lot # K001500 and expiry date: 06-NOV-2016, 0.5 ml, intramuscular) which had been improperly stored. No adverse effects were reported. Additional information is not expected as there was no consent to contact physician.
I had a headache and dizzy for about 24 hours after the vaccine. In October I had a seizure. I was in for a dental appointment, I was getting an lidocaine injection for a procedure. The dentist was injecting me and I started having a seizure. I ended up being fine after that and haven't any more seizures since then. I went to the ER and had some test ran while I was there. The EEG was normal.
szs; father called said pt had 1st immun @ 2 1/2mons & right p/devel encephalitis; pt was hospitalized w/szs;
t102.4 9 days following vax;rash started on extremities-one eurption on face;rash lasted 6 days
This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-MAY-2017, the patient was vaccinated with a dose of improperly stored VARIVAX lot # M027344 with expiration date on 01-JUN-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688:
patient received 3 doses /Dose 1: 11/5/2020/ Dose 2:01/7/2021/ Dose 3:07/01/2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number J454X, expiry date 4th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th November 2020, (batch number zj432, expiry date 27th May 2022)) and Shingrix (received 2nd dose on 7th January 2021, (batch number zj432, expiry date 27th May 2022)).   On 1st July 2021, the patient received the 3rd dose of Shingrix. On 1st July 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: Age at vaccination was not reported. The reporter reported that the patient received 3 doses of Shingrix, which led to extra dose administered. The vaccine administration facility was the same as primary reporter. No further information reported. The reporter consented to follow up.
After arriving at the observation area, patient complained of a headache, has no other symptoms. BP on arrival 148/79, hear rate 82. Sufffers with headaches from time to time. Advised to remain for 30 more minutes. BP 15 mins later, 135/83 and at 10:08 125/76- felt better, headahce resolved.Advised to seek medical support if he becomes unwell later in the day. Patient verbalsed understanding.
passed out; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (passed out) outcome was unknown.            No concomitant medications were reported. The patient got the second shot of Moderna and passed out. No treatment medications were reported.  Company Comment This spontaneous case concerns a 65-years-old female patient, with no medical history reported who experienced the unexpected seriousness criterion medically significant event  of loss of consciousness in the context of the 2nd.  dose of  mRNA-1273 vaccine.  The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.    This case was linked to US-MODERNATX, INC.-MOD-2022-661939, US-MODERNATX, INC.-MOD-2022-662000 (Linked Report).; Sender's Comments: Company Comment This spontaneous case concerns a 65-years-old female patient, with no medical history reported who experienced the unexpected seriousness criterion medically significant event  of loss of consciousness in the context of the 2nd.  dose of  mRNA-1273 vaccine.  The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement. US-MODERNATX, INC.-MOD-2022-661939:MOD22-027301 (Same reporter) US-MODERNATX, INC.-MOD-2022-662000:MOD22-027301 (cross linked case) same reporter
8/2000 Knees started bothering me-problems walking, some aching. Has had knees injected 07/19/2001. Had surgery on left knee 10 yaers ago.
Mild Soreness at injection site, Sore,Achy muscles across upper back and shoulders.  No Treatment required.
Pt had vaccine on 7/8 and had a seizure on 7/13. He was at work and was found with blood on his ear and a mark on his face. He had no memory of the incident. Last seizure was at least 7 months prior.
The vial was initially stored in the refrigerator on 30-jun-2022 And was administered on 05-aug-2022; No adverse event; dose was administered from a vial that was more than 30 days after the initial thaw date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered from a vial that was more than 30 days after the initial thaw date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-jun-2022 And was administered on 05-aug-2022) and NO ADVERSE EVENT (No adverse event) in a 10-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered from a vial that was more than 30 days after the initial thaw date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-jun-2022 And was administered on 05-aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered from a vial that was more than 30 days after the initial thaw date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-jun-2022 And was administered on 05-aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose was administered from a vial that was more than 30 days after the initial thaw date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-jun-2022 And was administered on 05-aug-2022).    No concomitant medication reported. They have not experienced any symptoms. No treatment information reported.
Breakthrough covid case.  Patient tested positive with Abbott ID Now covid test at Hospital. Presented to ER with cough, HA, scratchy throat x 2 days. Exposed to positive coworker.  Discharged home.
Fever of 103 degrees.  Fluctuating between 101-103 until 12:00 noon on 11/14/2009.  Headache and stuffy nose.   Give 400mg of Ibuprophen every 4-5 hours.  Did not take the fever down much
Light headed, persistent headache, arm ache where vaccine was applied within one hour after vaccination. About 16 hours later, stronger headache, nausea, body ache and fatigue. Felt as having a strong hangover.
Staff had large area of redness, warmth, swelling and pain at the injection site on the left upper arm.  She was diagnosed with cellulitis at the injection site and was prescribed antibiotics, and told to also take ibprofen and benadryl.
pt recvd vax 19OCT95 & 25OCT95 pt devel indurated, swollen, tender, inc warmth of rt arm; heated w/analgesia & best
2days p/vax pt exp redness at inject site w/swelling. rx zithromax therapy & benadryl
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses (in the temperature between 14-46F (-9 to 8 degrees Celsius) for 1 hour and 3 minutes and in 14-46F for 1 hour and 4 minutes) of VARIVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. The call was made because of a data logger. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004711.
Pain, soreness, shingles like lesions at injection site - started day after vaccine, some lesions crusting/scabbing day 2 after vaccine, redness and tenderness continues.