chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Norovirus; Had dehydration; Diarrhea; Shaking; Throwing up; Soreness in arm; This case was reported by a consumer via other manufacturer and described the occurrence of gastroenteritis norovirus in a 77-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included heart transplant. Concurrent medical conditions included diabetes and asthma. Concomitant products included Herpes zoster (Shingles vaccine).   In December 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after receiving Shingles vaccine, the patient experienced gastroenteritis norovirus (serious criteria hospitalization and GSK medically significant), dehydration (serious criteria hospitalization), diarrhea (serious criteria hospitalization), tremor (serious criteria hospitalization), vomiting (serious criteria hospitalization) and pain in arm. On an unknown date, the outcome of the gastroenteritis norovirus, dehydration, tremor, vomiting and pain in arm were unknown and the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the gastroenteritis norovirus, dehydration, diarrhea, tremor, vomiting and pain in arm to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The reporter is reporting for himself. The age at vaccination was not reported. The patient had issues since COVID-19 shot.  He was trying to determine if the issues were from the shot or if he had something else was going on.  On 25th January 2021, the patient received Pfizer Covid 19 vaccine, batch number EK4176. The patient had the soreness in his arm for three days like most people.  On the first day, he had diarrhea.  The patient was heart transplant patient and had a compromised immune system.  The patient had diabetes and asthma. The patient's arm soreness was worse on 1st and 2nd day, by the third and fourth day it was better.  The patient clarified as it was his left arm.  The patient received COVID-19 vaccine in left arm because he was a heart transplant patient, he wanted to bring it to attention.  The patient asked, if there was a problem with heart transplant patients who were not having the same immunity or protection as a person who did not have those problems and clarified he was not referring to specific person. He only wanted clarification on this information.  After receiving Flu vaccine, the patient experienced soreness in arm. The patient's gastro doctor took the patient's stool sample and he ended up in the hospital with Norovirus. The patient was hospitalized with diarrhea and other symptom s. The patient was throwing up, had dehydration and diarrhea. He was shaking so bad because of the dehydration and diarrhea. For the tolerance of Shingles vaccine dose, refer linked case US2021AMR057551.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR057551:Same reporter.
Body aches, chills, headache, sweats, sore throat, arm redness, fatigue
This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 66-year-old female patient. A 66-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3246, Expiration date: unknown), via intramuscular route of administration, in Arm Left on 02Feb2021 at 09:00 AM (at the age of 66-years-old) as single dose for Covid-19 immunization at hospital. The patient medical history included migraines, depression, high cholesterol, melanoma, bladder carcinoma, cholecystectomy, hysterectomy. The patient received the medications within 2 weeks of vaccination included aspirin, Depakote, Lipitor, vitamin D, omega-3. The patient also received first dose of BNT162B2 (Solution for injection, Lot number: El3246) via intramuscular route, in Arm Left on 12Jan2021 at 14:00 PM (at the age of 66-years-old) as single dose for Covid-19 immunization.  Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 02Feb2021, she had her second dose of COVID-19 vaccine this morning. She was fine for 15 minutes and return to work. On 02Feb2021 at 09:15 AM, She felt flushed and her entire head felt numb. She also felt like her heart was racing. She did return to employee health, and they gave treatment as Claritin and Pepcid orally for the events. She stated that she was feeling better now. She denies any chest pain or shortness of breath. The patient went to emergency room/department or urgent care due to an adverse events. The outcome of all events was recovered on an unspecified date.  No follow-up attempts are possible, No further information is expected.
This spontaneous report was received from an unspecified reporter via company representative regarding multiple adult (reported as aged 25-29) female patients of unknown age. Information on pertinent medical conditions and concomitant medications was not reported. On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (dosing details and lot # were not reported) for prophylaxis. It was reported that there was a lowered probability of pregnancy in females who received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (female infertility). Outcome of the event was not reported. Causality assessment was not provided.
Acute hepatic failure. Patient became jaundiced within a few hours of administration of varivax/hepatitis A/prevnar/MMR vaccines on 07/09/07. Stools were white-colored for several days. Patient was taken to emergency room for jaundice on 07/15/07. At the time, liver enzymes were elevated (SGPT 6303, SGOT 4444), INR elevated (2.6), and bilirubin elevated (21.3). Patient was admitted to a hospital, and transferred for possible liver transplant on 07/17/07 to another hospital.  07/31/2007 MR received from transferring facility for DOS 7/15-17/2007.  Infant presented with 1 week hx of jaundice and intermittant acholic "white" stools which began the day of her vax.  PE (+) for jaundice and hepatomegaly, otherwise WNL. Assessment: Acute Liver Failure of unknown etiology.  Obstructive etiology r/o, most likely infection vs. autoimmune. Transfered to regional hospital further eval and possible placement on Liver Transplant list. 8/21/2007 MR received for DOS 7/17-8/04/2007 for admitting DX of Acute Liver Failure with elevated liver enzymes and coagulopathy. As above. Improvement noted on methylprednisolone Transfered back to original hospital for further management. Discharge DX:  Acute Liver Failure with elevated liver enzymes and coagulopathy. 1/11/2010 Diagnose with Autoimmune Hepatitis by doctor of Pediatrics Gastroenterology at hospital. Currently on Azuthioprine treatment.
Got vaccine had slight case/suspected vaccination failure; Had slight case; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got vaccine had slight case/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had slight case).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine in last year and in this week he/she experienced slight case of shingles. The patient think that the shingles vaccine protected him/her from a more serious shingles case. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Since my second COVID vaccination, I developed high blood pressure.  I did not have high blood pressure before the vaccination.  I had headaches and ringing of the ears after being vaccinated.  On August 5, 2021, I had a biometric screening at work which my blood pressure was 164/110.  It was retaken 4 times with rest times on both arms, same result.  I was told to schedule a doctors appointment to address my blood pressure.  I had an appointment on 8/11/2021 which my blood pressure was high.  I was placed on blood pressure meds, Losartan at 25 mg.  My blood pressure was rechecked and the results were still high.  I was increased to 50 mg of Losartan.  My blood pressure was rechecked again, and was still high.  I was increased to 100mg of Losartan.  My last check was 9/24/2021 where my blood pressure was still elevated but better 124/92.  I have another visit scheduled in December.
Vomiting; Runny stools; Headache; Weak muscles; Nausea; First dose:21May2021/ Second dose:16Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4140883.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 16Jun2022 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose:1), administration date: 21May2021, for Covid-19 immunization, reaction(s): "Vomiting", "Runny stools", "Weak muscles", "Nausea"; BNT162b2 (dose:1), administration date: 21May2021, for COVID-19 Immunization, reaction(s): "Headache". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Jun2022, outcome "unknown", described as "First dose:21May2021/ Second dose:16Jun2022"; VOMITING (non-serious), outcome "not recovered"; DIARRHOEA (non-serious), outcome "not recovered", described as "Runny stools"; HEADACHE (non-serious), outcome "not recovered"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Weak muscles"; NAUSEA (non-serious), outcome "not recovered". The action taken for risankizumab was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200083948 same reporter/drug/patient, different doses/AE;US-PFIZER INC-202201234111 same reporter/drug/patient, different doses/AE;
Turned dusky/blue twice within one week of receiving immunizations. Self resolved. Concern for possible seizure. Jul 29 2016 11:19AM At daycare, playing in saucer at daycare, went stiff at daycare. Face turned purple in color. Unresponsive, came out of it rather quickly. White face after that. First time this had ever had happened. NO food or drink when this happened. NO fevers or other signs of illness. Did have shots on Tuesday. No history in the family of seizures or heart rhythm issues. Sent to PCH for EEG, EKG, and CBC/ferritin. Preliminary EKG is normal and has normal CBC. Called and talked with mom about results. Will follow-up next week once results are back. Jul 29 2016 9:52AM Mom called in today said daycare said he had a possible seizure yesterday. Please call and see if wants to do follow up.
slight soreness in the arm; pain upon injection while receiving the first dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm and injection site pain. On 4th September 2020, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm and injection site pain to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported experiencing slight soreness in the arm and pain upon injection while receiving the 1st dose of the Shingrix vaccine. The reporter consent to follow up. For tolerance after 2nd dose of Shingrix, refer case US2020185503.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020185503:same reporter
pt devel rash started 14MAY AM to low extremities by PM; rash on entire body x/face; took DPH; by 15MAY AM rash worse called ER: itching & swelling in joints had also occurred;
Skin reaction to right thigh 4" induration. Tx Motrin. No fever. No pain.
The Patient presented to our pharmacy after making an appointment for a booster dose of her Moderna vaccine. The patient stated they had a compromised immune system and their last dose was administered on 2/8/21. Consistent with the law we administered a booster for the patient.  Within several minutes the patient's face became red and they stated they had difficulty breathing. it was at this moment I as the pharmacist made used my clinical judgement  to administer an Epipen dose to the patient. I asked my staff call emergency services. within moments their face came back to normal coloring and they were able to breath better. they did state their heartbeat was racing consistent with administration of the Epipen. I remained with the patient and counseled to focus on breathing. emergency services arrived several minutes later and took the patient in the ambulance with them. they then went to the hospital.
Information has been received from a nurse concerning a 56 year old male with glaucoma, headache, depression and diabetes who in 2003 was vaccinated IM with his first dose of PNEUMOVAX (lot number not reported).  The patient was vaccinated IM with his second dose of PNEUMOVAX (lot number 661899/0519X).  Concomitant therapy included METFORMIN, ZOLOFT, glyburide, LANTUS and NEURONTIN.  Subsequently the patient developed allergic reaction.  The medical attention was sought.  There are no other information for now.  The patient also developed an adverse event while on therapy with LISINOPRIL (manufacturer unknown) (WAES #.......).  This is one of several reports received from the same source.  Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates since 01-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL (lot number K005881 and expiration date 14-JAN-2017, lot number K008931 and expiration date 04-MAR-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administered after temperature excursion; No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 20-DEC-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot # U015681 and expiration date of 18-MAY-2023, at a dose of 0.5 milliliter, administered subcutaneously for prophylaxis (strength was not provided). The vaccine was exposed to a temperature excursion of 6.8°F with a time frame 8 hours and 5 minutes. There was no previous temperature excursion. No additional adverse events or product quality complaint (PQC) were reported.  .
Patient reported a Metallic  Taste in the mouth after receiving vaccine. Patient was given 5ml of Benadryl and a peppermint. She waited 30 minutes before leaving the pharmacy. At that time she felt fine.
Cutaneous grade 3 toxicity (blistering rash) on bilateral lower extremities starting September 15th, 2021. This followed a flu like illness week prior. The rash continued for about one month despite topical steroids. Oral steroids were taken and the rash disappeared for a week, but then reappeared. Since then, new cutaneous lesions have appeared on upper extremities, lower extremities and trunk. Most of the original skin lesions have disappeared but some are still present, now almost 4 months later. Cutaneous lesions wax and wane, requiring continued topical steroid use.  I have had a viral illness in October and November, and each time the rash exacerbates following the illness.
Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022; Vaccine administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported as the vial was stored in refrigerator on 18-May-2022 and administered to patient past 30-day use by date or after manufacturer date of expiry.  The vial did not undergo any temperature excursion.  The reporter believed that lot numbers for previous doses of the patient was moderna, but was unsure.  No treatment medication were provided.
This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unknown age and gender received TRUMENBA at single dose on unknown date for immunization. Relevant medical history and concomitant medications were unknown. On unknown date the patient passing out. The outcome of the event was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018357772 same reporter, same event and drug, different patient; US-PFIZER INC-2018353910 same reporter, same event and drug, different patient
pt recvd vax 16JUL92 & on  23JUL92 devel Bell's palsy; poss of Lyme disease an an etiology for Bell's Palsy; Lab eval for Lyme disease was indeterminate w/some cross antigenicity appearing in the tests; MRI nl;
Pt recv vax on 10/9/98; 1 hr post vax pt exp blood under skin/ purple/ sore/ hot x 3 day
Starting the day after I received the vaccine I noticed an extreme loss in appetite. So specific food aversions but a total loss of appetite in general as well as extreme exhaustion.
Vomiting, started with a stomach ache at 7am, first episode of vomiting at 7:45, then 8:50, then 9:05.  Child given a bath, and 4mg ondansetron (9:50).
Received first dose underage; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received first dose underage) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received first dose underage). On 18-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received first dose underage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received contained: An update for a possible change in patient initial (Needs confirmation)
pt recvd vax & exp burning of eyes & eyelids, extremely cold hands & feet, tiredness; the burning was generalized from neck down on both sides; also had chest pain & tightness as well as heart palpitations; also exp muscle pains;
Pt received PNEUMOVAX on 6/19, on 6/23 at 2am, pt notice swelling, inflammation, redness, warmth to touch, on the upper part of arm that was injected with the vaccine. Pain level 3/10. Pt was advise to take OTC ADVIL TID and apply cool compress. The arm became less swollen on 6/22, but certain swelling still occur in other parts of the same arm. Will cont to monitor.
24 hrs after the injection I had pain at the injection site which lasted 3 days 6 days after the injection I had itching and pain at injection site and also a large reddened  raised area which was warm to touch  I put a over the counter Lidocaine ointment to area
BP 108/64 Pulse 98 Temp 98.1 Disorientation x 3 hrs problems breathing and weakness evening after TDAP injection: Medical attnetion sought 12:12 pm 9/26/08. Slighty weak and soreness site of injection; No SOB-exam WNL
I developed intense itching with hives, a low fever, stuffy nose and sore throat and fatigue.
After my first shot I developed a rash all over my body 12 hours after the shot was administered. I had a slight headache and the rash lasted for 20 minutes.
Approximately 2 hours after vaccination, arm became very sore. By 6 hours later, had decreased ROM in that arm--unable to lift arm above 90 degrees. This soreness and decreased ROM continued, but got better over months. Took ibuprofen and used ice to area x 1st few weeks. Still has soreness and occasional "jolt" to area of injection. Unable to sleep on right side without soreness.