chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lightheadedness, warm flushing feeling, general weakness. Patient sat down and had a snack as she had not eaten food all day. At 3:42 PM she reports her symptoms experienced and that all symptoms resolved other than weakness/tiredness which persist.
With in 5 minutes my tongue felt weird. They gave me oral Benadryl and had me wait longer. Felt a little better and left. With in 2 hours my tongue felt strange and the left side of my mouth and face felt numb. My heart was racing and I started feeling intense itching everywhere.  Went to the ER and was feeling out of it. Heart racing red lines up my arms and entire body itching.  Was given IV Benadryl, iv Pepcid and IV  steroids. After a couple of hours symptoms were better and I was sent home on the oral of those meds.  The itching continued for 4 days. Lack of appetite, weight loss and acid reflux started. Anxiety increased and a weird vibration in my chest daily for weeks.  In march my GP diagnosed me with gastritis and prescribed omeprazole. Continued losing weight and feeling revved up. Blood work shows hyperthyroid - synthroid dosage has been reduced and I am still hyper thyroid and diagnosis is saying auto immune thyroiditis now. I have had a consult with a GI dr but the earliest they can get me in for an endoscopy and colonoscopy is September.
covid test date=17Aug2021 / covid test result=Positive; covid test date=17Aug2021 / covid test result=Positive; I was spilling protein into my urine; kidney issues; edema issues; high cholesterol; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 13:30 (Lot number: Ew0161) at the age of 33 years as dose 2, single and administered in arm left, administration date 16Mar2021 12:45 (Lot number: En6208) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. it was reported that No other vaccine was taken in for weeks, In the month of April reporter was informed by a nurse for a place of hiring that patient was spilling protein into his urine. She recommended that I check with patients primary care physician to see what the deal was. Fast forward to December patient was having kidney issues that is causing edema issues high cholesterol and fatigue. Patient was healthy 34 year old male. With no smoking history, With No drinking or illicit drug history. No kidney problems in patient family tree and just out of the blue this is happening. It began in April and has progressed to me seeing a nephrologists for treatment. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2021, outcome "unknown" and all described as "covid test date=17Aug2021 / covid test result=Positive"; PROTEIN URINE PRESENT (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "I was spilling protein into my urine"; RENAL DISORDER (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "kidney issues"; OEDEMA (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "edema issues"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "high cholesterol"; FATIGUE (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "fatigue". The events "i was spilling protein into my urine", "kidney issues", "edema issues", "high cholesterol" and "fatigue" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood cholesterol: (22Apr2021) high; protein urine: (22Apr2021) spilling protein into my urine; sars-cov-2 test: (17Aug2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of protein urine present, renal disorder, oedema, blood cholesterol increased, fatigue. No follow-up attempts are possible no further information expected.
I got them again; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (5 years ago from the reporting date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles. Shingles vaccine was discontinued. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter mentioned, he/she just got over shingles for the second time. The patient got his/her first Shingles shot and three weeks later got shingles again. The reporter mentioned, he/she would not get the second shot and that was for sure. Additional Supportive Information: Follow-up would not possible as no contact details were available.
This spontaneous report was received from a medical assistant via company representative, referring to a 60 year old male patient. Information about the patient's medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On 29-DEC-2016, the patient was vaccinated with the first dose of ZOSTAVAX subcutaneously for prevention of shingles (dose, lot # and expiration date were not provided). On an unknown date, after being vaccinated with ZOSTAVAX. Furthermore, the reporter stated that the patient's wife thought her husband the patient had polymyalgia rheumatica (PMR). At the time of this report, the outcome of polymyalgia rheumatica and pain was reported as not recovered. The reporter did not assess the relationship between ZOSTAVAX) and polymyalgia rheumatica. Upon internal review, polymyalgia rheumatica was considered to be medically significant. Additional information is not expected as the reporter did not want to be contacted.
Patient received high dose of influenza vaccine in left deltoid in usual manner on 10/26/2010 in our office. Since then she has complained of chronic, severe pain in upper left arm. Orthopedist consultation has revealed no other cause for pain. This is being reported only now, because it seems clear now that this pain is unusual in length and intensity from any pain experienced after any other injection in our physician's 17 year practice of medicine. Product was FLUZONE HIGH DOSE Sanofi Pasteur U3599AA 30 Jun 11 0.5 ml.
lightheadedness and stomach pain at night; lightheadedness and stomach pain at night; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 17-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 22Jul2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient experienced light-headedness and stomach pain at night. The patient was asking if these are normal side effects of the vaccine or if she needs to see a doctor. The outcome of the event was unknown.    Information about lot/Batch number has been requested.  Information about lot/batch number cannot be obtained. No further information expected.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353238USA. A female patient between the ages of 19-24 years, who experienced encephalitis and encephalomyelitis following immunization procedures (confirmed) (Serious, since 18-Feb-2012, until 23-Feb-2012) while enrolled in a study. The patient was an active recruit. Adenovirus vaccine was administered on 12-Dec-2011. The patient was seen in outpatient visit, treatment medications included prescription and OTC; diphenhydramine (25mg, QID, oral) started on 19-Feb-2012, stopped on 21-Feb-2012 for immunization reaction; sulfamethoxazole/trimethoprim (800/160mg, BID, oral) started on 21-Feb-2012, stopped on 02-Nov-2012 for unknown indication; ibuprofen (800mg, QID, oral) started on 21-Feb-2012, stopped on 25-Feb-2012, unknown indication; penicillin G benzathine 600,000 (2 mL, one time, IM) started on 27-Feb-2012, stopped 27-Feb-2012. The patient also received MCV4P on 17-Feb-2012 (lot#U4259AA manufacture PCM), Tdap on 17-Feb-2012 (lot#AC52B074BA manufacture SKB), and influenza on 17-Feb-2012 (lot#UT423AA, manufacture PMC); HAVRIX (hep A-child) on 22-Feb-2012 (lot#AHAVB541DA, manufacture SKB); IPV 22-Feb-2012 (lot#H1305, manufacturer PMC). At the time of the report the outcome of the AEs were: Encephalitis and encephalomyelitis following immunization procedures : recovered/resolved. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. The patient's concomitant medication influenza vaccine, diphtheria-tetanus-pertussis vaccine, meningococcal vaccine, HAVRIX, IPV. The patient's past medication were unspecified. Action taken with suspect drug: - Not applicable. Lab tests were not reported. This event was assessed as moderate in severity, seriousness not assessed. The medical monitor has assessed the causal relationship of the event as possibly related to the Adenovirus vaccine. This case was considered serious based on the following criteria: medically serious.
As I was cleaning my face the second evening after receiving the vaccine, I noticed the skin on my face had gotten very bumpy underneath the surface. By the next morning I noticed that certain areas of my face,  neck and arms had gotten a bit of a rash and itched. It's now four days later and the bumpiness has not disappeared but the itch seems to have subsided.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J006831 and expiry date: 14-SEP-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Huge local swelling and pain after Tdap injection to left deltoid on 7-16-08. ADACEL C2844AA; See different notes
This case was reported by a consumer via call center representative and described the occurrence of tingling in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tingling and numbness. On an unknown date, the outcome of the tingling and numbness were not recovered/not resolved. It was unknown if the reporter considered the tingling and numbness to be related to Shingrix. Additional details were provided are as follows: The case was reported by patient's wife. The age at vaccination was not reported. The caller stated that she and her husband both received a dose of Shingirx vaccine 5 weeks ago and since receiving the vaccine her husband had experienced tingling and numbing down his neck, arm, leg, and toe. The caller was inquiring if this was normal. The caller was requesting for recommendation regarding next steps. The reporter was given information from Shingrix frequently asked questions content, provided medical advice disclaimer and referred to health care professional. The caller provided permission to contact health care professional. No additional details were provided by the caller. The reporter consented to follow-up.
This spontaneous report was received from a nurse referring to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 18-NOV-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX subcutaneously, lot # of M024700 and an expiration date of 18-JUL-2017 (strength, dose number, and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 10 minutes: 11 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.
Information has been received on 19-APR-2017 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 16-DEC-2015, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-JAN-2011, the patient was treated by a physician for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient has been prescribed acyclovir to manage his symptoms. As a direct and proximate result of these malfunctions, 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, and pain and suffering and other damages. Additional information has been requested.
I had chills for 48 hours as well as an extremely unusual and strong headache during the same time period
Woke up the next morning with muscle aches all over. Not very severe but I did end up taking some ibuprofen to lessen them. I did NOT have any fever or other symptoms. When I woke up the following morning, I still have very mild muscle aches which got less as the day went on. Also had mild tenderness at the vaccine site on left arm.
pt recvd vax 12OCT93 @ 12noon & began crying almost immed & cont to cry for 9 hrs; mom able to console pt for only 5-10mins @ a time;
Called the reporter to verify she had been vaccinated for COVID.  She had been and provided Pfizer lot number GJ2524.; Called the reporter to verify she had been vaccinated for COVID.  She had been and provided Pfizer lot number GJ2524.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ2524) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart attack", start date: 2021 (unspecified if ongoing), notes: heart attack two years ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Called the reporter to verify she had been vaccinated for COVID.  She had been and provided Pfizer lot number GJ2524.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: still tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Product Quality Group provided investigational results on 08May2023 for BNT162b2: The complaint for "Pfizer-BioNTech COVID-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GJ2524. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. # concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.
did feel a little bad after both doses; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date refer case US2023AMR037378).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: did feel a little bad after both doses). Rechallenge with Shingrix was positive. The outcome of the feeling bad was recovered/resolved (duration 4 days).   It was not reported if the reporter considered the feeling bad to be related to Shingrix.     It was not reported if the company considered the feeling bad to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR037378   Additional Information: GSK Receipt date: 28-FEB-2023 This case was reported by a patient via interactive digital media. The reporter reported that the shingrix was more than 90 percent effective at preventing shingles and long-term nerve pain.  The reporter mentioned that's about as good as you could get.  The reporter reported that when he/she was in his/her fifties got the original Shingles vaccine, but it was not nearly as effective. The patient did feel a little bad after the dose and lasted about four days, but mentioned that more than worth it to avoid the shingles. Additional Supportive Information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR037378:Same patient/same product
pc from mom 15JUL94 130PM states pt had sz-like activity-twitches throughout whole body-10-20 min duration-3-4 hrs p/vax had fever not hot; T not taken seen by MD 11JUL; MD stated  was DTP rxn;
headache; This is a Spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 26Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history included tooth extraction and have had been taking pain medication after. The patient concomitant medications were not reported. On an unspecified date, the patient experienced headache. Patient asked if this was part of the covid vaccine's side effect. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Subacromial bursitis, starting day after injecting persisting at >1 week. difficulty sleeping, pain, unable to lift arm above head. patient reports practitioner injected high
has had pain in lt arm since got the shot 11MAR93; about 6 days ago devel pain in rt shoulder w/tightness in chest & chest pain; seen by MD;
COUGH, FEVER, LOSS OF TASTE/SMELL, BODY ACHES, VOMITING, DIARRHEA
Information regarding PREVENAR was received from a healthcare professional regarding a 4-month-old male patient who experienced rash all over body, fussiness, red swollen feet, and loose bowel movements. At 4 months. On 07-Apr-2009, the patient experienced rash all over body, fussy, red swollen feet and loose bowel movements. The events resolved. No additional information was available at the time of this report.
Fever 105.3 on or before 5:00 PM 8/20/2003. Febrile seizure 5:05PM approximately 8/20/03.
swelling of lower lip, soreness of throat, and itching on Left forearm and left bicep
The Moderna Covid Vaccine (Dose 2) was given 1 week earlier than it was supposed to be given.  No reactions at the time it was given or 15 minutes after being given.
Information has been received from a physician concerning a 12 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. There was no concomitant medication or vaccine reported. It was reported that the patient fainted for about 45 seconds. She had no other events or issues. It was reported that no treatment was needed and the patient was recovering at the time of the report. Additional information has been requested.
This spontaneous report as received from a healthcare worker (also reported as office manager) refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with  improperly stored (incorrect product storage) VARIVAX (Merck) (lot # L012034, 06-APR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was unknown. No product quality complaint was reported. Additional information has been requested.
Anthrax vaccine developed cramps and joint pains. Joints hurt from time to time, comes and goes to include hip, knees, and elbows.
Cough; Minor breath problems; No energy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the right arm on 14Mar2021 at 09:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included montelukast sodium (SINGULAIR) from unknown date for unspecified indication. The patient previously received acetylsalicylic acid (ASPIRIN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced cough, minor breath problems, no energy. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events cough, breathing difficult, loss of energy was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Screaming for hours, threw up through nose and mouth, irritable, restless. Symptoms for the next six days: loss of eye contact, loss of babbling noises, loss of smile, loss of care for interaction with parents, only sleeping 2-3 hours at night, throwing up, not wanting to be held, arching back, grunting for hours.