chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients (ages and genders not specified) who reported that one dose of VARIVAX (Merck) and 10 doses of PROQUAD (Merck) that were improperly stored were administered to an unspecified number of patients. No adverse effects were reported. Follow up information has been received from licensed practical nurse via telephone call on 12-FEB-2015 refers to a 2-5 year old patient. Total number of doses administered of VARIVAX (Merck) was 13. On an unknown date patient was vaccinated with improperly stored VARIVAX (Merck) (lot # K006136, expiry: 29-APR-2016). There was no need for revaccination. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports from the same reporter. Additional information had been requested.
Date of Admission: 10/25/2022   Date of Discharge: 10/26/2022   Admission Diagnosis:     ICD-10-CM ICD-9-CM 1. Moderate persistent asthma with status asthmaticus  J45.42 493.91 2. COVID  U07.1 079.89     Hospital Principal Problem (Discharge Diagnoses): Moderate persistent asthma with status asthmaticus
Moderna COVID-19 Vaccine EUA Chest/Back muscle pain that made it painful to breath, starting at 10:44 AM and subsiding at 11:00 AM
In the middle of the night i had a lot of pain did not take any medication but had a lot of pain and when I woke up to give food to my dog i passed out on the floor of kitchen.
I had cold like symptoms. Sore throat, stuffed head, coughing and fatigue. I also lost taste and smell. I took TYLENOL and ROBITUSSIN DM to treat the symptoms. The doctor did not prescribe anything else but after 3 days I felt better but the fatigue lasted several weeks. I feel like I am currently recovered compared to how I felt. I also reached out to my allergy doctor who prescribed me prednisone which I did not end up taking.
Case number PHEH2015US021220, is an initial spontaneous report from a health care professional received on 19 Oct 2015. This report refers to a 5 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly on 15 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Fever, body aches and Swollen lips and face for 3 days after the vaccine.
Patient was admitted to Hospital on 4/12 with shortness of breath and diagnosed with Acute Pulmonary Embolism .
Case number PHEH2014US004075 is an initial spontaneous report received from a pharmacist on 25 FEB 2014. This report refers to a 09-year-old male child.  He had a pre-existing medical history of autism. His concomitant medications were not reported. On an unknown date in JAN 2014, he was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly. No adverse event was reported following this administration error (inappropriate age at vaccine administration). However upon insisting by this pharmacist the child's pediatrician has been contacted about this incident.  Following an internal review on 18 AUG 2014 of the data received on 25 FEB 2013, it ws identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
This was very unfortunate 51 years old male with past medical history of hypertension, hyperlipidemia, obesity.  Patient presented with chief complaint of shortness of breath and chest pain. EMS reported that the patient has been complaining of some shortness of breath and chest pain intermittent for couple of weeks. 12 leads EKG showed evidence of anterior ST elevation myocardial infarction.  Code heart was called.  Patient developed PEA arrest in the Cath Lab.  CPR ACLS was initiated.  ROSC was achieved initially after 30 minutes of CPR.  Intra-aortic balloon pump was placed.  Coronary arteries were essentially clean.  Due to high suspicion for massive PE-TPA was given 100 mg without meaningful clinical improvement.  CPR was continued for more than an hour.  Despite all aggressive measures patient continued to deteriorate.  At 3:26 PM patient has no spontaneous breathing, no peripheral pulses, no heartbeats by auscultation or by monitor.  Pupils were fixed and dilated.  No cough no gag reflexes . patient was pronounced dead.
Fatigue, nausea, headache, arm pain, brain fog, some palpitations, chest tightness. Went to ER, was told I was dehydrated. Fatigue and palpitations continued for 8 weeks. Was subsiding, then on July 30 I developed shooting pain and tingling on left arm, back and shoulder pain. Treated at urgent care with steroids. Pain lessened but continues to this day. Now experiencing right side muscle pain. Given naproxen 500mg and cyclobenzaprine 10mg prn. Experience sporadic muscle twitches as well as aching pain in feet at times. Still experiencing some fatigue but not consistent.
Patient got their first vaccine in January2021 & still not received second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient got their first vaccine in January2021 & still not received second dose) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient got their first vaccine in January2021 & still not received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient got their first vaccine in January2021 & still not received second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment information was provided by the reporter.   Reporter did not allow further contact
I developed severe joint aches in both arm and legs; shoulders to hands and hips to ankles, starting during the night following administration of the vaccine. There has been no fever or headache. No outside medical attention was obtained. As a healthcare professional, I was able to self-diagnose and treat with anti-inflammatory medications and other palliative remedies. The pain is severe enough to disrupt sleep and normal ADLs. Symptoms are still present after 4 days.
Pfizer-BioNTECH COVID-19 Vaccine EUA Patient received Pfizer COVID Vaccines on 1/29/2021 and 2/22/2021. Patient presented to ED on 7/16/2021 with worsening shortness of breath for the last few days. Admit diagnosis of Pneumonia due to COVID-19. Patient was treated with remdesivir daily (7/16 - 7/20), IV steroids, and Tocilizumab 800 mg x2 doses (7/20&21). Patient expired on 7/29/2021.
Moderna product expired on 14-Jan-2022 was administered on 15-Jan-2022 to 3 patientsas a booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna product expired on 14-Jan-2022 was administered on 15-Jan-2022 to 3 patientsas a booster dose.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna product expired on 14-Jan-2022 was administered on 15-Jan-2022 to 3 patientsas a booster dose.). On 15-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna product expired on 14-Jan-2022 was administered on 15-Jan-2022 to 3 patientsas a booster dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Patient is in her 40 s.It was reported that the vial did not undergo any temperature excursion.  Treatment information was not provided.   This case was linked to MOD-2022-455209, MOD-2022-455269, MOD-2022-455277 (Patient Link).
Pain (L) shoulder 15 minutes post injection. No redness or swelling. Decreased range of motion. No fever. Site of injection high - under acromion.
The second day after being administered the vaccine, my right arm began to have throbbing pain from the front on my right shoulder down to the bottom of the front of my bicep.  This was accompanied by swelling are deep pain.  It felt almost as if my arm was having the circulation cut off.  The following day my right hand, fingers, forearm began to have a numbing/pins and needle type feeling.  This has still not subsided and I 6 days post vaccine.  Along with the arm issue, on the second day after the vaccine; I began to have a hive/rash breakout on the sides of my upper legs and buttocks.  This is extremely sore and moderately itchy.  This has not subsided 6 days post vaccine.
pt recvd vax 28OCT93; began exp hives 2NOV93; seen by nurse then MD; allergist had pt take DPH;
Pediatric dose was administered when adult dose was needed. No problems with vaccine dose that was administered.
back hurts so bad; Can't sleep at night; neck hurts so bad; sore at the muscle and  muscle  hurts; joints huts; sore at the arm  and  arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore at the arm  and  arm hurts), BACK PAIN (back hurts so bad), INSOMNIA (Can't sleep at night), NECK PAIN (neck hurts so bad) and MYALGIA (sore at the muscle and  muscle  hurts) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, the patient experienced PAIN IN EXTREMITY (sore at the arm  and  arm hurts). On 20-Dec-2021, the patient experienced BACK PAIN (back hurts so bad), INSOMNIA (Can't sleep at night), NECK PAIN (neck hurts so bad), MYALGIA (sore at the muscle and  muscle  hurts) and ARTHRALGIA (joints huts). At the time of the report, PAIN IN EXTREMITY (sore at the arm  and  arm hurts), BACK PAIN (back hurts so bad), INSOMNIA (Can't sleep at night), NECK PAIN (neck hurts so bad), MYALGIA (sore at the muscle and  muscle  hurts) and ARTHRALGIA (joints huts) outcome was unknown.            Deep down in patient  joints, she had real sharp pain. No concomitant medication was provided. No treatment medication was provided.
This case was reported by a physician and described the occurrence of edema of eyelid in a 48-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced edema of eyelid, injection area hardness, redness and localized infection. At the time of reporting the outcome of the edema of eyelid, hardness injection site, injection site redness and localized infection were unspecified.
This spontaneous report as received from a medical assistant refers to a 17 years old female patient. On 11-APR-2013 the patient was vaccinated with GARDASIL (dose, route, indication and lot number were not provided) first dose. No other concomitant medications were reported. The medical assistant noted that the patient was administered with the first and second doses of GARDASIL (dose, route, indication and lot number not provided) on 11-APR-2013 and 10-MAY-2013, respectively. No adverse effect reported. Additional information has been requested.
Existing condition: Have had intermittent Tinnitus for a while (once/twice month) sometimes started by some strenuous activity or sometimes just randomly.   After shot and until right now (16 hours including sleep) very mild continuous tinnitus. Hoping it will go away with any other effects.
Tinnitus; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 001B21A, 039F4A and 048L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cholesterol and Insomnia. Concomitant products included ATORVASTATIN for Cholesterol, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.            Reportedly, patient also experienced tinnitus on 12-Mar-2021 and 09-Nov-2021 which was still ongoing.  Treatment medication was not provided by the reporter.  It was reported that patient did not know exactly when and realized that patient had 1000 cicadas chirping in her head. If Patient was not concentrating on something or distracted, patient noticed the noise, the noises started after the vaccinations.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Follow-up document contains updated patient demographics, concurrent conditions, suspect product information, updated event details, report type and narrative updated accordingly.
This case was reported by a consumer and described the occurrence of injection site pain in a 6-month old female subject who was vaccinated with HIBERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included jaundice and respiratory syncytial virus. The subject received other vaccines, specific details were unknown. There were no concurrent medications. On the morning of 23 May 2012 the subject received unspecified dose of HIBERIX (unknown, left thigh) and experienced wrong vaccine administered. The subject was given HIBERIX instead of "regular HIB". On an unspecified date, less than one month after vaccination with HIBERIX, the subject experienced injection site pain, injection sire redness, high fever, and restlessness. The subject had a body temperature of 102, which was treated with TYLENOL. At the time of reporting the injection site pain, injection site redness, high fever, and restlessness were resolved.
I GOT IT ONCE YEARS AGO AND I GOT SO SICK; LACK OF DRUG EFFECT; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number UNKNOWN), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST.    The report described lack of effect for Flumist. The reported term was "lack of drug effect" (Preferred term: Drug ineffective).     On an unknown date, the patient experienced i got it once years ago and i got so sick (preferred term: Illness).     It is unknown if any action was taken with Flumist (influenza vaccine live reassort 3v).     The outcome of the event(s) of i got it once years ago and i got so sick and lack of drug effect was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Product Role: Suspect
spiked a 105 fever; chills; uncontrollably shaking; lips turned purple; 01Apr2021 dose 1 Lot number: EW0150 and dose two lot number: Ew0164 administered; This is a spontaneous report from a contactable consumer (patient).   A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Batch/Lot Number: Ew0164) as DOSE 2, SINGLE, (at the age of 43 years) dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 13:15 (Batch/Lot Number: EW0150) as DOSE 1, SINGLE  (at the age of 43 years) for covid-19 immunisation.  Medical history included drug hypersensitivity to penicillin and food allergy of banana. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced chills on 29Apr2021 15:00 with outcome of recovered, uncontrollably shaking on 29Apr2021 15:00 with outcome of recovered, spiked a 105 fever on 29Apr2021 15:00 with outcome of recovered, lips turned purple on 29Apr2021 15:00 with outcome of recovered and 01Apr2021 dose 1 lot number: EW0150 and dose two given lot number: Ew0164  were administered on 01Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: 105 on 29Apr2021 "I spiked a 105 fever", sars-cov-2 test: negative on 29Apr2021.  Therapeutic measures were taken as a result of chills, uncontrollably shaking, spiked a 105 fever, lips turned purple.  The husband brought the patient to the emergency room and treatment included IV Benadryl, epinephrine and Tylenol. No other vaccine given within 4 weeks.  The patient did not have COVID prior to vaccine.    No follow up attempts are possible. No further information is expected.
I had my 2nd Moderna Covid 19 vaccine on Thursday morning March 18, 2021 at  the hospital.  Everything went fine.  At approximately 4.00am Friday morning.  I was awakened and barely made it to the toilet where i vomited 3 times.  Following that took my temperature and it was 102.5.  I was shaking all over, ached all over as well as a headache.  very similar to my 1st vaccine reaction only much worse.  Again i was planning to play golf Friday and Saturday mornings but cancelled.  Can't play golf when you can barely walk.  I drank pedialyte and gatorade to  rehydrate and basically had no energy to do anything but sleep off and on for the next 2 days.  It wasn't until Tuesday that I began feeling normal.  Temperature slowly went down and finally was normal Monday night.
costochondritis; chest pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30- year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection administered in arm right, administration date 21May2021 (Lot number: WAQ4579) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Known allergies: Wheat" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: WAQ4579, Location of injection: Arm Right), administration date: 30Apr2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: COSTOCHONDRITIS (hospitalization) with onset 06Jun2021, outcome "not recovered", described as "costochondritis"; CHEST PAIN (hospitalization) with onset 06Jun2021, outcome "not recovered", described as "chest pain". The patient was hospitalized for costochondritis, chest pain (hospitalization duration: 1 day(s)). The events "costochondritis" and "chest pain" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of costochondritis, chest pain.
On April 1997, the pt had his first visable seisure. DPT show was given on 03/10/1997. Most of the shots the pt was given for immunizations at this time contatined Thimerasol. The mother recently found out that her son has a metal disorders and exposure to metals can cause neurological problems. He is autistic and has epilepsy. Annual follow up states: pt has not recovered. Epilepsy was controlled after 4 years so far. Could return per doctor. Autistic. We went ahead and gave additional vaccinations required at age 6 because to date there is no absolute proof this had caused any problems and school and doctor pressured to do it. I still and will probally always question this as the cause.
About 3 weeks after vaccine, severe shoulder pain occurred. A few days after that, shoulder movement Also called: adhesive capsulitis of shoulder became extremely limited and pain producing.  In March a visit to my PCP, I was diagnosed with a frozen shoulder,  also called: adhesive capsulitis of shoulder and received a steroid shot in the shoulder joint.  A month later I was seen by an Orthopedic surgeon who confirmed the diagnosis with X-ray. He also gave me a steroid shot in the joint and prescribed Meloxicam.  Shoulder has not improved.
INJECTION SITE IS RED, SWOLLEN, PAINFULL, ITCHING AND SEEMS TO BE SPREADING OUT FURTHER EACH DAY TOOK BENEDRYL  APPLIED ASPERCREME APPLIED CALAMINE SPRAY
blood pressure was high 210/106; facial tongue tingling; facial tongue tingling; numb; metallic taste in mouth; This is a spontaneous report from a contactable nurse.  A 75-year-old female patient received her first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After getting her first dose on unspecified date in Feb2021, the patient experienced facial tongue tingling and numb, blood pressure was high 210/106 and had a metallic taste in mouth. Paramedics gave her Benadryl and monitored for an hour. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Due to a positive drug-event temporal association and lacking identified alternative explanations, the company, despite no patient's medical history, concomitant medication and baseline and follow-up values of blood pressure have been provided, cannot completely exclude that the reported high value of blood pressure is related to BNT162b2 administration. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
w/in 10 mins tingling in lt hand fingertips & lt side of mouth & lips; only persistent findings is tingling in fingertips;
Received call from patient today to cancel appt. Was seen by PCP today and advised not to take 2nd dose due to development of symptoms after receiving 1st Moderna vaccine.  Said heart began racing @24 hours after vaccination. Blood sugar elevated over 200 and has been under control. Described heart as "jello with a fly in it"  Saw PCP today and he does not want her to have, thinks she is allergic to component in vaccine.
pt recv vax 17APR97 & 24APR97 pt devel rash & itching;
Evening 4-23-21 9:00pm frothing at the mouth, not breathing. Eyes bulging and abdomen distended and hard. Admitted for observation until 4-24-21. Lasted 4 to 5 minutes, no color change, responded to jaw/chin lift. (Brief, resolved unexplained event). 26 1/2 week preterm infant