chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Chills; Muscle ache; Joint ache; Left arm pain; Feeling "sick"; Slight fever; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6207), via an unspecified route administration in the left arm on 19Mar2021 at 12:45 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to mites, grass pollen, cats and latex (skin contact). Concomitant medications included multiple vitamins (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and bifidobacterium infantis; lactobacillus acidophilus (PROBIOTICS); all from unknown dates for unspecified indications. Prior to 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6205), via an unspecified route administration in the left arm on 26Feb2021 at 00:15 (at the age of 78-years-old), as a single dose for COVID-19 immunisation and received doxycycline hyclate (MANUFACTURER UNKNOWN) and potassium dichromate (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. On 19March2021 at 14:00, the patient experienced headache, chills, muscle ache, joint ache, left arm pain, feeling sick and slight fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, chills, muscle ache, joint ache, painful left arm, feeling sick, fever was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
63 year old vaccinated female was admitted for Covid-19 pneumonia and NSTEMI. Troponin was 0.05 initially. She was started on Heparin drip. Remdesivir was given. D dimer remains normal. Cardiology recommend DAPT therapy. She will be discharged home today in stable condition.
Day of injection: general pain (not at the site but whole arm), swelling - pt used ice and tylenol that didn't help Next day: swelling (3 inch difference between arms as measured by patient), flu-like body aches and fatigue (no fever) - pt treated with ice and rest Day 2 after injection:  pt returned to pharmacy and reported extreme tenderness radiating from the area (nothing at site) especially upper chest on right side, down the arm into the fingers and upper back near right arm, heat mostly gone at this point - pt will continue with ice and rest until monday and then visit dr if still needed
Expired ACTHIB was administered to a patient, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Regulatory Authority (Reference number- 00653907) and transmitted to Sanofi on 23-Jun-2021.  This case involves a 1-year-old female patient who received a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ264AAA, expiry date: 04-Jun-2021], via intramuscular route at the left thigh on 23-Jun-2021, for prophylactic vaccination (expired product administered).  The patient received no other vaccination.  Medical history, medical treatment, concomitant medication and family history were not reported.  It was a case of actual medication error due to expired vaccine used. (Latency: on same day)  At the time of report, no adverse event was reported.  At time of reporting, the outcome was of event reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Inflammation and extreme pain in my joints in my hands. Keep me awake at night.; Inflammation and extreme pain in my joints in my hands. Keep me awake at night.; Keep me awake at night.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 13:00 (Lot number: Eeo187) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19,, Brand=Pfizer,, Lot number=Ewo171,, Lot unknown=False,, Administration date=01May2021,, Administration time=01:30 P.M., Dose number=1, Vaccine location=Left arm,), administration date: 01May2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: ARTHRITIS (non-serious), ARTHRALGIA (non-serious) all with onset 02Jun2021, outcome "not recovered" and all described as "Inflammation and extreme pain in my joints in my hands. Keep me awake at night."; INSOMNIA (non-serious) with onset 02Jun2021, outcome "not recovered", described as "Keep me awake at night.". The events "inflammation and extreme pain in my joints in my hands. keep me awake at night.", "inflammation and extreme pain in my joints in my hands. keep me awake at night." and "keep me awake at night." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthritis, arthralgia, insomnia.  Additional information: No other vaccine in four weeks No COVID prior vaccination No COVID tested post vaccination  Follow-Up (30Aug2021): Follow-up attempts are completed. No further information is expected.
Member was vaccinated with Anthrax #6 on 21 Apr 03.  About 15 seconds after injection member felt a stinging sensation that subsided shortly after vaccination.  On 22 Apr 03 member felt burning and itching at the injection site.  There was swelling and mild stiffness also noted. Member has a large area of erythema extending from deltoid to elbow.  Area is warm to touch.  He has no fever, chills or constitutional symptoms related to the Anthrax vaccine.  On 23 Apr 03 member reported to be evaluated by a  surgeon.  Member was seen and was evaluated as having a local reaction to the vaccine.  Member was given a prescription for Motrin 600mg and for 25mg Atarax for the itching.  Member was advised to return if symptoms worsen or persist.
Pfizer bivalent booster for ages 5-11 years given to patient instead of the 12 and older dose.  Patient was called 1 hour later, and incident was thoroughly explained.  Per recommendations, patient should be given an adult dose immediately.   Patient was given the appropriate dose at 12:30 pm
pt  & fiance consumed 2/3 of the contents of soda bottle, a vial of varicella vax came out p/the rest of contents were poured from the bottle;no apparent damage to vax vial;1 day later devel a high fever & went to ER;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient had no known allergies or other medical history. The patient's relavant past drug history was reported as allergy (as reported). From 23Jun2022 to 27Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19.
Severe worsening pain with movement of any kind of my right arm. Intermittent numbness and tingling, extreme weakness of right arm.
Pt received shot 10/12/11 11:55pm; she said later that evening around 12 midnight she had severe shakes & fever of 101-102 degrees. Which she described as coming on like a freight train. This lasted about 45 minutes and then she felt better. Upon awakening that morning she felt fine.
2-16-21; headache, eyes sensitive sunlight, sore left shoulder. 2-17-21; sore left shoulder, eyes sensitive to sunlight, headache, triceps on left arm sensitive to the touch with some swelling. 2-18-21: armpit swollen with a huge round circle underneath armpit area. no rash, no redness, no fluid leakage. Called and spoke with on-call nurse, who told me to use cold packs. Made an appointment with my doctor over the telephone. administered probiotics/antibiotics for 7 days. NOTE: Shot was given in my left shoulder, all problems are on the left side. I also had corvid in September 2020 and it took me at least 3 months to recover or feel normal again.
DTAP-HIB combo given before 15 months of age.  No side-effects reported.
Headache; fatigue; sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: EL3302), via intramuscular in right arm on 05Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included Migraines and aortic valve insufficiency. Concomitant medications included acetyl carnitine hydrochloride (NEUROTIN), candesartan cilexetil (ATACAND), rosuvastatin calcium (CRESTOR), allopurinol (ELAVIL), topiramate (TOPAMAX) and calcium on unknown date. On 06Feb2021, the patient experienced headache, fatigue and sore arm. Treatment information was reported no. The outcome of the events was recovered on Mar2021.  No follow up attempts are possible. No further information is expected.
feeling cold; chills; Nausea; threw up all night; tested positive for COVID; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID), FEELING COLD (feeling cold), CHILLS (chills), NAUSEA (Nausea) and VOMITING (threw up all night) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), HYDROXYZINE and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). On an unknown date, the patient experienced FEELING COLD (feeling cold), CHILLS (chills), NAUSEA (Nausea) and VOMITING (threw up all night). On 27-Jan-2021, SARS-COV-2 TEST POSITIVE (tested positive for COVID) had resolved. At the time of the report, FEELING COLD (feeling cold), CHILLS (chills), NAUSEA (Nausea) and VOMITING (threw up all night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, COVID-19: (Positive) tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information is not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up received and added new events Feeling cold, chills, nausea, threw up all night.
GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH.  EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATIENT TOOK BENADRYL. SYMPTOMS RESOLVED NEXT MORNING
Information has been received from an office manager concerning a retired 75 yr old white male with an allergy to codeine who on 18Jan05 was vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). There was no illness at the time of vaccination. On 19Jan05 the pt developed injection site pain, redness and swelling. Unspecified medical attention was sought. The pt was treated with rest, moist heat and cephalexin (Keflex) for 7 days. No diagnostic lab tests were performed. Within 72 to 96 hrs, the pt recovered. It was also noted that there were no adverse events following prior vaccinations. No product quality complaint was involved. No further information is expected. It was also reported that four other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed adverse events (WAES0503USA00536 through 0503USA00538, and 0503USA00540).
Patient fainted and was sweating while in post vaccination observation area. Patient recovered and mother took patient to ED for follow up. Patient discharged from ED with no issues.
This spontaneous report was received from a registered nurse regarding multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored (incorrect product storage) oral, ROTATEQ lot# K023537 and expiry date of 22-JUN-2016 and Lot# K024700, with an expiry date of 30-JUL-2016). No adverse events were reported. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Shortly after vaccine the patient experienced an itchy arm and later the arm told red around the injection site, about the size of a softball.  Patient states it still itches and is red 4 days later.  Patient also said she had an headache the afternoon after the vaccine.
This case was reported by a lawyer via call center representative and described the occurrence of Guillain Barre syndrome in a female patient who received FLUARIX QUADRIVALENT (batch number 57C93, expiry date unknown). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was previously reported to VAERS. The patient received a dose of FLUARIX QUADRIVALENT, and experienced Guillain Barre syndrome. The reporter wanted to know whether the FLUARIX vaccine contained egg.
Body aches; swollen arm; nausea; vomiting; fatigue; couldn't keep eyes open; This spontaneous case was reported by a patient and describes the occurrence of OCULAR DISCOMFORT (couldn't keep eyes open), PERIPHERAL SWELLING (swollen arm), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (Body aches) in a 25-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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced OCULAR DISCOMFORT (couldn't keep eyes open), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue). On 21-May-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. On 25-Apr-2021, NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) had resolved. On 23-May-2021, OCULAR DISCOMFORT (couldn't keep eyes open) and PERIPHERAL SWELLING (swollen arm) had resolved. At the time of the report, MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was provided.   This case was linked to MOD21-100216, MOD-2021-182849 (Patient Link).
This spontaneous report as received from a health professional refers to unspecified number of unspecified patients. On an unspecified day in May 2015 (reported as 07-MAY-2015 or 08-MAY-2015), the patients were vaccinated with unspecified number of doses of improperly MMR II (lot# not reported, subcutaneously). No adverse event were reported. This is one of several reports from the same reporter. Additional information has been requested.
A family of 7 came in today for their first dose Pfizer, 1 adult + 4 children age >12 + 2 children age <12. When prepping the pediatric Pfizer vaccine, the intern did not diluted the vaccine with the diluent and was given to the two pediatric patients. The vaccine was immediately disposed of upon realization of error. The dad was informed of this while waiting for 15 minutes in store. For the duration of stay in store, none of the family reported any changes or discomfort. He was advised to monitor for the adverse effects of fever, headache, fatigue, N/V, and sore arm. He was also informed that the side effects may be more severe than usual and advise him to monitor them closely. The dad understood the situation and was not too concern and left the pharmacy after his COVID and flu vaccine.
This spontaneous report was received from a registered nurse, concerning a female patient of an unknown age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 02-AUG-2013, 16-SEP-2014 and 10-AUG-2015, the patient was vaccinated with the first, second and third dose of GARDASIL (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 24-FEB-2017 and 05-APR-2017, the patient was vaccinated with the first and second dose of GARDASIL 9 (dose, frequency and route were not reported) lot # M017983 with expiration date of 30-MAY-2018 and lot # M016193 with expiration date of 24-APR-2018, respectively, for prophylaxis. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Loud, uncontrollable, high pitched screaming for >1hr duration p/1st DTP; unlike any cry a/or since; no other problems;
Rapid heartbeat (104-110) shortly after injection, arm hurt at injection site a few hours later (lasted for 2 days), fatigue and felt off the next day,  felt anxiety and short periods of racing heart for 1.5 weeks after dose.
From mail correspondence received at manufacturer on 8/26/02, it was reported that an 18 y.o. male was vax'd on 8/16/02 at 14:10. No product info provided on report. PT c/o'd numbness, decreased muscle control, and facial swelling at 24:00 on 8/17/02. PT was seen in ED on 8/18/02 and Dx'd with Bell's Palsy on 8/19/02. PT was also seen by another MD on 8/20/02. Treatment w/steroids and antibiotics. No signs of improvement at this time according to PT's mother. From phone contact to reporter on 8/28/02, the PT received Meningococcal vax SC in left upper arm.
4 swollen lymph nodes. Two near clavicle, one in arm pit, one behind right knee.
Patient given Primary Orange COVID vaccine 5 years to 11 yr old. Patient was schedule to be given BOOSTER Bivalent vaccine. patient waited 15 mins with mother and sister, who received the same vaccine. Patient left within normal limits. Mother was notified of wrong vaccine given. Advise mother patient(s) cane return in 2 month for BOOSTER. Provider MD notified and was okay with vaccine.
Pt had a syncopal event w/ associated dizziness. Vitals: 115/75, 61, 18 Pt stable and released from the vaccination site.
Bradycardia, but no symptoms.  Onset on 9/20/22.   Problem resolved after pacemaker placed 9/23/22
PAIN; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st September 2019, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased and injection site pain. On 2nd September 2019, the outcome of the injected limb mobility decreased and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced pain at the injection site at the time of receiving Shingrix. Her arm was incapacitated for that day. The reporter did not consent to follow-up.
Two days later iI started having severe chest pains unlike I have never had in my life. It felt like I was having a heart attack and so my mother called 911. The paramedics saw something in my EKG they do when they arrive at the home and advised me to not wait and and to let them take me to a hospital. I had tests done in the emergency room and was told to stay in the hospital for a few days.
Complaint of injection sites (arms) extremely sore, myalgia, lethargy, headache, dizziness evening of immunizations and next day, not improving with taking Ibuprofen, symptoms not improved day after immunizations.
Subject received COVID-19 0.3 ml intramuscular on 01/19/2021. Returned on 02/09/2021 to same vaccination facility and received inadvertently a second dose of Covid_19 0.5 ml.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-DEC-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 11-MAY-2016, the patient was treated at a hospital by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term 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, and pain and suffering, and other damages. Additional information has been requested.