chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of overdose in a 9-month-old male patient who received HAV (Havrix adult) (batch number U95H7, expiry date 22nd May 2022) for prophylaxis. Co-suspect products included HAV (Havrix adult) (batch number U95H7, expiry date unknown) for prophylaxis. Previously administered products included Havrix (received first dose on unknown date). On 12th September 2021, the patient received the 3rd dose of Havrix adult. On an unknown date, the patient received the 2nd dose of Havrix adult. On 12th September 2021, unknown after receiving Havrix adult and not applicable after receiving Havrix adult, the patient experienced overdose, adult product administered to child and extra dose administered. On an unknown date, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the overdose, adult product administered to child, extra dose administered, adult product administered to child and overdose were unknown. Additional details were provided as follows: The pharmacist reported that patient received the adult dose of the Havrix vaccine inadvertently for their second and third dose of the series. The patients were administered the third dose of the vaccine series, which led to overdose, adult product administered to child, extra dose administered. The batch number was for second and third dose of Havrix vaccine was same. The reporter consented to follow up. The case has been linked to US2021254948 and US2021254932, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021254948:Same reporter. US-GLAXOSMITHKLINE-US2021254932:Same reporter.
06/15 Very sleepy for 2 days. On 6/22 admitted to hospital due to fever and bowels changed to green color, diarrhea. Put on IV antibiotics. Diagnosed with noninfectious gastroenteritis.
Caught covid.  Mild case.  Positive home tests. Congestion, runny nose, sore throat, coughing.  No fever.  Went to urgent care; got Paxlovid.  Symptoms better after about 5 days, tests negative by day 7.  About a week later, rebounded; symptoms and positive tests returned.  Did not treat second time (other than cough drops, acetaminophen).  Better after 5-7 days.
The vaccine is PPV. Extreme pain in my left arm, neck and back. Could not sleep for the last 48 hours and could not do my daily routing work.
Patient called the pharmacy to inform us that he had broken out a few days after receiving the shot and has presented with shingles on his body. There is some itching and the patient is in mild pain
Within 12 hours of receiving vaccine, patient experienced generalized tonic-clonic seizure lasting several minutes. She recovered fully.
8x9mm area of redness, warm to touch right deltoid area at Tdap injection site, redness just noted today 8/7/09. Area of 11.5 mm x 12 mm area of redness, warmth noted today, redness  started 8/6/09. Darker area of redness noted 3 1/2 mm x 4 mm left arm.
Angioedema, throat swelling, itching, lungs tight-unable to take a full breath,  tachycardia, anxiety, face flushed.  I took 75 mg of Benadryl an hour before the injection. Had some caffeine after I became symptomatic. Was monitored for 1.5 hours.
Fever, from about 30' to 60' after receiving dose/First 39.3, 39.4. After that improved, then came back again, now 38.5; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever, from about 30' to 60' after receiving dose/First 39.3, 39.4. After that improved, then came back again, now 38.5) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PYREXIA (Fever, from about 30' to 60' after receiving dose/First 39.3, 39.4. After that improved, then came back again, now 38.5). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever, from about 30' to 60' after receiving dose/First 39.3, 39.4. After that improved, then came back again, now 38.5) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) negative. On an unknown date, Urine analysis: negative (Negative) negative. On an unknown date, X-ray: negative (Negative) negative.     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.   Concomitant medication was not reported.
Next day post vax, the pt reportedly awoke with joint aches and entire body ache, and a high fever. On 11/15/99, the pt was seen by the physician who noted that the pt did not take his temperature, but reported that it was high.
NOT RECONSTITUTED PROPERLY/the adjuvant may have been given without the lyophilized antigen; NOT RECONSTITUTED PROPERLY/the adjuvant may have been given without the lyophilized antigen; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number CK3PY, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The reporter was an operation manager. The age at vaccination was not reported. The patient might had received the adjuvant portion of Shingrix without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
A week after getting  the Booster I began having wrist and arm pain, which I have to this day. I have had no treatment. I did talk to my Dr. about it,, she did not seem concerned about it.
Case number PHHY2011US49115 is an initial report from a health care professional received on 03 Jun 2011 with a follow up report received from health care professional on 21 Jun 2011. This report refers to an 18 year old male patient. He was vaccinated with MENVEO (batch number X10031) on 03 Jun 2011. He was administered 0.5 ml of only Men CYW-135 liquid conjugate without reconstituting it with Men A powder component. No adverse reaction occurred since this drug administration error.
A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a 33-month-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
pt recv vax 15OCT96 & DEC96 pt exp malaise, myalgia, cough & t100.4;10FEB97 MD confirmed pt exp fever, chills, myalgias & cough in DEC96;cough persisted for 2wk;pt since recovered;
had a cloudy mind for years and he told me it cleared up his mind as well; had a cloudy mind for years and he told me it cleared up his mind as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Cloudy mind" (unspecified if ongoing), notes: for years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "had a cloudy mind for years and he told me it cleared up his mind as well". 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-2021373334 same reporter and drug; similar event, different patient
Site injection - redness, mild swelling,hot, itchy; Site injection - redness, mild swelling,hot, itchy; Site injection - redness, mild swelling,hot, itchy; Site injection - redness, mild swelling,hot, itchy; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration on 13Sep2021 at 16:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphangioleiomyomatosis (LAM), diabetes type 2 and thyroid cancer. The patient had known allergy to computerized tomography (CT) contrast. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination. Concomitant medications included, varicella zoster vaccine recombinant glycoprotein E (rge) (cho) (SHINGRIX) and pertussis vaccine/ tetanus vaccine toxoid/diphtheria vaccine toxoid (DPT); both  taken on 24Aug2021 for immunisation, dapagliflozin propanediol monohydrate (FARXIGA), sirolimus (MANUFACTURER UNKNOWN), medroxyprogesterone acetate (MEDROXIPROGESTERONE), levothyroxine sodium (SYNTHROID), montelukast sodium (MONTELUCAST), semaglutide (RYBELSUS), fexofenadine hydrochloride (ALLEGRA), ezetimibe (MANUFACTURER UNKNOWN), irbesartan (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and paracetamol/ oxycodone hydrochloride/oxycodone terephthalate (PERCOCET); all for unknown indications from unknown dates and experienced drug allergy. On 15Sep2021, the patient experienced site injection - redness, mild swelling, hot, itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events site injection - redness, mild swelling, hot, itchy was resolving at the time of this report.
Localized rxn-4 x 6cm induration, erythema at L upper biceps area. Mildly tender to palp. no warmth.
I felt like I had the flue. It lasted for 15 hours. Woke up the next day feeling fine.
pt devel small wheat @ inj site w/redness;devel large wheal w/white center @ middle inj site & round large red wheal around MMR site;ice packed applied * pt kept for 1hr for observation w/o further adverse rxn noted;
pt to ED with c/o cough, congestion, rhinitis for approximately 1 wk; positive for COVID; COVID pneumonia and ARF; treated with O2, dexamethasone, diuretics, antibiotics; pt's condition worsened and he was found unresponsive with spontaneous respirations and without a pulse; CPR initiated but there was no response; pt died in the hospital
Pt reported Right arm developed redness and itching 1 week after receiving the vaccine.  Area of redness was 80mm.  Pt was prescribed prednisone by PCP.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccines were stored in freezer and required vials were taken out to place in fridge as needed.  No concomitant medications were reported. No treatment medications were reported.
Systemic morbilliform to the; head, neck, torso (front and back), and all four limbs.
p/vax pt devel chills, shivering progressing to muscle tightness & spasm in arms & legs, chest tightness, difficulty breathing.
About  8 hours after receiving my second shingrix shot, I had extreme chills and skin hurt all over from 6:30pm-12:30am ... it felt like a bad case of the flu ... these symptoms stopped abruptly and then I felt fairly normal the rest of the night into the morning, just a little tired and a slight headache also, had a sore arm at injection site ... nothing out of the normal for  an intramuscular shot I had the exact same reaction with my first shingrix shot that was given on 03/14/2019 at the same pharmacy so glad to be finished with these shots!
GOT FLUAD IN RIGHT ARM AND COMIRNATY IN LEFT ARM. NEXT MORNING CALLED WITH HIVES DOWN THE LEFT SIDE ONLY AND SURROUNDING THE COMIRNATY SITE.
Influenza A disease (verified by nasal swab); Influenza A disease (verified by nasal swab) / Lack of efficacy; This spontaneous case was received on 08-Jan-2023 from other healthcare professional (consumer) (reference number: SEQW23-00109) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.   On 15-Nov-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) for prevention of influenza disease. The batch number reported was 942370 and expiry date was 23-May-2023.   On 01-Jan-2023, in the late afternoon, one month and 17 days after receiving Flucelvax Quadrivalent, the patient experienced cough and slight fever.   On an unspecified date in Jan-2023, the patient underwent nasal swab that verified influenza A disease (explicitly coded as 'Vaccination failure'). The source of the infection was most likely the patient's roommate.   On 04-Jan-2023, in the late afternoon, the patient's fever disappeared.  The outcome of event 'influenza A virus infection' was unknown.  The reporter did not provide causality assessment.  The events of 'influenza A virus infection' and 'vaccination failure' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department  Company comment: A female patient of unreported age was vaccinated with Flucelvax Quadrivalent. One month and 17 days after vaccination, the patient experienced cough and slight fever. The patient underwent nasal swab that verified influenza A disease (explicitly coded as 'Vaccination failure'). Causal role of the suspect vaccine is assessed as possibly related for the events Influenza and vaccination failure, due to plausible temporal relationship.; Sender's Comments: A female patient of unreported age was vaccinated with Flucelvax Quadrivalent. One month and 17 days after vaccination, the patient experienced cough and slight fever. The patient underwent nasal swab that verified influenza A disease (explicitly coded as 'Vaccination failure'). Causal role of the suspect vaccine is assessed as possibly related for the events Influenza and vaccination failure, due to plausible temporal relationship.
Threw up after a feed, then apnea monitor kept alarming. To ED - found to have slow, shallow respirations. Became apneic/pulseless - unable to resuscitate despite intubation/CPR. Time of death 4:31 PM.
Pain began in shoulders of both arms and spread to neck, back and shoulder blades. NSAIDs helped a little, but condition very painful.
SUSPECTED COVID-19 INFECTION WORSE; COULDN'T SLEEP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 11:00 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced suspected covid-19 infection worse. On MAR-2021, the subject experienced couldn't sleep. Laboratory data included: Body temperature (NR: not provided) 99.6 F, 100.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the couldn't sleep and suspected covid-19 infection worse was not reported. This report was non-serious.
Swelling on right arm, black, blue and red. 6 x 6 cm bruising. No fever, some tenderness.
Pt describes left shoulder pain with abduction beyond 90 degrees. Symptoms began approximately 1 hour, post vax, on 6/22/00.
COVID 19 Treatment; COVID 19 Treatment; retested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "not recovered", described as "retested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: On day 3 after testing positive for Covid-19 I started taking Paxlovid; (Aug2022) Positive, notes: On Day 5 after first positive test I again tested positive; (Aug2022) Negative, notes: On Days 7, and 10 I tested negative; (Aug2022) Negative, notes: On Days 7, and 10 I tested negative; (Aug2022) Positive, notes: Some mild symptoms remained and on Day 13 worsened a bit and I retested and was positive; (Aug2022) Positive, notes: Also positive test on Day 14.tested positive. On Day. Therapeutic measures were taken as a result of drug ineffective, covid-19 included treatment with Paxlovid from 16Aug2022 to 20Aug2022.  Clinical course: Patient received Multivitamin in 2 weeks. Rebound after Paxlovid treatment. On day 3 after testing positive for Covid-19 the patient started taking Paxlovid. On Day 5 after first positive test he again tested positive. On Days 7, and 10 he tested negative. Some mild symptoms remained and on Day 13 worsened a bit and the patient retested and was positive. Also positive test on Day 14.tested positive. Patient had no known allergies.
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 51-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 50 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6203), on 17Mar2021 as dose 2, single (Lot number: EN6208), on 12Oct2021 as dose 3 (booster), single (Lot number: FD0810) and on 22Apr2022 as dose 4 (booster), single (Lot number: FT4989) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "Known allergies: kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metformin, reaction(s): "Known allergies: Metformin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Sep2023) Negative; (27Sep2023) Positive, notes: tested positive on 27Sep. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Vaccine went into 2-8 degree Celsius thawstate on or about 24-Dec-2021 and administered on 26-Feb-2022 at 3:30 PM; Vaccine went into 2-8 degree Celsius thawstate on or about 24-Dec-2021 and administered on 26-Feb-2022 at 3:30 PM; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thawstate on or about 24-Dec-2021 and administered on 26-Feb-2022 at 3:30 PM) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thawstate on or about 24-Dec-2021 and administered on 26-Feb-2022 at 3:30 PM) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022 at 3:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Feb-2022 at 3:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thawstate on or about 24-Dec-2021 and administered on 26-Feb-2022 at 3:30 PM). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thawstate on or about 24-Dec-2021 and administered on 26-Feb-2022 at 3:30 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thawstate on or about 24-Dec-2021 and administered on 26-Feb-2022 at 3:30 PM) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thawstate on or about 24-Dec-2021 and administered on 26-Feb-2022 at 3:30 PM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient received booster dose. Patient ethnicity reported. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2-to-8-degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment information was provided.