chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ITCHINESS ON BACK, ARM AND FOREHEAD; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 09:45 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced itchiness on back, arm and forehead. Treatment medications (dates unspecified) included: cetirizine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchiness on back, arm and forehead. This report was non-serious.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117, expiration date 06-OCT-2018, dose and route were not reported). The vaccine had been stored under the temperature of 34 Fahrenheit degrees for 72 hours and 35 Fahrenheit degrees for 72 hours. A data logger was used to log the temperatures. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Ringing in ears. Pain in chest. Feels like drunk. Agitated/aggravated. (saw 4 doctors). Still ringing in ear. No change after 3 month. Dizzy still, tinnitus?
This spontaneous report as received from a 64-year-old female patient refers to herself. The patient had allergy to codeine and gabapentin. She had no pertinent medical history. On an unknown date in October 2007, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided), to prevent shingles. Concomitant therapies included acetaminophen (manufacturer unknown), aspirin (+) citric acid (+) sodium bicarbonate (ALKA-SELTZER), and unspecified Bayer tablets. On an unknown date in February 2008, the patient experienced 15 shingles flair ups, with blistering, and internal pain, on her left side, upper hemisphere. The patient sought medical attention. She received acyclovir 800 mg, 5 times daily for the adverse event. No laboratory diagnostic studies were performed. The outcome of shingles was not reported. The relatedness between the adverse event of shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sore arm; slightly swollen two months after second vaccination; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 10:30 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, blood pressure high and cholesterol. The past drug included ALEEVE for unknown indication, from an unknown date. The patient received unspecified medication within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jan2021 at 10:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 23Feb2021 at 1900, the patient experienced sore arm and slightly swollen arm. The patient was concerned with length of time, since it continued to the present -May1. The events resulted in doctor or other healthcare professional office/clinic visit. On 01May2021, the patient underwent COVID test (nasal swab) and the result was negative. The clinical outcome of the event sore arm and swollen arm was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itching, redness, swelling, heat at injection site. Continues to itch occasionally.
Patient seen in ED this past weekend, at MC for gastroenteritis symptoms, he had headache, and fever symptoms, and abdominal cramping, nausea and vomiting, he also had a cough, he was treated with IV fluids, and supportive medicines, no antibiotics were prescribed, he states that he feels much better day, without any abdominal cramping, no nausea or vomiting, no diarrhea, no fever, no headache, no sore throat, his cough has also improved, he did notice a non-itching rash on his forearms this morning. His symptoms started after he took his second dose of oral typhoid immunization pills.  His symptoms are consistent with adverse reaction to oral vaccine.
This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a male patient who received Influenza vaccine. Concurrent medical conditions included bleeding tendency (and the patient was on anticoagulant therapy). Concomitant products included Anticoagulant. In 2014, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced injection site bruising, injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site bruising, injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site bruising and injection site pain to be related to Influenza vaccine. Additional details were provided as follows: This case was reported by the patient's wife. Last year in 2014, the pharmacist administered Flu vaccine to the patient not only in the wrong place on his arm but on his back muscle, which led to administration of the vaccine at inappropriate site. This maladministration also resulted in a huge bruise at injection site with additional pain.
Symptoms included tingling in both extremities, along w/numbness both arms, "itchy sensations", muscle pain both arms, "clumsiness difficulty holding pen. No hives, no respiratory symptoms.
Fever 104/103.9; sore throat; cough; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Jan2022 14:30 (Lot number: FJ1611) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart attack ", start date: 31Jan2022, stop date: 31Jan2022. Concomitant medication(s) included: PLAVIX; BABY ASPIRIN; ROSUVASTATIN. Past drug history included: Versed, reaction(s): "Known allergies: Versed". Vaccination history included: Bnt162b2 (EN9581, Intramuscular, Previous dose number: 2, Vaccine location: Left arm), administration date: 04Feb2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "Heart attack 13Jul2021"; Bnt162b2 (EK9231, Intramuscular, Previous dose number: 1, Vaccine location: Left arm), administration date: 13Jan2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant) with onset 15Jan2022 11:00, outcome "recovering", described as "Fever 104/103.9"; OROPHARYNGEAL PAIN (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "sore throat"; COUGH (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "cough"; HEADACHE (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: body temperature: (15Jan2022) 104/103.9; sars-cov-2 test: (15Jan2022) negative, notes: Nasal Swab; (17Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pyrexia, oropharyngeal pain, cough, headache, pain. Additional Information:  It was also reported that patient did not received any other vaccine in four weeks. Patient was not detected with Covid prior to vaccination. Patient was tested with covid post vaccination. Facility type vaccine was Workplace clinic.; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported  events headache , pain, oropharyngeal pain ,pyrexia , cough and the suspect drug BNT162B2 cannot be excluded. The impact 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
pt recv vax 8MAY96 & spiked temp of 103 9MAY96 & t101 ax 10MAY96;seen by MD 10MAY96 t100.7;otherwise nl exam;pt did fine thereafter;
Have several side effects / Symptoms after booster; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Have several side effects / Symptoms after booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2022, the patient experienced VACCINATION COMPLICATION (Have several side effects / Symptoms after booster). At the time of the report, VACCINATION COMPLICATION (Have several side effects / Symptoms after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided. Patient received the booster on Monday morning.
Tired; achy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Tired) and PAIN (achy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired) and PAIN (achy). At the time of the report, FATIGUE (Tired) and PAIN (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No current illness, lab data, allergies and historical condition was given. No concomitant and treatment medications was given.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Hives and throat tightening - ER -> IV BENADRYL, Epinephrine, SOLUMEDROL and PEPCID.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23, expiration date on 15-AUG-2015, (lot #, dose and route were not provided). No adverse effect reported. Additional information has been requested.
Induced seizures in each of them; they are epileptic; now they are epileptic; There is some correlation between the diagnosis of epilepsy, their medications (Unspecified Medications), the vaccine (Pfizer Covid-19 Vaccine);  had seizures as a result; This is a spontaneous report from a contactable consumer (parent). This consumer reported same events for two patients. This is the first of 2 reports. An adult female patient (reporter's daughter) received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EW0162) on unspecified date as a single dose for COVID-19 immunization. The patient's medical history included prematurity, brain damage, many disabilities, respiratory compromise, cognitive impairment, and legally blind. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, LOT#: EN6205) on 09Apr2021 as a single dose for COVID-19 immunization. Concomitant medications were not reported. After the second dose the patient with special needs which is having a medical condition and had seizures as a result. The patient experienced seizures, once within about 4 hours and then the next within 12 to 18 hours (unspecified dates). The reporter stated the patient has some different medical ailments, disability medications and it seems though there may be reactions within 24 hours, induced seizures and now epileptic. The patient has not had a breakthrough seizure in years and so reporter thought maybe there is some correlation between the diagnosis of epilepsy, her medications (unspecified products) and the vaccine she got. Lab test was not specified, but reporter stated there was because she was taken by ambulance to emergency room the night of her vaccine. The outcome of the events (seizures, epileptic, correlation between the diagnosis of epilepsy, her medications and the vaccine) was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021422246 Same reporter/diff patient
Woke at 3am and room was spinning (never happened to me before.  Next 17 hours severe headache and nausea - like a sinus headache on top of a migraine.  Could not tolerate food or drink.  Bowels emptied and threw up approx. 4:30 pm.  Did not take any meds.  Could not tolerate light or noise.
70 year old was given Adacel vaccination, no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 years old female patient who received 0.5 ml dose vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site on 17-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that a 70 year old was given Adacel vaccination because her daughter is expecting, and it was recommended that as a grandmother she receive Tdap.  At the time of reporting, no adverse reactions were reported.  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 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.  Information on the batch number was requested.  List of documents held by sender: none.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's concurrent conditions and medical history were not reported. The patient's concomitant therapy included DILUENT MRK INJ. On 18-MAY-2018, the patient was vaccinated with a dose of Oka/Merck VARIVAX (0.5 ml, once), lot # N027628, expiration date: 04-OCT-2019 via intramuscular route (product storage error, incorrect route of drug administration). The DILUENT MRK INJ was properly stored. No adverse events were reported. The temperature range was from 6 degree Fahrenheit to 14 degree Fahrenheit (max 10F) and time frame was 2 hours. No previous temperature excursions were reported. The call was from a digital data logger. No product quality complaint (PQC) was reported.
felt faint had head pressure after receiving vaccination.  Lost color in skin.  called paramedics who performed vitals and said everything was ok with her vitals.
Initial report received on 30 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an 10-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3930AA received on 20 September 2011, lot number C4081AA received on 30 November 2011 and lot number C4163AA received on 15 February 2012 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 18 June 2012, approximately 4 months after the last dose. On 24 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 24 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 August 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 30 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Narrative: 68 yo male with PMH of severe COPD GOLD stage Ill (FEVI 43% 2018) complicated by chronic hypoxic and hypercapnic respiratory failure, OSA (known non-adherence to CPAP), morbid obesity (BMI >40), HTN, HLD and paranoid schizophrenia. Patient was admitted to ICU on 9/10 for COVID with hypoxic respiratory failure and intubated. CRS grade 4. Patient was fully vaccinated with Pfizer on 1/15/21 and 2/5/21.
I early March 2023, I started hearing my heartbeat in my ears. It was especially loud at night when I was trying to sleep, I could move my pillow around to get the heartbeat blocked out so that I could sleep. Then I started to be able to her my heartbeat throughout the day. I made an appointment with PCP to see if we could find out what was going on. she ordered a CT scan with contrast that came back normal, she then ordered an MRI with contrast that came back normal. She did find a nodule on my thyroid; I have been referred to a doctor for that. I was advised to go home to see if the heartbeat coming through my ears so loudly will calm down. It has been about month since I seen my PCP, I am still hearing my heartbeat in m ears.
ACTHIB vaccine which comes with diluent stated that possibly got mixed with regular sterile water diluent and used instead, no AE; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves infant male patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ264AAA and expiration dtae:11-Mar-2022) vaccine which comes with diluent stated that possibly got mixed with regular sterile water diluent and used instead, via unknown route in unknown administration site for prophylactic vaccination (product preparation error) on an unknown date.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to wrong solution used in drug reconstitution (same day latency).   At the time of reports, no adverse event was reported.  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 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.
Pt lost consciousness 1-3 minutes after injections for approx. 15 seconds. Pt stated, "I feel dizzy", she became white, diaphoretic and unconscious. She was sitting in a chair and did not fall. She required consciousness and walked out of the clinic. She later with a steady gait.
Diarrhea; Nausea; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 29Dec2020 at 17:00 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none, and the patient had no known allergies. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 31Dec2020 at 12:30, the patient experienced diarrhea and nausea. The patient did not receive any treatment for the events. Since the vaccination, the patient had been tested for COVID-19 on 23Dec2020 (as reported) via nasal swab and the result was negative. The clinical outcome of the diarrhea and nausea was not resolved.  Information on lot/batch number has been requested.
On Monday morning, my hairdresser texted me that she had to cancel my appointment on Wednesday because she had COVID-19. I decided to test for COVID because I wasn't feeling well. I was shocked when it was positive. I thought I had a cold or allergies. I was very fatigues and had a sore throat. We thought it was from the heat. Something told me I should test. I had a fever. I had a headache on Sunday, but I attributed it to being out in the heat and being dehydrated.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for malignant tumor urinary bladder, dementia, anemia, neoplasm of kidney, gout, hyperlipidemia, ckd stage 3, essential htn, poor diabetic control, hydronephrosis, copd. Presented to ED 3/6/21 for altered mental status. Placed on hospice care in April. Pt was 86 years of age at time of death.
Within 24 hours of the vaccine started to develop episodes of tachycardia (mom who is a physician measure heart rates as high as 130-140) with minimal activity.   He noticed a couple of episodes of heart racing (was not noticing other episodes) but no HR obtained.   He developed more pluetitic chest pain at the site of his rib pain and persistent fatigue.   Seen in my office three times over the next 7-10 days. and symptoms persisted.   Testing included CXR and ECG which were normal.   COVID PCR NP swab was negative and blood work was normal (cbc, ebv/cmv titers, thyroid).  He was evaluated by cardiology on 5/24/21 and diagnosed with POTS.   Currently (early June) he continues to have fatigue significant enough that he can't get through an entire school day (very atypical for him) and has intermittent pleuritic chest pain (which had mostly resolved about 10 days after the vaccine)   The tachycardia has resolved for the most part (within 2 weeks of the vaccine)