chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He blacked out; This is a spontaneous report from a contactable consumer reporting for her grandson (patient).  A 14-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiry Date are unknown) via an unspecified route of administration on 14Jun2021 15:00 at the age of 14-years-old as dose 1, single for COVID-19 immunisation. The Patients Medical History including any illness at time of vaccination were none. The Patients concomitant medications were none. Family Medical History Relevant to AE(s) were none. Relevant Tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect were none. Prior Vaccinations within 4 weeks were none. AE(s) following prior vaccinations were none. On 14Jun2021 at 10 PM, 7 hours later, when he got out of his chair, he blacked out stated this morning, she checked on him. The patient underwent lab tests and procedures which included 'vitals (investigation): ok on an unspecified date in 2021, breathing (investigation): ok on an unspecified date in 2021, pulse (heart rate): ok on an unspecified date in 2021. The outcome of event was unknown.  Follow-up attempts are needed. Information on Batch/Lot number has been requested.  Follow up attempts are needed. Additional information has been requested.
Initial report received from a healthcare professional on 01 October 2013. A 70-year-old female patient had received an intramuscular dose of FLUZONE HD (batch number: U4715AA, expiry date: 04 June 2014 and dose number was not reported) in the right arm on 16 September 2013. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions and had no illness at time of vaccination. Concomitant medications were not reported. On 16 September 2013, same day of vaccination, the patient developed black and blue bruising 2" below injection site and knot at injection site. Laboratory tests were not reported and the patient did not seek any medical care. On an unspecified date, knot at injection site was resolved and the outcome of th event black and blue bruising 2" below injection site was unknown. List of documents held by sender: none
After vaccination patient contracts herpes simplex virus.; This case was reported by a nurse via call center representative and described the occurrence of herpes simplex in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that after taking Shingrix vaccine a patient contracted herpes simplex virus. The reporter did not consent to follow-up.
Patient had a topical allergic reaction around injection site and also down bicep.  Very red and warm.  No itching or pain.
DEATH; This spontaneous report received from a consumer concerned four female patients. 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: Unknown) dose was not reported, 1 total dose was administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On unspecified date in 2021, the patients died from unknown cause of death after vaccination. The autopsy details were not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210320422.; Sender's Comments: V0- 20210536600- Covid-19 vaccine ad26.cov2.s-death.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Information has been received from a nurse concerning a 7 year old pt who "may have" received a dose of MMRII. On approximately 04/03/03 the pt tested positive for measles. Unspecified medical attention was sought.  Additional information has been requested.
Information has been received on 15-JAN-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In November 2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a clinic. In 2014, the patient was treated by a healthcare provider at a clinic for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to himself, loss of services and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Information has been received from an office manager via a company representative referring to an 18 month old female patient. Information about concurrent condition, concomitant therapy, drug reactions/allergies and medical history was not provided. On an unknown date, the patient inadvertently received a dose of GARDASIL 9 (strength, route, lot # and expiration date were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Discovered a vaccine site reaction. Site is red, swollen, and itches, with hard lump about 6 cm in diameter. Self-treatment: Taking ibuprofen every six hours and using hydrocortisone 1% cream for itching.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster related conditions (the dosage regimen information was not reported). Subsequently, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In 2010, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and/or zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the events. The patient received the treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Since getting the vaccination, I notice I?ve been eating more sweets .I?ve gained weight and my sleep has been interrupted and I?m very tired. This is a couple of weeks into it now.  Throughout the entire pandemic I?ve slept fine for the most part . I haven?t been feeling anxious. Since taking the vaccine I?ve been a bit anxious as well. I?m also still very tired.  Today I woke up with bodyaches.
PAIN IN ARM AT INJECTION SITE.  PAIN LASTED IN MUSCLE FOR 5 MONTHS UNTIL END OF APRIL 2022.  hE STATES HIS MUSCLE WAS AGITATED AND THE PAIN INCREASED OVER THE FIRST FEW WEEKS AND THEN STAYED THE SAME, DECREASING IN APRIL UNTIL IT WENT AWAY BY END APRIL.
PATIENT RECEIVED FLU SHOT ON 10/08/12 AND STARTED GETTING RASH ALL OVER HER BODY ON 10/10/12 AFTER SUPPER. PATIENT TRIED BENADRYL TABLET AND BENADRYL SPRAY. IT TOOK A WHILE FOR PATIENT TO FEEL BETTER.
pt felt nauseated, passed out then had slow resp leading to resp & cardiac arrest;CPR initiated, pt intubated given versed, vecuronium & atropine & transferred to ped ICU;
parent brought pt to hlth dept on 7JUL92 w/t100.9, lt deltoid warm to touch w/red rash below inject site (about the size of 2inches round) pt stated didn't feel well, nauseated, will not eat;
loss of consciousness; felt flush; felt hot / felt warm; This case was reported by a pharmacist via call center representative and described the occurrence of loss of consciousness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. In November 2020, 1 day after receiving Shingrix, the patient experienced loss of consciousness (serious criteria GSK medically significant), flushing and feeling hot. On an unknown date, the outcome of the loss of consciousness, flushing and feeling hot were unknown.   It was unknown if the reporter considered the loss of consciousness, flushing and feeling hot to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced loss of consciousness, felt warm, felt hot, and felt flush the next day, one day after the first dose of Shingrix (unknown day in November 2020). Consented to follow up.
no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 05-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010136:Original Case : 2008USA010128 US-009507513-2008USA010137:Original Case : 2008USA010128 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010135:Original Case : 2008USA010128 US-009507513-2008USA010134:Original Case : 2008USA010128 US-009507513-2008USA010121:Original Case : 2008USA010000 2008USA010136: US-009507513-2008USA010137: US-009507513-2008USA010136: US-009507513-2008USA010134: US-009507513-2008USA010135:
Patient is a 47 y.o. male patient of, PA-C with history of relapsing remitting multiple sclerosis, seizure in the setting of MS, asthma, bipolar disorder, hypertension, hyperlipidemia, presented to Hospital with cough and shortness of breath over past few days.  While in the ER patient had chest x-ray concerning for multifocal pneumonia COVID-19 was positive, lactate was elevated concerning for sepsis.  Patient is being admitted for further management.   Sepsis likely in setting of viral pneumonia COVID-19 pneumonia Covid-19 Virus Infection Date of onset of symptoms: 3/31 Symptoms present on admission: Shortness of breath Date of covid positive test: 4/3 Vaccination status: vaccinated
Suspected vaccination failure; 4 times / Miserable illness! Ex, more miserable! / Rather have shingles; Miserable illness; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and illness. On an unknown date, the outcome of the vaccination failure, shingles and illness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and illness to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had all the shots. The reporter stated that 4 times. Miserable illness. Ex, more miserable. Rather had Shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
As soon as it was administered, I felt my heart start racing and felt a tingling sensation through my entire body especially in my hands and feet.  I let the nurse know under observation and she took my vitals and my BP was high for me as well 146/85.  I waited for an hour and then had my husband pick me up.  The tingling continued for a week and a half and made it impossible to sleep.  It?s slowly gotten better, but I still feel almost a palpitation/flutter feeling.
Pt. was given Tylenol 1 1/2hr after vaccine and about 4 hr later complained about a sore arm.  According to Mom, pt. arm was not swollen, or red at this time.  The next morning (about 18hr after shot) his arm was tender, red, & swollen.  At 48hr later, his reaction was warm to the touch, red, sore, and swollen approx. 19cm length & 15cm wide on arm where DTaP vaccine given.
Hissing in his ear; Dizziness; Sweating; Nausea; Injection site soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Hissing in his ear), DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (Tiredness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (Tiredness). On 19-Feb-2021, the patient experienced TINNITUS (Hissing in his ear), DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea). At the time of the report, TINNITUS (Hissing in his ear) had not resolved and DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Injection site soreness), FATIGUE (Tiredness) and NAUSEA (Nausea) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: The outcome of the event(s) injection site soreness, tiredness, dizziness, sweating and nausea changed from unknown to recovered .The outcome of the event hissing in ear change from unknown to not resolved. On 04-Jun-2021: Non-Significant F/U Case
Adverse event highly concerning for cytokine release syndrome/SIRS vs. anaphylaxis.  1.5hrs post immunization developed tightness, SOB, severe dysphagia, then nausea/vomiting. Treated emergently in ER, given epinephrine/diphenhydramine/solumedrol/Zantac, 3.3L saline, antibiotics for presumptive septic shock. Transferred to MICU for observation. Pt normalized lactate and fever rapidly.
Local soreness, redness and swelling at injection site lasting 3 days. Fever for 3 days with highest 101.5, gradually decreasing by end of third day, accompanied by intermittent chills. Muscle aches in arms, shoulders, and back for 3 days. Extreme fatigue that gradually decreased over about  5 days. Slight nausea and lack of appetite for about 3 days. Headache for 2 days. Same as with first dose.
a lump at the injection site; This spontaneous report was received from a dermatologist via a company representative referring to a 29-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis by an obstetrics and gynecology (OBGYN) heath care professional (HCP) (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, after the injection, the patient experienced a lump at the injection site (vaccination site mass). The patient had sought medical attention. The OBGYN HCP recommended for patient to see the dermatologist. The outcome of the event was unknown.   The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Left axillary lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 56-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), intramuscular on the left arm on 11Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history was reported as none. No known allergies to food, medications or other products. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 via the intramuscular route at the left arm for COVID-19 Immunization on 21Dec2020 at 09:00 at the age of 56 years old. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced left axillary lymphadenopathy on 12Jan2021 at 10:00. No treatment was administered for the event. The event was resolving.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years 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's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Other medical history: Mild asthma. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (22Sep2022) Positive, notes: Reoccurrence of symptoms at day 10 - 6 days after completing Paxlovid regimen. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient was not taken other medication within 2 weeks. The patient had no known allergies. Paxlovid was taken as treatment for COVID 19 with start date was 12Sep2022, treatment stop date was 16Sep2022. Reoccurrence of symptoms at day 10 to 6 days after completing Paxlovid regimen.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received vaccine on 05/09/2022. She began experiencing what was described to family as abdominal pain on 05/10/2022. At 0400 hours on 05/11/2022, she woke up with abdominal pain and took pepto bismol to go back to sleep. She was found unresponsive later that morning and resuscitation was unsuccessful. Autopsy revealed acute lymphocytic myocarditis.
Child began with rash to back and belly - began looking blotchy - worsened by 2 pm 11/5 - ped Benadryl given - no improvement - to ER given steroid 6pm. 11/5 50% improvement next am - by 11/6 pm worsened again - reported as "hives" to entire body - given epinephrine and Zantac per ER (2nd time to ER). 11/7 3-4 pm improved 11/8 am clear/ fully recovered
administration error.  patient received 0.5ml dose for booster instead of 0.25ml dose.  patient was fine at point of leaving.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 08-MAY-2013 the patient was vaccinated with an unsupported dose of GARDASIL (lot number 0101AE, expiry date 10-OCT-2014). No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.