chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu; Initial information received on 15-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Thanks, but I'll pass. Stopped getting the flu shot 18 years ago, and stopped getting the flu. And the one time I has it before that, a quick round of Tamiflu took care of it with no side effects."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Dry throat - First night (10-609) - Rash w/Bumps - Started day two -mildly - Full blown by noon - day 3
loud, strange, high-pitched cry; then unresponsive for 5 mins-limp, blue; then lethargic, listless, drowsy for 3 more hrs; back to nl in 12 hrs;
The morning after the vaccination, patient reports a thick piece of skin rolled off her abdomen above her belly button. It is painful like a skin graft and she has been putting topical lidocaine on it which is barely relieving it. Today she says the center is dark green with "flaming red" edges. She is seeing her doctor tomorrow (10/7) for diagnosis, but she suspects MRSA. She also experience a fever of 100F, chills, and itchy red welts on her face starting the day after the vaccine and improving today.
This case was reported by a healthcare professional (nurse) and described the occurrence of adverse reaction in a female subject aged between 30 and 39 years old who was vaccinated with influenza vaccine (manufacturer unspecified). On an unspecified date the subject received a dose of influenza vaccine (unknown details). At an unspecified time after vaccination with influenza vaccine, the subject experienced adverse reaction. The subject experienced a "reaction with flu shot (unknown brand) that occurred "couple" years ago." At the time of reporting the outcome of the event was unspecified. After the next vaccination with influenza vaccine the event recurred. See case A1008047A for details.
Flushing/sweaty, dizziness, vitals wnl. Water and apple juice.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patient completed the series GARDASIL 9 (lot # , dose and route were not reported). On 22-JUL-2016, the patient was inadvertently administered a fourth dose of GARDASIL 9 (extra dose administered). No adverse effects were reported. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient, self-reported). A 32-year-old non-pregnant female patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number: EN0153 and Expiration date: unknown), dose 1 via an unknown route of administration, in left arm on 20Apr2021 at 13:45 as single dose, dose 2 via an unknown route of administration, in left arm on 20Apr2021 (Batch/Lot Number: EN0175) as single dose for COVID-19 immunization (at the age of 31-years-old). The patient's medical history included hypothyroidism. Concomitant medication included levothyroxine sodium 88ug taken for an unspecified indication. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 23Apr2021 at 10:00, the patient experienced pain and swelling of supraclavicular lymph nodes. The patient was not tested for COVID-19 since the vaccination. No treatment was received for events. Outcome of events was not recovered.
Got the MMR at 11am, fine all day until 5pm she complained and was crying about a lower stomach ache and felt warm. At 6pm she vomitied, her temperature was 100.3 and 9pm she feel asleep and then vomited again at 12am. Called the 24 hour nurse. The fever stayed around 99.8-100.
Information has been received from a physician concerning her 17 year old daughter who on 17-APR-2007 was vaccinated with Gardasil.  On 25-APR-2007 the patient experienced pain in her upper right arm.  The physician noted there was no redness or swelling in the injection site area.  Subsequently, on 29-APR-2007, the patient recovered from pain in her upper right arm.  Additional information has been requested.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 73-year-old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on an unspecified date in MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested.  On 08-AUG-2021, the patient tested covid positive (confirmed covid-19 infection and confirmed clinical vaccination failure). The vaccine and monoclonal antibodies worked well. The patient had mild symptoms none of which lasted more than 24 hours. The whole disease lasted 8 days or so. The patient was out of quarantine after 10 days of positive testing (dose number in series 1). Concomitant medications was reported as monoclonal antibodies; the patient's PCP (Primary care physician) ordered monoclonal antibodies to ensure that patient did not have severe symptoms. The patient received the monoclonal antibodies on 10-AUG-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on 01-DEC-2021 for prophylactic vaccination (Dose number in series 2). It was not specified whether patient had any adverse reaction after vaccination (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on AUG-2021 and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000209557.; Sender's Comments: V0: 20211266632-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20211266632-covid-19 vaccine ad26.cov2.s- confirmed covid-19 infection. This event(s) is considered unassessable. The event(s) 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(s).
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2015, the patient was treated for a vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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.
Seizure associated with fever within 36 hour of immunization 12/06/07-records received for DOS 10/13-10/14/07-DC DX: seizures in setting of fever and URI.
Patient hospitalized on 4/30/2021 for 12 hours for renal stone. Patient had second covid vaccination dose on 5/16/2021. Patient hospitalized on 6/9/2021 for vaginal delivery. These visits are within 6 weeks of receiving COVID vaccination.  Patient had an uncomplicated hospital course.
Entire arm swole up and turned slightly red; Entire arm swole up and turned slightly red; Bruise in the are of the shot; Product administration error; This spontaneous case was retrieved on 22-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 898661-1), reported by other health professional and concerned a 68-year-old, female patient.  The patient's concurrent conditions included allergy to clavulanic acid, sulphonamide compounds, penicillin, sulfa antibiotics. The patient's concomitant medications were not reported.   On 25-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 279786.  On the same day, the patient was vaccinated with non-company, co-suspect Shingrix (varicella zoster vaccine rge (cho); dose reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was zx27e.  On 26-Sep-2020, one day after receiving Fluad Quadrivalent and co-suspect Shingrix, the patient's entire arm was swollen and turned slightly red. She had a bruise in the area of the shot.   On 27-Sep-2020, the patient returned for second dose and reported that her entire arm was still swollen and still slightly red. She still had a bruise in the area of the shot.   At the time of initial reporting on 22-Dec-2020, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 68-year-old female patient experienced peripheral swelling, erythema and vaccination site bruising one day after administration of Fluad Quadrivalent and a non-company, co-suspect Shingrix, both in left arm. Causality is assessed as possibly related for peripheral swelling and erythema and unassessable for vaccination site bruising. All events are confounded with reported co-suspect vaccine/ medication error. Product administration error is assessed as unrelated per company conventions.; Sender's Comments: A 68-year-old female patient experienced peripheral swelling, erythema and vaccination site bruising one day after administration of Fluad Quadrivalent and a non-company, co-suspect Shingrix, both in left arm. Causality is assessed as possibly related for peripheral swelling and erythema and unassessable for vaccination site bruising. All events are confounded with reported co-suspect vaccine/ medication error. Product administration error is assessed as unrelated per company conventions.
This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with GARDASIL (confirmed not GARDASIL 9) (lot# K016966 and expiration date 10-MAY-2017) (dose and route were not reported) that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
pleurisy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 08Mar2021 12:45 (Batch/Lot Number: EN6199) at the age of 62 years old as 1st dose, single dose for COVID-19 immunisation. Medical history included high cholesterol and Ulcerative Colitis that has been in remission for 11 years (not taking any medications). The patient had allergies to penicillin and "GOLIGHTLY." The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (medications the patient received within 2 weeks of vaccination) included estradiol, lovastatin, plecanatide (TRULANCE) and abaloparatide (TYMLOS), all taken for unspecified indications, start and stop dates were not reported. The patient received the first dose of Pfizer-BioNTech COVID-19 Vaccine on 08Mar2021 (Monday) at 12:45. The next day (on 09Mar2021) at 23:45 (11:45 PM), she went to urgent care and was diagnosed with pleurisy and the X-ray results showed "biapical pleural thickening." She wanted to know if this has been reported before. 1000 mg TYLENOL or ibuprofen beforehand (as reported). She is trying to figure out if this event was actually a side effect from Pfizer-BioNTech COVID-19 Vaccine or coincidence. It would be very odd because they have not seen this event, did not know of anyone else who reported that with the Pfizer-BioNTech COVID-19 Vaccine but she wanted to ask Pfizer directly because they know more about the product than the urgent care would. The Urgent care doctor told her to take ADVIL before the test and now her doctor says take TYLENOL 1000 mg, curious if anyone with Pfizer could provide information about this recommendation and event. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the diagnosis of pleurisy was COVID 19 vaccination related. Adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received included IV anti-inflammatory and IV fluids and aspirin. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report from a non-contactable consumer (patient).  A 41-year-old (reported as 42-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm, on 05Mar2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pericarditis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included emtricitabine, tenofovir disoproxil fumarate (TRUVADA), omeprazole (PRILOSEC), cetirizine hydrochloride (ZYRTEC), and fluticasone propionate (FLONASE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced suicidal thoughts, site pain, chills, body aches, tinnitus, and depression on 06Mar2021 at 04:00. The patient underwent lab tests and procedures which included nasal swab: negative on 01Jul2020. The clinical outcome of suicidal thoughts, site pain, chills, body aches, tinnitus, and depression was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a Retired physician concerning his colleague, a male dermatologist, who was vaccinated with a dose of ZOSTAVAX (Merck). The patient developed shingles and post herpetic pain post vaccination. The dermatologist was hospitalized for a couple of days and was treated with narcotics for the pain. The patient was released from the hospital had has recovered on an unspecified date. No further information is available.
Information has been received from a 15 year old patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # and route not reported). The consumer stated that she was worried because almost everyone she knew had been having unspecified side effects but not her. No further information is available.
Four hours after the 2nd shot he had a stroke. The ambulance took him to Hospital where he was transferred to another facility. He had to be in the hospital for 7 or 8 days. He is partially paralized on his left side. His symptoms were dizziness and collapse. Sweating profusly. He will have to go undergo extensive physical therapy, occupational therapy, doctors visits, and loss of his ability to work, or maintain any sort of regular daily living without assisstance. For the rest of his life. He was also the primary support of the household.
After a week Swollen Lymph node and Red and swollen injection site with redness and hot to touch.  Heaviness in R arm . No fever yet
Patient received a 3rd dose of Moderna. 1st dose on 1/25/21, 2nd dose on 2/22/21, 3rd dose on 5/12/21.
Red, raised bump at injection site.  Hard lump still remains at injection site. Also a strange rash has developed on his stomach.  Although the rash does not seem to bother him it has not gone away or gotten any better.
Bowel movements were like peanut butter after 2nd vaccination. Bowel movements have not been the same since.
15yo was anxious prior to receiving flu shot. shortly after, patient turned white in color, felt dizzy, light headed. she sat down for a bit, gave her some water. some dum-dums. threw up in imz room, stated temp loss of hearing and vision. gave her some chocolate, she sat down for a little bit and felt better. she has had flu shots prior, but stated was really anxious.
L arm red and indurated 4cm diameter red rash on arm. Urticaria on forearms and legs
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. It was reported that three doses of VAQTA (dose and lot# not reported) which was stored at temperatures outside of the current prescribing information might have been administered to patients on unspecified dates. No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 4th patient of 24 patients as described by the reporter.  Concomitant medications were not reported.  The vaccination clinic received incorrect guidance from the DOH in regards to the vaccination, who instructed to order and administer the vials with pink top to patients. This resulted in 24 patients being undervaccinated.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were aged between 6 months to 5 years. The patients were being contacted and revaccinated with the correct dose.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 ( Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
pt recv vax 26JUN95 & pt mom notified the office that child devel chickenpox (approx 20-25pox);6AUG97 pt was not seen in MD office & later recovered;