chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited case received from a consumer on 05 December 2016. This case involves a 70 years old male patient who was vaccinated with a dose of Fluzone HD (Batch number, Expiry date, dose was not reported) via intramuscularly route at left deltoid on 03 Oct 2016. The patient's Illness at time of vaccination reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as not known allergies. The patient concomitant medications were not reported. On 11 October 2016, 8 days (reported as one week) following the vaccination, the patient experienced fever, muscles aches, tiredness, lethargic, sweating. On unspecified date, following the vaccination patient also lost 15 pounds (lbs). The patient required doctor visit. The patient lab tests included blood tests and computed tomography (CAT) scan. It was reported that patient didn't know the result. Corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
This was the booster shot. Extreme pain all over body. I could barely walk. Pain was comparable to childbirth. Was immobilized to bed for a week. Original shot was mild arm pain.
Pt came in on 3/20/03 for immunizations. Mother had concern for area on pt's L thigh. Area was shown to MD. Appeared to be atrophy of the muscle. We are not certain that atrophy was caused by immunization. Mother stated area appeared after receiving shots on 1/15/03.
pt recvd vax;local rxn at site prolonged w/ swelling & redness;
Information regarding Flumist nasal solution was received from a consumer regarding a female patient who experienced sore throat. The patient received a dose on 12/13/03. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/13/3. Dose regimen was 1 dose (IN). Concomitant medications were not reported. The patient experienced sore throat on 12/13/03. The reporter declined to provide additional information and declined to grant permission for follow up investigation.
Information has been received from a physician concerning a female patient with a history of obesity who on an unknown date, was vaccinated with a dose of GARDASIL (series, route and lot number unspecified). It was reported that the patient received other vaccines but which ones were unspecified. A week after the vaccination, "sometime in October or November 2009", the patient experienced muscle pain in their arms and legs so the patient went to the emergency room. At the emergency room, the patient had to be put in a wheel chair because of the muscle pain. A serum creatine kinase (CPK) test was performed an the levels were over 1000. A blood work test was performed and the results were not provided. A complete blood cell count (CBC) work up was performed and the results were that probably the patient had a viral infection (unspecified). The physician reported that the patient stopped the series of GARDASIL and had recovered (date not reported). The patient was initially seen by another physician. Viral infection was considered to be disabling by the physician. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient had no pertinent medical history, drug reaction or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose #, route of administration, lot # and expiration date were unknown). Concomitant therapies included unspecified blood pressure and thyroid medications. On an unknown date, the patient developed extreme swelling of the arm where the vaccine was administered, and the injection site was red, hot to the touch and hard. The symptoms spread to the patient's collarbone on the morning after receiving the vaccine. The patient was treated with KEFLEX 500 mg three times a day for 7 days. No laboratory diagnostics were performed. On an unknown date, the patient had recovered from the adverse events. The causality assessment between the adverse events and PNEUMOVAX 23 was not provided. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1712USA013805.
arm swollen from shoulder to elbow; very warm to touch; painful 1 day p/inject; seen in ER;
Pt notified observers she was not feeling well. Was found diaphoretic, light headed, dizzy and nauseous. Pt was transferred to stretcher. Rapid Response was called 0748  BP 100/57 HR 63 O2 98%, 0752 BP 89/51 HR62 O2 98% 0754 BP 84/42 HR 93 O2 98% due to drop in BP was taken to the ER, remained oriented. Handoff to the ER staff.  Unable to reach due to no phone number on form.
ACUTE RESPIRATORY FAILURE 7/2/2021  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/4/2021  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/2/2021  ACUTE RESPIRATORY FAILURE 7/2/2021  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/4/2021  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/2/2021  ACUTE RESPIRATORY FAILURE 7/2/2021  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/4/2021  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/2/2021  ACUTE RESPIRATORY FAILURE 7/2/2021  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/4/2021  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/2/2021  ACUTE RESPIRATORY FAILURE 7/2/2021  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/4/2021  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/2/2021  ACUTE RESPIRATORY FAILURE 7/2/2021  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/4/2021  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/2/2021
Initial unsolicited report received from a physician on 14-Feb-2017. This case involves a 13-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch no: UI693AA, expiry date: 30-Jun-2017, dose, dose in series, route and site of administration were not reported), with a dose of HEPATITIS A VACCINE and HUMAN PAPILLOMAVIRUS VACCINE (HPV) (lot number, expiration date, dose, dose in series, route and site of administration were not reported for both the vaccines) on 09-Jan-2017. The illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 09-Jan-2017, same day following vaccination, the patient developed feeling of tiredness as well as unwell and thoughts of death. It was also reported that the patient was an extrovert, happy and straight, prior to vaccination but since vaccination she behaved like not happy, never smiles and grades at school were going down. Also stated that the patient had no social reason for behavior. On an unspecified day, the patient required ER/doctor visit. The lab test and corrective treatment was not reported. The outcome of all the events was not recovered. Documents held by sender: none.
Pt exp rash, confusion & serum type sickness following 1st dose of Engerix-B;
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; TINNITUS; This spontaneous report received from a consumer concerned a 74 year old male. Initial information was processed with the additional information received from complaint department on 07-SEP-2022. 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: 1802072 and expiry: 20-JAN-2022) dose was not reported, 1 total administered to the left arm on 09-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 73 years old.  No concomitant medications were reported. On an unspecified date in about MAY-2022, the patient experienced some adverse side effects of tinnitus and in the same month (MAY-2022), the patient had a constant runny nose that was clear and dripped all day long.  On an unspecified date in JUL-2022, the patient tested positive for covid-19 (coded as confirmed covid-19 infection and confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, and confirmed covid-19 infection, 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: 90000249350. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this report indicates medical adverse event for the patient. There is no product quality issue described. While the reporter states he was vaccinated, there is no report of covid related symptoms or statement indicating the vaccine did not work) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220910881.; Sender's Comments: V0: 20220922379.-covid-19 vaccine ad26.cov2.s- Confirmed Clinical Vaccination failure. 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. Therefore, this event(s) is considered not related.
Immediate mouth tingling which progressed to tongue tingling and  swelling that last approximately 16 hours
Severe vertigo, nausea, severe headache for days, weakness, exhausted physically.  Body aches, sweats and chills. Loss of appetite.
ARM TENDERNESS/ SORE ARM; This spontaneous report received from a consumer concerned a male of unspecified age. 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, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 09-APR-2021, the subject experienced arm tenderness/sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tenderness/sore arm. This report was non-serious.
Pt returned from pharmacy complaining of stuffy nose, itchy eyes and hives under left eyelid. Administered Adrenalin. Pt sent home and is doing better. Rx'd Benadryl.
RED CIRCULAR MARK AT SIGHT OF INJECTION FROM INTIAL TIME OF INJECTION 10/27/2012 UNTIL PRESENT DATE 01/18/2013.
CLIENT STATED 2 DAYS AFTER RECIEVING VACCINES SHE NOTICED A RASH WITH ITCHING TO LEFT ARM DELTOID WHERE SHE RECIVED A VACCINE. CLIENT STATED THE RASH WITH ICHING SPREAD TO HER ARMS, TORSO, AND BOTH LEGS. CLIENT STATED SHE WENT TO PCP AND RECEIVED ANTIBIOTIC CREAM TRIAMACOLONE AND NYASTATIN. CLIENT STATED SHE RETURNED  CLINIC BECAUSE THERE WAS NO IMPROVEMENT. ADVISED CLIENT TO RETURN TO PCP FOR FOLLOW UP.
Pfizer booster - administered in Left Deltoid by the other nurse on site, RN at 11:49am.     Shortness of breath and nausea at 12:20pm  911 called. no complaint of chest pain or headache, or swollen or tightening of throat and no inflammation of face or extremities.   Vital signs 12/25pm 148/94, R 24, pulse 93, SP02 99%room air, Temp 96.9 F room air.   Ems arrived and took her to hospital at 1230pm.
Symptom/time of onset/duration/treatment/outcome  Fatigue/April 1st,1:00pm/11 hours/rest/recovery Fever (up to 104.2 F)/April 1st, 2:00pm/ongoing/single ibuprofen dose at 8pm April 1st to lower temp/current temp 99-100 Chills/April 1st, 2:00pm/3 hours/rest/recovery Body aches/April 1st, 3:00pm/ongoing/none/ongoing  NUMBNESS IN LEFT HAND:  Started at about 3:00 pm with the onset of fever and chills and continued on and off for the rest of April 1st. Affected the left side of the left hand including the leftmost 2-3 fingers.  Called doctor, ADVISED urgent care but I waited it out; no treatment for this symptom. Has not returned April 2nd.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX 23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX 23 was unknown. The pharmacist was requesting a lot check for PNEUMOVAX 23 lot H014653 (Expired date 19-APR-2014). This is one of several reports received from the same source. Additional information has been requested.
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided. REMOVED FROM FREEZER 8 AM, 10/15/21
DIZZINESS; LACK OF ENERGY; This spontaneous report received from a patient 69-year-old male white not Hispanic or white patient. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, nonsmoker, coronary artery disease (takes blood pressure meds, cholesterol meds, and OTC glucosamine/supplements), penicillin allergy, scallops allergy, and contrast media allergy. The patient had no known drug allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose 1 total administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included glucosamine for coronary artery disease. On 29-MAY-2021, he woke up with dizziness, light-headedness, and low energy. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from dizziness, and lack of energy. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Patient states that on 4/16 she became very confused and was unable to even remember her name or DOB. She also reports a fever. She said the symptoms resolved within 24 hours. She does remember this happening with the initial covid vaccine but she didnt report. She also had this occur with a live flu vaccine many years ago.
On or about December 1, 2014, I began to experience severe hip and back pain. Pain was especially noticable during sleep making it painful to get out of bed. Pain began in hip area and began shooting into my legs & groin. Went to the Urgent Care Center for examination (incl x-rays). Followed recommendation to take Advil or Tylenol and mederated use of hip.  Condition improved somewhat but not completely. Subsequently, in February-March timeframe began to experience severe back pain, not as focused on the hip but more in lower and middle back area.  Pain also developed in the abdomen and shoulders. In both instances, I also experienced a significant decrease in muscular strength...abilty to pick up, lift and hold objects.
Fever 102.7 F, runny nose, sore throat, body aches. Had bloody nose 5 days, discontinued 81 mg aspirin per doctor instruction. Severe fatigue and body aches, no appetite, stomach upset.
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 20 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 22-OCT-2013, the patient was vaccinated with MMR II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 47 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's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Negative; (30Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was not taking any other medications/ products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Rebound positive test on day 11 after testing negative after 5 days prior. The patient received COVID-19 Treatment of Paxlovid from 21Jul2022 to 26Jul2022.  No follow-up attempts are possible. No further information is expected.
Can't see out of the right eye; Shingles\right side of their face, right eye and scalp have shingles and are damaged; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles\right side of their face, right eye and scalp have shingles and are damaged) and VISUAL IMPAIRMENT (Can't see out of the right eye) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-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 17-Mar-2021, the patient experienced HERPES ZOSTER (Shingles\right side of their face, right eye and scalp have shingles and are damaged). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Can't see out of the right eye). At the time of the report, HERPES ZOSTER (Shingles\right side of their face, right eye and scalp have shingles and are damaged) and VISUAL IMPAIRMENT (Can't see out of the right eye) outcome was unknown. Not Provided          No concomitant medication was reported  No treatment medication was reported Case is crosslinked to MOD21-079093   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Event detail updated
This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns 50-year-old, adult, male patient. The patient's current condition included diabetes. The patient's concomitant medications were reported to be unknown. On 24-Oct-2018, the patient under age of 65 years was accidentally administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250800, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious. This case (201805057) was cross-linked to the source case: 201805049 reported by the same reporter.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient did not have concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported) diluted with sterile diluent (DILUENT MRK INJECTION) (dose, route of administration, lot number and expiration date were not reported).     The patient had rheumatoid arthritis diagnosed on an unspecified date and was currently taking unspecified immunosuppressive medications. On an unknown date (reported as an unspecified amount of time later) the patient "got shingles" (herpes zoster). Therefore, she sought medical attention and received unspecified treatment. No laboratory tests were performed. The outcome of rheumatoid arthritis and shingles (herpes zoster) was unknown. No product quality complaint was involved. The causal relationship between the events and the suspect therapies ZOSTAVAX and sterile diluent (DILUENT MRK INJECTION) was unknown. Upon internal review the event rheumatoid arthritis was considered to be medically significant. Additional information has been requested.
Patient was given first dose of Pfizer COVID-19 vaccine.  I counseled the patient on side effects and asked him to wait 15 minutes afterwards in our waiting area.  After about 5 minutes, the patient starting complaining of feeling dizzy.  We asked him to sit back in the chair and brought him a bottle of water.  I asked the patient if he had eaten today and he replied no.  I offered a snack and also a glucose tablet to help with shakiness.  As I went to get a bottle of glucose tablets off the shelf, the patient fainted and fell out of his chair.  I immediately ran to get an Epipen while my technicians called for a Code White and 911.  I was about to inject the patient with the Epipen when he came to about 10 seconds later.  He said he was really hot, sweaty, dizzy, and nauseous.  Paramedics and AP arrived to evaluate him and take a statement.  Patient left on his own will and received a ride home from his mother-in-law, who is an associate at our store.
I still feel soreness in my upper arm-it was bad the first week-not as bad now.
This spontaneous report was received from a pharmacist who was also a female patient. The pharmacist stated that on 12-APR-2014, after administering a dose of ZOSTAVAX (lot number unknown) to a patient, she had a 'needle stick' with that same needle that was used to immunize an unspecified patient. The pharmacist was evaluated at an unspecified emergency room as per the 'needle stick' protocol at her pharmacy. Human immunodeficiency virus (HIV) blood test and other unspecified blood tests were collected in the emergency room. The pharmacist (age unknown) had a chicken pox in the past. No adverse effect reported. Additional information has been requested.