chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 57 year old female consumer with a history of shingles who in October 2007, was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 13-MAR-2008 the patient presented with a shingles outbreak. Medical attention was sought, the patient contacted the physician. At the time of the report the patient had not recovered. There was no product quality complaint involved.  This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information has been received from the physician's office concerning this 57 year old female consumer with DARVON, DEMEROL, penicillin, erythromycin and aspirin allergies and a history of shingles and chickenpox (at age 10) who on 01-NOV-2007 (also reported in October 2007) was vaccinated in the left arm with 0.65ml of ZOSTAVAX (Merck) (lot # 657766/0620U). There was no concomitant medication. There was no rash at the site of injection or elsewhere within 42 days of vaccination. Subsequently, on 28-APR-2008 the patient developed pain, rated 7 on a scale of 0 to 10. It was reported that the patient developed pruritis and felt hot (her body temperature was not measured). On 29-APR-2008 (also reported as 13-MAR-2008) the patient developed a painful, pruritic papular rash on her back. The papular lesions developed on the right side of the L3 vertebral area. It was reported that there was no recent exposure to chickenpox or herpes zoster. At the time of report the patient's status was unknown. The patient was currently on VALTREX. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The sample of the lesions was collected on 10-APR-2008, and sent to the laboratory on 01-MAY-2008. The sample was taken from a papular lesion. The PCR results for the specimen from the papular lesion was an inadequate swab - capillary tube- negative. Follow-up information indicated that the PCR results from the specimen from the papular lesion was an adequate specimen. No VZV identified-negative. There was B-globin DNA amplified. On 16-JUN-2008, the physician indicated that the patient developed another rash. However, he did not see the patient and couldn't confirm anything. Additional information has been requested.
Received FLUZONE vaccine to left deltoid had immediate reaction of edema, redness and complains of numbness/tingling from site to elbow.
six people with the same death; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "six people with the same death". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300173561 same reporter/product/AE, different patient;US-PFIZER INC-202300176094 same reporter/drug/event, different patient;US-PFIZER INC-202300177046 same reporter/drug/event, different patient;US-PFIZER INC-202300177045 same reporter/drug/event, different patient;US-PFIZER INC-202300177043 same reporter/drug/event, different patient;US-PFIZER INC-202300177044 same reporter/drug/event, different patient;; Reported Cause(s) of Death: six people with the same death
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the HCP mentioned because of miscommunication as a coworker told that there were some lot number whose expiration dates had been extended, patient received expired dose. The patient received second booster dose. No treatment information was reported.
Information has been received from a physician concerning an unspecified amount of female patients who on unspecified dates were vaccinated IM with three doses of GARDASIL. Subsequently the patients had PAP smears which were positive for Human papillomavirus (HPV). No lot number, expiration date, patient demographics, or number of patients provided. At the time of reporting, the patients' outcome were unknown. It was unspecified if the patients sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from the physician. The approximately 16 year old patient informed the physician that she received the full series of vaccines from her pediatrician and had Pap smear be HPV with low grade squamous intraepithelial lesion (LGSIL). This is one of several reports received from the same source. Additional information has been requested.
Pt recvd immun @ 9AM; At about 1130AM pt started screaming in high pitched tone for about 15 min; Nothing would console pt; It was a different cry according to mom;
Took the shot and got it 2 days later; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Took the shot and got it 2 days later). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles shot and got shingles 2 days later. The follow up would not possible as no contact details were available.
Breakthrough case admission after 4 vaccines Pfizer 3/1/21 Lot# EN6199;  Pfizer 4/1/21 Lot# ER8730;  Pfizer 11/12/21 Lot# FF2593;  Pfizer 7/30/22 Lot# FP7150
blood clot on the shaft of their penis; Bruise; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (blood clot on the shaft of their penis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot on the shaft of their penis) (seriousness criterion medically significant) and CONTUSION (Bruise). At the time of the report, THROMBOSIS (blood clot on the shaft of their penis) and CONTUSION (Bruise) outcome was unknown.            No concomitant or treatment medications were reported.    Reporter did not allow further contact; 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.   However, very limited information regarding this event/s has been provided at this time.  Further information cannot be requested because Consent to a follow up from  safety was not granted. The reporter did not provide further contact information.
Right thigh with pink 4-5 cm area. Augmentin and Motrin prescribed.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 53 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 16Apr2022 at 10:00 as dose 4 (booster), single (Lot number: 084J21A), in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022 at 10:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2022) Negative, notes: Tested negative on 09Dec; (16Dec2022) Positive, notes: Cough came back a few days later. Felt worse and tested positive again on 16Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. Other medication in 2 weeks reported as no. The patient was not pregnant at the time of vaccination. Therapeutic measures included Antiviral details, Product: COVID 19 Treatment, Brand: Paxlovid, Indication: Treatment of COVID-19.
First time flu shot- prior to giving shot, stayed in observation area. IM administration to left deltoid, client c/o headache. BP taken, 118/76, pulse 58. No c/o SOB or itching. Continued to monitor, no distress noted or SOB. Asked if he wanted 911 to be called, return to work, or go home. Called his boss about going home.  11:15 continued sitting with his boss, being observed. 11:30 condition unchanged- remain sitting with his boss. 11:55 returned to work, his boss stated he was fine.
fever 102F; chills; headache; very nauseous, like I was going to pass out; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (very nauseous, like I was going to pass out), PYREXIA (fever 102F), CHILLS (chills) and HEADACHE (headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced NAUSEA (very nauseous, like I was going to pass out). On 21-Jan-2021, the patient experienced PYREXIA (fever 102F), CHILLS (chills) and HEADACHE (headache). On 22-Jan-2021, NAUSEA (very nauseous, like I was going to pass out), PYREXIA (fever 102F), CHILLS (chills) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Patient had a seizure following administration of second dose of COVID-19 vaccine. Versed was given.
Myalgia, Diarrhea, NauseaVomiting, chills Narrative:  Other Relevant History:
This is a spontaneous report from a contactable nurse. This nurse reported similar events for 5 patients. This is 5th of 5 report (3 different lot #'s appear to be involved). An adult patient of unspecified age (60 years or older), ethnicity and gender started to receive PREVNAR 13 via an unspecified route of administration on an unspecified date in 2015. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2015 the patient experienced cellulitis, swelling, redness, chills, and lethargy. The outcome of the events was unknown.
Havrix dose administered subcutaneously instead of intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 20-month-old female patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2022, the patient received Havrix (subcutaneous) and Havrix Pre-Filled Syringe Device. On 10th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The patient received Havrix dose subcutaneously instead of intramuscularly.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive Information: The patient received havrix subcutaneously instead of intramuscularly which led to intramuscular formulation administered by other route.
Stiff neck Dec 11, 2021, Very stiff neck Dec 12, 2021. Awakened by Severe neck and head Pain at 1:47 am  Dec 13, 2021 pain prevented sleeping, used about 8 200mg ibuprofen to deal with pain until going to Chiropractor @ 5PM Dec 13, 2021. Chiropractic adjustment relieved some of pain. About an hour later I felt numbness in upper lip. Woke up about 4 am Dec 14, 2021 with watering right eye, and pain right side of head near ear, face felt strange, didn't seem to work correctly. Went to get a drink of water and it ran down my face. Noticed right side of my face drooping, Right eye not shutting, lips not working correctly. Left a message with Dr. office that morning. They instructed me to go to Emergency Room. Got to E.R. around 11:45 am. By then I had difficulty speaking properly. had blood drawn, physical exam, C.T. scan, Diagnosed with Bell's Palsy
13AUG92 devel arm stiffness, itching @ inject site, sleepy, irritability, mild h/a, sore arm & sleeping difficulty;
No further information is available; patient received an expired RECOMBIVAX.; This spontaneous report was received from an administrator in the office and refers to a female patient of unknown age. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 18-JAN-2021, the patient was vaccinated with an expired hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) lot # R015160, expiration date 09-NOV-2020, dose of 0.5 ml once (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No further information was available.
Kawasaki disease IVIG.  7/6/07 Received vax records from pcp which confirms RO dose & lot# as reported.  7/17/07 Received hospital medical records which reveal patient experienced fever, irritability, extremity swelling, diarrhea, decreased oral intake x 1 week, then a rash, foot swelling, red eyes, rhinorrhea & persistent diarrhea on day of admission.  Admitted 4/21-4/25/07.  ID, cardiology & rheumatology consults done.  Tx w/IVIG & ASA w/good improvement.  D/C to home on continued ASA after afebrile x 36 hrs to cardio & pcp f/u. FINAL DX: Kawasaki Disease.
PATIENT INITIALLY RECEIVED MODERNA 28 DAYS AGO.  THE NURSE INADVERTENTLY ADMINISTERED THE PFIZER /BIONTECH VACCINE.  NO SIGNS OR SYMPTOMS EXHIBITED. EXPLAINED TO PATIENT OF THE ERROR AND RELAYED TO HER THAT BOTH VACCINES MECHANISM OF ACTION ARE SIMILAR. AS WELL AS SIMMIAR SIDE AFFECTS
experienced symptoms similar to a heart attack; This is a spontaneous report from a Pfizer Sponsored Program received from a contactable consumer. A male patient of an unspecified age received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced symptoms similar to a heart attack on an unspecified date. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Red and swollen of (R) thigh, 10.5cm L x 12cm W. Warm to touch. Cephalexin 250/5 1 tsp TID x 10 days. BENADRYL 1 tsp every 6-8 hours for 24-48 hours. Ice, TYLENOL/ADVIL PRN.
Vaccinated on Monday 9/27/21 3:30 pm. Woke up Tuesday morning 9/28/21 with headaches and dizziness.  Couldn`t sit up or keep my balance.  Vomiting and fever came later.  Stayed in bed all day Tuesday and Wednesday fever and vomiting and dizziness, (no balance) taking many fluids and couldn`t keep food down.  Thursday felt better, could walk from room to room with the assistance of the wall. Friday at noon the left half of my head went numb and had no balance to the left. got up and ran straight into the wall. Called Dr.'s office and they suggested I go to urgent care. went to a local Hospital around 1:00 pm. There they ran tests and determined I had three blood clots in my cerebellum and transfered me to another local Hospital. I was there from Friday afternoon to the following  friday.
This spontaneous report as received from a physician refers to a 15 year old male patient with allergic rhinitis and migraine and no drug reactions or allergies, who on 09-APR-2013, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # H021861, Exp. Date: 09-OCT-2015). Concomitant therapies included BENAZAQUINE, fluticasone and sumatriptan. The physician reported that on 09-APR-2013, the patient experienced headaches with increased severity and dizziness. It was stated that acetaminophen and ibuprofen did not bring the patient relief. On 15-MAY-2013, the patient was seen for dizziness and left ear pain and was treated for otitis media with floxacin drops, which brought temporary relief. On 10-JUN-2013, the patient was vaccinated with the second dose of GARDASIL (lot # H021861, Exp. Date: 09-OCT-2015). At a follow up visit on 25-JUN-2013, the patient's parents reported that the patient's dizziness had not resolved since the first dose of GARDASIL and that his headaches had increased in frequency and severity. It was also reported that the sumatriptan for his headaches was less effective. No lab diagnostics studies were performed. At the time of the report the patient had not recovered from headaches and dizziness and the outcome regarding left ear pain was unknown. The relatedness for headaches, dizziness and left ear pain and GARDASIL was unknown. Additional information has been requested.
Burning, aching mid of neck and chest, lower back. Per annual report-Achy run down, burning recurred in throat, chest, low back
Description: Caller is a nurse who reports a pediatric dose of RECOMBIVAX HB was given to 25 year old; Caller is a nurse who reports a pediatric dose of RECOMBIVAX HB was given to 25 year old. Patient had no symptoms or adverse effects from receiving dose. Reporter states that this was the patient's first dose in his series; he had to get titers for; This spontaneous report was received from a nurse (also reported as medical assistant ) and refers to a 25-year-old male patient. The patient had never been vaccinated for hepatitis B. His hepatitis B antibody and hepatitis B antigen test were negative. The patient's concomitant therapies were not reported.  On 19-MAY-2022, the patient was vaccinated with the first pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thimerosal-free intramuscular injection, 0.5 milliliter, lot #U001837 was confirmed to be valid, expiration date: 21-NOV-2022, for prophylaxis as "he had to get titers for school" (strength, route and site of administration were not provided) (incorrect dose administered). The patient had no symptoms or adverse effects from receiving dose.
received a dose from a vial that was opened for more than 6 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of OUT OF SPECIFICATION PRODUCT USE (received a dose from a vial that was opened for more than 6 hours) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced OUT OF SPECIFICATION PRODUCT USE (received a dose from a vial that was opened for more than 6 hours). On 29-Mar-2021, OUT OF SPECIFICATION PRODUCT USE (received a dose from a vial that was opened for more than 6 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This report refers to a case of 23-years-old male patient who experienced non-serious unexpected event of received a dose from a vial that was opened for more than 6 hours (out of specification product use) for mRNA-1273, lot # 037A21B), Exp date-unknown. There were no reported AEs associated with this case of out of specification product use.; Sender's Comments: This report refers to a case of 23-years-old male patient who experienced non-serious unexpected event of received a dose from a vial that was opened for more than 6 hours (out of specification product use) for mRNA-1273, lot # 037A21B), Exp date-unknown. There were no reported AEs associated with this case of out of specification product use.
Patient developed fever, cough, and redness at the sight of vaccine. He was admitted to the hospital for possible cellulitis and tested positive for influenza. While on antibiotics, the redness continued to grow to max of 10cmX10cm. CT showed no abscess. Patient went howm on Cleocin and Amoxicillin 11/9/2009 MR from 10/24/10/28/2009. Patient with c/o's fever, URI sx, lt thigh erythema and redness/swelling, difficulty breathing and nausea/vomiting.Tx: O2, Tamiflu, IV ABX. DC Dx's: Influenza A + with secondary pneumonia, Lt thigh cellulitis, Bilateral acute otitis media.
Patient was given Pfizer Monovalent injection for injection #3 (booster) rather than Pfizer Bivalent booster.