chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got both shots n didn't help; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got both shots n didn't help). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 15-APR-2024 This case was reported by a patient via (social media) interactive digital media. The reporter reported that he/she got both shots and did not help. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had both my shingles vaccines/had it a couple of years ago on my forehead/Suspected vaccination failure; Shingles/ I had it a couple of years ago on my forehead; Painful/It is very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both my shingles vaccines/had it a couple of years ago on my forehead/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles/ I had it a couple of years ago on my forehead) and pain (Verbatim: Painful/It is very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 19-APR-2024 The case was received from the patient via interactive digital media.   The patient reported he/she had both shingles vaccines and couple of years ago got shingles on forehead. The patient stated his/her would have been more severe and a larger area. It was very painful. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: RV1
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: Spit up; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation in a infant patient who received Rota (Rotarix lyophilized formulation) (batch number GG2YS, expiry date 18-OCT-2025) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (oral). On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced regurgitation (Verbatim: Spit up). The outcome of the regurgitation was unknown.   It was unknown if the reporter considered the regurgitation to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Ear pain, Headache
Clinical narrative: Blisters on face; Ear pain; Pain in head; This non-serious case was reported by a consumer and described the occurrence of blister in a 54-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 58160082311) for prophylaxis.   The patient's past medical history included blister.   On 10-APR-2024, the patient received the 1st dose of Shingles vaccine. On 10-APR-2024, less than a day after receiving Shingles vaccine, the patient experienced headache (Verbatim: Pain in head). On 12-APR-2024, the patient experienced blister (Verbatim: Blisters on face) and ear pain (Verbatim: Ear pain). The outcome of the blister, headache and ear pain were not resolved.   It was unknown if the reporter considered the blister, headache and ear pain to be related to Shingles vaccine.     It was unknown if the company considered the blister, headache and ear pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-APR-2024 The Blisters on face, pain in head and ear pain were not treated. The reporter provided permission to contacted.
Sex: U
Vaccine: RVX
Symptoms: Pulmonary thrombosis
Clinical narrative: blood clots in my lungs; This serious case was reported by a consumer via interactive digital media and described the occurrence of pulmonary thrombosis in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In JAN-2024, the patient received RSV vaccine. In FEB-2024, between 1 and 2 months after receiving RSV vaccine, the patient experienced pulmonary thrombosis (Verbatim: blood clots in my lungs) (serious criteria GSK medically significant). The patient was treated with warfarin. The outcome of the pulmonary thrombosis was not reported.   It was unknown if the reporter considered the pulmonary thrombosis to be related to RSV vaccine.     It was unknown if the company considered the pulmonary thrombosis to be related to RSV vaccine.   Additional Information: GSK Receipt date: 19-APR-2024 This case was reported by patient via (social media) interactive digital media. The patient self-reported. He/she got the RSV shot and then he/she had to go to the hospital and he/she had blood clots in his/her lungs. He/she have never had blood clots before now he/she on Warfarin because he/she can't afford Eliquis because it was so expensive. Got the shot in January and had blood clots in his/her lungs in February.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: It hurt like heck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: It hurt like heck). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-APR-2024 The case was received from the patient via interactive digital media. The patient received shingles vaccine. The reporter reported that after the vaccination patient had hurt like heck but not bad as shingles.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Chest discomfort, Condition aggravated, Diabetes mellitus, Heart rate increased
Clinical narrative: heart rate intermittently increased to 106 to 127/ elevated heart rate; chest tightness; after receiving the vaccine her blood sugar values started to climb /elevate/ increased blood sugar values; after receiving the vaccine her blood sugar values started to climb /elevate/ increased blood sugar values; This non-serious case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes. Concomitant products included glibenclamide (Glyburide).   On 07-MAR-2024, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 08-MAR-2024, 1 days after receiving Shingrix, the patient experienced blood sugar increased (Verbatim: after receiving the vaccine her blood sugar values started to climb /elevate/ increased blood sugar values) and condition aggravated (Verbatim: after receiving the vaccine her blood sugar values started to climb /elevate/ increased blood sugar values). On 09-MAR-2024, the patient experienced heart rate increased (Verbatim: heart rate intermittently increased to 106 to 127/ elevated heart rate) and chest tightness (Verbatim: chest tightness). The patient was treated with tirzepatide (Mounjaro) and insulin glargine (Basaglar). Shingrix was discontinued. The outcome of the heart rate increased, chest tightness, blood sugar increased and condition aggravated were not resolved.   It was unknown if the reporter considered the heart rate increased, chest tightness, blood sugar increased and condition aggravated to be related to Shingrix.     It was unknown if the company considered the heart rate increased, chest tightness, blood sugar increased and condition aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-APR-2024 The patient self-reported this case. The patient reported that 2 days after she received vaccine her heart rate intermittently increased to 106 to 127. Increased heart rate was accompanied by chest tightness. The patient stated these symptoms had not resolved. The patient reported that 1 day after receiving the vaccine her blood sugar values started to climb/ elevate and stated her physician increased her Glyburide from 2mgs to 4 mgs due to the increasing blood sugar values. The patient reported her blood sugars value increased after the increase of Glyburide. The patient reported by 20th March 2024 her physician taken her off from PO (oral) diabetic medications and started Mounjaro once a week injection. Blood sugar values reached 200-400 by 25th March 2024. The patient reported that her physician added daily Basaglar insulin to her medication on 2nd April 2024. No lot number was available at the time of call. The reporter did provide an NDC (national drug code) 58160-823-55. The patient reported she would not be getting the second dose of the vaccine series. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: she inadvertently administered only the diluent portion of the Shingrix; she inadvertently administered only the diluent portion of the Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-APR-2024, the patient received the 1st dose of Shingrix. On 13-APR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: she inadvertently administered only the diluent portion of the Shingrix) and inappropriate dose of vaccine administered (Verbatim: she inadvertently administered only the diluent portion of the Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-APR-2024 The reporter stated that she inadvertently administered only the diluent portion of the Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter did not had the date of birth nor lot and expiration date at the time of the call. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient waited more than 30 days to get the second Twinrix dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient waited more than 30 days to get the second Twinrix dose). The outcome of the incomplete course of vaccination 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-APR-2024 The patient received 1st dose of Twinrix on 28-FEB-2024. The reporter called in to request data about the sequential vaccination of a patient if they waited more than 30 days to get the second dose of Twinrix. The reporter provided partial patient, vaccine and event information. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to an incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient got 1st dose of Engerix-B on Dec 15th 2023 and did not get the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (On 15th December 2023, received first dose with batch number 337tc and expiry date 29th March 2024).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Patient got 1st dose of Engerix-B on Dec 15th 2023 and did not get the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-APR-2024 The reporter reported that the patient got the 1st dose of Engerix-B on 15 December 2023 and did not receive the second dose. The reporter consented to follow-up. Till the time of reporting patient did not receive the second dose of Engerix-B, which led to incomplete course of vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inadvertently administered a patient's second dose of Shingrix too early; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number L995Y, expiry date 15-MAY-2026) for prophylaxis.   Additional patient notes included patient was not immunocompromised or immunosuppressed. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 15-APR-2024, the patient received the 2nd dose of Shingrix. On 15-APR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: inadvertently administered a patient's second dose of Shingrix too early). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 15-APR-2024 The patient received first dose of Shingrix on 05-MAR-2024. The pharmacist stated she inadvertently administered a patient's second dose of Shingrix too early.  The pharmacist did not had the lot number information for the first dose.   The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix earlier than recommended time interval, which led to shortening of vaccination schedule.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient has not received the second dose of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th October 2021 in right arm).   On an unknown date, the patient did not received the 2nd dose of Shingrix (intramuscular, right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient has not received the second dose of the vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 16 Apr 2024: The reporter was an HCP/ pharmacist. HCP reported patient received his 1st dose for Shingrix vaccine it was injected in the right arm.  The HCP reported that patient had not received the second dose of the vaccine.  HCP did not indicate the reasons why the patient did not received the 2nd dose of the vaccine during the 2 to 6 months window after the 1st dose.  No additional information was reported. Lot and Expiry date were not provided. The reporter consented to follow up. Till the time of reporting the patient did not receive 2nd dose which led to incomplete course if vaccination.
Age: 0.67
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 8 month old patient needed a Pentacel dose but they accidentally administered Kinrix; 8 month old patient needed a Pentacel dose but they accidentally administered Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 8-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 15-APR-2024, the patient received Kinrix. On 15-APR-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: 8 month old patient needed a Pentacel dose but they accidentally administered Kinrix) and inappropriate age at vaccine administration (Verbatim: 8 month old patient needed a Pentacel dose but they accidentally administered Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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 16 Apr 2024 The Medical Assistant explained that an 8 month old patient needed a Pentacel dose but they accidentally administered Kinrix and they know this one was only for patients 4 to 6 years of age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient got her 1st Shingrix vaccine in 2018 (7/22/2018) and just now completed the Shingrix series (4/3/2024).; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 3959S, expiry date 12-DEC-2025) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd July 2018).   On 03-APR-2024, the patient received the 2nd dose of Shingrix. On 03-APR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient got her 1st Shingrix vaccine in 2018 (7/22/2018) and just now completed the Shingrix series (4/3/2024).). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-Apr-2024 The reporter reported that the patient received first dose of Shingrix vaccine in 2018 and just completed the Shingrix vaccine series, which led to which led to lengthening of vaccination schedule. The reporter asked does patient need a 3rd dose. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: vaccine fridge was set on coldest setting and the temperature was reading at -4C.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ZF5C7, expiry date 13-OCT-2025) for prophylaxis.   On 16-APR-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: vaccine fridge was set on coldest setting and the temperature was reading at -4C.). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 18-APR-2024 Clinical Operations Director stated she went to one of their clinical sites on 16th April 2024 and discovered that vaccine fridge was set on coldest setting and the temperature was reading at -4degree Celsius  She stated that the Medical Assistant at that facility had not documented a temperature recording since 05th April 2024, so she was unsure how long the temperature was out of range.  The Vaccine Administration Facility was the same as Primary Reporter There was a dose administered to a 76 year old male, which led to incorrect storage of drug. At the time of reporting, the dose had not been repeated. The reporter consented to follow up. The case is linked with US2024050063,US2024050064, by same reporter.; Sender's Comments:  US-GSK-US2024050063:Same reporter/Different patient US-GSK-US2024050064:SAME REPORTER / DIFFERENT PATIENT
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine fridge was set on coldest setting and the temperature was reading at -4C.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 2YC74, expiry date 17-MAY-2026) for prophylaxis.   On 09-APR-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: vaccine fridge was set on coldest setting and the temperature was reading at -4C.). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-Apr-2024 The reporter reported that she went to the one of their clinical sites on 16th April 2024 and discovered that vaccine fridge was set on coldest setting and the temperature was reading at minus 4 degree Celsius.  The reporter stated that the medical assistant at that facility had not documented a temperature recording since 05th April 2024, so she was unsure how long the temperature was out of range.  There was a dose of Shingrix vaccine administered on 09th April 2024 to a 55 year old male, which led to incorrect storage of drug. The reporter reported that at the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. This case was 1 of 6 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024050073:same reporter US-GSK-US2024050077:same reporter US-GSK-US2024050074:same reporter US-GSK-US2024050076:same reporter US-GSK-US2024050075:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix stored out of range; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 2YC74, expiry date 17-MAY-2026) for prophylaxis.   On 17-APR-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Shingrix stored out of range). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt date: 18-APR-2024 The reporter stated she went to one of their clinical sites on 16 April 2024 and discovered that vaccine fridge was set on coldest setting and the temperature was reading at minus 4 Celsius. She stated that facility had not documented a temperature recording since 05 April 2024, so she was unsure how long the temperature was out of range. There was a dose of Shingrix administered on 17 April 2024 to a 59 year old female which led to incorrect storage of drug. At the time of reporting, the dose had not been repeated. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024050077:Same reporter US-GSK-US2024050074:same reporter US-GSK-US2024050075:same reporter US-GSK-US2024050073:same reporter US-GSK-US2024050072:same reporter
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Norovirus infection, Renal impairment
Clinical narrative: spike in his liver enzymes; Creatinine level of 9.61; Acute kidney injury; pretty bad colitis symptoms; Decrease of kidney function/his kidney function is down; Bloody water in stool; he also has Norovirus.; This serious case was reported by a pharmacist via call center representative and described the occurrence of elevated liver enzymes in a 30-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 13-APR-2024, the patient received Boostrix. In APR-2024, an unknown time after receiving Boostrix, the patient experienced elevated liver enzymes (Verbatim: spike in his liver enzymes) (serious criteria hospitalization), creatinine increased (Verbatim: Creatinine level of 9.61) (serious criteria hospitalization), acute kidney injury (Verbatim: Acute kidney injury) (serious criteria GSK medically significant), colitis (Verbatim: pretty bad colitis symptoms) (serious criteria GSK medically significant), function kidney decreased (Verbatim: Decrease of kidney function/his kidney function is down) (serious criteria GSK medically significant), blood in stool (Verbatim: Bloody water in stool) (serious criteria GSK medically significant) and norovirus infection (Verbatim: he also has Norovirus.). In APR-2024, the outcome of the elevated liver enzymes was resolved. The outcome of the creatinine increased was resolving and the outcome of the acute kidney injury, colitis, blood in stool and norovirus infection were unknown and the outcome of the function kidney decreased was not resolved.   It was unknown if the reporter considered the elevated liver enzymes, creatinine increased, acute kidney injury, colitis, function kidney decreased, blood in stool and norovirus infection to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the elevated liver enzymes, creatinine increased, acute kidney injury, colitis, function kidney decreased, blood in stool and norovirus infection to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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: 18-APR-2024 A pharmacist reported that a patient received Boostrix, and then was admitted to the hospital with like a spike in his liver enzymes, and now he had an acute kidney injury, his kidney function is down to, like, his creatinine was now 9.06, and he had pretty bad colitis symptoms. The liver enzymes had resolved, but the kidney function continues to decline, and he also had norovirus. The reporter mentioned that the patient was admitted to the hospital on 14th April 2024 and also reporter mentioned that when the patient was admitted to the hospital, the creatinine levels of the patient were 1.61.  The reporter also mentioned that the patient had bloody water in stool. The reporter was not able to provide details on vaccine lot number since it was administered on another facility, but agreed to follow up by safety team.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had his first dose of Shingrix in 2020/ But with only one dose, and it being 4 years later,; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had his first dose of Shingrix in 2020/ But with only one dose, and it being 4 years later,). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-APR-2024 and 19-APR-2024 Back in 2020, the patient took the first injection of Shingrix with planned to take the second. Then the pandemic came and he was afraid to take the second injection of Shingrix with taking the Covid vaccinations. The reporter wanted to be certain, he was vaccinated for Shingles but with only one dose and it being 4 years later and asked if he would have just go to take the second dose or he need to start all over. The reporter asked for professional opinion on what he should do. No further information was known such as site of vaccination, date of vaccination or lot number. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARES; This spontaneous report received from a health care professional concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: juvenile idiopathic arthritis (jia). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that, patient had been experiencing rheumatoid arthritis (RA) flares (dose series 1) since she received the vaccine in 2021. Her JIA disease was well controlled until a week after receipt of the vaccine when she started to experience joint pain similar to the pains she had as a child. Flares had cause RA disease to progress to severe manifestations of RA unable to be controlled by numerous therapies attempted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rheumatoid arthritis flares. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Rheumatoid arthritis. The event 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. Specifically: UNDERLYING DISEASE, NATURE OF EVENT(Progressive nature of juvenile idiopathic arthritis (jia) and Rheumatoid arthritis). Therefore, this event is considered inconsistent with vaccine administration.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Dysuria, Ophthalmological examination, Overdose, Urinary tract infection
Clinical narrative: UTI; 16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.; Dysuria; Conjunctivitis; This spontaneous case was reported by an other health care professional and describes the occurrence of URINARY TRACT INFECTION (UTI), DYSURIA (Dysuria), CONJUNCTIVITIS (Conjunctivitis) and OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.) in a 7-year-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5556B) for COVID-19 prophylaxis.     Concomitant products included SODIUM FLUORIDE (FLUORIDE [SODIUM FLUORIDE]) for an unknown indication.    On 02-Jan-2024 at 9:56 AM, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) .5 milliliter. On 24-Jan-2024, the patient experienced DYSURIA (Dysuria) and CONJUNCTIVITIS (Conjunctivitis). On 01-Feb-2024 at 9:56 AM, the patient experienced OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.). On 02-Feb-2024, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI), DYSURIA (Dysuria), CONJUNCTIVITIS (Conjunctivitis) and OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2023, Ophthalmological examination: Abnormal, the condition was ongoing..     For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 7th out of 16 patients as described by the reporter.  As per reporter, between 01-Jan-2024 and 15-Feb-2024, 16 children were given the 6 to 11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.  There were 5 different lots involved, AU5556 with expiry date 08-Jun-2024, AU5554 with expiry date 06-Jun-2024, AU5558 with expiry date 15-Jun-2024, AU5551 with expiry date 30-May-2024 and AU5555 with expiry date 07-Jun-2024.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-760906 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2024: Significant follow-up received: Additional reporters, patient's details, medical history, concomitant drug, dosage details of suspect drug, and additional events were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760906:Patient 7 out of 16
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Pain, SARS-CoV-2 test
Clinical narrative: Just minor soreness; took Paxlovid but did not exhibit a negative test and then a rebound positive test; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of PAIN (Just minor soreness) and COVID-19 (took Paxlovid but did not exhibit a negative test and then a rebound positive test) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included Pain with Pfizer and Pfizer.   In February 2024, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2024, the patient experienced COVID-19 (took Paxlovid but did not exhibit a negative test and then a rebound positive test). On an unknown date, the patient experienced PAIN (Just minor soreness). At the time of the report, PAIN (Just minor soreness) outcome was unknown and COVID-19 (took Paxlovid but did not exhibit a negative test and then a rebound positive test) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2024, SARS-CoV-2 test: Positive.         Concomitant medications were not reported.  The sequence of the COVID-19 vaccine received by patient and her husband over the past 3 years as followed. On 22-Feb-2021 Pfizer with batch no. EN6200,  On 23-Mar-2021 Pfizer with batch no. EN6208,  On 24-Sep-2021 Pfizer with batch no. FC3184,  On 01-Apr-2022 Pfizer with batch no. J87762,  On 08-Sep-2022 Moderna Bivalent with batch no. AS7143C and  On 17-May-2023 Moderna Bivalent with batch no. 045H22A and on an unknown date Comirnaty XBB 1.5 2023-2024 formula.  Patient took Paxlovid but did not exhibit a negative test, patient remained positive for about two weeks after completing the five-day drug and then tested positive rebound test.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-765994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-765994:Same reporter (husband case)
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: He got COVID twice; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He got COVID twice) in a 75-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Infection (In recent years bad infection), Stent replacement (He had two stands put in his heart) in 1998, Surgery and Cardiac operation. Previously administered products included for Product used for unknown indication: FLU; for Drug use for unknown indication: Montelukast (In recent years he got a bad infection that required surgery and after that he took Monkelukast). Past adverse reactions to the above products included No adverse event with FLU and Montelukast. Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN for High cholesterol.   In January 2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In February 2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In May 2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (He got COVID twice). At the time of the report, COVID-19 (He got COVID twice) outcome was unknown.            Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication was reported.   This case was linked to MOD-2024-766013 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Rhinalgia
Clinical narrative: bad sore in my nose; I have never ever had a cold sore and since the shot I keep getting these and I even have one right now and this is the first time with the nose thing, that I have on the bridge now I have on my lip; This spontaneous case was reported by a patient and describes the occurrence of RHINALGIA (bad sore in my nose) and ORAL HERPES (I have never ever had a cold sore and since the shot I keep getting these and I even have one right now and this is the first time with the nose thing, that I have on the bridge now I have on my lip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 017B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RHINALGIA (bad sore in my nose) and ORAL HERPES (I have never ever had a cold sore and since the shot I keep getting these and I even have one right now and this is the first time with the nose thing, that I have on the bridge now I have on my lip). At the time of the report, RHINALGIA (bad sore in my nose) and ORAL HERPES (I have never ever had a cold sore and since the shot I keep getting these and I even have one right now and this is the first time with the nose thing, that I have on the bridge now I have on my lip) had not resolved.            It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-766132 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-766132:husband case
Age: 62.0
Sex: F
Vaccine: PPV, RSV
Symptoms: Injection site reaction
Clinical narrative: Sever to hung to injection aite; This is a spontaneous report received from a Nurse.  A 62-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 21Apr2024 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 21Apr2024), in left arm. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: codeine, reaction(s): "Allergies". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Apr2024, outcome "not recovered", described as "Sever to hung to injection aite". Therapeutic measures were not taken as a result of vaccination site pain. Additional information included: the patient received Thyroid medicine in 2 weeks.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination Failure; COVID-19; This is a spontaneous report received from a Nurse.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa antibiotic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Apr2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Apr2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 15Apr2024 to 19Apr2024.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COMIRNATY 2023-2024 FORMULA can not be fully excluded.
Sex: M
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site rash, Rash
Clinical narrative: he's still itching in the area where he got the shot; He broke out at the injection site and other places too, on his face, his other arm and different areas; He broke out at the injection site and other places too, on his face, his other arm and different areas; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 81-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for pneumonia. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "not recovered", described as "he's still itching in the area where he got the shot"; VACCINATION SITE RASH (non-serious), RASH (non-serious), outcome "not recovered" and all described as "He broke out at the injection site and other places too, on his face, his other arm and different areas".  Additional information: Caller called in mentioned that he got a Pfizer shot for his pneumonia and it has been five and a half months and he's still itching in the area where he got the shot. It was the Prevnar 20 prefilled syringe that he received. He broke out at the injection site and other places too, on his face, his other arm and different areas. Caller stated this seemed like the only thing he could think of that it could be. Caller stated it still itches around the site. He has had all of the other Pfizer shots and he had no reaction, but he had a reaction with this one. Caller is asking if there is anything to counteract his reaction. He notices the itching more when gets out of a warm shower. He wishes he wouldn't of gotten the shot. He wouldn't think after 5.5 months it would still itch. Caller stated this reaction must have been what was in it.   Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dermatitis
Clinical narrative: Dermatitis; Cardiac issues; The initial case was missing the following minimum criteria: specific adverse event. Upon receipt of follow-up information on 23Apr2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a consumer.  A 35-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (DOSE 1; intramuscular), administration date: Apr2021, for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious) with onset Dec2021, outcome "recovered with sequelae", described as "Cardiac issues"; DERMATITIS (non-serious) with onset Dec2021, outcome "recovered with sequelae". Therapeutic measures were not taken as a result of dermatitis, cardiac disorder.  Additional Information: The patient was not taking other medications within 2 weeks prior to the event onset. The patient was administered with the second dose two weeks after the first COVID-19 Vaccine. The patient experienced an adverse event after taking a Pfizer product (immunization requirement). The patient asked how to detox from the Pfizer COVID-19 vaccine.