chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Influenza, Myalgia
Clinical narrative: like I've got the flu; sick to my stomach; Muscle aches/Muscle pains; Joint aches/Joint pains; chills; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (like I've got the flu), ABDOMINAL DISCOMFORT (sick to my stomach), MYALGIA (Muscle aches/Muscle pains), ARTHRALGIA (Joint aches/Joint pains) and CHILLS (chills) in an elderly female patient who received mRNA-1273 (Spikevax) 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 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (like I've got the flu), ABDOMINAL DISCOMFORT (sick to my stomach), MYALGIA (Muscle aches/Muscle pains), ARTHRALGIA (Joint aches/Joint pains), CHILLS (chills) and NAUSEA (nausea). At the time of the report, INFLUENZA (like I've got the flu), ABDOMINAL DISCOMFORT (sick to my stomach), MYALGIA (Muscle aches/Muscle pains), ARTHRALGIA (Joint aches/Joint pains), CHILLS (chills) and NAUSEA (nausea) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had the same side effects with each dose, all lasting about 36 hrs. About 12 hrs after the shot, patient experienced all events. It was unknown whether the patient experienced a similar event in the past. Concomitant drugs were not reported. Treatment details were not reported.   This case was linked to MOD-2022-573328, MOD-2022-573338, MOD-2022-573339 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19 virus on 16May2022/ COVID-19 positive after receiving three Pfizer COVID-19 Vaccines; Positive for COVID-19 virus on 16May2022/ COVID-19 positive after receiving three Pfizer COVID-19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER2613, NDC number and Expiry Date are Unknown), in left arm, on 17Apr2021 as dose 2, single (Lot number: EW0158, NDC number and Expiry Date are Unknown), in left arm and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number, NDC number and Expiry Date are Unknown) at the age of 46 years, in left arm, all intramuscular for covid-19 immunisation. The patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was None. There were no concomitant medications. Time the vaccination was given was not provided. First two doses were at a (pharmacy name withheld). Booster dose was at (pharmacy name withheld). Additional vaccines administered on same date of the pfizer suspect were none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): Possible she got the Flu vaccine in that window surrounding her booster dose. NDC/LOT/EXP unknown. AE(s) following prior vaccinations were none. Relevant Tests were none. Predisposing factors were Unknown. No culture was performed. Antipyretic Use (around the date(s) of Vaccination) was None.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022 at 20:00, outcome "unknown" and all described as "Positive for COVID-19 virus on 16May2022/ COVID-19 positive after receiving three Pfizer COVID-19 Vaccines". AE(s) did not require a visit to Emergency Room, Physician Office. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Positive COVID-19 virus on 16May2022 after receiving three Pfizer COVID-19 Vaccines. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive for COVID-19 virus on 16May2022/ COVID-19 positive after receiving three Pfizer COVID-19 Vaccines; Positive for COVID-19 virus on 16May2022/ COVID-19 positive after receiving three Pfizer COVID-19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER2613, NDC number and Expiry Date are Unknown), in left arm, on 17Apr2021 as dose 2, single (Lot number: EW0158, NDC number and Expiry Date are Unknown), in left arm and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number, NDC number and Expiry Date are Unknown) at the age of 46 years, in left arm, all intramuscular for covid-19 immunisation. The patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was None. There were no concomitant medications. Time the vaccination was given was not provided. First two doses were at a (pharmacy name withheld). Booster dose was at (pharmacy name withheld). Additional vaccines administered on same date of the pfizer suspect were none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): Possible she got the Flu vaccine in that window surrounding her booster dose. NDC/LOT/EXP unknown. AE(s) following prior vaccinations were none. Relevant Tests were none. Predisposing factors were Unknown. No culture was performed. Antipyretic Use (around the date(s) of Vaccination) was None.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022 at 20:00, outcome "unknown" and all described as "Positive for COVID-19 virus on 16May2022/ COVID-19 positive after receiving three Pfizer COVID-19 Vaccines". AE(s) did not require a visit to Emergency Room, Physician Office. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Positive COVID-19 virus on 16May2022 after receiving three Pfizer COVID-19 Vaccines. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Vaccine dose given was more than prescribed. Correct vaccine given but Patient received a "double dose". Vaccine was not diluted prior to administration which resulted in the error in preparation and resulting accidental additional amount given in office to patient.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Vaccine dose given was more than prescribed. Correct vaccine given but Patient received a "double dose". Vaccine was not diluted prior to administration which resulted in the error in preparation and resulting accidental additional amount given in office to patient.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dosing of booster was administered. Patient received a 0.5 ml dose instead of 0.25 ml dose
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal sleep-related event, Dyskinesia, Screaming, Sleep disorder
Clinical narrative: I began having a sleep disorder where I yelled out in my sleep cuss words. I also began thrashing wildly in my sleep with arms and legs. Today, a year later I?ve found that CBD w/ THC helps limit these episodes.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient received second dose of moderna vaccine 0.25mL; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received second dose of moderna vaccine 0.25mL) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No known allergies to medications, food and other products were reported.  Concurrent medical conditions included Iron deficiency and Chronic kidney disease stage 3 (Stage 3B Chronic Kidney Disease) since 2021.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received second dose of moderna vaccine 0.25mL). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received second dose of moderna vaccine 0.25mL) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not provided.   This case was linked to MOD-2022-573301 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Syncope
Clinical narrative: Fainted in the night; Patient's husband found her on the bathroom floor; Felt quiet poorly as if she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted in the night) in a 72-year-old female patient 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainted in the night) (seriousness criterion medically significant), FALL (Patient's husband found her on the bathroom floor) and FEELING ABNORMAL (Felt quiet poorly as if she had the flu). At the time of the report, SYNCOPE (Fainted in the night), FALL (Patient's husband found her on the bathroom floor) and FEELING ABNORMAL (Felt quiet poorly as if she had the flu) outcome was unknown.            No concomitant medication were reported.   No treatment information were provided.    Reporter reported she was getting the 4th shot until a close friend had an experience with the Moderna vaccine who was same age as the caller.  Company Comment: This spontaneous case concerns a 72-year-old female patient with no medical history reported, who experienced the unexpected (listed in US factsheet and US PI) serious (medically significant) event of Syncope and non-serious events of Fall and Feeling abnormal unspecified days after a dose (second booster) of mRNA-1273 vaccine. It was reported that Patient fainted in the night after getting the 2nd booster dose as she was walking to the bathroom. The patient's husband found her on the bathroom floor, and she felt quiet poorly as if she had the flu but felt ok after taking care of herself day after next. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-572766 (Patient Link).; Sender's Comments: This spontaneous case concerns a 72-year-old female patient with no medical history reported, who experienced the unexpected (listed in US factsheet and US PI) serious (medically significant) event of Syncope and non-serious events of Fall and Feeling abnormal unspecified days after a dose (second booster) of mRNA-1273 vaccine. It was reported that Patient fainted in the night after getting the 2nd booster dose as she was walking to the bathroom. The patient's husband found her on the bathroom floor, and she felt quiet poorly as if she had the flu but felt ok after taking care of herself day after next. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other issues or concerns noted.; Per caller the product has been stored in the refrigerator since 20-APR-2022. Date of administration: 22-APR-2022.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided.  Per the reporter, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot# W004694, expiration date 08-AUG-2023) had been stored in the refrigerator since 20-APR-2022. The temperature was 45 degrees Fahrenheit (F). On 22-APR-2022, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot# W004694, expiration date 08-AUG-2023; strength, dose and route were not reported) for prophylaxis (product storage error). The time frame of the excursion was 120 hours, and the reporter called to check stability of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD). It was reported that there was no previous temperature excursion. No other issues or concerns were noted.
Sex: F
Vaccine: HPV9
Symptoms: Loop electrosurgical excision procedure, Smear cervix abnormal
Clinical narrative: Reported she had a high risk PAP smear JANUARY 2021 and then had a LEEP procedure performed in; This spontaneous report was received from other health professional referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.      On an unknown date when the patient was 11 years old, she was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unknown date in January 2021, the patient had a high risk PAP smear (smear cervix abnormal) and then had a loop electrosurgical excision (LEEP) procedure performed in April 2021. The outcome of smear cervix abnormal was unknown.   The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and smear cervix abnormal was unknown.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; dose of PROQUAD expired on 4/11/2022 and was administered today, 4/26/2022; This spontaneous report was received from a nurse and referred to a 4-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapy and drug reactions or allergies were not reported. The patient had 2 sisters.  On 26-APR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (Therapy type: recombinant Human albumin (rHA)), 0.5 milliliter (route of administration was not provided; lot #T034828 has been verified to be a valid lot number, expiration date: 11-APR-2022) for prophylaxis (Expired vaccine used). It was reported that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) never had a temperature excursion. No additional adverse event reported (No adverse event).
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; Nurse reports that an expired dose of ROTATEQ was administered; This spontaneous report was received from a licensed practical nurse, referring to a 9-week-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-APR-2022, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), orally, lot # 1705097, expiration date 20-APR-2022 (dose was not reported) for prophylaxis (Expired product administered). There was no additional adverse event reported (No adverse event).
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Customer calling for TE evaluation on frozen products states that 7 vaccines stored outside of recommended range were administered to patients.   Names of vaccines involved (including lot/exp) VARIVAX; U010398; 4/1/2023        ?    Temperature 6°F; This spontaneous report as received from a registered nurse and an administrator, referring to a 26 years old female patient. Concomitant therapies included sterile diluent. The patient's historical condition and current condition were not reported.  It was reported that multiple patients received vaccines that underwent the temperature excursion prior to the office being aware of it, between 08-APR-2022 to 02-MAY-2022. On 27-APR-2022, the patient was vaccinated with incorrectly storge of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U010398 with expiration date: 01-APR-2023; dose, route and strength were unknown) for prophylaxis (product storage error).   Administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below 6 Fahrenheit degrees (F) up to 14F (7.9F) for 4 hours 8 minutes 0 seconds. No previous temperature excursions reported. The reporter reported the office was unaware of the temperature excursion until she completed a data logger download on 02-MAY-2022.  No adverse events have been reported to the office at the time of the report.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA001061: US-009507513-2205USA000973:02158523 US-009507513-2205USA001202: US-009507513-2205USA001043: US-009507513-2205USA001205: US-009507513-2205USA001272:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: Nurse calling to report a dose of GARDASIL 9 that was given after its expiration date. Expiration date: 3/26/2022, date administered: 5/6/2022. Nurse verified that the GARDASIL 9 had not undergone any previous temperature excursions. No PQC. No addit; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 06-MAY-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S023475, expiration date: 26-MAR-2022, administered for prophylaxis (strength, and route of administration were not provided)(Expired product administered). The vaccine did not undergone any previous temperature excursion.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No other issues or concerns noted; Caller reported that a patient was given a dose of MMRII Intramuscular instead of  Subcutaneous Administration.  No other issues or concerns noted.  Admin 5/19/2022 MMRII:  LOT:  U014655 EXP: May 7, 2023; This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-MAY-2022, the patient was administered measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II)  intramuscularly intead of subcutaneously (incorrect route of product administration), lot #U014655, expiration date reported and established as 07-MAY-2023 (formulation, strength was not provided) for prophylaxis. No other issues or concerns noted (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: Took 2 weeks in bed to recover from the shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles with the blisters twice).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter questioned if it was necessary to take the shingles shot. The patient had shingles with the blisters twice prior to taking the vaccine. The patient took 2 weeks in bed to recover from the shingles vaccine. Additional Supportive Information: The follow-up would not be possible as no contact details were available. Note: The case was kept valid conservatively as no clear information adverse event given in the case only consequences of event was reported. Also follow up was not possible for this case.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Very bad pain in my left leg; It's only the nerve sharp shooting pain; Tingling; Stiffness of my nerves in my shin area.; This case was reported by a consumer via interactive digital media and described the occurrence of pain in extremity in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received Shingrix. On an unknown date, 20 days after receiving Shingrix, the patient experienced pain in extremity, nerve pain, tingling and stiffness. On an unknown date, the outcome of the pain in extremity, nerve pain, tingling and stiffness were unknown.   It was unknown if the reporter considered the pain in extremity, nerve pain, tingling and stiffness to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine about one month ago and after almost 20 days he/she had very bad pain in his/her left leg. It was only the nerve. Sharp shooting pain tingling and stiffness of his/her nerves in his/her shin area. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Discomfort, Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles, right torso, 4th outbreak; 4-5 blisters which are uncomfortable; uncomfortable; Incomplete course of vaccination; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, blister, discomfort and incomplete course of vaccination. The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown and the outcome of the blister and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister and discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's comment: The patient got the Shingrix vaccine in July 2021 and within 7 days patient got shingles for the first time on right torso.  The patient's physician said to go ahead and get the second shot as the vaccine might lessen the severity of any future outbreaks. Now patient was experiencing the 4th outbreak of about 4 to 5 blisters which were uncomfortable.  The patient had the anti-viral pills to lessen the time. The patient knew did not report this data back to you, so the patient was. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Note: Incomplete course event was coded as 6 months' timeline was extended for 2nd dose and nowhere said that due to the reported event vaccine was not administered.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site swelling, Rash, Rash vesicular
Clinical narrative: Shingles, right torso, 4th outbreak; 4-5 blisters which are uncomfortable; uncomfortable; Incomplete course of vaccination; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, blister, discomfort and incomplete course of vaccination. The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown and the outcome of the blister and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister and discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's comment: The patient got the Shingrix vaccine in July 2021 and within 7 days patient got shingles for the first time on right torso.  The patient's physician said to go ahead and get the second shot as the vaccine might lessen the severity of any future outbreaks. Now patient was experiencing the 4th outbreak of about 4 to 5 blisters which were uncomfortable.  The patient had the anti-viral pills to lessen the time. The patient knew did not report this data back to you, so the patient was. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Note: Incomplete course event was coded as 6 months' timeline was extended for 2nd dose and nowhere said that due to the reported event vaccine was not administered.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Shingles, right torso, 4th outbreak; 4-5 blisters which are uncomfortable; uncomfortable; Incomplete course of vaccination; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, blister, discomfort and incomplete course of vaccination. The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown and the outcome of the blister and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister and discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's comment: The patient got the Shingrix vaccine in July 2021 and within 7 days patient got shingles for the first time on right torso.  The patient's physician said to go ahead and get the second shot as the vaccine might lessen the severity of any future outbreaks. Now patient was experiencing the 4th outbreak of about 4 to 5 blisters which were uncomfortable.  The patient had the anti-viral pills to lessen the time. The patient knew did not report this data back to you, so the patient was. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Note: Incomplete course event was coded as 6 months' timeline was extended for 2nd dose and nowhere said that due to the reported event vaccine was not administered.
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received one dose Bexsero. Do I need a second dose?; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 69-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included splenectomy.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 21-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient was 69 years old at the time of reporting. The patient received 1 dose of Bexsero at not the recommended age. The patient asked if 2nd dose was required or not. Additional Supportive Information: The patient received Bexsero at not the recommended age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: It is over a year since I had my first dose of Shingrix.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. It was over a year since the patient had 1st dose of Shingrix. The patient asked that if he or she needed to start over with 1st dose. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of only the liquid component; administration of only the liquid component; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-MAR-2022 Reporter's Comment: The reporter had called to request information on inadvertent administration of only the liquid component (menCWY) of Menveo. Additional supportive information: The patient inadvertently administered only the liquid component of Menveo, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This case had been linked with case US2022AMR083221, reported by the same facility.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083221:Same facility
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of only the liquid component; administration of only the liquid component; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 18-March-2022 Reporter's comment: The reporter had called to request information on inadvertent administration of only the liquid component (menCWY) of Menveo. Additional supportive information: The patient inadvertently administered only the liquid component of Menveo, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This case had been linked with case US2022AMR083216, reported by the same facility.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083216:Same facility
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: 2 years later had shingles/suspected vaccination failure; 2 years later had shingles; Horrible and painful; This 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-May-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient got the vaccine, 2 years later had shingles, the doctor said it would had been worse if the patient had not got the vaccine, the patient thought it was horrible and painful. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: shot made be sick for about 12 hours; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had Shingles 3 times, every time was worse than the time before).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   The reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-May-2022 Reporter's comment: The case was received by the patient via interactive digital media. The patient stated that the Shingles shot made him/her sick for about 12 hours, but it was much better than getting shingles. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patient's mother had shingles).   On 20th May 2022, the patient received the 1st dose of Shingles vaccine. On 20th May 2022, less than a day after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles vaccine on the date of reporting and felt like arm was killing him or her. The patients mother had shingles hence the patient decided to take the Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm was only is; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles vaccine and experienced sore arm. It was worth the price and side effect was not that bad. Fortunately, the patient's insurance paid part of the cost. Additional Supportive Information: For tolerance of 2nd dose refer case US2022AMR083272.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083272:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm was only is; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, for tolerance refer case US2022AMR083269).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles vaccine and experienced sore arm. The patient stated that it was worth the price and side effect was not that bad. Fortunately, the patient's insurance paid part of the cost.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083269:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Death, Herpes zoster, Immune system disorder, Neoplasm malignant, Nervous system disorder
Clinical narrative: died with shingles, destroying spine and brain; died with shingles, destroying spine and brain; Suspected vaccination failure; cancer; amun system was gone; terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced shingles (serious criteria death), central nervous system disorder (serious criteria death), vaccination failure (serious criteria GSK medically significant), cancer (serious criteria GSK medically significant), immune system disorder and pain. On an unknown date, the outcome of the shingles and central nervous system disorder were fatal and the outcome of the vaccination failure, cancer, immune system disorder and pain were unknown. The reported cause of death was shingles and central nervous system disorder.   It was unknown if the reporter considered the shingles, central nervous system disorder, vaccination failure, cancer, immune system disorder and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 21-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter was the patient's spouse. The patient died with shingles that got into his insides destroying his spine and brain. The patient's immune system was gone due to cancer. The patient had both shingles shots, he could not swollen, he lived 12 days and was in terrible pain. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.; Reported Cause(s) of Death: died with shingles, destroying spine and brain; died with shingles, destroying spine and brain
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Vaccination failure
Clinical narrative: died with shingles, destroying spine and brain; died with shingles, destroying spine and brain; Suspected vaccination failure; cancer; amun system was gone; terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced shingles (serious criteria death), central nervous system disorder (serious criteria death), vaccination failure (serious criteria GSK medically significant), cancer (serious criteria GSK medically significant), immune system disorder and pain. On an unknown date, the outcome of the shingles and central nervous system disorder were fatal and the outcome of the vaccination failure, cancer, immune system disorder and pain were unknown. The reported cause of death was shingles and central nervous system disorder.   It was unknown if the reporter considered the shingles, central nervous system disorder, vaccination failure, cancer, immune system disorder and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 21-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter was the patient's spouse. The patient died with shingles that got into his insides destroying his spine and brain. The patient's immune system was gone due to cancer. The patient had both shingles shots, he could not swollen, he lived 12 days and was in terrible pain. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.; Reported Cause(s) of Death: died with shingles, destroying spine and brain; died with shingles, destroying spine and brain
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the vaccination, still got shingles/suspected vaccination failure; shingles; painful; This 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-May-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got the vaccination also, but the patient still got the shingles. Most painful thing patient ever had. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient of 1 YO received Kinrix; received Kinrix instead of receiving DTAP and IPV separately; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24t2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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:18-May-2022 Reporter's comments: Nurse practitioner reported that few months ago the patient of 1year age received Kinrix instead of receiving DTAP and IPV separately. The consent to follow up was given.  Additional Supportive Information: The 1 year old patient received Kinrix instead of receiving DTAP and IPV separately, which led to inappropriate age at vaccine administration and wrong vaccine administered.