chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistance reported 1 administration of ROT ATEQ following a temperature excursion; This spontaneous report as received from a medical assistant concerning  a patient of unknown age  and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.      On 15-OCT-2021, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot #: 1694405, expiration date: 06-DEC-2021 for prophylaxis following a temperature excursion (dose and route of administration were not reported)  (product storage error). No additional adverse event reported. No product quality complaint reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE.; administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 13OCT2021 the patient was vaccinated with with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # T013204 was confirmed to be valid with expiration date 03-DEC-2021 (route of administration, anatomical location were not reported) for prophylaxis. The administered dose underwent a temperature excursion of 50.5 degrees Fahrenheit for 30 minutes. There were no previous temperature excursions. No additional adverse effect was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2110USA007269: US-009507513-2110USA007288: US-009507513-2110USA007316:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. In or around February 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered shingles and postherpetic neuralgia. As a direct and proximate result of the vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the product, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the events to be disability.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Needle issue, No adverse event
Clinical narrative: No additional AEs reported; She reported that 0.1ml of VARlVAX was left in the syringe that the patient did not receive; This spontaneous report was received from a nurse and refers to a child patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-OCT-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U016064, expiration date not provided but after internal validation determined as 20-MAY-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis. During vaccination, the patient jumped, and the needle came out during the injection. Reporter stated that 0.1 mL of varicella virus vaccine live (Oka/Merck) (VARIVAX) was left in the syringe that the patient did not received (incomplete dose administered). No additional adverse event was reported.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Extensive swelling of vaccinated limb, Vaccination site swelling
Clinical narrative: Swelling has moved doesn't toward my elbow; Swelling belowinjection site; This spontaneous report was received from a consumer referring to himself, a 78-year-old male patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On 25-OCT-2021 at 2 pm (reported as monday), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On 26-OCT-2021 (reported as tuesday), the patient experienced swelling below injection site (vaccination site swelling) and, on 27-OCT-2021 (reported as today), the patient's swelling had moved but did not towards his elbow (extensive swelling of vaccinated limb).  The patient reported that he still had the events at the reporting time (not recovered).  The reporter considered vaccination site swelling and extensive swelling of vaccinated limb to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) administration.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: the patient received PROQAD and VARlV AX, the patient was supposed to get MMRII and V ARlVAX.; the patient received PROQAD and VARlV AX, the patient was supposed to get MMRII and V ARlVAX.; This spontaneous report was received from a Licensed Practical Nurse (LPN) and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U009260 with expiration date of 19-SEP-2022) and with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T024285 with expiration date of 15-JUL-2022) for prophylaxis (doses, routes of administration, and anatomical location were not reported). The reporter stated that the patient was supposed to get Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMRII) and varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration and wrong product administered). No other issues or concerns were noted. No product quality complaint (PQC) was reported.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE; expire dose administered; Information has been received from a medical assistant, referring to a 45 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-OCT-2021, the patient was vaccinated with an expire dose of hepatitis a vaccine, inactivated(VAQTA) lot # T017179, expiration date on 26-OCT-2021 (anatomical location, dose and administration route were not reported) for prophylaxis. No adverse effects were reported and was stated that the hepatitis a vaccine, inactivated(VAQTA) vaccine had not experienced a temperature excursion.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; unknown number of patients receive improperly stored vaccines; This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.  Since 23-SEP-2021, the patients were vaccinated with improperly stored vaccines (product storage error) as varicella virus vaccine live (oka/merck)(VARIVAX) and measles (+) mumps(+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis  (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported).  The doses of varicella virus vaccine live (oka/merck)(VARIVAX) and measles (+) mumps(+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) were exposed to a temperature excursion of -14.4 degrees Celsius (°C) during a time frame of 7 minutes. There was no prior temperature excursion and no adverse events were reported.
Sex: M
Vaccine: MMR
Symptoms: Injury
Clinical narrative: My son was injured by MMR shot; This spontaneous report was received from patient's mother concerning to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (strength, formulation, dose, dose number, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported).  It was reported that on an unknown date, the patient was injured (injury) by measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) shot. The outcome of the event injury was not reported.  The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the occurrence event was considered as related.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: This is a spontaneous report from a contactable physician via Company Representative. The reporter reported for 4 patients. This is the first of four reports. An elderly male patient received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for cerebrovascular accident prophylaxis. The patient medical history and concomitant medications were not reported. The patient experienced bi-lateral pulmonary emboli on an unspecified date. The physician reported that 4 patients in his practice got the Pfizer COVID-19 vaccine and each developed Bilateral Pulmonary Emboli within a month of the vaccine. 3 of the 4 patients were male. 1 was female. All were age 70 or older. One male patient on this group was also on apixaban for atrial fibrillation and still developed pulmonary embolism. For apixaban, the reporter did not provide any causality assessments. The action taken in response to the event for apixaban was unknown. Outcome of the event was unknown.  This case was received via Pfizer Inc (Reference number: 202101406989) on 19-Oct-2021 and was forwarded to BMS on 22-Oct-2021. Based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-111615), license party for apixaban (ELIQUIS). BMS Medical Evaluation Comment: This patient had pulmonary embolism after receiving apixaban therapy. This patient was also vaccinated for COVID-19. Based on the limited information available regarding the therapy details, event onset date, action taken with the suspect and outcome of the event, it cannot be ascertained with the reasonable possibility that the apixaban could have contributed to the event pulmonary embolism.  Causality Assessment: ELIQUIS; Pulmonary embolism; Per Reporter = No Information; Per Company (Bristol-Myers Squibb) = Not Related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available the reported event is considered not related to suspect drugs.,Linked Report(s) : US-PFIZER INC-202101407018 Same reporter, different patient/event.;US-PFIZER INC-202101407019 Same reporter, different patient/event.;US-PFIZER INC-202101407020 Same reporter, different patient/event.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered a Dose of Heplisav-B that Underwent a Temperature Excursion; Initial Report Received 24-Sep-2021 and 27-Sep-2021  A nurse reported that a 52-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  The patient had no known allergies.   No concomitant medications were reported.  On 27-Aug-2021, a dose of HEPLISAV-B (Lot # 935840, Expiration Date 11-Sep-2022, NDC # 43528-003-01) was administered in the left deltoid.   It was reported that the HEPLISAV-B administered had undergone a temperature excursion.  No adverse reactions were reported by the patient at the time of report.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered a Dose of Heplisav-B that Underwent a Temperature Excursion; Initial Report Received 24-Sep-2021 and 27-Sep-2021  A nurse reported that a 71-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  The patient had no known allergies.   No concomitant medications were reported.  On 02-Sep-2021, a dose of HEPLISAV-B (Lot # 935840, Expiration Date 11-Sep-2022, NDC # 43528-003-01) was administered in the right deltoid.   It was reported that the HEPLISAV-B administered had undergone a temperature excursion.  No adverse reactions were reported by the patient at the time of report.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: "Multiple Doses Were Given Over A 30-Day Period After Excursions"; Initial Report Received on 08-Oct-2021  A registered nurse reported that multiple patients (initials, gender, age, race, and ethnicity unknown) were administered HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a low temperature excursion occurred.  No medical history was reported.  No relevant concomitant medications were reported.    On unknown dates over a 30-day period, multiple patients received a dose of HEPLISAV-B (Lot #s, expiration dates, NDC #s, and serial #s unknown) at the clinic.  The HEPLISAV-B had a low temperature excursion. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Device use error, Exposure via skin contact
Clinical narrative: Did Not Receive the Full Dose; "Some Dripped Down the Patient's Arm"; Vaccine Leaked Out Due to User Error; Initial Report Received on 13-Oct-2021 and 14-Oct-2021.  A pharmacist reported that a 29 year-old female patient (race and ethnicity unknown) did not receive the full dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as some had dripped down her arm.  The patient had no known drug allergies and allergies to dietary gluten. No other medical history was reported.  No relevant concomitant medications were reported.    On 12-Oct-2021, the patient received dose 1 of HEPLISAV-B (Lot # 934973, expiration date 24-Jul-2022, NDC # on syringe 43528-003-01, NDC # on box 43528000305 and serial # 302622208001) in the right deltoid from the pharmacist (reporter).  It was reported that the Luer-lock needle did not have a good seal and some of the vaccine leaked out. It appeared to be a fairly small amount that dripped out. The patient did not receive the full dose of HEPLISAV-B as some had dripped down the patient's arm. The pharmacist had inspected the syringe and did not see anything wrong with the syringe; however, she discovered that the needle was not tightly on the syringe due to user error. No additional information was reported.   No potential device malfunction requiring investigation was identified.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 42.0
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Dose Given After Excursion; Initial Report Received on 11-Oct-2021  A registered nurse reported that a 42-year-old male (race, and ethnicity unknown) were administered HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred.  No medical history was reported.  No relevant concomitant medications were reported.    On 25-Aug-2021, the patient received a dose of HEPLISAV-B (Lot #s, expiration dates, NDC #s, and serial #s unknown) at the clinic.  The HEPLISAV-B had a temperature excursion. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pain, Pyrexia
Clinical narrative: fever; aches, and pain; first dose over a year ago; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced fever, pain and incomplete course of vaccination. On an unknown date, the outcome of the fever and pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for 2nd dose. The reporter stated feeling there was no need to file adverse event, so did not provide further demographics. The patient experienced fever, aches and pain for a few days. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details were provided.   Follow up information was received on 28th October 2021: The reporter was unable to contact after corresponding phone attempts. The outcome of the callback performed was reported as FU NO - Permission Denied.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: got shingles on my eye; mild case of shingles on my face; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the first Shingrix shot and a month later the patient got shingles on face and in eye. It was a mild case.  The patient was due to get the 2nd shot the first week of November.  The patient asked if it was okay to get the 2nd shot 3 weeks after having shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; bout of shingles.; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included chickenpox (had as a kid) and shingles.   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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient had chickenpox as a kid as the vaccine was not available then, also had shingles too. About 3 to 4 years ago, the patient was offered the Shingles vaccine and was ensured that the fact he/she had both chickenpox and shingles would not make a difference.  After receiving Shingles vaccine, the patient was getting over a bout of shingles at the time of reporting. The patient stated that, obviously, the vaccine was not always effective. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: DTAPIPV
Symptoms: Accidental exposure to product, Exposure via eye contact
Clinical narrative: exposure on her right eye to Kinrix Vaccine; exposure on her right eye to Kinrix Vaccine; This case was reported by a other health professional and described the occurrence of accidental occupational exposure to product in a female employee while administering DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th October 2021 10:53, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced accidental occupational exposure to product and exposure via eye contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via eye contact 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 details were provided as follows: The age at vaccination was not applicable for this report. The other health professional reported that on 27th October 2021 at 10.53 AM, employee had exposure on her right eye to Kinrix Vaccine, which led to accidental occupational exposure to vaccine and exposure via eye contact. The reporter informed that the employee had rinsed her eye for 15 minutes after the exposure, and she's requesting additional medical advice. The patient suffered an exposure on her right eye, resulting in no symptoms. No further information reported. The reporter consented to follow up. This case has been linked with case US2021091657, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021091657:same reporter
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Abdominal distension, Chills, Decreased appetite, Headache, Hyperhidrosis
Clinical narrative: Severe headache; runny nose; watery eyes; severe fever; severe chills; nausea; reduced apetite; bloating; sweats; This case was reported by a consumer and described the occurrence of headache in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis.   Concurrent medical conditions included heart disease, unspecified and immunodeficiency.   On 25th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season, Fluarix Tetra Pre-Filled Syringe Device and the 3rd dose of COVID 19 VACCINE PFIZER. In October 2021, 4 hrs after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating. On an unknown date, the outcome of the headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating were recovered/resolved.   It was unknown if the reporter considered the headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 3rd Covid vaccine from (Pfizer) along with the Flu vaccine on Monday. Four hours after the injections of Covid vaccine and Flu vaccine, the patient started with a severe headache, runny nose and watery eyes. Then, every two to three hours (less than a day after vaccination), the patient developed severe symptoms of fever and chills, nausea but no vomit, reduced appetite, bloating and sweats. This all ended in a 12 hour period. The patient was extremely cautious there, wearing masks and taking our exposure seriously and had not been exposed to anyone with any Flu like symptoms. The patient had reported this to his/her Immunologist and in the last 24 hours, his/her sense of normal had return. The patient would not get a Covid vaccine and a Flu vaccine at the same time if at all in the future. It was unknown if the reporter considered the headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating to be related to Covid vaccine.
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Lacrimation increased, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Severe headache; runny nose; watery eyes; severe fever; severe chills; nausea; reduced apetite; bloating; sweats; This case was reported by a consumer and described the occurrence of headache in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis.   Concurrent medical conditions included heart disease, unspecified and immunodeficiency.   On 25th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season, Fluarix Tetra Pre-Filled Syringe Device and the 3rd dose of COVID 19 VACCINE PFIZER. In October 2021, 4 hrs after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating. On an unknown date, the outcome of the headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating were recovered/resolved.   It was unknown if the reporter considered the headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 3rd Covid vaccine from (Pfizer) along with the Flu vaccine on Monday. Four hours after the injections of Covid vaccine and Flu vaccine, the patient started with a severe headache, runny nose and watery eyes. Then, every two to three hours (less than a day after vaccination), the patient developed severe symptoms of fever and chills, nausea but no vomit, reduced appetite, bloating and sweats. This all ended in a 12 hour period. The patient was extremely cautious there, wearing masks and taking our exposure seriously and had not been exposed to anyone with any Flu like symptoms. The patient had reported this to his/her Immunologist and in the last 24 hours, his/her sense of normal had return. The patient would not get a Covid vaccine and a Flu vaccine at the same time if at all in the future. It was unknown if the reporter considered the headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating to be related to Covid vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be unrelated to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination were not reported. The patient reported a shingles outbreak five days after getting the vaccine for the same.  The patient's MD (physician), believed it was unrelated and patient's friends who had MD's said the same, along with nurses. But the patient thought it was curious and wanted to report it. The reporter also asked to advise of the proper agency. Consent to follow up granted.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received a dose 12 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. Last year from the date of reporting, the patient received 2 doses of Shingles vaccine. The patient had shingles at the time of reporting.  The patient stated that, he/she would not say it had been a mild case. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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 details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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 details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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 details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; had Shingles; painful; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected 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 was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient got shingles 2 times in less than a year and it was extremely painful. The patient had already received the Shingles vaccine and stated there would not be a third time.  This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st Shingrix dose almost 4 years ago; This case was reported by a pharmacist via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received almost 4 years ago).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination. The pharmacist asked as a pharmacist, if he/she should go ahead and administer the 2nd dose or he should start the series over.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles.   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient had shingles twice and received Shingles shot in between. The patient stated that, 200 dollars each and 2 doses needed. Guess, it was not going to happen for could not afford that. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; after shot, shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got shingles on face and had intermittently since then, but worse than as that of reporter. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided. This case had been linked with case US2021AMR224902, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224902:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; have phn; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles and post herpetic neuralgia. On an unknown date, the outcome of the shingles was unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingrix.  Additional details were provided are as follows: The case reported by patient himself/herself. The age at vaccination was not reported. The patient received a shot of Shingrix and 3 days after 1st shot, the patient contracted shingles. At the time of reporting, the patient had post herpetic neuralgia. The patient asked that he/she should get his/her 2nd shot. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: injection site is red slightly swollen; injection site is red slightly swollen; injection site very itchy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a dose of Shingrix vaccination on Tuesday and the injection site was red slightly swollen and very itchy. The patient asked that there was anything that he/she use to reduce the itch. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: fever of 103; feeling terrible; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29th October 2021, the patient received the 2nd dose of Shingles vaccine. In October 2021, less than a day after receiving Shingles vaccine, the patient experienced fever and feels awful. On an unknown date, the outcome of the fever and feels awful were recovering/resolving.   It was unknown if the reporter considered the fever and feels awful to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received his/her 2nd dose of the Shingles vaccine yesterday (day before reporting date). On 30th October 2021, at around 1 am last night at midnight he/she woke up feeling terrible with a fever of 103-degree F and on morning the patient was feeling much better. The patient stated he/she had dinner with his/her daughter last night around 6 pm, he/she should be concerned. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: gave me shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient thought that his/her 1st Shingles shot gave him/her shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: little red dots; This case was reported by a consumer via interactive digital media and described the occurrence of red spotty rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th October 2021, the patient received the 1st dose of Shingles vaccine. On 31st October 2021, 1 day after receiving Shingles vaccine, the patient experienced red spotty rash. On an unknown date, the outcome of the red spotty rash was unknown.   It was unknown if the reporter considered the red spotty rash to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got a dose of vaccine for shingles day before reporting date and on reporting date, saw little red dots on his/her arm. The patient asked that these was ok. The follow-up could not be possible as no contact details were available.