chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Off label use, Pulmonary embolism
Clinical narrative: experienced  pulmonary embolism with booster.In the hospital currently intubated; experienced pulmonary embolism with booster; experienced pulmonary embolism with booster; This is a spontaneous report from a non-contactable consumer(patient) or other non hcp. A female patient of an unspecified age received third dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus. Concomitant medication included insulin. The historical vaccines include bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE and via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date the patient experienced coagulation after first two shots and experienced pulmonary embolism with booster. The patient was taken to emergency care and currently in the hospital, intubated after first two IV treatment. The patient was hospitalised for 5days. On an unspecified date patient developed experienced pulmonary embolism with booster (immunisation) and experienced pulmonary embolism with booster (off label use). The event outcome for pulmonary embolism was reported as recovering. The event outcome for experienced pulmonary embolism with booster (immunisation) and experienced pulmonary embolism with booster (off label use) was reported as unknown. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coagulopathy
Clinical narrative: experienced  pulmonary embolism with booster.In the hospital currently intubated; experienced pulmonary embolism with booster; experienced pulmonary embolism with booster; This is a spontaneous report from a non-contactable consumer(patient) or other non hcp. A female patient of an unspecified age received third dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus. Concomitant medication included insulin. The historical vaccines include bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE and via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date the patient experienced coagulation after first two shots and experienced pulmonary embolism with booster. The patient was taken to emergency care and currently in the hospital, intubated after first two IV treatment. The patient was hospitalised for 5days. On an unspecified date patient developed experienced pulmonary embolism with booster (immunisation) and experienced pulmonary embolism with booster (off label use). The event outcome for pulmonary embolism was reported as recovering. The event outcome for experienced pulmonary embolism with booster (immunisation) and experienced pulmonary embolism with booster (off label use) was reported as unknown. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; products experienced an excursion of 4C fo 20 minutes; This spontaneous report was received from a registered nurse concerning a 4-year-old patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.   On 11-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot # U015682, expiry date: 18-MAY-2023, for prophylaxis. The dose was stored  between -10 to 8 degrees celsius (C) (4 C) for 20 minutes. A previous temperature excursion showed the dose was stored between -10 to 8 C (4 C) for 7 hours and 30 minutes.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005662: US-009507513-2109USA005648:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's reported; temperature excursion for VARlVAX; This spontaneous report was received from a registered nurse referring to an 4 years old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (strength, dose, route, frequency, were not provided) for prophylaxis; Lot# U002394 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 22-JAN-2023, and upon internal validation established as the same.  The nurse reported that the vaccine dose was administered on 11-SEP-2021 and there was a temperature excursion for varicella virus vaccine live (Oka/Merck) (VARIVAX). The product experienced an excursion of 4 Celsius degrees (C) from -10 C to 8 C for 20 minutes on 07-SEP-2021 during the transport; and of 4C from -10 C to 8 C for 20 minutes on 09-SEP-2021, again during transport. Previous temperature excursion included from -10 C to 8 C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of 26 reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005648: US-009507513-2109USA005662: US-009507513-2109USA005760:
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE; patient was admnistered GARDASIL 9 that had undergone a temperature excursion; This spontaneous report as received from a physician assistant refers to a male patient of unknown age.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that had undergone a temperature excursion (product storage error) (lot # S033308 has been verified to be a valid lot number, expiration date reported as 06-AUG-2021, but upon internal validation established as 08-APR-2022); the patient received 1 injection (dose number, route of administration, and anatomical location were not reported) for prophylaxis.    The temperature excursion occurred within 2020 (reported as the past year), but the patient received the dose. The physician assistant was unsure of the administration date but it was before the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) expiration date on the product label. No additional AE/PQC details were obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient received an expired dose of VARIVAX; This spontaneous report as received from a nurse refers to a patient of unknown age and gender.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 01-OCT-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S017226, expiration date 04-JUN-2021) at a dose of 0.5 milliliter (dose number, route of administration, and anatomical location were not reported) for prophylaxis.         The reporter confirmed that there were no prior temperature excursions and no additional adverse events (AE) reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional details; expired PNEUMOVAX 23 vaccine was administered to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   The pharmacist reported that on 06-OCT-2021, the patient was administered with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) expiration date 21-JUN-2021 for prophylaxis (dosage, route of administration, anatomical location and lot number were not reported). No additional information.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information has been received regarding the pt's past medical history, concurrent conditions, or concomitant medications. On or about 01-JUN-2012 (at 64 years old), the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a clinic, by a healthcare provider, for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not provided). Subsequently, the pt was treated by healthcare providers at a clinic for shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received 2 doses of VARIVAX as a child./ they gave her a third dose.; No additional AE information reported; This spontaneous report was received from a patient's mother and refers to a 21-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown dates in the patient's childhood, she was vaccinated with two doses of varicella virus vaccine live (oka/merck) (VARIVAX) (formulations, concentrations, exact doses, anatomical locations, routes of administration, lot # and expiration dates were not reported) for prophylaxis. On an unknown date reported as recently, the patient was vaccinated with the third dose of varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, concentration, exact dose, anatomical location, route of administration, lot # and expiration dates were not reported) for prophylaxis (Extra dose administered). No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional Adverse Event; Improperly stored VARIVAX was administered to a patient; This spontaneous report as received from a medical assistant refers to a 13 year old female patient. Information regarding patient's medical history and concomitant medications were not provided.   The reporter stated that on 05-AUG-2021, a temperature excursion of varicella virus vaccine live (Oka/Merck)(VARIVAX) occurred during one hour, at 14.98°C. On 03-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T040507 and expiration date 02-DEC-2022, for prophylaxis (strength, dose, and route of administration were not reported) ( product storage error). No additional Adverse Events reported.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Human papilloma virus infection; This spontaneous report was received from a consumer referring to herself, a 25-year-old female patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On an unknown date, when the patient was 17-year-old, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) dose 1 and 2 to prevent HPV (strength, dose, route, anatomical site, lot# and expiration date were not reported).  On an unknown date in 2019 (reported as when she was 25), the patient get the HPV virus (papilloma viral infection). The reporter stated that the doctor said to had the infection rechecked two years later, and on 18-OCT-2021 has the test, but she did not had the results.  At the reporting time, the outcome of papilloma viral infection was unknown.  The causality assessment between the occurrence of the event and the suspect vaccine administration was not provided.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer and refers to a currently 80 year-old patient of unknown gender concerning a case in litigation. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles, and was treated witn unspecified medication.   The outcome of herpes zoster was unknown.     The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: wrongful death; shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information has been received regarding the pt's past medical history, concurrent conditions, or concomitant medications. In 2013, the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) at a clinic, by a healthcare professional, for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not provided). Subsequently, the pt was treated by a healthcare professional at a medical center for shingles (herpes zoster). On an unknown date, the pt died (reported under specific allegations as Count IV: wrongful death) (conflicting information: pt's death was reported, however the pt was reporting on behalf of herself/himself). It was unknown if an autopsy was performed, and the cause of death was not reported. The outcome of herpes zoster was unknown. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: Wrongful death; Shingles; Information has been received from a lawyer regarding a case in litigation concerning an elderly patient (pt) of unknown gender. No information has been received regarding the pt's past medical history, concurrent conditions, or concomitant medications. On or about 10-JAN-2010 (at 66 years old), the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) at a pharmacy, by a pharmacist, for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not provided). Subsequently, the pt was treated by a physician at a medical center for shingles (herpes zoster). On an unknown date, the pt died (reported under specific allegations as Count IV: wrongful death) (conflicting information: pt's death was reported, however the pt was reporting on behalf of herself/himself). It was unknown if an autopsy was performed, and the cause of death was not reported. The outcome of herpes zoster was unknown. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Breast feeding, Delivery, Diabetes mellitus, Exposure during pregnancy, Immunodeficiency
Clinical narrative: diabetes; immune compromised; Pregnancy; breastfeeding; This spontaneous retrospective pregnancy report as received from a consumer and refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced diabetes and was immune compromised. In addition, the patient became pregnant. The last menstrual period (LMP), estimated due date and estimated date of delivery (EDD) were not reported. On an unknown date, the patient delivered a infant of unknown gender. Therefore, the patient was breastfeeding. The outcome of diabetes mellitus, maternal exposure during breast feeding and immunosuppression was reported as unknown.    The reporter considered diabetes mellitus, maternal exposure during breast feeding, immunosuppression and exposure during pregnancy to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).  Upon internal review, the events of diabetes mellitus and immunosuppression were considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Maternal exposure during breast feeding, Pregnancy
Clinical narrative: diabetes; immune compromised; Pregnancy; breastfeeding; This spontaneous retrospective pregnancy report as received from a consumer and refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced diabetes and was immune compromised. In addition, the patient became pregnant. The last menstrual period (LMP), estimated due date and estimated date of delivery (EDD) were not reported. On an unknown date, the patient delivered a infant of unknown gender. Therefore, the patient was breastfeeding. The outcome of diabetes mellitus, maternal exposure during breast feeding and immunosuppression was reported as unknown.    The reporter considered diabetes mellitus, maternal exposure during breast feeding, immunosuppression and exposure during pregnancy to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).  Upon internal review, the events of diabetes mellitus and immunosuppression were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on neck; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.   Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter asked could 1 side effect be a rash on his/her neck and also asked did Shingrix cause a rash. The patient asked what he/she could put on this rash.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Less fever but chills; Swollen lymph node above clavicle/supraclavicle lymph node; Painful lymph node above my clavicle/ painful supraclavicle lymph node; Certainly arm and shoulder pain; Shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced chills, supraclavicular lymph nodes enlarged, lymph node pain, pain in arm and shoulder pain. On an unknown date, the outcome of the chills, supraclavicular lymph nodes enlarged, lymph node pain, pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the chills, supraclavicular lymph nodes enlarged, lymph node pain, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got the Shingrix vaccine on Monday before the reporting date and had all the symptoms above (other symptoms) less fever but had chills. Moreover, the patient also developed a swollen, painful lymph node above his/her clavicle, certainly arm and shoulder pain. The patient developed painful supraclavicle lymph node and was asking if he/she was okay and was that normal to happen. The reporter wished that he/she could send a photo of the same.
Sex: F
Vaccine: TDAP
Symptoms: Illness, Neurological symptom, Premature menopause
Clinical narrative: Very sick; Unexplained neurological symptoms; Menopause in my 30's after this one; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced sickness, neurological symptom and early menopause. On an unknown date, the outcome of the sickness and neurological symptom were unknown and the outcome of the early menopause was not recovered/not resolved.   It was unknown if the reporter considered the sickness, neurological symptom and early menopause to be related to Tdap Vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got very sick after a booster of vaccine with unexplained neurological symptoms and went into menopause in her thirties after that vaccine. This case has been linked to US2021AMR214141 (husband's case), reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR214141:Same reporter, husband's case
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: sweel pretty big knot; red pretty big knot; red pretty big knot; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site nodule and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site nodule and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling, injection site nodule and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient got shingles shot and it was all red and swell pretty big knot.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd dose 3 weeks after 1st dose; This case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: This case was reported by the physician. The physician reported that patient was given second dose only 3 weeks after the first dose. No adverse event reported by the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: pain in the muscle; flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 5th October 2021 03:00, the patient received the 2nd dose of Shingrix. On 6th October 2021, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 7th October 2021, the patient experienced muscle pain. On an unknown date, the outcome of the influenza-like symptoms and muscle pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt like flu like symptoms and had a real bad pain in the muscle area. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: fatigue; fever; diarrhea; nauseous; This case was reported by a consumer via media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2021, the patient received Shingrix. On 17th October 2021, 2 days after receiving Shingrix, the patient experienced fatigue, fever, diarrhea and nausea. On an unknown date, the outcome of the fatigue, fever, diarrhea and nausea were unknown.   It was unknown if the reporter considered the fatigue, fever, diarrhea and nausea to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported.  The patient received dose of Shingrix vaccine and experienced fatigue, fever, diarrhea, and felt nauseous. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: DTAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: vaccinated and still had whooping cough/ suspected vaccination failure; whooping cough; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to DTaP vaccine.  Additional details were provided as follows: This case was reported by the parents for their kids. The age at vaccination was not applicable for this report. The reporter stated that they recommend the tetanus shot every 10 years due to infections. Unfortunately, that tetanus vaccine has the other stuff in it too (Diphtheria and pertussis). The patients were vaccinated and still had whooping cough.  The reporter stated not every shot works. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for whooping cough and time to onset were unknown. This case has been linked with the case US2021AMR215942, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215942:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: killed my arm; 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 Covid-19 vaccine with an associated reaction of pain in extremity (received Covid vaccine on an unknown date and killed his/her arm).   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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingles vaccine and the vaccine killed his/her arm, just like Covid vaccine. The patient reported that he/she was waiting for second shot in December.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: arm is still very sore; This case was reported by a consumer via media and described the occurrence of pain in arm in a 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.   In October 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. In October 2021, less than 2 weeks after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero 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 provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had second dose of Bexsero a week ago and his/her arm was still very sore.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: body aches; tired; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th October 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced general body pain and tiredness. On an unknown date, the outcome of the general body pain and tiredness were unknown.   It was unknown if the reporter considered the general body pain and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got shingles vaccine and experienced body aches and was tired. The patient was being told that the second one was worst and the patient was not looking forward to that. This case was linked with the case US2021AMR217039, reported by same reporter.
Sex: U
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: temperature excursions due to refrigerator failure; This case was reported by a nurse via sales rep and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Shingrix, Boostrix, FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Shingrix, Boostrix, FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The reporter disclosed temperature excursions for vaccines Shingrix, Boostrix, FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device due to refrigerator failure, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: had them in spite of having had 3 shots/suspected vaccination failure; had them 3 times; had 3 shots; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 3 Shingles shot, which led to extra dose administered. The patient had 3 times shingles already in spite of having had 3 Shingles shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had shingles, even had the shingles shots/ suspected vaccination failure; shingles 4 times; 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.   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 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 and Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received Shingles shots and had shingles 4 times. The patient stated that shingles was very painful. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Chills, Mobility decreased
Clinical narrative: lower back pain; chills; put me in bed; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced back pain, chills and mobility decreased. On an unknown date, the outcome of the back pain, chills and mobility decreased were recovering/resolving.   It was unknown if the reporter considered the back pain, chills and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the second Shingle vaccine and that put him/her in bed with lower back pain and chills.  The patient was all better next morning. The patient's SIL got shingles and said it was very painful.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt/ sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine and it hurt 4 days and was still sore.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Boostrix administered to patient 10 days past its expiration date; This case was reported by a other health professional and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The Boostrix was administered to a patient 10 days past its expiration date, which led to expired vaccine used. The reporter ask was the dose still viable.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: got both, little sore arm; 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced little sore arm, nothing else.  The follow-up would not possible as no contact details were available. For 2nd dose refer case US2021AMR218961, reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR218961:2nd dose
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration to patient under the age of 4 years old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   On 12th October 2021, the patient received Kinrix (intramuscular). On 12th October 2021, unknown after receiving Kinrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were reported as follows: The health care professional reported the administration of Kinrix to a patient under the age of 4 years old, which led to inappropriate age at vaccine administration. The health care professional stated that the formulation was a vial and batch number confirms this. The reporter consented to follow-up.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant pt received FLUARIX; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a female 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.   On 14th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 1st January 2022. The patient received Fluarix Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   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 case was reported by the patient.  A pregnant female who received the FLUARIX 2021-2022 vaccine.  The estimated delivery date is in January 2022.  The last menstrual period date was unknown but the gestational age at exposure was 23 weeks. Patient could not provide information on the lot and expiration of FLUARIX. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: achy knee joints; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 24th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 25th August 2021, 1 days after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reporter this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix  in left arm and experienced achy knees 1 day after vaccination. The patient also received steroid injections for pre-existing Rheumatoid Arthritis. The patient contacted her doctor and no medications have worked to clear this up. The patient also reported that her achy knee joints seem to be getting worse. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: subcutaneously instead of intramuscularly; subcutaneously instead of intramuscularly; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 15th October 2021, the patient received the 2nd dose of Shingrix (subcutaneous) and Influenza vaccine Quadrivalent unspecified season (subcutaneous). On 15th October 2021, unknown after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route and intramuscular formulation administered by other route were unknown.  Additional details were provided as follows: The patients might received her 2nd dose of Shingrix and a flu vaccine subcutaneously instead of intramuscularly. The vaccine was administered at a different unnamed facility. The pharmacist did not know which vaccine was given into which arm, only that she got one of the vaccines in her right arm, and the other one in her left arm. The pharmacist believes it was given subcutaneously because it was given into the back of the arm, which led to intramuscular formulation administered by other route and intramuscular formulation administered. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: not received second dose due to COVID pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 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 social problem. On an unknown date, the outcome of the social problem 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 of Shingrix due to COVID pandemic, which led to Social problem. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Inflammation, Pain in extremity
Clinical narrative: sore arm; inflammation; Hypersensitivity; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, inflammation and hypersensitivity. On an unknown date, the outcome of the pain in arm, inflammation and hypersensitivity were unknown.   It was unknown if the reporter considered the pain in arm, inflammation and hypersensitivity to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. Registered nurse stated that several patients had reported sore arms following administration of Shingrix.  The reporter seen lots of sore arms, hypersensitivity and inflammation following administration of Shingrix vaccine. The reporter consented to follow up. No specific details regarding patients available or product details (lot/expiration date). This case was 1 of 3 case reported by he same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215443:same reporter US-GLAXOSMITHKLINE-US2021215511:same reporter