chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: thrombocytopenia; I started to feel pain on the inner part of my left arm; A red circle formed and it swelled; A red circle formed and it swelled; I have a lump that feels hard to the touch; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient, non-pregnant received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FF2589), via an unspecified route of administration, administered in left arm on 11Sep2021 15:00 (at the age of 62-years-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included arthritis rheumatoid, fibromyalgia, type 2 diabetes, sick cell trait, and Sjogren's. Concomitant medications included duloxetine hydrochloride (DULOXETINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin; and previously received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced thrombocytopenia on 17Sep2021 17:00. The patient also started to feel pain on the inner part of her left arm, a red circle formed and it swelled and she had a lump that felt hard to the touch, all on 17Sep2021 17:00. Events resulted in Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Therapeutic measures were taken as a result of all events except for the lump that felt hard to the touch. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events were not recovered. The clinical course was reported as follows: Six days later, the patient started to feel pain on the inner part of her left arm (very close to the elbow). A red circle formed, and it swelled. She called her doctor and her doctor told her that it could be a thrombocytopenia. Her doctor recommended to kept her arm up and put ice on it. The pain continued very strong. She went yesterday (reported as 21-Sept) to the emergency room. She was given an antibiotic and anti-inflammatory by intravenous (IV). She was not at home taking clindamycin and ketorolac. Although the inflammation has reduced a little, she continued with the pain and she had a lump that felt hard to the touch. She had no other symptoms.
Sex: F
Vaccine: MMR
Symptoms: Therapy non-responder
Clinical narrative: recently discovered she did not have antibodies to measles.; This spontaneous report was received from a 42-year-old female patient referring to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (when she was a child), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, dose of 0.5 milliliter (strength, anatomical location, route of administration, lot # and expiration date were not reported) as prophylaxis. On an unknown date (recently), the patient discovered she did not have antibodies to measles (measles antibody negative). She stated she did have antibodies to mumps and rubella. The outcome of the event was unknown. There was not any treatment given for the event and the patient did not seek medical attention.  The causality assessment was not provided.
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: one dose of V ARlV AX was administered to a patient while it was undergoing a temperature excursion.; no adverse event; This spontaneous report as received from a medical assistant and 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 varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (route of administration and anatomical localtion were not reported) (lot # U012222 has been verified to be a valid lot number, expiration date reported as 16-APR-2023) for prophylaxis.         The vaccine was administered while undergoing a temperature excursion (product storage error). The patient did not report any adverse events from receiving the varicella virus vaccine live (oka/merck) (VARIVAX) dose.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concomitant medication, previous drug reactions, or allergies was provided.  On 10-SEP-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 170746 has been verified to be valid, expiration date reported and validated as 14-MAR-2022) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number T026961 has been verified to be valid, expiration date reported and validated as 02-APR-2023) for prophylaxis (administered dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were unknown by the reporter) (product storage error).  On an unknown date, the vaccines experienced a temperature excursion of 48.7 degrees Fahrenheit for a time frame of 10 minutes. There wasn't a previous temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was not provided.  On 13-SEP-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # 1707457, expiration date 23-FEB-2022 (dose number and dose were not reported) for prophylaxis (product storage error).  The vaccine administered to the patient was stored improperly on 10-SEP-2021, in the temperature 48.7 degrees Fahrenheit (F) for a time frame of 10 minutes. There was no previous temperature excursion. The outcome was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; improperly stored MMR II were administered; This spontaneous report as received from another health professional (medical assistant) referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant therapies, and drug allergies and reactions were not reported.      On 28-SEP-2021, the patient was vaccinated with the temperate excursion vaccines of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength was not provided; lot# was T016197 and expiration date was 11-MAY-2022) for prophylaxis. The vaccine underwent a temperature excursion of 10.5 degree Celsius (C) to 8.5 C for a period of 6 hours and 46 minutes and 1 hour and 24 minutes. The vaccine did not undergo a previous temperature excursion. The patient did not experience any adverse event.  This was one of two reports received from the same reporter.  ; Sender's Comments:  US-009507513-2109USA007381:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: ?? symptoms were reported/ No additional AE's; PROQUAD was administered to (1) patient ?? 9/28/21; with the initials ED, after the excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 28-SEP-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant Human albumin) (PROQUAD) Dose/Frequency reported as 1 (concentration, vaccination scheme frequency, route and anatomical site of administration were nor provided; lot number U009261 that was verified to be a valid lot number with an expiration date reported and established as 19-SEP-2022) for prophylaxis after underwent a temperature excursion of 33.1 degrees Fahrenheit (F) during a time frame of 4 hours and 15 minutes.  No symptoms or additional adverse events (AEs) were reported
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events; Extra dose administered; This spontaneous report has been received from a clinic manager, referring to a female patient, who at the reporting time would be 17-year-old. Information regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies was not reported.  On 30-AUG-2021, the patient was vaccinated with an extra dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # T007232 has been verified as valid, and expiration date established as 27-FEB-2022 (strength, dose, vaccination scheme, route and anatomical location of administration).  The patient said she was already vaccinated when she was a child. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; a patient was administered an expired dose of MMRII; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 29-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, lot number S016678, expiration date 30-MAY-2021 (route of administration not provided) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: any additional AE; V ARlV AX on 9/29/2021 with a labeled expiry; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-SEP-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # S024369, expiration date06-AUG-2021) (formulation, strength and route of administration were not reported) for prophylaxis. There was no temperature excursions involved. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around October 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as shortly after received zoster vaccine live (ZOSTAVAX), the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not presented prior the used of zoster vaccine live (ZOSTAVAX). The patient was also experienced mental and emotional distress due to resulted physical limitations and seriousness of patient's condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient 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 zoster vaccine live (ZOSTAVAX) conduct, the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, concerning a currently 74-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On approximately 20-MAY-2012, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information, lot number and expiration date were not provided) for its intended purpose: the prevention of shingles (herpes zoster) at the local Hospital & Clinics office.  Subsequently, the patient was treated for singles resulting from Zoster Vaccine Live (ZOSTAVAX) use. The reporter considered the event of shingles to be related to suspect therapy. At the time of the report, the patient's outcome was not provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, concerning a currently 70-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On approximately 14-FEB-2012, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information, lot number and expiration date were not provided) for its intended purpose: the prevention of shingles (herpes zoster) at the local Pharmacy.  Subsequently, the patient was treated for singles resulting from Zoster Vaccine Live (ZOSTAVAX) use. The reporter considered the event of shingles to be related to suspect therapy. At the time of the report, the patient's outcome was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around September 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as shortly after received zoster vaccine live (ZOSTAVAX), the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not presented prior the used of zoster vaccine live (ZOSTAVAX). The patient was also experienced mental and emotional distress due to resulted physical limitations and seriousness of patient's condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient 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 zoster vaccine live (ZOSTAVAX) conduct, the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: other zoster related injuries; shingles; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. In or about 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a health care provider (HCP) at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation, the patient was treated by a physician at the clinic for shingles and other zoster-related conditions(Ill-defined disorder). As a direct and proximate result of the use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles and other zoster-related conditions was considered to be not recovered and causal relationship was assessed as related.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Injury
Clinical narrative: other zoster-related conditions; herpes zoster; Information has been received from a lawyer referring to an elderly patient of unknown gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 02-NOV-2013 (at 67 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a healthcare provider at a school for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by healthcare providers at a hospital for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and other zoster-related conditions (Ill-defined disorder). The outcome of both events was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around February 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as shortly after received zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not presented prior the used of zoster vaccine live (ZOSTAVAX). The patient was also experienced mental and emotional distress due to resulted physical limitations and seriousness of patient's condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient 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 zoster vaccine live (ZOSTAVAX) conduct, the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages. The outcome of deafness was not recovered. The reporter considered deafness to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, deafness was determined to be medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: neuropathy; shingles; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 01-OCT-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around August 2014, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles and neuropathy. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient 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 Defendants' conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of neuropathy peripheral and shingles was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event neuropathy peripheral was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Myocarditis
Clinical narrative: myocarditis; Information has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In or around August 2015, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information, lot number and expiration date were not provided) for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, on unknown date, the patient suffered myocarditis.  As a result of the receipt of the vaccination, the patient experienced sustained severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event of myocarditis to be related to suspect therapy. At the time of the report, the patient's outcome was not recovered.  Upon internal review, myocarditis was considered to be a medically significant and disabling event.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects; May have received smaller than recommended dose; unsuccessful attempt of the administration of GARDASIL 9; This spontaneous report was received from a nurse referring to a 13-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 01-OCT-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T026323 with expiration date 22-FEB-2023, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). It was stated that the patient might have received smaller than recommended dose due to unsuccessful attempt of the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AEs reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 25-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, subcutaneous, lot number U015689, expiration date reported as 13-MAY-2023 but upon internal validation was determined as 18-MAY-2021 for prophylaxis. No adverse event was reported.  The vaccine underwent a temperature excursion of 25.9 degrees Farhrenheit for 1 hour and 30 minutes. No previous temperature excursions were detected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster; postherpetic neuralgia; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 04-OCT-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unknown date, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered herpes zoster, and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by a medical provider and was still under their care. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient 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 Defendants' conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of herpes zoster, and postherpetic neurlgia was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient believes that she started Gardasil 9 series but did not complete it; No other adverse event reported; This spontaneous report was received from a pharmacist referring to a 32-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The pharmacist reported that the patient believes that she started hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series but did not complete it (inappropriate schedule of product administration ).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; patient received an expired PNEUMOVAX 23; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot # T017385, expiration date 01-SEP-2021 (route of administration and anatomical location were not provided) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE reported; a dose of PNEUMOVAX 23 expired on 03-OCT-2021 and was administered 04-OCT-2021; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T021329, expiration date 03-OCT-2021 (route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No adverse event (AE) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AEs or PQC reported; administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of an unspecified age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 01-OCT-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U015689, expiration date was reported as 13-MAY-2023, however upon internal validation, it was established as 18-MAY-2023, 0.5 ml, subcutaneously (sq) for prophylaxis (strength was not provided).  It was stated, that the vaccine before administration was stored at the temperature of 25.9 Fahrenheit degree (F) for 1 hour and 30 minutes (improper storage of product in use). No previous temperature excursion was detected. It was not specified, if the data logger was involved. No other adverse events (AEs) or product quality complaint (PQC) were reported (no adverse event).
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: received PROQUAD vaccine that had undergone temperature excursion; No additional AE reported; This spontaneous report was received from a registered nurse referring to a male patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number T015598, expiration date 02-NOV-2021 (dose and route of administration not reported) for prophylaxis. No adverse event was reported.  The vaccine underwent a temperature excursion of 13.8 degrees Farhrenheit for 1 hour and 48 minutes. No previous temperature excursions detected.  This is one of 5 cases notified by the same reporter.; Sender's Comments:  US-009507513-2110USA001589: US-009507513-2110USA001521: US-009507513-2110USA001664:
Sex: F
Vaccine: HEP
Symptoms: Adverse reaction
Clinical narrative: Reaction to the vaccine; This spontaneous report as received from a current 71-year-old female retired public health nurse on 05-OCT-2021.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (dose regimen details, indication, lot # and expiration date were not provided).         On an unknown date the patient experienced a reaction to the vaccine.The outcome of the event. Causality was considered related. .
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: severe arm pain; soreness where the vaccine was administered; as well as some swelling where the vaccine was administered; This spontaneous report as received from a the patient's boyfriend on 05-OCT-2021 and refers to a female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 05-OCT-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose regimen details, indication, lot # and expiration date were not provided).         On the same date, the patient experienced severe pain and soreness where the vaccine was administrated, as well as some swelling. The outcome of the events and the causality assessment were not provided.
Sex: M
Vaccine: FLUX, PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: is arm was sore following the vaccinations; This spontaneous report as received from a pharmacist on 05-OCT-2021 refers to a male patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 01-OCT-2021 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose regimen details, indication, lot # and expiration date were not provided).  Other suspect therapies included influenza vaccine and varicella zoster vaccine rge (cho)(SHINGRIX) (dose regimen details, indication, lot # and expiration date were not provided).  On the same day, the patient experienced soreness in the arm..  The outcome of the event and the causality assessment were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Extremely sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that he/she got extremely sick after receiving shingles vaccine. For second suspect and tag post refer linked case US2021AMR205452, reported by the same patient for Flu vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205851:tag at post US-GLAXOSMITHKLINE-US2021AMR205452:
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Bad reaction/scary/ouch; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad 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 feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   The reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had received the vaccine and got a bad reaction which was scary. The patient stated that there would be no second shingle vaccine for him/her.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered a Tdap (Boostrix) vaccination to a 6 year old by accident; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included DTaP vaccine (patient was fully vaccinated with DTaP).   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, 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 provided as follows: The reporter's medical group recently administered a Tdap (Boostrix) vaccination to a 6 year old patient by accident, which led to inappropriate age at vaccine administration. Hence, the reporter was asked to contact PV safetyin order to find out if there were any known risks associated with giving the Boostrix vaccine to a 6-year old patient; more so than just the typical risks associated with using the vaccine in an adult patient. The child was fully vaccinated with DTaP and didn't really need a tetanus booster at all, hence the reporter's group were just trying to determine whether there was additional harm  that could have been caused by giving the patient a boostrix shot, or if it was just a benign mistake that they could avoid in the future.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot in june 2019; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2019).   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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting,the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if need to start over.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: 1st dose 2 years ago, didn´t get 2nd dose /Suspects pt didn't get 2nd dose within recommended interval due to pandemic.; This case was reported by a other health professional via sales rep and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago from the date of reporting).   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 reporter was the physician's assistant. The age at vaccination was not applicable for this report. The reporter was inquired about 2nd dose of Shingrix administration 2 years after the 1st dose. The health care professional declined to provide further information because she wanted to get patient consent first. The patient was scheduled to get 2nd dose of Shingrix November 2021 (specific date not shared). Till the time of reporting, the patient did not receive 2nd dose of Shingrix, due to pandemic, which led to social problem. The reporter suspected patient did not get 2nd dose within recommended interval due to pandemic. The reporter did not consent to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Hurt worse than last year; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included 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 FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, less than 2 years after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to FluLaval Quadrivalent and Flulaval 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 provided were as follows: The age at vaccination was not applicable for this report. The patients received Flulaval last year and the reporter stated that it hurt. No call was dropped before getting further information about vaccines such as lot number and expiration date. No vaccination date mentioned. The reporter did not consent to follow-up. This case had been linked with US2021206241, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206241:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 3 years ago I had one dose, did not get the second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient did not get the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination.  The reporter also asked could he/she get the 2nd dose now or do start over. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm is swollen; arm is red; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 1st October 2021, the patient received Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient received the Shingles vaccine on Friday before reporting and the patient's arm was swollen and red. The patient enquired about what should be done. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Enema administration, Intestinal obstruction, Vaccine positive rechallenge
Clinical narrative: pinched colon; abdominal pain / pinched colon; This case was reported by a other health professional via sales rep and described the occurrence of intestinal obstruction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal pain (1st dose received on 21st September 2020, for tolerance refer case US2021AMR206096).   In January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced intestinal obstruction (serious criteria GSK medically significant) and abdominal pain. The patient was treated with enema preparations (nos) (Enema (Unknown)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the intestinal obstruction was unknown and the outcome of the abdominal pain was recovered/resolved.   It was unknown if the reporter considered the intestinal obstruction and abdominal pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had similar symptom symptoms as that of 1st dose after receiving 2nd dose in January 2021. The patient received diagnosis of pinched colon. Enema relieved the abdominal pain. The reporter consented to follow up. This case has been linked with the case US2021AMR206873 (patient's father case), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206873:same reporter US-GLAXOSMITHKLINE-US2021AMR206096:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I have it now and yes I've been vaccinated / suspected vaccination failure; I have it now; the pain is horrible,; 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. The patient was treated with calamine and antivirals nos. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient was vaccinated and had shingles now. The pain was horrible. The patient was on an antiviral medication for pain and calamine. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.