chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular, Skin lesion, Urticaria
Clinical narrative: Since 26 November she has complained of recurrent episodes of localized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body from the waist up and typically occur at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, spare her palms and soles, and resolve without post-inflammatory changes. She denies generalized cutaneous, laryngeal, pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 19 November, seven days prior to onset of symptoms. She has used oral antihistamines with control of symptoms. She denies constitutional symptoms. score today is 25 (2, 4, 4, 3, 3, 3, 3, 3).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood test, Computerised tomogram, Electrocardiogram, Headache
Clinical narrative: Numbness Right arm, Numbness tongue, head ache, tachycardia, hypertension, hyperglycemia
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia, Hypertension, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging
Clinical narrative: Numbness Right arm, Numbness tongue, head ache, tachycardia, hypertension, hyperglycemia
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Troponin
Clinical narrative: Numbness Right arm, Numbness tongue, head ache, tachycardia, hypertension, hyperglycemia
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Started developing shortness of breath 1 month after receiving the vaccine
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE reported; expired vaccine administered; This initial spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was provided.  On 05-JAN-2022, the patient was administered an expired measles, mumps, and rubella virus vaccine, live (recombinant human albumin, rHA) (M-M-R II), 0.5 milliliter subcutaneously (SQ), lot # S015961, expiration date 23-MAY-2021 (anatomical location was not reported) for prophylaxis (expired product administered). No other information provided. No additional adverse events (AEs) or product quality complaint (PQC) reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired ROTATEQ (EXP: 17DEC2021) to a patient on 17JAN2022.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions or concomitant therapies provided.  On 17-JAN-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, expiration date reported as 17-DEC-2021 (exact dose and lot # were not reported) for prophylaxis (expired product administered). The reporter confirmed the vaccine was stored within recommended storage range, with no temperature excursions prior to administration. No adverse event (AE) was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient had no known side effects; Vaccine Coordinator reported a temperature excursion for VAQTA which was supported. Caller reported that 1 dose of VAQTA was administered to a patient.; This spontaneous report was received from a vaccine coordinator, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-JAN-2022, the patient was vaccinated with a 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # U024505, expiration date: 15-OCT-2022; strength, route and site of administration were not provided) for prophylaxis (product storage error). Temperature excursion for hepatitis a vaccine, inactivated (VAQTA) was supported. The patient had no known side effects (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2201USA006297:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U016975, expiration date: 24-NOV-2022 (strength and route of administration were not provided) for prophylaxis. The vaccine experienced a temperature excursion of -14.1 degrees Celsius for 12 minutes prior to being administered (Product storage error). There was no previous temperature excursion.  No additional adverse event reported (No adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: Male patient receiving 2nd and 3rd dose of GARDASIL 9, first dose in 2019; This spontaneous report was received from a pharmacist regarding a 37-year-old male patient. The patient's medical history, concurrent condition, concomitant medications, drug reactions or allergies were not provided.     On an unspecified date in 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route, lot # and expiration date were not provided).  The reporter requested alternate dosing information for the patient to receive second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Nurse reporting a dose of Improperly stored VARIVAX has been administered to a patient; This spontaneous report as received from registered nurse refers to a 13-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 24-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml dose, lot # U020244, expiration date 28-JUN-2023 (route of administration and anatomical location were not reported) for prophylaxis (product storage error). The temperature excursion was from 6 Fahrenheit degree up to 14 (13.8) Fahrenheit degree for 1 hour 45 minutes and 14 Fahrenheit degree up to 46 (14.4) Fahrenheit degree for 25 minutes. No previous temperature excursions were reported. No additional adverse events reported (no adverse event).
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: nerve pain; This spontaneous report was received from a consumer of unknown age and gender referring to itself via social media. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, lot number and expiration date not reported) and in April 2021, received covid-19 vaccine(COVID-19 VACCINE) (dose, route of administration, lot number and expiration date not reported) both fro prophylaxis.      On an unknown date in 2021, the patient experienced nerve pain (neuralgia).      The outcome of neuralgia was reported as ongoing. The causal relationship between neuralgia and the vaccines was not reported.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Blood test abnormal, Impaired work ability, Inflammation, Joint stiffness
Clinical narrative: Rheumatoid arthritis; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID:857327) on 04-FEB-2022, referring to a 33 year old female patient.  The patient had none allergies, and none illness at the time of vaccination. None prescriptions, over-the-counter medications, dietary supplements, or herbal remedies taken at the time of vaccination were reported.  On an unknown day in January 2019, and on 12-JUL-2019, the patient was vaccinated with 2nd and 3rd doses respectively of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in the left arm (strength, lot #, expiry date, route of administration, and indication were not provided).   On an unknown date in 2019, after 2ns shot, the patient experienced shoulder pain and inability to move arm.  Shoulder pain progressed and was reported to doctors who said it was nothing.  On 15-JUL-2019, the patient experienced shoulder pain that made her call off of work.  Joint was stiff for at least 3 days.  Over the last months pain and inflammation had spread to neck, both shoulders, fingers were swollen and had spread to feet.  After pain had not stopped, inflammation getting worse, fingers being swollen and feet starting to swell, the patient got blood work done.  Blood test results showed that the patient had rheumatoid arthritis (conflicting information: date reported as "results received on 20-JAN-2019").  As a result of adverse event, the patient required doctor/healthcare professional office/clinic visit At the time of reporting, the patient had not recovered from the event of Rheumatoid arthritis.   The agency considered this case as serious with disability criteria. The agency did not give the causality assessment between the event and the suspect vaccine.  As of 14-FEB-2022, no further information was available.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Neck pain, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID:857327) on 04-FEB-2022, referring to a 33 year old female patient.  The patient had none allergies, and none illness at the time of vaccination. None prescriptions, over-the-counter medications, dietary supplements, or herbal remedies taken at the time of vaccination were reported.  On an unknown day in January 2019, and on 12-JUL-2019, the patient was vaccinated with 2nd and 3rd doses respectively of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in the left arm (strength, lot #, expiry date, route of administration, and indication were not provided).   On an unknown date in 2019, after 2ns shot, the patient experienced shoulder pain and inability to move arm.  Shoulder pain progressed and was reported to doctors who said it was nothing.  On 15-JUL-2019, the patient experienced shoulder pain that made her call off of work.  Joint was stiff for at least 3 days.  Over the last months pain and inflammation had spread to neck, both shoulders, fingers were swollen and had spread to feet.  After pain had not stopped, inflammation getting worse, fingers being swollen and feet starting to swell, the patient got blood work done.  Blood test results showed that the patient had rheumatoid arthritis (conflicting information: date reported as "results received on 20-JAN-2019").  As a result of adverse event, the patient required doctor/healthcare professional office/clinic visit At the time of reporting, the patient had not recovered from the event of Rheumatoid arthritis.   The agency considered this case as serious with disability criteria. The agency did not give the causality assessment between the event and the suspect vaccine.  As of 14-FEB-2022, no further information was available.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Blood thyroid stimulating hormone, Chest X-ray, Electrocardiogram, Electrocardiogram ambulatory, Full blood count
Clinical narrative: Postural orthostatic tachycardia syndrome; Information has been received from Food & Drug Administration (FDA) (VAERS # 857405-2) on 04-FEB-2022.   This spontaneous report has been received from a healthcare professional (also reported as staff), referring to a 14-year-old male patient. His concurrent conditions included allergies to honeybees and strawberries, mild intermittent asthma, left thigh sprain, and fatigue. Concomitant medications included cyclobenzaprine, ibuprofen, and hepatitis a vaccine, inactivated (VAQTA).  It was noted that the patient did not have an adverse event following any previous vaccine.  On an unspecified date, the patient received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the dose number series for prophylaxis.  On 02-MAR-2018 at 15:36:00, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered intramuscularly (IM) at the left arm (concentration was not reported; lot number N014470 that was verified to be a valid lot number for syringe formulation with an expiration date not reported but established as 17-JUN-2019) for prophylaxis.  The healthcare professional reported that on 04-JUN-2019 at 10:02 (also reported as started around 04-JUN-2019), the patient experienced postural orthostatic tachycardia syndrome (POTS) and required doctor or other healthcare professional office/clinic visit.  The following medical and laboratory tests were performed: electrocardiogram (EKG), Cardiac Holter Monitor, Chest X-Ray; Complete blood cell count; comprehensive metabolic panel, TSH, Heterophile AB screen and strep throat screen (results were not provided).   At the time of reporting, the patient had not recovered from the adverse event.  The causal relationship between the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  The healthcare professional reported the event as non-serious, but the Postural orthostatic tachycardia syndrome (POTS) was considered medically significant by the agency (consolidated). After a further review it was determined that the information reported in the source document pertains to two patients so the information regarding the male patient was updated in the case US-009507513-2202USA002170 and the female patient information was reported in the case US-009507513-2202USA003242.  As of 11-FEB-2022, all telephone attempts trying to obtain additional information has been unsuccessful. No further information was available.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Metabolic function test, Mononucleosis heterophile test, Postural orthostatic tachycardia syndrome, Streptococcus test
Clinical narrative: Postural orthostatic tachycardia syndrome; Information has been received from Food & Drug Administration (FDA) (VAERS # 857405-2) on 04-FEB-2022.   This spontaneous report has been received from a healthcare professional (also reported as staff), referring to a 14-year-old male patient. His concurrent conditions included allergies to honeybees and strawberries, mild intermittent asthma, left thigh sprain, and fatigue. Concomitant medications included cyclobenzaprine, ibuprofen, and hepatitis a vaccine, inactivated (VAQTA).  It was noted that the patient did not have an adverse event following any previous vaccine.  On an unspecified date, the patient received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the dose number series for prophylaxis.  On 02-MAR-2018 at 15:36:00, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered intramuscularly (IM) at the left arm (concentration was not reported; lot number N014470 that was verified to be a valid lot number for syringe formulation with an expiration date not reported but established as 17-JUN-2019) for prophylaxis.  The healthcare professional reported that on 04-JUN-2019 at 10:02 (also reported as started around 04-JUN-2019), the patient experienced postural orthostatic tachycardia syndrome (POTS) and required doctor or other healthcare professional office/clinic visit.  The following medical and laboratory tests were performed: electrocardiogram (EKG), Cardiac Holter Monitor, Chest X-Ray; Complete blood cell count; comprehensive metabolic panel, TSH, Heterophile AB screen and strep throat screen (results were not provided).   At the time of reporting, the patient had not recovered from the adverse event.  The causal relationship between the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  The healthcare professional reported the event as non-serious, but the Postural orthostatic tachycardia syndrome (POTS) was considered medically significant by the agency (consolidated). After a further review it was determined that the information reported in the source document pertains to two patients so the information regarding the male patient was updated in the case US-009507513-2202USA002170 and the female patient information was reported in the case US-009507513-2202USA003242.  As of 11-FEB-2022, all telephone attempts trying to obtain additional information has been unsuccessful. No further information was available.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Autonomic nervous system imbalance, Constipation, Cytogenetic analysis normal, Electrocardiogram
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); dysautonomia; Syncope; Constipation; Arm/Shoulder/ Joint Pain; Sinus Tachycardia; Information has been received from Food & Drug Administration (FDA) (VAERS # 857405-1) on 04-FEB-2022.   This spontaneous report has been received from a parent (also reported as guardian or caregiver), referring to a non-pregnant 14-year-old female patient. Her concurrent conditions included allergies to bee venom and strawberries, and asthma. Concomitant medications included hepatitis a vaccine inact (HAVRIX) syringe (SYR). It was noted that the patient did not have an adverse event following any previous vaccine.  On an unspecified date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, vaccination scheme frequency, anatomical site of application, lot number and expiration date, were not reported).  On 02-MAR-2018 at 15:00, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly (IM) (dose, anatomical site of application, lot number and expiration date were not reported) for prophylaxis.   On 03-JUN-2019 at 8:00, the parent reported that the patient experienced postural orthostatic tachycardia syndrome (POTS), dysautonomia (autonomic nervous system imbalance), syncope, constipation, arm/shoulder/joint pain (arthralgia), and sinus tachycardia.    On an unspecified date, the patient was admitted to the emergency room/department or urgent care and was hospitalized due to his experience for two days. The following medical and laboratory tests were performed: electrocardiogram (EKG), electroencephalogram (EEG), holter monitor for 1 week; holter monitor for 30 days; full laboratory panels, thyroid panels (results were not provided). A Genetics review and counseling was also performed to rule out the potential for anything else that could have contributed, and the result was negative. It was noted that patient had a Medtronic LOOP Monitor Implant in chest wall.  At the time of reporting, the patient had not recovered from the adverse events.  The causality assessment between all the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  The reporter considered that postural orthostatic tachycardia syndrome (POTS), dysautonomia, syncope, constipation, arm/shoulder/joint pain, and sinus tachycardia events were disabling or caused permanent damage.  As of 11-FEB-2022, all telephone attempts trying to obtain additional information had been unsuccessful. No further information was available.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram ambulatory, Electroencephalogram, Genetic counselling, Implantable cardiac monitor insertion, Laboratory test
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); dysautonomia; Syncope; Constipation; Arm/Shoulder/ Joint Pain; Sinus Tachycardia; Information has been received from Food & Drug Administration (FDA) (VAERS # 857405-1) on 04-FEB-2022.   This spontaneous report has been received from a parent (also reported as guardian or caregiver), referring to a non-pregnant 14-year-old female patient. Her concurrent conditions included allergies to bee venom and strawberries, and asthma. Concomitant medications included hepatitis a vaccine inact (HAVRIX) syringe (SYR). It was noted that the patient did not have an adverse event following any previous vaccine.  On an unspecified date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, vaccination scheme frequency, anatomical site of application, lot number and expiration date, were not reported).  On 02-MAR-2018 at 15:00, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly (IM) (dose, anatomical site of application, lot number and expiration date were not reported) for prophylaxis.   On 03-JUN-2019 at 8:00, the parent reported that the patient experienced postural orthostatic tachycardia syndrome (POTS), dysautonomia (autonomic nervous system imbalance), syncope, constipation, arm/shoulder/joint pain (arthralgia), and sinus tachycardia.    On an unspecified date, the patient was admitted to the emergency room/department or urgent care and was hospitalized due to his experience for two days. The following medical and laboratory tests were performed: electrocardiogram (EKG), electroencephalogram (EEG), holter monitor for 1 week; holter monitor for 30 days; full laboratory panels, thyroid panels (results were not provided). A Genetics review and counseling was also performed to rule out the potential for anything else that could have contributed, and the result was negative. It was noted that patient had a Medtronic LOOP Monitor Implant in chest wall.  At the time of reporting, the patient had not recovered from the adverse events.  The causality assessment between all the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  The reporter considered that postural orthostatic tachycardia syndrome (POTS), dysautonomia, syncope, constipation, arm/shoulder/joint pain, and sinus tachycardia events were disabling or caused permanent damage.  As of 11-FEB-2022, all telephone attempts trying to obtain additional information had been unsuccessful. No further information was available.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Postural orthostatic tachycardia syndrome, Sinus tachycardia, Syncope, Thyroid function test
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); dysautonomia; Syncope; Constipation; Arm/Shoulder/ Joint Pain; Sinus Tachycardia; Information has been received from Food & Drug Administration (FDA) (VAERS # 857405-1) on 04-FEB-2022.   This spontaneous report has been received from a parent (also reported as guardian or caregiver), referring to a non-pregnant 14-year-old female patient. Her concurrent conditions included allergies to bee venom and strawberries, and asthma. Concomitant medications included hepatitis a vaccine inact (HAVRIX) syringe (SYR). It was noted that the patient did not have an adverse event following any previous vaccine.  On an unspecified date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, vaccination scheme frequency, anatomical site of application, lot number and expiration date, were not reported).  On 02-MAR-2018 at 15:00, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly (IM) (dose, anatomical site of application, lot number and expiration date were not reported) for prophylaxis.   On 03-JUN-2019 at 8:00, the parent reported that the patient experienced postural orthostatic tachycardia syndrome (POTS), dysautonomia (autonomic nervous system imbalance), syncope, constipation, arm/shoulder/joint pain (arthralgia), and sinus tachycardia.    On an unspecified date, the patient was admitted to the emergency room/department or urgent care and was hospitalized due to his experience for two days. The following medical and laboratory tests were performed: electrocardiogram (EKG), electroencephalogram (EEG), holter monitor for 1 week; holter monitor for 30 days; full laboratory panels, thyroid panels (results were not provided). A Genetics review and counseling was also performed to rule out the potential for anything else that could have contributed, and the result was negative. It was noted that patient had a Medtronic LOOP Monitor Implant in chest wall.  At the time of reporting, the patient had not recovered from the adverse events.  The causality assessment between all the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  The reporter considered that postural orthostatic tachycardia syndrome (POTS), dysautonomia, syncope, constipation, arm/shoulder/joint pain, and sinus tachycardia events were disabling or caused permanent damage.  As of 11-FEB-2022, all telephone attempts trying to obtain additional information had been unsuccessful. No further information was available.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No other issues or concerns noted; Improperly sorted PNUEMOV AX 23 administered 2/8/2022; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent condition, concomitant medication and drug reaction/allergy was not provided.  On 08-FEB-2022, the patient was vaccinated with improperly sorted (previous temperature excursion was 15.7 degrees Celsius for 8 hours, 10 degrees Celsius for 6 hours) pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U018309 with expiration date 08-JAN-2023; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). No other issues or concerns noted. The outcome of product storage error was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; Nurse calling to report that an expired dose of GARDASIL 9 was administered to a patient; This spontaneous report has been received from a registered nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant therapies were not provided.  On 22-DEC-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe 0.5mL, lot# S010729, expiration date 01-DEC-2021 (frequency, route of administration, and anatomical location were not provided), as prophylaxis (Expired product administered). The reported also confirmed that the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not experience a temperature excursion. No additional adverse event (AE) was reported.
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Bronchial disorder, Dyspnoea, Injection site pain, Pyrexia
Clinical narrative: sore arm at the injection site; joint ache; low grade fever; bronchial tightness; difficulty breathing; symptoms for 7 days after the vaccine; minor symptoms lasting for about 5 days; This spontaneous report was received from Consumer and refers to a 46-year-old male.  The patient's medical history included severe reaction to prochlorperazine (COMPAZINE). The patient's concurrent conditions were not reported.  Concomitant medications included empagliflozin (JARDIANCE) and metoprolol.   On an unknown date in 2014, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injectionunk, administered for prophylaxis (strength, dose details, lot #, and expiry date were not provided). After this vaccination the patient experienced similar symptoms (no details provided) for 7 days after the vaccine.   On an unknown date, the patient received an immunotherapy injection and he experienced minor symptoms lasting for about 5 days.   On 07-FEB-2022 at 10:00, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injectionunk, administered intramuscular for prophylaxis (strength, lot #, and expiry date were not provided). After this vaccination the patient experienced similar symptoms (no details provided) for 7 days after the vaccine.   On the same date, he began to experience joint ache and low grade fever that "comes and goes". On an unknown date in Febraury 2022, he also experienced bronchial tightness and difficulty breathing. On 09-FEB-2022, his arm was sore at the injection site. On an unspecified date in February 2022, he went to the doctor who couldn't fit him in, therefore he went to urgent care instead where they gave him an fluticasone propionate (+) salmeterol (ADVAIRE) inhaler. The caller confirmed that these symptoms were not as severe as in 2014.  On 11-FEB-2021, the patient was experiencing more joint pain.   On unknown dates, the patient recovered from general symptoms (2014) and from minor symptoms after immunotherapy injection.  At the time of this report, the patient had not recovered from joint pain, low grade fever, difficulty breathing, bronchial tightness, and soreness at the injection site.   The patient was not sure if these symptoms were due to the vaccine or not. Causality assessment for all the events was reported as unknown.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Physician states that GARDASIL 9 was administered to a pregnant female who is 30 weeks pregnant; This prospective pregnancy spontaneous report has been received from a physician concerning a 27-year-old female patient. The patient's concurrent conditions included diabetes mellitus. Her medical history was not reported. There was none drug reactions/allergies reported. Concomitant medications included the following: insulin, metformin, prenatal vitamins, and acetylsalicylic acid (ASPIRINE).   On an unknown date, the patient became pregnant. Her last menstrual period was on approximately 16-JUL-2021. The estimated date of conception was not reported.   The physician stated that on 11-FEB-2022, the patient who was 30 weeks pregnant, was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot #1775808, expiration date: 20-AUG-2023, administered intramuscularly for prophylaxis. The physician spoke with the patient and none laboratories were performed. At the reporting time, information regarding the pregnancy outcome and estimated date of delivery (EDD) was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No Adverse event; a dose was administered to a patient after a temperature excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-JAN-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, 1 dose, lot #U008315, expiration date: 15-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided) after a temperature excursion occurred. The vaccine underwent a temperature excursion of 0.5 degree Celsius (C) for a period of 168 hours. The vaccine did not undergo previous temperature excursion. The patient did not experience any adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: she is not completely well; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a 99-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unwell. On an unknown date, the outcome of the unwell was not recovered/not resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by the son/daughter of the patient. The age at vaccination was unknown, as patient could be 98 years or 99 years old at the time of vaccination. The patient had her first Shingrix shot six months ago. The patient was planning on getting her second shot at the time of reporting, but she was not completely well. The reporter asked if she could get one shot and not the second shot.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm pain; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and fatigue. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingrix.     Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was unknown. The reporter stated patient experienced arm pain and fatigue after she received Shingrix vaccine.  The reporter provided limited information and did not wish to provide personal information. The reporter did not consent to follow-up. This case was 1 of 4 cases reported by same reporter. For tolerance of 2nd dose refer case US2022026668.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026665:same reporter US-GLAXOSMITHKLINE-US2022026674:same reporter US-GLAXOSMITHKLINE-US2022026673:same reporter US-GLAXOSMITHKLINE-US2022026668:same reporter US-GLAXOSMITHKLINE-US2022026673:same reporter US-GLAXOSMITHKLINE-US2022026665:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; After each shot I have had an outbreak of shingles.; After each shot I have had an outbreak of shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and shingles. On an unknown date, the outcome of the vaccination failure, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles 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 reported that he/she had both Shingrix shots and had shingles, after each shot the patient had an outbreak of shingles and wanted to know if it was normal. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received a dose of shingrix on 12/23, also received a dose in 11/1; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 23rd December 2021, the patient received the 2nd dose of Shingrix. On 23rd December 2021, 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 provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not have consent to share any patient details. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA576A, expiry date July 2022) for prophylaxis.   In January 2022, the patient received Menveo. In January 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The case was reported by the Medical assistant. The age at vaccination was not reported. The reporter stated that, last month the patient was administered Menveo which was reconstituted with sterile water instead of the liquid component provided with the vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter didn't have the demographics from patient since the vaccination was long ago. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: 18 YO was administered Engerix-B adult/Inappropriate Dose Administered; 18 YO was administered Engerix-B adult/Inappropriate Dose Administered; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 434SR, expiry date 11th August 2023) for prophylaxis.   On 1st February 2022, the patient received the 1st dose of Engerix B adult. On 1st February 2022, unknown after receiving Engerix B adult, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: Nurse reported that 18 year of age patient was administered the Engerix-B adult vaccine on right deltoid inadvertently, which led to accidental overdose and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 15 yo patient received an adult dose; a 15 yo patient received an adult dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 15-year-old patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that a 15 year old patient received an adult dose of Havrix, which led to overdose and adult product administered to child. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 15th October 2021, batch number DK23D, expiry date 08th February 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete vaccination schedule but was schedule to be administered on 14th February 2022. Nurse confirmed that, the delay in schedule was due to the patient's compliance and not due to any supply issue.   The reporter consented to follow up.  VAERS details pertained to the 1st dose of Twinrix. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Itchiness; redness, at the injection site; Swelling at injection site; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2022, the patient received the 1st dose of Shingrix. On 7th February 2022, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On 8th February 2022, the patient experienced pruritus. In February 2022, the outcome of the injection site swelling and injection site pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema and pruritus were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in right arm on Monday 7th February 2022 and she experienced swelling, redness and pain at the injection site later that evening in her right arm.   The patient also stated that she experienced itchiness which started the day after her vaccination.   The patient stated that pain and swelling at injection site had since resolved. The patient still had redness and itchiness but both had improved. The patient spoke as per package insert content. The patient gave medical advice disclaimer. Reporter provided limited information and did not wish to provide personal information. The reporter did not consent to follow-up. The case was reported for 1 of 4 report.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026668:same reporter US-GLAXOSMITHKLINE-US2022026673:same reporter US-GLAXOSMITHKLINE-US2022026674:same reporter US-GLAXOSMITHKLINE-US2022AMR027150:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was unknown. The reporter stated that her patient experienced flu like symptoms for approximately 2 days after shingrix vaccine. The reporter did not consent to follow up. The reporter provided limited information. This case is 1 out of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026665:same reporter US-GLAXOSMITHKLINE-US2022026668:same reporter US-GLAXOSMITHKLINE-US2022AMR027150:same reporter US-GLAXOSMITHKLINE-US2022026674:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not received dose two; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, over 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.