chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Headache, Orthostatic intolerance
Clinical narrative: Autonomic nervous system imbalance; Orthostatic intolerance; dizziness; headache; Information has been received from a lawyer referring to a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, lot# and route unknown) for prophylaxis. On an unknown date, the patient experienced autonomic nervous system imbalance orthostatic intolerance, dizziness, and headache. Reported date of injury was unspecified date in 2007. The outcome of the event was not reported. The causality assessment was considered as related by the lawyer.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: syncope; Orthostatic Intolerance; autonomic dysfunction; dizziness; fatigue; headaches; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 14-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced orthostatic intolerance, autonomic dysfunction, syncope, dizziness, headache, fatigue. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: syncope; Orthostatic Intolerance; autonomic dysfunction; dizziness; fatigue; headaches; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 14-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced orthostatic intolerance, autonomic dysfunction, syncope, dizziness, headache, fatigue. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; fatigue; dizziness; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 15-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), syncope, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: syncope; POTS; autonomic dysfunction; orthostatic intolerance; fatigue; dizziness; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 17-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; autonomic dysfunction; orthostatic intolerance; fatigue; dizziness; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 17-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; fatigue; dizziness; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 19-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), syncope, fatigue, and dizziness. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: syncope; POTS (autonomic dysfunction, orthostatic intolerance, fatique, dizziness, headache, syncope); autonomic dysfunction; orthostatic intolerance; fatique; dizziness; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 21-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS (autonomic dysfunction, orthostatic intolerance, fatique, dizziness, headache, syncope); autonomic dysfunction; orthostatic intolerance; fatique; dizziness; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 21-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Fatigue, Headache, Orthostatic intolerance, Postural orthostatic tachycardia syndrome
Clinical narrative: syncope; POTS; orthostatic intolerance; autonomic dysfunction; fatigue; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 22-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: syncope; POTS; orthostatic intolerance; autonomic dysfunction; fatigue; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 22-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Orthostatic intolerance, Postural orthostatic tachycardia syndrome
Clinical narrative: syncope; POTS; orthostatic intolerance; autonomic dysfunction; dizziness; fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 23-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, and dizziness. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: syncope; POTS; orthostatic intolerance; autonomic dysfunction; dizziness; fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 23-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, and dizziness. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Stomatitis, Varicella, Varicella virus test positive
Clinical narrative: Varicella was confirmed by a PCR; decent rash; mouth sores; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient. The patient was a  health child otherwise and was not immunocompromised. The child's concurrent conditions, medical history and concomitant therapies were not provided.   On an unknown date in 2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # reported as 5015460 however after internal review established as S015460 (expiration date established as 20-MAY-2021) (route of administration and anatomical location were not reported) for prophylaxis.         On an unknown date in January 2023, the patient experienced rash and mouth sores. On an unknown date in January 2023, also reported as that past weekend, the patient was either seen in an urgent care or an emergency room (ER) and varicella was confirmed by a polymerase chain reaction (PCR). It was reported that it was not a mild case) (also reported that the patient was doing okay). The outcome of the events was reported as not recovered.  Causality assessment was not reported.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; headache; fatigue; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 13-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2010, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, headache, and fatigue. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; fatigue; Dizziness; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 15-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2010, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, dizziness, and fatigue. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; headache; dizziness; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 15-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2011, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, dizziness, and headache. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: syncope; seizures; POTS; autonomic dysfunction; orthostatic intolerance; dizziness; headache; fatigue; This spontaneous report was received from a lawyer regarding a case in litigation concerning an 18-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2011, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, autonomic dysfunction, orthostatic intolerance, seizures, dizziness, headache, and fatigue. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope and seizures were considered medically significant events.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Seizure, Syncope
Clinical narrative: syncope; seizures; POTS; autonomic dysfunction; orthostatic intolerance; dizziness; headache; fatigue; This spontaneous report was received from a lawyer regarding a case in litigation concerning an 18-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2011, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, autonomic dysfunction, orthostatic intolerance, seizures, dizziness, headache, and fatigue. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope and seizures were considered medically significant events.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; dizziness; headache; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 15-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2012, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, dizziness, and headache. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 12-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2013, the pt experienced Postural orthostatic tachycardia syndrome (POTS) and syncope. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Orthostatic intolerance, Syncope
Clinical narrative: syncope; orthostatic intolerance; autonomic dysfunction; fatigue; dizziness; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 12-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2013, the pt experienced syncope, orthostatic intolerance, autonomic dysfunction, fatigue, and dizziness. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: syncope; autonomic dysfunction; orthostatic intolerance; dizziness; headache; fatigue; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 12-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2013, the pt experienced syncope, orthostatic intolerance, autonomic dysfunction, fatigue, headache, and dizziness. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: syncope; autonomic dysfunction; orthostatic intolerance; dizziness; headache; fatigue; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 12-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2013, the pt experienced syncope, orthostatic intolerance, autonomic dysfunction, fatigue, headache, and dizziness. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: autonomic dysfunction; orthostatic intolerance; dizziness; headache; fatigue; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 12-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. In 2013 following vaccination, the pt experienced autonomic dysfunction, orthostatic intolerance, dizziness, headache, and fatigue. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: syncope; POTS; autonomic dysfunction; orthostatic intolerance; fatigue; dizziness; headache; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 13-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2013, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, orthostatic intolerance, autonomic dysfunction, fatigue, headache, and dizziness. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; autonomic dysfunction; orthostatic intolerance; fatigue; dizziness; headache; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 13-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2013, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, orthostatic intolerance, autonomic dysfunction, fatigue, headache, and dizziness. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; dizziness; headache; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 13-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. In 2013 following vaccination, the pt experienced Postural orthostatic tachycardia syndrome (POTS), dizziness and headache. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired PNEUMOVAX 23 (pfs) was administered to a patient; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 20-JAN-2023 (reported also as "today"), the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection, lot # U021995 confirmed to be valid with expiration date 13-JAN-2023 (exact dose, route of administration, and anatomical location were not reported), for prophylaxis (expired product administered). The vaccine was stored according to prescribing information through the date of administration. There was no additional adverse event reported.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mechanical urticaria, Rash, Urticaria
Clinical narrative: Dermographism: hives and/or rash appearing wherever I lightly scratch myself, started noticing it a couple days ago when I got hives on my under-boob bra line, then had hives on my upper back. Was taking Benadryl but since it didn't go away still I went to the doctor today and they said it's dermographism and prescribed a topical. The only reason I'm reporting this is because I've seen a couple studies online that linked the Moderna booster to cases of dermographism.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Decreased appetite, Feeling of body temperature change, Nasopharyngitis
Clinical narrative: I had a bad head cold. I had phlegm, hot, cold, body ache, and loss appetite. I tested positive for COVID-19 and my doctor prescribed me PAXLOVID. I tested negative for COVID-19 01/09/2023 and I ended up tested positive again on Wednesday. I had the same symptoms as the first time. I also had a cough, congestion, and worse body aches. My doctor gave me prednisone and cough syrup. I still have body aches.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pain, Productive cough, Respiratory tract congestion, SARS-CoV-2 test positive, Symptom recurrence
Clinical narrative: I had a bad head cold. I had phlegm, hot, cold, body ache, and loss appetite. I tested positive for COVID-19 and my doctor prescribed me PAXLOVID. I tested negative for COVID-19 01/09/2023 and I ended up tested positive again on Wednesday. I had the same symptoms as the first time. I also had a cough, congestion, and worse body aches. My doctor gave me prednisone and cough syrup. I still have body aches.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: site of injection red and swollen
Age: 1.5
Sex: M
Vaccine: COVID19-2, HEPA
Symptoms: Unevaluable event
Clinical narrative: There is a possibility patient may have received 0.25 ml of vaccine rather than the recommended 0.2 ml. of the Moderna Bivalent presentation for 6 months to 5 years.  A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined if the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Ammonia, Blood albumin, Blood calcium, Blood chloride, Blood creatinine
Clinical narrative: Pt. took 4 vaccines at once total (3 intramuscular and one oral) at the age of 8 week on May 03rd 2022. By the end of the same month, we started noticing a weird jerking movement (Moro reflex alike) that happens in clusters. This movement was subtle first and became more obvious and dominant. In June, she was diagnosed with infantile spasms. Before the vaccine, she was a healthy baby, hitting her developmental milestones like any normal child. We have done multiple tests to rule out genetic reasons, metabolism, pregnancy issues, delivery issues; all were clear. Looking back, we believe vaccines taken on May 03rd 2022 were the main culprit to her diagnoses; Taking all 4 vaccines at once and, specifically, taking the (DTaP-HBV-POL) which is on the contraindications list for infantile spasm and uncontrolled seizures.  Pt. has relapsed twice. she was treated with Prednisolone (Once for a month in June 2022), ACTH (Twice in August 2022 and December 2022) and currently on Vigabatrin (Starting in July 2022). She is currently in the process to being surgically evaluated.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood electrolytes, Blood glucose, Blood magnesium, Blood phosphorus, Blood potassium
Clinical narrative: Pt. took 4 vaccines at once total (3 intramuscular and one oral) at the age of 8 week on May 03rd 2022. By the end of the same month, we started noticing a weird jerking movement (Moro reflex alike) that happens in clusters. This movement was subtle first and became more obvious and dominant. In June, she was diagnosed with infantile spasms. Before the vaccine, she was a healthy baby, hitting her developmental milestones like any normal child. We have done multiple tests to rule out genetic reasons, metabolism, pregnancy issues, delivery issues; all were clear. Looking back, we believe vaccines taken on May 03rd 2022 were the main culprit to her diagnoses; Taking all 4 vaccines at once and, specifically, taking the (DTaP-HBV-POL) which is on the contraindications list for infantile spasm and uncontrolled seizures.  Pt. has relapsed twice. she was treated with Prednisolone (Once for a month in June 2022), ACTH (Twice in August 2022 and December 2022) and currently on Vigabatrin (Starting in July 2022). She is currently in the process to being surgically evaluated.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood sodium, Blood urea, Carbon dioxide, Differential white blood cell count, Dyskinesia
Clinical narrative: Pt. took 4 vaccines at once total (3 intramuscular and one oral) at the age of 8 week on May 03rd 2022. By the end of the same month, we started noticing a weird jerking movement (Moro reflex alike) that happens in clusters. This movement was subtle first and became more obvious and dominant. In June, she was diagnosed with infantile spasms. Before the vaccine, she was a healthy baby, hitting her developmental milestones like any normal child. We have done multiple tests to rule out genetic reasons, metabolism, pregnancy issues, delivery issues; all were clear. Looking back, we believe vaccines taken on May 03rd 2022 were the main culprit to her diagnoses; Taking all 4 vaccines at once and, specifically, taking the (DTaP-HBV-POL) which is on the contraindications list for infantile spasm and uncontrolled seizures.  Pt. has relapsed twice. she was treated with Prednisolone (Once for a month in June 2022), ACTH (Twice in August 2022 and December 2022) and currently on Vigabatrin (Starting in July 2022). She is currently in the process to being surgically evaluated.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram, Full blood count, Gene mutation identification test negative, Infantile spasms, Influenza A virus test
Clinical narrative: Pt. took 4 vaccines at once total (3 intramuscular and one oral) at the age of 8 week on May 03rd 2022. By the end of the same month, we started noticing a weird jerking movement (Moro reflex alike) that happens in clusters. This movement was subtle first and became more obvious and dominant. In June, she was diagnosed with infantile spasms. Before the vaccine, she was a healthy baby, hitting her developmental milestones like any normal child. We have done multiple tests to rule out genetic reasons, metabolism, pregnancy issues, delivery issues; all were clear. Looking back, we believe vaccines taken on May 03rd 2022 were the main culprit to her diagnoses; Taking all 4 vaccines at once and, specifically, taking the (DTaP-HBV-POL) which is on the contraindications list for infantile spasm and uncontrolled seizures.  Pt. has relapsed twice. she was treated with Prednisolone (Once for a month in June 2022), ACTH (Twice in August 2022 and December 2022) and currently on Vigabatrin (Starting in July 2022). She is currently in the process to being surgically evaluated.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Influenza B virus test, Liver function test, Magnetic resonance imaging head, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: Pt. took 4 vaccines at once total (3 intramuscular and one oral) at the age of 8 week on May 03rd 2022. By the end of the same month, we started noticing a weird jerking movement (Moro reflex alike) that happens in clusters. This movement was subtle first and became more obvious and dominant. In June, she was diagnosed with infantile spasms. Before the vaccine, she was a healthy baby, hitting her developmental milestones like any normal child. We have done multiple tests to rule out genetic reasons, metabolism, pregnancy issues, delivery issues; all were clear. Looking back, we believe vaccines taken on May 03rd 2022 were the main culprit to her diagnoses; Taking all 4 vaccines at once and, specifically, taking the (DTaP-HBV-POL) which is on the contraindications list for infantile spasm and uncontrolled seizures.  Pt. has relapsed twice. she was treated with Prednisolone (Once for a month in June 2022), ACTH (Twice in August 2022 and December 2022) and currently on Vigabatrin (Starting in July 2022). She is currently in the process to being surgically evaluated.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Seizure, Somnolence, Staphylococcus test
Clinical narrative: Pt. took 4 vaccines at once total (3 intramuscular and one oral) at the age of 8 week on May 03rd 2022. By the end of the same month, we started noticing a weird jerking movement (Moro reflex alike) that happens in clusters. This movement was subtle first and became more obvious and dominant. In June, she was diagnosed with infantile spasms. Before the vaccine, she was a healthy baby, hitting her developmental milestones like any normal child. We have done multiple tests to rule out genetic reasons, metabolism, pregnancy issues, delivery issues; all were clear. Looking back, we believe vaccines taken on May 03rd 2022 were the main culprit to her diagnoses; Taking all 4 vaccines at once and, specifically, taking the (DTaP-HBV-POL) which is on the contraindications list for infantile spasm and uncontrolled seizures.  Pt. has relapsed twice. she was treated with Prednisolone (Once for a month in June 2022), ACTH (Twice in August 2022 and December 2022) and currently on Vigabatrin (Starting in July 2022). She is currently in the process to being surgically evaluated.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Faeces soft, Gastrointestinal pain, Rectal tenesmus
Clinical narrative: Bowel cramps with  tenesmus and changes of bowel movement with soft stools.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: There is a possibility Patient may have received 0.25 ml of vaccine rather than the recommended 0.2 ml. of the Moderna Bivalent presentation for 6 months to 5 years.  A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined if the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
Age: 1.25
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: There is a possibility patient may have received 0.25 ml of vaccine rather than the recommended 0.2 ml. of the Moderna Bivalent presentation for 6 months to 5 years. A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined if the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: There is a possibility Patient may have received 0.25 ml of vaccine rather than the recommended 0.2 ml. of the Moderna Bivalent presentation for 6 months to 5 years.  A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined if the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was given Hep A, Vaccine was Expired Date Jan. 16,2023  . Patients mother was notified .
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Fatigue, Headache, Injection site pain
Clinical narrative: Soreness at injection site, temporary/brief abdominal muscle pain, joint aches (neck, shoulders, elbows, hands, fingers, leg/hip joint, thigh muscle ache, mild headache, tired
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Soreness at injection site, temporary/brief abdominal muscle pain, joint aches (neck, shoulders, elbows, hands, fingers, leg/hip joint, thigh muscle ache, mild headache, tired
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Energy increased, Herpes zoster
Clinical narrative: Shingrix vaccine caused extreme burst of energy. Very much unanticipated and not included in any of the handouts regarding this vaccine.  I also had an extreme burst of energy during my incidence of Shingles during February 2022. This lasted about eight hours. No further effects, but it was very strange.