chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Menstrual disorder, Metabolic function test, Mitral valve incompetence
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Mitral valve prolapse, Obstructive sleep apnoea syndrome, Oestradiol, Orthostatic hypertension, Panic reaction
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Positive airway pressure therapy, Pyrexia, SARS-CoV-2 antibody test, Seizure like phenomena, Syncope
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Thyroid function test, Tic, Tremor, Vertigo
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B1, Vitamin B12, Vitamin D, Vomiting, X-ray of pelvis and hip normal
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Age: 1.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored vaccine; This spontaneous report was received from a healthcare worker referring to a 14-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 08-FEB-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) injection (1 dose, lot#: w020525, expiration date: 14-DEC-2023; route of administration, and anatomical location were not reported) for prophylaxis. This vaccine was once stored in 30F for 3 hours and 15 minutes (product storage error) and the vaccine had no previous temperature excursion. No adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got Vx, months later got shingles/ suspected vaccination failure; Shingles, horrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient got the Shingles vaccine and few months later got shingles and stated that they were horrible. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding completion of primary vaccination schedule and laboratory test confirming shingles was unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm was a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media.  The patient got 2 shots because his/her doctor advised it. The patient had no side effects other that arm was a little sore for a day or 2 days. Additional Supportive Information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR024105:Same reporter Same patient - 1st dose
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: He states that they are not sure if a geriatric patient received an expired 2nd Monovalent dose of Moderna vaccine beyond MFG expiration date.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He states that they are not sure if a geriatric patient received an expired 2nd Monovalent dose of Moderna vaccine beyond MFG expiration date.) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He states that they are not sure if a geriatric patient received an expired 2nd Monovalent dose of Moderna vaccine beyond MFG expiration date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He states that they are not sure if a geriatric patient received an expired 2nd Monovalent dose of Moderna vaccine beyond MFG expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He states that they are not sure if a geriatric patient received an expired 2nd Monovalent dose of Moderna vaccine beyond MFG expiration date).    Concomitant medication was not provided. Treatment information was not reported.   Reporter did not allow further contact
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Altered visual depth perception, Asthenopia, Astigmatism, Binocular eye movement disorder, Blood test normal
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Body temperature increased, Carbon dioxide increased, Cognitive disorder, Computerised tomogram head normal, Corrective lens user
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Decreased appetite, Disorientation, Disturbance in attention, Dizziness, Dyschromatopsia
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Eye disorder, Eyelid disorder, Fatigue
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Feeling abnormal, Feeling hot, Gait inability, Glare, Head discomfort
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Headache, Heterophoria, Hyperacusis, Hyperhidrosis, Hypersomnia
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Immediate post-injection reaction, Intraocular pressure increased, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Malaise
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Mental impairment, Migraine, Motion sickness, Mydriasis, Myopia
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Nausea, Neck pain, Ocular discomfort, Orthodontic appliance user, Pain in jaw
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Peripheral coldness, Photophobia, Posture abnormal, Presyncope, Pupil dilation procedure
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Reading disorder, Sensory disturbance, Sensory overload, Somnolence, Syncope
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Tension headache, Thinking abnormal, Tinnitus, Trismus, Unresponsive to stimuli
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, FLU4, MNQ
Symptoms: Vertigo, Vision blurred, Visual impairment, Vitamin B12 increased, Vitamin D decreased
Clinical narrative: syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: who got the shot got shingles right after; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-FEB-2023  Reporter's comment: This case was reported via interactive digital media. The reporter stated that everyone he/she knew who got the Shingles shot, had got shingles right after, get this off from his/her feed.  Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Hasn't received a second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 13-Feb-2023 Reporter's comment: The pharmacist reported that the patient received first dose of Shingrix over a year ago and had not received a second dose. The reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not received the 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of adjuvant portion only; Administration of adjuvant portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: The reporter was medical assistant. The reporter stated that what were the recommendations for a patient that had been given the Shingrix vaccine without reconstitution. The reporter confirmed the administration of the adjuvant portion only. The reporter disconnected the chat before providing any additional information.  The reporter address was not available.  The reporter was unable to obtain follow up permission due to this. The reporter stated that please follow up via email, if follow up was made. Additional Supportive Information: The reporter confirmed the administration of the adjuvant portion only to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.