chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: In mid-December 2022 I began to wheeze and cough.  It became more difficult to breath on December 22, 2022.  I had a low-grade fever.  I visited an urgent care on this day and tested positive for Influenza A.  I am still recovering and having trouble breathing.  My cough was a dry, deep, barking.  I then had body aches and slept for 36 hours straight I was so exhausted I could not move.  I was so fatigued I had to crawl to the restroom.  I was prescribed Tamiflu. My fever lasted for about 3 days and was accompanied with chills.  My lingering symptoms are coughing and difficulty breathing as well as fatigue.  I nap all the time and just cannot seem to stay awake.  In early January,  I went to the emergency department at 3:00am because I could not breathe.  They gave me a nebulizer treatment and it did not help.  They did a chest X-Ray and it was negative for pneumonia.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Influenza, Influenza A virus test positive, Mobility decreased, Pain
Clinical narrative: In mid-December 2022 I began to wheeze and cough.  It became more difficult to breath on December 22, 2022.  I had a low-grade fever.  I visited an urgent care on this day and tested positive for Influenza A.  I am still recovering and having trouble breathing.  My cough was a dry, deep, barking.  I then had body aches and slept for 36 hours straight I was so exhausted I could not move.  I was so fatigued I had to crawl to the restroom.  I was prescribed Tamiflu. My fever lasted for about 3 days and was accompanied with chills.  My lingering symptoms are coughing and difficulty breathing as well as fatigue.  I nap all the time and just cannot seem to stay awake.  In early January,  I went to the emergency department at 3:00am because I could not breathe.  They gave me a nebulizer treatment and it did not help.  They did a chest X-Ray and it was negative for pneumonia.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Wheezing
Clinical narrative: In mid-December 2022 I began to wheeze and cough.  It became more difficult to breath on December 22, 2022.  I had a low-grade fever.  I visited an urgent care on this day and tested positive for Influenza A.  I am still recovering and having trouble breathing.  My cough was a dry, deep, barking.  I then had body aches and slept for 36 hours straight I was so exhausted I could not move.  I was so fatigued I had to crawl to the restroom.  I was prescribed Tamiflu. My fever lasted for about 3 days and was accompanied with chills.  My lingering symptoms are coughing and difficulty breathing as well as fatigue.  I nap all the time and just cannot seem to stay awake.  In early January,  I went to the emergency department at 3:00am because I could not breathe.  They gave me a nebulizer treatment and it did not help.  They did a chest X-Ray and it was negative for pneumonia.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced/reported by patient.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Blood glucose normal, Clonus, Loss of consciousness, Pallor
Clinical narrative: Patient experienced a loss of consciosness after vaccine.Patient was lowered to the floor.  Patient exhibited seizure activity, clonic movements, for a short period of time. Pallor noted to skin.  Patient regained consciousness.  B/P -120/78 Pulse-69 O2 saturation 99%. Patient was helped to chair. B/P was 102/68 in sitting position. Offered water and a candy pop.  Patient again became weak.  Lowered back down to the floor. EMS called.  AED was brought to patient's side. EMS arrived @ 5:15PM. Treatment of glucose check and VS by EMS.  BS was 105.  VS stable.  Standing B/p 120/70.  Mother declined EMS transfer to hospital. Stated she will bring patient to urgent care.  EMS escorted patient to thei car.  Patient fol Patient Follow Up on /1/26/2023- Patient's mother was called in AM.  They did not bring him to Urgent Care.  Patient went home and recovered.  Patient went to school the next moning 01/26/2023.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Seizure
Clinical narrative: Patient experienced a loss of consciosness after vaccine.Patient was lowered to the floor.  Patient exhibited seizure activity, clonic movements, for a short period of time. Pallor noted to skin.  Patient regained consciousness.  B/P -120/78 Pulse-69 O2 saturation 99%. Patient was helped to chair. B/P was 102/68 in sitting position. Offered water and a candy pop.  Patient again became weak.  Lowered back down to the floor. EMS called.  AED was brought to patient's side. EMS arrived @ 5:15PM. Treatment of glucose check and VS by EMS.  BS was 105.  VS stable.  Standing B/p 120/70.  Mother declined EMS transfer to hospital. Stated she will bring patient to urgent care.  EMS escorted patient to thei car.  Patient fol Patient Follow Up on /1/26/2023- Patient's mother was called in AM.  They did not bring him to Urgent Care.  Patient went home and recovered.  Patient went to school the next moning 01/26/2023.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced/reported by patient.
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Mother said the pt. is fine, no adversed reactions.  We used the adult primary vial to  mix with diluent and given 0.2ml instead of the pediatric vial.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Adulterated product, No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Dyspnoea, Ear discomfort, Fatigue, Muscular weakness
Clinical narrative: aches and pain, skin rash, difficulty breathing (felt like respiratory infection)hives, itching, muscle weakness especially hands ,head ache, right ear felt blocked, unusual tired and weakness. patient went to the urgent care and she was prescribed prednisone
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain, Pruritus, Rash, Urticaria
Clinical narrative: aches and pain, skin rash, difficulty breathing (felt like respiratory infection)hives, itching, muscle weakness especially hands ,head ache, right ear felt blocked, unusual tired and weakness. patient went to the urgent care and she was prescribed prednisone
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Provided expired vaccine, no adverse affects.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 3.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Incorrect product formulation administered, No adverse event, Product administration error, Wrong product administered
Clinical narrative: Administration Error:  Incorrect vaccine given. Received booster instead of first series of the COVID vaccine.  I called mother and she stated pt. has no side effects at this time. Called mother on Monday the 23rd.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Headache, chills, sweats, muscle aches, tiredness
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 month old was given the 5-11 age group vaccine in July 2022.  Event was discovered today when pt. came for 3rd dose in primary series.  Patient did not experience any adverse effects from dose in July of 2022 and was given 2nd dose in primary series in August 2022.  No adverse effects were reported by caregiver.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Adulterated product, No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient should have been given a standard (original formulation) Pfizer Covid vaccine, but was given a Bivalent vaccine instead.  No harm to patient reported.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperate excursion.  No adverse events experienced/reported by patient.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Hypophagia, Lethargy, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient brought to the ED by EMS on 11/24 with increasing lethargy and fever. Two days prior (11/22) he tested positive for COVID-19. His facility was concerned his symptoms could indicate something critical so they called EMS. COVID PCR test done in the ED was also positive. Ultimately patient admitted 11/24/22 - 11/29/22 for COVID-19 infection with lethargy and poor p.o. intake.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Adulterated product, No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient due for Hep B, given Hep A in error.  Physician aware of error and parents notified.  No adverse reaction to vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Adulterated product, No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced/reported by patient.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient should have received a bivalent covid vaccine, but was instead given an original dose covid vaccine.  No harm reported by patient.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse event
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary, Cardiac monitoring, Cardiac stress test, Dyspnoea exertional, Full blood count
Clinical narrative: SOB with exertion that has started shortly after vaccine administration and persisted since that time.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Metabolic function test, Pulmonary function test
Clinical narrative: SOB with exertion that has started shortly after vaccine administration and persisted since that time.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Adulterated product, No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 42.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient given Pfizer booster but had not completed a primary series for Pfizer vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: the Moderna vaccine was pulled the morning of the event the pt was given a vaccine given expired best by use date BUD of 01/20/2023 expired by three days Moderna was contacted and they state that the vaccine is still good patient involved was contacted by management.
Age: 66.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received a Pfizer Monovalent booster instead of a Bivalent booster. She requested this instead of waiting for the arrival of the Bivalent booster which had not yet arrived in our clinic.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccination site nodule, Vaccination site pain, Vaccination site swelling
Clinical narrative: this pt. has a raised bump at or around the vaccine location site of a size of a dime, no treatment no outcome, no redness some tenderness and it is not growing in side.
Age: 18.0
Sex: M
Vaccine: COVID19, HEPA, MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None. Patient was given the adult dosage of Havrix, Hep A, instead of the right dosage. He denied adverse symptoms appr. 45 minutes later. I phoned him today. He denies any adverse symptoms since receiving the dose.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal pain upper, Arthralgia, Cough, Discomfort, Dyspnoea
Clinical narrative: My arm turned very hard and painful I couldn't move arm got rash on arm very itchy and felt extremely hot to touch got severe pain between shoulder blades pain down legs nd on L hip stomach cramps lots of sneezing and some cough lungs felt very heavy hard to breathe had to keep using albuterol and got headaches also got hives all over my back
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Induration, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: My arm turned very hard and painful I couldn't move arm got rash on arm very itchy and felt extremely hot to touch got severe pain between shoulder blades pain down legs nd on L hip stomach cramps lots of sneezing and some cough lungs felt very heavy hard to breathe had to keep using albuterol and got headaches also got hives all over my back
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Rash, Skin warm, Sneezing, Urticaria
Clinical narrative: My arm turned very hard and painful I couldn't move arm got rash on arm very itchy and felt extremely hot to touch got severe pain between shoulder blades pain down legs nd on L hip stomach cramps lots of sneezing and some cough lungs felt very heavy hard to breathe had to keep using albuterol and got headaches also got hives all over my back
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye laser surgery, Laboratory test, Retinal tear, Vitreous detachment, Vitreous haemorrhage
Clinical narrative: Patient had hemorrhagic vitreous detachment, retinal tear.  Treatment was laser surgery and rest. Outcome was back to normal.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Skin lesion, Urticaria
Clinical narrative: Patient called pharmacy on 1/22/203 at approx. 5:20 pm stating that he started developing hives and itching the next day that started on feet and moved to his hands. After doing an internet search regarding the adverse effects of Shingrix, he wanted to know if I, as a pharmacist could offer any other suggestions to treat the hives. He started taking Diphenhydramine and took a cool shower.  He was told that he was doing everything that I would have suggested and said he should follow up with his primary doctor.  A follow up phone call on 1/24/2023 found that he had hives and sores all over his body but quickly resolved and his last dose of Diphenhydramine was 1/23/23 at noon.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ventricular extrasystoles
Clinical narrative: Patient was diagnosed with Premature ventricular contractions in December two months after the shot.
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: PATIENT CAME IN FOR A COVID PRIMARY SECOND DOSE MONOVALENT AND RECEIVED BIVALENT VACCINE BY MISTAKE. PATIENT DIDN'T STATE ANY ADVERSE SYMPTOMS AND CAME BACK IN THE NEXT DAY TO FOLLOW UP ON THE INCIDENT AND ALSO DIDN'T STATE ANY ADVERSE SYMPTOMS. WE HAD CALLED PFIZER AND CDC TO VERIFY OUR NEXT STEPS AND THEY RECOMMENDED NOT NEEDING TO BE REVACCINATED AND BIVALENT CAN COUNT AS A FULL 30 MCG DOSE AND TO CONTINUE REGULAR VACCINE SCHEDULE.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: None vaccine was administered after BUD of 1/20/23
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 12 year old patient was given a Pfizer bivalent 5-11.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; HCP reporting an expired dose of STERILE DILUENT was administered to a patient. Caller stated the dose of STERILE DILUENT was used to reconstitute a dose of MMR II (which was not expired) was administered on 12-DEC-2022; This spontaneous report was received from a nurse and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent, concomitant therapies and previous drugs reactions or allergies were not reported.  On 12-DEC-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) dose given per the prescribing information, lot #U006485, expiration date: 26-FEB-2023, administered for prophylaxis (strength, and route of administration were not provided) reconstitute with an expired sterile diluent (MERCK STERILE DILUENT) dose given per the prescribing information, lot #U031356, expiration date: 23-NOV-2022 (Expired product administered). No additional adverse event was reported.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Product preparation error, Wrong product administered
Clinical narrative: No additional AE/PQC was reported; patient was administered MMRII and VARIVAX on 1/12/2023 that were reconstituted using lidocaine in lieu of the supplied Merck sterile diluent; patient was administered MMRII and VARIVAX on 1/12/2023 that were reconstituted using lidocaine in lieu of the supplied Merck sterile diluent; This spontaneous report was received from medical assistant and refers to a 4-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-JAN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot #W023072, expiration date: 05-APR-2024, administered subcutaneously into right arm; and with varicella virus vaccine live (oka/merck) (VARIVAX) lot #W021740, expiration date: 10-JUL-2024, administered subcutaneously into left arm, for prophylaxis (dose was not provided). Vaccines were reconstituted using lidocaine in lieu of the supplied sterile diluent (vaccine incorrect diluent use, wrong product administered). No additional adverse event (AE) was reported.
Sex: F
Vaccine: HPV4
Symptoms: Aluminium overload, Chronic fatigue syndrome, Postural orthostatic tachycardia syndrome
Clinical narrative: Aluminum intoxication; POTS; CFS; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 13-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), chronic fatigue syndrome (CFS) and aluminum intoxication. 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 aluminum intoxication 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, Orthostatic intolerance, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; orthostatic intolerance; presyncope; dizziness; headache; fatigue; 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 postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, presyncope, 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).    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: POTS; orthostatic intolerance; presyncope; dizziness; headache; fatigue; 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 postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, presyncope, 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).    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: POTS; autonomic dysfunction; orthostatic intolerance; presyncope; dizziness; headache; fatigue; 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), autonomic dysfunction, orthostatic intolerance, presyncope, 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).   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, Presyncope
Clinical narrative: POTS; autonomic dysfunction; orthostatic intolerance; presyncope; dizziness; headache; fatigue; 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), autonomic dysfunction, orthostatic intolerance, presyncope, 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).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Immune-mediated neurological disorder, Orthostatic intolerance, Post vaccination syndrome, Postural orthostatic tachycardia syndrome
Clinical narrative: HANS (HPV vaccination associated neuro-immunopathic syndrome); POTS-Like Symptoms; Orthostatic Dysregulation; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 16-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)-like symptoms, orthostatic dysregulation and HPV vaccination associated neuro-immunopathic syndrome (HANS). 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 HANS 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: Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; palpitations; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 18-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) and palpitations. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered both events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).   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: Orthostatic Intolerance; autonomic dysfunction; presyncope; dizziness; headache; 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 orthostatic intolerance, autonomic dysfunction, presyncope, 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).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Orthostatic Intolerance; autonomic dysfunction; presyncope; dizziness; headache; 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 orthostatic intolerance, autonomic dysfunction, presyncope, 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).   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, Orthostatic intolerance
Clinical narrative: Orthostatic Intolerance; dizziness; headache; 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 orthostatic intolerance, 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).   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
Clinical narrative: POTS; dizziness; headache; 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), 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).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Autonomic nervous system imbalance, Dizziness, Fatigue, Headache
Clinical narrative: Autoimmune Disorder; POTS; orthostatic intolerance; autonomic dysfunction; dizziness; fatigue; headache; 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 autoimmune disorder, postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, fatigue, dizziness, and headache. Reported date of injury was unspecified date in 2013. The outcome of the events were 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 autoimmune disorder 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: Orthostatic intolerance, Postural orthostatic tachycardia syndrome
Clinical narrative: Autoimmune Disorder; POTS; orthostatic intolerance; autonomic dysfunction; dizziness; fatigue; headache; 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 autoimmune disorder, postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, fatigue, dizziness, and headache. Reported date of injury was unspecified date in 2013. The outcome of the events were 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 autoimmune disorder 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: 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 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, 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).   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
Clinical narrative: 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 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, 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).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic neuropathy, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: Autonomic Neuropathy; orthostatic intolerance; Headache; Fatigue; dizziness; 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 autonomic neuropathy, orthostatic intolerance, dizziness, headaches, and 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 autonomic neuropathy 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: MMR
Symptoms: Accidental exposure to product, Product container issue, Product package associated injury, Skin laceration
Clinical narrative: Nurse also reports she cut herself while cleaning out the box of MMR II; one vial is completely shattered; Nurse also reports she cut herself while cleaning out the box of MMR II; Nurse also reports she cut herself while cleaning out the box of MMR II; This spontaneous report was received from a female nurse of unknown age referring to herself.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 18-JAN-2023, the reporter discovered upon opening a box that the vial of started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) subcutaneous injection, lot #W009750, expiration date: 22-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) was broken (product container issue). The vial was completely shattered and everything else was sticky. The lid was stuck to the bottom of the box. Nurse reported the affected product was not available for retrieval as it was completely shattered and has been discarded. On 18-JAN-2023, the reporter cut herself while cleaning out the box (skin laceration, accidental exposure to product, product package associated injury).  At the time of reporting, the outcome of the event was not known.  According to the question section: The damage was noted upon opening the carton. The damage affected the entire vial, everything was sticky. The vial was completely shattered into many pieces. There was a broken glass in the carton. The carton or label did not appear wet, just sticky. The carton or label appear to have been potentially wet in the past and dried. There was not any product remaining in the broken vial. The vial was from a multi-vial carton or tray (10x (ten-by) carton), the affected vial was second row far on the left. The vial's carton was not damaged upon receipt. The product was stored in its original carton after it was received. The shipping container/Styrofoam shipper was not damaged upon receipt. The product was not administered or exposed to patient's bodily fluids. The complaint sample cannot be returned as it has been discarded.   The reporter considered product package associated injury to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The causal relationship between skin laceration and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Postural orthostatic tachycardia syndrome, Presyncope
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Presyncope; Fatigue; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 23-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination postural orthostatic tachycardia syndrome (POTS), headache, dizziness, fatigue and presyncope.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007594: US-009507513-2301USA007602: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007595:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Headache, Orthostatic intolerance, Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Autonomic Dysfunction; Orthostatic Intolerence; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 23-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination postural orthostatic tachycardia syndrome (POTS), headache, dizziness, orthostatic intolerance and autonomic nervus system imbalance.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007498:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Pain, Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Presyncope; Fatigue; Dizziness; Headache; Chronic Pain; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 30-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome, pain, headache, dizziness, fatigue and presyncope.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007498:
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Presyncope; Fatigue; Dizziness; Headache; Chronic Pain; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 30-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome, pain, headache, dizziness, fatigue and presyncope.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007498: