chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired quality of life, Nausea, Tinnitus
Clinical narrative: This is the second time I have had severe tinnitus after a Pfizer Covid-19 shot. It was bad after the second shot and much worse - often debilitating - after the third shot. It makes me dizzy and nauseous and is unrelenting. I experienced severe headaches after the first shot which lasted about 5 weeks, until i ended up taking aspirin,w hich seemed to help. No tinnitus to speak of then. But the second two shots have left me with progressively worse tinnitus. This is not something I've ever had in my life before, and it is destroying my quality of life!! I am not on any other medications, and I do not have any other health conditions. I am healthy, not overweight, exercise well. But the ringing in my ears will not go away or subside and I don't know what to do!! Please help! It very clearly started right after the vaccine, and I resent articles saying there is no proof of this being caused by the vaccine. it is very clearly caused by the vaccine!
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular disorder, Chest pain, Hypoaesthesia, Pain, Swelling
Clinical narrative: Circulatory issues in patient. chronic pain and swelling in complete left side, toes going numb, pain in chest.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Electric shock sensation, Headache, Immediate post-injection reaction
Clinical narrative: Immediate pain at injection site then an intense ache radiating down forearm into wrist and hand which gradually subsided over about 15 minutes.  Felt light headed and dizzy but able to walk around.    Increased "racing" heart which subsided over about 15 minutes.   At 30 minutes after injection I experienced an intense electrical shock sensation EXACTLY in the middle of the top of my head.   I can still locate the exact location and there is still a "sensation" in this location.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pain in extremity, Palpitations
Clinical narrative: Immediate pain at injection site then an intense ache radiating down forearm into wrist and hand which gradually subsided over about 15 minutes.  Felt light headed and dizzy but able to walk around.    Increased "racing" heart which subsided over about 15 minutes.   At 30 minutes after injection I experienced an intense electrical shock sensation EXACTLY in the middle of the top of my head.   I can still locate the exact location and there is still a "sensation" in this location.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Tinnitus
Clinical narrative: The evening of the day I received the second dose of Pfizer, I noticed a ringing sound in my left ear that began very suddenly.  It's continuous and hasn't stopped since I received the second dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Cerebrovascular accident, Laboratory test, Optic ischaemic neuropathy
Clinical narrative: Exactly one week after getting the Covid vaccine due to a mandate by the Governor in order to keep my job I lost vision in the top part of my left eye.  I first went to the Clinic to the eye dr.  She stated I had an optic nerve stroke.  I was referred to a neuro ophthamologist at Hospital.  I don't remember his name. He stated the same thing - but called it an ischemic Optic neuropathy.  He stated that it could have been caused by the vaccine or by my diabetes. However, since I have been diabetic for 14 plus years it is more likely from the vaccine.  He would not put that in writing however.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Injection site pain, Nasal congestion, Nausea
Clinical narrative: Headache, stuffy nose, extremely sore throat difficult to swallow, sore arm injection site, nausea Taking Tylenol
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Malaise, Nausea, Pallor
Clinical narrative: Verified patient's name/DOB/allergies. nurse administered the vaccines correctly and sent patient to observation because he received the meningitis vaccine which causes some patients to become dizzy, nauseated.  When I went to check on the patient 5 mins later, he looked pale and was having cold sweats. The patient said he sees "white" and did not feel well at all. Patient stated that he was not having any difficulty breathing but he did feel like vomiting. I assisted the patient to vomit, but only spit. Patient's vitals were monitored and patient was given water to sip on.  Vitals:  09:35a BP @ 89/55 | O2 @ 99% | P @ 81 09:45a BP @ 106/74 | O2 @ 99% | P @ 81 09:55 BP @ 108/73 | O2 @ 99% | P @ 70  Patient was taken to school principal's office to lie down and speak with his father, which made him feel better. Patient pallor returned to normal and patient verbally stated that he felt good. Patient was then sent back to class.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Visual impairment
Clinical narrative: Verified patient's name/DOB/allergies. nurse administered the vaccines correctly and sent patient to observation because he received the meningitis vaccine which causes some patients to become dizzy, nauseated.  When I went to check on the patient 5 mins later, he looked pale and was having cold sweats. The patient said he sees "white" and did not feel well at all. Patient stated that he was not having any difficulty breathing but he did feel like vomiting. I assisted the patient to vomit, but only spit. Patient's vitals were monitored and patient was given water to sip on.  Vitals:  09:35a BP @ 89/55 | O2 @ 99% | P @ 81 09:45a BP @ 106/74 | O2 @ 99% | P @ 81 09:55 BP @ 108/73 | O2 @ 99% | P @ 70  Patient was taken to school principal's office to lie down and speak with his father, which made him feel better. Patient pallor returned to normal and patient verbally stated that he felt good. Patient was then sent back to class.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Discomfort, Hepatic enzyme, Hepatitis, Hepatomegaly, Immediate post-injection reaction
Clinical narrative: Immediately after receiving my third dose of the Pfizer Covid vaccine I began to have pain in my right side under my ribs.  The sensation was pressure under my ribs over the next few weeks.  I made an appointment during the holidays to see my primary care provider and was able to make an appointment in January.  However the pressure became worse and spread to my entire mid abdomen and was shooting in nature.  I went to the ER and was diagnosed with hepatitis with no changes in my labs.  I followed up with my physician and he diagnosed me with NASH and I continue to have daily pain even after losing 20 pounds.  My labs continue to remain unchanged.  My doctor suggested that I report my NASH diagnosis to the government so that they can track the incidence of hepatitis occuring after the third booster shots.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test normal, Musculoskeletal chest pain, Non-alcoholic steatohepatitis, Pain, Scan with contrast
Clinical narrative: Immediately after receiving my third dose of the Pfizer Covid vaccine I began to have pain in my right side under my ribs.  The sensation was pressure under my ribs over the next few weeks.  I made an appointment during the holidays to see my primary care provider and was able to make an appointment in January.  However the pressure became worse and spread to my entire mid abdomen and was shooting in nature.  I went to the ER and was diagnosed with hepatitis with no changes in my labs.  I followed up with my physician and he diagnosed me with NASH and I continue to have daily pain even after losing 20 pounds.  My labs continue to remain unchanged.  My doctor suggested that I report my NASH diagnosis to the government so that they can track the incidence of hepatitis occuring after the third booster shots.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound abdomen, Weight decreased
Clinical narrative: Immediately after receiving my third dose of the Pfizer Covid vaccine I began to have pain in my right side under my ribs.  The sensation was pressure under my ribs over the next few weeks.  I made an appointment during the holidays to see my primary care provider and was able to make an appointment in January.  However the pressure became worse and spread to my entire mid abdomen and was shooting in nature.  I went to the ER and was diagnosed with hepatitis with no changes in my labs.  I followed up with my physician and he diagnosed me with NASH and I continue to have daily pain even after losing 20 pounds.  My labs continue to remain unchanged.  My doctor suggested that I report my NASH diagnosis to the government so that they can track the incidence of hepatitis occuring after the third booster shots.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Menstruation delayed, Migraine
Clinical narrative: Worst migraine I have ever experienced for almost 10 hours. could not stomach anything.  period was late every month by 4-5 days for 4+ months following 2nd dose. my period hsa never been late since I started menstruating at 12 years old.  I also became pregnant in Dec 2020 and miscarried at 6 weeks pregnant. I was seen at the ER For this miscarriage
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Immediate post-injection reaction
Clinical narrative: Tinnitus, began immediately after dose 2 and still have it more than a year later.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX underwent a temperature excursion, and the VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent.  On 01-MAR-2022 (also reported as 01-MAR-2023), the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot# U016063, expiration date 20-MAY-2023, at a dose 0.5 milliliter (route of administration and dose number were not provided) for prophylaxis (product storage error). The vaccine was diluted with sterile diluent (0.5ml, lot# reported as T029529, expiration date reported as 16-APR-2023). The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.3 Celsius degree for 40 minutes. No previous temperature excursion involved. No additional adverse event (AE) or product quality complaints (PQC) was reported.
Sex: U
Vaccine: HEPA
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No additional AE reported; HBP stated an adult patient was administered a pediatric dose of VAQTA by mistake.; This spontaneous report was received from a healthcare business professional and refers to an adult patient of unknown gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 02-MAR-2022, the patient was by mistake vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 ml (dose number, route of administration, anatomical location, lot # and expiration date were not provided) or prophylaxis (Accidental underdose). No additional adverse event was reported (No adverse event).
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; vaccine administered after temperature excursion occurred; This spontaneous report was received from a registered Medical Assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 01-FEB-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #T037957 was confirmed to be valid, expiration date 09-MAY-2022 (albumin status rHA), administered for prophylaxis (strength, and route of administration were not provided). The temperature excursion was 9.9 degrees Fahrenheit (F) for 13 hours. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA001996: US-009507513-2203USA001996:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccines were administered after temperature excursion; This spontaneous report has been received from an office manager regarding a patient of an unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.  On 25-OCT-2021, the following vaccine had undergone temperature excursion at temperature of 6 up to 14 Fahrenheit degree for 4 hours and 14 up to 46 Fahrenheit degree for 4 hours and 45 minutes: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (valid lot # U017140, valid expiration date: 28-NOV-2022) 0.5 mL (strength, route, and anatomical location were not provided) as prophylaxis. Additionally, 0.5 ml of diluent MRK was administered. The vaccine was administered after the excursion (product storage error). There was no previous temperature excursion. No additional adverse event (AE) was reported.; Sender's Comments:  US-009507513-2203USA001850:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; a temperature excursion/ vaccines were administered after the excursion; This spontaneous report was received from an office manager and concerns a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.   On 02-NOV-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) 0.5 ml, lot # U017140 was confirmed to be valid, expiration date 28-NOV-2022, (route of administration was not reported (product storage error). The administered dose was exposed to the temperature of 6 degrees Fahrenheit (F) up to 14 F for 4 hours and 14 F up to 46 F for 4 hours and 45 minutes. The temperature excursion was identified right away and there were no reported adverse events. There were no previous temperature excursions.   This is one of several reports received from the same reporter.; Sender's Comments:  US-09507513-2203USA001716: US-09507513-2203USA001612: US-09507513-2203USA001617: US-09507513-2203USA001688: US-09507513-2203USA001728: US-09507513-2203USA001850: US-09507513-2203USA001890: US-009507513-2203USA001578: US-009507513-2203USA007379:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; vaccine administered after temperature excursion occurred; This spontaneous report was received from a registered Medical Assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 14-FEB-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #T037957 was confirmed to be valid, expiration date 09-MAY-2022 (albumin status rHA), administered for prophylaxis (strength, and route of administration were not provided). The temperature excursion was 9.9 degrees Fahrenheit (F) for 13 hours. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA001390:
Sex: F
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient who does not meet criteria to receive GARDASIL 9 because "patient is in her 50s", but is planning to receive GARDASIL 9; There was no report of GARDASIL 9 being administered at time of the call; No additional AE reported.; This spontaneous report was received from a medical assistant and refers to a female patient who is in her 50s. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The reporter stated that on an unknown date, the patient was planning to receive a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), despite the fact she did not meet criteria to be vaccinated due to her age (product administered to patient of inappropriate age, circumstance or information capable of leading to medication error). No additional adverse event reported.
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: the patient's mumps titer was low; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient was a nurse. Her pertinent medical history and drug reactions or allergies were not provided. Concomitant therapies included tildrakizumab (ILUMYA). The reporter did not know if the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in the past.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient's mumps titer was low (mumps antibody test negative). The outcome of the event was unknown.  The relatedness between the event and the suspect therapy was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of MMR II; no additional AE reported; This spontaneous report was received from a medical assistant and refers to patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 01-MAR-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot number T007233 with expiration date 27-FEB-2022 (expired product administered), (dose, route, anatomical location were not reported) for prophylaxis. No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No PQC reported; VARIVAX mistakenly administered to a patient instead of PROQUAD; This spontaneous report was received from a physician assistant referring to a 4 years old male patient of unknown gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 11-MAR-2021, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter subcutaneously for prophylaxis (lot # T002847, expiration date 23-JAN-2022). It was supposed to be Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) that was administered but it was documented in the system that varicella virus vaccine live (Oka/Merck) (VARIVAX) was given (wrong product administered). No PQC reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE reported; patient was accidently administered a dose of V ARlV AX and PROQUAD on 17-MAR-2022; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not reported.  On 17-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), once, (lot number T022315, expiration date 30-JUN-2022) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant human albumin) (PROQUAD), once, (lot number U002535, expiration date 24-JUL-2022) for prophylaxis (accidental overdose). For both vaccines dose, formulation, route of administration and injection site were not provided. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 17-MAR-2022, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rHA)) (PROQUAD) dose 0.5 milliliter (lot# U029147 verified as valid with expiration date: 16-MAR-2023) (dose number, frequency, route of administration and anatomical location were not provided) for prophylaxis. The aforementioned vaccine underwent a temperature excursion of 9 degrees Fahrenheit for 1 hour and 25 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Autoimmune disorder, Autonomic nervous system imbalance, Blood pressure decreased, Chronic fatigue syndrome
Clinical narrative: autonomic, neurological, heterogenous autoimmune disease; autonomic dysfunction; POTS; radiating pain, body aches; Post-HPV Vaccination Syndrome; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 11-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 17-SEP-2018, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) both for preventing cervical cancer.  On 04-SEP-2019, she was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Shortly after received the second dose, she experienced generalized radiating pain throughout her body and body weakness, specifically her legs. She could not walk further that a city block without needing assistance. She began constantly complaining of many abnormalities including drops in blood pressure, shortness of breath, radiating pain, body aches, heart palpitations and an ongoing fatigue. The patient was seen by physician who stated that she had the symptom complex of headache, fleeting pains, fatigue, dizziness and paresthesias occurring after HPV vaccination. This new Post-HPV Vaccination Syndrome had been described by different clinicians from different parts of the world. Post-HPV Vaccination Syndrome resembles chronic fatigue syndrome/fibromyalgia.  Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including, but not limited to, autonomic dysfunction. Plaintiffs contends that patient human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, POTS, and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her Gardasil-induced autoimmune disorder. Autoimmune Disease and Other Related Injuries and had resulted in her suffering from severe, debilitating, disabling and painful chronic injuries.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Fatigue, Fibromyalgia, Gait disturbance
Clinical narrative: autonomic, neurological, heterogenous autoimmune disease; autonomic dysfunction; POTS; radiating pain, body aches; Post-HPV Vaccination Syndrome; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 11-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 17-SEP-2018, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) both for preventing cervical cancer.  On 04-SEP-2019, she was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Shortly after received the second dose, she experienced generalized radiating pain throughout her body and body weakness, specifically her legs. She could not walk further that a city block without needing assistance. She began constantly complaining of many abnormalities including drops in blood pressure, shortness of breath, radiating pain, body aches, heart palpitations and an ongoing fatigue. The patient was seen by physician who stated that she had the symptom complex of headache, fleeting pains, fatigue, dizziness and paresthesias occurring after HPV vaccination. This new Post-HPV Vaccination Syndrome had been described by different clinicians from different parts of the world. Post-HPV Vaccination Syndrome resembles chronic fatigue syndrome/fibromyalgia.  Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including, but not limited to, autonomic dysfunction. Plaintiffs contends that patient human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, POTS, and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her Gardasil-induced autoimmune disorder. Autoimmune Disease and Other Related Injuries and had resulted in her suffering from severe, debilitating, disabling and painful chronic injuries.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Loss of personal independence in daily activities, Muscular weakness, Nervous system disorder, Pain
Clinical narrative: autonomic, neurological, heterogenous autoimmune disease; autonomic dysfunction; POTS; radiating pain, body aches; Post-HPV Vaccination Syndrome; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 11-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 17-SEP-2018, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) both for preventing cervical cancer.  On 04-SEP-2019, she was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Shortly after received the second dose, she experienced generalized radiating pain throughout her body and body weakness, specifically her legs. She could not walk further that a city block without needing assistance. She began constantly complaining of many abnormalities including drops in blood pressure, shortness of breath, radiating pain, body aches, heart palpitations and an ongoing fatigue. The patient was seen by physician who stated that she had the symptom complex of headache, fleeting pains, fatigue, dizziness and paresthesias occurring after HPV vaccination. This new Post-HPV Vaccination Syndrome had been described by different clinicians from different parts of the world. Post-HPV Vaccination Syndrome resembles chronic fatigue syndrome/fibromyalgia.  Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including, but not limited to, autonomic dysfunction. Plaintiffs contends that patient human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, POTS, and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her Gardasil-induced autoimmune disorder. Autoimmune Disease and Other Related Injuries and had resulted in her suffering from severe, debilitating, disabling and painful chronic injuries.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Paraesthesia, Post vaccination syndrome, Postural orthostatic tachycardia syndrome
Clinical narrative: autonomic, neurological, heterogenous autoimmune disease; autonomic dysfunction; POTS; radiating pain, body aches; Post-HPV Vaccination Syndrome; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 11-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 17-SEP-2018, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) both for preventing cervical cancer.  On 04-SEP-2019, she was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Shortly after received the second dose, she experienced generalized radiating pain throughout her body and body weakness, specifically her legs. She could not walk further that a city block without needing assistance. She began constantly complaining of many abnormalities including drops in blood pressure, shortness of breath, radiating pain, body aches, heart palpitations and an ongoing fatigue. The patient was seen by physician who stated that she had the symptom complex of headache, fleeting pains, fatigue, dizziness and paresthesias occurring after HPV vaccination. This new Post-HPV Vaccination Syndrome had been described by different clinicians from different parts of the world. Post-HPV Vaccination Syndrome resembles chronic fatigue syndrome/fibromyalgia.  Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including, but not limited to, autonomic dysfunction. Plaintiffs contends that patient human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, POTS, and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her Gardasil-induced autoimmune disorder. Autoimmune Disease and Other Related Injuries and had resulted in her suffering from severe, debilitating, disabling and painful chronic injuries.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient was administered expired PROQUAD; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not provided.  On 18-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) 0.5 ml, lot # T028297 was confirmed to be valid, expiration date 16-FEB-2022 (expired product administered) (route of administration and injection site were not provided) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a patient was administered PROQUAD after a temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, and drug reactions or allergies was provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) (lot number T018038 is an invalid lot number for sterile diluent (MERCK STERILE DILUENT). Lot number T018038 does not match any Company product as confirmed by Lot Verification team).   On 21-MAR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) at a dose of 0.5 ml for prophylaxis (lot number U039255 was verified to be a valid lot number, expiration date: 09-JUN-2023; route of administration, vaccination scheme frequency, and anatomical location were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion at minus 14 degree Celsius up to minus 10 degree Celsius (minus 10.8 degree Celsius) for 0 hours 45 minutes and 0 seconds, and at minus 10 degree Celsius up to 8 degree Celsius (minus 5 degree Celsius) for 1 hour, 0 minutes and 0 seconds. The vaccine was reconstituted with the sterile diluent, however, sterile diluent was not improperly stored. There were no previous temperature excursions. No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; vaccine stored out of recommended storage range was administered to patient; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 11-MAR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot #T027937, expiration date reported as 08-AUG-2022 but upon internal validation established as 18-AUG-2022, for prophylaxis (strength, dose and route of administration were not provided). The administered vaccine was stored out of recommended storage range (product storage error). No additional adverse event (AE) reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No further adverse events; PROQUAD was administered via IM route.; This spontaneous report was received from a nurse referring to a 5 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 25-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose, for prophylaxis (exact dose, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported) via intramuscular route (incorrect route of product administration). No further adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; administration of expired vaccine; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 25-MAR-2022, the patient was vaccinated with a 0.5 ml expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection given once (lot number: t032150, expiration date: 20-MAR-2022; route of administration, vaccination scheme frequency, and anatomical location not reported) for prophylaxis (expired product administered). There were no prior temperature excursions. The reporter inquired about safety and potency of the vaccine after expiration. No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurts a lot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR053700   Additional Information: GSK Receipt Date: 23-Mar-2022 Reporter's Comments: This case was received from consumer via interactive digital media.  Additional Supportive Information: The patient self-reported this report. The patient called and stated that received 2 doses of Shingrix and hurts a lot but supposed to be vastly better than the earlier one. For tolerance of 2nd dose, refer case US2022AMR053700.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR053700:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurts a lot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date and experienced pain, refer case US2022AMR053688).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR053688   Additional Information: GSK Receipt Date: 23-Mar-2022 Reporter's Comments: This case was received from consumer via  interactive digital media.  Additional Supportive Information: The patient self-reported this report. The patient called and stated that received 2 doses of Shingrix and hurts a lot but supposed to be vastly better than the earlier one.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR053688:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Deal with shingles even though I got the vaccine; I deal with shingles all the time; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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: 23-Mar-2022 Reporter's Comments: The case was received from consumer via interactive digital media. The patient deal with shingles all the time even though he/she got the vaccination. Additional Supportive Information: The patient self-reported this case. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received the MenA lyophilized component diluted with sterile water; received the MenA lyophilized component diluted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adult male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-March-2022 Additional Supportive Information: The nurse reported that the patient received dose of Menveo component diluted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further information reported. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022054955:Same reporter - duplicate - FU1
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had my first dose in 2019 and my 2nd dose last week; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient had received first dose of Shingrix in 2019).   In March 2022, the patient received the 2nd dose of Shingrix. In March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 25-MAR-2022 Reporter's Comments: The patient self-reported this case. The patient received second dose in last week prior to reporting date. The reporter wanted to know he/she required to take another dose. The reporter had not provided any contact information. Additional Supportive Information: The patient received 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received first injection 3 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received almost 3 years before the date of reporting).   On 21st March 2022, the patient received the 2nd dose of Shingrix. On 21st March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 24-March-2022 Additional Supportive Information: The patient self-reported this case via Shingrix GSK Chatbot. The patient received 2nd dose of Shingrix dose this past Monday, which led to lengthening of vaccination schedule. The patient asked if this could be considered his/her 2nd dose or had too much time elapsed. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gastrointestinal disorder, Nausea, Vomiting
Clinical narrative: She experienced dizziness; gastrointestinal symptoms; Symptoms such as nausea; Symptoms such as vomiting; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than a day after receiving Shingrix, the patient experienced dizziness, gastrointestinal symptom nos, nausea and vomiting. On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the gastrointestinal symptom nos, nausea and vomiting were recovered/resolved.   It was unknown if the reporter considered the dizziness, gastrointestinal symptom nos, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was unknown as patient could be 60 years or 61 years old at the time of vaccination. The patient refused to provide full demographics and refused to provide healthcare professional information. The reporter wanted to know additional information on symptoms experienced after Shingrix.  The reporter explained that she received Shingrix about 5 and a half months ago approximately in October 2021 (exact date not provided).  The patient stated that she experienced dizziness as well as gastrointestinal symptoms such as nausea and vomiting on the same day after receiving the vaccine and informed that the gastrointestinal symptoms had since resolved but the dizziness was persisting.  The reporter was provided medical advice disclaimer and information on adverse reactions per package insert. The reporter refused to provide health care professional information. The reporter did not consent to follow-up.