chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blood test, Dyspnoea, Erythema, Gait disturbance, Muscular weakness
Clinical narrative: Pain and redness in arm, entire body had sever muscle aches, high temperatures, short of breath, muscle weakness, struggle to walk, White blood count elevated. Patient states he came to clinic to be evaluated two days after in a wheelchair, and was short of going to the Emergency room.
Age: 50.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia, Wheelchair user, White blood cell count increased
Clinical narrative: Pain and redness in arm, entire body had sever muscle aches, high temperatures, short of breath, muscle weakness, struggle to walk, White blood count elevated. Patient states he came to clinic to be evaluated two days after in a wheelchair, and was short of going to the Emergency room.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse event; inadvertently administered a dose of RECOMBIVAX instead of ENGERIX-B; This spontaneous report as received from a medical assistant (also reported as nurse) refers to a 23- year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 28-MAY-2020, the patient was inadvertently vaccinated with a dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thimerosal-free injection, lot # R028529, expiry date 09-JUN-2021 (dose, route of administration and vaccination site were not specified) instead of hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B). No additional adverse event was reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: had the shingle shots end of 2018; Shingle in my eye; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th September 2018, the patient received the 1st dose of Shingles vaccine. On 3rd December 2018, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional information was received as follows: The patient's age at vaccination was not reported, however it was captured as adult as per vaccine indication. The patient received Shingrix and experienced shingles in eye. This case considered as suspected vaccination failure as time to onset from 2nd dose was not satisfying criteria. The reporter consented for follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling of body temperature change, Hyperhidrosis, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: hot and cold; Achy feeling/ achy mostly in his legs and left arm hurts; fever; sweats; Awoke after 13 hours of sleep; This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 3rd March 2020, refer case US2020AMR090729).   On 26th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). In May 2020, less than a week after receiving Shingrix, the patient experienced tiredness. On 26th May 2020, the patient experienced fever, sweating and pain in extremity. On 27th May 2020, the patient experienced feeling hot and cold. On an unknown date, the outcome of the fever and pain in extremity were unknown and the outcome of the sweating and feeling hot and cold were not recovered/not resolved and the outcome of the tiredness was recovering/resolving.   It was unknown if the reporter considered the fever, sweating, feeling hot and cold, pain in extremity and tiredness to be related to Shingrix.  Additional information was provided as follows: The patient claimed that he had two nights of fever, an achy feeling and sweats that started on the evening of  the day of vaccination. On 27th May 2020, 1 day after receiving vaccine, the patient went to bed at 8:00 PM and awoke after 13 hours of sleep and called out of work today. The patient was hot and cold at the time of reporting and achy mostly in his legs and his left arm hurts. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: hot and cold; Achy feeling/ achy mostly in his legs and left arm hurts; fever; sweats; Awoke after 13 hours of sleep; This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 3rd March 2020, refer case US2020AMR090729).   On 26th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). In May 2020, less than a week after receiving Shingrix, the patient experienced tiredness. On 26th May 2020, the patient experienced fever, sweating and pain in extremity. On 27th May 2020, the patient experienced feeling hot and cold. On an unknown date, the outcome of the fever and pain in extremity were unknown and the outcome of the sweating and feeling hot and cold were not recovered/not resolved and the outcome of the tiredness was recovering/resolving.   It was unknown if the reporter considered the fever, sweating, feeling hot and cold, pain in extremity and tiredness to be related to Shingrix.  Additional information was provided as follows: The patient claimed that he had two nights of fever, an achy feeling and sweats that started on the evening of  the day of vaccination. On 27th May 2020, 1 day after receiving vaccine, the patient went to bed at 8:00 PM and awoke after 13 hours of sleep and called out of work today. The patient was hot and cold at the time of reporting and achy mostly in his legs and his left arm hurts. The reporter consented to follow up.
Age: 26.0
Sex: F
Vaccine: HPV9, TD
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Myalgia
Clinical narrative: On Monday, 06/01/2020, we had a patient that received her third HPV vaccine and a Tenivac vaccine. She came in this morning complaining of back spasms and muscle pain that began three hours after receiving the vaccines. When she arrived she was walking briskly with a normal gait with no apparent distress. She stated that she was unable to report to work yesterday or today due to the severity of her pain. Staff and I gave her copies of the VIS for both vaccines and discussed them with her. We also reviewed both vaccine inserts and explained to her that this was not normally a side effect to these vaccines.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Skin warm, Swelling
Clinical narrative: Patient's mother called on 06/03/2020 at 10:26am and stated that the patient and her noticed around Noon on 06/02/2020 that he had redness and swelling on his left arm, as well as he was having pain and the skin that was red was more warm to the touch than other skin in the area. Mother stated that it had gotten worse over night and when they woke up on 06/03/2020 that he was having more pain, swelling, and spread out redness in the area which both vaccines were administered. Mother was advised to ice the area as well as to treat with Motrin as needed. Patient was seen VIA Telemedicine on 06/03/2020 by CPNP-PC to see the redness and swelling. Patient and mother were advised to continue to monitor the area, continue to move arm around, Use moist warm compresses to the left deltoid 3 times a day for 2-3 days as well as take Ibuprofen 400-600mg 4 times daily with food for 2-3 days and that we would follow up with them on Friday  06/05/2020 to see how the arm is doing and to see if the redness and swelling has went down.
Age: 18.0
Sex: F
Vaccine: FLU4, HEP, MNQ, TDAP
Symptoms: Burning sensation, Hypersensitivity, Injection site rash
Clinical narrative: Patient complain of acute allergic reaction after receiving immunizations. Patient reported burning rash on bilateral upper arms denies throat swelling, difficulty breathing  or GI distress. Patient given benedryl and observed for an extended period with improvement in rash appearance. Benedryl prescribed and next day follow up scheduled with precautions to seek emergency treatment for oral, respiratory or GI distress.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient stated that about 24 hours later she has developed a red swollen area that is warm to the touch.  She states her arm is sore.  She does not have a fever.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: After receiving the second Shingles vaccine, the next day I was covered in a full body rash.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash
Clinical narrative: Rash
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pustule, Rash maculo-papular, Urticaria
Clinical narrative: 1) pox-trunk & face -maculopapular rash 2) Arms, legs, buttocks - urticaria Diphenhydramine Q4-5 hours Afebrile, normal behavior
Age: 75.0
Sex: M
Vaccine: FLUC4
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: & SIRVA
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PPV, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Developing fever 1 day after 6 month shots given. -temp max 101 degree F improved after 1 day. -Also developed mild diarrhea 2 days after given shots. Condition self improved.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Ophthalmic herpes zoster
Clinical narrative: vision loss; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 27-SEP-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, route, dose, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a clinic for long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequent to vaccination), the patient was treated for vision loss and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was considered to be medically significant.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Dysgeusia, Fatigue, Influenza like illness
Clinical narrative: woke up with EXTREMELY painful joints....i was tearful during movement...entire body-worse pain than any arthritis flare i have ever had. my fingers/hands were extremely painful.  my neck was sore throughout the day and night, sore throat, stuffiness...  my entire body felt like i had the flu. at 1st i was afraid i may have covid because i had an hour or two later in afternoon that i was experiencing a taste and smell of a metallic something. i had an initial temp of 101.8. my temp averaged 101 over the course of the day and night.  i was very tired all day and night. i developed an itchy nonraised rash on my abdomen at around 5:00 pm.  so i took a benadryl. i also took my hydrocodone 4 x from morning until  11 pm when i was finally able to fall asleep.  it helped with the pain for only a few hours at a time. i actually went back to bed early afternoon- which is totally uncharacteristic for me.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: woke up with EXTREMELY painful joints....i was tearful during movement...entire body-worse pain than any arthritis flare i have ever had. my fingers/hands were extremely painful.  my neck was sore throughout the day and night, sore throat, stuffiness...  my entire body felt like i had the flu. at 1st i was afraid i may have covid because i had an hour or two later in afternoon that i was experiencing a taste and smell of a metallic something. i had an initial temp of 101.8. my temp averaged 101 over the course of the day and night.  i was very tired all day and night. i developed an itchy nonraised rash on my abdomen at around 5:00 pm.  so i took a benadryl. i also took my hydrocodone 4 x from morning until  11 pm when i was finally able to fall asleep.  it helped with the pain for only a few hours at a time. i actually went back to bed early afternoon- which is totally uncharacteristic for me.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Parosmia, Rash, Rash pruritic, Tearfulness
Clinical narrative: woke up with EXTREMELY painful joints....i was tearful during movement...entire body-worse pain than any arthritis flare i have ever had. my fingers/hands were extremely painful.  my neck was sore throughout the day and night, sore throat, stuffiness...  my entire body felt like i had the flu. at 1st i was afraid i may have covid because i had an hour or two later in afternoon that i was experiencing a taste and smell of a metallic something. i had an initial temp of 101.8. my temp averaged 101 over the course of the day and night.  i was very tired all day and night. i developed an itchy nonraised rash on my abdomen at around 5:00 pm.  so i took a benadryl. i also took my hydrocodone 4 x from morning until  11 pm when i was finally able to fall asleep.  it helped with the pain for only a few hours at a time. i actually went back to bed early afternoon- which is totally uncharacteristic for me.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Electroencephalogram normal, Full blood count normal, Magnetic resonance imaging brain normal, Pyrexia, Rash
Clinical narrative: Received vaccines on 5/19. On 5/27, had seizure activity. Hospitalized, normal CBC, EEG, and MRI. Then on 5/28 developed fever x1-2 days up to 101. Fever resolved and developed full body rash on 5/30. Rash resolved in about 1 day.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Seizure
Clinical narrative: Received vaccines on 5/19. On 5/27, had seizure activity. Hospitalized, normal CBC, EEG, and MRI. Then on 5/28 developed fever x1-2 days up to 101. Fever resolved and developed full body rash on 5/30. Rash resolved in about 1 day.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: UPON INJECTION PATIENT FELT FAINT, HAD TO SIT WITH HEAD BETWEEN KNEES, COOL RAG ON BACK OF NECK.  BECAME ADAMANT ABOUT GETTING UP TO GO OUTSIDE DUE TO BEING HOT.  ASSISTED BY MYSELF AND RN TO WALK PATIENT OUTSIDE.  AT ENTRANCE DOOR PATIENT PASSED OUT, LOWERED TO THE GROUND BY RN.  HE DID HIS HIS HEAD ON THE FLOOR FROM APPROXIMATELY 2 INCHES FROM THE FLOOR.  HAD PATIENT AND MOM STAY AT OFFICE FOR 30 MINUTES PRIOR TO ALLOWING THEM T LEAVE.  PATIENT WAS GIVEN A DRINK OF SODA AND MOM WAS GOING TO LOCAL CONVENIENCE STORE TO GET HIM FOOD UPON LEAVING OFFICE.  MOM STATED HE HAD NOT EATEN LUNCH YET ON THIS DAY.  INSTRUCTED MOM ON SIGNS TO MONITOR FOR CONCUSSION, RECOMMENDED PATIENT TO BE EVALUATED AT PCP.  CALLED MOM THE NEXT DAY WHO REPORTED CHILD WAS DOING FINE WITH NO CONCERNS.
Age: 39.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Pain
Clinical narrative: achy and chills starting at 7:30 pm and felt better the following evening around 7:30pm
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itchy, red area around injection site bout the size of a fist. Red and itchy. Patient has been taking Benadryl and using cortisone cream. Area is better per patient
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired vaccine.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom called the morning of 06/02/20 and stated that patient's right thigh was the size of a tennis ball with redness and swelling and the area was tender to touch. Mom was advised to apply cold compresses and give OTC Benadryl for the next 24 hours and call back if symptoms worsened. Mom called back today 06/03/20 stating that symptoms are worse and patient is limping. provider saw patient with the following description to the rt thigh (Area of erythema, mild tenderness, no drainage, not warm. ) Pt was prescribed the following medications and treatment plan:1) orapred 1 tsp once a day for three days 2) clindamycin 1 tsp twice a day for one week 3) 7ml of Benadryl at bedtime only 4) continue to use tylenol if needed for pain, 5) call on Friday 06/05/2020 with update
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site erythema, Injection site papule, Local reaction, Pyrexia
Clinical narrative: Localized reaction- Small pink papule Left upper lateral thigh, Fever
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anion gap normal, Anisocytosis, Bacterial test negative, Blood calcium normal, Blood chloride normal
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood creatinine normal, Blood culture, Blood glucose normal, Blood osmolarity normal, Blood pH normal
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood potassium normal, Blood prolactin increased, Blood sodium normal, Blood urea normal, Blood urine present
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Carbon dioxide normal, Chest X-ray normal, Chromaturia, Computerised tomogram head normal, Drug screen negative
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyspnoea, Electroencephalogram normal, Eosinophil count normal, Eosinophil percentage, Eye movement disorder
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Glucose urine absent, Haematocrit normal, Haemoglobin normal, Hyporesponsive to stimuli, Influenza A virus test negative
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Influenza B virus test, Influenza virus test negative, Lethargy, Lymphocyte count increased, Lymphocyte percentage increased
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume normal, Mental status changes
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Metabolic function test, Monocyte count normal, Monocyte percentage decreased, Neutrophil count decreased, Neutrophil percentage decreased
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nitrite urine absent, Platelet count normal, Poikilocytosis, Procalcitonin normal, Protein urine absent
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Red blood cell burr cells present, Red blood cell count normal, Red blood cell microcytes present, Red blood cell morphology abnormal, Red blood cells urine negative
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Red cell distribution width normal, Respiratory syncytial virus test negative, Specific gravity urine decreased, Urine ketone body absent, White blood cell count normal
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: White blood cells urine negative, pH urine normal
Clinical narrative: Pt noted to be lethargic, eyes rolling backward, decreased responsiveness in ER 7 days after previous well visit; mother noting same with difficulty breathing prior to arrival in ER.  pt was admitted to hospital.  CT and EEG wnl.  Later seen by neurology and scheduled to return as needed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Redness  Soreness Headache  Fever Chills Tired Aches
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness  Soreness Headache  Fever Chills Tired Aches
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eye movement disorder, Unresponsive to stimuli
Clinical narrative: Mother reports baby rolling her eyes backward and not responding to mother and that she took baby to the ER but nothing was noted to be wrong.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Swelling and redness at injection site - area of swelling 3" x 4", area of redness and itching 2" x 3"; lethargy and fatigue beginning 6/2/20; headache beginning around noon 6/2/20; upset stomach beginning 10pm on 6/1/20;  shivering and fever beginning about 5pm on 6/2/20; fever spiked to 102.4 at 8 pm 6/2/20; additional ibuprofen broke fever 11:30 pm; some lingering fatigue and muscle ache on 6/3/20.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Lethargy, Myalgia, Pyrexia
Clinical narrative: Swelling and redness at injection site - area of swelling 3" x 4", area of redness and itching 2" x 3"; lethargy and fatigue beginning 6/2/20; headache beginning around noon 6/2/20; upset stomach beginning 10pm on 6/1/20;  shivering and fever beginning about 5pm on 6/2/20; fever spiked to 102.4 at 8 pm 6/2/20; additional ibuprofen broke fever 11:30 pm; some lingering fatigue and muscle ache on 6/3/20.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Headache, muscle ache, fatigue, sore arm, nausea
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: MA, administered Hep A to five day old child in error. Hepatitis B had been ordered.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: THE PATIENT ACCIDENTLY RECEIVED 3 DOSES OF SHINGRIX INSTEAD OF THE RECOMMENDED TWO DOSES. THE DOSES WERE GIVEN ON 01-20-20, 05-12-20 AND 05-26-20. THE PATIENT DID NOT HAVE ANY ADVERSE EVENTS WITH RECEIVING THE THIRD DOSE.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea. Dizziness
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; On 29-APR-2020 an improperly stored VARIVAX was administered to a patient.; This spontaneous report as received from  a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided.   On 29-APR-2020,  the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S025913 has been verified to be a valid lot number, expiration date reported as  20-AUG-2021), for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported.   Administered dose of vaccine experienced the temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-11.2 Celsius degrees)  for 9 hours and 58 minutes and  of -9 Celsius degrees to 8 Celsius degrees   (3 Celsius degrees)  for 13  hours and 35 minutes. Data logger was not involved. There were no previous excursions reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not provided. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, she was treated by a healthcare provider for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome not herpes zoster was considered to be not recovered.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Herpes Zoster Ophthalmicus; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 30-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered a bad case of herpes zoster ophthalmicus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster ophthalmicus was not recovered and causal relationship was assessed as related.   The lawyer considered the event herpes zoster ophthalmicus to be disability.   Upon internal review, the event herpes zoster ophthalmicus was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 22-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered a bad case of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was not recovered and causal relationship was assessed as related.   The lawyer considered the event shingles to be disability.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Accidental underdose, No adverse event, Wrong technique in product usage process
Clinical narrative: No additional adverse event; inadvertently administering less fuan a full recommended dose of GARDASIL 9.; fuat is was due to user error, she had removed fue syringe before fue entire amount was injected; This spontaneous report was received from a medical assistant referring to a 27 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 28-MAY-2020, the patient was inadvertently vaccinated with less than a full recommended dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R023609, expiration date 30-APR-2021; strength, dose, frequency and route were not reported) for prophylaxis (accidental underdose and wrong technique in product usage process). It was due to user error, the medical assistant had removed the syringe before the entire amount was injected. No additional adverse event was reported.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R023609; expirationdate: 30-APR-2021; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Herpes zoster, Pain, Skin lesion
Clinical narrative: severe,painful and debilitating shingles, consisting of bands of blisters and lesions across chest,stomach and back; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-AUG- 2016, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at a health department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). Subsequently, pt. vaccination the pt, suffered severe painful and debilitating shingles, consisting of bands of blisters and lesions across pt's chest, stomach and back, on an unknown date. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic significant conscious pain and suffering, consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as  mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).  Herpes zoster was considered to be disabling.
Sex: F
Vaccine: HPV4
Symptoms: Cardiac disorder, Fatigue, Kyphosis, Loss of consciousness, Renal disorder
Clinical narrative: became unconscious after the second; movement that looks like seizures; Kidney disease; heart complications; kyphosis; Fatigued; Vomiting; This spontaneous report was received from a female patient of unknown age reporting on herself.   The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with the first and second doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  Since unspecified dates in 2007 (reported as since 2007 or 2008), after receiving two separate doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the patient experienced the following events: became unconscious after the second (loss of consciousness), heart complications (cardiac disorder), fatigued, vomiting, kyphosis, movement that looks like seizures (seizure like phenomena), and kidney disease (nephropathy) (It was not clarified if the events started at the same time, in what order occurred, and after which dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) occurred). No treatment was given for the events. The outcome of the events was reported as not recovered. The causal relationship between the suspect vaccine and the events was not reported.  Upon internal review, the events loss of consciousness and seizure like phenomena were determined to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Seizure like phenomena, Vomiting
Clinical narrative: became unconscious after the second; movement that looks like seizures; Kidney disease; heart complications; kyphosis; Fatigued; Vomiting; This spontaneous report was received from a female patient of unknown age reporting on herself.   The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with the first and second doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  Since unspecified dates in 2007 (reported as since 2007 or 2008), after receiving two separate doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the patient experienced the following events: became unconscious after the second (loss of consciousness), heart complications (cardiac disorder), fatigued, vomiting, kyphosis, movement that looks like seizures (seizure like phenomena), and kidney disease (nephropathy) (It was not clarified if the events started at the same time, in what order occurred, and after which dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) occurred). No treatment was given for the events. The outcome of the events was reported as not recovered. The causal relationship between the suspect vaccine and the events was not reported.  Upon internal review, the events loss of consciousness and seizure like phenomena were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia; Mental and emotional distress; This initial spontaneous report was received from a lawyer on 01-JUN-2020, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 12-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving the vaccination), the patient suffered post herpetic neuralgia. As a direct and proximate result vaccination, the patient's symptoms have resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of vaccination, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; a dose of improperly stored GARDASIL 9 was administered to a patient; This spontaneous report was received from a nurse prescriber referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-MAY-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route and anatomical location not reported) for prophylaxis (product storage error). Lot number for improperly stored vaccines were reported as R020200 with expiration date of 05-MAY-2021 and R036913 with expiration date of 23-SEP-2021. However, the specific lot number of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered to the patient was unknown. The vaccine was stored at a temperature of 34 Fahrenheit (below 36 Fahrenheit) for 18 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint (PQC) was present. No additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: Instrument, Surgical, Disposable (KDC); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R020200; expirationdate: 05-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was inadvertently administered with a dose of Pneumovax23 which expired on 26-MAR-2020; No adverse effect reported; This spontaneous report was received from a Nurse Practitioner reporting about a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions or concomitant medications was not reported.     On 02-JUN-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R017900 that expired on 26-MAR-2020 (dose number, dose, route of administration or anatomical location were not reported). No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: R017900; expirationdate: 26-MAR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold Sores; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced cold sores. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the cold sores was recovered/resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix and experienced cold sores. The reporter did not consented for follow up.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: large local reaction, entire R upper arm swollen and painful and maximum temperature of 100.3