chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9, HEPA, HPV9
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient walked out to waiting room after vaccination and stated she felt light headed. I suggested she sit down in a vacant chair next to me, which she promptly did. In the chair while seated, she had an episode of fainting/syncope with a brief jerking motion suggestive of seizure. Her pupils were dilated and fixed during the episode, as her eyes were open but she was not responding to verbal prompts. I signaled for nursing assistance and patient was moved from the chair safely to the floor, in a supine position. Juice boxes were given to patient in an attempt to increase her blood pressure. She drank two juice boxes and then immediately vomited three times. She was then moved back into an examination room where she laid down for 10 minutes and recovered. Her left arm is sore at the injection site.
Age: 17.0
Sex: F
Vaccine: HPV9, HEPA, HPV9
Symptoms: Syncope, Vomiting
Clinical narrative: Patient walked out to waiting room after vaccination and stated she felt light headed. I suggested she sit down in a vacant chair next to me, which she promptly did. In the chair while seated, she had an episode of fainting/syncope with a brief jerking motion suggestive of seizure. Her pupils were dilated and fixed during the episode, as her eyes were open but she was not responding to verbal prompts. I signaled for nursing assistance and patient was moved from the chair safely to the floor, in a supine position. Juice boxes were given to patient in an attempt to increase her blood pressure. She drank two juice boxes and then immediately vomited three times. She was then moved back into an examination room where she laid down for 10 minutes and recovered. Her left arm is sore at the injection site.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypnagogic hallucination, Narcolepsy, Sleep study, Somnolence
Clinical narrative: After receiving vaccination, symptoms referencing Narcolepsy began to become apparent. Excessive daytime sleepiness and hypnagogic hallucinations evolving and eventually a clinical diagnosis in July 2015.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: Pt was given DTaP at 12 months, gave another dose at her 18 month visit.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Child presented today with large area (approx. 10 cm x 10 cm) with induration on left thigh, very warm and tender to touch. Family member reports symptoms started yesterday evening. No fever. No drainage. Will treat with cephalexin for cellulitis and instructed to give BENADRYL. Apply ice 3-4 times daily. May give ibuprofen for pain. Will see patient back for follow-up and evaluation in 2 days. Family member instructed to call with any changes or if child develops fever.
Age: 16.0
Sex: F
Vaccine: YF
Symptoms: Bladder pain, Burning sensation, Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: 5 minutes post vaccination patient complained of chest and bladder pain described as short and hot. 10 minutes post vaccination patient felt an urgent need to urinate. 15 minutes post vaccination patient begin to urinate, projectile vomit and have extreme diarrhea. This was followed by shortness of breath. Patient projectile vomited 4 times within a 15 minutes span. Patient defecated twice within the same 15 minutes span. Patient shortness of breath lasted approximately 15 to 20 minutes. EMTs arrived approximately 40 minutes after onset of allergic reaction. Patient transported to Hospital for observation and follow up.
Age: 16.0
Sex: F
Vaccine: YF
Symptoms: Micturition urgency, Vomiting projectile
Clinical narrative: 5 minutes post vaccination patient complained of chest and bladder pain described as short and hot. 10 minutes post vaccination patient felt an urgent need to urinate. 15 minutes post vaccination patient begin to urinate, projectile vomit and have extreme diarrhea. This was followed by shortness of breath. Patient projectile vomited 4 times within a 15 minutes span. Patient defecated twice within the same 15 minutes span. Patient shortness of breath lasted approximately 15 to 20 minutes. EMTs arrived approximately 40 minutes after onset of allergic reaction. Patient transported to Hospital for observation and follow up.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Barium double contrast, Enema administration, Intussusception, Ultrasound scan
Clinical narrative: Intussusception; Intense abdominal pain, vomiting
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting, X-ray
Clinical narrative: Intussusception; Intense abdominal pain, vomiting
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Information was receved from a field representative who received information from a pharmacist reporting on a male of unknown age received a dose of ZOSTAVAX, vial for prevention of shingles "a few weeks ago"  (lot # and expiration unknown). Concomitant medication and medical history were unknown. The pharmacist reported that the patient reported to her, he developed itchiness at the injection site. It was unknown if treatment was given to the patient. Outcome was unknown. No other information was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 17-JUL-2017 from a registered nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The registered nurse reported that unspecified patients were administered doses of improperly stored PROQUAD, VARIVAX, or ZOSTAVAX on unspecified dates for prophylaxis. Sterile diluent (unknown Lot numbers and expiration dates) used for reconstitution were properly stored. The following are the names of the vaccines involved with the reported Lot numbers and expiration dates (dose, site of administration and route of administration were not reported): PROQUAD [Lot # M021731, exp date 29-OCT-2017 (The date of 26-OCT-2017 automatically showed in the product screen); Lot # M044022, exp date 01-MAY-2018; Lot # M031566, exp date 24-DEC-2017; Lot # M042500, exp date 17-APR-2018] and VARIVAX [M038857, exp date 14-SEP-2018; M037642, exp date 01-SEP-2018; Lot number N001527 (as reported), exp date 13-JAN-2019; Lot # N014368 (as reported), exp date 09-MAY-2019] and ZOSTAVAX [Lot # M034765, exp date 26-OCT-2017.] The temperature excursion was reported to be 15 degrees Fahrenheit to 46 degrees Fahrenheit (19.6F). The time frame was reported as 13 hours. There was no previous temperature excursions. The call was because of a "data logger." No adverse effects reported. No further information provided. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Syringe issue
Clinical narrative: Information was received from a registered nurse concerning a male patient of unknown age. No information was reported regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on 06-JUL-2017 during vaccination of RECOMBIVAX HB into the patient, 5 mcg/0.5 ml per prefilled syringe (lot # M001578, expiration date 21-NOV-2018), the "plunger rod fell out" of the prefilled syringe. A second separate vaccination of RECOMBIVAX HB was used successfully (lot number not provided). No adverse effects reported. Product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 17-JUL-2017 from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-JUN-2017 the patient was vaccinated with ROTATEQ lot # M046000 expiration 27-JUN-2018 for prophylaxis which was improperly stored. No adverse effects reported. The vaccine was stored at the temperature of 50 degrees Fahrenheit for the time frame of 16 hours. There was no previous temperature excursion. The call was made due to a data logger. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. In 2003, the patient was vaccinated with VARIVAX for prophylaxis. In 2003 the patient experienced herpes zoster. The outcome of herpes zoster was reported as recovered/resolved. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot numbers included were lot# N000238, expiry date25-OCT-2019, lot# N007750, expiry date: 29-NOV-2019, lot# M046134, expiry date: 27-SEP-2019, and lot# N000235,  expiry date: 26-OCT-2019; for prophylaxis. The vaccines were exposed to temperature of  "47°F to 77°F (71.4 F)" for a time frame of 10 hours. Previous temperature excursion was reported which was of  "47°F to 77°F (73F)" for 13 hours. Data logger was involved. No adverse effect reported. No product quality complaint was present. No further details provided.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-JUL-2017, the patient was vaccinated with a dose of PROQUAD injection, lot number N013270, expiration date: 25-OCT-2018 (strength, route and dose were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot # and expiration # was not provided). Other co-suspect or concomitant medications were not reported. On an unknown date, a year later the patient received another dose of GARDASIL which was outside of the prescribing information (inappropriate schedule of drug administration). The outcome of inappropriate schedule of drug administration was unknown. Additional information is not expected as no consent to obtain follow-up information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Pain, Rash vesicular
Clinical narrative: Information was received on 24-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It was reported that the patient was inoculated with a dose of ZOSTAVAX on about 11-MAY-2007 at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JAN-2013, the patient was treated in the emergency department for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles, spreading to his genitals and causing nerve pain. The patient was prescribed famciclovir (manufacturer unknown) for management of his excruciating outbreak. As a direct an proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HEP, PNC13, RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event. Wrong formulation of vaccine given. Patient got a KINRIX instead of a PEDIARIX.
Age: 34.0
Sex: F
Vaccine: ANTH, RAB
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Patient presented to clinic on 26-Jul-2017, in no acute distress, 3 days after receiving Anthrax #6 and Rabies #1 on 23-Jul-2017, with chief complaint of Itching, burning, and swelling to the right deltoid muscle. Physical examination Skin- Deltoid with mild edema and erythema with tightness noted to the muscle. No LAD noted. Patient was given DIPHENHYDRAMINE 25MG, LORATADINE 10MG, and ACETAMINOPHEN 325M. Patient reported relief of symptoms within 4 hours of presenting to clinic with use of medication. Patient released with no work restrictions and to follow up as needed if symptoms do not decrease or worsen. Patient encounter documented in AHLTA.
Age: 34.0
Sex: F
Vaccine: ANTH, RAB
Symptoms: Injection site swelling, Muscle tightness
Clinical narrative: Patient presented to clinic on 26-Jul-2017, in no acute distress, 3 days after receiving Anthrax #6 and Rabies #1 on 23-Jul-2017, with chief complaint of Itching, burning, and swelling to the right deltoid muscle. Physical examination Skin- Deltoid with mild edema and erythema with tightness noted to the muscle. No LAD noted. Patient was given DIPHENHYDRAMINE 25MG, LORATADINE 10MG, and ACETAMINOPHEN 325M. Patient reported relief of symptoms within 4 hours of presenting to clinic with use of medication. Patient released with no work restrictions and to follow up as needed if symptoms do not decrease or worsen. Patient encounter documented in AHLTA.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus generalised
Clinical narrative: Patient his PCP which was not in the office. PCP's nurse called the Health Department to report Patients symptoms. I spoke with the Patient after 5 to 10 minutes after the call He made to the PCP. Patient reported itching from head to toe that started about an hour after vaccine and his lunch. Denied difficulty breathing or swelling. Denied having new foods or food that were not normally in his diet for lunch. Patient took BENADRYL as the packing instructed. Patient reports about 30 minutes after BENADRYL he is fine; no more itching. Patient was not seen in the PCP office or the Emergency room.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling from injection site down to mid arm.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Swelling
Clinical narrative: Patient experiences redness, swelling and discomfort of the arm below the vaccination site, but not at the vaccination site itself.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Hypersensitivity, Rash
Clinical narrative: Pt. went to the ER the day after her PREVNAR shot when a rash that she had had for several days spread and worsened and presented as hives. The ER documented a non-specific allergic reaction without a direct link to the PREVNAR shot due to the patient having reported a chronic and persistent fungal infection and a rash of several days. Pt received prednisone and famotidine for treatment. Patient reported to be much better within 2 days, but was seeing her dermatologist for follow-up on the allergic reaction and history of skin disorder.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Painful at injection site with raised red rash radiating from upper left arm down to forearm.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Painful at injection site with raised red rash radiating from upper left arm down to forearm.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose normal, Dizziness, Nausea, Pallor, Syncope
Clinical narrative: At 3:35PM patient felt dizzy then experienced an episode of syncope in waiting room after menactra vaccine administration at 3:32 PM. No fall was witnessed as she was sitting in a chair at time of incident. Mother was with her and called for help. Within seconds of arrival, patient started to come back to. Face was pale. Voiced knowledge of name and place. Expressed nausea, no vomiting. Fasting blood sugar 104. She did eat lunch prior to coming to the office. Given water and protein bar now which she ate and tolerated well. VS 3:39PM 110/40 BP sitting, 60 pulse 40 , 99% o2 and 14 resps VS 3:40 PM BP 89/55 sitting, pulse 60 O2 99% and resps 14 VS taken at 3:57PM 90/60 BP, pulse 67, 02 97% , resps 15. Patient reported nausea resolved, color returned to face. VS 4:03 BP 89/62 , pulse 67, o2 99% and resps 15 VS 4:07 pm 85/60 O2 99%, pulse 64, resps 14 Patient expressed feeling "completely normal". Heart regular rate and rhythm, lung fields clear. Walked to car with supervision from nurse and mother. Voiced that similar experience has occurred in the past surrounding an injection. Encouraged to call the office as needed.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient noted to have redness and swelling to site that night. Mom put hydrocortisone on it, and it seemed bigger. Itches and hurts. Mom brought child in on 7/26 because area is now approx. 4cm x 4cm in size, warm to touch, tender
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Pain, Pyrexia, Visual impairment
Clinical narrative: Pt developed fever 103.1, severe headache, body aches, numbness in fingers and toes, visual disturbances.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pt has redness around site and a small edema around area with shoulder pain.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 14-JUL-2017 from a registered nurse regarding an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The registered nurse reported that an unspecified number of unspecified patients were administered improperly stored doses of PROQUAD lot # M002053, expiration 11-JUL-2017 subcutaneous for prophylaxis on 01-JUN-2015, 05-JUN-2017, 19-JUN-2017, 21-JUN-2017 and 27-JUN-2017. No adverse effects. The vaccines were stored at a temperature range of 47 degrees Fahrenheit to 77 degrees Fahrenheit for the time frame of 7 hours. There was no previous temperature excursion. The call was made due to a data logger. No further information to report. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 11-JUL-2017 via a phone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 (Lot number M042853, expiration 17-JUL-2019) was administered to a patient on 03-JUL-2017 (age and gender not provided; only the initials of the patient were provided). The GARDASIL 9 had been stored in at 32 to 35 degrees Fahrenheit for 2 hours and 30 minutes. There had been a previous temperature excursion of 32 to 35 degrees Fahrenheit for 15 minutes. The registered nurse had reported this due to a data logger. No adverse effects were reported. No further information was provided. Additional information was requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 15 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 01-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. It was reported that the patient missed the second and third doses of GARDASIL 9 and subsequently on 20-JUL-2017, the patient visited the office to receive the next dose. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47 Fahrenheit degrees (°F) to 77 Fahrenheit degrees (°F) for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with GARDASIL 9 lot # M036059 for prophylaxis. On 2017 the patient experienced incorrect product storage. The vaccine was exposed from 47°F to 77°F for 12 hours. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered no adverse event and incorrect product storage to be not related to GARDASIL 9. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 (lot # M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008799; US-009507513-1707USA008817: US-009507513-1707USA008818: US-009507513-1707USA008819: US-009507513-1707USA008862: US-009507513-1707USA008863: US-009507513-1707USA008793: US-009507513-1707USA008820: US-009507513-1707USA008821: US-009507513-1707USA008839: US-009507513-1707USA008864: US-009507513-1707USA008865: US-009507513-1707USA008794: US-009507513-1707USA008822: US-009507513-1707USA008823: US-009507513-1707USA008840: US-009507513-1707USA008866: US-009507513-1707USA008867: US-009507513-1707USA008795: US-009507513-1707USA008824: US-009507513-1707USA008825: US-009507513-1707USA008841: US-009507513-1707USA008868: US-009507513-1707USA008869: US-009507513-1707USA008796: US-009507513-1707USA008826: US-009507513-1707USA008827: US-009507513-1707USA008828: US-009507513-1707USA008842: US-009507513-1707USA008870: US-009507513-1707USA008797: US-009507513-1707USA008829: US-009507513-1707USA008830: US-009507513-1707USA008843: US-009507513-1707USA008798: US-009507513-1707USA006643: US-009507513-1707USA008832: US-009507513-1707USA008844: US-009507513-1707USA008845: US-009507513-1707USA008800: US-009507513-1707USA008833: US-009507513-1707USA008801: US-009507513-1707USA008802: US-009507513-1707USA008834: US-009507513-1707USA008846: US-009507513-1707USA008803: US-009507513-1707USA008804: US-009507513-1707USA008835: US-009507513-1707USA008847: US-009507513-1707USA008848: US-009507513-1707USA008805: US-009507513-1707USA008806: US-009507513-1707USA008849: US-009507513-1707USA008850: US-009507513-1707USA008807: US-009507513-1707USA008808: US-009507513-1707USA008851: US-009507513-1707USA008852: US-009507513-1707USA008853: US-009507513-1707USA008789: US-009507513-1707USA008809: US-009507513-1707USA008810: US-009507513-1707USA008854: US-009507513-1707USA008855: US-009507513-1707USA008790: US-009507513-1707USA008811: US-009507513-1707USA008812: US-009507513-1707USA008836: US-009507513-1707USA008856.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an improperly storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, for prophylaxis (dose and route of administration were not reported). The vaccine was exposed to a temperature between 47°F to 77°F for 12 hours. There was no previous temperature excursion reported. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 47 Fahrenheit degrees (°F) to 77 Fahrenheit degrees (°F) for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 24-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX on or about 10-NOV-2015, administered by his physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent  strain of herpes zoster. On or about 22-NOV-2015, the patient was on vacation when she was rushed to an urgent care center for treatment of a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir (manufacturer unknown) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 24-JUL-2017 from a lawyer concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 05-NOV-2012 at a medical center, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAR-2016, the patient was treated in the emergency room for the onset of a blistering vesicular rash accompanied by a weakened immune system, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 24-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX on or about 07-NOV-2011 at a medical facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-AUG-2014, the patient was treated by her physician for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster. or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 24-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 29-SEP-2008 at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-MAR-2011, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAY-2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-NOV-2016, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular, Vaccination failure
Clinical narrative: Information was received on 24-JUL-2017 from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about August 2012, the patient was vaccinated at a local pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-NOV-2012, the patient was treated for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. His condition worsened as the shingles spread to his eyes. On or about 07-NOV-2012, he was treated by eye surgeon for treatment of shingles in the eye, diagnosed as herpes zoster keratitis with vision interference. The patient has been treated continuously for ongoing issues with his eyes secondary to herpes zoster keratitis. As a direct an proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review the event of herpes zoster keratitis was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Information was received on 24-JUL-2017 from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about August 2012, the patient was vaccinated at a local pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-NOV-2012, the patient was treated for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. His condition worsened as the shingles spread to his eyes. On or about 07-NOV-2012, he was treated by eye surgeon for treatment of shingles in the eye, diagnosed as herpes zoster keratitis with vision interference. The patient has been treated continuously for ongoing issues with his eyes secondary to herpes zoster keratitis. As a direct an proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review the event of herpes zoster keratitis was determined to be medically significant. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: The following morning she developed a paresthesia in both legs where they felt numb, and this lasted for 5 days, which made her and her mom feel very anxious and worried about it.  No other symptoms, no muscle weakness or paralysis, no pain in her legs, no dizziness, no visual problems.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Vaccination site rash
Clinical narrative: Employee was given the MMR vaccine in L arm, 30 minutes later employee called the clinic stating that she was developing a rash in the area where she was given the vaccine. The next day she did develop a fever that lasted for 2 days.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Migraine
Clinical narrative: Migraine.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Expired product administered
Clinical narrative: Vaccine was drawn up and administered. Afterwards when logging vaccine was noted that dose had expired in May 2017.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was drawn up and administered. Afterwards when logging vaccine was noted that dose had expired in May 2017.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site reaction, Injection site vesicles
Clinical narrative: Immediately following the administration of PCV13 and MMRV, in the Right Thigh, the thigh became reddened and had a bleb of what appeared to be fluid beneath the skin. Initially the bleb measured 1 cm and redness measure 42 mm. After 5 minutes the bleb had increased to 2 cm and redness to 42 mm.
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling to entire thigh, red, hard area 3" x 2" to injection site.
Age: 4.0
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Abdominal pain, Diarrhoea, Pruritus generalised, Rash generalised, Sneezing
Clinical narrative: 5 minutes after vaccines given, patient started sneezing and clearing throat.  No wheeze or stridor on exam. Pulse Ox 99%. At 12:52 Zyrtec 7.5 mg given by mouth and within a few minutes sneezing and clearing throat resolved. Then developed abdominal pain, loose stool x 2. At 13:25 Tylenol 320 mg given by mouth. Pain resolved over the next 20 minutes. He was observed for 1 hour after the Zyrtec was given. At that time point he developed a bright red rash on face, trunk and extremeties with itching. No definite urticaria or petechiae. No pain and acting normal. At 13:57 Prednisolone 37.5 mg given. At this point, outpatient observation is warranted. Anticipate observation at least overnight.  More aggressive treatment for anaphylaxis if symptoms progress or worsen.
Age: 4.0
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Throat irritation
Clinical narrative: 5 minutes after vaccines given, patient started sneezing and clearing throat.  No wheeze or stridor on exam. Pulse Ox 99%. At 12:52 Zyrtec 7.5 mg given by mouth and within a few minutes sneezing and clearing throat resolved. Then developed abdominal pain, loose stool x 2. At 13:25 Tylenol 320 mg given by mouth. Pain resolved over the next 20 minutes. He was observed for 1 hour after the Zyrtec was given. At that time point he developed a bright red rash on face, trunk and extremeties with itching. No definite urticaria or petechiae. No pain and acting normal. At 13:57 Prednisolone 37.5 mg given. At this point, outpatient observation is warranted. Anticipate observation at least overnight.  More aggressive treatment for anaphylaxis if symptoms progress or worsen.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Skin rash localized to right upper arm where the vaccine was given.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Impaired work ability, Joint range of motion decreased, Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Patient received his vaccination at an onsite clinic and administered by onsite nurse (at work). Patient had pain after the shot which steadily got worse. He was seen at our clinic on Feb 2016 complaining of shoulder pain after the injection. Got an intra-articular injection to the shoulder which didn't help.  Range of motion got severe restricted. He self-referred to a chiropractor in 2016 who treated it with what sounds like TENS unit, ultrasound and exercises. This improved the range of motion but pain is still present. Pain was a 10/10 initially; now down to a 5-6/10. Causes sharp pain with certain movements - affecting job as mechanic and interfering with rest/sleep.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Therapeutic procedure, Ultrasound therapy
Clinical narrative: Patient received his vaccination at an onsite clinic and administered by onsite nurse (at work). Patient had pain after the shot which steadily got worse. He was seen at our clinic on Feb 2016 complaining of shoulder pain after the injection. Got an intra-articular injection to the shoulder which didn't help.  Range of motion got severe restricted. He self-referred to a chiropractor in 2016 who treated it with what sounds like TENS unit, ultrasound and exercises. This improved the range of motion but pain is still present. Pain was a 10/10 initially; now down to a 5-6/10. Causes sharp pain with certain movements - affecting job as mechanic and interfering with rest/sleep.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient inner arm swollen, painful, and red. She is taking ibuprofen and BENADRYL and using cold compresses.
Age: 68.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, X-ray limb
Clinical narrative: About 4 hours after receiving the flu vaccine, I experienced acute pain in my upper left arm and shoulder when trying to raise my arm. I have had ongoing pain when raising my arm, reaching back or across my chest since then. I have had 5 weeks of PT with little improvement.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Chest discomfort, Dizziness, Headache, Hypoaesthesia oral, Palpitations
Clinical narrative: Chest tightness, palpitations, dizziness, headache, generalized itchiness, lip numbness, throat tightness - symptoms improved after Benadryl 25mg though headache persists today.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus generalised, Throat tightness
Clinical narrative: Chest tightness, palpitations, dizziness, headache, generalized itchiness, lip numbness, throat tightness - symptoms improved after Benadryl 25mg though headache persists today.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Haematemesis, Seizure
Clinical narrative: Throwing up blood.  Seizures.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Migraine, Muscle spasms, Myalgia, Pain
Clinical narrative: Migraine headache - Left forehead; pounding pain lasting several hours. 400mg MOTRIN OTC - for pain; rest. Muscle ache - Legs bilaterally effected with cramps lasting 1-2 hours. Rest/400mg MOTRIN.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Disorientation, Dizziness, Syncope
Clinical narrative: Patient fainted, pharmacist laid him down on the floor gently, 911 was called, EMTs checked him out and said he was OK;patient was dizzy/disoriented for 5-10 minutes after the initial syncope.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, Expired product administered, Extra dose administered, Wrong drug administered
Clinical narrative: On 6-14/17 I was  given  a verbal order to give the patient a DTaP, Polio, Hib, PREVNAR 13 and Rotavirus. I got up from my desk where I had been entering vaccines, went to the refrigerator and grabbed the vaccines ordered. I came back to the lab area and asked another employee to assist me, which she had done in the past and again willingly. I have a system that I have used for years when giving vaccines to make it easier when documenting, so I know what vaccines I want to go together and where. Since that employee does not like to give the PREVNAR vaccine, I began drawing up the PREVNAR and Hib to go in one leg and she began drawing up the DTaP and Polio to go in the other.  In the midst of drawing up the vaccines, another employee stopped us in the middle and asked why we were giving four vaccines instead of PENTACEL and PREVNAR. I immediately realized and told her I was thinking PEDIARIX due to just seeing it on a patient's vaccine record and I knew I wasn't giving a Hep B so that is why I grabbed the four individual vaccines. I told her that you can administer several vaccines at one time, which is even noted on the CDC webpage. We talked about the individual vaccines again, but since they were already opened and drew up, if they were not used right then, they would have been wasted and thrown away. Nothing more was said. We went and administered the vaccines to the patient. I then finished rooming the rest of my patients for the day, making and returning patients calls, working on pre-cert/prior authorizations, faxing documents, as well as documenting the vaccines/injections given that day. On July 5th, it was brought to my attention that the DTaP I gave had expired on June 11, 2017. The provider researched the vaccine and afterwards I informed the patient's mom of the error. I told her that no harm would come to child for receiving the expired vaccine, but the dose would have to be repeated at his 9 month well child checkup. In the past six months, multiple vaccine errors have been made with different employees. The one lady that stopped me asking why I was giving so many vaccines was giving KINRIX to infants until our lead manager at the time noticed and told her not to do that anymore since it was only to be given to children 4-6 years olds. Since then our team lead is no longer there and this same employee took over being the vaccine coordinator. VFC and private vaccines was being tossed in together so on a few incidents private vaccines was given to VFC patients and vice versa. Multiple expired vaccines was in the refrigerator. Some vaccines were expired on the box, but written on box with expiration not expiring for another year. After my error, I went through and organized the vaccine refrigerator, so no other errors could be made.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Patient presented to the clinic with a large redness at site of injection. Measured at 8 cm by 6 cm. treated with Diphenhydramine syrup and hydrocortisone cream.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site rash, Pain, Pyrexia
Clinical narrative: Fever, pain, chills, rash at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: He was seen at clinic for his 4-yo WCC 2 days prior to visit and received varicella vaccine in R thigh. His school first noticed a reddish area on the left upper thigh 7/25/17 which was non-painful. Since yesterday, the area of redness has doubled in size, remains warm to touch, and is starting to become tender to touch. He has been afebrile. No other rashes. He has never had any reaction to any vaccine. He is walking without difficulty.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large, raised red patch covering most of upper left thigh where vaccine was administered. Hot to the touch, though no fever is present. Child says it does not itch or hurt.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, TDAP
Symptoms: Asthenia, Nausea, Syncope, Tremor
Clinical narrative: Fainting, quaking, extreme nausea and weakness for more than 6 hours.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, TDAP
Symptoms: Abdominal pain, Blood glucose normal, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Fainting, quaking, extreme nausea and weakness for more than 6 hours.