chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 27-APR-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "1", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Age: 0.75
Sex: M
Vaccine: HEP, MMR, YF
Symptoms: Injection site bruising, Injection site erythema, Vaccination site mass
Clinical narrative: Initial unsolicited report received from a physician on 05-JUN-2017. This case involves a nine months old male patient who was vaccinated with a first dose of YF VAX (batch number UI266ab, expiry date, dose and route of administartion was not reported) at left thigh on 30-May-2017. Patient's medical history reported as none. Concomitant medications included as vaccination with HEPATITIS B VACCINE (Heb B) and with MEASLES, MUMPS AND RUBELLA VACCINE (MMR) on unspecified date. On 05-Jun-2017, six days following the vaccination, the patient experienced a welt like lump over the vaccination site, a bullseye type ring on his left thigh with a dark redddish spot in the center and measured it to be 2 cm by 1cm with no heat but bruising noted at the center. It was reported that the patient required emergency room/doctor visit. Laboratory investigations was reported as none. Patient received no corrective treatment. It was reported that patient did not recovered from the events. List of documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cough, Decreased appetite, Influenza like illness, Oral discomfort
Clinical narrative: Initial unsolicited report received from a consumer on 06-Jun-2017. This case involves a 35-year-female patient (also reported as 36 year) who was vaccinated with a dose of INFLUENZA VACCINE (Unknown Flu) and tested with TUBERCULIN PPD (Unknown PPD) intramuscularly (Batch number, expiration date, dose, dose in series and site of administration were not reported) on 17-Apr-2017. Patients medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Illness at the time of vaccination was also reported as none. Any other vaccinations within four weeks of vaccinations were unknown. On 18-Apr-2017, one day (since the day) after following the vaccination, the patient started cough, weakness and flu like symptoms. On an unknown date, following vaccination patient developed burning in her mouth and throat had no appetite after receiving (NAPROXEN SODIUM) Aleve and corocidin (reported as Corocidin). Patient had been to the emergency room 4 times and the doctor visit was 5 times and some weeks it was 2 times in the week. They have given her medicines but, she doesn't take them they don't help. She has another appointment with her primary care physician advised her to continue his follow up recommendations. Laboratory investigations was unknown. Corrective treatment were Aleve 2 times and a weeks of corocidin (reported as Corocidin). The outcome of the events were not recovered. List of documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Throat irritation
Clinical narrative: Initial unsolicited report received from a consumer on 06-Jun-2017. This case involves a 35-year-female patient (also reported as 36 year) who was vaccinated with a dose of INFLUENZA VACCINE (Unknown Flu) and tested with TUBERCULIN PPD (Unknown PPD) intramuscularly (Batch number, expiration date, dose, dose in series and site of administration were not reported) on 17-Apr-2017. Patients medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Illness at the time of vaccination was also reported as none. Any other vaccinations within four weeks of vaccinations were unknown. On 18-Apr-2017, one day (since the day) after following the vaccination, the patient started cough, weakness and flu like symptoms. On an unknown date, following vaccination patient developed burning in her mouth and throat had no appetite after receiving (NAPROXEN SODIUM) Aleve and corocidin (reported as Corocidin). Patient had been to the emergency room 4 times and the doctor visit was 5 times and some weeks it was 2 times in the week. They have given her medicines but, she doesn't take them they don't help. She has another appointment with her primary care physician advised her to continue his follow up recommendations. Laboratory investigations was unknown. Corrective treatment were Aleve 2 times and a weeks of corocidin (reported as Corocidin). The outcome of the events were not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) on 30 May 2017. Manufacture control number: 2017222696. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergies to influenza vaccine. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness, Deafness, Feeling hot, Pallor, Syncope
Clinical narrative: Fainting with difficulty reviving. Event lasted approximately 3 minutes and 2 ammonia packets were used with limited success. Patient reported that she was unable to hear or see during event. After initial event, patient was taken by wheelchair to room to lie down where she reported feeling hot though she was cool to the touch. It took approximately 10-15 minutes for her to recover color and feel well enough to speak with staff.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 67 year old male patient. On an unknown date in June 2015 (reported as two years ago), the patient was vaccinated with PREVNAR 13. No other information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in May 2017 (reported as last week), the patient was vaccinated with PNEUMOVAX 23, injection in the arm (dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2017 (reported as after receiving PNEUMOVAX 23), the patient's arm was swollen from injection site to elbow accompanied by being red, hot, and painful. The patient sought medical attention by contacting the office. On the next day, 02-JUN-2017, the patient was coming in for a follow-up visit. At the time of the report, the patient did not recover from the adverse events. There was no product quality complaint involved. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 01-JUN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (exact dose was not reported), via intramuscular route, lot # L036437 with expiration date of 18-MAY-2017. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and concomitant therapies provided. In approximately February 2013 the patient has received first dose of PNEUMOVAX 23 for prophylaxis. In approximately May 2017, the patient was vaccinated with second dose of PNEUMOVAX 23 lot # M022947, expiration date 12-NOV-2017 (dose and route of administration were not reported) for prophylaxis. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information was received on 06-JUN-2017 from a physician via a company representative regarding a 65 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2017 the patient received PNEUMOVAX 23 (lot # M043424, expiration date unknown, dose not reported) for the prevention of pneumonia. On 04-MAY-2017 the injection site "was hot to touch and patient's left arm swelled from the injection site down to her elbow." The patient sought medical attention by sending a picture of her left arm to the physician's office. Treatment was received (not further specified). The symptoms lasted for 4-5 days. The patient recovered. No further information was provided. The physician did not rate the causal relationship. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV9, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an unspecified amount of patients. Patient demographics, medical histories, concurrent conditions and concomitant medication usage were not provided. From 06-APR-2017 to 06-JUN-2017 an unspecified amount of patients received improperly stored doses of vaccines. The temperature excursions ranged from 32 degrees Fahrenheit to 35 degrees Fahrenheit. Time frame = 528 hours. There was no previous temperature excursion. The findings were not the result of a data logger. The vaccines involved included the following: PNEUMOVAX 23 lot # M037533, expiration date 17-MAY-2018; GARDASIL 9 Lot# M018810, expiration date 28-MAY-2018; ROTATEQ Lot# M031802, expiration date 09-NOV-2017; VAQTA Lot# M038572, expiration date 11-MAY-2018; RECOMBIVAX HB Lot# L023387, expiration date 22-JUN-2017 and Lot# M037771, expiration date 21-FEB-2019.  No adverse effects were reported. Additional information is not expected as the reporter stated that there was no further information to provide.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 30-MAY-2017 (reported as "today"), the patient was vaccinated with an expired dose of VAQTA 50 U/1.0 ml, injection (lot # M040421, expiration date: 26-MAY-2017; exact dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015651:
Sex: F
Vaccine: HPV9
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter; a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 08-JUN-2017, the patient was scheduled to receive GARDASIL, but that day, after the administration of the vaccine a nurse indicated to the reporter that the patient was vaccinated with Hepatitis A vaccine (manufacturer unknown). However, after a lot verification it was confirmed that the patient was vaccinated with GARDASIL 9 (dose, route and expiration date were not reported) (lot # M040412) for prophylaxis. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative and refers to a 60-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. In approximately 2016 (reported as "roughly a year ago"), the patient was vaccinated with ZOSTAVAX (19400 plaque-forming units, PFU) subcutaneously (dose, anatomical location, lot # and expiration date were not reported), for prevention of herpes zoster. On 15-MAY-2017, the patient had gotten shingles after being vaccinated with with ZOSTAVAX. The patient sought medical attention and saw a physician, who gave her acyclovir 800 mg, for 7 days as a treatment for her shingles. The outcome of shingles was unknown at the time of the report. No product quality complaint (PQC) was involved. The causality assessment between the event of shingles and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and drug reactions or allergies was provided. On 13-JUN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD injection (lot # M041508, expiration date: 09-APR-2018; exact dose and route of administration were not reported). The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of PROQUAD was stored at the temperature of -9 to 8 degrees Celsius (C) for 18 hours 52 minutes, on unknown dates. Previous temperature excursions included storage at the temperature of -9 to 8 degrees C for 13 hours 37 minutes, on unknown dates. Data logger was used to detect temperature excursions. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-JUN-2017, the patient was vaccinated with the improperly stored (15.8 degrees Fahrenheit for 3 hours) dose of PROQUAD (for prophylaxis, lot # M041083, expiration date 04-APR-2018, albumin status rHA; dose and route of administration were not reported) that was reconstituted with the correctly stored sterile diluent (lot # N003192, expiration date 05-JUL-2019 (also reported as 27-MAR-2018)). No previous temperature excursion and no adverse effects were reported. Data logger was involved. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Agitation, Anxiety, Asthenia, Dizziness, Gait disturbance
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 57-year-old male patient. The patient's concurrent conditions included cerebral palsy, mild bipolar disorder and mild psychosis, as well as allergies to aspirin (manufacturer unknown), ibuprofen, unspecified penicillin, erythromycin, CIPRO, ZANAFLEX and COMPAZINE. On 28-MAR-2017, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (exact dose, lot# and expiry date were not reported), intramuscularly as a general vaccination. His concomitant therapies included HARVONI, CELEXA, ATIVAN and "other unspecified medications". On an unknown date in 2017, reported as "an unspecified time after the vaccination", the patient became agitated and irritable. Subsequently, on 09-MAY-2017, the patient received the second dose of RECOMBIVAX HB injection (exact dose, lot# and expiry date were not reported), intramuscularly. On an unknown date in 2017, the patient could not feed himself (he went from feeding himself every meal to only 30% of the time), was dizzy and weak. On 12-MAY-2017, the reporting nurse could not wake the patient up from bed, he was unresponsive. On the same day, the patient was taken to the emergency room due to the unresponsiveness and inability to be woken up, and subsequently admitted to the hospital due to those events (also reported as "due to an unspecified reason") on the same date. The patient underwent unspecified tests while at the hospital (reported as: "he was thoroughly worked up"; no result was provided) and was discharged on 15-MAY-2017 with no diagnosis, however he was "a little bit better". On unknown dates in 2017, after being discharged from the hospital, the patient experienced seizure-like movements, incontinence, migraines, paresthesia, insomnia, anxiety, tachycardic episodes and neck stiffness. Anxiety was treated with VISTARIL. On an unknown date in 2017, the patient experienced gait disturbance (reported as "went from not needing lateral supports to needing them"). The nurse also reported that the patient's symptoms were intermittent. The outcome of the events was not reported. The relatedness between the events and RECOMBIVAX HB was not reported. The reporter considered the events of "could not feed himself" and gait disturbance ("needing lateral supports") to be disabling. Upon internal review, the events of unresponsiveness and seizure-like movements were determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA008253: US-009507513-1706USA008675.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Incontinence, Insomnia, Irritability, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 57-year-old male patient. The patient's concurrent conditions included cerebral palsy, mild bipolar disorder and mild psychosis, as well as allergies to aspirin (manufacturer unknown), ibuprofen, unspecified penicillin, erythromycin, CIPRO, ZANAFLEX and COMPAZINE. On 28-MAR-2017, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (exact dose, lot# and expiry date were not reported), intramuscularly as a general vaccination. His concomitant therapies included HARVONI, CELEXA, ATIVAN and "other unspecified medications". On an unknown date in 2017, reported as "an unspecified time after the vaccination", the patient became agitated and irritable. Subsequently, on 09-MAY-2017, the patient received the second dose of RECOMBIVAX HB injection (exact dose, lot# and expiry date were not reported), intramuscularly. On an unknown date in 2017, the patient could not feed himself (he went from feeding himself every meal to only 30% of the time), was dizzy and weak. On 12-MAY-2017, the reporting nurse could not wake the patient up from bed, he was unresponsive. On the same day, the patient was taken to the emergency room due to the unresponsiveness and inability to be woken up, and subsequently admitted to the hospital due to those events (also reported as "due to an unspecified reason") on the same date. The patient underwent unspecified tests while at the hospital (reported as: "he was thoroughly worked up"; no result was provided) and was discharged on 15-MAY-2017 with no diagnosis, however he was "a little bit better". On unknown dates in 2017, after being discharged from the hospital, the patient experienced seizure-like movements, incontinence, migraines, paresthesia, insomnia, anxiety, tachycardic episodes and neck stiffness. Anxiety was treated with VISTARIL. On an unknown date in 2017, the patient experienced gait disturbance (reported as "went from not needing lateral supports to needing them"). The nurse also reported that the patient's symptoms were intermittent. The outcome of the events was not reported. The relatedness between the events and RECOMBIVAX HB was not reported. The reporter considered the events of "could not feed himself" and gait disturbance ("needing lateral supports") to be disabling. Upon internal review, the events of unresponsiveness and seizure-like movements were determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA008253: US-009507513-1706USA008675.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Migraine, Musculoskeletal stiffness, Paraesthesia, Seizure like phenomena, Somnolence
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 57-year-old male patient. The patient's concurrent conditions included cerebral palsy, mild bipolar disorder and mild psychosis, as well as allergies to aspirin (manufacturer unknown), ibuprofen, unspecified penicillin, erythromycin, CIPRO, ZANAFLEX and COMPAZINE. On 28-MAR-2017, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (exact dose, lot# and expiry date were not reported), intramuscularly as a general vaccination. His concomitant therapies included HARVONI, CELEXA, ATIVAN and "other unspecified medications". On an unknown date in 2017, reported as "an unspecified time after the vaccination", the patient became agitated and irritable. Subsequently, on 09-MAY-2017, the patient received the second dose of RECOMBIVAX HB injection (exact dose, lot# and expiry date were not reported), intramuscularly. On an unknown date in 2017, the patient could not feed himself (he went from feeding himself every meal to only 30% of the time), was dizzy and weak. On 12-MAY-2017, the reporting nurse could not wake the patient up from bed, he was unresponsive. On the same day, the patient was taken to the emergency room due to the unresponsiveness and inability to be woken up, and subsequently admitted to the hospital due to those events (also reported as "due to an unspecified reason") on the same date. The patient underwent unspecified tests while at the hospital (reported as: "he was thoroughly worked up"; no result was provided) and was discharged on 15-MAY-2017 with no diagnosis, however he was "a little bit better". On unknown dates in 2017, after being discharged from the hospital, the patient experienced seizure-like movements, incontinence, migraines, paresthesia, insomnia, anxiety, tachycardic episodes and neck stiffness. Anxiety was treated with VISTARIL. On an unknown date in 2017, the patient experienced gait disturbance (reported as "went from not needing lateral supports to needing them"). The nurse also reported that the patient's symptoms were intermittent. The outcome of the events was not reported. The relatedness between the events and RECOMBIVAX HB was not reported. The reporter considered the events of "could not feed himself" and gait disturbance ("needing lateral supports") to be disabling. Upon internal review, the events of unresponsiveness and seizure-like movements were determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA008253: US-009507513-1706USA008675.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Tachycardia, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 57-year-old male patient. The patient's concurrent conditions included cerebral palsy, mild bipolar disorder and mild psychosis, as well as allergies to aspirin (manufacturer unknown), ibuprofen, unspecified penicillin, erythromycin, CIPRO, ZANAFLEX and COMPAZINE. On 28-MAR-2017, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (exact dose, lot# and expiry date were not reported), intramuscularly as a general vaccination. His concomitant therapies included HARVONI, CELEXA, ATIVAN and "other unspecified medications". On an unknown date in 2017, reported as "an unspecified time after the vaccination", the patient became agitated and irritable. Subsequently, on 09-MAY-2017, the patient received the second dose of RECOMBIVAX HB injection (exact dose, lot# and expiry date were not reported), intramuscularly. On an unknown date in 2017, the patient could not feed himself (he went from feeding himself every meal to only 30% of the time), was dizzy and weak. On 12-MAY-2017, the reporting nurse could not wake the patient up from bed, he was unresponsive. On the same day, the patient was taken to the emergency room due to the unresponsiveness and inability to be woken up, and subsequently admitted to the hospital due to those events (also reported as "due to an unspecified reason") on the same date. The patient underwent unspecified tests while at the hospital (reported as: "he was thoroughly worked up"; no result was provided) and was discharged on 15-MAY-2017 with no diagnosis, however he was "a little bit better". On unknown dates in 2017, after being discharged from the hospital, the patient experienced seizure-like movements, incontinence, migraines, paresthesia, insomnia, anxiety, tachycardic episodes and neck stiffness. Anxiety was treated with VISTARIL. On an unknown date in 2017, the patient experienced gait disturbance (reported as "went from not needing lateral supports to needing them"). The nurse also reported that the patient's symptoms were intermittent. The outcome of the events was not reported. The relatedness between the events and RECOMBIVAX HB was not reported. The reporter considered the events of "could not feed himself" and gait disturbance ("needing lateral supports") to be disabling. Upon internal review, the events of unresponsiveness and seizure-like movements were determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA008253: US-009507513-1706USA008675.
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Mobility decreased, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 51-year-old female patient received PREVNAR 13, in Jun2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. In Jun2017 the patient experienced arm swelling and limitation of arm movement. The local reaction expanded to the entire arm, including the elbow. The outcome of the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Adenoma benign, Injection site reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer representative. A patient of unspecified age and gender received PREVNAR 13, on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced lymphadenoma in arm at the injection site on an unspecified date with outcome of unknown.
Sex: M
Vaccine: PNC13
Symptoms: Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via sales representative reporting for himself. This 40-year-old male patient of unknown race/ethnicity received PREVNAR 13 on an unknown date at 0.5 ml single to prevent pneumococcal pneumonia. Medical history included pneumonia three times in the past 5 years. Concomitant medications were not provided. In May2017, about 3 weeks before this report the patient had left arm pain for a week, fever over 101 F for a day and flu like symptoms. Outcome of fever was recovered in May2017. Outcome of the other events was recovered on an unspecified date in 2017.
Sex: M
Vaccine: FLUX
Symptoms: Axonal neuropathy, Biopsy peripheral nerve abnormal, Electromyogram abnormal, Hyporeflexia, Muscular weakness
Clinical narrative: Initial unsolicited report received from the literature on 07-Jun-2017. The following is verbatim from the article: Objective: To discuss the clinical and pathological features, pathophysiology, and treatment of neuralgic amyotrophy. Background: Neuralgic amyotrophy, also referred to as brachial neuritis or Parsonage-Turner syndrome, is a rare neurological disorder affecting the brachial plexus and/or its individual nerves. It is characterized by abrupt onset of unilateral shoulder or upper extremity pain and weakness followed by atrophy in the muscles of shoulder girdle or upper and lower plexus. Pathophysiology remains unclear and there is paucity of pathology data in most cases. However, recent evidence suggests an immune epineurial microvasculitis. This case provides further evidence that ischemic injury from microvasculitis is implicated in neuralgic amyotrophy. This case involves a 67-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration was not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, two weeks following vaccination, the patient presented with abrupt onset left arm pain and approximately one month later, the patient developed left wrist drop accompanied by sensory loss. A left superficial radial sensory nerve biopsy, done within a month of onset showed clear evidence of epineurial microvasculitis (implicated in neuralgic amyotrophy or brachial neuritis or Parsonage-Turner syndrome) and axonal degeneration. Neurologic exam revealed weakness predominantly in the left greater than right radial and median innervated muscles, right scapular winging, sensory loss in the left radial nerve distribution, and hyporeflexia in the upper extremities. Electrodiagnostic studies showed bilateral radial nerve palsy, left greater than right. The patient received corrective treatment with SOLUMEDROL and subsequently cyclophosphamide was added. Patient was recovered from left arm pain and recovering from other events. It was reported that remarkable recovery with complete resolution of pain and slow but definite improvement of strength. Upon internal review the case was considered as serious because of important medical event: Parsonage-Turner syndrome. Documents held by sender: none. Sender's Comments: Sanofi company comment dated 13-Jun-2017: In this case, the symptoms left arm pain, axonal degeneration, Radial nerve palsy, sensory loss, hyporeflexia in the upper extremities are consistent with reported diagnosis of Neuralgic amyotrophy. The time to onset is compatible with the role of vaccine. Additional information regarding results of investigations (infectious work-up and cerebral work-up as EEG, MRI) ruling out alternative etiology, patient's birth history, immune status during vaccination, previous vaccination and tolerance is needed to fully assess this case.
Sex: M
Vaccine: FLUX
Symptoms: Neuralgic amyotrophy, Neurological examination abnormal, Pain in extremity, Radial nerve palsy, Sensory loss
Clinical narrative: Initial unsolicited report received from the literature on 07-Jun-2017. The following is verbatim from the article: Objective: To discuss the clinical and pathological features, pathophysiology, and treatment of neuralgic amyotrophy. Background: Neuralgic amyotrophy, also referred to as brachial neuritis or Parsonage-Turner syndrome, is a rare neurological disorder affecting the brachial plexus and/or its individual nerves. It is characterized by abrupt onset of unilateral shoulder or upper extremity pain and weakness followed by atrophy in the muscles of shoulder girdle or upper and lower plexus. Pathophysiology remains unclear and there is paucity of pathology data in most cases. However, recent evidence suggests an immune epineurial microvasculitis. This case provides further evidence that ischemic injury from microvasculitis is implicated in neuralgic amyotrophy. This case involves a 67-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration was not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, two weeks following vaccination, the patient presented with abrupt onset left arm pain and approximately one month later, the patient developed left wrist drop accompanied by sensory loss. A left superficial radial sensory nerve biopsy, done within a month of onset showed clear evidence of epineurial microvasculitis (implicated in neuralgic amyotrophy or brachial neuritis or Parsonage-Turner syndrome) and axonal degeneration. Neurologic exam revealed weakness predominantly in the left greater than right radial and median innervated muscles, right scapular winging, sensory loss in the left radial nerve distribution, and hyporeflexia in the upper extremities. Electrodiagnostic studies showed bilateral radial nerve palsy, left greater than right. The patient received corrective treatment with SOLUMEDROL and subsequently cyclophosphamide was added. Patient was recovered from left arm pain and recovering from other events. It was reported that remarkable recovery with complete resolution of pain and slow but definite improvement of strength. Upon internal review the case was considered as serious because of important medical event: Parsonage-Turner syndrome. Documents held by sender: none. Sender's Comments: Sanofi company comment dated 13-Jun-2017: In this case, the symptoms left arm pain, axonal degeneration, Radial nerve palsy, sensory loss, hyporeflexia in the upper extremities are consistent with reported diagnosis of Neuralgic amyotrophy. The time to onset is compatible with the role of vaccine. Additional information regarding results of investigations (infectious work-up and cerebral work-up as EEG, MRI) ruling out alternative etiology, patient's birth history, immune status during vaccination, previous vaccination and tolerance is needed to fully assess this case.
Sex: M
Vaccine: FLUX
Symptoms: Winged scapula
Clinical narrative: Initial unsolicited report received from the literature on 07-Jun-2017. The following is verbatim from the article: Objective: To discuss the clinical and pathological features, pathophysiology, and treatment of neuralgic amyotrophy. Background: Neuralgic amyotrophy, also referred to as brachial neuritis or Parsonage-Turner syndrome, is a rare neurological disorder affecting the brachial plexus and/or its individual nerves. It is characterized by abrupt onset of unilateral shoulder or upper extremity pain and weakness followed by atrophy in the muscles of shoulder girdle or upper and lower plexus. Pathophysiology remains unclear and there is paucity of pathology data in most cases. However, recent evidence suggests an immune epineurial microvasculitis. This case provides further evidence that ischemic injury from microvasculitis is implicated in neuralgic amyotrophy. This case involves a 67-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration was not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, two weeks following vaccination, the patient presented with abrupt onset left arm pain and approximately one month later, the patient developed left wrist drop accompanied by sensory loss. A left superficial radial sensory nerve biopsy, done within a month of onset showed clear evidence of epineurial microvasculitis (implicated in neuralgic amyotrophy or brachial neuritis or Parsonage-Turner syndrome) and axonal degeneration. Neurologic exam revealed weakness predominantly in the left greater than right radial and median innervated muscles, right scapular winging, sensory loss in the left radial nerve distribution, and hyporeflexia in the upper extremities. Electrodiagnostic studies showed bilateral radial nerve palsy, left greater than right. The patient received corrective treatment with SOLUMEDROL and subsequently cyclophosphamide was added. Patient was recovered from left arm pain and recovering from other events. It was reported that remarkable recovery with complete resolution of pain and slow but definite improvement of strength. Upon internal review the case was considered as serious because of important medical event: Parsonage-Turner syndrome. Documents held by sender: none. Sender's Comments: Sanofi company comment dated 13-Jun-2017: In this case, the symptoms left arm pain, axonal degeneration, Radial nerve palsy, sensory loss, hyporeflexia in the upper extremities are consistent with reported diagnosis of Neuralgic amyotrophy. The time to onset is compatible with the role of vaccine. Additional information regarding results of investigations (infectious work-up and cerebral work-up as EEG, MRI) ruling out alternative etiology, patient's birth history, immune status during vaccination, previous vaccination and tolerance is needed to fully assess this case.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Hypoacusis, Throat irritation
Clinical narrative: Within minutes of having the GARDASIL vaccine her Throat got itchy and scratchy and her hearing got muffled for a few minutes. Dr.  checked oxygen levels and blood pressure both were fine.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Patient came for evaluation 6/19/17 with umbilicated vesicle widespread over body. Diagnosis given was Varicella.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Half dollar size reddened raised area at point of injection. Lasted several days and was treated with 25mg Benedryl.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: After injection of PPSV23 I had redness extending from injection site down to elbow, up to shoulder and around to mid back. Unable to move arm in any direction due to severe pain, swelling. Used ice pack, Bendadryl and Advil. Day two my entire upper arm was still red and a little swollen but I could move it. On the third day the upper arm had turned yellow but the swelling was gone. All symtoms were gone by day five.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: After injection of PPSV23 I had redness extending from injection site down to elbow, up to shoulder and around to mid back. Unable to move arm in any direction due to severe pain, swelling. Used ice pack, Bendadryl and Advil. Day two my entire upper arm was still red and a little swollen but I could move it. On the third day the upper arm had turned yellow but the swelling was gone. All symtoms were gone by day five.
Age: 0.33
Sex: F
Vaccine: DPP, HEP, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Continuous throwing up fever that got up to 103 and would not break got  fever down to 102 with continuous Tylenol had a fever for 3 days we do not know if they will be long-term harm from this do too she is only 5 months old now.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt states arm is swollen where shingles shot given. Area raw and warm to touch.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Disturbance in attention, Dyskinesia, Fatigue, Middle insomnia, Pain
Clinical narrative: Pain w/L lifting or rotating my left arm, reaching arm across front or stretching back. Waking up in the nights when moving arm unintentionally, tired, lack of concentration.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Presyncope
Clinical narrative: 5-10 minutes post vaccination patient began not feeling well, had near syncope episode. Patient was monitored for 30 minutes - symptoms fully resolved and discharged home with mother.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Papule, Rash papular, Rash vesicular
Clinical narrative: Less than 1 mm papular rash on back, arms, legs with scattered 1-3mm mild erythematous papules, some with vesicular centers.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness, pain and swelling to vaccinated area.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall
Clinical narrative: Gave pt. MENACTRA First (R) deltoid. Then gave 1st HPV (L) Deltoid. Was talking to pt. about upcoming birthday while putting sharps in sharps container. Pt was sitting on table went to stand up and fell to the floor. Did not hit his head or hurt himself dad and I asked if he was okay, immediately grabbed a nurse.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 16-MAY-2017, the patient was vaccinated with a dose of M-M-R II, for prophylaxis (dose, route of administration, lot number and expiration date were not reported), and on 25-MAY-2017 the patient was vaccinated with VARIVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Other suspect therapy included sterile diluent (DSM STERILE DILUENT).   On 25-MAY-2017, the pharmacist called to report that a patient received 2 live vaccines too close together. It is unknown if there is relevant lab work. As of 25-MAY-2017, it was unknown if the patient would continue on the M-M-R II or VARIVAX. The pharmacist stated she would discuss with the patient that according to information provided to her, the VARIVAX would be considered invalid and that the patient would need to be redosed in 28 days. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unspecified date, the patient was most likely vaccinated with a improperly stored dose of one of the following vaccines that were reconstituted with sterile diluent (manufacturer unknown) (unspecified lot number and expiration date), but is not sure which of the lots the unspecified patient received. Sterile diluent (manufacturer unknown) did not undergo a temperature excursion. The vaccines involved were M-M-R II  lot number # M017346 and expiration date of 06-APR-2018 and lot number # M011667 and expiration date of 08-MAR-2018, or VARIVAX lot # M035142 and expiration date of 03-AUG-2018 (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of -14 Celcius degrees to -10 Celcius degrees for 7 hours. Previous temperature excursion was reported frozen multiple excursion.  No adverse effects were reported. Digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning to an unknown number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of ROTATEQ. Lots and expiration dates were unknown by the reporter. No adverse effects reported. The call was made due to a data logger. Excursion information was: Temperature and time frame:  0°C to 1°C for 2.5 hours 9°C to 25°C (9.36C) for 8.75 hours No previous temperature excursion. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA008767: US-009507513-1706USA008768:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (dose, frequency and route were not reported) lot # M046004 with expiration date of 18-NOV-2018 or lot # M028547 with expiration date of 07-JUN-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion of the VARIVAX was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005174: US-009507513-1706USA005175: US-009507513-1706USA005177: US-009507513-1706USA005178: US-009507513-1706USA005179:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (dose, frequency and route were not reported) lot # M046004 with expiration date of 18-NOV-2018 or lot # M028547 with expiration date of 07-JUN-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion of the VARIVAX was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005174: US-009507513-1706USA005175: US-009507513-1706USA005176: US-009507513-1706USA005178: US-009507513-1706USA005179: