chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2016US107525 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 636940) on 01 Aug 2016. This report refers to a female patient of unknown age. Historical condition was not reported. Concurrent conditions include Stephens Johnson syndrome, asthma, GERD (Gastro esophageal reflux disease), ischemic heart disease, allergic to Sulfa, bee sting, thrombophlebitis in left arm, hypertension and diabetes mellitus. Concomitant medications included VENTOLIN HFA, Aspirin, metformin, escitalopram oxalate, Flexeril, Ibuprofen; ZETIA, azelastine, fluticasone, ATROVENT; lisinopril, NEXIUM, fluticasone propionate, temazepam, FLONASE, bupropion and DUONEB. The patient was vaccinated with influenza virus vaccine( Unknown seasonal or pandemic, manufacturer: unknown, batch number: not reported) on an unknown date. It was reported that, the patient experienced red swollen arms every time she received Influenza vaccine. Outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Case number PHHY2016US134530, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 639428) website on 29 Sep 2016. This report refers to an 83 years old female patient. Past medical history included anemia, stage III chronic kidney disease (CKD), hyperlipidemia, Non Hodgkins lymphoma and peripheral vascular disease (PVD). Current conditions included hypertension (HTN) and allergies to BACTRIM, Vancomycin and angiotensin converting enzyme (ACE) inhibitors. Concomitant medications included ASA, LIPITOR, folic acid, LASIX, labetalol, nifedipine, pantoprazole, valsartan, ZETIA and tramadol. The patient was vaccinated with FLUVIRIN (batch number: 1515901) intramuscularly into left arm on 04 Sep 2015. On 04 Oct 2015, the patient experienced lower extremity weakness and numbness and paraesthesias of both (B) hands. The patient visited the emergency room. On 04 Nov 2015, the patient was hospitalized. On an unknown date, laboratory data included Electromyography (EMG) that showed Guillain Barre Syndrome. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as serious (medically significant) by the reporter. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2016US005427, is an initial spontaneous report received from a consumer on 29 Feb 2016. This report refers to an adult female patient. Past medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, manufacture and batch number: not reported) on an unknown date. On an unknown date, the patient suffered with allergic reaction to influenza vaccine. The outcome, seriousness and causality of the event were not reported. Non significant follow up received via Vaccine Adverse Events Reporting System (VAERS reference number: 640777) on 23 Aug 2016: VAERS reference number updated.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cerebellar ataxia, Fall, Gait disturbance, Influenza, Nasopharyngitis
Clinical narrative: Acute Cerebellar Ataxia for 12-24 hours - my daughter woke up from a nap, she was ill from cold/flu and could not sit independently.  She was walking just fine before the nap and then for about 24 hours she slowly regained her ability to walk without falling over.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Posture abnormal
Clinical narrative: Acute Cerebellar Ataxia for 12-24 hours - my daughter woke up from a nap, she was ill from cold/flu and could not sit independently.  She was walking just fine before the nap and then for about 24 hours she slowly regained her ability to walk without falling over.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Decreased eye contact, Gianotti-Crosti syndrome, Insomnia, Irritability, Pyrexia
Clinical narrative: Irritable, not sleeping, low grade fever, rash. Have Tylenol as instructed by doctor. By Monday he was covered in a severe rash and brought him back to the doctor. They ruled out allergic reaction. Dr referred to a dermatologist who said it's a vaccine injury "Gianotti Crosti".
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash generalised, Unresponsive to stimuli
Clinical narrative: Irritable, not sleeping, low grade fever, rash. Have Tylenol as instructed by doctor. By Monday he was covered in a severe rash and brought him back to the doctor. They ruled out allergic reaction. Dr referred to a dermatologist who said it's a vaccine injury "Gianotti Crosti".
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site inflammation, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient had no pertinent medical history and no drug reactions/allergies. There were no concomitant medications. On 25-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX23 lot # M027552 with an expiration date: 04-FEB-2018 for prophylaxis (dose, route of vaccination and anatomical location were not reported). On 26-SEP-2016, reported as about one day after receiving the vaccine, the patient experienced cellulitis, swelling and inflammation about 2 inches below the injection site. The patient sought medical attention and visited physician. The patient was given unspecified antibiotics for the event. The outcome of cellulitis, inflammation and swelling was unknown. No lab diagnostics studies were performed. The relatedness between the events and vaccination PNEUMOVAX23 was not reported. Upon internal review cellulitis was determined to be medically significant. This is one of two reports from the same source. Follow up information has been received on 25-OCT-2016 from the pharmacist. Patient demographics were updated (83 year old male). On 25-SEP-2016, at 11 am, the patient received first dose of PNEUMOVAX23 intramuscularly on his left deltoid. On the same day at 13:00 he experienced cellulitis, inflammation and swelling. On 27-SEP-2016, the patient recovered from the events cellulitis, inflammation and swelling. Follow up information has been received on 10-JAN-2017. An investigation into the manufacture of lot M027552 was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Additional information is not expected as all correspondence was received. Product and narrative were updated. Sender's Comments: US-009507513-1609USA013332: MERCK 1609USA014340: Mfr number.
Age: 54.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 54 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On 16-DEC-2016, the patient was vaccinated with a dose of PROQUAD (strength, dose, route, lot # and expiration date were not reported) for prophylaxis; instead of M-M-R II. No adverse symptoms were reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # M035146, expiration date 26-JUL-2016, for prophylaxis (dose, route and anatomical administration were not reported) following a temperature excursion of between 10.7 F and 30 F (-11.8 and -1.1 Celsius), exact details unknown, for 14 hours. No adverse effects were reported in the patient. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old male patient. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 26-AUG-2013, the patient was vaccinated with the first dose of GARDASIL (lot # J006236, expiration date 25-FEB-2016) (strength and dose were not reported) intravenously for prophylaxis and on 04-SEP-2014, the patient was vaccinated with the second dose of GARDASIL (lot # J009243, expiration date 23-APR-2016) (strength and dose were not reported) intravenously for prophylaxis (Inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On 29-OCT-2016, ROTATEQ (lot# L008054, expiration date 30-NOV-2016; lot# M019691, expiration date 02-NOV-2017) (dose and frequency were unknown) were exposed to temperatures outside of the recommended range. The vaccines were exposure to 52.9 Fahrenheit for 15 hours. There was no previous temperature excursion reported. The incorrect storage of vaccines was not found by a digital data logger. Doses of the vaccine had been administered to unspecified patients on unspecified dates since 29-OCT-2016. The doses were not administered after the expiration date. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005060.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates of 2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M001746, expiration date: 07-APR-2017) (dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature of 8 Fahrenheit degree during a time frame of 1 hour and 30 minutes. Previous temperature excursion was 25 Fahrenheit degree during a time frame of 1 hour. After the initial excursion and not the current excursion, the patients had administered the vaccine. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004450: US-009507513-1701USA004451.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This solicited report has been received from a 61 years old male patient referring to himself, who was enrolled in a market research. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date in December 2016, the patient was vaccinated with ZOSTAVAX (dose, lot #, expiration date and route not reported) as vaccine for shingles. On an unknown date in December 2016, the patient experienced an unspecified adverse event. The outcome of the event was reported as recovered/resolved with sequelae. The reporter considered the event to be related to ZOSTAVAX. Additional information is not expected as there was no consent to contact the reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 63 year old female patient, with no drug reaction or allergies. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (dose, route and anatomical location were not reported), reported lot # M026876, expiration date 26-JUL-2017. The patient called the pharmacy, on 04-JAN-2017, with complaints of "hive type rash" (urticaria) and "burning at injection site" (injection site pain) which started on 03-JAN-2017. The outcome of "hive type rash" and "burning at injection site" (injection site pain) was unknown. It was reported that the patient sought medical attention; no lab diagnostic studies were performed; no interventions to prevent serious criteria were performed; no significant disability or incapacity; no life threatening; no hospitalization was required. The relationship between ZOSTAVAX and "hive type rash" (urticarial) and "burning at injection site" was not reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent medical conditions, concomitant therapies, medical history and allergies were not provided. On 30-DEC-2016 the patient received a dose of VARIVAX (strength, dose, route, lot# and expiration date were unknown) and received a second dose of VARIVAX (strength, dose, route, lot# and expiration date were unknown) on 06-JAN-2017 for prophylaxis (drug use for unapproved schedule). No adverse effect reported.    Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were administered improperly stored ROTATEQ (lot # M011832, expiration date: 25-JAN-2018; M017558, expiration date: 27-FEB-2018) (dose unknown), orally for prophylaxis. The vaccines were stored for 1 hour and 24 minutes at 35 Fahrenheit degree (F) as per data logger information. There was no prior excursions for these vaccines. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for follow up. Sender's Comments: US-009507513-1701USA004645.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates of 2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M027886, expiration date: 03-JUN-2018, lot # M033211, expiration date: 13-JUL-2018, lot # M032493, expiration date: 06-JUL-2018, lot # M028547, expiration date: 07-JUN-2018) (dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature of 8 Fahrenheit degree during a time frame of 1 hour and 30 minutes. Previous temperature excursion was 25 Fahrenheit degree during a time frame of 1 hour. After the initial excursion and not the current excursion, the patients had administered the vaccine. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004451: US-009507513-1612USA014837.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates of 2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L033698, expiration date: 28-FEB-2017, lot # M032498, expiration date: 02-JAN-2018) (dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature of 8fahrenheit degree during a time frame of 1 hour and 30 minutes. Previous temperature excursion was 25fahrenheit degree during a time frame of 1 hour. After the initial excursion and not the current excursion, the patients had administered the vaccine. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014837: US-009507513-1701USA004450:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were administered improperly stored GARDASIL 9 (M028323, expiration date: 26-SEP-2018; M032650, expiration date: 31-MAR-2019) (dose and route unknown) for prophylaxis. The vaccines were stored for 1 hour and 24 minutes at 35 Fahrenheit degree (F) as per datalogger information. There was no prior excursion for these vaccines. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for follow up.; Sender's Comments: US-009507513-1701USA003802:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On 15-DEC-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, lot # M026878, expiration date 27-JUL-2017, subcutaneously for prophylaxis, which was exposed to a temperature excursion of 13F for 1.5 hours. It was reported that the vaccine had a previous temperature excursion of 14F for 1.5 hours. The reporter stated that the temperature excursion was detected by a data logger. No adverse effects were reported. This is one of several report from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004912.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On 30-DEC-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, lot # M035148, expiration date 25-OCT-2017, subcutaneously for prophylaxis, which was exposed to a temperature excursion of 13F for 1.5 hours. It was reported that the vaccine had a previous temperature excursion of 14F for 1.5 hours. The reporter stated that the temperature excursion was detected by a data logger. No adverse effects were reported. This is one of several report from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA004734:
Sex: F
Vaccine: HPV9, VARZOS
Symptoms: Injection site pain, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 18 year old female patient. The patient's medical history, current conditions and concomitant medications were not reported. On 05-JAN-2017, the patient was inadvertently vaccinated with ZOSTAVAX (dose, route and lot number were not reported) for prophylaxis instead of receiving VARIVAX. On the same day, she also received her last dose of GARDASIL 9 (dose, route and lot number were not reported) for prophylaxis. On 05-JAN-2017, after receiving the vaccines, the patient developed soreness at the injection site (injection site pain) which lasted for an unspecified duration of time. The outcome of injection site pain was unknown. The causality between the suspect drugs and injection site pain was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of  15 through 19 years old age of unknown gender. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. Nurse reported that on unknown dates, these patients received one to two doses of M-M-R II for prophylaxis. On unknown dates after receiving vaccine doses, the patients developed contracting mumps. Outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received an improperly stored dose of VARIVAX (lot# M023382, expiration date 11-MAY-2018; lot# M023382, expiration date 04-MAY-2018) (dose, frequency and route were unknown). The vaccines (lot# M023382, expiration date 11-MAY-2018) were exposure to -15 to -10 degree centigrade for 13 hours 48 minutes. The vaccines (lot# M023382, expiration date 04-MAY-2018) were exposure to -15 to -10 degree centigrade for 14 hours 5 minutes. There was no previous temperature excursion reported. The improper storage of vaccines was not found by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.; Sender's Comments: US-009507513-1612USA014219:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On 29-OCT-2016, PNEUMOVAX 23 (lot# L013428, expiration date 03-FEB-2016; dose, frequency and route were unknown) were exposed to temperatures outside of the recommended range. The vaccines were exposure to 52.9 Fahrenheit for 15 hours. There was no previous temperature excursion reported. The incorrect storage of vaccines was not found by a digital data logger. Doses of the vaccine had been administered to unspecified patients on unspecified dates since 29-OCT-2016. The doses were not administered after the expiration date. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014768.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hypoaesthesia, Injection site erythema, Injection site pain, Muscular weakness
Clinical narrative: Associate experienced regular site soreness day after administration.  About 4 weeks later she noted increasing pain, redness, numbness in fingers and hand; As well as weakness in the shoulder muscles and hand. Low grade fevers and fatigue that have persisted.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Associate experienced regular site soreness day after administration.  About 4 weeks later she noted increasing pain, redness, numbness in fingers and hand; As well as weakness in the shoulder muscles and hand. Low grade fevers and fatigue that have persisted.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: At 10pm pain was level 5 on a scale of 1-10. At 1 am arm was in unbearable pain (level 8 pain) and patient could hardly move it. Took pain reliever and was able to get some sleep. In the morning 1/12/16 9:56 AM pain is at level 6.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Seizure, Syncope
Clinical narrative: Syncope and collapse with convulsions X 3.
Age: 43.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Asthenia, Breast tenderness, Fatigue, Lymphadenopathy, Pain
Clinical narrative: Generalized fatigue and weakness, body aches, no fever, swollen lymph nodes to neck, collar bone, axillary and groin. Tender to touch on neck and breast area.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, X-ray
Clinical narrative: Received flu vaccination and now has consistent arm pain that is worse when she raises her arm.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an adult patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On 14-OCT-2016, the patient was vaccinated with a pediatric dose of VAQTA lot # L036300, 0.5 ml for prophylaxis. No adverse event was reported. As of 09-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: HPV9
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. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 07-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported). The second dose was administered on 10-OCT-2016 (dose, route of administration, lot # and expiry date were not reported). The patient received the third dose on 15-DEC-2016 (dose and route of administration were not reported) lot # M034195, expiry date: 14-APR-2019. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information regarding the patient's concomitant medications, medical history and drug reactions/allergies was not reported. On 12-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 degrees Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments:  US-009507513-1610USA011133: US-009507513-1610USA011245:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information regarding the patient's concomitant medications, medical history and drug reactions/allergies was not reported. On 09-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 degrees Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1610USA011133: US-009507513-1610USA011245.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information regarding the patient's concomitant medications, medical history and drug reactions/allergies was not reported. On 08-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 degrees Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1610USA011133: US-009507513-1610USA011245.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ for prophylaxis (dose and route of administration were not reported). Reporter was unsure which lot number was administrated M016238 with an expiration date 07-DEC-2017 or L010126 with an expiration date 22-JAN-2017. Administered doses of vaccines experienced the following temperature excursions: on 15-DEC-2016 of 11 degrees Celsius for 4 hours 13 minutes, on 16-DEC-2016 of 11 degrees Celsius for 9 hours 20 minutes, on 29-DEC-2016 of 11 degrees Celsius for 3 hours 37 minutes, a total  temperature excursion was 17 hours 10 minutes cumulative hours in more than 8 degrees Celsius and less than 25 degrees Celsius. Data logger was involved. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005205: US-009507513-1701USA005206: US-009507513-1701USA005207.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 05-JAN-2017 the patient was vaccinated with an expired dose of M-M-R II (rHA) lot # K015374 with expiration date 18-SEP-2016 for prophylaxis (dose and route were not reported). No adverse effects were reported. A product quality compalint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates since 01-AUG-2016, the unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L048265 with expiration date 10-JUN-2017 for prophylaxis (dose and route were not reported). It was stated that the temperature excursion was between 32 and 36 Fahrenheit degrees for 4 days. No previous temperature excursion was reported. No adverse effect had been reported. A product quality complaint (PQC) was not involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA001682: US-009507513-1701USA004137.
Sex: U
Vaccine: HPVX
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis (lot number M023169, expiration date 13-JUN-2018; dose and route of administration were not reported). Reporter was unsure whether GARDASIL 9 or GARDASIL (captured in case MARRS # 1701USA005206) was administrated. Administered doses of vaccines experienced the following temperature excursions: on 15-DEC-2016 of 11 degrees Celsius for 4 hours 13 minutes, on 16-DEC-2016 of 11 degrees Celsius for 9 hours 20 minutes, on 29-DEC-2016 of 11 degrees Celsius for 3 hours 37 minutes, a total  temperature excursion was 17 hours 10 minutes cumulative hours in more than 8 degrees Celsius and less than 25 degrees Celsius. Data logger was involved. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005206: US-009507513-1701USA005207: US-009507513-1701USA001537.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL for prophylaxis (lot number K006960, expiration date 19-FEB-2017; dose and route of administration were not reported). Reporter was unsure whether GARDASIL or GARDASIL 9 (captured in case MARRS # 1701USA005205) was administrated. Administered doses of vaccines experienced the following temperature excursions: on 15-DEC-2016 of 11 degrees Celsius for 4 hours 13 minutes, on 16-DEC-2016 of 11 degrees Celsius for 9 hours 20 minutes, on 29-DEC-2016 of 11 degrees Celsius for 3 hours 37 minutes, a total  temperature excursion was 17 hours 10 minutes cumulative hours in more than 8 degrees Celsius and less than 25 degrees Celsius. Data logger was involved. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA001537: US-009507513-1701USA005207: US-009507513-1701USA005205.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB for prophylaxis (lot number L044707, expiration date 06-OCT-2018; dose and route of administration were not reported). Administered doses of vaccines experienced the following temperature excursions: on 15-DEC-2016 of 11 degrees Celsius for 4 hours 13 minutes, on 16-DEC-2016 of 11 degrees Celsius for 9 hours 20 minutes, on 29-DEC-2016 of 11 degrees Celsius for 3 hours 37 minutes, a total  temperature excursion was 17 hours 10 minutes cumulative hours in more than 8 degrees Celsius and less than 25 degrees Celsius. Data logger was involved. There was no adverse effect reported. This is one of several reports received from the same reporter.Additional information has been requested.; Sender's Comments: US-009507513-1701USA005206: US-009507513-1701USA005205: US-009507513-1701USA001537:
Sex: F
Vaccine: PNC13
Symptoms: Chills, Malaise, Nasopharyngitis, Pyrexia
Clinical narrative: A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history included ongoing disability.  Concomitant medications were not reported. The patient experienced, chills, fever, cold and felt really sick all on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Swelling face, Throat irritation, Urticaria
Clinical narrative: Urticaria, facial swelling, itchy throat.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Blister, Crying, Eye swelling, Lip haemorrhage, Lip swelling
Clinical narrative: Red rash around face, red swollen eye, lips swollen and started bleeding, crying uncontrollably. Eventually blisters appeared and skin peeling. Given diagnosis of Staphylococcus Scalded Skin syndrome. Required hospitalization for 3 days and given Clindomycin via IV and then orally for 10 days.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Ocular hyperaemia, Rash, Rash erythematous, Skin exfoliation, Staphylococcal scalded skin syndrome
Clinical narrative: Red rash around face, red swollen eye, lips swollen and started bleeding, crying uncontrollably. Eventually blisters appeared and skin peeling. Given diagnosis of Staphylococcus Scalded Skin syndrome. Required hospitalization for 3 days and given Clindomycin via IV and then orally for 10 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus, Swelling
Clinical narrative: Large red swollen patch around injection site (5inches by 6 inches), tenderness, itching, swelling into armpit, body aches.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Large red swollen patch around injection site (5inches by 6 inches), tenderness, itching, swelling into armpit, body aches.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, X-ray
Clinical narrative: Pain in left shoulder. Pain was ongoing until visiting an orthopedist in June 2016 for xray and pain medication. Since then it has turned into a constant dull pain instead of sharp pain.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Cognitive disorder, Vomiting
Clinical narrative: Repeated vomiting lasting 4-6 hours. Noticed change in cognitive function subsequently, which is persistent and progressive.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism, Emotional distress, Encephalopathy, Irritability, Nuclear magnetic resonance imaging
Clinical narrative: Ran high fever, then became increasingly fussy and hard to console. Within a week, began screaming inconsolably and wouldn't stop. Took him to the emergency room where they administered Tylenol with codeine. Was diagnosed with encephalopathy and autism.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Screaming
Clinical narrative: Ran high fever, then became increasingly fussy and hard to console. Within a week, began screaming inconsolably and wouldn't stop. Took him to the emergency room where they administered Tylenol with codeine. Was diagnosed with encephalopathy and autism.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Increased pain, redness and swelling at injection site.  Headache,  nausea, chills.  Diagnosed with cellulitis.  Antibiotic was prescribed.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Nausea
Clinical narrative: Increased pain, redness and swelling at injection site.  Headache,  nausea, chills.  Diagnosed with cellulitis.  Antibiotic was prescribed.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Upper L arm noted with 7cmx8cm red, warm to touch indurated area.  Mom states she did not notice it until she got home from work on 11/12/2017. Child c/o itching at the site but denies pain.  Mother was instructed to give Benadryl and Rx for antibiotics was given in no improvement noted.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Chemotherapy, Human papilloma virus test positive, Leukaemia in remission, Lymphocytic leukaemia
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 24 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. Approximately in 2007, 2008 and 2013 (reported as "at age 15 years, 16 years and 21 years"), the patient received a complete series of properly stored GARDASIL injection (dose, route and site of administration, lot # and expiration date were not provided) as vaccination against papillomavirus. In approximately 2014, reported as "2 and 1/2 years ago", the patient experienced myeloblastic lymphocytic leukemia. On an unknown date, she developed two genital warts and had a Papanicolaou (Pap) test that showed human papillomavirus (HPV), which was "not the type of high risk for neoplasm". The patient sought medical attention and received unspecified "chemotherapy type" treatment for myeloblastic lymphocytic leukemia. Product quality complaint was not involved. At the time of reporting, the patient's myeloblastic lymphocytic leukemia was in remission since an unknown date. The outcome of the event of HPV infection was not reported. The relatedness between the events of myeloblastic lymphocytic leukemia and HPV infection and the vaccination with GARDASIL was not reported. Upon internal review, myeloblastic lymphocytic leukemia was considered to be medically significant.  Follow-up information has been received from the reporting nurse practitioner on 06-JAN-2017. The patient's concurrent conditions included seizure disorder. Concomitant medications included unspecified anti-seizure medication. The patient recovered from genital warts (on an unknown date) without treatment and had no recurrence. The nurse practitioner was not able to provide any further information as she was not in her office at the time of the call. The reporter also stated that she did not think that myeloblastic leukemia or lymphocytic leukemia was related to GARDASIL. Additional information is not expected. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL and the reported events cannot be established. Is pending important information about the patient's pertinent medical history,concurrent conditions and concomitant medications. also is important that the patient recovered from genital warts  without treatment and had no recurrence. Company Comment- No changes to the GARDASIL safety information are warranted at this time.  Merck and Co., Inc., known as MSD, continues to monitor the safety profile of the GARDASIL.; Sender's Comments: MERCK 1611USA013477:Mfr number.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Myeloid leukaemia, Papilloma viral infection
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 24 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. Approximately in 2007, 2008 and 2013 (reported as "at age 15 years, 16 years and 21 years"), the patient received a complete series of properly stored GARDASIL injection (dose, route and site of administration, lot # and expiration date were not provided) as vaccination against papillomavirus. In approximately 2014, reported as "2 and 1/2 years ago", the patient experienced myeloblastic lymphocytic leukemia. On an unknown date, she developed two genital warts and had a Papanicolaou (Pap) test that showed human papillomavirus (HPV), which was "not the type of high risk for neoplasm". The patient sought medical attention and received unspecified "chemotherapy type" treatment for myeloblastic lymphocytic leukemia. Product quality complaint was not involved. At the time of reporting, the patient's myeloblastic lymphocytic leukemia was in remission since an unknown date. The outcome of the event of HPV infection was not reported. The relatedness between the events of myeloblastic lymphocytic leukemia and HPV infection and the vaccination with GARDASIL was not reported. Upon internal review, myeloblastic lymphocytic leukemia was considered to be medically significant.  Follow-up information has been received from the reporting nurse practitioner on 06-JAN-2017. The patient's concurrent conditions included seizure disorder. Concomitant medications included unspecified anti-seizure medication. The patient recovered from genital warts (on an unknown date) without treatment and had no recurrence. The nurse practitioner was not able to provide any further information as she was not in her office at the time of the call. The reporter also stated that she did not think that myeloblastic leukemia or lymphocytic leukemia was related to GARDASIL. Additional information is not expected. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL and the reported events cannot be established. Is pending important information about the patient's pertinent medical history,concurrent conditions and concomitant medications. also is important that the patient recovered from genital warts  without treatment and had no recurrence. Company Comment- No changes to the GARDASIL safety information are warranted at this time.  Merck and Co., Inc., known as MSD, continues to monitor the safety profile of the GARDASIL.; Sender's Comments: MERCK 1611USA013477:Mfr number.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 03-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 04-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.