chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 5 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 03-SEP-2015, the patient was vaccinated with an improperly stored PROQUAD (Merck) lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 64 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 64 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2-16). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 3 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored PROQUAD lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. Medical history, concurrent condition, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K007243 expiration date: 13-DEC-2015 and lot # L008059 expiration date: 18-DEC-2016) (dose, indication, route of administration were unspecified). Concomitant therapies were not provided. No adverse symptoms were reported. No product quality complain was involved. This is one of several reports from the same source (MARRS: 1511USA014672; 1511USA014713; 1511USA014714; 1511USA014712). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a adult patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-NOV-2015, the adult patient received two doses of VAQTA (lot # L004742, expiry date: 18-AUG-2016) (25U/0.5ML) combined as total of 1 ml in a syringe for one adult dose. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from registered nurse referring to an unspecified number of patients of unknown ages and genders. Medical history, concurrent condition, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # K026246 expiration date: 28-JAN-2017 and lot # L014415 expiration date: 25-JUL-2017) (dose, indication, route of administration were unspecified). Concomitant therapies were not provided. No adverse symptoms were reported. No product quality complaint was involved. This is one of several reports from the same source (MARRS: 1511USA014672; 1511USA014713; 1511USA014712; 1511USA014715). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. Medical history, concurrent condition, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX (Merck), (lot # L016124 expiration date: 06-MAY-2017 and lot # reported as L024253 expiration date: 01-JUL-2017) (dose, indication, route of administration were unspecified). Concomitant therapies were not provided. No adverse symptoms were reported. No product quality complain was involved. This is one of several reports from the same source (MARRS: 1511USA014712; 1511USA014713; 1511USA014714; 1511USA014715). Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 28-AUG-2015, the patient was vaccinated with an improperly stored PROQUAD lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: JEVX, JEVX, RAB
Symptoms: Electromyogram, Muscular weakness, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Developed rt upper extremity paresthesia gradually progressing over 3 days from distal fingertips to elbow in context of recent rabies/Japanese B encephalitis vaccination. Diagnosed with brachial neuritis.
Age: 79.0
Sex: M
Vaccine: JEVX, JEVX, RAB
Symptoms: CSF protein increased, Paraesthesia, Radiculitis brachial
Clinical narrative: Developed rt upper extremity paresthesia gradually progressing over 3 days from distal fingertips to elbow in context of recent rabies/Japanese B encephalitis vaccination. Diagnosed with brachial neuritis.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Electrocardiogram, Heart rate decreased, Hyperhidrosis, Hypotension
Clinical narrative: Case number PHHY2015US154516, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 600950) website on 24 Nov 2015. This report refers to a 68 years old male patient. Medical history was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P) intramuscular in right arm at 09:30 am on 05 Oct 2015. The patient kept in exam room for 15 minutes following vaccination to monitor for possible reaction. The patient started to experience red bumps on both lower forearms. The physician observed the patient and prescribed SOLU-MEDROL 125 mg and BENADRYL 25 mg. The patient became pale and diaphoretic, blood sugar was taken and it was normal. The patient was taken to exam room. Vitals and electrocardiogram was taken. Two liter oxygen was given via nasal cannula. The patient's blood pressure and pulse was low. The patient was treated with epinephrine (manufacturer unknown) 01 mg. Normal saline was given intravenously. Emergency department services was called and the patient was transported to hospital. The outcome of the events red bumps on both lower forearms, hyperhidrosis and pale was completely recovered and heart rate decreased, hypotension were condition unchanged. The seriousness of the events were reported as non-serious and causality was not reported. The seriousness of the events heart rate decreased, hypotension and hydrohidrosis was upgraded based on the information available in source document.    Case number PHHY2015US154516, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 600950) website on24 Nov 2015. This report refers to a 68 years old male patient. Medical history was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P) intramuscular in right arm at 09:30 AM on 05 Oct 2015. The patient kept in exam room for 15 minutes following vaccination to monitor for possible reaction. The patient started to experience red bumps on both lower forearms. The physician observed the patient and prescribed SOLUMEDROL 125 mg and BENADRYL 25 mg. The patient became pale and diaphoretic, blood sugar was taken and it was normal. The patient was taken to exam room. Vitals and electrocardiogram was taken. Two liter oxygen was given via nasal cannula. The patient's blood pressure and pulse was low. The patient was treated with epinephrine (manufacturer unknown) 01 mg. Normal saline was given intravenously. Emergency department services was called and the patient was transported to hospital. The outcome of the events red bumps on both lower forearms, hyperhidrosis and pale was completely recovered and heart rate decreased, hypotension were condition unchanged. The seriousness of the events were reported as non-serious and causality was not reported. The seriousness of the event heart rate decreased, hypotension and hyperhidrosis was upgraded based on the information available in source document.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pallor, Rash, Rash erythematous
Clinical narrative: Case number PHHY2015US154516, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 600950) website on 24 Nov 2015. This report refers to a 68 years old male patient. Medical history was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P) intramuscular in right arm at 09:30 am on 05 Oct 2015. The patient kept in exam room for 15 minutes following vaccination to monitor for possible reaction. The patient started to experience red bumps on both lower forearms. The physician observed the patient and prescribed SOLU-MEDROL 125 mg and BENADRYL 25 mg. The patient became pale and diaphoretic, blood sugar was taken and it was normal. The patient was taken to exam room. Vitals and electrocardiogram was taken. Two liter oxygen was given via nasal cannula. The patient's blood pressure and pulse was low. The patient was treated with epinephrine (manufacturer unknown) 01 mg. Normal saline was given intravenously. Emergency department services was called and the patient was transported to hospital. The outcome of the events red bumps on both lower forearms, hyperhidrosis and pale was completely recovered and heart rate decreased, hypotension were condition unchanged. The seriousness of the events were reported as non-serious and causality was not reported. The seriousness of the events heart rate decreased, hypotension and hydrohidrosis was upgraded based on the information available in source document.    Case number PHHY2015US154516, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 600950) website on24 Nov 2015. This report refers to a 68 years old male patient. Medical history was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P) intramuscular in right arm at 09:30 AM on 05 Oct 2015. The patient kept in exam room for 15 minutes following vaccination to monitor for possible reaction. The patient started to experience red bumps on both lower forearms. The physician observed the patient and prescribed SOLUMEDROL 125 mg and BENADRYL 25 mg. The patient became pale and diaphoretic, blood sugar was taken and it was normal. The patient was taken to exam room. Vitals and electrocardiogram was taken. Two liter oxygen was given via nasal cannula. The patient's blood pressure and pulse was low. The patient was treated with epinephrine (manufacturer unknown) 01 mg. Normal saline was given intravenously. Emergency department services was called and the patient was transported to hospital. The outcome of the events red bumps on both lower forearms, hyperhidrosis and pale was completely recovered and heart rate decreased, hypotension were condition unchanged. The seriousness of the events were reported as non-serious and causality was not reported. The seriousness of the event heart rate decreased, hypotension and hyperhidrosis was upgraded based on the information available in source document.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Blood pressure decreased, Electrocardiogram, Heart rate decreased, Hyperhidrosis
Clinical narrative: Case number PHHY2015US154516, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 600950) website on 24 Nov 2015. This report refers to a 68 years old male patient. Medical history was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P) intramuscular in right arm at 09:30 am on 05 Oct 2015. The patient kept in exam room for 15 minutes following vaccination to monitor for possible reaction. The patient started to experience red bumps on both lower forearms. The physician observed the patient and prescribed SOLU-MEDROL 125 mg and BENADRYL 25 mg. The patient became pale and diaphoretic, blood sugar was taken and it was normal. The patient was taken to exam room. Vitals and electrocardiogram was taken. Two liter oxygen was given via nasal cannula. The patient's blood pressure and pulse was low. The patient was treated with epinephrine (manufacturer unknown) 01 mg. Normal saline was given intravenously. Emergency department services was called and the patient was transported to hospital. The outcome of the events red bumps on both lower forearms, hyperhidrosis and pale was completely recovered and heart rate decreased, hypotension were condition unchanged. The seriousness of the events were reported as non-serious and causality was not reported. The seriousness of the events heart rate decreased, hypotension and hydrohidrosis was upgraded based on the information available in source document.    Case number PHHY2015US154516, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 600950) website on24 Nov 2015. This report refers to a 68 years old male patient. Medical history was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P) intramuscular in right arm at 09:30 AM on 05 Oct 2015. The patient kept in exam room for 15 minutes following vaccination to monitor for possible reaction. The patient started to experience red bumps on both lower forearms. The physician observed the patient and prescribed SOLUMEDROL 125 mg and BENADRYL 25 mg. The patient became pale and diaphoretic, blood sugar was taken and it was normal. The patient was taken to exam room. Vitals and electrocardiogram was taken. Two liter oxygen was given via nasal cannula. The patient's blood pressure and pulse was low. The patient was treated with epinephrine (manufacturer unknown) 01 mg. Normal saline was given intravenously. Emergency department services was called and the patient was transported to hospital. The outcome of the events red bumps on both lower forearms, hyperhidrosis and pale was completely recovered and heart rate decreased, hypotension were condition unchanged. The seriousness of the events were reported as non-serious and causality was not reported. The seriousness of the event heart rate decreased, hypotension and hyperhidrosis was upgraded based on the information available in source document.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypotension, Pallor, Rash, Rash erythematous
Clinical narrative: Case number PHHY2015US154516, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 600950) website on 24 Nov 2015. This report refers to a 68 years old male patient. Medical history was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P) intramuscular in right arm at 09:30 am on 05 Oct 2015. The patient kept in exam room for 15 minutes following vaccination to monitor for possible reaction. The patient started to experience red bumps on both lower forearms. The physician observed the patient and prescribed SOLU-MEDROL 125 mg and BENADRYL 25 mg. The patient became pale and diaphoretic, blood sugar was taken and it was normal. The patient was taken to exam room. Vitals and electrocardiogram was taken. Two liter oxygen was given via nasal cannula. The patient's blood pressure and pulse was low. The patient was treated with epinephrine (manufacturer unknown) 01 mg. Normal saline was given intravenously. Emergency department services was called and the patient was transported to hospital. The outcome of the events red bumps on both lower forearms, hyperhidrosis and pale was completely recovered and heart rate decreased, hypotension were condition unchanged. The seriousness of the events were reported as non-serious and causality was not reported. The seriousness of the events heart rate decreased, hypotension and hydrohidrosis was upgraded based on the information available in source document.    Case number PHHY2015US154516, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 600950) website on24 Nov 2015. This report refers to a 68 years old male patient. Medical history was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P) intramuscular in right arm at 09:30 AM on 05 Oct 2015. The patient kept in exam room for 15 minutes following vaccination to monitor for possible reaction. The patient started to experience red bumps on both lower forearms. The physician observed the patient and prescribed SOLUMEDROL 125 mg and BENADRYL 25 mg. The patient became pale and diaphoretic, blood sugar was taken and it was normal. The patient was taken to exam room. Vitals and electrocardiogram was taken. Two liter oxygen was given via nasal cannula. The patient's blood pressure and pulse was low. The patient was treated with epinephrine (manufacturer unknown) 01 mg. Normal saline was given intravenously. Emergency department services was called and the patient was transported to hospital. The outcome of the events red bumps on both lower forearms, hyperhidrosis and pale was completely recovered and heart rate decreased, hypotension were condition unchanged. The seriousness of the events were reported as non-serious and causality was not reported. The seriousness of the event heart rate decreased, hypotension and hyperhidrosis was upgraded based on the information available in source document.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Dizziness, Feeling abnormal, Nausea
Clinical narrative: Case number PHHY2015US156616, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602259) website on 24 Nov 2015. This report refers to a 28 years old female patient. Medical history included asthma as a child, chronic sinusitis (stable currently) and allergy-rash due to Penicillin. Current illness and concomitant medications were none. The patient was vaccinated with FLUVIRIN (batch number: 157001) intramuscularly into right arm on 13 Oct 2015 at 01:10 PM. At 01:13 PM on her way back to her desk while in elevator patient felt dizziness, nausea and like her right pinky was "falling asleep" (as reported). The patient walked back to clinic and immediately assisted to exam room and to lay down. Upon examination her blood pressure was 90/60 mmHg, heart rate was 63 bpm, blood glucose was 128 mg/dl and other examinations were unremarkable. The patient was monitored closely and given water. No weakness or skin discoloration. No edema or erythema at injection site. Symptoms resolved except for the sensation of her right pinky "falling asleep". Sensation in fact was to bilateral hands. Upon re-examination her blood pressure improved to 100/60 and heart rate to 74 bpm. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "blood pressure decreased" was upgraded based on information in the source document.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Blood pressure decreased, Dizziness, Hypoaesthesia, Nausea
Clinical narrative: Case number PHHY2015US156616, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602259) website on 24 Nov 2015. This report refers to a 28 years old female patient. Medical history included asthma as a child, chronic sinusitis (stable currently) and allergy-rash due to Penicillin. Current illness and concomitant medications were none. The patient was vaccinated with FLUVIRIN (batch number: 157001) intramuscularly into right arm on 13 Oct 2015 at 01:10 PM. At 01:13 PM on her way back to her desk while in elevator patient felt dizziness, nausea and like her right pinky was "falling asleep" (as reported). The patient walked back to clinic and immediately assisted to exam room and to lay down. Upon examination her blood pressure was 90/60 mmHg, heart rate was 63 bpm, blood glucose was 128 mg/dl and other examinations were unremarkable. The patient was monitored closely and given water. No weakness or skin discoloration. No edema or erythema at injection site. Symptoms resolved except for the sensation of her right pinky "falling asleep". Sensation in fact was to bilateral hands. Upon re-examination her blood pressure improved to 100/60 and heart rate to 74 bpm. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "blood pressure decreased" was upgraded based on information in the source document.
Age: 1.6
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Lethargy, Polymerase chain reaction, Rash generalised, Scab, Skin lesion
Clinical narrative: This spontaneous report was received from a dentist and refers to a 19 month old female patient, the reporter's daughter. It was reported that the patient did not have any drug reactions/ allergies. No information regarding the patient's pertinent medical history was provided. On 13-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # K002919, expiration date 26-FEB-2016, exact dose and route of administration were not provided). Concomitant therapies included unspecified inactivated influenza virus vaccine, received on the same day. On 26-NOV-2015, the patient started to exhibit severe lethargy. On 27-NOV-2015, the patient had fever and crusting lesions on her thigh and abdomen. The patient was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the patient's body and on 28-NOV-2015, she was admitted to the hospital. The patient was treated with acyclovir, intravenously and unspecified antibiotic. No PQC (product quality complaint) was involved. The outcome of the event was reported as not recovered. The reporter's daughter was still experiencing chicken pox like vesicles. The relatedness between the event and VARIVAX (Merck) was not provided. The reporting physician requested a lot # check. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test
Clinical narrative: This spontaneous report was received from a dentist and refers to a 19 month old female patient, the reporter's daughter. It was reported that the patient did not have any drug reactions/ allergies. No information regarding the patient's pertinent medical history was provided. On 13-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # K002919, expiration date 26-FEB-2016, exact dose and route of administration were not provided). Concomitant therapies included unspecified inactivated influenza virus vaccine, received on the same day. On 26-NOV-2015, the patient started to exhibit severe lethargy. On 27-NOV-2015, the patient had fever and crusting lesions on her thigh and abdomen. The patient was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the patient's body and on 28-NOV-2015, she was admitted to the hospital. The patient was treated with acyclovir, intravenously and unspecified antibiotic. No PQC (product quality complaint) was involved. The outcome of the event was reported as not recovered. The reporter's daughter was still experiencing chicken pox like vesicles. The relatedness between the event and VARIVAX (Merck) was not provided. The reporting physician requested a lot # check. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Eczema, Herpes virus infection, Polymerase chain reaction, Pyrexia, Rash pruritic
Clinical narrative: This spontaneous report was received from a dentist and refers to a 19 month old female patient, the reporter's daughter. It was reported that the patient did not have any drug reactions/ allergies. No information regarding the patient's pertinent medical history was provided. On 13-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # K002919, expiration date 26-FEB-2016, exact dose and route of administration were not provided). Concomitant therapies included unspecified inactivated influenza virus vaccine, received on the same day. On 26-NOV-2015, the patient started to exhibit severe lethargy. On 27-NOV-2015, the patient had fever and crusting lesions on her thigh and abdomen. The patient was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the patient's body and on 28-NOV-2015, she was admitted to the hospital. The patient was treated with acyclovir, intravenously and unspecified antibiotic. No PQC (product quality complaint) was involved. The outcome of the event was reported as not recovered. The reporter's daughter was still experiencing chicken pox like vesicles. The relatedness between the event and VARIVAX (Merck) was not provided. The reporting physician requested a lot # check. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Simplex virus test positive, Skin lesion
Clinical narrative: This spontaneous report was received from a dentist and refers to a 19 month old female patient, the reporter's daughter. It was reported that the patient did not have any drug reactions/ allergies. No information regarding the patient's pertinent medical history was provided. On 13-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # K002919, expiration date 26-FEB-2016, exact dose and route of administration were not provided). Concomitant therapies included unspecified inactivated influenza virus vaccine, received on the same day. On 26-NOV-2015, the patient started to exhibit severe lethargy. On 27-NOV-2015, the patient had fever and crusting lesions on her thigh and abdomen. The patient was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the patient's body and on 28-NOV-2015, she was admitted to the hospital. The patient was treated with acyclovir, intravenously and unspecified antibiotic. No PQC (product quality complaint) was involved. The outcome of the event was reported as not recovered. The reporter's daughter was still experiencing chicken pox like vesicles. The relatedness between the event and VARIVAX (Merck) was not provided. The reporting physician requested a lot # check. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Blister, Injection site reaction, Lethargy, Pyrexia, Scab
Clinical narrative: This spontaneous report was received from a dentist and refers to a 19 month old female patient, the reporter's daughter. It was reported that the patient did not have any drug reactions/ allergies. No information regarding the patient's pertinent medical history was provided. On 13-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # K002919, expiration date 26-FEB-2016, exact dose and route of administration were not provided). Concomitant therapies included unspecified inactivated influenza virus vaccine, received on the same day. On 26-NOV-2015, the patient started to exhibit severe lethargy. On 27-NOV-2015, the patient had fever and crusting lesions on her thigh and abdomen. The patient was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the patient's body and on 28-NOV-2015, she was admitted to the hospital. The patient was treated with acyclovir, intravenously and unspecified antibiotic. No PQC (product quality complaint) was involved. The outcome of the event was reported as not recovered. The reporter's daughter was still experiencing chicken pox like vesicles. The relatedness between the event and VARIVAX (Merck) was not provided. The reporting physician requested a lot # check. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a dentist and refers to a 19 month old female patient, the reporter's daughter. It was reported that the patient did not have any drug reactions/ allergies. No information regarding the patient's pertinent medical history was provided. On 13-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # K002919, expiration date 26-FEB-2016, exact dose and route of administration were not provided). Concomitant therapies included unspecified inactivated influenza virus vaccine, received on the same day. On 26-NOV-2015, the patient started to exhibit severe lethargy. On 27-NOV-2015, the patient had fever and crusting lesions on her thigh and abdomen. The patient was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the patient's body and on 28-NOV-2015, she was admitted to the hospital. The patient was treated with acyclovir, intravenously and unspecified antibiotic. No PQC (product quality complaint) was involved. The outcome of the event was reported as not recovered. The reporter's daughter was still experiencing chicken pox like vesicles. The relatedness between the event and VARIVAX (Merck) was not provided. The reporting physician requested a lot # check. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Injection site reaction, Lethargy, Pyrexia, Rash vesicular, Scab
Clinical narrative: This spontaneous report was received from a dentist and refers to a 19 month old female patient, the reporter's daughter. It was reported that the patient did not have any drug reactions/ allergies. No information regarding the patient's pertinent medical history was provided. On 13-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # K002919, expiration date 26-FEB-2016, exact dose and route of administration were not provided). Concomitant therapies included unspecified inactivated influenza virus vaccine, received on the same day. On 26-NOV-2015, the patient started to exhibit severe lethargy. On 27-NOV-2015, the patient had fever and crusting lesions on her thigh and abdomen. The patient was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the patient's body and on 28-NOV-2015, she was admitted to the hospital. The patient was treated with acyclovir, intravenously and unspecified antibiotic. No PQC (product quality complaint) was involved. The outcome of the event was reported as not recovered. The reporter's daughter was still experiencing chicken pox like vesicles. The relatedness between the event and VARIVAX (Merck) was not provided. The reporting physician requested a lot # check. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, FLUN4, VARCEL
Symptoms: Lethargy, Pyrexia, Rash generalised, Scab, Skin lesion
Clinical narrative: This spontaneous report was received from a dentist and refers to a 4 year old male patient, the reporter's son. No information regarding the patient's medical history and concurrent conditions was reported. On 13-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # K002919, expiration date 26-FEB-2016 exact dose and route of administration were not provided). Concomitant therapies included FLUMIST, received on the same day. On 26-NOV-2015, the patient began to experience fever and tenderness on his feet. The patient developed lesions on the inside of his throat, his hands and bottoms of his feet. On 27-NOV-2015, the patient was seen by the family physician and was diagnosed with post vaccine varicella. The patient was treated with acyclovir on an unspecified date. It was reported that the patient was not hospitalized. The outcome of the event was reported as not recovered. The reporter's son was still experiencing chicken pox like vesicles. The relatedness between the event and VARIVAX (Merck) was not provided. The reporting physician requested a lot # check. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, FLUN4, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a dentist and refers to a 4 year old male patient, the reporter's son. No information regarding the patient's medical history and concurrent conditions was reported. On 13-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # K002919, expiration date 26-FEB-2016 exact dose and route of administration were not provided). Concomitant therapies included FLUMIST, received on the same day. On 26-NOV-2015, the patient began to experience fever and tenderness on his feet. The patient developed lesions on the inside of his throat, his hands and bottoms of his feet. On 27-NOV-2015, the patient was seen by the family physician and was diagnosed with post vaccine varicella. The patient was treated with acyclovir on an unspecified date. It was reported that the patient was not hospitalized. The outcome of the event was reported as not recovered. The reporter's son was still experiencing chicken pox like vesicles. The relatedness between the event and VARIVAX (Merck) was not provided. The reporting physician requested a lot # check. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, FLUN4, VARCEL
Symptoms: Blister, Pyrexia, Skin lesion, Tenderness, Throat lesion
Clinical narrative: This spontaneous report was received from a dentist and refers to a 4 year old male patient, the reporter's son. No information regarding the patient's medical history and concurrent conditions was reported. On 13-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # K002919, expiration date 26-FEB-2016 exact dose and route of administration were not provided). Concomitant therapies included FLUMIST, received on the same day. On 26-NOV-2015, the patient began to experience fever and tenderness on his feet. The patient developed lesions on the inside of his throat, his hands and bottoms of his feet. On 27-NOV-2015, the patient was seen by the family physician and was diagnosed with post vaccine varicella. The patient was treated with acyclovir on an unspecified date. It was reported that the patient was not hospitalized. The outcome of the event was reported as not recovered. The reporter's son was still experiencing chicken pox like vesicles. The relatedness between the event and VARIVAX (Merck) was not provided. The reporting physician requested a lot # check. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Adenovirus test positive, Ataxia, CSF virus no organisms observed, CSF white blood cell count increased, Electroencephalogram
Clinical narrative: Developed seizure activity. Admitted to hospital and treated with anti-convulsant. MRI normal. Spinal tap with 15 WBC. HSV and EV PCR negative. Acyclovir discontinued.  Discharged but readmitted to another hospital with new seizure activity and ataxia as well as mild mental status change. Repeat MRI negative. Repeat lumbar puncture with continued 11 WBC. Repeat HSV PCR negative. Adenovirus PCR From nasopharyngeal swab positive but CSF negative. Required multiple anti-convulsant to control seizure and discharged on combination anticonvulsant therapy.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Epstein-Barr virus test negative, Herpes simplex serology negative, Mental status changes, Nuclear magnetic resonance imaging normal, Polymerase chain reaction
Clinical narrative: Developed seizure activity. Admitted to hospital and treated with anti-convulsant. MRI normal. Spinal tap with 15 WBC. HSV and EV PCR negative. Acyclovir discontinued.  Discharged but readmitted to another hospital with new seizure activity and ataxia as well as mild mental status change. Repeat MRI negative. Repeat lumbar puncture with continued 11 WBC. Repeat HSV PCR negative. Adenovirus PCR From nasopharyngeal swab positive but CSF negative. Required multiple anti-convulsant to control seizure and discharged on combination anticonvulsant therapy.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Developed seizure activity. Admitted to hospital and treated with anti-convulsant. MRI normal. Spinal tap with 15 WBC. HSV and EV PCR negative. Acyclovir discontinued.  Discharged but readmitted to another hospital with new seizure activity and ataxia as well as mild mental status change. Repeat MRI negative. Repeat lumbar puncture with continued 11 WBC. Repeat HSV PCR negative. Adenovirus PCR From nasopharyngeal swab positive but CSF negative. Required multiple anti-convulsant to control seizure and discharged on combination anticonvulsant therapy.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose, Neck pain, Pallor, Throat tightness, Tremor
Clinical narrative: Patient started to shake without control and felt like he had no control over arm.  He then became very pale in color and had a sore neck from shaking without control for several minutes.  He then complained of a tight throat for a few minutes.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Pain, Pyrexia
Clinical narrative: Continuing soreness from shot two days prior, low-grade fever (99.7) for almost two weeks, with certain movements still have pain around injection site, sometimes migrating to joint. Intensity seems to be increasing.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. On unknown dates since 01-OCT-2015, the patients were vaccinated with improperly stored MMR II (lot # K006141, expiration date 29-APR-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. On unknown dates since 01-OCT-2015, the patients were vaccinated with improperly stored ROTATEQ (lot # L008054, expiration date 30-NOV-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot# K02800 with expiration date 05-JUN-2016 (dose and route of vaccination were not reported). No adverse effects were reported. No concomitant medication was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. On unknown dates since 01-OCT-2015, the patients were vaccinated with improperly stored GARDASIL (lot # K016966, expiration date 10-MAY-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a healthcare student and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 27-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) that was reconstituted with an unspecified sterile water that was not diluent supplied for the vaccine. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from The director of nursing regarding 2 unspecified patients of unknown demographics. There was no information about concurrent condition. Sometime between 18-APR-2015 and 23-OCT-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L012042, expired date as 18-NOV-2016, route, dose, dose number and strength were unspecified). On 18-NOV-2015 and 19-NOV-2015, unspecified patients were revaccinated with PNEUMOVAX 23 lot # L017406, expiration date 20-FEB-2017, 0.5ml intramuscularly. On an unknown date in November 2015, the patient developed cellulitis at the injection site. Patient received unspecified antibiotics for treatment. The outcome of cellulitis at the injection site was unknown. Causality between cellulitis at the injection site and PNEUMOVAX 23 was unknown. This is one of the two reports that received from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUR3
Symptoms: Fatigue, Headache, Joint stiffness, Musculoskeletal stiffness, Nausea
Clinical narrative: Nausea in the evening 11/2/15.  11/3/15 muscle/joint stiffness started in back, shoulders, neck, hips, and legs and fatigue started.  Stiffness intensified throughout the week.  Headaches started 11/8/15.  Patient has been seeing massage therapist, chiropractor, and physical therapist for muscle/joint stiffness.
Age: 31.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Syringe issue
Clinical narrative: Full Vaccine administration was not carried out due to malfunctioning syringe. GSK manufacturer's syringe- needle holder popped away from glass vial.
Age: 0.26
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Crying, Depressed level of consciousness, Grip strength decreased, Heart rate increased, Hypotonia
Clinical narrative: Twitching of arms and legs, increased heart rate, irregular breathing, limp arm 9:45 PM on 11/23/2015. Loss of motor skills, weak arms, reduced ability to grasp, reduced consciousness, hours of inconsolable  crying 9:00 AM 11/24/2015.  Still has reduced ability to hold head upright and steady, turn head to the left, move arm, and grasp 12/2/2015.
Age: 0.26
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Irregular breathing, Mobility decreased, Motor dysfunction, Muscle twitching, Muscular weakness
Clinical narrative: Twitching of arms and legs, increased heart rate, irregular breathing, limp arm 9:45 PM on 11/23/2015. Loss of motor skills, weak arms, reduced ability to grasp, reduced consciousness, hours of inconsolable  crying 9:00 AM 11/24/2015.  Still has reduced ability to hold head upright and steady, turn head to the left, move arm, and grasp 12/2/2015.
Age: 0.26
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Posture abnormal
Clinical narrative: Twitching of arms and legs, increased heart rate, irregular breathing, limp arm 9:45 PM on 11/23/2015. Loss of motor skills, weak arms, reduced ability to grasp, reduced consciousness, hours of inconsolable  crying 9:00 AM 11/24/2015.  Still has reduced ability to hold head upright and steady, turn head to the left, move arm, and grasp 12/2/2015.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Muscular weakness, Neurological examination abnormal, Pain in extremity, Sensory loss
Clinical narrative: Client received injectable influenza vaccination on 10/13/2015 in left deltoid.  The client tolerated the injection but reports over the next couple of days that she noticed increased soreness in the area and then began to experience a radiating pain.  The pain began in the proximal left upper extremity and radiated toward the shoulder.  Over the next few weeks, she notice occasional "zings" that radiated down her left arm.  She also began to experience weakness and increased pain with this occurring two weeks after the injection which is now subsiding.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Autoimmune disorder, Injection site pain, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Client received injectable influenza vaccination on 10/13/2015 in left deltoid.  The client tolerated the injection but reports over the next couple of days that she noticed increased soreness in the area and then began to experience a radiating pain.  The pain began in the proximal left upper extremity and radiated toward the shoulder.  Over the next few weeks, she notice occasional "zings" that radiated down her left arm.  She also began to experience weakness and increased pain with this occurring two weeks after the injection which is now subsiding.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age. On 01-DEC-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K026387, expiration date 15-DEC-2016, dose and route were unknown). No adverse event was reported. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Hearing aid user
Clinical narrative: 7 days later with right hearing loss.