chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding an unspecified number of patients of unknown ages and gender. The patients medical history, drug reactions or allergies were not provided. Between 09-OCT-2015 and 16-OCT-2015, an unspecified number of patients received unspecified doses in the M-M-R II immunization series (dose and route were not provided, Lot number J016232, expiration date 19-DEC-2015, and Lot number K026366, expiration date 15-DEC-2016). Concomitant medications were not provided. There was no adverse effects reported. This is one of several reports from the same source (MARRS #1510USA013291 and 1510USA013292). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown gender and age. On an unspecified date in 2006, the patient was vaccinated at an unspecified clinic with a dose of ZOSTAVAX (dose, route and lot# not provided). On 20-OCT-2015, the patient visited an unspecified community based outpatient clinic and was inadvertently given a second dose of ZOSTAVAX (dose, route and lot# not provided). No adverse event was reported. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This is spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 04-FEB-2008, the patient was vaccinated with ZOSTAVAX, (lot #, dose, frequency and route of administration not reported). On 23-OCT-2015, the patient was inadvertently administered with the second dose of ZOSTAVAX. No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, HEPA, HPV4
Symptoms: Blood pressure decreased, Dizziness, Hypotension, Loss of consciousness
Clinical narrative: Pt. fainted after GARDASIL vaccine. Orthostatic BP done and juice given.
Age: 13.0
Sex: M
Vaccine: HPV4, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Pt. fainted after GARDASIL vaccine. Orthostatic BP done and juice given.
Age: 11.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Blood pressure decreased, Loss of consciousness, Syncope
Clinical narrative: Pt. fainted after the GARDASIL vaccine, orthostatic BP was done and juice was given. No other reaction after other vaccines were given 10 min later.
Age: 11.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt. fainted after the GARDASIL vaccine, orthostatic BP was done and juice was given. No other reaction after other vaccines were given 10 min later.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Dizziness, Underdose
Clinical narrative: Pt. felt lightheaded had pt lay down, gave juice and water, checked BP x 3 Q 5-10 min.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: Pt. felt lightheaded had pt lay down, gave juice and water, checked BP x 3 Q 5-10 min.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye discharge, Fatigue, Feeling cold, Headache, Myalgia
Clinical narrative: After receiving the vaccine the patient had discharge from the eye, extreme cold throughout the body, headache, red eyes, stomach, fatigue, swollen at injection site and sore. Fatigue for 2-3 days.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Pain
Clinical narrative: After receiving the vaccine the patient had discharge from the eye, extreme cold throughout the body, headache, red eyes, stomach, fatigue, swollen at injection site and sore. Fatigue for 2-3 days.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Eye discharge, Fatigue, Feeling cold, Headache
Clinical narrative: After receiving the vaccine the patient had discharge from the eye, extreme cold throughout the body, headache, red eyes, stomach, fatigue, swollen at injection site and sore. Fatigue for 2-3 days.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Injection site swelling, Ocular hyperaemia
Clinical narrative: After receiving the vaccine the patient had discharge from the eye, extreme cold throughout the body, headache, red eyes, stomach, fatigue, swollen at injection site and sore. Fatigue for 2-3 days.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist who reported for two patients. This is the first of two reports. A 72 year old female patient received on 29Sep2015, PREVNAR 13 (Lot. L82219, Expiration date: 29Mar2016, NDC 0005-1974-02) single dose. Relevant medical history included blood cholesterol abnormal (treated with some cholesterol medications and atorvastatin), diabetes (treated with LANTUS), and blood pressure abnormal. She had allergic reaction due to MOTRIN, codeine and PERCOCET. Concomitant medications included LANTUS 65 IU, daily, for diabetes mellitus; Lisinopril 10 mg, daily, for blood pressure; atorvastatin 20 mg, daily, for cholesterol; escitalopram 20 mg, daily; ferrous sulfate 325 mg twice daily; methylfolate 1 DF, twice daily; nateglinide 120 mg, 3 times a day before meal; SYNTHROID 112 ug, once daily and Flu vaccine received concomitantly with PREVNAR 13. On an unspecified date, in Oct2015, the patient's arm was swollen, red, hot and itchy. Cellulitis was diagnosed. The patient was put on antibiotics for cellulitis. Pharmacist mentioned that she did not know if it was an allergic reaction. Clinical outcome of the event was unknown at time of this report. Pharmacist mentioned that the events occurred after vaccination with PREVNAR 13 so it was definitely related to PREVNAR 13.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist who reported for two patients. This is the first of two reports. A 72 year old female patient received on 29Sep2015, PREVNAR 13 (Lot. L82219, Expiration date: 29Mar2016, NDC 0005-1974-02) single dose. Relevant medical history included blood cholesterol abnormal (treated with some cholesterol medications and atorvastatin), diabetes (treated with LANTUS), and blood pressure abnormal. She had allergic reaction due to MOTRIN, codeine and PERCOCET. Concomitant medications included LANTUS 65 IU, daily, for diabetes mellitus; Lisinopril 10 mg, daily, for blood pressure; atorvastatin 20 mg, daily, for cholesterol; escitalopram 20 mg, daily; ferrous sulfate 325 mg twice daily; methylfolate 1 DF, twice daily; nateglinide 120 mg, 3 times a day before meal; SYNTHROID 112 ug, once daily and Flu vaccine received concomitantly with PREVNAR 13. On an unspecified date, in Oct2015, the patient's arm was swollen, red, hot and itchy. Cellulitis was diagnosed. The patient was put on antibiotics for cellulitis. Pharmacist mentioned that she did not know if it was an allergic reaction. Clinical outcome of the event was unknown at time of this report. Pharmacist mentioned that the events occurred after vaccination with PREVNAR 13 so it was definitely related to PREVNAR 13.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Feeling cold, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient's medical history was not reported. Patient's concurrent condition included hypertension. Patient was allergic to Penicillin, Metronidazole, she is not allergic to Prednisone but felt jittery when takes the drug. On 13-OCT-2015 the patient was vaccinated with ZOSTAVAX strength, 0.65 ml, lot # L020482 with an expiry date of 02-SEP-2016 subcutaneously in the right arm. Concomitant therapies included metoprolol, NORVASC and estradiol. On 13-OCT-2015, in the evening the patient experienced severe soreness at the injection site of the right arm. On 14-OCT-2015 the next day patient had a big swollen bump at the injection site. On 15-OCT-2015 the patient informed that he had red, swollen welts at the injection site that was approximately 3 inches in diameter. The reporter stated that there was a huge spot at the injection site and it was warm to touch. Patient was weak, had shivers, feverish and experienced flu like symptoms. Patient then went to local urgent care center (unspecified name). The healthcare worker placed a demarcation around the injection site and the patient was told if the bump swelled beyond that area he should begin BACTRIM DS therapy. Reporter stated that he was told by the patient that the swelling increased and she had started the therapy with BACTRIM DS. Pharmacists stated that prednisone was not prescribed by the health care provider because the patient gets jittery if she takes the product. The outcome of the events urticaria, vaccination site pain, vaccination site warmth, vaccination site swelling, vaccination site erythema, pyrexia, asthenia, influenza like illness, vaccination site scar and chills was reported as not recovered/not resolved. The reported did not provide the causality between the event and the suspect therapy. There was no product quality complaint. This is one of the two reports refers to same patient. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient's medical history was not reported. Patient's concurrent condition included hypertension. Patient was allergic to Penicillin, Metronidazole, she is not allergic to Prednisone but felt jittery when takes the drug. On 13-OCT-2015 the patient was vaccinated with ZOSTAVAX strength, 0.65 ml, lot # L020482 with an expiry date of 02-SEP-2016 subcutaneously in the right arm. Concomitant therapies included metoprolol, NORVASC and estradiol. On 13-OCT-2015, in the evening the patient experienced severe soreness at the injection site of the right arm. On 14-OCT-2015 the next day patient had a big swollen bump at the injection site. On 15-OCT-2015 the patient informed that he had red, swollen welts at the injection site that was approximately 3 inches in diameter. The reporter stated that there was a huge spot at the injection site and it was warm to touch. Patient was weak, had shivers, feverish and experienced flu like symptoms. Patient then went to local urgent care center (unspecified name). The healthcare worker placed a demarcation around the injection site and the patient was told if the bump swelled beyond that area he should begin BACTRIM DS therapy. Reporter stated that he was told by the patient that the swelling increased and she had started the therapy with BACTRIM DS. Pharmacists stated that prednisone was not prescribed by the health care provider because the patient gets jittery if she takes the product. The outcome of the events urticaria, vaccination site pain, vaccination site warmth, vaccination site swelling, vaccination site erythema, pyrexia, asthenia, influenza like illness, vaccination site scar and chills was reported as not recovered/not resolved. The reported did not provide the causality between the event and the suspect therapy. There was no product quality complaint. This is one of the two reports refers to same patient. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient's medical history was not reported. Patient's concurrent condition included hypertension. Patient was allergic to Penicillin, Metronidazole, she is not allergic to Prednisone but felt jittery when takes the drug. On 13-OCT-2015 the patient was vaccinated with ZOSTAVAX strength, 0.65 ml, lot # L020482 with an expiry date of 02-SEP-2016 subcutaneously in the right arm. Concomitant therapies included metoprolol, NORVASC and estradiol. On 13-OCT-2015, in the evening the patient experienced severe soreness at the injection site of the right arm. On 14-OCT-2015 the next day patient had a big swollen bump at the injection site. On 15-OCT-2015 the patient informed that he had red, swollen welts at the injection site that was approximately 3 inches in diameter. The reporter stated that there was a huge spot at the injection site and it was warm to touch. Patient was weak, had shivers, feverish and experienced flu like symptoms. Patient then went to local urgent care center (unspecified name). The healthcare worker placed a demarcation around the injection site and the patient was told if the bump swelled beyond that area he should begin BACTRIM DS therapy. Reporter stated that he was told by the patient that the swelling increased and she had started the therapy with BACTRIM DS. Pharmacists stated that prednisone was not prescribed by the health care provider because the patient gets jittery if she takes the product. The outcome of the events urticaria, vaccination site pain, vaccination site warmth, vaccination site swelling, vaccination site erythema, pyrexia, asthenia, influenza like illness, vaccination site scar and chills was reported as not recovered/not resolved. The reported did not provide the causality between the event and the suspect therapy. There was no product quality complaint. This is one of the two reports refers to same patient. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient's medical history was not reported. Patient's concurrent condition included hypertension. Patient was allergic to Penicillin, Metronidazole, she is not allergic to Prednisone but felt jittery when takes the drug. On 13-OCT-2015 the patient was vaccinated with ZOSTAVAX strength, 0.65 ml, lot # L020482 with an expiry date of 02-SEP-2016 subcutaneously in the right arm. Concomitant therapies included metoprolol, NORVASC and estradiol. On 13-OCT-2015, in the evening the patient experienced severe soreness at the injection site of the right arm. On 14-OCT-2015 the next day patient had a big swollen bump at the injection site. On 15-OCT-2015 the patient informed that he had red, swollen welts at the injection site that was approximately 3 inches in diameter. The reporter stated that there was a huge spot at the injection site and it was warm to touch. Patient was weak, had shivers, feverish and experienced flu like symptoms. Patient then went to local urgent care center (unspecified name). The healthcare worker placed a demarcation around the injection site and the patient was told if the bump swelled beyond that area he should begin BACTRIM DS therapy. Reporter stated that he was told by the patient that the swelling increased and she had started the therapy with BACTRIM DS. Pharmacists stated that prednisone was not prescribed by the health care provider because the patient gets jittery if she takes the product. The outcome of the events urticaria, vaccination site pain, vaccination site warmth, vaccination site swelling, vaccination site erythema, pyrexia, asthenia, influenza like illness, vaccination site scar and chills was reported as not recovered/not resolved. The reported did not provide the causality between the event and the suspect therapy. There was no product quality complaint. This is one of the two reports refers to same patient. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP, MNQ
Symptoms: Arthropathy, Asthenia, Computerised tomogram normal, Eye pain, Fatigue
Clinical narrative: Initial unsolicited report received from a physician on 16 October 2015. This case was linked to 2015SA166542, 2015SA164326, 2015SA164327 (same reporter, same vaccine). This case involves 11-years-old patient (gender not reported) who was vaccinated with a dose of MENACTRA (batch number: U4847AA, dose, dose in series, route and site of administration were not reported) on 23 September 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient collapsed at school/could not walk and the patient was diagnosed with migraine, syncope, and staring spells. On 24 September 2015, the patient was hospitalized and was in hospital for 3-4 days. It was reported that there was increased frequency and more violent seizure activity. Laboratory data included EEG which showed abnormal spikes not consistent with seizure activity and then neurology. The patient received corrective treatment with TOPAMAX. The outcome of the event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP, MNQ
Symptoms: Feeling abnormal, Full blood count normal, Headache, Mental status changes, Metabolic function test normal
Clinical narrative: Initial unsolicited report received from a physician on 16 October 2015. This case was linked to 2015SA166542, 2015SA164326, 2015SA164327 (same reporter, same vaccine). This case involves 11-years-old patient (gender not reported) who was vaccinated with a dose of MENACTRA (batch number: U4847AA, dose, dose in series, route and site of administration were not reported) on 23 September 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient collapsed at school/could not walk and the patient was diagnosed with migraine, syncope, and staring spells. On 24 September 2015, the patient was hospitalized and was in hospital for 3-4 days. It was reported that there was increased frequency and more violent seizure activity. Laboratory data included EEG which showed abnormal spikes not consistent with seizure activity and then neurology. The patient received corrective treatment with TOPAMAX. The outcome of the event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP, MNQ
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging normal, Posture abnormal, Pregnancy test negative, Staring
Clinical narrative: Initial unsolicited report received from a physician on 16 October 2015. This case was linked to 2015SA166542, 2015SA164326, 2015SA164327 (same reporter, same vaccine). This case involves 11-years-old patient (gender not reported) who was vaccinated with a dose of MENACTRA (batch number: U4847AA, dose, dose in series, route and site of administration were not reported) on 23 September 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient collapsed at school/could not walk and the patient was diagnosed with migraine, syncope, and staring spells. On 24 September 2015, the patient was hospitalized and was in hospital for 3-4 days. It was reported that there was increased frequency and more violent seizure activity. Laboratory data included EEG which showed abnormal spikes not consistent with seizure activity and then neurology. The patient received corrective treatment with TOPAMAX. The outcome of the event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP, MNQ
Symptoms: Syncope
Clinical narrative: Initial unsolicited report received from a physician on 16 October 2015. This case was linked to 2015SA166542, 2015SA164326, 2015SA164327 (same reporter, same vaccine). This case involves 11-years-old patient (gender not reported) who was vaccinated with a dose of MENACTRA (batch number: U4847AA, dose, dose in series, route and site of administration were not reported) on 23 September 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient collapsed at school/could not walk and the patient was diagnosed with migraine, syncope, and staring spells. On 24 September 2015, the patient was hospitalized and was in hospital for 3-4 days. It was reported that there was increased frequency and more violent seizure activity. Laboratory data included EEG which showed abnormal spikes not consistent with seizure activity and then neurology. The patient received corrective treatment with TOPAMAX. The outcome of the event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP, MNQ
Symptoms: Abasia, Electroencephalogram abnormal, Migraine, Seizure, Staring
Clinical narrative: Initial unsolicited report received from a physician on 16 October 2015. This case was linked to 2015SA166542, 2015SA164326, 2015SA164327 (same reporter, same vaccine). This case involves 11-years-old patient (gender not reported) who was vaccinated with a dose of MENACTRA (batch number: U4847AA, dose, dose in series, route and site of administration were not reported) on 23 September 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient collapsed at school/could not walk and the patient was diagnosed with migraine, syncope, and staring spells. On 24 September 2015, the patient was hospitalized and was in hospital for 3-4 days. It was reported that there was increased frequency and more violent seizure activity. Laboratory data included EEG which showed abnormal spikes not consistent with seizure activity and then neurology. The patient received corrective treatment with TOPAMAX. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site vesicles
Clinical narrative: This spontaneous report was received from a non-pregnant female registered nurse via company representative regarding herself. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 08-OCT-2015, the patient was vaccinated with one shot of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In October 2015 (reported as on an unspecified date after receiving her vaccination), the patient experienced "cellulitis and shingles (herpes zoster) blisters (injection site vesicles) around the injection site". The patient sought medical attention at an unspecified emergency room on an unspecified date and was treated with unspecified antibiotics. At the time of the report, the outcome of the patient experienced cellulitis and shingles blisters around the injection site was reported as recovering. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site cellulitis, Injection site reaction, Injection site vesicles
Clinical narrative: This spontaneous report was received from a non-pregnant female registered nurse via company representative regarding herself. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 08-OCT-2015, the patient was vaccinated with one shot of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In October 2015 (reported as on an unspecified date after receiving her vaccination), the patient experienced "cellulitis and shingles (herpes zoster) blisters (injection site vesicles) around the injection site". The patient sought medical attention at an unspecified emergency room on an unspecified date and was treated with unspecified antibiotics. At the time of the report, the outcome of the patient experienced cellulitis and shingles blisters around the injection site was reported as recovering. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Adenovirus test, Coxsackie virus test, Cytomegalovirus test, Eye pain, Mouth ulceration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of Stevens Johnson syndrome in a 41-year-old female patient who received FLUARIX QUADRIVALENT (batch number NJ4PP, expiry date 23rd June 2016). Previously administered products included FLUZONE (in the past 2 years the patient had at least received FLUZONE vaccine each year without any problems). Concurrent medical conditions included penicillin allergy. On 14th October 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 20th October 2015, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced Stevens Johnson syndrome (serious criteria hospitalization, GSK medically significant, life threatening and other: as per reporter) and myalgia. On 22nd October 2015, the patient experienced rash. On an unknown date, the outcome of the Stevens Johnson syndrome was not recovered/not resolved and the outcome of the myalgia and rash were unknown. The reporter considered the Stevens Johnson syndrome, myalgia and rash to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: In the past 2 years at least patient had received FLUZONE each year without any problems. The patient had amoxicillin allergy and no known other concomitant medications or medical conditions. The patient was vaccinated in Employee Health Clinic at Hospital/Health System and began to have myalgia within 6 days after vaccination and went to emergency department on 20th October 2015. They assessed her for influenza, etc and released her. By 22nd October 2015, she had rash and went to emergency department and was admitted with Steven Johnson Syndrome Diagnosis. At the time of reporting, the patient was hospitalized and being treated for condition. The reported batch number MJ4PP does not exist, however as per the sales data the correct batch number should be NJ4PP.
Age: 41.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Myalgia, Pain, Pyrexia, Stevens-Johnson syndrome, Viral infection
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of Stevens Johnson syndrome in a 41-year-old female patient who received FLUARIX QUADRIVALENT (batch number NJ4PP, expiry date 23rd June 2016). Previously administered products included FLUZONE (in the past 2 years the patient had at least received FLUZONE vaccine each year without any problems). Concurrent medical conditions included penicillin allergy. On 14th October 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 20th October 2015, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced Stevens Johnson syndrome (serious criteria hospitalization, GSK medically significant, life threatening and other: as per reporter) and myalgia. On 22nd October 2015, the patient experienced rash. On an unknown date, the outcome of the Stevens Johnson syndrome was not recovered/not resolved and the outcome of the myalgia and rash were unknown. The reporter considered the Stevens Johnson syndrome, myalgia and rash to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: In the past 2 years at least patient had received FLUZONE each year without any problems. The patient had amoxicillin allergy and no known other concomitant medications or medical conditions. The patient was vaccinated in Employee Health Clinic at Hospital/Health System and began to have myalgia within 6 days after vaccination and went to emergency department on 20th October 2015. They assessed her for influenza, etc and released her. By 22nd October 2015, she had rash and went to emergency department and was admitted with Steven Johnson Syndrome Diagnosis. At the time of reporting, the patient was hospitalized and being treated for condition. The reported batch number MJ4PP does not exist, however as per the sales data the correct batch number should be NJ4PP.
Age: 41.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Vulval ulceration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of Stevens Johnson syndrome in a 41-year-old female patient who received FLUARIX QUADRIVALENT (batch number NJ4PP, expiry date 23rd June 2016). Previously administered products included FLUZONE (in the past 2 years the patient had at least received FLUZONE vaccine each year without any problems). Concurrent medical conditions included penicillin allergy. On 14th October 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 20th October 2015, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced Stevens Johnson syndrome (serious criteria hospitalization, GSK medically significant, life threatening and other: as per reporter) and myalgia. On 22nd October 2015, the patient experienced rash. On an unknown date, the outcome of the Stevens Johnson syndrome was not recovered/not resolved and the outcome of the myalgia and rash were unknown. The reporter considered the Stevens Johnson syndrome, myalgia and rash to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: In the past 2 years at least patient had received FLUZONE each year without any problems. The patient had amoxicillin allergy and no known other concomitant medications or medical conditions. The patient was vaccinated in Employee Health Clinic at Hospital/Health System and began to have myalgia within 6 days after vaccination and went to emergency department on 20th October 2015. They assessed her for influenza, etc and released her. By 22nd October 2015, she had rash and went to emergency department and was admitted with Steven Johnson Syndrome Diagnosis. At the time of reporting, the patient was hospitalized and being treated for condition. The reported batch number MJ4PP does not exist, however as per the sales data the correct batch number should be NJ4PP.
Age: 41.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Myalgia, Rash, Stevens-Johnson syndrome
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of Stevens Johnson syndrome in a 41-year-old female patient who received FLUARIX QUADRIVALENT (batch number NJ4PP, expiry date 23rd June 2016). Previously administered products included FLUZONE (in the past 2 years the patient had at least received FLUZONE vaccine each year without any problems). Concurrent medical conditions included penicillin allergy. On 14th October 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 20th October 2015, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced Stevens Johnson syndrome (serious criteria hospitalization, GSK medically significant, life threatening and other: as per reporter) and myalgia. On 22nd October 2015, the patient experienced rash. On an unknown date, the outcome of the Stevens Johnson syndrome was not recovered/not resolved and the outcome of the myalgia and rash were unknown. The reporter considered the Stevens Johnson syndrome, myalgia and rash to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: In the past 2 years at least patient had received FLUZONE each year without any problems. The patient had amoxicillin allergy and no known other concomitant medications or medical conditions. The patient was vaccinated in Employee Health Clinic at Hospital/Health System and began to have myalgia within 6 days after vaccination and went to emergency department on 20th October 2015. They assessed her for influenza, etc and released her. By 22nd October 2015, she had rash and went to emergency department and was admitted with Steven Johnson Syndrome Diagnosis. At the time of reporting, the patient was hospitalized and being treated for condition. The reported batch number MJ4PP does not exist, however as per the sales data the correct batch number should be NJ4PP.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Altered state of consciousness, Dizziness, Dyspnoea, Heart rate increased, Impaired driving ability
Clinical narrative: Presented back in office appoximately 1.5 hours after immunization c/o dizziness, breathing difficulties, flushed.  Transported to ER.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Dizziness, Dyspnoea, Flushing
Clinical narrative: Presented back in office appoximately 1.5 hours after immunization c/o dizziness, breathing difficulties, flushed.  Transported to ER.
Age: 7.0
Sex: M
Vaccine: FLUN4, FLUN4, FLUN4
Symptoms: Aggression, Agitation, Asthenia, CSF glucose normal, CSF mononuclear cell count increased
Clinical narrative: Timeline of events: 10-14-15 FLUMIST 4:00 pm. 10-15-15 patient fever 100.5 missed soccer and school. 10-16-15 Didn't take temperature, but didn't seem to have a fever, but had swollen eyes. Thought it was allergies. Gave patient Motrin and Benadryl before bed. 10-17-15 patient lethargic for soccer game. Not eating much over the weekend. 10-19-15 (Monday) patient had swollen eyes. Gave him Zyrtec before school. Patient laid on the couch after school. Temperature of 101.3.  10-20-15 (Tuesday) patient started throwing up in the middle of the night. Fevers and throwing up continued on the Thursday. Had swollen lymph nodes today. 10-22-2015 Thursday. Patient had a fever of 104.9 F. He said, "Cut my head off. It's going to explode." Took patient to Pediatrician. He barely walked in. Strep tested positive. Started amoxicillin right away. 10-23-15 Friday. Amoxicillin didn't work. Fever persisted. Throwing up slowed down. Patient asked me to carry him to the bathroom or he will crawl. I took him to the bathroom, and he couldn't stand. 3:30 pm After I picked up siblings, patient was laying in his pee (blue sweat pants). He said he didn't pee. 3:50 pm took him back for Dr. this time. She said he has to go to the hospital. I had to carry him in. She sat him up and he threw up. (Pressure in the head). Then, he peed when he sat up. 5:15 pm in the PedsER. Patient is appropriate at first, just in pain. "Cut my head off. Cut my leg off." He can't understand to pee in urinal. Over the next 5 hours he gets x-ray, LP, blood work. WBC elevated. LP looks like viral meningitis. Elevated WBC's and elevated protein. Dr. (In charge of the PICU) admitted him. 10-24-15 Another Dr. saw him. Explained everything. Patient was thrashing and more uncomfortable. Noticed that when he had fevers he was more disoriented. Gave him Tyenol and Motrin around the clock and switched this to Toradal. He was still talking, just irritated. 10-25-15 Sunday Calmer, but more comatose state. Neurologist came and saw him. Recommended EEG. After started having Chain Stroke breathing. Ventilator placed outside the room. Dilantin given as a precaution to possible seizures. Occupational and physical therapy started. 10 pm someone said he loved him and patient said, "I love you too, Dad." 10-26-15 EEG done. PICC line placed in Right brachial. NG weighted placed in left nare. Patient a lot more alert today for longer periods. Still doesn't talk much. I brushed his teeth and kissed him. He said, "Could you please just stop." I did it again and laughed with tears of joy, and he said, "Just be quiet." Family came in the evening. Infectious disease Dr. came. He said he believed this was encephalitis from the FLUMIST. I completely agree. EEG came back negative, except for encephalitis features. He just needs time. Occupational and physical therapy. 10-27-15 Only said, "Hi, mom" today. Weaker than yesterday. Speech not as clear as yesterday. Three Dr's. saw him today. Occupational and physical therapy.
Age: 7.0
Sex: M
Vaccine: FLUN4, FLUN4, FLUN4
Symptoms: Decreased activity, Encephalitis, Hyporesponsive to stimuli, Intensive care, Lethargy
Clinical narrative: Timeline of events: 10-14-15 FLUMIST 4:00 pm. 10-15-15 patient fever 100.5 missed soccer and school. 10-16-15 Didn't take temperature, but didn't seem to have a fever, but had swollen eyes. Thought it was allergies. Gave patient Motrin and Benadryl before bed. 10-17-15 patient lethargic for soccer game. Not eating much over the weekend. 10-19-15 (Monday) patient had swollen eyes. Gave him Zyrtec before school. Patient laid on the couch after school. Temperature of 101.3.  10-20-15 (Tuesday) patient started throwing up in the middle of the night. Fevers and throwing up continued on the Thursday. Had swollen lymph nodes today. 10-22-2015 Thursday. Patient had a fever of 104.9 F. He said, "Cut my head off. It's going to explode." Took patient to Pediatrician. He barely walked in. Strep tested positive. Started amoxicillin right away. 10-23-15 Friday. Amoxicillin didn't work. Fever persisted. Throwing up slowed down. Patient asked me to carry him to the bathroom or he will crawl. I took him to the bathroom, and he couldn't stand. 3:30 pm After I picked up siblings, patient was laying in his pee (blue sweat pants). He said he didn't pee. 3:50 pm took him back for Dr. this time. She said he has to go to the hospital. I had to carry him in. She sat him up and he threw up. (Pressure in the head). Then, he peed when he sat up. 5:15 pm in the PedsER. Patient is appropriate at first, just in pain. "Cut my head off. Cut my leg off." He can't understand to pee in urinal. Over the next 5 hours he gets x-ray, LP, blood work. WBC elevated. LP looks like viral meningitis. Elevated WBC's and elevated protein. Dr. (In charge of the PICU) admitted him. 10-24-15 Another Dr. saw him. Explained everything. Patient was thrashing and more uncomfortable. Noticed that when he had fevers he was more disoriented. Gave him Tyenol and Motrin around the clock and switched this to Toradal. He was still talking, just irritated. 10-25-15 Sunday Calmer, but more comatose state. Neurologist came and saw him. Recommended EEG. After started having Chain Stroke breathing. Ventilator placed outside the room. Dilantin given as a precaution to possible seizures. Occupational and physical therapy started. 10 pm someone said he loved him and patient said, "I love you too, Dad." 10-26-15 EEG done. PICC line placed in Right brachial. NG weighted placed in left nare. Patient a lot more alert today for longer periods. Still doesn't talk much. I brushed his teeth and kissed him. He said, "Could you please just stop." I did it again and laughed with tears of joy, and he said, "Just be quiet." Family came in the evening. Infectious disease Dr. came. He said he believed this was encephalitis from the FLUMIST. I completely agree. EEG came back negative, except for encephalitis features. He just needs time. Occupational and physical therapy. 10-27-15 Only said, "Hi, mom" today. Weaker than yesterday. Speech not as clear as yesterday. Three Dr's. saw him today. Occupational and physical therapy.
Age: 7.0
Sex: M
Vaccine: FLUN4, FLUN4, FLUN4
Symptoms: Lymphadenopathy, Meningitis, Nausea, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Timeline of events: 10-14-15 FLUMIST 4:00 pm. 10-15-15 patient fever 100.5 missed soccer and school. 10-16-15 Didn't take temperature, but didn't seem to have a fever, but had swollen eyes. Thought it was allergies. Gave patient Motrin and Benadryl before bed. 10-17-15 patient lethargic for soccer game. Not eating much over the weekend. 10-19-15 (Monday) patient had swollen eyes. Gave him Zyrtec before school. Patient laid on the couch after school. Temperature of 101.3.  10-20-15 (Tuesday) patient started throwing up in the middle of the night. Fevers and throwing up continued on the Thursday. Had swollen lymph nodes today. 10-22-2015 Thursday. Patient had a fever of 104.9 F. He said, "Cut my head off. It's going to explode." Took patient to Pediatrician. He barely walked in. Strep tested positive. Started amoxicillin right away. 10-23-15 Friday. Amoxicillin didn't work. Fever persisted. Throwing up slowed down. Patient asked me to carry him to the bathroom or he will crawl. I took him to the bathroom, and he couldn't stand. 3:30 pm After I picked up siblings, patient was laying in his pee (blue sweat pants). He said he didn't pee. 3:50 pm took him back for Dr. this time. She said he has to go to the hospital. I had to carry him in. She sat him up and he threw up. (Pressure in the head). Then, he peed when he sat up. 5:15 pm in the PedsER. Patient is appropriate at first, just in pain. "Cut my head off. Cut my leg off." He can't understand to pee in urinal. Over the next 5 hours he gets x-ray, LP, blood work. WBC elevated. LP looks like viral meningitis. Elevated WBC's and elevated protein. Dr. (In charge of the PICU) admitted him. 10-24-15 Another Dr. saw him. Explained everything. Patient was thrashing and more uncomfortable. Noticed that when he had fevers he was more disoriented. Gave him Tyenol and Motrin around the clock and switched this to Toradal. He was still talking, just irritated. 10-25-15 Sunday Calmer, but more comatose state. Neurologist came and saw him. Recommended EEG. After started having Chain Stroke breathing. Ventilator placed outside the room. Dilantin given as a precaution to possible seizures. Occupational and physical therapy started. 10 pm someone said he loved him and patient said, "I love you too, Dad." 10-26-15 EEG done. PICC line placed in Right brachial. NG weighted placed in left nare. Patient a lot more alert today for longer periods. Still doesn't talk much. I brushed his teeth and kissed him. He said, "Could you please just stop." I did it again and laughed with tears of joy, and he said, "Just be quiet." Family came in the evening. Infectious disease Dr. came. He said he believed this was encephalitis from the FLUMIST. I completely agree. EEG came back negative, except for encephalitis features. He just needs time. Occupational and physical therapy. 10-27-15 Only said, "Hi, mom" today. Weaker than yesterday. Speech not as clear as yesterday. Three Dr's. saw him today. Occupational and physical therapy.
Age: 7.0
Sex: M
Vaccine: FLUN4, FLUN4, FLUN4
Symptoms: Respiration abnormal, Restlessness, Seizure, Streptococcus test positive, Urinary incontinence
Clinical narrative: Timeline of events: 10-14-15 FLUMIST 4:00 pm. 10-15-15 patient fever 100.5 missed soccer and school. 10-16-15 Didn't take temperature, but didn't seem to have a fever, but had swollen eyes. Thought it was allergies. Gave patient Motrin and Benadryl before bed. 10-17-15 patient lethargic for soccer game. Not eating much over the weekend. 10-19-15 (Monday) patient had swollen eyes. Gave him Zyrtec before school. Patient laid on the couch after school. Temperature of 101.3.  10-20-15 (Tuesday) patient started throwing up in the middle of the night. Fevers and throwing up continued on the Thursday. Had swollen lymph nodes today. 10-22-2015 Thursday. Patient had a fever of 104.9 F. He said, "Cut my head off. It's going to explode." Took patient to Pediatrician. He barely walked in. Strep tested positive. Started amoxicillin right away. 10-23-15 Friday. Amoxicillin didn't work. Fever persisted. Throwing up slowed down. Patient asked me to carry him to the bathroom or he will crawl. I took him to the bathroom, and he couldn't stand. 3:30 pm After I picked up siblings, patient was laying in his pee (blue sweat pants). He said he didn't pee. 3:50 pm took him back for Dr. this time. She said he has to go to the hospital. I had to carry him in. She sat him up and he threw up. (Pressure in the head). Then, he peed when he sat up. 5:15 pm in the PedsER. Patient is appropriate at first, just in pain. "Cut my head off. Cut my leg off." He can't understand to pee in urinal. Over the next 5 hours he gets x-ray, LP, blood work. WBC elevated. LP looks like viral meningitis. Elevated WBC's and elevated protein. Dr. (In charge of the PICU) admitted him. 10-24-15 Another Dr. saw him. Explained everything. Patient was thrashing and more uncomfortable. Noticed that when he had fevers he was more disoriented. Gave him Tyenol and Motrin around the clock and switched this to Toradal. He was still talking, just irritated. 10-25-15 Sunday Calmer, but more comatose state. Neurologist came and saw him. Recommended EEG. After started having Chain Stroke breathing. Ventilator placed outside the room. Dilantin given as a precaution to possible seizures. Occupational and physical therapy started. 10 pm someone said he loved him and patient said, "I love you too, Dad." 10-26-15 EEG done. PICC line placed in Right brachial. NG weighted placed in left nare. Patient a lot more alert today for longer periods. Still doesn't talk much. I brushed his teeth and kissed him. He said, "Could you please just stop." I did it again and laughed with tears of joy, and he said, "Just be quiet." Family came in the evening. Infectious disease Dr. came. He said he believed this was encephalitis from the FLUMIST. I completely agree. EEG came back negative, except for encephalitis features. He just needs time. Occupational and physical therapy. 10-27-15 Only said, "Hi, mom" today. Weaker than yesterday. Speech not as clear as yesterday. Three Dr's. saw him today. Occupational and physical therapy.