chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood blister, Dyspnoea, Peripheral swelling
Clinical narrative: Case number PHHY2015US031816, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553997) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 358454) on 19 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358454) on 16 Apr 2015. This report refers to a 35-year-old female patient. The patient was allergic to penicillin and just had baby by C-section. Concomitant medications included MOTRIN, VICODIN and Prenatal vitamins. She was vaccinated with FLUVIRIN (batch number: 145405) intramuscularly into the right arm on 07 Nov 2014. On the same day after vaccination, the patient's hands and feet were swollen and the patient developed blood blister all over hands. Further, the patient had hard time breathing and was weak. The patient went to the emergency room and was hospitalized for two days. The outcome of the events was condition unchanged. The causality assessment of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 145405) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 358454) on 19 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 358454) on 16 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis
Clinical narrative: Case number PHHY2015US032197 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 554365) on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 358790) on 20 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358790) on 16 Apr 2015. This report refers to a 64 years old female patient. Her historical drug included Meperidine and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1414201A) intramuscularly and ZOSTAVAX (other manufacturer, batch number: K011004) subcutaneously; both vaccines administered on 14 Nov 2014. On 15 Nov 2014, she had cellulitis. She went to emergency room and was treated with CIPRO 500 mg and Naproxen 550 mg. The events outcome was unknown. The events were reported as non-serious, but the event cellulitis was upgraded as medically significant based on the information available in the NVS-IME list. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1414201A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 358790) on 20 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 358790) on 16 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 46.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Case number PHHY2015US032207 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 554366) on 16 Mar 2015, with the follow-up information received from the Quality Assurance Department (reference number: 358796) on 20 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358796) on 16 Apr 2015: This report refers to a 46 years old patient whose gender was not reported. The patient's medical history included seizure disorder. The patient's concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145202) and PNEUMOVAX (other manufacturer, batch number: K009107); both vaccines administered in the left arm on an unknown date. On an unspecified date after vaccination, the patient had cellulitis reaction. The events outcome was reported as complete recovery. The events were reported as non-serious, but the event cellulitis was upgraded as medically significant based on the information available in the NVS-IME list. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 145202) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 358796) on 20 Mar 2015: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 358796) on 16 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 48.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2015US031881, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554793) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 358293) on 18 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358293) on 15 Apr 2015. This report refers to a 48-year-old male patient. He had no known allergies and no current illness. He was vaccinated with FLUVIRIN (batch number: 1413401) intramuscularly and PNEUMOVAX (other manufacturer and batch number: K009876) intramuscularly on 17 Nov 2014. On the same date, after vaccination the patient experienced fever, nausea, stomach discomfort, pain in back, arm and waist. Following these events, the patient had an emergency room visit and lab test showed cellulitis (not specified). On an unknown date, the patient was hospitalized for 4 days due to the events. Final outcome of the events reported as not yet recovered. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 358293) on 18 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 358293) on 15 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 48.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Abdominal discomfort, Abdominal pain, Back pain, Cellulitis, Laboratory test abnormal
Clinical narrative: Case number PHHY2015US031881, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554793) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 358293) on 18 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358293) on 15 Apr 2015. This report refers to a 48-year-old male patient. He had no known allergies and no current illness. He was vaccinated with FLUVIRIN (batch number: 1413401) intramuscularly and PNEUMOVAX (other manufacturer and batch number: K009876) intramuscularly on 17 Nov 2014. On the same date, after vaccination the patient experienced fever, nausea, stomach discomfort, pain in back, arm and waist. Following these events, the patient had an emergency room visit and lab test showed cellulitis (not specified). On an unknown date, the patient was hospitalized for 4 days due to the events. Final outcome of the events reported as not yet recovered. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 358293) on 18 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 358293) on 15 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 48.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2015US031881, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554793) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 358293) on 18 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358293) on 15 Apr 2015. This report refers to a 48-year-old male patient. He had no known allergies and no current illness. He was vaccinated with FLUVIRIN (batch number: 1413401) intramuscularly and PNEUMOVAX (other manufacturer and batch number: K009876) intramuscularly on 17 Nov 2014. On the same date, after vaccination the patient experienced fever, nausea, stomach discomfort, pain in back, arm and waist. Following these events, the patient had an emergency room visit and lab test showed cellulitis (not specified). On an unknown date, the patient was hospitalized for 4 days due to the events. Final outcome of the events reported as not yet recovered. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 358293) on 18 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 358293) on 15 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 91.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Pain in extremity, Staphylococcal infection
Clinical narrative: Case number PHHY2015US031913, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554880) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 359075) on 23 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 359075) on 17 Apr 2015. This report refers to a 91-year-old male patient. His historical conditions and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1413301), intramuscularly on left arm and PNEUMOVAX (other manufacturer and batch number: K004483) intramuscularly on right arm, on 24 Sep 2014. On 26 Sep 2014, the patient complained of a sore arm and he went to the hospital where it was discovered that he had a MRSA (Methicillin resistant staphylococcus aureus) infection at the injection site of his flu shot (left arm). On an unknown date, the patient was hospitalized for 5 days due to events and treated with intravenous antibiotics. Final outcome of the events reported as recovered. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 359075) on 23 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 359075) on 17 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Case number PHHY2015US032967, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 555946) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 359230) on 23 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 359230) on 17 Apr 2015. This report refers to a 54 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145603) into right arm on 19 Nov 2014. On the same day after vaccination, her arm swelled up in the night. On 20 Nov 2014, she went to urgent care and was diagnosed with cellulitis. The patient was given antibiotics. On 21 Nov 2014, she went to a hospital for intravenous antibiotics as her condition was not improving. She was not hospitalized. Final outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of cellulitis was upgraded (medically significant) as per NVS-IME list. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 145603) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 359230) on 23 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 359230) on 17 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Eye discharge, Hypersensitivity, Insomnia, Productive cough, Rash
Clinical narrative: Rash on back, neck, lower legs; Sore throat with swelling; Red, pus in eyes; Headache; Cough (productive with mucus); Runny nose; slight fever (99 F).  Treated with rest and fluids, Tylenol for headache as needed. Sore throat, pus in eyes, and headache have receded, however rash and cough persists till current date (4/29/2015). Visited urgent care doctor on 4/18/2015 because symptoms were peaking. Doctor recommended more rest, avoid public without protective face mask, return if symptoms get worse. Said not to get second round of vaccine as I'm showing symptoms of Measles. Also asked me to report VAERS event.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Rhinorrhoea, Sputum discoloured
Clinical narrative: Rash on back, neck, lower legs; Sore throat with swelling; Red, pus in eyes; Headache; Cough (productive with mucus); Runny nose; slight fever (99 F).  Treated with rest and fluids, Tylenol for headache as needed. Sore throat, pus in eyes, and headache have receded, however rash and cough persists till current date (4/29/2015). Visited urgent care doctor on 4/18/2015 because symptoms were peaking. Doctor recommended more rest, avoid public without protective face mask, return if symptoms get worse. Said not to get second round of vaccine as I'm showing symptoms of Measles. Also asked me to report VAERS event.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Eye infection, Headache, Ocular hyperaemia, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Rash on back, neck, lower legs; Sore throat with swelling; Red, pus in eyes; Headache; Cough (productive with mucus); Runny nose; slight fever (99 F).  Treated with rest and fluids, Tylenol for headache as needed. Sore throat, pus in eyes, and headache have receded, however rash and cough persists till current date (4/29/2015). Visited urgent care doctor on 4/18/2015 because symptoms were peaking. Doctor recommended more rest, avoid public without protective face mask, return if symptoms get worse. Said not to get second round of vaccine as I'm showing symptoms of Measles. Also asked me to report VAERS event.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Productive cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Rash on back, neck, lower legs; Sore throat with swelling; Red, pus in eyes; Headache; Cough (productive with mucus); Runny nose; slight fever (99 F).  Treated with rest and fluids, Tylenol for headache as needed. Sore throat, pus in eyes, and headache have receded, however rash and cough persists till current date (4/29/2015). Visited urgent care doctor on 4/18/2015 because symptoms were peaking. Doctor recommended more rest, avoid public without protective face mask, return if symptoms get worse. Said not to get second round of vaccine as I'm showing symptoms of Measles. Also asked me to report VAERS event.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Conjunctivitis, Eye discharge, Headache, Oropharyngeal pain, Productive cough
Clinical narrative: Rash on back, neck, lower legs; Sore throat with swelling; Red, pus in eyes; Headache; Cough (productive with mucus); Runny nose; slight fever (99 F).  Treated with rest and fluids, Tylenol for headache as needed. Sore throat, pus in eyes, and headache have receded, however rash and cough persists till current date (4/29/2015). Visited urgent care doctor on 4/18/2015 because symptoms were peaking. Doctor recommended more rest, avoid public without protective face mask, return if symptoms get worse. Said not to get second round of vaccine as I'm showing symptoms of Measles. Also asked me to report VAERS event.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash on back, neck, lower legs; Sore throat with swelling; Red, pus in eyes; Headache; Cough (productive with mucus); Runny nose; slight fever (99 F).  Treated with rest and fluids, Tylenol for headache as needed. Sore throat, pus in eyes, and headache have receded, however rash and cough persists till current date (4/29/2015). Visited urgent care doctor on 4/18/2015 because symptoms were peaking. Doctor recommended more rest, avoid public without protective face mask, return if symptoms get worse. Said not to get second round of vaccine as I'm showing symptoms of Measles. Also asked me to report VAERS event.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Eye discharge, Hypersensitivity, Insomnia, Productive cough, Rash
Clinical narrative: 2 months after vaccination, pt experienced rash on upper back, chest, lower leg, conjunctivitis in both eyes with discharge, sore throat, productive cough, headache.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Rhinorrhoea, Sputum discoloured
Clinical narrative: 2 months after vaccination, pt experienced rash on upper back, chest, lower leg, conjunctivitis in both eyes with discharge, sore throat, productive cough, headache.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Eye infection, Headache, Ocular hyperaemia, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: 2 months after vaccination, pt experienced rash on upper back, chest, lower leg, conjunctivitis in both eyes with discharge, sore throat, productive cough, headache.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Productive cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: 2 months after vaccination, pt experienced rash on upper back, chest, lower leg, conjunctivitis in both eyes with discharge, sore throat, productive cough, headache.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Conjunctivitis, Eye discharge, Headache, Oropharyngeal pain, Productive cough
Clinical narrative: 2 months after vaccination, pt experienced rash on upper back, chest, lower leg, conjunctivitis in both eyes with discharge, sore throat, productive cough, headache.
Age: 59.0
Sex: M
Vaccine: MMR, MMR, VARZOS, MMR, VARZOS
Symptoms: Rash generalised
Clinical narrative: 2 months after vaccination, pt experienced rash on upper back, chest, lower leg, conjunctivitis in both eyes with discharge, sore throat, productive cough, headache.
Age: 0.16
Sex: M
Vaccine: DTAP, HEP, IPV, RVX, UNK
Symptoms: Crying, Injection site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swollen, hard to touch, hot and red left thigh in the place were vaccine was given. Horrific cry that lasted non stop for over 2 hrs.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Fatigue, Immediate post-injection reaction, Seizure like phenomena
Clinical narrative: Seizure like reaction lasting just over a minute when vaccine for Hep A was given.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Cough, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Shortness of breath and Cough, Pain where the shot was given, Swelling and redness, Fever and headache, Nausea and diarrhea, stomach ache, Swelling of uper arm.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Peripheral swelling
Clinical narrative: Shortness of breath and Cough, Pain where the shot was given, Swelling and redness, Fever and headache, Nausea and diarrhea, stomach ache, Swelling of uper arm.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Shortness of breath and Cough, Pain where the shot was given, Swelling and redness, Fever and headache, Nausea and diarrhea, stomach ache, Swelling of uper arm.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: CSF test normal, Electroencephalogram normal, Endotracheal intubation, Febrile convulsion, Intensive care
Clinical narrative: Febrile seizure (atypical) approx 2 wks later. Required intubation for prolonged seizure. Transferred to PICU.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Laboratory test
Clinical narrative: Febrile seizure (atypical) approx 2 wks later. Required intubation for prolonged seizure. Transferred to PICU.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Tenderness
Clinical narrative: Redness and tender to touch. Noticed it 4 day after vaccination. Location below deltoid.
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism, Lethargy
Clinical narrative: Information has been received from a consumer referring to a male patient of unknown age who was one of hist friend's sons. The patient had 5 siblings. the patient was one of the first 4 boy patients out of 6 children. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unspecified date the patient was vaccinated with M-M-R II (dose, frequency, route and lot # were not reported). The reporter reported that on unspecified date, following M-M-R II vaccinations, the patient had some minor changes in his behaviors (type of behavior changes unspecified) and within a week of vaccinations with M-M-R II, his behavior changes were very unclear and drastic and they all became less interactive and lethargic. In unknown date the patient was diagnosed with autism. The reporter stated that his friend decided not to vaccinate his two other children with M-M-R II after experienced with his 4 boys and these two children did not have autism. The outcome of autism was not reported. This case was linked with other 3 cases as they are siblings. And the cases were from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. On 13-FEB-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot number dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site scab
Clinical narrative: Pt presented today w/ scab on area where shot was given. Shot was given 2/19/15. Did not look infected, no redness, no swelling, no pus. Scab was approx size of pencil eraser. Would have expected complete healing by now. Told pt to have primary MD look at it.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. On 10-MAR-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot numbers, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unkown age and gender. On 27-APR-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot#, exp date, dose and route were not reported). No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Pruritus, Rash morbilliform, Skin discolouration, Urticaria
Clinical narrative: About 1/2hr. after receiving the vaccine, patient's cheeks were red.  About 1 1/2 hours after receiving the vaccine, he started itching.  Rash notice on his back, described as looking like a measles rash.  He also had 2 hives on his neck. Legs looked mottled, but no rash or itching.  Rash lasted approximately 4-5 hours. By 9pm, the rash was gone.  He slept well and has no rash this morning.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C. M. A.) refers to an unknown number of patients of unkonwn age and gender. Medical history and drug allergies were not reported. On an unknown ate, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot# J014235 with expiration date 07-MAY-2015 dose, frequency and route of administration were not reported). Concomitant medications were not reported. The reporter stated that the vaccines were not expired at the time of administration. The reporter was calling for stability information for excursions that occurred before the vaccines expired. It was reported that the vaccines were supported with in-house stability data. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to 3 patients of unknown age and gender. Medical history and drug allergies were not specified by the reporter. On unknown dates, the patients received an unspecified number of doses of VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). Concomitant medication was not specified by the reporter. In approximately 2015 (reported as within the past month), all 3 patients developed shingles. It was not specified if any treatment was given for the adverse event and if the patients sought any medical attention. The outcome of shingles was not specified. Causality assessment between shingles and the therapy with VARIVAX (Merck) was not provided. Product quality complain (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. On 23-MAR-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot number, dose and route were unknown). 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: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. On 04-APR-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C. M. A.) refers to an unknown number of patients of unknown age and gender. Medical history and drug allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # H010915 with expiration date 13-FEB-2015 and lot# K007828 with expiration date 02-MAR-2017, dose, frequency and route of administration were not reported). Concomitant medications were not reported. The reporter stated that the vaccines were not expired at the time of administration. The reporter was calling for stability information for excursions that occurred before the vaccines expired. It was reported that the vaccines were not supported with in-house stability data. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant (C. M. A.) refers to an unknown number of patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot# J014402 with expiration date 13-NOV-2015 and lot#K003412 with expiration date 06-MAR-2016, dose, frequency and route of administration were not reported). Concomitant medications were not reported. The reporter stated that the vaccines were not expired at the time of administration. The reporter was calling for stability information for excursions that occurred before the vaccines expired. It was reported that the vaccines were supported with in-house stability data. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. 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: This spontaneous report as received from a certified medical assistant (C. M. A.) refers to an unknown number of patients of unknown age and gender. Medical history and drug allergies were not reproted. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# reported as K013411 with expiration date 19-MAR-2016 and lot# reported as K015841 with expiration date 01-MAY-2016, route of administration default to oral, dose and frequency were not reported). Concomitant medications were not reported. The reporter stated that the vaccines were not expired at the time of administration. The reporter was calling for stability information for excursions that occurred before the vaccines expired. It was reported that the vaccines were not supported with in-house stability data. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Dyspnoea, Tachycardia, Urticaria
Clinical narrative: PATIENT CALLED IN AND REPORTED WELPS ON BOTH LEGS AND ARMS WITH SHORTNESS OF BREATH AND TACHYCARDIA.  PATIENT STATES SYMPTOMS PRESNTED 1 DAY AFTER VACCINATION.  PATIENT WAS ADVISED TO VISIT NEAREST EMERGENCY ROOM AS SOON AS POSSIBLE.
Age: 22.0
Sex: F
Vaccine: SMALL, TYP, SMALL, TYP
Symptoms: Smallpox
Clinical narrative: Smallpox vaccine like lesions noted to left face and inside left inferior lip.
Age: 22.0
Sex: F
Vaccine: SMALL, TYP, SMALL, TYP
Symptoms: Orthopox virus infection
Clinical narrative: Smallpox vaccine like lesions noted to left face and inside left inferior lip.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Frequent bowel movements
Clinical narrative: 2 days after vaccine(s) had 10 days of diarrhea 6-8 stools/day or more.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse who refers to an unspecified number of patients of unknown age and gender for which their concurrent conditions, medical history and concomitant medications were unknown. It was reported that improperly stored doses of GARDASIL (strength, dose, and route were not reported) were administered to an unspecified number of patients on an unknown date. No adverse effects were reported. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Ocular hyperaemia, Peripheral swelling, Rash
Clinical narrative: Information has been received from a consumer refers to his 90 year old father. On an unknown date the patient was vaccinated with PNEUMOVAX23, (strength, dose, lot #, route and application site were not reported). Other suspect or concomitant therapies were not reported. The reporter stated on an unspecified date 2 to 3 weeks after receiving PNEUMOVAX23 the patient began experiencing swelling of the feet, a rash and bumps on the tops of his hands, bloodshot eyes and feeling of fatigue. The outcome of events was reported as not recovered. The causality between PNEUMOVAX23 and the events was unknown. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: A spontaneous report was received from a consumer who is a Merck employee regarding her mother-in-law who is an 81 year old female who received ZOSTAVAX vaccine a few years ago (exact date unknown) (lot number and expiration date not reported). Medical history and concomitant medications were not provided. On an unspecified date, the patient developed shingles. The outcome of the shingles has been requested. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received form a nurse (office manager) via a company representative refers to a patient of unknown demographics with history of shingles. On 14-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant mediations were reported. On 24-MAY-2014, the patient developed shingles. The nurse also stated that the patient received ZOSTAVAX again (at an unspecified time) and developed shingles again. The patient sought medical attention and contacted the nurse. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Peripheral swelling, Pigmentation disorder, Swelling, Ultrasound scan
Clinical narrative: SWELLING IN THE LEFT FOREARM, SWELLING ON HEAD AND PIGMENTATION ON PATIENTS RIGHT SOLE.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Intussusception, Ultrasound scan
Clinical narrative: Intussusception. Transferred to medical center for treatment.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: C/o nausea, vomiting, fever muscle and joint pain.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Induration, Pain in extremity, Peripheral swelling, Swelling face, Urticaria
Clinical narrative: Swelling, pain, hives, and hard down to elbow. Reported swelling of face. Epi used in emergency room.
Age: 35.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Based on the additional information received on 20 April 2015, this case is initially considered as non-serious was upgraded to serious due important medical event: Cellulitis. Initial unsolicited report received from a nurse on 26 march 2015. A 35-year-old male patient, whose medical history were not reported, had received a fourth dose of MENACTRA (batch number-U4798AA, expiry date- 11 September 2015, route of administration was not reported) in left deltoid on 23 March 2015 at 13:30:00. At the age of 31 years the patient had experienced adverse event (not specified) after the first dose of MENACTRA on 15 September 2011. The patient did not receive any other medication. The patient had no illness at the time of vaccination and patient was allergic to penicillin. On 25 March 2015 at 14:20:00, two days after vaccination, the patient developed arm swollen, red and warm to touch, 2/10 pain with movement and temperature 98.5 degree Fahrenheit. The patient required doctor visit. The patient had no other laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of events were unknown. Documents held by sender: none. Follow-up information received from a health care professional on 20 April 2015. The patient was administered with the vaccine via intramuscular route. On unspecified date, the patient experienced cellulitis at the vaccination site. The patient did not have any medical history. The patient did not receive any concomitant medications. The patient has no illness at the time of vaccination. As of 7 April 2015, the patient was recovered from the event. List of documents held by Sender: none.
Age: 35.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination site cellulitis
Clinical narrative: Based on the additional information received on 20 April 2015, this case is initially considered as non-serious was upgraded to serious due important medical event: Cellulitis. Initial unsolicited report received from a nurse on 26 march 2015. A 35-year-old male patient, whose medical history were not reported, had received a fourth dose of MENACTRA (batch number-U4798AA, expiry date- 11 September 2015, route of administration was not reported) in left deltoid on 23 March 2015 at 13:30:00. At the age of 31 years the patient had experienced adverse event (not specified) after the first dose of MENACTRA on 15 September 2011. The patient did not receive any other medication. The patient had no illness at the time of vaccination and patient was allergic to penicillin. On 25 March 2015 at 14:20:00, two days after vaccination, the patient developed arm swollen, red and warm to touch, 2/10 pain with movement and temperature 98.5 degree Fahrenheit. The patient required doctor visit. The patient had no other laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of events were unknown. Documents held by sender: none. Follow-up information received from a health care professional on 20 April 2015. The patient was administered with the vaccine via intramuscular route. On unspecified date, the patient experienced cellulitis at the vaccination site. The patient did not have any medical history. The patient did not receive any concomitant medications. The patient has no illness at the time of vaccination. As of 7 April 2015, the patient was recovered from the event. List of documents held by Sender: none.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Mass, Pain in extremity, Pruritus, Skin irritation
Clinical narrative: Patient had the adverse reaction of a red, itchy, sore arm with a lump. She went to urgent care because the lump was bothering her on day 3, they gave her a steroid shot. She is now experiencing an itchy sensation that began 5 days after the vaccine on a spot on her back where she was affected by shingles 9 years ago. She believes the mild irritation resulted from obtaining the vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Patient had the adverse reaction of a red, itchy, sore arm with a lump. She went to urgent care because the lump was bothering her on day 3, they gave her a steroid shot. She is now experiencing an itchy sensation that began 5 days after the vaccine on a spot on her back where she was affected by shingles 9 years ago. She believes the mild irritation resulted from obtaining the vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Ill-defined disorder
Clinical narrative: Rec'd shingles vaccine 12/3/14 within 30 days severe back pain between shoulder blades worse at night, some days better than others becoming chronic. Other symptoms also.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness area of injection 4" wide by 3" long area (R) deltoid.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Inflammation, Pain
Clinical narrative: Patient's arm was red and inflamed near injection site. She described pain and discomfort. Recommended ice and acetaminophen.
Age: 19.0
Sex: F
Vaccine: HEPA, TDAP, YF
Symptoms: Distractibility, Eye movement disorder, Fear, Muscle rigidity, Pallor
Clinical narrative: Pt received Tdap, Hep A then YFV. About 1 min. after receiving YFV she became pale, eyes rolled back and she became rigid. Lowered her to floor from chair. This lasted about 30 sec. When supine she immediately woke frightened. Ice pack to back of neck, rapid resps for 2 min. Color became pink and she was coherent. Supine 10 min., chair 2 min. seemed distracted, supine 5 min., chair 5 min. Dad present, drove her home.
Age: 19.0
Sex: F
Vaccine: HEPA, TDAP, YF
Symptoms: Respiratory rate increased
Clinical narrative: Pt received Tdap, Hep A then YFV. About 1 min. after receiving YFV she became pale, eyes rolled back and she became rigid. Lowered her to floor from chair. This lasted about 30 sec. When supine she immediately woke frightened. Ice pack to back of neck, rapid resps for 2 min. Color became pink and she was coherent. Supine 10 min., chair 2 min. seemed distracted, supine 5 min., chair 5 min. Dad present, drove her home.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic shock, Death, Pharyngeal oedema
Clinical narrative: Initial unsolicited case received from a health care professional on 14 April 2015. A female patient (confidential), whose medical history and concomitant medications were not reported, had received a dose of Influenza Vaccine (batch number, route and site of administration were not reported) on unspecified date. On unspecified date, the patient experienced a severe reaction, swollen throat and anaphylactic shock and died while using the vaccine. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was fatal. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: MMR, RAB, SMALL
Symptoms: Bundle branch block left, Cardiac murmur, Cardiovascular evaluation, Chest X-ray normal, Echocardiogram abnormal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This solicited case was received from the investigator in a trial on 17 April 2015. A 30 year-old male subject whose past medical history included high blood pressure and cardiomyopathy was found to have hypertrophic obstructive cardiomyopathy on 13 March 2015, 23 days after the subject had received the following vaccines on 18 February 2015: an injection of Smallpox (Vaccinia) Live Vaccine, (number, route and site of administration not reported), Rabies Vaccine (reported as Rabbies - IM (4)), (manufacturer, lot number, route and site of administration not reported), and MMR (2) (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal ECG (electrocardiogram) on an unreported date. Troponin I, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. An ECG on 27 February 2015 was abnormal. Treatments were not reported. Adjudication Follow-up Report. 9 Days Post Vaccination. Outpatient Visit Patient with history of murmurs presented for a cardiac examination. Labs and CXR were normal but abnormal EKGs showed inverted T-wave activity. Recommend cardiac evaluation. CXR - (Normal) PA/LAT shows satisfactory inspiration with no evidence of active pulmonary disease. The cardiac silhouette is normal with no evidence of enlargement and mediastinum, great vessels, pleura, diaphragm, and bony thorax are unremarkable. EEG1 - (14:20) Sinus bradycardia with sinus arrhythmia, rightward axis, and T wave abnormality with QT-QTc = 432/427ms EEG2 - (14:22) NSR, sinus arrhythmia, rightward axis, and T-wave abnormality with QT/QTc = 420/446ms EEG3 - (14:24) NSR with left posterior fascicular block, T-wave abnormality, and QT/QTc = 422/471ms. 23 Days Post Vaccination Cardiology Visit Patient has history of LVH without evidence of HOCM on stress ECHO done on April, 2014. A/P - Cardiomyopathy hypertrophic with an IVSD = 1.6 and mild SAM without outflow tract obstruction (mean gradient = 4 mmHg). 30 Days Post Vaccination. Cardiology Visit Chief compliant is evaluation of hypertrophic cardiomyopathy. ECHO demonstrated hypertrophic cardiomyopathy with LVEF = 55% and septal wall = 1.8 cm. Left atrium was mildly enlarged at 4.3 cm, myocardial perfusion study with an anteroseptal fixed detect and an LVEF = 53%. No hypotension and/or drop in BP noted on the treadmill test. Patient remains asymptomatic with no SOB, chest pain, or syncope. 33 Days Post Vaccination. Outpatient Visit Patient was screened for cardiovascular disorders. Holter monitor was unremarkable with no episodes of non-sustained ventricular tachycardia. The subject's outcome was not reported. Additional information  will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.