chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 2006-2013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 328 patients who, on unknown dates, developed HZ in the 1st year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010592, 1703USA010593, 1703USA010594, 1703USA010595, 1703USA010596, 1703USA010597). Additional information has been requested. Sender's Comments: US-009507513-1703USA010595: US-009507513-1703USA010596: US-009507513-1703USA010597: US-009507513-1703USA010593: US-009507513-1703USA010592: US-009507513-1703USA010594.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse via Pfizer, Inc. and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, also reported as MMR (lot #, expiration date, dose and route of administration were not reported). Administered doses of vaccines experienced the highest temperature of 9.1 degrees Celsius and "out of range for five days, was at 8 degrees Celsius". It was not specified if a digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011907: US-009507513-1703USA011908: US-009507513-1703USA011909: US-009507513-1703USA011910.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 20062013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 315 patients who, on unknown date, developed HZ in the 2nd year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010593, 1703USA010594, 1703USA010595, 1703USA010596, 1703USA010597). A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010321:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 2006-2013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 225 patients who, on unknown dates, developed HZ in the 3rd year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010592, 1703USA010594, 1703USA010595, 1703USA010596, 1703USA010597). Additional information has been requested. Sender's Comments:  US-009507513-1703USA010321.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 2006-2013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 169 patients who, on unknown dates, developed HZ in the 4th year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010592, 1703USA010593, 1703USA010595, 1703USA010596, 1703USA010597). Additional information has been requested. Sender's Comments:  US-009507513-1703USA010321.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 20062013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal ntiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 120 patients who, on unknown date, developed HZ in the 5th year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010592, 1703USA010593, 1703USA010594, 1703USA010596, 1703USA010597). Additional information has been requested.; Sender's Comments:  US-009507513-1703USA010321:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 2006-2013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis.  This report refers to 74 patients who, on unknown date, developed HZ in the 6th year after the vaccination (considered as lack of efficacy).The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010592, 1703USA010593, 1703USA010594, 1703USA010595, 1703USA010597). Additional information has been requested. Sender's Comments: US-009507513-1703USA010321.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 2006-2013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 11 patients who, on unknown dates, developed HZ in the 7th year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010592, 1703USA010593, 1703USA010594, 1703USA010595, 1703USA010596). Additional information has been requested. Sender's Comments:  US-009507513-1703USA010321.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse via Pfizer, Inc. and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of unspecified HIB vaccine (lot #, expiration date, dose and route of administration were not reported). Administered doses of vaccines experienced the highest temperature of 9.1 degrees Celsius and "out of range for five days, was at 8 degrees Celsius". It was not specified if a digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010426: US-009507513-1703USA011908: US-009507513-1703USA011909: US-009507513-1703USA011910:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse via Pfizer, Inc. and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of unspecified Hepatitis A vaccine (reported as Hep A) (lot #, expiration date, dose and route of administration were not reported). Administered doses of vaccines experienced the highest temperature of 9.1 degrees Celsius and "out of range for five days, was at 8 degrees Celsius". It was not specified if a digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010426: US-009507513-1703USA011909: US-009507513-1703USA011907: US-009507513-1703USA011910:
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Influenza like illness, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old male patient of an unspecified race received TRUMENBA at single dose and MENACTRA, both doses were given in separate locations on the same unknown date. Within 24 hours patient had flu like symptoms, chills, nausea and fever. Patient return to the office the next day where resulted positive for the flu. Patient was given Oseltamivir (TAMIFLU).
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Osteoarthritis, Pain in extremity, Vaccination site pain
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 13-Mar-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of FLUZONE HD (Batch number, expiration date, dose, dose in series, site of administration were not reported) via intramuscular route on an unspecified date in December 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as autoimmune disease; hepatitis, lupus and osteoarthritis. Illness at the time of vaccination was not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On unknown date in Dec 2016, following the vaccination the patient developed pain in the shoulder where the vaccine was administered and the pain moved down the arm into the fingers and both arms were then effected. It was reported that the patient was previously diagnosed with osteoarthritis and was stable for 20 years, everything was exacerbated after receiving the flu vaccine. Relevant laboratory investigations and corrective treatment was not reported. The outcome of the event was reported as Unknown. List of documents held by the sender: None.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site joint pain, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 13-Mar-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of FLUZONE HD (Batch number, expiration date, dose, dose in series, site of administration were not reported) via intramuscular route on an unspecified date in December 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as autoimmune disease; hepatitis, lupus and osteoarthritis. Illness at the time of vaccination was not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On unknown date in Dec 2016, following the vaccination the patient developed pain in the shoulder where the vaccine was administered and the pain moved down the arm into the fingers and both arms were then effected. It was reported that the patient was previously diagnosed with osteoarthritis and was stable for 20 years, everything was exacerbated after receiving the flu vaccine. Relevant laboratory investigations and corrective treatment was not reported. The outcome of the event was reported as Unknown. List of documents held by the sender: None.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Induration, Malaise, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 08 MAR 2017. This case involves a 72-years-old female patient who was vaccinated with a dose of FLU SHOT and PNEUMOCOCCAL VACCINE (manufacturer: unknown, batch number, dose in series, dose, route and site of administration was not reported) on 28 February 2017. The patient reported having ongoing orthostatic hypotension, low blood sodium and kidney issues (which started before PRALUENT therapy). The patient had a medical history of minor palpitations for a long time prior to PRALUENT, the patient stated that due to the palpitations and chest pain, she had a CT scan towards the end of 2016 which showed that the heart had over 70 percent of blockage in the LAD artery where she had a stent placed in 2014 (exact dates unknown). The patient also stated that shortly after 29 Dec 2016 (exact date unknown) she went to see her electrophysiologist who advised her to "wear a monitor for thirty days.", but lately the heart palpitations have been intense and wake up in the morning (exact time frame of events unknown). The palpitations go on for a period of several hours. The patient reported that the palpitations occur about every two or three days and were not always as intense. The patient reported that the "palpitations go on for a period of several hours." She stated that "the rest of the day she had chest aches and became very fatigued" (exact duration of symptoms unknown). In Jan 2017, started having a lot of different symptoms and was not feeling well (exact time frame of events unknown). Concomitant medications included PRALUENT (batch number- 6F052A, expiration date-30 Jun 2017) 75 mg injections every two weeks on 10 Jan2017 for cholesterol, with the most recent injection on 8Mar2017. The patient stated that she has had a total of five injections at the time of this report, with the first injection given into the stomach and the rest of the injections given into the thigh. The patient reported that while injecting the medication into the thigh per IFU on 8Mar2017. On an unspecified date, since vaccination, the patient was feeling sick and arm with the pneumonia vaccine got so sore and red and was getting to be a round hard spot that were still really sore. The patient was referred to her physician for consultation. Corrective treatment was not reported. The outcome of the event was not recovered. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Malaise, Vaccination site induration, Vaccination site pain
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 08 MAR 2017. This case involves a 72-years-old female patient who was vaccinated with a dose of FLU SHOT and PNEUMOCOCCAL VACCINE (manufacturer: unknown, batch number, dose in series, dose, route and site of administration was not reported) on 28 February 2017. The patient reported having ongoing orthostatic hypotension, low blood sodium and kidney issues (which started before PRALUENT therapy). The patient had a medical history of minor palpitations for a long time prior to PRALUENT, the patient stated that due to the palpitations and chest pain, she had a CT scan towards the end of 2016 which showed that the heart had over 70 percent of blockage in the LAD artery where she had a stent placed in 2014 (exact dates unknown). The patient also stated that shortly after 29 Dec 2016 (exact date unknown) she went to see her electrophysiologist who advised her to "wear a monitor for thirty days.", but lately the heart palpitations have been intense and wake up in the morning (exact time frame of events unknown). The palpitations go on for a period of several hours. The patient reported that the palpitations occur about every two or three days and were not always as intense. The patient reported that the "palpitations go on for a period of several hours." She stated that "the rest of the day she had chest aches and became very fatigued" (exact duration of symptoms unknown). In Jan 2017, started having a lot of different symptoms and was not feeling well (exact time frame of events unknown). Concomitant medications included PRALUENT (batch number- 6F052A, expiration date-30 Jun 2017) 75 mg injections every two weeks on 10 Jan2017 for cholesterol, with the most recent injection on 8Mar2017. The patient stated that she has had a total of five injections at the time of this report, with the first injection given into the stomach and the rest of the injections given into the thigh. The patient reported that while injecting the medication into the thigh per IFU on 8Mar2017. On an unspecified date, since vaccination, the patient was feeling sick and arm with the pneumonia vaccine got so sore and red and was getting to be a round hard spot that were still really sore. The patient was referred to her physician for consultation. Corrective treatment was not reported. The outcome of the event was not recovered. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Bone pain, Chills, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Dr, I received 2 vaccines last Monday. I have had many tetanus shots so I'm pretty sure that was ok but I had a severe reaction to the second shot, pneumonia vaccine that you should be aware of and report. My injection arm was swollen shoulder to elbow, hot, bright red, hard and itchy and even today there is some hardness to my arm. I had a 101 degree fever, chills, bone pain and achiness for 3 days that made me take to my bed. I would like you to tell me what was in that vaccine so I know what I am allergic to and make sure it is in my chart that I can't tolerate this vaccine. Until I know what I am allergic to I can't think about getting the shingles shot you recommend I get, in case some of the same is in this vaccine also.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Dr, I received 2 vaccines last Monday. I have had many tetanus shots so I'm pretty sure that was ok but I had a severe reaction to the second shot, pneumonia vaccine that you should be aware of and report. My injection arm was swollen shoulder to elbow, hot, bright red, hard and itchy and even today there is some hardness to my arm. I had a 101 degree fever, chills, bone pain and achiness for 3 days that made me take to my bed. I would like you to tell me what was in that vaccine so I know what I am allergic to and make sure it is in my chart that I can't tolerate this vaccine. Until I know what I am allergic to I can't think about getting the shingles shot you recommend I get, in case some of the same is in this vaccine also.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Bone pain, Chills, Dyspnoea, Headache, Injection site erythema
Clinical narrative: Dr, I received 2 vaccines last Monday. I have had many tetanus shots so I'm pretty sure that was ok but I had a severe reaction to the second shot, pneumonia vaccine that you should be aware of and report. My injection arm was swollen shoulder to elbow, hot, bright red, hard and itchy and even today there is some hardness to my arm. I had a 101 degree fever, chills, bone pain and achiness for 3 days that made me take to my bed. I would like you to tell me what was in that vaccine so I know what I am allergic to and make sure it is in my chart that I can't tolerate this vaccine. Until I know what I am allergic to I can't think about getting the shingles shot you recommend I get, in case some of the same is in this vaccine also.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP, PNC13, TDAP
Symptoms: Injection site induration, Injection site pruritus, Injection site warmth, Peripheral swelling, Pyrexia
Clinical narrative: Dr, I received 2 vaccines last Monday. I have had many tetanus shots so I'm pretty sure that was ok but I had a severe reaction to the second shot, pneumonia vaccine that you should be aware of and report. My injection arm was swollen shoulder to elbow, hot, bright red, hard and itchy and even today there is some hardness to my arm. I had a 101 degree fever, chills, bone pain and achiness for 3 days that made me take to my bed. I would like you to tell me what was in that vaccine so I know what I am allergic to and make sure it is in my chart that I can't tolerate this vaccine. Until I know what I am allergic to I can't think about getting the shingles shot you recommend I get, in case some of the same is in this vaccine also.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Acute respiratory distress syndrome, Bilevel positive airway pressure, Brain natriuretic peptide increased, Endotracheal intubation, Influenza A virus test positive
Clinical narrative: Acute respiratory distress, to ER by 911, admitted to ICU on BiPAP, within 24 hours was intubated.  Remains ventilator dependent, and today had a tracheostomy performed.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Intensive care, Mechanical ventilation, Tracheostomy
Clinical narrative: Acute respiratory distress, to ER by 911, admitted to ICU on BiPAP, within 24 hours was intubated.  Remains ventilator dependent, and today had a tracheostomy performed.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an elderly patient (over the age of 65 year old) of unknown gender. The patient's concurrent conditions, medical history, known allergies and concomitant therapy were not reported. On an unknown date, after reaching age 65, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, anatomical location, lot# and expiry date were not reported). The patient was scheduled to receive a dose of PREVNAR 13 in the near future, in the reverse order of established guidelines. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant concerning to multiple unknown patients who on an unknown dates were vaccinated with a dose of GARDASIL 9 (Lot No. M009116, exp. 13-JUN-2018) (route and site not reported) for prophylaxis. No adverse effects were reported. The excursion details were: Temperature: 32F: 32F to 35F Time frame: 4 hours  Temperature: 32F: 32F to 35F Time frame: 4 hours   Temperature: 32F: 32F to 35F Time frame: 4 hours Temperature: 32F: 32F to 35F Time frame: 4 hours Total cumulative hours: 16 hours. The vaccines were administered. There was no previous temperature excursion. No data logger involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, GARDASIL 9 was inferred to have experienced the following temperature excursions: 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours; and 38.6  F for 20 minutes on 27-DEC-2016, at 07:51 hours. They were called out because of a digital data logger. On 27-DEC-2016, at 15:51 hours, the patient was vaccinated with the third, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M021407 with an expiration date of 30-APR-2018), intramuscularly, in the left arm, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA011160: US-009507513-1703USA011161: US-009507513-1703USA011162: US-009507513-1703USA011158: US-009507513-1703USA010731.
Sex: U
Vaccine: HPVX
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse via Pfizer, Inc. and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of unspecified HPV vaccine (lot #, expiration date, dose and route of administration were not reported). Administered doses of vaccines experienced the highest temperature of 9.1 degrees Celsius and "out of range for five days, was at 8 degrees Celsius". It was not specified if a digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011907: US-009507513-1703USA011908: US-009507513-1703USA010426: US-009507513-1703USA011910.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse via Pfizer, Inc. and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of pneumococcal vaccine (reported as PNEUMOVAX) (lot #, expiration date, dose and route of administration were not reported). Administered doses of vaccines experienced the highest temperature of 9.1 degrees Celsius and "out of range for five days, was at 8 degrees Celsius". It was not specified if a digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011907: US-009507513-1703USA011908: US-009507513-1703USA011909: US-009507513-1703USA010426.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 65-year-old female patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced redness at the injection site 6 months to a year before report with outcome of unknown.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersomnia, Influenza like illness, Pyrexia, Swelling
Clinical narrative: Fever, flu-like symptoms, excessive sleeping (22 hours straight), extreme redness and swelling, approximately 5 inches in diameter.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Vomiting projectile
Clinical narrative: Child projectile vomited X 4 within 10-15 minutes after receiving the MMR vaccine.
Age: 7.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Abasia, Blood creatine phosphokinase MB normal, Blood creatine phosphokinase normal, Body temperature increased, C-reactive protein normal
Clinical narrative: 6 hours after Pneumovax 23 was given the patient had severe left leg pain, unable to walk, nausea and a temperature of 101.0. He was sent to the emergency room for testing and pain management.
Age: 7.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Computerised tomogram normal, Full blood count normal, Metabolic function test normal, Nausea, Pain in extremity
Clinical narrative: 6 hours after Pneumovax 23 was given the patient had severe left leg pain, unable to walk, nausea and a temperature of 101.0. He was sent to the emergency room for testing and pain management.
Age: 7.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: 6 hours after Pneumovax 23 was given the patient had severe left leg pain, unable to walk, nausea and a temperature of 101.0. He was sent to the emergency room for testing and pain management.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash developed from mid spine to front of breast bone around one side of the body.  Patient went to the Doctor and got a prescription for gabapentin and topical lidocaine.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Itchy rash developed from mid spine to front of breast bone around one side of the body.  Patient went to the Doctor and got a prescription for gabapentin and topical lidocaine.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Swelling at site of injection, persistent lump, not tender, no redness.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Sharp pain in upper arm, attributed to flu shot, but has not gone away, and has become chronic, keeping me up at night, etc. Reported to Doctor, and now following up here. Never had this problem before.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Sleep disorder, Swelling, Weight bearing difficulty
Clinical narrative: Within a few hours of administration patient had pain in shoulder.  Pain has persisted and patient reports noticeable swelling still as of 3/26. She states that she can not lift her grandchildren or open cabinets. Patient has been icing and taking OTC pain medications. She complains that she is unable to sleep because of the pain.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Injection site red for 6x3 inches surrounding injection site, warm to touch, not tender, knot at injection site.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Two errythemic tender warmth areas on exam today. Does appear to be infectious, also consider allergic. Will treat with keflex, also gave cetirizine. F/u with any worsening symptoms or if not improving in next 2-3 days.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a medical assistant via a vendor refers to a 18 month old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date the patient was vaccinated with an expired dose of VAQTA (dose, frequency, route, lot # and expiration date were not provided) for prophylaxis. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse who is an immunization official refers to unspecified patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency, route, lot # and expiration date were not provided) for prophylaxis. The vaccines were improperly stored in January 2017 with a temperature excursion of - 14 °C to - 10 °C for a time frame of 16 hours. There was no data logger involved. There were no previous temperature excursions. No product quality complaint was involved. This is one of two reported received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA011950.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information was received on 10-MAR-2017 from a pharmacy technician regarding multiple unknown patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date the reporter noted that multiple, unknown patients received GARDASIL 9 (lot and expiry information unknown) after beginning the HPV vaccine series with GARDASIL (HPV4) (lot and expiry information unknown). No adverse effects were reported. No additional information was provided. Additional information has been requested.