chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received improperly stored doses of VARIVAX (lot # M014309 with expiration date: 21-MAR-2018 and lot # M010480 with expiration date: 01-MAR-2018) (dose and route of administration were not reported). The administered doses of vaccine were exposed to a temperature of 27 degrees Fahrenheit (F) for 30 minutes. No previous temperature excursions were reported. It was unknown if a data logger was used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was 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 medical assistant 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 ROTATEQ lot # M004890, expiration date 10-NOV-2017, lot# M019691, expiration date 02-NOV-2017 and lot# M031802, expiration date 09-NOV-2017, orally (dose and site of administration were not reported). There was no adverse symptoms reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site macule, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a physician and a pharmacist via VZV questionnaire concerning a 60 year old female patient with allergy to codeine and latex, asthma, hypothyroidism, irritable bowel syndrome (IBS), migraine and hypertension (HTN). The patient's medical history included migraine, chickenpox (exact date unknown) and an episode of herpes zoster in the left upper arm in 2010. It was reported that the patient had no prior history of herpes zoster ophthalmicus. On 25-OCT-2016 the patient was vaccinated with an unspecified dose of ZOSTAVAX (strength, dose, lot # and expiration date were not provided), subcutaneously in the left arm at another facility. Other concomitant vaccine included FLUVIRIN (strength, dose, indication, lot # and expiration date were not provided). Concomitant therapies included losartan potassium (+) hydrochlorothiazide (manufacturer unknown), VENTOLIN, nortriptyline, levothyroxine sodium (manufacturer unknown), QVAR, SINGULAIR, cyclobenzaprine hydrochloride, desonide, FLONASE, METROGEL and AMBIEN. The physician reported that, on 26-OCT-2016 (also reported by the pharmacist as at noon of 27-OCT-2016), approximately 24 hours post injection, the patient experienced a blistered rash at injection site which was diffuse, macular with elevation warm to touch; in addition, it was reported an area of redness of 22cm x 15cm elliptical around the injection site with an area of 6cm x 4.5cm bright, slightly elevated and tender. The physician reported that, on 27-OCT-2016, date in which the patient was seen in clinic, the patient had a temperature of 99.7 (units not provide) on the forehead and a temperature of 100.6 (units not provided) over rash. It was reported that the patient did not developed other systemic symptoms and had no recent exposure to chickenpox or shingles. No product quality complaint was involved and it was informed that no sample of VZIP specimen was collected. On 02-NOV-2016, the patient recovered from the events of injection site vesicles, injection site pain, injection site warmth, injection site erythema, rash maculo-papular and injection site macule. The causality between ZOSTAVAX and the events of injection site vesicles, injection site pain, injection site warmth, injection site erythema, rash maculo-papular and injection site macule was not assessed. The reporting pharmacist considered that the adverse events were no life threatening. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash maculo-papular
Clinical narrative: This spontaneous report was received from a physician and a pharmacist via VZV questionnaire concerning a 60 year old female patient with allergy to codeine and latex, asthma, hypothyroidism, irritable bowel syndrome (IBS), migraine and hypertension (HTN). The patient's medical history included migraine, chickenpox (exact date unknown) and an episode of herpes zoster in the left upper arm in 2010. It was reported that the patient had no prior history of herpes zoster ophthalmicus. On 25-OCT-2016 the patient was vaccinated with an unspecified dose of ZOSTAVAX (strength, dose, lot # and expiration date were not provided), subcutaneously in the left arm at another facility. Other concomitant vaccine included FLUVIRIN (strength, dose, indication, lot # and expiration date were not provided). Concomitant therapies included losartan potassium (+) hydrochlorothiazide (manufacturer unknown), VENTOLIN, nortriptyline, levothyroxine sodium (manufacturer unknown), QVAR, SINGULAIR, cyclobenzaprine hydrochloride, desonide, FLONASE, METROGEL and AMBIEN. The physician reported that, on 26-OCT-2016 (also reported by the pharmacist as at noon of 27-OCT-2016), approximately 24 hours post injection, the patient experienced a blistered rash at injection site which was diffuse, macular with elevation warm to touch; in addition, it was reported an area of redness of 22cm x 15cm elliptical around the injection site with an area of 6cm x 4.5cm bright, slightly elevated and tender. The physician reported that, on 27-OCT-2016, date in which the patient was seen in clinic, the patient had a temperature of 99.7 (units not provide) on the forehead and a temperature of 100.6 (units not provided) over rash. It was reported that the patient did not developed other systemic symptoms and had no recent exposure to chickenpox or shingles. No product quality complaint was involved and it was informed that no sample of VZIP specimen was collected. On 02-NOV-2016, the patient recovered from the events of injection site vesicles, injection site pain, injection site warmth, injection site erythema, rash maculo-papular and injection site macule. The causality between ZOSTAVAX and the events of injection site vesicles, injection site pain, injection site warmth, injection site erythema, rash maculo-papular and injection site macule was not assessed. The reporting pharmacist considered that the adverse events were no life threatening. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via employee and refers to a male patient in his early sixties. Concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date (unspecified time after receiving ZOSTAVAX) the patient's unspecified physician diagnosed him with shingles. The patient sought medical attention and visited his physician. The pharmacist reported that at the unspecified time that the patient was speaking with her, he was not "currently active". No product quality complaint (PQC) was reported. The outcome of shingles was not reported. Relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a nurse referring to a 18 year old female patient. The patient has no significant medications to report and no significant medical history. The patient's drug reactions/allergies was reported as none. On an unknown date (reported as "as an infant"), the patient was vaccinated with a series for hepatitis B vaccine (recombinant) 5/05 mcrg/ml (manufacturer unknown) (lot # M006708, expiration date 02-JUN-2018; dose and route were unknown). The reporter stated the patient came to office in July 2016 as her school required hepatitis B protection/vaccination. The reporter stated titers were taken at time of July 2016 visit where titers were discovered to be low. At that time, July 2015, the patient was vaccinated with RECOMBIVAX HB. The reporter stated the patient was doing fine. The outcome of the event was reported as recovered. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (concentration, dose, route and anatomical place of vaccination were not reported) which had the following lots # l040459, M014929 and m014929 with expirations dates of April 2017, 27-MAY-2017 and 27-APR-2017 respectively. Which were reported because a data logger and were exposed to 30.1F for 84.75 hours, 55.2F For 90 minutes, 31F for 124 Hours, 51.F 2 hours for 30 minutes and 28.2F for 28.25 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (concentration, dose, route and anatomical place of vaccination were not reported) which had the following lots # of M000442 and M000442 with expirations dates of 31-MAR-2018 respectively. Which were reported because a data logger and were exposed to 31F for 124 Hours, 51.F 2 hours for 30 minutes and 28.2F for 28.25 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (concentration, dose, route and anatomical place of vaccination were not reported) which had the following lots # of M009377 and M011839 with expirations dates of 17-JUN-2017 and 13-SEP-2017 respectively. Which were reported because a data logger and were exposed to 31F for 124 Hours, 51.F 2 hours for 30 minutes and 28.2F for 28.25 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age and gender. The patient's concurrent condition included allergy to aspirin (manufacturer unknown). The patient's concomitant medication was stated as "the patients takes "a long list of medications" but did not have time to provide the list". On 31-OCT-2016, the patient was vaccinated with ZOSTAVAX, subcutaneously, lot # M017095 and expiration date: 28-JUN-2017 (dose number was not provided). On 02-NOV-2016, the patient called the pharmacy and reported that he developed "redness, swelling and tenderness" at the injection site. The events have not subsided at the time of reporting and the patient have to received any treatment for them. The reporter did not assessed causality between the events and the use of ZOSTAVAX. There was any product quality complaint (PQC) involved. This is one of 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. The patient's medical history, drug reactions/allergies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX lot number: M011665, expiration date: 17-MAY-2017 (concentration, dose, frequency and via were not reported), which were improperly stored at 32.5 Fahrenheit degrees for 16 hours. No previous temperature excursion was reported and it was not detected due to a data logger. No adverse effect were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a 60-year-old female patient and refers to herself. The patient's concurrent conditions included ductal carcinoma in situ (DCIS). It was reported that the patient did not have any drug reactions or allergies, however the patient's concomitant medications included unspecified allergy medicine. Other concomitant medications included MAGNESIA and unspecified fiber tablet. On an unknown date, after receiving the ZOSTAVAX, the patient experienced a shingles outbreak, which was very painful. The patient sought a medical attention by contacting the physician. The unspecified treatment was given for the event. No laboratory diagnostics studies were performed. The outcome of the event was reported as not recovered at the time of this report. The relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to multiple patient of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored VAQTA, lot number M036459, expiration date 18-JAN-2018, (dose, frequency, route, anatomical location were not reported). No other suspect or concomitant therapies were reported. The vaccines were exposed to 34.1 Fahrenheit degrees for 8 hours. A digital data logger was involved and there were no prior excursions. No adverse events were reported. No product quality complain was involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to 6 unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. Since 19-OCT-2016, the patients were vaccinated with GARDASIL 9 (Lot number reported as M01180, expiration date 01-FEB-2018) dose and route were not provided. There was no concomitant medication reported. The temperature excursion was 33 F for 15 hours. It was also reported a previous temperature excursion of 33F for 15 hours, the call was not because of a "data logger". The excursion was reported as "supported: yes". No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received on 24-OCT-2016 from a medical assistant refers to a patient of unknown age and gender. No information about the patient's pertinent medical history or concomitant medications. The medical assistant reported that the patient received the first dose of "GARDASIL 4" (It is not clear if the patient was vaccinated with GARDASIL on 24-OCT-2015.) on 24-OCT-2015 and is currently in the office today 24-OCT-2016 to receive a dose of GARDASIL 9. The indication for the vaccines was prophylaxis. The routes of administration, Lot numbers and expirations dates were not reported. No adverse effects reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 11 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On an unknown date, the patient was vaccinated with and improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 26-OCT-2016, the patient was vaccinated with ZOSTAVAX, 19400 plaque forming units (PFU), Lot # L040445, expiration date: 15-JAN-2017, on the same day he received a second dose of ZOSTAVAX lot # and expiration date were not reported (The vaccines strength, dose, and route were not provided). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 71 year old female patient. Medical history and concomitant medications were not provided. Historical medications included PREVNAR 13 in 2015. On 25-OCT-2016, the patient received PNEUMOVAX 23 (lot # not specified). That evening, the patient experienced pain rated as a 6 on pain scale and injection site redness and soreness. The outcome of the events was not provided. Additional information is not expected as the reporter did not provide consent to follow up.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen area, hot to touch.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Granuloma
Clinical narrative: Granuloma.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, extreme swelling/redness from elbow to armpit.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: 9cm x 10cm size skin redness at (Rt) shoulder prior injection site.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Incorrect dose administered
Clinical narrative: 10-3-16-patient given 0.25mL flu vaccine. 11-8-16-patient given 0.25mL flu vaccine. Provider will call parent and recommend revaccinating with correct dose.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient stated had arm pain (whole arm) shortly after receiving vaccination. Patient was advised to use ice, Ibuprofen to help pain, primary doctor was contacted and pt was told to call if symptoms worsen. Patient called pharmacy again on 11/15 approximately 10 AM and stated arm was still sore where injection was given. Patient states can't lift her arm because too painful.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient stated had arm pain (whole arm) shortly after receiving vaccination. Patient was advised to use ice, Ibuprofen to help pain, primary doctor was contacted and pt was told to call if symptoms worsen. Patient called pharmacy again on 11/15 approximately 10 AM and stated arm was still sore where injection was given. Patient states can't lift her arm because too painful.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction: redness, swelling, itching.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Pt c/o (L) upper arm pain origination at vaccination site, extending down to elbow. Erythema, edema of (L) upper arm within 24 hrs, subjective fever, pain with movement of extremity.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chest X-ray, Electrocardiogram, Full blood count, Immune system disorder, Nasal congestion
Clinical narrative: Pt was seen at allergist's office for routine visit 8/12/16 (one day after vaccine) and  offered no complaints. On 8/16/16 she presented to ED with c/o fever (99.7) and one day history of sore throat and achy ears. Physical exam was normal (see  attached)  and platelet count was close to baseline (38K). She was given prescription for Azithro as empiric treatment for possible sinusitis. 8/18/2016: Follow-up phone call to patient. Spoke with daughter who stated pt doing much better (she was busy and couldn't come to phone). 8/20/2016: Presented to ED with c/o bruising but no other complaints. (Pt has ITP and develops ecchymosis/petechiae when platelet count drops). Labs revealed Plt count 9K. ED/hospitalist notes state pt had been carrying/moving heavy boxes and bruises were in appropriate distribution. Pt was admitted for observation, started on Prednisone. 8/21/2016: Pt requested blood draw from peripheral IV which was flushed first with NS, then 6-7 cc blood discarded before specimen collected. Lab results: WBC 9.5, Hgb 13.6, Platelets 10K. Pt was seen by covering hematologist who noted in response to pt questioning, that pt received "live" meningitis vaccine. (BEXSERO is a recombinant vaccine). This led patient to believe that she should not have received it, and she believes sore throat, achy ears and subsequent drop in Plts due to meningococcal vaccine. Spoke with patient's primary hematologist who thought vaccine was given appropriately (indication=splenectomized pt). Felt it was unclear as to whether pt developed "sinusitis" due to increased susceptibility to bacterial infection vs a side effect of vaccine. Pt was stable with decreased petechiae, and was discharged home on 8/21/2016 on an increased dose of PROMACTA and ongoing Prednisone taper. She has continued to do well  -  has since received a flu vaccine and pneumococcal vaccine (weeks apart) without further incident.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Oropharyngeal pain, Petechiae, Platelet count decreased
Clinical narrative: Pt was seen at allergist's office for routine visit 8/12/16 (one day after vaccine) and  offered no complaints. On 8/16/16 she presented to ED with c/o fever (99.7) and one day history of sore throat and achy ears. Physical exam was normal (see  attached)  and platelet count was close to baseline (38K). She was given prescription for Azithro as empiric treatment for possible sinusitis. 8/18/2016: Follow-up phone call to patient. Spoke with daughter who stated pt doing much better (she was busy and couldn't come to phone). 8/20/2016: Presented to ED with c/o bruising but no other complaints. (Pt has ITP and develops ecchymosis/petechiae when platelet count drops). Labs revealed Plt count 9K. ED/hospitalist notes state pt had been carrying/moving heavy boxes and bruises were in appropriate distribution. Pt was admitted for observation, started on Prednisone. 8/21/2016: Pt requested blood draw from peripheral IV which was flushed first with NS, then 6-7 cc blood discarded before specimen collected. Lab results: WBC 9.5, Hgb 13.6, Platelets 10K. Pt was seen by covering hematologist who noted in response to pt questioning, that pt received "live" meningitis vaccine. (BEXSERO is a recombinant vaccine). This led patient to believe that she should not have received it, and she believes sore throat, achy ears and subsequent drop in Plts due to meningococcal vaccine. Spoke with patient's primary hematologist who thought vaccine was given appropriately (indication=splenectomized pt). Felt it was unclear as to whether pt developed "sinusitis" due to increased susceptibility to bacterial infection vs a side effect of vaccine. Pt was stable with decreased petechiae, and was discharged home on 8/21/2016 on an increased dose of PROMACTA and ongoing Prednisone taper. She has continued to do well  -  has since received a flu vaccine and pneumococcal vaccine (weeks apart) without further incident.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Condition aggravated, Contusion, Ear pain, Ecchymosis, Haemoglobin normal
Clinical narrative: Pt was seen at allergist's office for routine visit 8/12/16 (one day after vaccine) and  offered no complaints. On 8/16/16 she presented to ED with c/o fever (99.7) and one day history of sore throat and achy ears. Physical exam was normal (see  attached)  and platelet count was close to baseline (38K). She was given prescription for Azithro as empiric treatment for possible sinusitis. 8/18/2016: Follow-up phone call to patient. Spoke with daughter who stated pt doing much better (she was busy and couldn't come to phone). 8/20/2016: Presented to ED with c/o bruising but no other complaints. (Pt has ITP and develops ecchymosis/petechiae when platelet count drops). Labs revealed Plt count 9K. ED/hospitalist notes state pt had been carrying/moving heavy boxes and bruises were in appropriate distribution. Pt was admitted for observation, started on Prednisone. 8/21/2016: Pt requested blood draw from peripheral IV which was flushed first with NS, then 6-7 cc blood discarded before specimen collected. Lab results: WBC 9.5, Hgb 13.6, Platelets 10K. Pt was seen by covering hematologist who noted in response to pt questioning, that pt received "live" meningitis vaccine. (BEXSERO is a recombinant vaccine). This led patient to believe that she should not have received it, and she believes sore throat, achy ears and subsequent drop in Plts due to meningococcal vaccine. Spoke with patient's primary hematologist who thought vaccine was given appropriately (indication=splenectomized pt). Felt it was unclear as to whether pt developed "sinusitis" due to increased susceptibility to bacterial infection vs a side effect of vaccine. Pt was stable with decreased petechiae, and was discharged home on 8/21/2016 on an increased dose of PROMACTA and ongoing Prednisone taper. She has continued to do well  -  has since received a flu vaccine and pneumococcal vaccine (weeks apart) without further incident.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Immune thrombocytopenic purpura, Oropharyngeal pain, Petechiae, Platelet count decreased, Pyrexia
Clinical narrative: Pt was seen at allergist's office for routine visit 8/12/16 (one day after vaccine) and  offered no complaints. On 8/16/16 she presented to ED with c/o fever (99.7) and one day history of sore throat and achy ears. Physical exam was normal (see  attached)  and platelet count was close to baseline (38K). She was given prescription for Azithro as empiric treatment for possible sinusitis. 8/18/2016: Follow-up phone call to patient. Spoke with daughter who stated pt doing much better (she was busy and couldn't come to phone). 8/20/2016: Presented to ED with c/o bruising but no other complaints. (Pt has ITP and develops ecchymosis/petechiae when platelet count drops). Labs revealed Plt count 9K. ED/hospitalist notes state pt had been carrying/moving heavy boxes and bruises were in appropriate distribution. Pt was admitted for observation, started on Prednisone. 8/21/2016: Pt requested blood draw from peripheral IV which was flushed first with NS, then 6-7 cc blood discarded before specimen collected. Lab results: WBC 9.5, Hgb 13.6, Platelets 10K. Pt was seen by covering hematologist who noted in response to pt questioning, that pt received "live" meningitis vaccine. (BEXSERO is a recombinant vaccine). This led patient to believe that she should not have received it, and she believes sore throat, achy ears and subsequent drop in Plts due to meningococcal vaccine. Spoke with patient's primary hematologist who thought vaccine was given appropriately (indication=splenectomized pt). Felt it was unclear as to whether pt developed "sinusitis" due to increased susceptibility to bacterial infection vs a side effect of vaccine. Pt was stable with decreased petechiae, and was discharged home on 8/21/2016 on an increased dose of PROMACTA and ongoing Prednisone taper. She has continued to do well  -  has since received a flu vaccine and pneumococcal vaccine (weeks apart) without further incident.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: White blood cell count increased
Clinical narrative: Pt was seen at allergist's office for routine visit 8/12/16 (one day after vaccine) and  offered no complaints. On 8/16/16 she presented to ED with c/o fever (99.7) and one day history of sore throat and achy ears. Physical exam was normal (see  attached)  and platelet count was close to baseline (38K). She was given prescription for Azithro as empiric treatment for possible sinusitis. 8/18/2016: Follow-up phone call to patient. Spoke with daughter who stated pt doing much better (she was busy and couldn't come to phone). 8/20/2016: Presented to ED with c/o bruising but no other complaints. (Pt has ITP and develops ecchymosis/petechiae when platelet count drops). Labs revealed Plt count 9K. ED/hospitalist notes state pt had been carrying/moving heavy boxes and bruises were in appropriate distribution. Pt was admitted for observation, started on Prednisone. 8/21/2016: Pt requested blood draw from peripheral IV which was flushed first with NS, then 6-7 cc blood discarded before specimen collected. Lab results: WBC 9.5, Hgb 13.6, Platelets 10K. Pt was seen by covering hematologist who noted in response to pt questioning, that pt received "live" meningitis vaccine. (BEXSERO is a recombinant vaccine). This led patient to believe that she should not have received it, and she believes sore throat, achy ears and subsequent drop in Plts due to meningococcal vaccine. Spoke with patient's primary hematologist who thought vaccine was given appropriately (indication=splenectomized pt). Felt it was unclear as to whether pt developed "sinusitis" due to increased susceptibility to bacterial infection vs a side effect of vaccine. Pt was stable with decreased petechiae, and was discharged home on 8/21/2016 on an increased dose of PROMACTA and ongoing Prednisone taper. She has continued to do well  -  has since received a flu vaccine and pneumococcal vaccine (weeks apart) without further incident.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: Case number PHEH2016US028818, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017) on 06 Oct 2016. The patient was also vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in the opposite arm on 06 Oct 2016. On the same day, the patient developed myalgia in the same hand where PNEUMOVAX 23 was administered. On 07 Oct 2016, the patient could not move her arm (unspecified arm). The pharmacist stated that, there was no redness, bumps or swelling at the injection site when she inspected the arm. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2016US028818, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017) on 06 Oct 2016. The patient was also vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in the opposite arm on 06 Oct 2016. On the same day, the patient developed myalgia in the same hand where PNEUMOVAX 23 was administered. On 07 Oct 2016, the patient could not move her arm (unspecified arm). The pharmacist stated that, there was no redness, bumps or swelling at the injection site when she inspected the arm. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Case number PHEH2016US028818, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017) on 06 Oct 2016. The patient was also vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in the opposite arm on 06 Oct 2016. On the same day, the patient developed myalgia in the same hand where PNEUMOVAX 23 was administered. On 07 Oct 2016, the patient could not move her arm (unspecified arm). The pharmacist stated that, there was no redness, bumps or swelling at the injection site when she inspected the arm. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Case number PHEH2016US028818, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017) on 06 Oct 2016. The patient was also vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in the opposite arm on 06 Oct 2016. On the same day, the patient developed myalgia in the same hand where PNEUMOVAX 23 was administered. On 07 Oct 2016, the patient could not move her arm (unspecified arm). The pharmacist stated that, there was no redness, bumps or swelling at the injection site when she inspected the arm. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHEH2016US028818, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017) on 06 Oct 2016. The patient was also vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in the opposite arm on 06 Oct 2016. On the same day, the patient developed myalgia in the same hand where PNEUMOVAX 23 was administered. On 07 Oct 2016, the patient could not move her arm (unspecified arm). The pharmacist stated that, there was no redness, bumps or swelling at the injection site when she inspected the arm. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Case number PHEH2016US028818, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017) on 06 Oct 2016. The patient was also vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in the opposite arm on 06 Oct 2016. On the same day, the patient developed myalgia in the same hand where PNEUMOVAX 23 was administered. On 07 Oct 2016, the patient could not move her arm (unspecified arm). The pharmacist stated that, there was no redness, bumps or swelling at the injection site when she inspected the arm. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Disability, Mobility decreased
Clinical narrative: Case number PHEH2016US028818, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017) on 06 Oct 2016. The patient was also vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in the opposite arm on 06 Oct 2016. On the same day, the patient developed myalgia in the same hand where PNEUMOVAX 23 was administered. On 07 Oct 2016, the patient could not move her arm (unspecified arm). The pharmacist stated that, there was no redness, bumps or swelling at the injection site when she inspected the arm. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: Case number PHEH2016US028821, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017), both on 06 Oct 2016. On 07 Oct 2016, the patient could not move his arm. The pharmacist stated that, there was no redness, bumps or swelling at the injection site when he inspected the arm. Also, there was significant disability or incapacity. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2016US028821, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017), both on 06 Oct 2016. On 07 Oct 2016, the patient could not move his arm. The pharmacist stated that, there was no redness, bumps or swelling at the injection site when he inspected the arm. Also, there was significant disability or incapacity. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Case number PHEH2016US028821, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017), both on 06 Oct 2016. On 07 Oct 2016, the patient could not move his arm. The pharmacist stated that, there was no redness, bumps or swelling at the injection site when he inspected the arm. Also, there was significant disability or incapacity. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Case number PHEH2016US028821, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017), both on 06 Oct 2016. On 07 Oct 2016, the patient could not move his arm. The pharmacist stated that, there was no redness, bumps or swelling at the injection site when he inspected the arm. Also, there was significant disability or incapacity. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHEH2016US028821, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017), both on 06 Oct 2016. On 07 Oct 2016, the patient could not move his arm. The pharmacist stated that, there was no redness, bumps or swelling at the injection site when he inspected the arm. Also, there was significant disability or incapacity. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Case number PHEH2016US028821, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017), both on 06 Oct 2016. On 07 Oct 2016, the patient could not move his arm. The pharmacist stated that, there was no redness, bumps or swelling at the injection site when he inspected the arm. Also, there was significant disability or incapacity. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Disability, Mobility decreased
Clinical narrative: Case number PHEH2016US028821, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a 75 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and PNEUMOVAX 23 vaccine (manufacturer unknown and batch number: L038522, expiry date: 11 Aug 2017), both on 06 Oct 2016. On 07 Oct 2016, the patient could not move his arm. The pharmacist stated that, there was no redness, bumps or swelling at the injection site when he inspected the arm. Also, there was significant disability or incapacity. The outcome of the events was not reported. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: Patient reports receiving influenza vaccine at work 10-12-16. She presented to clinic 10-17-16. Reports that she developed itchy hives on extremities and trunk on 10-15-16. Pt denies lip/tongue swelling/difficulty breathing. Pt reports similar RXN last year after flu shot. Treatment antihistamines prn. Offered consult to allergist.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reports receiving influenza vaccine at work 10-12-16. She presented to clinic 10-17-16. Reports that she developed itchy hives on extremities and trunk on 10-15-16. Pt denies lip/tongue swelling/difficulty breathing. Pt reports similar RXN last year after flu shot. Treatment antihistamines prn. Offered consult to allergist.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Peripheral swelling
Clinical narrative: Flu vaccine FLUARIX QUADRIVALENT
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Unevaluable event
Clinical narrative: Flu vaccine FLUARIX QUADRIVALENT
Age: 56.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site pain
Clinical narrative: The shot was given in the shoulder which was an incorrect area to give a shot. I have been to 2 Drs. I am taking medication and having physical therapy for the pain in my shoulder.
Age: 56.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: The shot was given in the shoulder which was an incorrect area to give a shot. I have been to 2 Drs. I am taking medication and having physical therapy for the pain in my shoulder.