chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Case number PHHY2015US173410 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 608193) on 29 Dec 2015. This report refers to a 37 year old female patient. Her current conditions included asthma and seasonal allergies. She had no concomitant medications. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 16 Oct 2015. On 18 Oct 2015, she experienced headache, fatigue and body aches. After one week, she had sore throat. After few days she experienced tight lungs with cough, fever and body aches that lasted 3 full weeks. She went to emergency room. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Case number PHHY2015US173656 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 608200) on Dec 2015. This report refers to a 70 year old female patient. The patient's current conditions included type 2 diabetes, hyperparathyroidism and osteoporosis. The patient's concomitant medications were calcium and vitamin D, calcitriol and lithium. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 04 Nov 2015. On 04 Nov 2015, the patient had pain in left arm at the site of injection and pain down left side of the arm. It was painful to move or raise arm. The pain persisted for four days with no indication of lessening. The outcome of the events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Case number PHHY2015US173582, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 608283) website on 29 Dec 2015. This report refers to a male patient of an unknown age. Historical condition was not reported. Past medication included antibiotic which the patient just finished last week for unknown issue. Current conditions included allergic to penicillin and rash from his grandson. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 04 Nov 2015. On 06 Nov 2015 after vaccination, the patient had mild headache, mild nausea and feeling tired. It was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported.
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased
Clinical narrative: Case number PHHY2015US173621 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 608496) website on 29 Dec 2015. This report refers to a 31-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) into right arm on 28 Oct 2015.  On same day after vaccination, the patient's vaccinated right arm developed inability to move arm/very decreased range of motion. The patient visited the clinic and placed on MEDROL. The outcome of the event was reported as unknown. Seriousness of the event was reported as non serious and causality not reported.
Sex: M
Vaccine: FLUX
Symptoms: Vaccination site swelling
Clinical narrative: Case number PHHY2015US173840, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 608518) website on 29 Dec 2015. This report refers to a child male patient of an unknown age. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number: not reported) in to thigh on an unknown date in 2013. After vaccination, the patient developed swelling of the leg limited to the site of vaccination on the thigh. The outcome, seriousness and causality of the event were not reported.
Age: 60.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Injection site pain, Musculoskeletal disorder
Clinical narrative: Case number PHHY2015US173645, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 608762) website on 29 Dec 2015. This report refers to a 60-year-old male patient. Historical condition was not reported. Current condition included type II diabetes. Concomitant medication was not reported. The patient was vaccinated with second dose of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) and zoster (varicella zoster vaccine (manufacturer unknown), batch number: not reported) both into left arm on 02 Nov 2015. On 03 Nov 2015 after vaccination, the patient developed arm/shoulder pain where vaccination received (left arm) and inability to function/lift items. The patient required bed rest at home. It was reported as he still laid up as of 10 Nov 2015 and remained of weak pain. The outcome of the event was reported as condition unchanged. Seriousness of the event was reported as non serious and casualty not reported.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Pyrexia
Clinical narrative: Case number PHHY2015US173612, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 608957) on 29 Dec 2015. This report refers to a 33 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with third dose of seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) intramuscularly into the right arm on 26 Oct 2015. On 28 Oct 2015, she experienced extreme fatigue and fever lasting 24 hours. The outcome of the events was reported as complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Decreased appetite, Fatigue, Headache
Clinical narrative: Case number PHHY2015US173642 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609024) on 29 Dec 2015. This report refers to a 61 year old female patient. Medical history was not reported. Concomitant medications included DEXILANT, COLACE and Fish oil. The patient was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) and PREVNAR 13 (other manufacturer, batch number: not reported) on 04 Nov 2015. On the same day after vaccination, the patient developed extreme fatigue, headache and loss of appetite. The events lasted for more than several days. It was reported that it was the first time with combined flu shot and pneumonia shot. The outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality of the events was not reported.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Cough, Croup infectious
Clinical narrative: Case number PHHY2015US173880, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 609067) on 29 Dec 2015. This report refers to a 5 years old female patient. Past medical history and concomitant medications were not reported. Current condition included asthma. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) into the left arm on 11 Nov 2015. After vaccination, she experienced sudden, severe croup coughing with elevated body temperature (2 degrees above normal 97 Fahrenheit for her). The outcome of the events was reported as unknown. The events were assessed as non serious and causality was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2015US173876 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 609068) on 29 Dec 2015. This report refers to a 52 year old male patient. He had no medical history or current conditions. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 22 Oct 2015. After vaccination, on 06 Nov 2015 he had pain in arm and he could not lift arm by itself over his head. It was reported that he could move the arm only in certain directions. The final outcome of the events was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, X-ray normal
Clinical narrative: Case number PHHY2015US173589, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 609333) website on 29 Dec 2015. This report refers to a 50 years old male patient. Past medical history and concomitant medication were not reported. The patient went to the physician to rule out an intestinal blockage, he had vomited food 64 hours earlier and food did not seem to be leaving in stomach. He checked and ruled out a blockage. It was stated that, the original cause of the vomiting is unknown, but presumably food poisoning of some sort. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 19 Oct 2015. On the same day after vaccination, the patient arm was sore for two days after shot in the area of the shot. It was stated that, two weeks later it was still sore at the injection point but the pain had increased. The patient called the physician and they said to watch it and let them know in a week. A week later, he called and let them know it was still quite severe, and had spread. It ranges from the shoulder to the elbow. The patient did an x ray and did not see anything. On 12 Nov 2015, the patient still suffered with pain. The outcome of pain was reported as condition unchanged and rest of events was reported as unknown. The seriousness of the event was reported as non-serious. The causality of the event was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Myalgia
Clinical narrative: Case number PHHY2015US173833, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 609370) website on 29 Dec 2015. This report refers to a 71 years old male patient. Medical history was not reported. The concomitant medication included insulin (manufacturer unknown), ibuprofen (manufacturer unknown), baby aspirin, lovastatin (manufacturer unknown), lisinopril (manufacturer unknown), omeprazole (manufacturer unknown), metoprolol (manufacturer unknown), one a day vitamin (not specified), Vitamin D3. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number not reported) on 22 Oct 2015. On 23 Oct 2015, next morning after taking the shot, started having some minor aching in arm muscles. To this day been having very severe pain in arms muscles and joints. The outcome of the events was not reported. The seriousness of the events was reported as non serious and causality not reported.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: Case number PHHY2015US173631 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 609484) on 29 Dec 2015. This report refers to a 54 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 09 Nov 2015. On 10 Nov 2015, she had rash on left forearm. She also noticed rash on upper left thigh on 11 Nov 2015 and on upper right thigh on 12 Nov 2015. It was reported that on 13 Nov 2015 her face became itchy and she began to get rash on middle back. The events outcome was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Pain
Clinical narrative: Case number PHHY2015US173932 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609688) website on 29 Dec 2015. This report refers to a 9-year-old male patient. Historical conditions included Asperger's, attention deficit hyperactivity disorder and oppositional defiant disorder. Past vaccination history included influenza vaccine (no adverse event was reported). Concomitant medications included VYVANSE, GEODON, Multi Vitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) into left arm intramuscularly on 13 Nov 2015. On 14 Nov 2015 the patient experienced redness, hives around injection site measuring about 2 inches in diameter, itching and the area is swollen. Patient stated that pain since initial injection but that it increased this morning after waking and that's when itching started. The patient took off bandaid ten minutes post injection. The patient was treated with BENADRYL. The outcome of the events was reported as unknown. The seriousness was reported as non-serious and causality was not reported.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV9
Symptoms: Angiogram, Arthralgia, Blood test, Borrelia test, Computerised tomogram head
Clinical narrative: This spontaneous report was received from the patient's mother concerning her daughter, a 14 year old female patient with no drug reactions/allergies. The patient's current conditions included a pink eye at the time of an unspecified vaccination. The patient's medical history was not reported. Concomitant therapies included hepatitis A Vaccine, Inactivated (manufacturer unknown). On 18-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L048459, in the left deltoid, for prophylaxis (dose, route of administration and expiration date were not reported). On the same date, shortly after receiving the vaccination, the patient developed a headache, neck pain and "heavy arms" (limb discomfort ). It was also reported that the patient felt as if "a band was held very tight around her head" (tension headache). The reporter indicated that, on unknown dates, the patient had been seen by several unspecified doctors and one of them prescribed her an unspecified antidepressant for headache relief. Laboratory diagnostics studies, performed on unknown dates, included two magnetic resonance imaging (MRI) scans, a computed tomography (CT scan), a magnetic resonance angiogram (MRA) scan and other unspecified blood tests. However, the results were not reported. It was stated that, on an unknown date since taking the antidepressant, the patient no longer felt like "a band is around her head", but the headache was still present (not recovered, also reported as "has had little relief"). It was not specified if the patient stopped the therapy with the unspecified antidepressant, nor whether or not her neck pain and "heavy arms" subsided. The causality relationship between the events and GARDASIL 9 vaccination was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV9
Symptoms: Dizziness, Headache, Intracranial pressure increased, Limb discomfort, Nausea
Clinical narrative: This spontaneous report was received from the patient's mother concerning her daughter, a 14 year old female patient with no drug reactions/allergies. The patient's current conditions included a pink eye at the time of an unspecified vaccination. The patient's medical history was not reported. Concomitant therapies included hepatitis A Vaccine, Inactivated (manufacturer unknown). On 18-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L048459, in the left deltoid, for prophylaxis (dose, route of administration and expiration date were not reported). On the same date, shortly after receiving the vaccination, the patient developed a headache, neck pain and "heavy arms" (limb discomfort ). It was also reported that the patient felt as if "a band was held very tight around her head" (tension headache). The reporter indicated that, on unknown dates, the patient had been seen by several unspecified doctors and one of them prescribed her an unspecified antidepressant for headache relief. Laboratory diagnostics studies, performed on unknown dates, included two magnetic resonance imaging (MRI) scans, a computed tomography (CT scan), a magnetic resonance angiogram (MRA) scan and other unspecified blood tests. However, the results were not reported. It was stated that, on an unknown date since taking the antidepressant, the patient no longer felt like "a band is around her head", but the headache was still present (not recovered, also reported as "has had little relief"). It was not specified if the patient stopped the therapy with the unspecified antidepressant, nor whether or not her neck pain and "heavy arms" subsided. The causality relationship between the events and GARDASIL 9 vaccination was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV9
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Vertigo
Clinical narrative: This spontaneous report was received from the patient's mother concerning her daughter, a 14 year old female patient with no drug reactions/allergies. The patient's current conditions included a pink eye at the time of an unspecified vaccination. The patient's medical history was not reported. Concomitant therapies included hepatitis A Vaccine, Inactivated (manufacturer unknown). On 18-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L048459, in the left deltoid, for prophylaxis (dose, route of administration and expiration date were not reported). On the same date, shortly after receiving the vaccination, the patient developed a headache, neck pain and "heavy arms" (limb discomfort ). It was also reported that the patient felt as if "a band was held very tight around her head" (tension headache). The reporter indicated that, on unknown dates, the patient had been seen by several unspecified doctors and one of them prescribed her an unspecified antidepressant for headache relief. Laboratory diagnostics studies, performed on unknown dates, included two magnetic resonance imaging (MRI) scans, a computed tomography (CT scan), a magnetic resonance angiogram (MRA) scan and other unspecified blood tests. However, the results were not reported. It was stated that, on an unknown date since taking the antidepressant, the patient no longer felt like "a band is around her head", but the headache was still present (not recovered, also reported as "has had little relief"). It was not specified if the patient stopped the therapy with the unspecified antidepressant, nor whether or not her neck pain and "heavy arms" subsided. The causality relationship between the events and GARDASIL 9 vaccination was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV9
Symptoms: Angiogram, Blood test, Computerised tomogram, Headache, Limb discomfort
Clinical narrative: This spontaneous report was received from the patient's mother concerning her daughter, a 14 year old female patient with no drug reactions/allergies. The patient's current conditions included a pink eye at the time of an unspecified vaccination. The patient's medical history was not reported. Concomitant therapies included hepatitis A Vaccine, Inactivated (manufacturer unknown). On 18-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L048459, in the left deltoid, for prophylaxis (dose, route of administration and expiration date were not reported). On the same date, shortly after receiving the vaccination, the patient developed a headache, neck pain and "heavy arms" (limb discomfort ). It was also reported that the patient felt as if "a band was held very tight around her head" (tension headache). The reporter indicated that, on unknown dates, the patient had been seen by several unspecified doctors and one of them prescribed her an unspecified antidepressant for headache relief. Laboratory diagnostics studies, performed on unknown dates, included two magnetic resonance imaging (MRI) scans, a computed tomography (CT scan), a magnetic resonance angiogram (MRA) scan and other unspecified blood tests. However, the results were not reported. It was stated that, on an unknown date since taking the antidepressant, the patient no longer felt like "a band is around her head", but the headache was still present (not recovered, also reported as "has had little relief"). It was not specified if the patient stopped the therapy with the unspecified antidepressant, nor whether or not her neck pain and "heavy arms" subsided. The causality relationship between the events and GARDASIL 9 vaccination was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV9
Symptoms: Neck pain, Nuclear magnetic resonance imaging, Tension headache
Clinical narrative: This spontaneous report was received from the patient's mother concerning her daughter, a 14 year old female patient with no drug reactions/allergies. The patient's current conditions included a pink eye at the time of an unspecified vaccination. The patient's medical history was not reported. Concomitant therapies included hepatitis A Vaccine, Inactivated (manufacturer unknown). On 18-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L048459, in the left deltoid, for prophylaxis (dose, route of administration and expiration date were not reported). On the same date, shortly after receiving the vaccination, the patient developed a headache, neck pain and "heavy arms" (limb discomfort ). It was also reported that the patient felt as if "a band was held very tight around her head" (tension headache). The reporter indicated that, on unknown dates, the patient had been seen by several unspecified doctors and one of them prescribed her an unspecified antidepressant for headache relief. Laboratory diagnostics studies, performed on unknown dates, included two magnetic resonance imaging (MRI) scans, a computed tomography (CT scan), a magnetic resonance angiogram (MRA) scan and other unspecified blood tests. However, the results were not reported. It was stated that, on an unknown date since taking the antidepressant, the patient no longer felt like "a band is around her head", but the headache was still present (not recovered, also reported as "has had little relief"). It was not specified if the patient stopped the therapy with the unspecified antidepressant, nor whether or not her neck pain and "heavy arms" subsided. The causality relationship between the events and GARDASIL 9 vaccination was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Bronchial hyperreactivity, Chest discomfort, Cough, Erythema, Feeling hot
Clinical narrative: Fever between 101.7 and 102.1, shortness of breath, tightness is chest, body aches, injection site pain, followed by hot feeling on/near site, white mucus, coughing, difficulty breathing, wheezing (not controlled by treatment / rescue inhaler).
Age: 44.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Local swelling, Musculoskeletal pain, Pyrexia, Wheezing
Clinical narrative: Fever between 101.7 and 102.1, shortness of breath, tightness is chest, body aches, injection site pain, followed by hot feeling on/near site, white mucus, coughing, difficulty breathing, wheezing (not controlled by treatment / rescue inhaler).
Age: 44.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest discomfort, Cough, Dyspnoea, Injection site pain, Injection site warmth
Clinical narrative: Fever between 101.7 and 102.1, shortness of breath, tightness is chest, body aches, injection site pain, followed by hot feeling on/near site, white mucus, coughing, difficulty breathing, wheezing (not controlled by treatment / rescue inhaler).
Age: 44.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain, Pyrexia, Secretion discharge, Wheezing
Clinical narrative: Fever between 101.7 and 102.1, shortness of breath, tightness is chest, body aches, injection site pain, followed by hot feeling on/near site, white mucus, coughing, difficulty breathing, wheezing (not controlled by treatment / rescue inhaler).
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 25-OCT-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments:  US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist referring to an adult female patient of unknown age (reported as adult). The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot # , dose, route and site of administration and expiration date were not reported). However, the reporter was not able to confirm if the patient had ever been vaccinated with VARIVAX in the past or if she had ever had chickenpox. On an unknown date, the patient had low varicella titers. The outcome of the event and causality assessment were not reported. This is one of two reports for the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011634:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an administrator concerning a patient of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M017983 with expiration date of 30-MAY-2018 for prophylaxis (route and dose were not provided). It was reported that the vaccine had been stored for 15 minutes  in a temperature between 32 degrees Fahrenheit and 36 degrees Fahrenheit as recorded by a digital data logger. There were no previous temperature excursions. No adverse effect was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified adult patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with two pediatric doses of VAQTA 25/0.5 for prophylaxis (route of administration, anatomical location, lot# and expiration date were not reported). No adverse event was reported. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 11-JAN-2017, the patients were vaccinated with doses of improperly stored PROQUAD lot # M022400 and expiration date: 01-NOV-2017 (route, dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered doses of vaccine experienced a temperature excursion of more than 5 grades F (Fahrenheit) but less than 14 grades F for 2 hours and 30 minutes, and more than 14 grades F but less than 46 grades F for 12 hours and 15 minutes. Data logger was involved and there was no previous temperature excursion reported. Furthermore, no product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA013144:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of PROQUAD, lot # M037011, expiration date 21-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. It was reported, that the vaccines had a temperature excursion of 9.0 Fahrenheit (F) with a time frame of 70 minutes, also, it was reported that no previously excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted.; Sender's Comments:  US-009507513-1701USA013126: US-009507513-1701USA013127:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.     From 01-SEP-2016 to 17-JAN-2017,  the unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque forming units (PFU) lot # M019646, expiration date: 18-JUL-2017, as prophylaxis (Dose was not reported), which experienced a temperature excursion between -15 and -10 Celsius degrees for 15 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On 18-JAN-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX injection (expiration date 24-DEC-2016; dose, site and route of administration and lot # were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Chest X-ray normal, Urine analysis normal, White blood cell count increased
Clinical narrative: This spontaneous report has been received from a consumer via company representative referring to a 1 year old male patient. There were no drug reactions, pertinent medical history, and concurrent conditions reported. Concomitant vaccines included PREVNAR 13 and influenza virus vaccine (manufacturer unknown). On 16-JAN-2017, the patient was vaccinated with VARIVAX, (dose, frequency, route of administration, lot#, and expiration date were not provided) for prophylaxis, and also was vaccinated with M-M-R II (dose, frequency, route of administration, lot#, and expiration date were not provided) for prophylaxis. On the same date of the vaccination, after the patient woke up from a nap, the patient had a temperature of 105 (units not provided). On 17-JAN-2017,  the patient's mother went to the pediatrician because her son still had a temperature of 103.8 (units not provided), she stated that the pediatrician did a unspecified blood test which resulted in a "white blood cell count of  30000" (units not provided), also it was performed an unspecified urinalysis test and chest x-ray which both came back negative. The patient's mother stated that her son had no signs of the flu, respiratory syncytial virus infection (RSV) or strep infection, the patient was treated with ROCEPHIN and also reported that she will visit the pediatrician on 19-JAN-2017. The outcome of the events was unknown. The relatedness between the events and VARIVAX, M-M-R II were not reported. Upon internal review, the temperature of 105/ 103.8, and white blood cell count of 30000 were determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician and refers to a 45-year-old female patient with psoriatic arthropathy and an unspecified medical condition. No other information regarding the patient's medical history or drug allergies/reactions were reported. Concomitant therapies included etanercept (ENBREL) and valacyclovir hydrochloride (VALTREX). On 13-JAN-2017, the patient was vaccinated with a dose of VARIVAX (Lot #, expiration date, regimens dose and anatomical location were not provided) for prophylaxis; the patient had not experienced chicken pox in the past. Subsequently, on 14-JAN-2017, the patient developed "soreness in her arm and lump at the injection site" after the vaccination. The patient sought medical attention by a phone call to her doctor's office when unspecified treatment was given. On an unknown date in January 2017, she recovered from the events. No lab diagnostics studies were performed. No product quality complaint (PQC) was involved. The causality assessment between the events and the suspect therapy was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions, allergies and concomitant therapies was not provided. On 18-JAN-2017, the patient was inadvertently  vaccinated with and expired dose of PNEUMOVAX23, (strength, route of administration, dose, and frequency were not provided), lot # L012215, expiration date 13-JAN-2017 for prophylaxis. No adverse effect was reported nor product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist technician, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L035504, expiration date on 16-DEC-2016, intramuscularly (strength, dose and anatomical location were not reported) for prophylaxis. No side effects were reported.  No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M035688 with expiration date of 10-AUG-2018, lot number M033906 with expiration date of 20-JUL-2018 or lot number M028551 with expiration date of 07-JUN-2018 (strength, dosage schedule, anatomical location and route of administration were not provided) for prophylaxis. The administered doses with lot number M035688 were exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours (digital data logger) without any previous temperature excursion. The administered doses with lot number M033906 were exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours (digital data logger) with two previous temperature excursion at a temperature higher than -10°C but lower than 8°C for 16 hours and 52 minutes (digital data logger)  an at a temperature of  -2.8°C for 1 hour and 32 minutes (digital data logger). The administered doses with lot number M028551 were exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours (digital data logger) with two previous temperature excursion at a temperature higher than -10°C but lower than 8°C for 20 hours and 16 minutes (digital data logger)  an at a temperature of  -2.8°C for 1 hour and 32 minutes (digital data logger). No adverse effects were reported. There was no product quality complaint involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA008111:
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: Information has been received from a nurse practitioner referring to a 1 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 19-JAN-2017, the patient was vaccinated with PROQUAD (dose, route, lot number and expiration date were unknown) and possibly VAQTA (dose, route, lot number and expiration date were unknown) for immunization schedule at clinic. On 20-JAN-2017, the patient experienced fever and development of seizures and was seen in Emergency room of an unspecified hospital. The events were life threatening. Treatment (unspecified) for the events was given. The outcome of the events was reported as not recovered. The causal relationship between the suspect drugs and the events was not provided. Upon internal review, seizures was determined to be medical significant. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was inadvertently vaccinated with a dialysis dose (40 mcg) of RECOMBIVAX HB as second dose in RECOMBIVAX HB immunization series where a standard dose (10mcg) was expected (route of administration, anatomical location, lot number and expiration date were not provided). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L015046 and expiration date 29-APR-2017, subcutaneously (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccine had an unspecified temperature excursion, reported as more than 14 Fahrenheit (F) and less than 46 F with a time frame of 40 minutes. No previous temperature excursions were reported and a digital data logger was involved. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a vaccine coordinator via a company representative concerning a 1 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On an unspecified date in June 2016 (reported as "four months ago"), the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, strength and route of administration were not reported) instead VARIVAX (lot number, expiration date, dose, strength and route of administration were not reported) (wrong drug administered). It was reported that the patient seemed fine. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 20-JAN-2017, the patient was vaccinated with: VARIVAX (lot #: M030138 with expiration date: 15-JUN-2018) (dose, dosage schedule and anatomical location were not reported) subcutaneously, for prophylaxis; and with M-M-R II (lot #: M029229 with expiration date: 08-JUN-2018) (dose, dosage schedule and anatomical location were not reported) subcutaneously, for prophylaxis. These two vaccines had been drawn into plastic syringes and had been stored at refrigerated temperatures (36°F-46°F) for eight days. No adverse effects were reported.  Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Crying
Clinical narrative: This spontaneous report was received from a physician referring a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route, lot # and expiration date were not reported). It was stated that after receiving this dose, the patient "cried almost non-stop for 24 hours", after which it resolved. A product quality complaint was not involved. The causality assessment between persistent crying and  GARDASIL 9 was not provided. 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 medical assistant referring to a 2 unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL Lot#: M034437, expiration date on 03-FEB-2019 (strength, dose number, route and anatomical location were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. No product quality complaint was involved. The vaccines experienced the following temperature excursions during 20 minutes: 32°F (Fahrenheit), 36°F and 46°F; during 41 minutes: 77°F; during 1 hour and 20 minutes: freezer 5°F and 14°F. The aforementioned ones were identified due to a data logger. There was no previous temperature excursion. It was reported that the vaccines were supported. This is one of several reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided.; Sender's Comments: US-009507513-1701USA012391: US-009507513-1701USA012392:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 11-JAN-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot # M025864 and expiration date: 24-MAY-2018 (route, dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered doses of vaccine experienced a temperature excursion of more than 5 grades F (Fahrenheit) but less than 14 grades F for 2 hours and 30 minutes, and more than 14 grades F but less than 46 grades F for 12 hours and 15 minutes. Data logger was involved and there was no previous temperature excursion reported. Furthermore, no product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007989:
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Incisional drainage, Injection site abscess, Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited report received from nurse on 19-Jan-2017. This case involves a 17-month-old female patient who was vaccinated with a dose of DAPTACEL (Batch number: C5148AA and expiry date: 09 Feb 2019) and ACTHIB (Batch number: UI645AA and expiry date: 21 Jul 2017) both intramuscularly in right thigh on 21-Nov-2016. Patient do not had any illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medication was not reported. On 21 Nov 2016, five days following the vaccination, the patient developed an abcess on right leg about 4 cm in diameter, redness and swelling to that area. On an unspecified date, patient was seen in emergency room where patient was treated and released. On an unspecified date Lab data investigation performed it includes I&D (Incision and Drainage): crystalized material. Corrective treatment was not reported. On an unspecified date, patient was recovered from events. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness, Influenza virus test negative, Malaise
Clinical narrative: Initial unsolicited report received from a non-health care professional on 18 Jan 2017. This case is linked to 2017SA010345 (same reporter). This case involves 15 patients (age and gender was not reported) who were vaccinated with a dose of FLUZONE HD intramuscularly and FLUZONE QIV (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as rheumatological Disorders. Concomitant medications were not reported. On an unknown date, following the vaccination, the patients had experienced flu like symptoms. It was a Life-threatening Illness. The patient required Emergency room or doctor visit. The patient's laboratory data included flu with throat swab test showed negative result for flu. Corrective treatment was not reported. The outcome was unknown. case was considered as serious due to a Life-threatening Illness. List of documents held by sender: none. Sender's Comments: It was reported that about 15 patients who received either INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE or INFLUENZA QUADRIVAL A-B VACCINE and experienced ill with flu like symptoms. Time to onset is unknown. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.