chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 44 year old female patient. Information about the patient's medical history was not reported. On 05-FEB-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K008409, expiration date reported as 04-MAR-2016, 0.5 ml dose (dose number was not reported), intramuscular while being hospitalized (unspecified date of hospitalization) in an unspecified hospital for an unspecified hospital condition. Information about concomitant therapies was not provided. On 06-FEB-2015, the patient experienced injection site reaction that was red, indurated, hot to touch and very painful. The pharmacist stated that no treatment was given, but comfort measures of warm compress and TYLENOL were administered for discomfort due to swelling (experienced on 05-FEB-2015). No laboratory diagnostic studies were performed. The patient sought medical attention as she as at the hospital while receiving the dose of PNEUMOVAX 23. The pharmacist stated that the adverse events did not increase length of stay at the hospital The outcome of adverse events was reported as recovering/resolving. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Exfoliative rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old male patient with high cholesterol, high blood pressure, glaucoma and allergic reaction to sulfa drug. On 29-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous. Concomitant therapies included niacin, lisinopril, pravastatin, vitamin D3, aspirin, latanoprost and LUMIGAN. On an unknown date approximately in January 2015 (about 15 days ago) the patient experienced red scaly rash on both the sides of his back and on the arm (opposite the arm that received the ZOSTAVAX injection) on the back of the waist and on the upper part of the back of the legs. Treatment was not given to the patient. Patient sought medical attention, went to see the pharmacist. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender, who were administered improperly stored doses of vaccinated with PROQUAD (Merck) since 10-DEC-2014. No adverse events were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dysarthria, Gait disturbance, Urinary retention
Clinical narrative: This spontaneous report as received from a nurse refers to her husband - a male patient of unknown age with urinary retention and Parkinson's disease. On 19-DEC-2014 the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). On the same day, the patient started therapy with SINEMET (lot #, expiration date, strength, dose and frequency were not reported) for Parkinson's disease. On an unknown date (reported as after started SINEMET) the patient became blistered from neck to ankle (also reported as allergic reactions). SINEMET was discontinued and the blistering cleared up (on an unknown date). On an unknown date, the patient began taking MIRAPAX and experienced slurred speech, impaired gait and "seemed like he was drunk when he wasn't". The nurse said after 48 hours, the MIRAPAX was discontinued and the patient went back to normal (on an unknown date). The nurse stated that the patient was then started on a medication for urinary retention called MYRBETRIQ, and that he immediately "started breaking out again" so it was discontinued immediately. Outcome was not reported. The nurse stated that the patient was not taking any medication for Parkinson's disease or urinary retention because of the allergic reactions and that both conditions are "progressing rapidly". There was no treatment given for adverse events. Patient sought medical attention via visiting the office. The relatedness between adverse events and suspected therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding drug reactions or allergies and medical history was not reported. The nurse reported that on 13-FEB-2015 the patient was inadvertently administered PNEUMOVAX 23 (dose, route of administration, anatomical location, lot# were not reported) that had expired on 12-FEB-2015. Concomitant therapies were not reported. No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 18-year-old female patient who received ENGERIX B. In August 2014, the patient received the 2nd dose of ENGERIX B .5 ml. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information received: The pharmacist is not sure if the patient received her first or second dose of the ENGERIX B vaccine in August. The patient is trying to get the next dose of the ENGERIX B vaccine. If she received the first dose of the ENGERIX B vaccine in August then she is technically not receiving a late dose now. If she received the second dose of the ENGERIX B vaccine in August then she is late for her third dose.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (immunization administrator) concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of M-M-R II (Lot # not provided) which were exposed a supported temperature excursion, continued to be administered to unspecified patients on unspecified dates since 07-AUG-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. Ten patients received BOOSTRIX that was exposed to temperature of 30.4F. Two lot numbers 3P9CL exp 15Apr2016 or HM4FY exp 06Dec2016.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Erythema, Swelling face
Clinical narrative: Facial swelling and facial redness - resolved in 36 hours on its own.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Eating disorder, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: This spontaneous report as received from a male consumer of unknown age reporting himself with allergy to VIDOCIN. None pertinent medical history was provided. In October 2014, the patient was vaccinated with a dose of ZOSTAVAX in the right side (dose, route, lot number and expiry date were not reported). It was reported that the patient was on therapy with an unspecified blood pressure and cholesterol medication. In approximately October 2014 reported as three days after receiving the ZOSTAVAX, the patient was in pain. The patient stated that had a swollen gland from his ear to the side of his neck, the pain was also in his throat. The patient stated that he has difficulty eating and swallowing soft food. It was also reported that there was a "sensation in his neck and shoulder on the right side". None laboratory diagnostics studies were performed and the patient did not seek medical attention. The outcome of pain, swollen gland from his ear to the side of his neck, "sensation in his neck and his shoulder on the right side", difficulty eating and swallowing soft food and pain in his throat was reported as not recovered at the time of the report. Relatedness between the therapy with ZOSTAVAX and the events: pain, swollen gland from his ear to the side of his neck, "sensation in his neck and his shoulder on the right side", difficulty eating and swallowing soft food and pain in his throat was not reported. Additional information is not expected, because reporter refused additional contact.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Pruritus, Skin warm
Clinical narrative: Quarter sized, moderate localized reaction. Hot and itchy.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Full blood count normal, Influenza like illness
Clinical narrative: Fatigue, weakness, flu-like symptoms onset on 2/6/14-No treatment except advised to rest-called back 2/10/15. Same symptoms-CBC ordered-CBC normal-called again 2/16/15-continued symptoms-advised to see PCP.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Since 12-FEB-2014 the patients were vaccinated with VARIVAX (Merck) which was administered subcutaneously and underwent supported temperature excursions on unknown date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling, Vomiting
Clinical narrative: Patient experienced left arm redness, swelling and pain for about 3-4 days. Vomiting for 2 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Developed redness, swelling at area of injection. Symptoms started few hours after receiving vaccines. Continued to increase. Started tx with KEFLEX 2 days after getting vaccine for cellulitis. Symptoms got better, then worsened again on day 6 of abx. -> switched to BACTRIM.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patients of unknown age and gender. Patients medical history and current conditions were not provided. On an unknown date the patients were vaccinated with a doses of improperly stored GARDASIL (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Skin discolouration, Skin warm
Clinical narrative: Pt reported on 2/12/15 about a hypersensitivity reaction from ZOSTAVAX vaccination she got on 2/09. Patient said it looked pinkish and felt warm to the touch.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site scab
Clinical narrative: Case number PHHY2014US171403, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546367) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 340400) on 06 Feb 2015. This report refers to an 84 year old female patient. Medical history and concomitant medication was not reported. On 15 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1413301) into right arm. On 18 Sep 2014, she developed area of infection at injection site and scab approximately 1 cm with redness 3/5 cm. She went to the emergency room. Doctor started the patient on a sulfa drug. Patient was asked if immunizer had used alcohol swab and she said yes. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of vaccination site infection, erythema and scab was upgraded based on information available in the source documents. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 345775) on 12 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 340400) on 06 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Laboratory test, Lymphadenopathy, Sepsis
Clinical narrative: Case number PHHY2014US170657, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547149) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 344966) on 04 Feb 2015. This report refers to a 44-year-old female patient. Past medical history included hemifacial spasm. Concomitant medications included BOTOX, lisinopril, Vitamin B12, Vitamin D, progesterone and VIVELLE DOT Patch. She was vaccinated with FLUVIRIN (batch number: 13393P) intramuscularly into the right arm on 15 Oct 2013. On 29 Oct 2013, the patient had headache, enlarged lymph nodes and septicemia. The patient was hospitalized for two days. The patient underwent unspecified lab test; however, the results of the test were not reported. The patient did not receive any medication during the hospitalization. The final outcome of the events was complete recovery. The events were reported as serious (hospitalization). Causality of the events were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 13393P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 344966) on 05 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 344966) on 04 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site erythema, Injection site hypoaesthesia
Clinical narrative: Case number PHHY2014US171152, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547746) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 345763) on 04 Feb 2015. This report refers to a 54 year old female patient. Current condition included nylon sensitivity and hypothyroidism. Historical condition included breast cancer survivor (left breast). Concomitant medications included SYNTHROID and tamoxifen. On 02 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 145602) intramuscular into left arm. On the same day she also received PNEUMOVAX (batch number: K010016, other manufacturer) intramuscular into left arm. On 03 Oct 2014, 24 hours after vaccination, injection site became red, hot and a rash appeared and left arm became painful. Following day her inner bicep began to turn blotchy red and was full blown red, hot to touch and numb. She went to emergency room for treatment. She was diagnosed with cellulitis and an allergic reaction. Treatment medication included cephalexin 500 g QID for 7d and BENADRYL 25 g Q6H prn. Final outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of cellulitis and symptoms were upgraded based on information available in the source documents. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 145602) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 345763) on 12 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345763) on 04 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site reaction, Injection site warmth, Pain in extremity, Rash macular
Clinical narrative: Case number PHHY2014US171152, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547746) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 345763) on 04 Feb 2015. This report refers to a 54 year old female patient. Current condition included nylon sensitivity and hypothyroidism. Historical condition included breast cancer survivor (left breast). Concomitant medications included SYNTHROID and tamoxifen. On 02 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 145602) intramuscular into left arm. On the same day she also received PNEUMOVAX (batch number: K010016, other manufacturer) intramuscular into left arm. On 03 Oct 2014, 24 hours after vaccination, injection site became red, hot and a rash appeared and left arm became painful. Following day her inner bicep began to turn blotchy red and was full blown red, hot to touch and numb. She went to emergency room for treatment. She was diagnosed with cellulitis and an allergic reaction. Treatment medication included cephalexin 500 g QID for 7d and BENADRYL 25 g Q6H prn. Final outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of cellulitis and symptoms were upgraded based on information available in the source documents. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 145602) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 345763) on 12 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345763) on 04 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Case number PHHY2014US171152, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547746) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 345763) on 04 Feb 2015. This report refers to a 54 year old female patient. Current condition included nylon sensitivity and hypothyroidism. Historical condition included breast cancer survivor (left breast). Concomitant medications included SYNTHROID and tamoxifen. On 02 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 145602) intramuscular into left arm. On the same day she also received PNEUMOVAX (batch number: K010016, other manufacturer) intramuscular into left arm. On 03 Oct 2014, 24 hours after vaccination, injection site became red, hot and a rash appeared and left arm became painful. Following day her inner bicep began to turn blotchy red and was full blown red, hot to touch and numb. She went to emergency room for treatment. She was diagnosed with cellulitis and an allergic reaction. Treatment medication included cephalexin 500 g QID for 7d and BENADRYL 25 g Q6H prn. Final outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of cellulitis and symptoms were upgraded based on information available in the source documents. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 145602) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 345763) on 12 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345763) on 04 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Dehydration, Nausea, Pain
Clinical narrative: Case number PHHY2014US170532, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548565) website on 29 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 344920) on 04 Feb 2015. This report refers to a 53-year-old male patient. Concomitant drug included sertraline. He was vaccinated with FLUVIRIN (batch number: 1412201) along with PNEUMOVAX (other manufacturer, batch number: K009105) and ZOSTAVAX (other manufacturer, batch number: K003604), in the left arm on 02 Oct 2014. On 03 Oct 2014, he developed cellulitis of vaccinated arm, nausea, pain and dehydration. The patient visited the emergency room on 04 Oct 2014. She received treatment with antibiotics, drugs for nausea and pain and intravenous fluids for nausea and dehydration. The outcome of the events reported as recovered. The events reported as non-serious. Seriousness assessment of the event (cellulitis) was upgraded based on the available information in the source document. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1412201) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 344920) on 05 Jan 2015: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 344920) on 04 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Abscess drainage, Herpes zoster, Subcutaneous abscess
Clinical narrative: Case number PHHY2015US014848 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548680) on 03 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 351650) on 12 Feb 2015. This report refers to a 54 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 161205) intramuscularly in the left arm on 07 Oct 2014. On 10 Oct 2014, three days after vaccination, she had 3 abscesses formed in left axilla. 10 days after abscess, she had shingles in forehead. She went to emergency room and abscess was incised and drained. She was treated with antibiotics. The outcome of event was reported as unknown. The events were reported as non-serious, but the events abscess was upgraded based on the information available in the NVS-IME list and shingles was upgraded as medically significant based on the information available in the source document. The causality of the events was not reported. Upon follow-up from QA department, it was stated that reported batch number: 161205 not a FLUVIRIN batch and QA had confirmed that it belongs to FLUCELVAX. The suspect product recoded from FLUVIRIN to FLUCELVAX. Follow-up information received from Quality Assurance Department (reference number: 351650) on 12 Feb 2015: The suspect product recoded from FLUVIRIN to FLUCELVAX and QA reference number updated.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US171098 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 549519) website on 29 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 345438) on 04 Feb 2015. This report refers to an 83 year old female patient. Her current conditions included hypertension and dyslipidemia. Her concomitant medications included hydrochlorothiazide, citalopram, lovastatin and atenolol. On 08 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1413301) intramuscularly into her right arm and with PNEUMOVAX (other manufacturer, batch number: K009106) intramuscularly into her left arm. On the same day after the vaccination, she had cellulitis in her left arm. Most of her upper arm had swelling, redness, pain and was hot to touch. She was diagnosed by a primary care provider and was treated with clindamycin at a dose of 300 mg three times daily. The outcome of the events was unknown. The events were reported as non serious but the seriousness of cellulitis was upgraded based on the information available in the source documents and causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 345438) on 08 Jan 2015: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 345438) on 04 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Dizziness, Hypotension, Unresponsive to stimuli
Clinical narrative: Case number PHHY2015US018392, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 550030) website on 03 Feb 2015. This report refers to an 84 year old female patient. Medical history included stroke, high blood pressure and hyperlipidaemia. Concurrent conditions included chronic weakness since stroke in the past. No concomitant medication was reported. On 24 Oct 2014, the patient was vaccinated with FLUVIRIN (batch number: 146605) intramuscularly in right arm. On the same day after vaccination, the patient became unresponsive. She was conscious but not answering. The patient was lowered on the ground and her legs were lifted up. She became responsive and started to talk. The patient was then seated on a chair and she stopped talking. She was asked to lie down on the floor again. Her blood pressure (BP) was 126/62 (her normal). Emergency medical service arrived and they checked the patient's vitals. Her blood glucose was 150 and BP was 126/62. She felt lightheaded. Patient was seated. Her BP was low with a value of 80/50 in sitting position. Patient told that she took three BP medicine before (no further details was given). The patient was suggested to go to a hospital and find out the reason of her weakness and adjust BP medicines. Final outcome of the events was reported as complete recovery. Events were reported as non serious. Seriousness assessment of the events unresponsive and blood pressure low was upgraded (medically significant) based on the information available in source document. The reporter stated that the events were most likely not related to FLUVIRIN but related to her BP medicine dosing.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Cerebrovascular accident, Computerised tomogram, Computerised tomogram head abnormal
Clinical narrative: Case number PHHY2015US013452 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 550393) on 03 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 350991) on 10 Feb 2015. This report refers to an 85 years old female patient. Her current condition included increased blood pressure. Her concomitant medications were lisinopril for blood pressure, metoprolol and alprazolam. She could walk with cane and could drive when she went for vaccination. She was vaccinated with FLUVIRIN (batch number: 1411501) in the left arm on 22 Oct 2014. On the same day after vaccination, she experienced slurred speech. She became progressively weaker over the past five days in Oct 2014 and her health deteriorated and she was unable to either sit or stand without assistance and she needed assistance even for transferring position in bed. Her doctors including her primary care physician, blamed her slurred speech on a reaction between the flu vaccine and lisinopril. On an unknown date she had a computerised tomogram (CAT) scan. She underwent three blood profiles and an ultrasound. Later a friend discussed the possibility of Guillain Barre syndrome and she was taken to the emergency room for the third time in five days. A second CT scan was done in the third emergency room visit and a small stroke was found on the right side of her brain. Only after the stroke was found, the patient was told that the initial CAT scan would only detect a brain bleed and that it would take 24 hours for evidence of a small stroke to be present in the scan. The patient was hospitalized In Oct 2014 for 8 days. The outcome of events was unknown. The events were reported as serious. The reporter did not believe that these events were coincidental. No further information was provided. Upon follow-up from QA, it was confirmed that the reported batch number 1141501 is incorrect and QA investigation will be performed with batch number 1411501. Follow-up information received from the Quality Assurance Department (reference number: 350991) on 10 Feb 2015: Updated QA comments and QA reference number.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Dysarthria, Dysstasia, General physical health deterioration, Mobility decreased, Ultrasound scan
Clinical narrative: Case number PHHY2015US013452 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 550393) on 03 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 350991) on 10 Feb 2015. This report refers to an 85 years old female patient. Her current condition included increased blood pressure. Her concomitant medications were lisinopril for blood pressure, metoprolol and alprazolam. She could walk with cane and could drive when she went for vaccination. She was vaccinated with FLUVIRIN (batch number: 1411501) in the left arm on 22 Oct 2014. On the same day after vaccination, she experienced slurred speech. She became progressively weaker over the past five days in Oct 2014 and her health deteriorated and she was unable to either sit or stand without assistance and she needed assistance even for transferring position in bed. Her doctors including her primary care physician, blamed her slurred speech on a reaction between the flu vaccine and lisinopril. On an unknown date she had a computerised tomogram (CAT) scan. She underwent three blood profiles and an ultrasound. Later a friend discussed the possibility of Guillain Barre syndrome and she was taken to the emergency room for the third time in five days. A second CT scan was done in the third emergency room visit and a small stroke was found on the right side of her brain. Only after the stroke was found, the patient was told that the initial CAT scan would only detect a brain bleed and that it would take 24 hours for evidence of a small stroke to be present in the scan. The patient was hospitalized In Oct 2014 for 8 days. The outcome of events was unknown. The events were reported as serious. The reporter did not believe that these events were coincidental. No further information was provided. Upon follow-up from QA, it was confirmed that the reported batch number 1141501 is incorrect and QA investigation will be performed with batch number 1411501. Follow-up information received from the Quality Assurance Department (reference number: 350991) on 10 Feb 2015: Updated QA comments and QA reference number.
Age: 20.0
Sex: M
Vaccine: ANTH, FLU3, SMALL, TYP, ANTH, FLU3, SMALL, TYP
Symptoms: Blood bilirubin increased, Pruritus, Rash generalised
Clinical narrative: Case number PHHY2015US013967 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551068) on 03 Feb 2015, with the follow-up information received from Quality Assurance Department on 11 Feb 2015. This report refers to a 20 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown), BIOTHRAX (other manufacturer, batch number: FAV387A), ACAM2000 (other manufacturer, batch number: VVD4-003A) and TYPHIM VI (other manufacturer, batch number: J1629); all vaccines administered on 26 Sep 2014. On 09 Oct 2014, he experienced rash which began in legs. Rash spread to rest of the body including face and hands. He also had pruritus and he was afebrile. There was mild increase of bilirubin to 1.4 (units and normal values were not reported). He was hospitalized for 2 days and was treated with BENADRYL. The outcome of event reported as complete recovery. The event was reported as serious. The causality of the events was not reported. Upon follow-up from QA, it was confirmed that the provided batch number T58B05 for this case is not a valid FLUVIRIN batch number. Therefore no QA investigation will be performed. Follow-up information received from the Quality Assurance Department on 11 Feb 2015: Updated QA comments.
Age: 33.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Myelitis transverse
Clinical narrative: Case number PHHY2015US013914 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 552030) on 03 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 351134) on 11 Feb 2015. This report refers to a 33 years old female patient. She denied allergies. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 14581) intramuscularly in the left arm and ADACEL (other manufacturer, batch number: C4332BA); both vaccines administered on 16 Oct 2014. On 25 Oct 2014, she experienced transverse myelitis. She went to the emergency room and was hospitalized due to the event for 10 days. The outcome of event was not reported. The event was reported as serious. The causality of the events was not reported. Upon follow-up from QA, it was confirmed that the reported batch number 14581 is incorrect and QA the investigation will be performed with batch number 14581P. Follow-up information received from the Quality Assurance Department (reference number: 351134) on 11 Feb 2015: Updated QA comments and QA reference number.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Retinal exudates, Vision blurred
Clinical narrative: Case number PHHY2015US013903, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553794) website on 03 Feb 2015, with the follow-up information received from Quality Assurance Department on 11 Feb 2015. This report refers to an 18 year old male patient. Medical history and concomitant medication was not reported. On 10 Oct 2014, he was vaccinated with FLUVIRIN (batch number: unknown) intramuscular. On 17 Oct 2014 one week after vaccination, he developed blurry vision in left eye. He went to the emergency room. He was diagnosed with Multiple Evanescent White Dot Syndrome (MEWDS) by retinal specialist. Final outcome of the events was condition unchanged. Causality assessment was not reported. Events were reported as serious (permanent disability). Upon follow-up from QA, it was confirmed that the provided batch number 66521011710 for this case is not a valid FLUVIRIN batch number. Therefore no QA investigation will be performed. Follow-up information received from the Quality Assurance Department on 11 Feb 2015: Updated QA comments.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site atrophy, Injection site discolouration, X-ray
Clinical narrative: Atrophy/ tissue loss at site of injection and discoloration.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Joint injury, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Severe pain deep where shot was given. Ended up going to drs a week later dx with tendonitis, later ended up with bursitis, given antibotic for infection due to site being hot and fever, later referred to Ortho and given cortisone, did not work, severe pain in arm 3 months later, surgery to determine inflammatory and tendinopathy issues seen on MRI.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Bursitis, Inflammation, Injection site infection, Injection site pain, Injection site warmth
Clinical narrative: Severe pain deep where shot was given. Ended up going to drs a week later dx with tendonitis, later ended up with bursitis, given antibotic for infection due to site being hot and fever, later referred to Ortho and given cortisone, did not work, severe pain in arm 3 months later, surgery to determine inflammatory and tendinopathy issues seen on MRI.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Pyrexia, Surgery, Tendonitis
Clinical narrative: Severe pain deep where shot was given. Ended up going to drs a week later dx with tendonitis, later ended up with bursitis, given antibotic for infection due to site being hot and fever, later referred to Ortho and given cortisone, did not work, severe pain in arm 3 months later, surgery to determine inflammatory and tendinopathy issues seen on MRI.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Severe pain deep where shot was given. Ended up going to drs a week later dx with tendonitis, later ended up with bursitis, given antibotic for infection due to site being hot and fever, later referred to Ortho and given cortisone, did not work, severe pain in arm 3 months later, surgery to determine inflammatory and tendinopathy issues seen on MRI.
Age: 48.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Injection site pain, Joint injury, Nuclear magnetic resonance imaging abnormal, Vaccination complication
Clinical narrative: Severe pain deep where shot was given. Ended up going to drs a week later dx with tendonitis, later ended up with bursitis, given antibotic for infection due to site being hot and fever, later referred to Ortho and given cortisone, did not work, severe pain in arm 3 months later, surgery to determine inflammatory and tendinopathy issues seen on MRI.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 9 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with the third dose of GARDASIL 1 single shot (dose, frequency, lot/batch number and expiration date were not reported). On 02-FEB-2015, the patient experienced blurred vision after receiving the third dose of GARDASIL. No treatment was given for the event. The patient sought medical attention by visiting the office (date unspecified). It was reported that the patient did not experience any adverse effects after receiving the first dose and the second dose of GARDASIL (dates of vaccinations were not reported). The outcome of blurred vision was reported as recovering/resolving. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Catheter placement, Pain, Ulcer
Clinical narrative: Information has been received from a consumer via a company representative concerning her niece of unknown age. On an unspecified date, the patient received GARDASIL (dose, frequency, route and lot# were not reported) and experienced minor ulcers on an unknown date in an unspecified location. On an unknown date, the patient received with the third dose of GARDASIL (lot#, dose/frequency and route unknown). After vaccination, the patient experienced severe pain and to see the doctor. The pain was so much that she had to be prescribed unspecified steroids and needed to be catheterized. On an unknown date, the patient was hospitalized at an unknown hospital for an unknown amount of days. At the time of reporting, the outcome of severe pain and minor ulcers was unknown. The relationship between severe pain and minor ulcer and GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Adverse event, Chemotherapy
Clinical narrative: Information has been received from an unknown age licensed practical nurse via field representative referring to herself. There was no information about the nurse's medical history. On an unknown date, when the nurse was a child, she received M-M-R II injection, (lot number, expiry date, route and dose were not reported). On an unknown date after she received M-M-R II, the nurse was treated with chemotherapy for an unspecified condition. Subsequently, on an unknown date, the nurse was fully recovered. Upon internal review, the nurse was treated with chemotherapy for an unspecified condition was considered to be medically significant. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: Individual received MMR shot. Individual stated then the next few days started in with itchy rash.
Age: 43.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Ear pruritus, Injection site pruritus, Injection site urticaria, Pyrexia
Clinical narrative: Individuals reported hives at the injection site. Fever. Itchy spot on right shoulder and right ear.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient woke up, removed bandaid from left deltoid, noticed injection site was warm to touch and tender. By 15Feb2015, site's tenderness had increased and developed a hardened ball like feeling at injection site. Patient reported to urgent care center on 15Feb2015, was prescribed Prednislone, Cephalexin 500mg every 12hr for 5days.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt c/o itching, swelling of injection site, redness, hardness, and uncomfortable pain that started on Feb 10th and has persisted to present day.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose normal, Computerised tomogram head normal, Computerised tomogram normal, Fall, Feeling abnormal
Clinical narrative: Patient had brief loss of consciousness with loss of bladder control. She fell and hit head on door. She was dazed and not answering questions immediately after event. 15 minutes after event she was alert, interactive, oriented.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Patient had brief loss of consciousness with loss of bladder control. She fell and hit head on door. She was dazed and not answering questions immediately after event. 15 minutes after event she was alert, interactive, oriented.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis, Herpes zoster, Nerve injury, Pain, Rash
Clinical narrative: Shingles and shingles rash and pain.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Burning sensation, Dilated pores, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Sore, painful arm, c/o burning, pins and needles sensation to bilateral face, almost like a sensation of a rug burn. Client observed pores on face enlarge, which after this subsided she c/o her cheek muscles being very sore.  This episode lasted approximately 30-45 minutes.  Client took Tylenol mid way through this episode. Nest day, no residual side effects noted to face, still has extremely sore arm. Only received the Adult Hep. A vaccine.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Flushing, Generalised erythema, Vomiting
Clinical narrative: This spontaneous report was received from a physician refers to a 4 year old male patient without pertinent medical history and allergy to unspecified flu vaccine. Concurrent conditions were not reported. On 06-FEB-2015, the patient was vaccinated with a dose of PROQUAD (Merck), (strength, dose, frequency and anatomical location were not reported), intramuscular, (lot # K008868; expiration date: December 2015). Concomitant therapies included SYNTHROID, baclofen, KEPPRA, clonidine, unspecified growth hormone injection and PREVACID. The reporter indicated that 5 minutes after receiving PROQUAD (Merck), the patient developed a full body erythematous reaction which was described as "he was completely flushed from head to toe" and severe vomiting. The reporter stated that they gave to the patient BENADRYL as treatment while the patient was in their office, and then the patient was sent to emergency room for further medical attention. It was reported that the patient received SOLU-MEDROL and unspecified intravenous (IV) antihistamines in the emergency room. The patient was sent home later that day. Lab diagnostics studies were not performed. The physician reported that in the acute phase the events were life threatening and the patient was followed up a couple of days afterwards and the patient was completely recovered. The outcome of full body erythematous reaction and severe vomiting was reported as recovered/resolved on an unknown date in February 2015. The relatedness between full body erythematous reaction and severe vomiting and therapy with PROQUAD (Merck) was not reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pruritus
Clinical narrative: Itch in vicinity of shot but did not pay to much attention until I removed my shirt and noticed the rash approximately 10 cm in diameter.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Arthritis, Chills, Headache, Inflammation, Influenza virus test negative
Clinical narrative: Chills, body aches, headache, fever, arthritis inflammation.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Chills, body aches, headache, fever, arthritis inflammation.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylatic reaction. Epipen, Benadryl and steroids. Pt was admitted to the hospital.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphasia, Blood test, Lip swelling, Pruritus generalised, Swollen tongue
Clinical narrative: Anaphylatic reaction. Epipen, Benadryl and steroids. Pt was admitted to the hospital.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Throat tightness
Clinical narrative: Anaphylatic reaction. Epipen, Benadryl and steroids. Pt was admitted to the hospital.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal discomfort, Arthralgia, Joint swelling, Liver function test, Rash
Clinical narrative: Swelling of ankles, joint pain and a rash developed. The rash spread each day for another two weeks. Joint pain and swelling went away after 2-3 days. Mild stomach discomfort that lasted a couple of weeks.