chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent conditions, pertinent medical history and drug allergies of the patient were not reported. On an unknown date in March 2015, the patient was vaccinated with first dose of GARDASIL 9 (lot, expiry date, dose units, route and anatomical location were not specified). On 21-DEC-2015 the patient was vaccinated with second dose of GARDASIL 9 (lot, expiry date, dose units. route and anatomical location were not specified). No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60-year-old female patient. The patient's medical history was not reported. On 07-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose and site of administration were not reported) and it might be administered intramuscularly instead of subcutaneously. On 08-APR-2016, the patient experienced redness, swelling and welt that localized at the injection site. The patient sought medical attention and came in to the pharmacy. No treatment was given for the adverse events. The outcome of redness, swelling and welt that localized at the injection site was reported as recovering/resolving. The relatedness between redness, swelling and welt that localized at the injection site and ZOSTAVAX was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister
Clinical narrative: Blister above injection site. Dr gave her a Rx for VALTREX 1 gm tid x 10 day.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Blister above injection site. Dr gave her a Rx for VALTREX 1 gm tid x 10 day.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Polymerase chain reaction positive, Poor quality sleep, Pyrexia, Rash generalised
Clinical narrative: Generalized varicella-form rash. 40-50 lesions at 24 hours of symptoms. Fussy poor sleep restless on day 9 s/p vaccine, low grade temp on day 6 s/p vaccine.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash vesicular, Restlessness, Skin lesion, Varicella virus test positive
Clinical narrative: Generalized varicella-form rash. 40-50 lesions at 24 hours of symptoms. Fussy poor sleep restless on day 9 s/p vaccine, low grade temp on day 6 s/p vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Infection, Inflammation, Swelling
Clinical narrative: Infection inflammation - cellulitis. Treated with Clindamycin. Contacted pt - arm is healing - swelling going down.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 61 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Pt. has redness on half the arm. Slightly warm to touch. Vaccine administered 6 days ago.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cough, Crying, Decreased appetite, Erythema, Poor quality sleep
Clinical narrative: Dtap left thigh and PREVNAR (PCV13) left thigh given at approximately 4:56 pm on 3-30-16. At approximately 8 pm he developed red dots and patches on his face. At 11 pm he started crying inconsolably. Slept fretfully that night. No f. Hives, red patches on his body that came and went on entire body developed on 3/31/16. 3/31/16 mom called advice nurse. Pt had loss of appetite of 3/31/16 but was otherwise. Had a slight cough but very happy. 4/1/16 Dad picked up pt. Pt did not go to day care. Pt was acting ok but very red hives that came and go. Hives gone 4-5-16.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Dtap left thigh and PREVNAR (PCV13) left thigh given at approximately 4:56 pm on 3-30-16. At approximately 8 pm he developed red dots and patches on his face. At 11 pm he started crying inconsolably. Slept fretfully that night. No f. Hives, red patches on his body that came and went on entire body developed on 3/31/16. 3/31/16 mom called advice nurse. Pt had loss of appetite of 3/31/16 but was otherwise. Had a slight cough but very happy. 4/1/16 Dad picked up pt. Pt did not go to day care. Pt was acting ok but very red hives that came and go. Hives gone 4-5-16.
Age: 65.0
Sex: F
Vaccine: VARZOS, FLUX
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a 65 year old female consumer referring to herself with chronic pain and was allergic to unspecified influenza vaccine. On 10-NOV-2015 the patient was vaccinated with a dose of ZOSTAVAX, (dose, lot# and expiration date were unknown, subcutaneous). Concomitant therapies included unspecified mild opiate. On 11-NOV-2015 the patient experienced injection site reactions included swelling and slight pain. It took about 1 week for the swelling to disappear (on 18-NOV-2015). Soon after the swelling went away the patient developed injection site itchiness (in November 2015). It took another 3 weeks for the injection site to stop itching (in December 2015). On an unknown date the patient recovered from injection site pain. No lab diagnostics studies were performed. The patient spoke with physician for medical attention. Additional information is not expected as we have no consent to contact the physician.
Age: 65.0
Sex: F
Vaccine: VARZOS, FLUX
Symptoms: Allergy to vaccine, Pain
Clinical narrative: Information has been received from a 65 year old female consumer referring to herself with chronic pain and was allergic to unspecified influenza vaccine. On 10-NOV-2015 the patient was vaccinated with a dose of ZOSTAVAX, (dose, lot# and expiration date were unknown, subcutaneous). Concomitant therapies included unspecified mild opiate. On 11-NOV-2015 the patient experienced injection site reactions included swelling and slight pain. It took about 1 week for the swelling to disappear (on 18-NOV-2015). Soon after the swelling went away the patient developed injection site itchiness (in November 2015). It took another 3 weeks for the injection site to stop itching (in December 2015). On an unknown date the patient recovered from injection site pain. No lab diagnostics studies were performed. The patient spoke with physician for medical attention. Additional information is not expected as we have no consent to contact the physician.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 60 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 53 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 62 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 64 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not provided. It was reported that on 29-OCT-2015, the patient was administered (Merck) VARIVAX (lot # K011082, expiration date: 08-AUG-2016, dose and route were not provided), that was improperly stored (temperature: 24.3 F, time frame: 57 hours; there was no previous temperature excursion). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 61 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 62 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 60 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No previous quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not provided. It was reported that on 04-DEC-2015, the patient was administered (Oka/Merck) VARIVAX (lot # K011082, expiration date: 08-AUG-2016, dose and route were not provided), that was improperly stored (temperature: 24.3 F, time frame: 57 hours; there was no previous temperature excursion). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 60 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L027322, expiry date unspecified (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX was involved in temperature incident. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not provided. It was reported that on 30-DEC-2015, the patient was administered VARIVAX (Merck) (lot # K011082, expiration date: 08-AUG-2016, dose and route were not provided), that was improperly stored (temperature: 24.3 F, time frame: 57 hours; there was no previous temperature excursion). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not provided. It was reported that on 15-DEC-2015, the patient was administered VARIVAX (Merck) (lot # K011082, expiration date: 08-AUG-2016, dose and route were not provided), that was improperly stored (temperature: 24.3 F, time frame: 57 hours; there was no previous temperature excursion). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 63 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L027322, expiry date unspecified (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX was involved in temperature incident. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to his son of unknown age. The patient's medical history and concurrent conditions were not provided. On 05-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (route, lot# and expiration date were not reported), and on 30-AUG-2014 the patient received the second dose of GARDASIL (route, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaints was not involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Red, warm and itchy.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Erythema multiforme, Local swelling, Pruritus, Urticaria
Clinical narrative: Slightly raised area on left deltoid. No increase in warmth. No drainage. 4 cm x 2 cm erythematic. Instructed to take diphenhydramine orally and hydrocortisone cream topically. Ice. Erythema multiform and urticaria pruritus.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. The pharmacist reported that physician's are writing a lots of prescriptions for less than 50 years of age clients to be vaccinated with ZOSTAVAX (dosing details were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Pt here for 12 mo check up received VARIVAX in (L) thigh large hive developed immed at insertion site, 2 hives on chest no resp s/sx BENADRYL given with improve on hives.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and mild swelling on inj. site.
Age: 86.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash, redness, swelling at site of injection (ZOSTAVAX).
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Rash, redness at site of injection also rash on neck.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not provided. "About three years ago" in approximately 2013, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot # not provided). No information was provided regarding first dose in the series. The nurse practitioner stated that at the time of the report on 07-APR-2016, the patient was in the office to receive the third dose in the series. It was reported that the patient would be administered GARDASIL 9 (dose, route and lot # not provided). Concomitant therapies were not provided. No adverse effects were reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness on (L) arm, mild redness and swelling at 80 cm.
Age: 15.0
Sex: F
Vaccine: HEPA, TYP, VARCEL
Symptoms: Cellulitis, Erythema, Oedema, Papule, Skin warm
Clinical narrative: Varicella received 4/5/17. Area has erythema and edema approx. 10 cm in diameter with few papules at touch. Warm to touch and slightly tender. Reaction vs cellulitis ?
Age: 15.0
Sex: F
Vaccine: HEPA, TYP, VARCEL
Symptoms: Tenderness, Vaccination complication
Clinical narrative: Varicella received 4/5/17. Area has erythema and edema approx. 10 cm in diameter with few papules at touch. Warm to touch and slightly tender. Reaction vs cellulitis ?
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: Influenza, Myalgia, Pain, Pneumonia, Tremor
Clinical narrative: Service number received the 2nd dose of MMR. About 3-4 weeks later started to experience tremors, muscle aches, pain and became shaky. Also noticed a rash in groin area. Went to the doctor but not able to determine if symptoms are due to vaccine. Recently diagnosed with influenza and pneumonia.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning multiple unspecified patients of unknown age and gender. On unspecified dates, the patients received doses of ZOSTAVAX (dosage and route not reported, lot # K016318 with expire date of 24-DEC-2015) that was improperly stored. The conditions storage was "-10 Centigrade" for 1464 hours. There was previous intermittent temperature excursion over a few months. No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 62 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The dose of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 58 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 60 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 66 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Facial paralysis
Clinical narrative: This spontaneous report as received from a consumer via company representative who was also a friend of patient and refers to a female non-pregnant patient of unknown age. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9 (dose, site and route of administration, lot # and expiration date were not reported). On an unknown date in 2016 (reported as last week), the patient was diagnosed with Bell's Palsy lasting for an unspecified duration of time. The outcome of Bell's Palsy was unknown. The relatedness between adverse event and suspect therapy was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 63 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Oedema peripheral, Peripheral swelling
Clinical narrative: Significant armpit swelling on (L) side, generalized (L) upper extremity edema. Constant ache in (L) armpit area, with increased pain with palpation. Began 4-9-16, increased symptoms at time of report, swelling has not decreased. Symptoms continue at time of report.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Lymph node pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm is sore, swollen about 1/2 dollar size, lymph node in armpit sore,  arm puffy and itchy around swollen area as well. Pt instructed to take ibuprofen (swelling) and BENADRYL (all. rxn).
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Headache
Clinical narrative: 4/4/16 Patient received PREVNAR-13 vaccine. 4/6/16 Patient called and complained of headache and stomach cramps. 4/7/16 Patient went to MD.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Contusion, Swelling
Clinical narrative: Approximately 6 hrs after the shot, the brother states a small swelling and bruise appeared. It improved with ice. 3 days later is 80% better.
Age: 0.79
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Ran fever of 102 for 4 days after vaccine.
Age: 59.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Left shoulder swollen. 3 in circle where BOOSTRIX was administered. Swelling started Saturday 4/2/16 and has dull pain in shoulder. Upon raising arm, sharp pain down arm.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: Patient developed chills, fever 24 hours after administration. Patient went to the doctor 72 hour after administration and had a diagnosis of cellulitis - Pt received IV antibiotics for 2 consecutives.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed chills, fever 24 hours after administration. Patient went to the doctor 72 hour after administration and had a diagnosis of cellulitis - Pt received IV antibiotics for 2 consecutives.
Age: 59.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal discomfort, Bed rest, Body temperature increased, Fatigue, Injection site pain
Clinical narrative: Elevated temp (approximately 100 degrees F), upset stomach, extreme pain and stiffness at injection site, headache, fatigue, and pain and achiness all over the body. Treatment was bed rest 12-16 hrs.
Age: 59.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Musculoskeletal stiffness, Pain
Clinical narrative: Elevated temp (approximately 100 degrees F), upset stomach, extreme pain and stiffness at injection site, headache, fatigue, and pain and achiness all over the body. Treatment was bed rest 12-16 hrs.
Age: 1.56
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash to neck, face, trunk area, arms, and right thigh. No fever, no SOB, no respiratory problems reported. Pt was given BENADRYL 25 mg.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Migraine
Clinical narrative: Initial unsolicited report received from a consumer on 02 November 2015. This case involves a 41-year-old male patient, who was vaccinated with ADACEL (batch number: U4689CA) (dose, dose in series, route and site of administration were not reported) on 06 January 2015. It was reported that patient had no illness at the time of vaccination. Patient had allergies to fish, mold, pollens and dogs and medical history of hypothyroidism and depression. Concomitant medications were not reported. On 06 January 2015, same day at night following vaccination, the patient had experienced the first migraine headache and stated that the patient had daily migraine headaches since the date of vaccination. It was reported that the patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. It was reported that he saw his own physician for treatment. At the time of this report the patient was not recovered from the event. Documents held by sender: none.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Pain, Skin exfoliation, Skin reaction
Clinical narrative: Case number PHHY2016US009112, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 608414) website on 18 Jan 2016. This report refers to a 32 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) into left arm on 07 Oct 2015. On the same day after vaccination, the patient experienced localized skin reaction and sloughing pain. Five days after vaccination, the patient experienced cellulitis versus reaction. The patient visited to the emergency room. Outcome of the events was reported as complete recovery on 15 Oct 2015. Seriousness of the events was reported as non serious. Causality of the events was not reported. Seriousness assessment of cellulitis was upgraded to medically significant based on the NVS IME list. Batch review report reference number (1013303) received from quality assurance department on 07 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (not reported) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up information received from Quality assurance (QA) department on 15 Mar 2016: QA reference number (1013303) added. Following an internal review done on 23 Mar 2016, for the data received on 18 Jan 2016, following correction was done: Changed the labeling of the serious event cellulitis from listed to unlisted. Significant follow up information received from Quality assurance (QA) department on 07 Apr 2016: QA summary added.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Sepsis, Skin disorder
Clinical narrative: Case number PHHY2016US007868, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 608512) website on 18 Jan 2016. This report refers to a 55 years old female patient. Past medical history was not reported. Concomitant medications included lactulose (manufacturer unknown). She was vaccinated with FLUVIRIN (batch number: 157101) intramuscularly in right arm and ZOSTAVAX (manufacturer unknown and batch number: L021610) subcutaneously in left arm both on 03 Oct 2015. On 07 Nov 2015, the mother of patient reported that patient had big circle on arm and underneath and her physician stated that it was blood poisoning. She visited the emergency room. The outcome of the events was not reported. The seriousness of the events was reported as non serious. The causality of the events was not reported. Batch review report (reference number: 1011505) received from quality assurance department on 08 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 157101, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report received from a Quality Assurance department (QA reference number: 1011505) on 28 Jan 2016: QA reference number updated. Significant follow up report received from a Quality Assurance Department (QA) on 08 Apr 2016: Updated batch review report (conclusion added).
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Inflammation, Injected limb mobility decreased, Malaise, Vaccination site cellulitis
Clinical narrative: Case number PHHY2016US029780, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 612158) website on 29 Feb 2016. This report refers to a 65 years old female patient. Past medical history was not reported. Current condition included as diabetes. A concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) and PREVNAR 13 vaccine (other manufacture, batch number: M13067) both received on the left arm on 04 Nov 2015. On the same day after vaccination, she had a severe reaction to PREVNAR. The patient experienced cellulitis which required an antibiotic prescription and she was ill in bed for a few days. She could not move her arm for a few days and arm was still extremely red and inflamed. The patient visited to the emergency room. Outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness of the event vaccination site cellulitis was upgraded to medically significant based on the available information in the source document. Batch review report (reference number [1013018] received from quality assurance department on [04 Apr 2016]: Based on the document review, it was stated that the concerned [FLUVIRIN] batch number [1516501] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report from the QA department (QA reference number: 1013018) received on 08 Mar 2016: Updated QA reference number only. Follow up report from the QA department received on 04 Apr 2016. QA summary report was added.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Cellulitis, Chills, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2016US028392, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 615885) on 29 Feb 2016. This report refers to a 31 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1517401) and PNEUMOVAX (other manufacturer, batch number: L014876) into the right arm on 10 Dec 2015. After vaccination, on the same day, she required emergency care, got fever, chills and extreme pain in her arm that ultimately prompted her to go to an emergency room. She was treated symptomatically and was sent home. She went to the local urgent care the following day because symptoms escalated and her arm became more swollen. At this point she was diagnosed with a bacterial infection with cellulitis and she was treated with antibiotics (unspecified). Laboratory data revealed that ultrasound of her arm and relative bolls work was done on an unknown date (results unspecified). 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. The seriousness assessment of the event cellulitis was upgraded based on Novartis Important Medical Events list. The seriousness assessment of the events peripheral swelling, pyrexia, chills and pain in extremity were upgraded (medically significant) based on the information available in the source document. Batch review report (reference number [1013021] received from quality assurance department on 07 Apr 2016: Based on the document review, it was stated that the concerned [FLUVIRIN] batch number [1517401] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report received from a Quality Assurance department (QA reference number: 1013021) on 08 Mar 2016: QA reference number updated. Significant follow up report received from a Quality Assurance department (QA reference number: 1013021) on 07 Apr 2016: Added batch review report.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Ultrasound scan
Clinical narrative: Case number PHHY2016US028392, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 615885) on 29 Feb 2016. This report refers to a 31 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1517401) and PNEUMOVAX (other manufacturer, batch number: L014876) into the right arm on 10 Dec 2015. After vaccination, on the same day, she required emergency care, got fever, chills and extreme pain in her arm that ultimately prompted her to go to an emergency room. She was treated symptomatically and was sent home. She went to the local urgent care the following day because symptoms escalated and her arm became more swollen. At this point she was diagnosed with a bacterial infection with cellulitis and she was treated with antibiotics (unspecified). Laboratory data revealed that ultrasound of her arm and relative bolls work was done on an unknown date (results unspecified). 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. The seriousness assessment of the event cellulitis was upgraded based on Novartis Important Medical Events list. The seriousness assessment of the events peripheral swelling, pyrexia, chills and pain in extremity were upgraded (medically significant) based on the information available in the source document. Batch review report (reference number [1013021] received from quality assurance department on 07 Apr 2016: Based on the document review, it was stated that the concerned [FLUVIRIN] batch number [1517401] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report received from a Quality Assurance department (QA reference number: 1013021) on 08 Mar 2016: QA reference number updated. Significant follow up report received from a Quality Assurance department (QA reference number: 1013021) on 07 Apr 2016: Added batch review report.
Age: 51.0
Sex: F
Vaccine: FLUC3, TDAP, FLUC3, TDAP
Symptoms: Dizziness, Injected limb mobility decreased, Injection site pain, Neck pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Case number PHHY2016US042371, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622726) website on 29 Mar 2016. This report refers to a 51-year-old female patient. Past medical history included anxiety disorder, mild herniated disc lower back and kidney cysts. Current conditions included cavernous malformations of the brain, left carotid aneurysm, mitral valve prolapse mild, allergies to codeine and contrast dye to computer tomography (CT). Concomitant medications included LEXAPRO and clonazepam. The patient was vaccinated with FLUCELVAX (batch number: 62577 0614 01) intramuscularly in right arm along with ADACEL (batch number: 49281 0400 15) intramuscularly in left arm, both on 01 Nov 2015. On 02 Nov 2015, the patient experienced sore upper right arm (reported as more than previous shot) and sore right  shoulder which progressively got worse with range of motion limited, painful to move arm at different angles, especially upwards and lifting things that were not very heavy at different angles, at night arm throbbed and the shoulder pain was felt on the right side of neck, very faint and lightheaded. Laboratory data included right shoulder magnetic resonance imaging indication tendinosis and bursal surface fraying of the supraspinatus tendon. The outcome of the events was reported as condition unchanged. The seriousness of the events were reported as non serious. The causality of the events was not reported. Seriousness assessment of the events injected limb mobility decreased, pain in extremity, pain, dizziness, neck pain, musculoskeletal pain, syncope and tendon disorder were upgraded based on the information available in the source documents. Upon follow up from quality assurance department, it was confirmed that, the reported batch number (62577 0614 01) was not a valid batch number for FLUCELVAX. Hence, standard QA investigation could not be performed and no further action would be taken. Follow up report received from Quality assurance department on 11 Apr 2016: Updated QA comments.
Age: 51.0
Sex: F
Vaccine: FLUC3, TDAP, FLUC3, TDAP
Symptoms: Pain, Tendon disorder
Clinical narrative: Case number PHHY2016US042371, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622726) website on 29 Mar 2016. This report refers to a 51-year-old female patient. Past medical history included anxiety disorder, mild herniated disc lower back and kidney cysts. Current conditions included cavernous malformations of the brain, left carotid aneurysm, mitral valve prolapse mild, allergies to codeine and contrast dye to computer tomography (CT). Concomitant medications included LEXAPRO and clonazepam. The patient was vaccinated with FLUCELVAX (batch number: 62577 0614 01) intramuscularly in right arm along with ADACEL (batch number: 49281 0400 15) intramuscularly in left arm, both on 01 Nov 2015. On 02 Nov 2015, the patient experienced sore upper right arm (reported as more than previous shot) and sore right  shoulder which progressively got worse with range of motion limited, painful to move arm at different angles, especially upwards and lifting things that were not very heavy at different angles, at night arm throbbed and the shoulder pain was felt on the right side of neck, very faint and lightheaded. Laboratory data included right shoulder magnetic resonance imaging indication tendinosis and bursal surface fraying of the supraspinatus tendon. The outcome of the events was reported as condition unchanged. The seriousness of the events were reported as non serious. The causality of the events was not reported. Seriousness assessment of the events injected limb mobility decreased, pain in extremity, pain, dizziness, neck pain, musculoskeletal pain, syncope and tendon disorder were upgraded based on the information available in the source documents. Upon follow up from quality assurance department, it was confirmed that, the reported batch number (62577 0614 01) was not a valid batch number for FLUCELVAX. Hence, standard QA investigation could not be performed and no further action would be taken. Follow up report received from Quality assurance department on 11 Apr 2016: Updated QA comments.