chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 26-NOV-2014 the patient was inadvertently vaccinated with an expired dose of VAQTA (0.5 ml, intramuscular, lot # 0271AE, expiration date 20-NOV-2014). No adverse effects reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient with allergy to penicillin. On 24-NOV-2014 (also reported as Monday) the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not reported) at her primary healthcare providers office. Concomitant medication, laboratory tests and pertinent medical history was not specified by reporter. The pharmacist stated that the patient came into the pharmacy on approximately 26-NOV-2014 (also reported as today), stating that she was not feeling well (onset date was not specified by reporter), approximately in November 2014. The pharmacist also stated that the patient had a prescription for CIPRO and wondered if that would not interfere with her ZOSTAVAX vaccination. The outcome of not feeling well was reported as not recovered. The relatedness between ZOSTAVAX and adverse event was unknown. Additional information is not expected, because the reporter didn't wish to be contacted.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles after ZOSTAVAX.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Flank pain, Herpes zoster, Rash
Clinical narrative: Patient developed shingles after ZOSTAVAX.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site irritation, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 25 year old female patient. Current condition was reported as Crohn's disease. Patient had no known allergies. On 01-NOV-2014 the patient was vaccinated with GARDASIL, 0.5 ml (lot # and expiration date not reported), subcutaneously in the right arm instead of intramuscularly. No concomitant therapy was reported. On 25-NOV-2014 (reported as last week) the patient visited pharmacy and complained of skin irritation and bump at the injection site of right arm. No treatment was given for the adverse event. On an unknown reporting pharmacist stated that the patient was referred to her primary physician for follow-up. No product quality complaint (PQC) was reported. Outcome of the events were not reported. Causality assessment was not provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26 year old female patient. No medical history or drug allergies were reported. On unknown dates (also reported as at an unspecified time in the past) the patient received two doses of (Oka/Merck) VARIVAX 1350 U (dose, route of administration, lot number and expiration date were not reported). On unknown dates (also reported as in the past, prior to the titers being drawn) the patient received two MMR II (dose, route of administration, lot number and expiration date were not reported). None concomitant medication was reported. On an unknown date approximately in 2014 (also reported as earlier this year) the patient had blood tests which showed negative titers for varicella, measles, rubella and mumps. On 07-NOV-2014 the patient was diagnosed with varicella (chickenpox). The patient sought medical attention by an office visit, but it was unspecified whether any treatment was given for adverse events. The outcome of adverse events was reported as not recovered. The relatedness between (Oka/Merck) VARIVAX, MMR II and adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral titre
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26 year old female patient. No medical history or drug allergies were reported. On unknown dates (also reported as at an unspecified time in the past) the patient received two doses of (Oka/Merck) VARIVAX 1350 U (dose, route of administration, lot number and expiration date were not reported). On unknown dates (also reported as in the past, prior to the titers being drawn) the patient received two MMR II (dose, route of administration, lot number and expiration date were not reported). None concomitant medication was reported. On an unknown date approximately in 2014 (also reported as earlier this year) the patient had blood tests which showed negative titers for varicella, measles, rubella and mumps. On 07-NOV-2014 the patient was diagnosed with varicella (chickenpox). The patient sought medical attention by an office visit, but it was unspecified whether any treatment was given for adverse events. The outcome of adverse events was reported as not recovered. The relatedness between (Oka/Merck) VARIVAX, MMR II and adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Rash macular
Clinical narrative: Patient had red blotches on face about 5 min after receiving vaccines. She was brought into a room with a provider to be looked at and BENADRYL given. She was observed for 30 mins at which time the redness had gone and she was allowed to leave with parents.
Age: 48.0
Sex: F
Vaccine: FLUN4, HEP, HEPA, TDAP
Symptoms: Arthralgia, Injection site bruising, Injection site erythema, Injection site reaction, Malaise
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 48 year old female patient. No medical history was reported. On 12-NOV-2014 the patient was vaccinated with RECOMBIVAX HB in the left deltoid (strength, dose, frequency). Other suspect therapies included HAVRIX given on left arm, TDAP and FLUMIST given on right arm. On 13-NOV-2014, the patient complained of body aches and general malaise. On 14-NOV-2014 the patient experienced fever of 101.4 F, and brushing at site of injection with continuing aches. The fever had subsided. Patient sought medical attention-she was seen in the physician's office on 17-NOV-2014 and complained of shoulder/joint pain in the shoulder region, redness with petechiae around and below the injection site, which was going toward the inner arm. The arm was not edematous or hot to the touch. No treatment was provided for the events. The outcome of fever was reported as 'subsided' (recovering), while patient had not recovered from the other events. The reporter did not provided the causality between the events and the suspect therapy. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLUN4, HEP, HEPA, TDAP
Symptoms: Musculoskeletal pain, Pain, Petechiae, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 48 year old female patient. No medical history was reported. On 12-NOV-2014 the patient was vaccinated with RECOMBIVAX HB in the left deltoid (strength, dose, frequency). Other suspect therapies included HAVRIX given on left arm, TDAP and FLUMIST given on right arm. On 13-NOV-2014, the patient complained of body aches and general malaise. On 14-NOV-2014 the patient experienced fever of 101.4 F, and brushing at site of injection with continuing aches. The fever had subsided. Patient sought medical attention-she was seen in the physician's office on 17-NOV-2014 and complained of shoulder/joint pain in the shoulder region, redness with petechiae around and below the injection site, which was going toward the inner arm. The arm was not edematous or hot to the touch. No treatment was provided for the events. The outcome of fever was reported as 'subsided' (recovering), while patient had not recovered from the other events. The reporter did not provided the causality between the events and the suspect therapy. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Paraesthesia
Clinical narrative: This spontaneous report as received from a 50 year old male Certified Registered Nurse Anesthetist refers to himself. The patient's medical history and past drug history were unknown. On 23-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). Concomitant medications were unknown. On an unknown date in 2014, after receiving the ZOSTAVAX, the patient experienced tingling in his nose as well as ophthalmic dermatome ("nasociliary tract"). On 01-NOV-2014 the patient was at an Urgent Care Center awaiting treatment or evaluation for an unknown reason. The patient asked what the incidence of infection was after receiving the vaccination. As of 01-NOV-2014 it was unknown if the patient continued to take ZOSTAVAX and the outcome of the tingling in his nose and ophthalmic dermatome ("nasociliary tract") was unknown. Additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown date in July 2014, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female twin of unknown age. On 20-OCT-2014 the patient was vaccinated with doses of PEDVAXHIB (strength, dose, route and lot # not reported) and RECOMBIVAX HB (strength, dose, route and lot # not reported) that were exposed to temperatures outside of the proper storage range. No adverse effect reported. This is one of the 2 reports regarding the twins. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a 58 year old female patient refers to herself. The patient's current condition included migraine headaches. The patient thought she had a prior case of shingles in 2006. On 02-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date were unknown, dose 1 injection, therapy route was reported as injection). Concomitant therapies included tramadol hydrochloride, ZOPITAN and Flu shot (unspecified brand name). On 09-OCT-2014 the patient had been experiencing an extreme painful, itch on the back side of her arm where she received her ZOSTAVAX injection. When the patient scratched this area it turned a fiery red. On 03-NOV-2014, the patient looked at the affected area she saw "raised bumps" and the area look bruised. The patient had been experiencing an itching sensation for the last three weeks in October 2014 (unspecified dates) and the area affected seems to be spreading and her symptoms did not seem to be subsiding. BENADRYL tablets and cream, alcohol and hydrocortisone were given for the adverse events by self administration. The patient did not seek for medical attention. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Joint swelling, Pruritus generalised
Clinical narrative: Pt reports body itching (no rash) and swelling of (R) elbow.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Activated partial thromboplastin time, Arthralgia, Aspartate aminotransferase increased, Blood albumin decreased, Blood bilirubin increased
Clinical narrative: This solicited case was received from the investigator of a trial on 19 November 2014. A 19-year-old male subject with no reported medical history had received the following vaccines on 11 June 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 21 June 2014, i.e. 11 days post vaccination, the subject was found with non-specific myopericarditis. Results of complementary investigations performed on 21 June 2014 were provided: ECG showed abnormal results (no details provided), electrocardiogram showed normal results; highest value of troponin I recorded was 23.12 ng/mL. MRI (brain, spinal cord, heart) and lumbar puncture were not performed. On 30 June 2014, the subject was diagnosed with acute pericarditis, unspecified. Outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Blood calcium decreased, Blood creatine phosphokinase MB increased, Blood glucose normal, C-reactive protein increased, Chest X-ray normal
Clinical narrative: This solicited case was received from the investigator of a trial on 19 November 2014. A 19-year-old male subject with no reported medical history had received the following vaccines on 11 June 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 21 June 2014, i.e. 11 days post vaccination, the subject was found with non-specific myopericarditis. Results of complementary investigations performed on 21 June 2014 were provided: ECG showed abnormal results (no details provided), electrocardiogram showed normal results; highest value of troponin I recorded was 23.12 ng/mL. MRI (brain, spinal cord, heart) and lumbar puncture were not performed. On 30 June 2014, the subject was diagnosed with acute pericarditis, unspecified. Outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Dyspnoea exertional, Echocardiogram abnormal
Clinical narrative: This solicited case was received from the investigator of a trial on 19 November 2014. A 19-year-old male subject with no reported medical history had received the following vaccines on 11 June 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 21 June 2014, i.e. 11 days post vaccination, the subject was found with non-specific myopericarditis. Results of complementary investigations performed on 21 June 2014 were provided: ECG showed abnormal results (no details provided), electrocardiogram showed normal results; highest value of troponin I recorded was 23.12 ng/mL. MRI (brain, spinal cord, heart) and lumbar puncture were not performed. On 30 June 2014, the subject was diagnosed with acute pericarditis, unspecified. Outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Effusion, Ejection fraction normal, Electrocardiogram ST segment elevation, Exertional headache, Full blood count normal
Clinical narrative: This solicited case was received from the investigator of a trial on 19 November 2014. A 19-year-old male subject with no reported medical history had received the following vaccines on 11 June 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 21 June 2014, i.e. 11 days post vaccination, the subject was found with non-specific myopericarditis. Results of complementary investigations performed on 21 June 2014 were provided: ECG showed abnormal results (no details provided), electrocardiogram showed normal results; highest value of troponin I recorded was 23.12 ng/mL. MRI (brain, spinal cord, heart) and lumbar puncture were not performed. On 30 June 2014, the subject was diagnosed with acute pericarditis, unspecified. Outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This solicited case was received from the investigator of a trial on 19 November 2014. A 19-year-old male subject with no reported medical history had received the following vaccines on 11 June 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 21 June 2014, i.e. 11 days post vaccination, the subject was found with non-specific myopericarditis. Results of complementary investigations performed on 21 June 2014 were provided: ECG showed abnormal results (no details provided), electrocardiogram showed normal results; highest value of troponin I recorded was 23.12 ng/mL. MRI (brain, spinal cord, heart) and lumbar puncture were not performed. On 30 June 2014, the subject was diagnosed with acute pericarditis, unspecified. Outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Injection site swelling, Liver function test normal, Lymph node pain, Metabolic function test normal, Myalgia
Clinical narrative: This solicited case was received from the investigator of a trial on 19 November 2014. A 19-year-old male subject with no reported medical history had received the following vaccines on 11 June 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 21 June 2014, i.e. 11 days post vaccination, the subject was found with non-specific myopericarditis. Results of complementary investigations performed on 21 June 2014 were provided: ECG showed abnormal results (no details provided), electrocardiogram showed normal results; highest value of troponin I recorded was 23.12 ng/mL. MRI (brain, spinal cord, heart) and lumbar puncture were not performed. On 30 June 2014, the subject was diagnosed with acute pericarditis, unspecified. Outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Myopericarditis, Nausea, Palpitations, Prothrombin time normal, Red blood cell sedimentation rate increased
Clinical narrative: This solicited case was received from the investigator of a trial on 19 November 2014. A 19-year-old male subject with no reported medical history had received the following vaccines on 11 June 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 21 June 2014, i.e. 11 days post vaccination, the subject was found with non-specific myopericarditis. Results of complementary investigations performed on 21 June 2014 were provided: ECG showed abnormal results (no details provided), electrocardiogram showed normal results; highest value of troponin I recorded was 23.12 ng/mL. MRI (brain, spinal cord, heart) and lumbar puncture were not performed. On 30 June 2014, the subject was diagnosed with acute pericarditis, unspecified. Outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Renal function test normal, Sinus arrhythmia, Sinus bradycardia, Troponin I increased, Troponin T normal
Clinical narrative: This solicited case was received from the investigator of a trial on 19 November 2014. A 19-year-old male subject with no reported medical history had received the following vaccines on 11 June 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 21 June 2014, i.e. 11 days post vaccination, the subject was found with non-specific myopericarditis. Results of complementary investigations performed on 21 June 2014 were provided: ECG showed abnormal results (no details provided), electrocardiogram showed normal results; highest value of troponin I recorded was 23.12 ng/mL. MRI (brain, spinal cord, heart) and lumbar puncture were not performed. On 30 June 2014, the subject was diagnosed with acute pericarditis, unspecified. Outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myopericarditis, Pericarditis, Troponin I increased
Clinical narrative: This solicited case was received from the investigator of a trial on 19 November 2014. A 19-year-old male subject with no reported medical history had received the following vaccines on 11 June 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 21 June 2014, i.e. 11 days post vaccination, the subject was found with non-specific myopericarditis. Results of complementary investigations performed on 21 June 2014 were provided: ECG showed abnormal results (no details provided), electrocardiogram showed normal results; highest value of troponin I recorded was 23.12 ng/mL. MRI (brain, spinal cord, heart) and lumbar puncture were not performed. On 30 June 2014, the subject was diagnosed with acute pericarditis, unspecified. Outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Convulsion, Hypotonia, Motor developmental delay, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of febrile seizure in a 9-month-old male patient who received PEDIARIX (batch number E4T92, expiry date unknown). Co-suspect products included PCV13 (batch number H06568, expiry date unknown and HIB VACCINE (batch number G1047AA, expiry date unknown). Concurrent medical conditions included hypotonia and motor developmental delay. On 6th August 2013 12:53, the patient received the 2nd dose of PEDIARIX, the 3rd dose of PCV13 and the 3rd dose of HIB VACCINE. On 7th August 2013 05:00, 1 days after receiving PEDIARIX, the patient experienced febrile seizure (serious criteria GSK medically significant). The patient was treated with ibuprofen. On an unknown date, the outcome of the febrile seizure was unknown. It was unknown if the reporter considered the febrile seizure to be related to PEDIARIX. Additional information: Patient's birth weight was 5 lbs 15 oz. The patient had no adverse events following prior vaccinations. Concomitant medication included lactulose mv. The febrile seizure occurred at home (106 Deg. F.) and lasted 10 minutes. The patient was taken to the emergency room where body temperature was measured (101.6 Deg. F) and were, according to the physician, there was an alert but the patient didn't experience seizure there. The patient drank a formula and was discharged from the emergency room with a prescription of Ibuprofen every 6-8 hours.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: This case was reported by a pharmacist and described the occurrence of febrile seizure in a 9-month-old male patient who received PEDIARIX (batch number E4T92, expiry date unknown). Co-suspect products included PCV13 (batch number H06568, expiry date unknown and HIB VACCINE (batch number G1047AA, expiry date unknown). Concurrent medical conditions included hypotonia and motor developmental delay. On 6th August 2013 12:53, the patient received the 2nd dose of PEDIARIX, the 3rd dose of PCV13 and the 3rd dose of HIB VACCINE. On 7th August 2013 05:00, 1 days after receiving PEDIARIX, the patient experienced febrile seizure (serious criteria GSK medically significant). The patient was treated with ibuprofen. On an unknown date, the outcome of the febrile seizure was unknown. It was unknown if the reporter considered the febrile seizure to be related to PEDIARIX. Additional information: Patient's birth weight was 5 lbs 15 oz. The patient had no adverse events following prior vaccinations. Concomitant medication included lactulose mv. The febrile seizure occurred at home (106 Deg. F.) and lasted 10 minutes. The patient was taken to the emergency room where body temperature was measured (101.6 Deg. F) and were, according to the physician, there was an alert but the patient didn't experience seizure there. The patient drank a formula and was discharged from the emergency room with a prescription of Ibuprofen every 6-8 hours.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Pain
Clinical narrative: L shoulder pain and limited range of motion due to pain.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: L shoulder pain and limited range of motion due to pain.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Skin infection, Skin warm, Swelling, Tenderness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On 15-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # K010646, expiration date 30-OCT-2015, 0.65 ml, subcutaneous deltoid region. On 17-NOV-2014, after she received ZOSTAVAX, her injection site began to hurt. The area became "very red" and "hard"; the patient's tricep-area also became warm and swollen. The patient filled a prescription for KEFLEX after she sought the attention of her physician. The pharmacist did not have much additional information about the patient, since the patient had not communicated with the pharmacy since she filled her prescription for KEFLEX on 17-NOV-2014. No additional information was provided. The outcome of the events was unknown. The pharmacist was requesting a lot check for ZOSTAVAX Lot # K010646 (expiration date 30-OCT-2015) because the patient and another patient experienced injection site adverse experiences after receiving this lot. The other patient's AE is reported in MARRS# 1411USA011420. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On 15-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # K010646, expiration date 30-OCT-2015, 0.65 ml, subcutaneous deltoid region. On 17-NOV-2014, after she received ZOSTAVAX, her injection site began to hurt. The area became "very red" and "hard"; the patient's tricep-area also became warm and swollen. The patient filled a prescription for KEFLEX after she sought the attention of her physician. The pharmacist did not have much additional information about the patient, since the patient had not communicated with the pharmacy since she filled her prescription for KEFLEX on 17-NOV-2014. No additional information was provided. The outcome of the events was unknown. The pharmacist was requesting a lot check for ZOSTAVAX Lot # K010646 (expiration date 30-OCT-2015) because the patient and another patient experienced injection site adverse experiences after receiving this lot. The other patient's AE is reported in MARRS# 1411USA011420. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (dose number, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. On an unknown date, 48 hours after vaccination, the patient experienced warmth, tenderness and swelling at injection site, flu like symptoms, achiness and rash. The reporter stated that the rash was not like varicella and was bubbly and streaky, almost like poison ivy. The patient sought medical attention by calling to the reporter's office. None treatment was given for the adverse events. The outcome of the events was unknown. The reporter considered rash was not due to poison ivy, but consider it to be related to ZOSTAVAX. The relatedness between the other events and ZOSTAVAX was not reported. Additional information  is not expected because the reporter refused additional contact.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (dose number, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. On an unknown date, 48 hours after vaccination, the patient experienced warmth, tenderness and swelling at injection site, flu like symptoms, achiness and rash. The reporter stated that the rash was not like varicella and was bubbly and streaky, almost like poison ivy. The patient sought medical attention by calling to the reporter's office. None treatment was given for the adverse events. The outcome of the events was unknown. The reporter considered rash was not due to poison ivy, but consider it to be related to ZOSTAVAX. The relatedness between the other events and ZOSTAVAX was not reported. Additional information  is not expected because the reporter refused additional contact.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (dose number, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. On an unknown date, 48 hours after vaccination, the patient experienced warmth, tenderness and swelling at injection site, flu like symptoms, achiness and rash. The reporter stated that the rash was not like varicella and was bubbly and streaky, almost like poison ivy. The patient sought medical attention by calling to the reporter's office. None treatment was given for the adverse events. The outcome of the events was unknown. The reporter considered rash was not due to poison ivy, but consider it to be related to ZOSTAVAX. The relatedness between the other events and ZOSTAVAX was not reported. Additional information  is not expected because the reporter refused additional contact.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (dose number, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. On an unknown date, 48 hours after vaccination, the patient experienced warmth, tenderness and swelling at injection site, flu like symptoms, achiness and rash. The reporter stated that the rash was not like varicella and was bubbly and streaky, almost like poison ivy. The patient sought medical attention by calling to the reporter's office. None treatment was given for the adverse events. The outcome of the events was unknown. The reporter considered rash was not due to poison ivy, but consider it to be related to ZOSTAVAX. The relatedness between the other events and ZOSTAVAX was not reported. Additional information  is not expected because the reporter refused additional contact.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (dose number, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. On an unknown date, 48 hours after vaccination, the patient experienced warmth, tenderness and swelling at injection site, flu like symptoms, achiness and rash. The reporter stated that the rash was not like varicella and was bubbly and streaky, almost like poison ivy. The patient sought medical attention by calling to the reporter's office. None treatment was given for the adverse events. The outcome of the events was unknown. The reporter considered rash was not due to poison ivy, but consider it to be related to ZOSTAVAX. The relatedness between the other events and ZOSTAVAX was not reported. Additional information  is not expected because the reporter refused additional contact.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Anuria, Blood pressure decreased, Diarrhoea, Haematochezia, Intensive care
Clinical narrative: Initial report received from healthcare professional on 21 Nov 2014. An 80-year-old female patient had received an intramuscular dose of FLUZONE HIGH DOSE (lot number: U5023CA, dose, dose number not reported) in the left arm and an intramuscular dose of PNEUMOVAX (Manufacturer: Merck, lot number: K010523, dose, dose number not reported) in the right arm on 20 Nov 2014. The patient had a medical history of muscle weakness, hypothyroidism, celiac disease, hypertension, cardiomyopathy, folate deficiency, osteoporosis, stress reaction, emotional disorder. Concomitant medications included benazepril (oral 10 mg tablet once a day), ferrous sulfate (325 mg tablet QD), calcitriol (oral 0.5 mg capsule every day), folic acid (oral 1 mg tablet daily), levothyroxine sodium (oral 200 mg tablet daily, with a 75 mcg tablet for a total of 275 mcg daily), vitamin D2 (1000 units 1 capsule QD), vitamin C (100 mg tablet once a day), metoprolol tartrate (25 mg tablet, two times a day), citalopram hydrochloride (20 mg tablet, once a day), alendronate (70 mg tablet once a week). It was reported that on 20 Nov 2014, in the evening shortly after dinner, the patient experienced watery diarrhea. Diarrhea continued and later patient experienced bloody and mucousy stool. The patient dropped her blood pressure, became anuric and was admitted to the ICU. Lab details and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Laboratory test, Mucous stools, Nausea, Vomiting
Clinical narrative: Initial report received from healthcare professional on 21 Nov 2014. An 80-year-old female patient had received an intramuscular dose of FLUZONE HIGH DOSE (lot number: U5023CA, dose, dose number not reported) in the left arm and an intramuscular dose of PNEUMOVAX (Manufacturer: Merck, lot number: K010523, dose, dose number not reported) in the right arm on 20 Nov 2014. The patient had a medical history of muscle weakness, hypothyroidism, celiac disease, hypertension, cardiomyopathy, folate deficiency, osteoporosis, stress reaction, emotional disorder. Concomitant medications included benazepril (oral 10 mg tablet once a day), ferrous sulfate (325 mg tablet QD), calcitriol (oral 0.5 mg capsule every day), folic acid (oral 1 mg tablet daily), levothyroxine sodium (oral 200 mg tablet daily, with a 75 mcg tablet for a total of 275 mcg daily), vitamin D2 (1000 units 1 capsule QD), vitamin C (100 mg tablet once a day), metoprolol tartrate (25 mg tablet, two times a day), citalopram hydrochloride (20 mg tablet, once a day), alendronate (70 mg tablet once a week). It was reported that on 20 Nov 2014, in the evening shortly after dinner, the patient experienced watery diarrhea. Diarrhea continued and later patient experienced bloody and mucousy stool. The patient dropped her blood pressure, became anuric and was admitted to the ICU. Lab details and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Mucous stools
Clinical narrative: Initial report received from healthcare professional on 21 Nov 2014. An 80-year-old female patient had received an intramuscular dose of FLUZONE HIGH DOSE (lot number: U5023CA, dose, dose number not reported) in the left arm and an intramuscular dose of PNEUMOVAX (Manufacturer: Merck, lot number: K010523, dose, dose number not reported) in the right arm on 20 Nov 2014. The patient had a medical history of muscle weakness, hypothyroidism, celiac disease, hypertension, cardiomyopathy, folate deficiency, osteoporosis, stress reaction, emotional disorder. Concomitant medications included benazepril (oral 10 mg tablet once a day), ferrous sulfate (325 mg tablet QD), calcitriol (oral 0.5 mg capsule every day), folic acid (oral 1 mg tablet daily), levothyroxine sodium (oral 200 mg tablet daily, with a 75 mcg tablet for a total of 275 mcg daily), vitamin D2 (1000 units 1 capsule QD), vitamin C (100 mg tablet once a day), metoprolol tartrate (25 mg tablet, two times a day), citalopram hydrochloride (20 mg tablet, once a day), alendronate (70 mg tablet once a week). It was reported that on 20 Nov 2014, in the evening shortly after dinner, the patient experienced watery diarrhea. Diarrhea continued and later patient experienced bloody and mucousy stool. The patient dropped her blood pressure, became anuric and was admitted to the ICU. Lab details and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Diarrhoea, Gastrointestinal disorder, Haematochezia, Hypotension, Intensive care
Clinical narrative: Initial report received from healthcare professional on 21 Nov 2014. An 80-year-old female patient had received an intramuscular dose of FLUZONE HIGH DOSE (lot number: U5023CA, dose, dose number not reported) in the left arm and an intramuscular dose of PNEUMOVAX (Manufacturer: Merck, lot number: K010523, dose, dose number not reported) in the right arm on 20 Nov 2014. The patient had a medical history of muscle weakness, hypothyroidism, celiac disease, hypertension, cardiomyopathy, folate deficiency, osteoporosis, stress reaction, emotional disorder. Concomitant medications included benazepril (oral 10 mg tablet once a day), ferrous sulfate (325 mg tablet QD), calcitriol (oral 0.5 mg capsule every day), folic acid (oral 1 mg tablet daily), levothyroxine sodium (oral 200 mg tablet daily, with a 75 mcg tablet for a total of 275 mcg daily), vitamin D2 (1000 units 1 capsule QD), vitamin C (100 mg tablet once a day), metoprolol tartrate (25 mg tablet, two times a day), citalopram hydrochloride (20 mg tablet, once a day), alendronate (70 mg tablet once a week). It was reported that on 20 Nov 2014, in the evening shortly after dinner, the patient experienced watery diarrhea. Diarrhea continued and later patient experienced bloody and mucousy stool. The patient dropped her blood pressure, became anuric and was admitted to the ICU. Lab details and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Shock
Clinical narrative: Initial report received from healthcare professional on 21 Nov 2014. An 80-year-old female patient had received an intramuscular dose of FLUZONE HIGH DOSE (lot number: U5023CA, dose, dose number not reported) in the left arm and an intramuscular dose of PNEUMOVAX (Manufacturer: Merck, lot number: K010523, dose, dose number not reported) in the right arm on 20 Nov 2014. The patient had a medical history of muscle weakness, hypothyroidism, celiac disease, hypertension, cardiomyopathy, folate deficiency, osteoporosis, stress reaction, emotional disorder. Concomitant medications included benazepril (oral 10 mg tablet once a day), ferrous sulfate (325 mg tablet QD), calcitriol (oral 0.5 mg capsule every day), folic acid (oral 1 mg tablet daily), levothyroxine sodium (oral 200 mg tablet daily, with a 75 mcg tablet for a total of 275 mcg daily), vitamin D2 (1000 units 1 capsule QD), vitamin C (100 mg tablet once a day), metoprolol tartrate (25 mg tablet, two times a day), citalopram hydrochloride (20 mg tablet, once a day), alendronate (70 mg tablet once a week). It was reported that on 20 Nov 2014, in the evening shortly after dinner, the patient experienced watery diarrhea. Diarrhea continued and later patient experienced bloody and mucousy stool. The patient dropped her blood pressure, became anuric and was admitted to the ICU. Lab details and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Ocular hyperaemia, Swollen tongue
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 18-Nov-2014) concerns a 37 year-old male patient who had an allergy to codeine. He received FLUVIRIN on 09-Jan-2014 without any reports of an adverse reaction. He did not receive any vaccinations in the past four weeks prior to the AFLURIA administration. On 17-Nov-2014 at 16:09 hours, the patient received intramuscular AFLURIA (batch number T51308) 0.5mL. AFLURIA was stored correctly. On 17-Nov-2014, approximately 2 hours following the AFLURIA administration, the patient experienced an anaphylactic reaction which included a swollen tongue, shortness of breath, difficulty breathing, red eyes, and redness all over the body. He presented to the Emergency Room at a hospital and discharged with a prescription for an Epipen and MEDROL dose pack. He was not hospitalised. On 18-Nov-2014, he presented to the pharmacy with the prescriptions and explained that he was fully recovered, but was feeling a bit down. He insisted that he did not eat anything between the vaccination and the onset of the reaction, and denied that any other vaccinations were concomitantly administered. Outcome was not recovered - anaphylaxis was reported as recovered. The outcome of 'feeling down' was not recovered.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 18-Nov-2014) concerns a 37 year-old male patient who had an allergy to codeine. He received FLUVIRIN on 09-Jan-2014 without any reports of an adverse reaction. He did not receive any vaccinations in the past four weeks prior to the AFLURIA administration. On 17-Nov-2014 at 16:09 hours, the patient received intramuscular AFLURIA (batch number T51308) 0.5mL. AFLURIA was stored correctly. On 17-Nov-2014, approximately 2 hours following the AFLURIA administration, the patient experienced an anaphylactic reaction which included a swollen tongue, shortness of breath, difficulty breathing, red eyes, and redness all over the body. He presented to the Emergency Room at a hospital and discharged with a prescription for an Epipen and MEDROL dose pack. He was not hospitalised. On 18-Nov-2014, he presented to the pharmacy with the prescriptions and explained that he was fully recovered, but was feeling a bit down. He insisted that he did not eat anything between the vaccination and the onset of the reaction, and denied that any other vaccinations were concomitantly administered. Outcome was not recovered - anaphylaxis was reported as recovered. The outcome of 'feeling down' was not recovered.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Depressed mood, Dyspnoea, Generalised erythema, Ocular hyperaemia
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 18-Nov-2014) concerns a 37 year-old male patient who had an allergy to codeine. He received FLUVIRIN on 09-Jan-2014 without any reports of an adverse reaction. He did not receive any vaccinations in the past four weeks prior to the AFLURIA administration. On 17-Nov-2014 at 16:09 hours, the patient received intramuscular AFLURIA (batch number T51308) 0.5mL. AFLURIA was stored correctly. On 17-Nov-2014, approximately 2 hours following the AFLURIA administration, the patient experienced an anaphylactic reaction which included a swollen tongue, shortness of breath, difficulty breathing, red eyes, and redness all over the body. He presented to the Emergency Room at a hospital and discharged with a prescription for an Epipen and MEDROL dose pack. He was not hospitalised. On 18-Nov-2014, he presented to the pharmacy with the prescriptions and explained that he was fully recovered, but was feeling a bit down. He insisted that he did not eat anything between the vaccination and the onset of the reaction, and denied that any other vaccinations were concomitantly administered. Outcome was not recovered - anaphylaxis was reported as recovered. The outcome of 'feeling down' was not recovered.
Age: 37.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Swollen tongue
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 18-Nov-2014) concerns a 37 year-old male patient who had an allergy to codeine. He received FLUVIRIN on 09-Jan-2014 without any reports of an adverse reaction. He did not receive any vaccinations in the past four weeks prior to the AFLURIA administration. On 17-Nov-2014 at 16:09 hours, the patient received intramuscular AFLURIA (batch number T51308) 0.5mL. AFLURIA was stored correctly. On 17-Nov-2014, approximately 2 hours following the AFLURIA administration, the patient experienced an anaphylactic reaction which included a swollen tongue, shortness of breath, difficulty breathing, red eyes, and redness all over the body. He presented to the Emergency Room at a hospital and discharged with a prescription for an Epipen and MEDROL dose pack. He was not hospitalised. On 18-Nov-2014, he presented to the pharmacy with the prescriptions and explained that he was fully recovered, but was feeling a bit down. He insisted that he did not eat anything between the vaccination and the onset of the reaction, and denied that any other vaccinations were concomitantly administered. Outcome was not recovered - anaphylaxis was reported as recovered. The outcome of 'feeling down' was not recovered.