chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received on 09-OCT-2015 from a pharmacist regarding a female who received a dose of PENUMOVAX23 approximately three years earlier and received a second dose of PNEUMOVAX23 (lot # L002310, expiration date 08-JUL-2016)  0.5 ml, intramuscular, on08-OCT-2014. Pharmacist reported patient received an unspecified influenza shot in the same arm, as PNEUMOVAX23, on 08-OCT-2015. NO adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Urticaria, Vomiting
Clinical narrative: 7/29/15 s/p #1 - Deltoid pain. 10/21/15 - hives/vomit.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from two Medical Assistants refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-OCT-2015, the patient was vaccinated with the second dose of an expired ROTATEQ lot # J011334, expiration date 13-MAY-2015 (dose, route of administration not provided). There was no adverse effect reported. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash, Rash morbilliform, Skin plaque
Clinical narrative: 10/21/15 - 18th day temp 98.7 HR 124 O2 100% length 2". Erythematous morbiliform papular plaques trunk and back. Treatment given - BENADRYL 10 mg po 1 6 hours a day. F/U or go to ED if worsens if SOA or difficulty breathing.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given to pt. (Dr prescribed PREVNAR 13, but ZOSTAVAX was given to pt by accident).
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Erythematous raised welt at all injection sites on both arms and multiple similar lesions on trunks, arms and legs.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Injection site reaction, Rash erythematous
Clinical narrative: Patient came in a week with a red stripy rash at injection site. Patient already had dry skin. Patient was told to go see PCP.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives developed 2-3 days following vaccination lasting several days. Steroids and antihistamine treatments.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Irritability, Mucous stools
Clinical narrative: Mild fussiness. Small amt mucous in stools. Temp 100.8. Mom reported has mucous last time too no other sx.
Age: 0.11
Sex: M
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) reporting on a 11 month old male patient. The patient's pertinent medical history and concomitant therapies were not reported. On an unknown date in 2001, the patient received (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not reported) 6 days before his first birthday, which was different from the prescribed label. There were no adverse event to report. The misuse of the vaccine was discovered at the close of the call therefore the reporter did not participate in this report. The mother sought medical attention by speaking with pediatrician. Additional information is not expected as there were no contact details provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 3 unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On 06-SEP-2015, one unspecified patient was vaccinated with a dose of improperly stored MMR II lot # L001336, expiry date 13-JAN-2017 (route and site of administration, dose were not reported). On 11-SEP-2015, two unspecified patients were vaccinated with doses of improperly stored MMR II lot # L001336, expiry date 13-JAN-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot # L004743, and expiration date- 01-JUN-2017 and lot # L017757, expiration date-08-APR-2018. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot number L019289 and expiration date 14-SEP-2017 and lot # L014415, expiration date 23-JUL-2017 (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding a 12 month old male patient. There was no information about concurrent condition and historical medication. On 28-SEP-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # K003422, expiration date- 06-MAR-2016, 0.5 ml, subcutaneous. No adverse event was reported. The outcome of the event was unknown. No Product quality complaint (PQC) was involved. Additional information is not expected because patient does not want to get contacted.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 year old female patient. No concurrent conditions, medical history or allergy/drug reactions were reported. On 06-OCT-2015, the patient was vaccinated with ZOSTAVAX vial (lot# L025001, expiry date: 06-OCT-2016) (dose and route unspecified) for prevention of shingles. No concomitant medication was reported. On 08-OCT-2015, the patient presented to her pharmacy with a large, red and swollen bump on her arm at the injection site. The patient was administered with BENADRYL, aspirin, and TYLENOL. Lab tests were reported as none. The outcome of the events was reported as not recovered. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored ROTATEQ orally, lot # L008034 exp. 05-AUG-2016 (dose was not provided). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored RECOMBIVAX (lot # L010595 exp. 12-NOV-2016) (dose and route of administration were not reported). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored VAQTA (lot # K012457 exp. 04-JUN-2017 and L023232 exp. 25-FEB-2017. There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # reported as "L011846" exp. date "16-JUN-2017", (route and dose were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unspecified dates, the patients were vaccinated orally with improperly stored doses of ROTATEQ oral liquid (lot# K016263, expiry date 26-JUL-2016; exact dose was not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. On 30-JUL-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection, lot # L001327, expiration date 13-JAN-2017 (dose, route and anatomical location were not reported). There were no adverse effects. This is one of the several reports received 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 pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-OCT-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot #, dose, route of administration and anatomical location were not provided). No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. On 29-JUL-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection, lot # L001327, expiration date 13-JAN-2017 (dose, route and anatomical location were not reported). There were no adverse effects. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Abdominal discomfort, Arthralgia, Chills, Cold sweat, Fatigue
Clinical narrative: Patient had an upset stomach in the afternoon on 10/16/15. At 9:30 pm on 10/16/15, she started vomiting. She vomited twice between 9:30 pm and 3:30 am. She stated that she had a fever. Chills, cold sweats, and body aches/joint pain (esp. knees), fatigue and a headache.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Patient had an upset stomach in the afternoon on 10/16/15. At 9:30 pm on 10/16/15, she started vomiting. She vomited twice between 9:30 pm and 3:30 am. She stated that she had a fever. Chills, cold sweats, and body aches/joint pain (esp. knees), fatigue and a headache.
Age: 65.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received the shingles vaccine and PREVNAR 13 on 9/3/15 at approx. 10:00 am. Around 3:00pm later that day she broke out in hives. Reports that the hives started on her head and then traveled to her neck, arms, and torso. She immediately took BENADRYL and noticed relief. She denies any swelling of tongue or throat, and denies any SOB, or CP. By the next day, the hives are completely gone. Patient states that she had never experience this kind of reaction to a vaccine before. Urticaria pruritus. Diphenhydramine 50 mg once.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Information has been received from Pfizer Inc. (Manufacturer report #2015332567) via a registered nurse on behalf of herself. The patient was a 62 year old female with an abnormal clotting factor diagnosed (dx.) 2008 and a medical history of pulmonary embolism (dx. DEC 1997) and pulmonary embolism (dx. 2008). On an unspecified date in AUG2012 the patient was vaccinated with PNEUMOVAX 23, (dose not provided), subcutaneously, in the arm (patient could not recall which arm), at approx. 1400 hours. Approximately 12 hours after she was vaccinated with PNEUMOVAX 23, (approximately 0200 in the morning the following day), the patient experienced severe muscle and joint pain. She reported that she could barely move. She also ran a temperature of 102 degrees or higher for three days. The patient completely recovered from the severe muscle pain, joint pain and temperature of 102 degrees or higher approximately three days later. She called her doctor and notified him of her experiences. She did not receive any additional medical treatment. "She just suffered through it until her experiences resolved". She did not have any tests done after the events. The patient placed a call to Pfizer to ask how PREVNAR 13 compared to PNEUMOVAX 23 and questioned if she would have the same reaction. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative regarding an 11 year old female patient. The patient's medical history, drug reactions or allergies were not provided. On 03-SEP-2015, the patient was vaccinated with her first dose of GARDASIL (dose, route, lot number and expiration date were not provided). On 09-OCT-2015, the patient was vaccinated with her second dose of GARDASIL 9 (dose, route, lot number and expiration date were not provided). On 09-OCT-2015, after the administration of the GARDASIL 9, while still in the unspecified physician's office, the patient fainted. The patient started to recover and was given some apple juice. The patient then experienced another episode of syncope. The patient recovered while in the physician's office, the patient was considered fully recovered on 09-OCT-2015. There was no additional treatment. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a physician referring to a female patient of unknown age. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiry date and route of administration not reported). Other co-suspect or concomitant medications were not reported. On an unknown date, the patient developed fever tightening of her chest injection site pain and swelling. The physician said the patient possibly received a previous dose of PNEUMOVAX 23 less than 5 years ago but the physician was not sure. The outcome of chest discomfort, injection site swelling, injection site pain and pyrexia was unknown. It was reported that the patient called the physician's office. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 18-OCT-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (the pharmacist did not know which of the following lots was administered to the patient: L025001, expiration date 06-OCT-2016; L012476, expiration date 10-JUL-2016; L026414, expiration date 15-OCT-2016) (strength, dose and route were not provided). Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a female patient of unknown age. Concurrent conditions and medical history were not reported. On an unspecified date approximately in October 2007 (reported as approximately 8 years ago) the patient was vaccinated with the first dose of GARDASIL intramuscular injection (strength, route, lot # and expiration date not reported). Concomitant therapies or vaccines were not reported. The reporter informed that the patient presented to the office on 16-OCT-2015, and received the second dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (dose, route and lot # not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # J005713, expiration date 25-OCT-2015) (strength, route and dose were not provided). Concomitant medication was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route ang lot # not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patiens were vaccinated with improperly stored doses of M-M-R-II (dose, route and lot # not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, route and lot # not reported). No adverse effect was reported. This is one of several reports received 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 as received from a registered nurse refers to unspecified number of patients of unknown age and gender. ON unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route and lot # not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from the patient's mother concerning her infant daughter, a female patient of unknown age. No concurrent conditions or medical history were reported. On an unknown date, the patient was accidentally vaccinated with a dose of PNEUMOVAX 23 instead of PVC13. No adverse reaction reported. No Product Quality Complaint (PQC) was involved. Additional information is not expected as no contact details were provided.
Age: 0.2
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to a 2 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, dose and route not reported). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received via from a physician via a company representative referring to a 65 year old female patient. No patient's medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, frequency, route of administration, lot # and expiration date not specified). On an unknown date the physician noticed that the patient had cellulitis, which started to expand and continued to expand at the time of the report. The patient sought medical attention. The outcome of cellulitis was unknown. The relatedness between PNEUMOVAX23 was not reported. Follow up information has been received from the physician on 20-OCT-2015, concerning the patient. On 05-AUG-2015 2:52 PM, the patient was vaccinated with her first dose of PNEUMOVAX23, lot # K004542 with expiration date 19-AUG-2015, intramuscularly in her left deltoid. On the same day, the patient experienced cellulitis, chills, body aches, and left arm erythema, edema, pain. The patient was treated with KEFLEX. The outcome of the events was reported as recovered on an unknown date of 2015. The reporter considered the events to be medically significant. Additional information is not expected as all scheduled follow up were received. Reporter and patient information, product, events and narrative had been updated.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Erythema, Oedema peripheral, Pain
Clinical narrative: Information has been received via from a physician via a company representative referring to a 65 year old female patient. No patient's medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, frequency, route of administration, lot # and expiration date not specified). On an unknown date the physician noticed that the patient had cellulitis, which started to expand and continued to expand at the time of the report. The patient sought medical attention. The outcome of cellulitis was unknown. The relatedness between PNEUMOVAX23 was not reported. Follow up information has been received from the physician on 20-OCT-2015, concerning the patient. On 05-AUG-2015 2:52 PM, the patient was vaccinated with her first dose of PNEUMOVAX23, lot # K004542 with expiration date 19-AUG-2015, intramuscularly in her left deltoid. On the same day, the patient experienced cellulitis, chills, body aches, and left arm erythema, edema, pain. The patient was treated with KEFLEX. The outcome of the events was reported as recovered on an unknown date of 2015. The reporter considered the events to be medically significant. Additional information is not expected as all scheduled follow up were received. Reporter and patient information, product, events and narrative had been updated.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received via from a physician via a company representative referring to a 65 year old female patient. No patient's medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, frequency, route of administration, lot # and expiration date not specified). On an unknown date the physician noticed that the patient had cellulitis, which started to expand and continued to expand at the time of the report. The patient sought medical attention. The outcome of cellulitis was unknown. The relatedness between PNEUMOVAX23 was not reported. Follow up information has been received from the physician on 20-OCT-2015, concerning the patient. On 05-AUG-2015 2:52 PM, the patient was vaccinated with her first dose of PNEUMOVAX23, lot # K004542 with expiration date 19-AUG-2015, intramuscularly in her left deltoid. On the same day, the patient experienced cellulitis, chills, body aches, and left arm erythema, edema, pain. The patient was treated with KEFLEX. The outcome of the events was reported as recovered on an unknown date of 2015. The reporter considered the events to be medically significant. Additional information is not expected as all scheduled follow up were received. Reporter and patient information, product, events and narrative had been updated.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Urticaria
Clinical narrative: 8/3/15 Patient experienced allergic reaction to GARDASIL 8/3/15. Patient experienced rash on face, back and abdomen. Patient returned on 8/6/15 to office with difficult breathing and rash developed on entire body 8/5/15.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Dyspnoea, Hypersensitivity, Rash generalised, Vaccination complication
Clinical narrative: 8/3/15 Patient experienced allergic reaction to GARDASIL 8/3/15. Patient experienced rash on face, back and abdomen. Patient returned on 8/6/15 to office with difficult breathing and rash developed on entire body 8/5/15.
Age: 92.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling cold, Tremor
Clinical narrative: 1 1/2 hrs. after the shot my mother started to shake violently and became extremely cold! She thought she was dying. Rushed her to emergency room on dr. orders.
Age: 92.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling abnormal, Feeling cold, Tremor
Clinical narrative: 1 1/2 hrs. after the shot my mother started to shake violently and became extremely cold! She thought she was dying. Rushed her to emergency room on dr. orders.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 62 year old male consumer referring to himself. Drug reactions/ allergies included allergic to sulfanilamide (reported as "sulfa"), codeine and garapentin. On 01-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route and lot number not provided) for prevention of shingles. On 21-SEP-2015, he expereinced a rash and it was very painful and sore. The patient could not sleep and was in a lot of pain. He underwent x-ray for cholesterol (result unknown). Patient went to the emergency room and was given pain medication fanciclovir 500 mg for 10 days. The outcome of the events was reported as not recovered/not resolved. Follow up information has been received from a healthcare professional on 07-OCT-2015. The patient had hydromorphone hydrochloride (DILAUDID) allergy. In approximately 1961 when the patient was 8 years old, he had chickenpox. The patient had no prior history of herpes zoster or herpes zoster ophthalmicus. On 01-SEP-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (0.65 ml, lot number K020187) subcutaneously in left arm. On 30-SEP-2015, sample was collected from the scab for polymerase chain reaction (PCR) test. Follow-up information has been received on 14-OCT-2015. A scab sample was sent for varicella zoster virus (VZV) PCR test and the result on 07-OCT-2015 showed that it was wild-type strain. The patient was on an oral antivirals prior to specimen collection. Additional information is not expected as all follow up information has been received. Reporter's information, lab test information and narrative were updated.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: Information has been received from a 62 year old male consumer referring to himself. Drug reactions/ allergies included allergic to sulfanilamide (reported as "sulfa"), codeine and garapentin. On 01-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route and lot number not provided) for prevention of shingles. On 21-SEP-2015, he expereinced a rash and it was very painful and sore. The patient could not sleep and was in a lot of pain. He underwent x-ray for cholesterol (result unknown). Patient went to the emergency room and was given pain medication fanciclovir 500 mg for 10 days. The outcome of the events was reported as not recovered/not resolved. Follow up information has been received from a healthcare professional on 07-OCT-2015. The patient had hydromorphone hydrochloride (DILAUDID) allergy. In approximately 1961 when the patient was 8 years old, he had chickenpox. The patient had no prior history of herpes zoster or herpes zoster ophthalmicus. On 01-SEP-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (0.65 ml, lot number K020187) subcutaneously in left arm. On 30-SEP-2015, sample was collected from the scab for polymerase chain reaction (PCR) test. Follow-up information has been received on 14-OCT-2015. A scab sample was sent for varicella zoster virus (VZV) PCR test and the result on 07-OCT-2015 showed that it was wild-type strain. The patient was on an oral antivirals prior to specimen collection. Additional information is not expected as all follow up information has been received. Reporter's information, lab test information and narrative were updated.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: Information has been received from a 62 year old male consumer referring to himself. Drug reactions/ allergies included allergic to sulfanilamide (reported as "sulfa"), codeine and garapentin. On 01-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route and lot number not provided) for prevention of shingles. On 21-SEP-2015, he expereinced a rash and it was very painful and sore. The patient could not sleep and was in a lot of pain. He underwent x-ray for cholesterol (result unknown). Patient went to the emergency room and was given pain medication fanciclovir 500 mg for 10 days. The outcome of the events was reported as not recovered/not resolved. Follow up information has been received from a healthcare professional on 07-OCT-2015. The patient had hydromorphone hydrochloride (DILAUDID) allergy. In approximately 1961 when the patient was 8 years old, he had chickenpox. The patient had no prior history of herpes zoster or herpes zoster ophthalmicus. On 01-SEP-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (0.65 ml, lot number K020187) subcutaneously in left arm. On 30-SEP-2015, sample was collected from the scab for polymerase chain reaction (PCR) test. Follow-up information has been received on 14-OCT-2015. A scab sample was sent for varicella zoster virus (VZV) PCR test and the result on 07-OCT-2015 showed that it was wild-type strain. The patient was on an oral antivirals prior to specimen collection. Additional information is not expected as all follow up information has been received. Reporter's information, lab test information and narrative were updated.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site rash
Clinical narrative: Information received for this spontaneous report on 07-OCT-2015 from a pharmacist refers to a 66 year old female patient with drug hypersensitivity to LEVAQUIN, drug hypersensitivity to SEPTRA and possible diabetes mellitus. On 04-OCT-2015 the patient was vaccinated with ZOSTAVAX, (lot # L021610, expiration 10-SEP-2016), 0.65 ml, subcutaneous in her arm (reported as lot # 1021610, L021610 confirmed as valid.) Other suspect therapies included FLUZONE in her opposite arm. Concomitant therapies included tramadol hydrochloride and unspecified diabetes medications. On 06-OCT-2015, 3 days after onset of therapy the patient developed a red densely bumpy area around her ZOSTAVAX injection site that spread to her elbow. On 07-OCT-2015, the patient went to the pharmacy to show the pharmacist her ZOSTAVAX injection site. The outcome of injection site reaction and injection site erythema was reported as not recovered/not resolved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information received for this spontaneous report on 07-OCT-2015 from a pharmacist refers to a 66 year old female patient with drug hypersensitivity to LEVAQUIN, drug hypersensitivity to SEPTRA and possible diabetes mellitus. On 04-OCT-2015 the patient was vaccinated with ZOSTAVAX, (lot # L021610, expiration 10-SEP-2016), 0.65 ml, subcutaneous in her arm (reported as lot # 1021610, L021610 confirmed as valid.) Other suspect therapies included FLUZONE in her opposite arm. Concomitant therapies included tramadol hydrochloride and unspecified diabetes medications. On 06-OCT-2015, 3 days after onset of therapy the patient developed a red densely bumpy area around her ZOSTAVAX injection site that spread to her elbow. On 07-OCT-2015, the patient went to the pharmacy to show the pharmacist her ZOSTAVAX injection site. The outcome of injection site reaction and injection site erythema was reported as not recovered/not resolved. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Injection site hypersensitivity, Injection site inflammation, Injection site mass
Clinical narrative: Hard, swollen lump, redness at injection site. Within three to four days below the swollen lump developed a bright red hive approximately 3/4" length resembling a blister. Within seven days of receiving the PREVNAR 13 susp visit to primary doctor and prescribed a six day course of prednisone. Injection site was painful.
Age: 69.0
Sex: U
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Blister, Erythema, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Hard, swollen lump, redness at injection site. Within three to four days below the swollen lump developed a bright red hive approximately 3/4" length resembling a blister. Within seven days of receiving the PREVNAR 13 susp visit to primary doctor and prescribed a six day course of prednisone. Injection site was painful.
Age: 69.0
Sex: U
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Hard, swollen lump, redness at injection site. Within three to four days below the swollen lump developed a bright red hive approximately 3/4" length resembling a blister. Within seven days of receiving the PREVNAR 13 susp visit to primary doctor and prescribed a six day course of prednisone. Injection site was painful.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Asthenia, Blood glucose normal, Dyspnoea, Faecal incontinence, Hypersomnia
Clinical narrative: Initial unsolicited report received from a consumer on 9 October 2015. This case involves an 81-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE (batch number, expiry date not reported) in the right arm and also received a dose of PREVNAR 13 (batch number, expiry date and route of administration not reported, manufacturer Pfizer) in right arm on 11 September 2015 at 12:00 hours. The medical history includes diabetes since 2013, cellulitis in left leg and the patient gets flu shots annually and concomitant medications were not reported. On an unspecified date after the vaccination the patient noticed that his hand was swollen. He was also complaining that his hand was hurting. The patient never complains about anything. He went to the emergency and they slammed him into the hospital, he went to the Urgent Care and they were not able to x-ray his hand to see what was going on with it. So the patient was taken to the emergency. The reporter thought that the patient was admitted in hospital for hand but was surprised to see the patient on breathing apparatus. He was getting oxygen and everything else and the patient seemed kind of dazed. The physician told the reporter that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. While receiving breathing treatment when lying flat the patient had inhaled something in his lungs and now the patient had Pneumonia. The patient was breathing alright prior to going to the hospital. The patient also does not have the body strength as he had before. Both arms are weak. His hand were still swollen. Within three days of being admitted to the hospital, the reporter found that the patient had Pneumonia, has no bowel control and can't speak plainly. He was non-responsive and sleeping all of the time. The patient required ER/doctor visit. Laboratory investigations were highest blood sugar has been is 110. X-ray of left hand done on 17 September 2015 for which results were unknown. Corrective treatments were not reported. The event outcome was reported as below: Hand really swollen: Persisting. No strength in either arm: Persisting. No bowel control: Persisting. Can't speak plainly: Persisting. Weak: Persisting. Sleeping all the time: Improved. Non-responsive: Improved. Problems breathing: Improved. Hand hurting: not reported. Seemed dazed: not reported. Inhaled something in his lungs: not reported. Pneumonia: not reported. Documents held by sender: none.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling, Pneumonia, Speech disorder
Clinical narrative: Initial unsolicited report received from a consumer on 9 October 2015. This case involves an 81-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE (batch number, expiry date not reported) in the right arm and also received a dose of PREVNAR 13 (batch number, expiry date and route of administration not reported, manufacturer Pfizer) in right arm on 11 September 2015 at 12:00 hours. The medical history includes diabetes since 2013, cellulitis in left leg and the patient gets flu shots annually and concomitant medications were not reported. On an unspecified date after the vaccination the patient noticed that his hand was swollen. He was also complaining that his hand was hurting. The patient never complains about anything. He went to the emergency and they slammed him into the hospital, he went to the Urgent Care and they were not able to x-ray his hand to see what was going on with it. So the patient was taken to the emergency. The reporter thought that the patient was admitted in hospital for hand but was surprised to see the patient on breathing apparatus. He was getting oxygen and everything else and the patient seemed kind of dazed. The physician told the reporter that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. While receiving breathing treatment when lying flat the patient had inhaled something in his lungs and now the patient had Pneumonia. The patient was breathing alright prior to going to the hospital. The patient also does not have the body strength as he had before. Both arms are weak. His hand were still swollen. Within three days of being admitted to the hospital, the reporter found that the patient had Pneumonia, has no bowel control and can't speak plainly. He was non-responsive and sleeping all of the time. The patient required ER/doctor visit. Laboratory investigations were highest blood sugar has been is 110. X-ray of left hand done on 17 September 2015 for which results were unknown. Corrective treatments were not reported. The event outcome was reported as below: Hand really swollen: Persisting. No strength in either arm: Persisting. No bowel control: Persisting. Can't speak plainly: Persisting. Weak: Persisting. Sleeping all the time: Improved. Non-responsive: Improved. Problems breathing: Improved. Hand hurting: not reported. Seemed dazed: not reported. Inhaled something in his lungs: not reported. Pneumonia: not reported. Documents held by sender: none.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Unresponsive to stimuli, White blood cell disorder, X-ray limb
Clinical narrative: Initial unsolicited report received from a consumer on 9 October 2015. This case involves an 81-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE (batch number, expiry date not reported) in the right arm and also received a dose of PREVNAR 13 (batch number, expiry date and route of administration not reported, manufacturer Pfizer) in right arm on 11 September 2015 at 12:00 hours. The medical history includes diabetes since 2013, cellulitis in left leg and the patient gets flu shots annually and concomitant medications were not reported. On an unspecified date after the vaccination the patient noticed that his hand was swollen. He was also complaining that his hand was hurting. The patient never complains about anything. He went to the emergency and they slammed him into the hospital, he went to the Urgent Care and they were not able to x-ray his hand to see what was going on with it. So the patient was taken to the emergency. The reporter thought that the patient was admitted in hospital for hand but was surprised to see the patient on breathing apparatus. He was getting oxygen and everything else and the patient seemed kind of dazed. The physician told the reporter that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. While receiving breathing treatment when lying flat the patient had inhaled something in his lungs and now the patient had Pneumonia. The patient was breathing alright prior to going to the hospital. The patient also does not have the body strength as he had before. Both arms are weak. His hand were still swollen. Within three days of being admitted to the hospital, the reporter found that the patient had Pneumonia, has no bowel control and can't speak plainly. He was non-responsive and sleeping all of the time. The patient required ER/doctor visit. Laboratory investigations were highest blood sugar has been is 110. X-ray of left hand done on 17 September 2015 for which results were unknown. Corrective treatments were not reported. The event outcome was reported as below: Hand really swollen: Persisting. No strength in either arm: Persisting. No bowel control: Persisting. Can't speak plainly: Persisting. Weak: Persisting. Sleeping all the time: Improved. Non-responsive: Improved. Problems breathing: Improved. Hand hurting: not reported. Seemed dazed: not reported. Inhaled something in his lungs: not reported. Pneumonia: not reported. Documents held by sender: none.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Asthenia, Blood glucose normal, Blood test normal, Dyspnoea, Faecal incontinence
Clinical narrative: Initial unsolicited report received from a consumer on 9 October 2015. This case involves an 81-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE (batch number, expiry date not reported) in the right arm and also received a dose of PREVNAR 13 (batch number, expiry date and route of administration not reported, manufacturer Pfizer) in right arm on 11 September 2015 at 12:00 hours. The medical history includes diabetes since 2013, cellulitis in left leg and the patient gets flu shots annually and concomitant medications were not reported. On an unspecified date after the vaccination the patient noticed that his hand was swollen. He was also complaining that his hand was hurting. The patient never complains about anything. He went to the emergency and they slammed him into the hospital, he went to the Urgent Care and they were not able to x-ray his hand to see what was going on with it. So the patient was taken to the emergency. The reporter thought that the patient was admitted in hospital for hand but was surprised to see the patient on breathing apparatus. He was getting oxygen and everything else and the patient seemed kind of dazed. The physician told the reporter that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. While receiving breathing treatment when lying flat the patient had inhaled something in his lungs and now the patient had Pneumonia. The patient was breathing alright prior to going to the hospital. The patient also does not have the body strength as he had before. Both arms are weak. His hand were still swollen. Within three days of being admitted to the hospital, the reporter found that the patient had Pneumonia, has no bowel control and can't speak plainly. He was non-responsive and sleeping all of the time. The patient required ER/doctor visit. Laboratory investigations were highest blood sugar has been is 110. X-ray of left hand done on 17 September 2015 for which results were unknown. Corrective treatments were not reported. The event outcome was reported as below: Hand really swollen: Persisting. No strength in either arm: Persisting. No bowel control: Persisting. Can't speak plainly: Persisting. Weak: Persisting. Sleeping all the time: Improved. Non-responsive: Improved. Problems breathing: Improved. Hand hurting: not reported. Seemed dazed: not reported. Inhaled something in his lungs: not reported. Pneumonia: not reported. Documents held by sender: none.