chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Cellulitis, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Pt reports left arm swelling, erythema that started about 2 hours s/p pneumonia vaccination - seen in ER on 11/1 (-) doppler U/S. Treated for cellulitis. Here for recheck. (L) arm w/ 5 x 8 cm erythema and mild swelling medial upper arm - no erythema at injection site. ? localized reaction vs cellulitis rec complete antbx FU if sx persist/worsen. Assessed pt via ODI. Pt reporting difficulty breathing, chest pain, generalized abdominal pain, and (L) arm pain. Pt going through application process and received some vaccinations to same arm yesterday. Began to have itching last night, now upper arm on the underside is red and swollen and tender to touch. Pt denies any drug allergies, unable to specify which vaccination was received. Pt has not tried anything for pain relief. Pt has good pulses to bilateral upper extremities. Lung sounds clear bilaterally on exam. History somewhat difficult to obtain due to language barrier.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Pt reports left arm swelling, erythema that started about 2 hours s/p pneumonia vaccination - seen in ER on 11/1 (-) doppler U/S. Treated for cellulitis. Here for recheck. (L) arm w/ 5 x 8 cm erythema and mild swelling medial upper arm - no erythema at injection site. ? localized reaction vs cellulitis rec complete antbx FU if sx persist/worsen. Assessed pt via ODI. Pt reporting difficulty breathing, chest pain, generalized abdominal pain, and (L) arm pain. Pt going through application process and received some vaccinations to same arm yesterday. Began to have itching last night, now upper arm on the underside is red and swollen and tender to touch. Pt denies any drug allergies, unable to specify which vaccination was received. Pt has not tried anything for pain relief. Pt has good pulses to bilateral upper extremities. Lung sounds clear bilaterally on exam. History somewhat difficult to obtain due to language barrier.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Ultrasound Doppler, Urine analysis
Clinical narrative: Pt reports left arm swelling, erythema that started about 2 hours s/p pneumonia vaccination - seen in ER on 11/1 (-) doppler U/S. Treated for cellulitis. Here for recheck. (L) arm w/ 5 x 8 cm erythema and mild swelling medial upper arm - no erythema at injection site. ? localized reaction vs cellulitis rec complete antbx FU if sx persist/worsen. Assessed pt via ODI. Pt reporting difficulty breathing, chest pain, generalized abdominal pain, and (L) arm pain. Pt going through application process and received some vaccinations to same arm yesterday. Began to have itching last night, now upper arm on the underside is red and swollen and tender to touch. Pt denies any drug allergies, unable to specify which vaccination was received. Pt has not tried anything for pain relief. Pt has good pulses to bilateral upper extremities. Lung sounds clear bilaterally on exam. History somewhat difficult to obtain due to language barrier.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: Swelling for a few days. Soreness after 3 weeks.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Arm swollen where PNEUMOVAX was given.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Carpal tunnel syndrome, Hypoaesthesia, Insomnia, Paraesthesia, Pruritus
Clinical narrative: Patient experienced carpal tunnel-like pain numbness, tingling, difficulty sleeping about a week after vaccination. 1 week later, itcing, which have since resolved.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pruritus
Clinical narrative: Swelling and itching on right side of neck.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Exostosis, Mobility decreased, Pain, X-ray abnormal
Clinical narrative: Pt received PREVNAR 13 on 10/12/15. Within a few days he had to seek treatment for severe pain. Patient states he has limited mobility on his arm. Per MD office xray shows bone spurring and MD does not feel related to shot.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Intense pain started in shoulders and joints. then spread 5 hours after shot that lasted through the night and subsided 9:00 am next morning. Took TYLENOL arthritis and used cold pack on arm.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Febrile convulsion, Platelet count decreased, Pyrexia
Clinical narrative: On 10/24/15, patient developed fever and febrile seizure which lasted no more than two minutes. Was seen in ER on 10/24/15 and followed up in office on 10/25/15.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Arthralgia, Decreased appetite, Fatigue, Headache
Clinical narrative: Joint ache, headache, lack of sleep, lack of appetite, stomach ache, exhausted for weeks.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia
Clinical narrative: Joint ache, headache, lack of sleep, lack of appetite, stomach ache, exhausted for weeks.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site cellulitis, Injection site induration, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient presented with a red rash surrounding the site of injection. The physician believed it to be cellulitis as it was warm and firm to the touch. Antibiotics were prescribed and ZYRTEC tabs.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a 26-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3JE9F, expiry date 20th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: The patient does not know which GlaxoSmithKline Flu vaccine of she received. However, according to the batch number and expiry date provided, the patient must had received FLUARIX QUADRIVALENT and after an unspecified time, she experienced an unspecified adverse event. At the time of reporting, any further information was not available.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction, Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lymphadenopathy in a 26-year-old female patient who received FLUARIX (batch number 3JE9F, expiry date unknown). In September 2014, the patient received FLUARIX. On an unknown date, less than a week after receiving FLUARIX, the patient experienced lymphadenopathy, injection site reaction and fever. On an unknown date, the outcome of the lymphadenopathy, injection site reaction and fever were recovered/resolved. It was unknown if the reporter considered the lymphadenopathy, injection site reaction and fever to be related to FLUARIX. Additional details provided were as follows: According to the reporter the patient was nurse and last year in September 2014 at the hospital, she received a dose of FLUARIX. Nex day (less than a week) after vaccination, the patient noticed swelling of the axillary lymph nodes and cervical lymph nodes on the left side where the vaccine was administered. An unspecified time after vaccination, additionally the patient experienced a large local reaction at the injection site and a low-grade fever of 101 degree F. On an unknown date, the patient was seen by her physician and the patient did not receive any treatment for it. The symptoms resolved after couple of days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K012875, expiration dates 27-AUG-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a female pharmacist of unknown age via company representative refers to herself who had unspecified drug reactions or allergy. Information regarding relevant medical history and concurrent condition were not reported. On an unspecified date in 2015 (reported as "this past week", which would be one day between and including 27-SEP-2015 and 01-OCT-2015), the patient was vaccinated with ZOSTAVAX (dose reported as "1 vial", route and lot # not reported). Information regarding concomitant medications was not reported. The day following the ZOSTAVAX vaccination, on an unknown date in 2015, she got a rash at the injection site. The pharmacist described the rash at the injection site as 3 inches in size and in oval shape. The patient did not seek medical attention. No treatment was given. No lab diagnostics studies were performed. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received via company representative from a pharmacist of unknown age regarding herself. Concurrent conditions and medical history were unknown. On 29-SEP-2015, three weeks earlier the patient was vaccinated with a dose of ZOSTAVAX (lot# unknown). Concomitant medications were not reported. On an unknown date approximately in 2015, the patient experienced rash at the injection site which was red, swollen and itchy and compared the rash to chicken pox. Varicella zoster virus identification program (VZVIP) packet was not sent. Treatment for the events included ice and hydrocortisone (unknown manufacturer). No medical attention was sought. It was unspecified if any laboratory diagnostics were performed. On an unknown date in October 2015, 10 days later the events resolved. Causality was not 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 certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On 16-SEP-2015, 17-SEP-2015, 18-SEP-2015 and 08-OCT-2015, the patients were vaccinated with doses of improperly stored GARDASIL (Lot #K010215, expiry date: 05-MAY-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist along with staff members in the pharmacy via a company representative refers to an unspecified number of patients of unknown age and gender (mentioned as "all of their patients"). Information regarding relevant medical history and concurrent condition were not reported. On unknown date, the patient were vaccinated with ZOSTAVAX (dose, route and lot # not reported). Information regarding concomitant medications was not reported. The reporters commented that all their patients had reactions to ZOSTAVAX and their arms swell (onset dates unspecified). The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No pertinent or historical conditions were reported. On unspecified dates starting on or after 21-OCT-2015, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (lot# L016959, expiration date 12-MAR-2018, strength, dose and route unknown). No adverse effect was reported. This is one of 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 certified assistant/healthcare worker refers to multiple patients of unknown demographics. On 27-JUL-2015, 28-JUL-2015, 29-JUL-2015, 30-JUL-2015, 31-JUL-2015, 03-AUG-2015, 05-AUG-2015, 06-AUG-2015, 07-AUG-2015, 12-AUG-2015, 25-AUG-2015, 04-SEP-2015, 10-SEP-2015, 14-SEP-2015, 17-SEP-2015 and 21-SEP-2015, the patients were vaccinated with doses of improperly stored GARDASIL (Lot # K011325, expiry date: 08-APR-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports 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 certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On 13-APR-2015, 16-APR-2015, 17-APR-2015, 20-APR-2015, 05-MAY-2015, 06-MAY-2015, 21-MAY-2015, 16-JUN-2015, 17-JUN-2015, 19-JUN-2015, 24-JUN-2015, 08-JUL-2015, 13-JUL-2015 and 14-JUL-2015, the patient were vaccinated with doses of improperly stored oral, ROTATEQ (Lot # K010217, expiry date: 31-MAY-2016 (also reported as 03-MAY-2016)). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports 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 physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of VAQTA lot # K005958, expiration date 09-FEB-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age. The patient's pertinent medical history or concurrent conditions were not provided. On 28-OCT-2015, the patient was vaccinated with a dose of improperly stored MMR II, lot # reported as L011528, expiration date: 03-APR-2017, (dose, route and anatomical location were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 28-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L023587, expiration date: 26-JUN-2017, (dose, route and anatomical location were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of children of unknown age and gender. On unknown dates, the children were vaccinated with improperly stored doses of oral ROTATEQ (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date between 03-AUG-2015 and 24-AUG-2015, the patient was vaccinated with the second dose in the PROQUAD (Merck) that was improperly stored (Lot # L007230, expiration date: 03-SEP-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # K010523, expiration date 25-FEB-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received form a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On 14-JUL-2015, 15-JUL-2015, 20-JUL-2015, 27-JUL-2015, 31-JUL-2015, 10-AUG-2015, 12-AUG-2015, 03-SEP-2015, 04-SEP-2015, 09-SEP-2015, 15-SEP-2015, 16-SEP-2015, 17-SEP-2015, 30-SEP-2015, 02-OCT-2015, 05-OCT-2015 and 12-OCT-2015, the patients were vaccinated with doses of improperly stored ROTATEQ (Lot # K023530, expiry date: 23-MAY-2016). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker who worked at a state immunization program referring to multiple unspecified patients of unknown age and gender. On multiple unspecified dates these patients were vaccinated with doses of improperly stored GARDASIL (dose was not reported, lot# K009482 with expiration 06-MAR-2017; lot # K009482 with expiration 06-MAR-2017; lot # K006124 with expiration 02-FEB-2017). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored doses of PEDVAXHIB (lot # L006545, exp.date: 16-NOV-2017) (route and dose were not reported). No adverse effects were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. 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 physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of oral ROTATEQ lot # K001831, expiration date 21-OCT-2015, by oral route (dose and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of children of unknown age and gender. On unknown dates, the children were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, referring to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unspecified date in October 2015, (reported as "between 05-OCT-2015 and 26-OCT-2015) the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (route, dosage, strength and lot# were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of two 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 certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On 04-MAY-2015, 13-MAY-2015, 19-MAY-2015, 20-MAY-2015, 21-MAY-2015, 10-JUN-2015, 11-JUN-2015, 15-JUN-2015, 23-JUN-2015 and 29-JUN-2015, the patients were vaccinated with doses of improperly stored oral ROTATEQ (Lot # K009182, expiry date: 26-APR-2016). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports 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 physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date 02-MAR-2017 and lot # K008621, expiration date 04-MAR-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. Pertinent medical history and concurrent conditions were not reported. On 19-OCT-2015, the patient was vaccinated with a dose of GARDASIL (lot # K010215, expiration date May 2017) 1 shot (strength, dose and route were not provided). Concomitant medication was not reported. The physician reported that the patient experienced a syncope expressed as "passed out" 15 seconds after getting the shot while using GARDASIL. The patient also received influenza virus vaccine (unspecified) reported as "the flu shot" in their other arm at the same time. The patient did not seek medical attention and no treatment was given for syncope. The patient recovered of syncope the same day on 19-OCT-2015. The reporter did not assess the relatedness of GARDASIL to syncope. Additional information is not expected because the physician did not have specific information to provide.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. Pertinent medical history and concurrent conditions were not reported. On 19-OCT-2015, the patient was vaccinated with a dose of GARDASIL (lot # K010215, expiration date May 2017) 1 shot (strength, dose and route were not provided). Concomitant medication was not reported. The physician reported that the patient experienced a syncope expressed as "passed out" 15 seconds after getting the shot while using GARDASIL. The patient also received influenza virus vaccine (unspecified) reported as "the flu shot" in their other arm at the same time. The patient did not seek medical attention and no treatment was given for syncope. The patient recovered of syncope the same day on 19-OCT-2015. The reporter did not assess the relatedness of GARDASIL to syncope. Additional information is not expected because the physician did not have specific information to provide.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dizziness, Headache, Pain, Paraesthesia
Clinical narrative: Headache, body aches and pains, dizziness, lightheadedness, tingling all over body. Temp 99-101 degrees from Friday PM to Saturday PM. Urgent care visit recommended alternating TYLENOL/ibuprofen. Ran 5K 3-4 h before shot. Better on Sunday.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: This report was received from a pharmacist via Pfizer and was assigned manufacturer report number 2015348600 for PREVNAR 13 regarding a female of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. In approximately 2009 (reported as six years ago), the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In approximately 2009, the patient had an allergic reaction to the PNEUMOVAX 23. Her arm swollen and red for two weeks after she received PNEUMOVAX 23. The reporter queried for literature. At the time of the report, the outcome of her arm swollen and red for two weeks was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient states the notice a painful rash on right thigh on 30 Oct 15. Patient saw her doctor on 31 Oct 15. The doctor diagnosed her with shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist 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 an unknown date, in 2014 (reported as "last year"), the patient was vaccinated with the first dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On 21-OCT-2015, the patient was vaccinated with the second dose of ZOSTAVAX lot # L028281, expiration date 28-OCT-2016 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. In May 2015 (reported as "five months ago"), the patient was vaccinated with a dose of PNEUMOVAX 23. Then on 29-OCT-2015, the patient was inadvertently given an extra dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not provided). The patient's outcome regarding the extra dose administered was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Chills, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from the patient's wife via an online experience survey and refers to a male patient of unknown age. The patient's pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date the patient, (reported as "on Friday", the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose, strength, route of administration and anatomical route were not reported). There was no concomitant medication reported. On an unknown date, almost immediately after the vaccination, the patient started to feel ill and experienced myalgia, nausea, chills, pyrexia of almost 103 degrees. The reporter stated that the patient was sick the entire weekend (date was not provided) until his fever broke on Sunday night (date was not specified). Additionally, the reporter stated that "he (the patient), spent the entire time in bed and missed a 50th birthday party and visiting relatives". At the reporting time, the outcome of myalgia, nausea, chills and malaise was unknown. The outcome of pyrexia was reported as recovered on an unspecified date. Additional information is not expected as no reporter details were provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Respiratory tract infection
Clinical narrative: This spontaneous report was received from a 62 year old female patient regarding herself. The patient's pertinent medical history included shingles twice, rheumatoid arthritis and breast cancer. The patient was allergic to morphine. On 14-OCT-2015, the patient was vaccinated with ZOSTAVAX (dose, frequency: 1 injection) in the right arm. Concomitant therapies included acyclovir and prednisone. On 16-OCT-2015, the patient experienced joint pain and on 18-OCT-2015, the patient had upper respiratory infection. The patient sought medical attention and cefdinir was given as treatment to the events. The outcome of joint pain and upper respiratory infection was reported as not recovered/not resolved. The relatedness of the events with ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Full blood count, Immediate post-injection reaction, Injection site pain, Tenderness
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 61 year old female patient with hepatic cancer, diabetes mellitus and chronic pain. On 16-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L012215, dose of 0.5 ml with exp. on 13-JAN-2017, intramuscular in left deltoid. Concomitant therapies included Vitamin D2, promethazine (manufacturer unknown), PROZAC, metformin, lisinopril (manufacturer unknown), PERCOCET, REQUIP, NEURONTIN, AMBIEN and ZANTAC. On 16-OCT-2015, immediately following the PNEUMOVAX 23 administration there was mild pain at injection site. The nurse practitioner stated that the patient reported having "quite a bit of pain at the injection site when she went to bed". Then on 17-OCT-2015, the patient experienced a contusion referred as "she had bruising in her left arm above the antecubital area and was tender to the touch on the opposite side of the arm from the injection site". The nurse practitioner reported that there was "no pain, tenderness, or bruising at the site of injection". The patient sought medical attention by walking in to clinic and the treatment ordered for the patient was warm compresses. The nurse practitioner stated "they had a CBC drawn and ordered an ultrasound of the affected area to rule out blood clots". The outcome of contusion and injection site pain was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No pertinent or historical conditions were reported. On unspecified dates starting on or after 21-OCT-2015, the patients were administered an unspecified number of improperly stored doses of VAQTA (lot L013380, expiration date 04-NOV-2017, strength, dose and route unknown). No adverse effect was 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 certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with doses of improperly stored oral, ROTATEQ (Lot # reported as 1010126, expiry date: 22-JAN-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Menstruation delayed
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 16 year old, non-pregnant female patient. The patient's concurrent conditions and medical history were not reported. On 26-AUG-2015 the patient was vaccinated with a first dose of GARDASIL 9 (lot# and route were not reported). The patient reported to physician that following this dose of GARDASIL 9 the expected onset of her next menstrual period was delayed for an unspecified number of days (expected menstrual period start date and actual menstrual period start date were unspecified). The patient experienced abdominal cramping associated with this delayed menstrual period, which she never experienced with any menstrual period prior to receiving GARDASIL 9. The patient e-mailed to physician. There was no treatment given for adverse events and none of lab diagnostic studies were performed. As a result, the patient reported to physician, that she did not wish to continue the GARDASIL 9 series. The outcome of the patient's events was not reported. The relatedness between vaccination with GARDASIL 9 and the patient's events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of children of unknown age and gender. On unknown dates, the children were vaccinated with improperly stored doses of VAQTA (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's pertinent medical history or concurrent conditions were not provided. The reporter stated that patient was vaccinated with two doses of ZOSTAVAX in a one year time frame. The first dose was received on unspecified date (lot # and expiry date were not provided), and second dose was received on 27-OCT-2015 (Lot # L028284, expiry date on 28-OCT-2016). At the time of the report, no adverse effects have been reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of children of unknown age and gender. On unknown dates, the children were vaccinated with improperly stored doses of M-M-R II (Lot number K015374 with expiration date 18-SEP-2016; Lot number K018965 with expiration date 15-OCT-2016; Lot number L003855 with expiration date 05-FEB-2017; reported lot number L007578 withe expiration date 05-MAR-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via a field representative regarding a 60 year old female patient. No historical or concurrent conditions were reported. On approximately 08-OCT-2015 ("about two weeks ago"), the patient was vaccinated with ZOSTAVAX subcutaneously (lot# unspecified). No concomitant medications were reported. On approximately 10-OCT-2015 ("Two days after receiving the injection"), the patient reported back to the pharmacist with complaints of redness and swelling at the injection site. The pharmacist stated the injection site was "warm to the touch". The patient sought medical attention - returned to the pharmacy. The pharmacist recommended BENADRYL and TYLENOL. No Product Quality Issue (PQC) was reported. The outcome of the events were unknown. Causality assessment was not provided. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 28-OCT-2015 the patient was inadvertently vaccinated with expired dose of MMR II (strength, dose, frequency were not reported) lot # J013131 expiry date of 17-OCT-2015. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of children of unknown age and gender. On unknown dates, the children were vaccinated with improperly stored doses of GARDASIL (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (Lot # reported as 1008574, expiry date: 22-NOV-2016) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No pertinent or historical conditions were reported. On unspecified dates starting on or after 21-OCT-2015, the patients were administered an unspecified number of improperly stored doses of M-M-R II (lot K024035, expiration date 26-NOV-2016, lot L003856, expiration date 02-MAY-2017, lot L009214, expiration date 17-MAR-2017, lot  L012479, expiration date 10-APR-2017, albumin status was rHA, strength, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse via company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL 9 (lot # and route unknown). On an unknown date the patient experienced  possible injection site reaction. The outcome was unknown. 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 certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On 21-JUL-2015, 24-JUL-2015, 28-JUL-2015, 29-JUL-2015, 03-SEP-2015, 10-SEP-2015, 14-SEP-2015, 28-SEP-2015, 29-SEP-2015, 01-OCT-2015, 02-OCT-2015, 05-OCT-2015, 07-OCT-2015, 12-OCT-2015, 20-OCT-2015 and 21-OCT-2015, the patients were vaccinated with doses of improperly stored ROTATEQ (Lot # K010755, expiry date: 19-MAY-2016) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema multiforme, Herpes simplex serology, Measles antibody, Mumps antibody test, Mycoplasma test
Clinical narrative: 5 October 2015 12 months old female received her 1-year-old vaccines to include MMR, varicella, and PREVNAR 13. Patient did well until approximately 5 days later on 10 October 15m pt developed a rash. Mother provided photos which were consistent with erythema multiforme. Also ED physician note and dermatologist both whom visualized the lesions concur with EM. Rash resolved without treatment after 5 days.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash, Rubella antibody test, Varicella virus test
Clinical narrative: 5 October 2015 12 months old female received her 1-year-old vaccines to include MMR, varicella, and PREVNAR 13. Patient did well until approximately 5 days later on 10 October 15m pt developed a rash. Mother provided photos which were consistent with erythema multiforme. Also ED physician note and dermatologist both whom visualized the lesions concur with EM. Rash resolved without treatment after 5 days.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL (lot # K010215, exp.date: 05-MAY-2017) (route and dose were not reported). No adverse effects were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure to product, Eye irritation
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age. No information about medical history, concurrent conditions was reported. The nurse practitioner reported that a patient had GARDASIL (unspecified lot and expiration date) inadvertently splashed in her eye on 18-AUG-2015. No adverse effects reported. Follow up information has been received on 27-OCT-2015 from the nurse practitioner, referring to a 48 year old female patient. The accidental exposure to GARDASIL was on 18-AUG-2015 at 11:00 A.M., lot # K008931. The patient's eye got burned and she went to the emergency room (ER) for an eye wash. The outcome of eye burns was reported as recovered on 18-AUG-2015. The patient was not ill at the time of the accidental exposure. Additional information is not expected as all correspondence requested was received.
Age: 0.77
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a 9 month old infant patient of unknown gender. Concurrent conditions and medical history were unknown. On an unknown date the infant patient was vaccinated with a pediatric dose of VAQTA 25/0.5 (units not reported) lot # L018499 expiry date- 25-FEB-2017 in error. Concomitant medications were unknown. The reporter did not provide the causality between the event and the suspect therapy. No adverse event was reported. No PQC involved. 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 patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (lot# K023432, expiration date 18-JUN-2016 or Lot # K011562, expiration date 08-APR-2017) (Strength, dose and route were not provided). Concomitant mediation was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date between 03-AUG-2015 and 24-AUG-2015, the patient was vaccinated with the second dose in the (Oka-Merck) PROQUAD series that was improperly stored (Lot # L007230, expiration date: 03-SEP-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: 68-year-old female c/o large local reaction to left upper arm after receipt of PREVNAR 13. Exam revealed large erythematous patch 18 x 16 cm to left upper arm with central induration 7x9 cm, tender to touch. The affected area is approx. one half of her upper arm, and does not extend to either her elbow or shoulder and is not circumferential. There are no papules, pustules, vesicles or erosions. See AHLTA Note attached for details of assessment and treatment by DHA-IHB provider.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Silver-dollar sized red spot at injection site.