chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Musculoskeletal pain, Myalgia
Clinical narrative: (L) upper arm - pain from neck to shoulder blade. Deep pain in muscle upper arm at site of injection. Initial redness/lump - now resolved.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Neck pain, Pain in extremity
Clinical narrative: (L) upper arm - pain from neck to shoulder blade. Deep pain in muscle upper arm at site of injection. Initial redness/lump - now resolved.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Couldn't move legs to get out of bed that night, in the morning was able to get out of bed, everything was normal again with no lingering effects.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age who is a medical assistant, regarding herself. Patient's concurrent conditions and relevant medical history was not reported. On 17-JUN-2014 the patient was vaccinated with M-M-R II (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date after vaccination with M-M-R II, the patient experienced pain and swelling in elbows, feet, hands and shoulders. The outcome of the events was reported as not recovered/not resolved. The causality of the events with M-M-R II was not reported. All the data provided was reconfirmed by the reporter. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer (the patient's wife) via Pfizer (MFR report number: 2014295257) refers to a male patient of unknown age. The patient's concurrent conditions and medical history was not provided. On an unkonwn date, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot number and expiration date were not reported). Concomitant therapies included influenza virus vaccine (unspecified). The consumer reported that, on an unknown date, after receiving PNEUMOVAX 23, her husband experienced unspecified adverse event. The outcome of adverse event was unkonwn. The relatedness between the event and the vaccination with PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Dyskinesia, Presyncope
Clinical narrative: This spontaneous report as received from a nurse via sales representative refers to a male patient of unknown age. There was no pertinent medical history. On an unknown date, the patient was vaccinated with the third dose of GARDASIL intramuscular (dose, lot #, expiration date were not reported). Concomitant medication included quadrivalent flu vaccine (dose, frequency and manufacturer were unspecified). In September 2014, the patient started to faint, but did not loose consciousness and his body began to jerk. On an unknown date, blood pressure test was performed (results were not provided). The patient sought medical attention, on an unknown date, he visited the office. The outcome of reported as recovered (recovery date was estimated as 2014). Causality assessment was not provided. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that on an unkonwn dates from 13-OCT-2014 through 29-OCT-2014, 2 doses of improperly stored PROQUAD (Merck) were inadvertently administered to the patients. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD (Merck) was not reported. Product quality issue was not involved. This case is linked to #1411USA003380 via same reporter link. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 45 year old female patient. Patient's pertinent medical history included rheumatoid arthritis. Other relevant medical history was not reported. On 11-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot number: K009809 with expiry date of 16-MAY-2015)(dose, frequency and route unspecified). Concomitant medications were not reported. The pharmacist reported that the patient experienced soreness at the injection site and at the shoulder after receiving PNEUMOVAX 23 on 1-SEP-2014. The pharmacist reported that the patient experienced the soreness for over 4 weeks and described that the pain was very bad and the patient felt like she broke her arm or shoulder. No treatment was given for the events. The patient did not sought medical attention. The pharmacist stated he would stop giving PNEUMOVAX 23 to his patients until further notice. The outcome of the events was reported as recovering/resolving. The causality of the events with PNEUMOVAX 23 was not reported. 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 patient of unknown age and gender. On 02-SEP-2014 the patient was vaccinated with a dose of VAQTA (lot number, expiration date, dose, route were not reported) that was improperly stored. No adverse effects were reported. This is one of 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On 09-OCT-2014, unspecified amount of patients were vaccinated with RECOMBIVAX HB lot # reported as J014855, expiry date 16-APR-2016 (dose, route of administration, were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. 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 licensed practical nurse refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On unknown dates, unknown number of patients have been administered PEDVAXHIB (lot number, dose, frequency and route unspecified) which was improperly stored. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PEDVAXHIB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On unknown dates, unknown number of patients have been administered VARIVAX (Merck) (lot number, dose, frequency and route unspecified) which was improperly stored. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Product quality issue was not involved. This is one of the several reports 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On 08-OCT-2014, unspecified amount patients were vaccinated with RECOMBIVAX HB lot # reported as J014855, expiry date 16-APR-2016 (dose, route of administration, were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. 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 Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates the patients were vaccinated with oral ROTATEQ (dose, lot number and route not provided), which was improperly stored since 28-OCT-2014. No adverse effects were 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 licensed practical nurse refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On unknown dates, unknown number of patients have been administered ROTATEQ (lot number, dose, frequency and route unspecified) which was improperly stored. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ROTATEQ was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On unknown dates, unknown number of patients have been administered GARDASIL (lot number, dose, frequency and route unspecified) which was improperly stored. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issues was not involved. This is one of the several reports 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 patient of unknown age and gender. On 14-OCT-2014 the patient was vaccinated with a dose of RECOMBIVAX HB (lot number, expiration date, dose, route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 26-SEP-2014 the patient was vaccinated with a dose of GARDASIL (lot number, expiration date, dose, route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information on her medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, dose number, route and site of injection, lot# and expiration date not reported. On an unknown date, after being administered ZOSTAVAX, the patient had shingles. The outcome of the adverse event was unknown. Relatedness between vaccination with ZOSTAVAX and the adverse event was not reported. 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 nurse practitioner refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that on an unknown dates from 13-OCT-2014 through 29-OCT-2014, 8 doses of improperly stored VARIVAX (Merck) were inadvertently administered to the patients. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Product quality issue was not involved. This case is linked to #1411USA001398 via same reporter link. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On 10-OCT-2014, unspecified amount patients were vaccinated with RECOMBIVAX HB lot # reported as J014855, expiry date 16-APR-2016 (dose, route of administration, were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old female patient. The patient had none pertinent medical history and none drug reactions or allergies. On 25-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). The patient did not take any concomitant medication. On 26-OCT-2014, the patient developed a tender, raised 5-6 inch rash at the injection site. On 26-OCT-2014, the patient also experienced fatigue and body aches. The patient sought medical attention, she was evaluated by the unspecified nurse practitioner but no treatment was prescribed. No lab diagnostics studies were performed. The outcome of body aches and fatigue was reported as recovering/resolving as the patient was still experiencing this symptoms. The outcome of a tender, raised 5-6 inch rash at the injection site was reported as recovered/resolved on an unspecified date in October 2014. The relatedness between the events and the vaccination with ZOSTAVAX was not provided. Additional information is not expected because there is no reporter's consent to further contact.
Sex: U
Vaccine: HEP
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. On an unspecified dates in 2014 (reported as "since 28-OCT-2014), an unspecified number of patients were administered with doses of RECOMBIVAX HB (doses, routes of administration, lot numbers and expiration dates were not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same reporter. 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 medical assistant refers to an unspecified patient of unknown age and gender. On 30-OCT-2014 the patient received an expired dose of M-M-R II (route, dose and frequency not reported, lot # H012571, expiration date 29-JUN-2014). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pain
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. In October 2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K009106, expiration date:) intramuscularly. In October 2014 (exact date unspecified) the patient developed an injection site reaction of redness, heat, hardness and pain. The affected area was approximately 8 inches. The patient also had body aches and fever (in October 2014). The physician described patient's symptoms as severe. The patient sought medical attention via office visit. At the time of the report the patient did not recover from the events. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. In October 2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K009106, expiration date:) intramuscularly. In October 2014 (exact date unspecified) the patient developed an injection site reaction of redness, heat, hardness and pain. The affected area was approximately 8 inches. The patient also had body aches and fever (in October 2014). The physician described patient's symptoms as severe. The patient sought medical attention via office visit. At the time of the report the patient did not recover from the events. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a 67 year old female patient with allergy to penicillin, refers to herself. No pertinent medical history was reported. On 27-OCT-2014 patient was vaccinated with PNEUMOVAX 23 (dose, route, lot # and expiration date were not provided) in the upper left arm at her local pharmacy. No concomitant medications were reported. On 28-OCT-2014, the next day after receiving the vaccine the patient developed swelling and redness at the injection site up to her lymph nodes under her arm and feels a complete achiness throughout her entire body. The patient sought medical attention via office visit on 29-OCT-2014. They physician advised her to report adverse effects that she developed as a result of receiving the PNEUMOVAX 23 vaccine and to take ADVIL and to use an ice pack for the swelling. No lab diagnostics studies were performed. At the time of the report the patient did not recover from the events. The events was considered to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified number of patients of unknown age. In July 2014, the patients were vaccinated with GARDASIL (dose, route and lot # not provided), that had been exposed to 1 degree Centigrade for 84 hours (temperature excursion was reported as "supported"). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The physician reported that, on 04-NOV-2014, the patient was vaccinated with expired dose of ZOSTAVAX subcutaneous (dose unspecified), lot # J003359, expiration date: 21-JUN-2014. No adverse effect was reported. 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 concerning unspecified number of patients of unknown age. In July 2014, the patients were vaccinated with RECOMBIVAX HB (dose, route and lot # not provided), that had been exposed to 1 degree centigrade for 84 hours (temperature excursion was reported as "supported"). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a male consumer of unknown age reporting on himself. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unspecified date, reported as "a few years ago", the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, anatomical location, lot/batch# and expiration date were not reported). On an unknown date (reported as "recently"), the patient was diagnosed with pneumonia. The outcome of pneumonia was unknown. The relatedness between PNEUMOVAX 23 and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, 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. On an unspecified dates in 2014 (reported as "since 28-OCT-2014), an unspecified number of patients were administered with GARDASIL (doses, routes of administration, lot numbers and expiration dates were not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health professional refers to an 8 year old patient. On an unknown date the patient was inadvertently vaccinated with a dose of oral ROTATEQ, (lot #, expiration date and dose unspecified) instead of an unspecified Influenza vaccine. The patient had already received 3 doses of oral ROTATEQ in the past as an infant so this was a fourth dose. No symptoms reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a registered nurse refers to a female patient of unknown age. No medical history was reported. On 26-AUG-2005, the patient was vaccinated with a first dose of VARIVAX (Merck) (lot #, expiry not reported0 0.5 ml, subcutaneous. On 25-MAR_2013, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot # H016578, expiry: 05-SEP-2014) 0.5 ml, subcutaneous. On 04-APR-2013, patient was confirmed as being 5 weeks pregnant. It was confirmed that she was given the second dose of VARIVAX (Merck) while pregnant. The patient became pregnant with last menstrual period (LMP) of 26-FEB-2013 and estimated delivery date (EDD) of 03-DEC-2013. The pregnancy outcome was outcome pending. No adverse effects noted. No treatment was received. Patient sought medical attention (office visit). Follow up has been received on 06-NOV-2014. No further information is available. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Pruritus, Pyrexia, Skin lesion
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old female patient. The patient's medical history included bronchiolitis. On 22-OCT-2014 the patient was vaccinated with a dose of PROQUAD (Merck) 0.5 ml, subcutaneously (lot# reported as K011311, expiration date: 14-FEB-2016). Concomitant therapies included albuterol sulfate (as needed). On 28-OCT-2014 the patient was taken to an emergency department in Hospital, with fever of 101F to 102F and "over 50 lesions." The nurse reported that the lesions were itchy. The patient was examined by her primary healthcare provider on 29-OCT-2014 and he diagnosed her with "classic chickenpox." The patient has not experienced an alteration in her appetite. The nurse did not know when the patient's symptoms began. The physician prescribed AVEENO bath and calamine lotion to ease the patient's discomfort. At the time of the report, the patient has not recovered. Causality was not provided. Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare professional (medical assistant) refers to a 18 month old patient (gender unspecified). On 08-SEP-2014, an 18 months old patient was vaccinated with ZOSTAVAX, 0.5ml, subcutaneous (lot # J014566, expiration date: 18-FEB-2015) when the patient supposed to receive VARIVAX (Merck). No dose of VARIVAX (Merck) was administered to the patient. No adverse effects were reported. 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 (certified medical assistant) refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of PEDVAXHIB injection (strength, dose, frequency, route of administration, indication, lot# and expiry date unspecified), that was exposed to temperatures outside of the proper storage range. No concomitant medications were reported. No adverse effect was reported. 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 concerning unspecified number of patients of unknown age. In July 2014, the patients were vaccinated with ROTATEQ (dose, route and lot # not provided), that had been exposed to 1 degree centigrade for 84 hours (temperature excursion was reported as "supported"). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported) that was exposed to temperatures outside of the proper storage range. There was no adverse effect. This is one of the four reports from the same reporter. (Linked to 1411USA002768, 1411USA002890 and 1411USA002892). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified number of patients of unknown age. In July 2014, the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot # not provided), that had been exposed to 1 degree centigrade for 84 hours (temperature excursion was reported as "supported"). No adverse effects were reported. This is one of several reports from the same source. 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 concerning unspecified number of patients of unknown age. In July 2014, the patients were vaccinated with VAQTA (dose, route and lot # not provided), that had been exposed to 1 degree centigrade for 84 hours (temperature excursion was reported as "supported"). No adverse effects were 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in 2014 (reported as "since 28-OCT-2014), an unspecified number of patient were administered with doses of ROTATEQ, oral route of administration (doses, lot numbers and expiration dates were not reported) that were improperly stored, No adverse events 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 as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in 2014 (reported as "since 28-OCT-2014), an unspecified number of patients were administered with doses of VAQTA (doses, routes of administration, lot numbers and expiration dates were not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to unspecified number of patients under the age of 50 years old of unknown gender. On an unknown dates, unspecified number of patients under the age of 50 years old were vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose, route were not reported). No concomitant medications were reported. No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates the patients were vaccinated with GARDASIL (dose, lot number and route not provided), which was improperly stored since 28-OCT-2014. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no drug reactions/allergies. Patient's concurrent conditions included: high blood pressure, high cholesterol, depression and diabetes. On 27-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX via intramuscular route, dose not reported (lot# reported as K010628, expiration date: 30-OCT-2015). Concomitant therapies included atenolol, DIOVAN HCT, ZOCOR, CYMBALTA, metformin hydrochloride and clonidine. On 28-OCT-2014 the patient developed hard, red area at the site of ZOSTAVAX injection. The patient sought medical attention, she went to see pharmacist. No treatment was given for the events. No laboratory diagnostic was performed. The patient is recovering from the events. Relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. On 27-OCT-2014, the patient was vaccinated with expired dose of ZOSTAVAX lot # J005721, exp. date: 29-AUG-2014) (dose, strength, site and route of administration not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On approximately 17-OCT-2014 (reported as "about one week or two weeks ago") the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml subcutaneously (lot # J011211) that had expired on 31-JUL-2014. No adverse effect reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 74 year old female patient. On an unknown date (reported as over 2 years ago) the patient was vaccinated with ZOSTAVAX (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date the patient experienced rash on her legs and groin that has persisted. The reporter stated that the patient also experienced rash that had blisters with fluid in them. The rash was appearing to be spots on the patient's legs and the patient reported that near her groin the lesions were still vesicular. The patient consulted her healthcare provided and the patient had used clobetasol and PROTOPIC topically. The outcome of events was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient in her fifties. On 17-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX, dose 0.65 ml, subcutaneous (lot number not reported). On 19-OCT-2014, the patient broke out in shingles. The pharmacist stated the client came into the pharmacy on 22-OCT-2014 and had shingles on right side from her neck down the right side of her body. The pharmacist stated client was experiencing pain; and the rash/blisters still remained. The pharmacist stated he would have the client followed up with her primary healthcare physician. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected as the consent for follow-up was not provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain
Clinical narrative: Patient claims she experienced a burning pain for about an hour after the vaccination. Then she noticed a raised "pus-like" rash at the injection site one day after the vaccine. She applied heat to it before noticing the rash. No systemic symptoms that she complains of. (She still has the rash today).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Skin discolouration
Clinical narrative: Itchy 24 hours after vaccine. Red, dark by Band-Aid area. Started to burn. No fever.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of VARIVAX (Merck) dose and route unknown (lot number unspecified) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnant before getting the vaccine. Initial exposure to VARIVAX (Merck) was at unknown week of gestation. The patient's last menstrual period (LMP) and estimated delivery date (EDD) were unspecified). The patient was exposed to VARIVAX (Merck) during unspecified trimester. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. Follow-up information was received from a registered nurse via telephone call.  The nurse stated that she vaguely remembers reporting the event, but she has no additional information to report at this time. Nurse stated she cannot remember patient's name and she believes she reported this event on behalf of someone else. No further information is available at this time. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported) that was exposed to temperatures outside of the proper storage range. There was no adverse effect. This is one of the four reports from the same reporter. (Linked to 1411USA002890, 1411USA002891 and 1411USA002892). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported) that was exposed to temperatures outside of the proper storage range. There was no adverse effect. This is one of the four reports from the same reporter. (Linked to 1411USA002768, 1411USA002890 and 1411USA002891). Additional information has been requested.
Age: 0.55
Sex: U
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV5
Symptoms: Irritability, Pyrexia, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse concerning to her child who is a 6 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. The reporter stated that on 24-SEP-2014, instead of receiving third dose of RECOMBIVAX the patient was inadvertently vaccinated with first dose of VAQTA (lot number: K007791 with expiry date of 22-AUG-2016) (dose, frequency and route unspecified) in the left thigh. On the same day the patient also received PREVNAR (lot number, dose, frequency and route unspecified, ROTATEQ (lot number, dose, frequency and route unspecified) and PENTACEL (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. The reporter stated that initially patient was typical, fussy and irritable with mild fever after vaccination. The reporter also stated that there were no adverse effects and the patient was completely fine. The outcome of the events was unknown. The causality of the events with the suspect therapies was not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported) that was exposed to temperatures outside of the proper storage range. There was no adverse effect. This is one of the four reports from the same reporter. (Linked to 1411USA002768, 1411USA002891 and 1411USA002892). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, 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 27-OCT-2014 patients were inadvertently vaccinated with improperly stored GARDASIL intramuscular injection (dose, strength, site and route of administration not reported). No adverse effect reported. This is one of the 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 healthcare worker, refers to an unspecified number of patients of unknown age and gender. On 27-OCT-2014 patient were inadvertently vaccinated with improperly stored ROTATEQ oral (dose, strength not reported). No adverse effect reported. This is one of the reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. In 2014 (reported as about month ago") the patient was vaccinated with VARIVAX (Merck) (dose and route of vaccination was not reported). In 2014 the patent was inadvertently administered VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Shoulder area of left arm became increasingly painful and now (almost 4 weeks later) have hard time reaching up or behind me to put on clothes.  At night cannot find a comfortable position in which to sleep.  Pain wakes me up.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Sleep disorder
Clinical narrative: Shoulder area of left arm became increasingly painful and now (almost 4 weeks later) have hard time reaching up or behind me to put on clothes.  At night cannot find a comfortable position in which to sleep.  Pain wakes me up.
Age: 43.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Muscle mass, Musculoskeletal pain, Nuclear magnetic resonance imaging normal, Pain, Tenderness
Clinical narrative: Extreme pain in right shoulder that night and for 4 to 5 days. Pain tapper off, but two lumps in the muscle were noted.  Sharp stabbing pain in right shoulder remain with certain movements and if resting on the right arm. Have had ultra sound and MRI that are negative for anything. Currently the doctor thinks this could possible be Chronic Regional Pain Syndrome or bursitis because pain remains after more than one month.
Age: 43.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Ultrasound scan normal
Clinical narrative: Extreme pain in right shoulder that night and for 4 to 5 days. Pain tapper off, but two lumps in the muscle were noted.  Sharp stabbing pain in right shoulder remain with certain movements and if resting on the right arm. Have had ultra sound and MRI that are negative for anything. Currently the doctor thinks this could possible be Chronic Regional Pain Syndrome or bursitis because pain remains after more than one month.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Syncope
Clinical narrative: Patient dizzy after vaccine laid back and appear to have fainted. Recovered in less than 30 seconds awake alert and oriented.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Erythema, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Localized redness, soreness, itching, swelling and muscle stiffness at shot site on arm.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Localized redness, soreness, itching, swelling and muscle stiffness at shot site on arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: Extreme chills with body shaking.  Fever went to 102.3 headache developed later. Took Tylenol.  The next day fever abated to 99.7.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: Malaise and achy and onset of fever of 100F. Was ill for 2 days. Felt like the flu. I received an MMR immunization for work requirements.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphemia
Clinical narrative: After picking patient up from child care around 6:00 pm, His father and I had noticed our son had developed a stutter. He has never stuttered before or had any problems with his speech until after the influenza vaccine.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Cough, Eye pruritus, Feeling abnormal, Headache
Clinical narrative: Soreness, where shot was given.  Itchy Eyes, Cough, Every bone in body hurt. Felt like I had been in a car wreck.  Headache.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Soreness, where shot was given.  Itchy Eyes, Cough, Every bone in body hurt. Felt like I had been in a car wreck.  Headache.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Throwing up and Fever.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: Started to feel fatigue with headache. Before the flu shot, I felt in great health and was able to exercise with no problem. The day after the vaccination, I started to feel under the weather and symptoms got much worse on the weekend.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Throwing up, Fever.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Significant swelling and soreness at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: Hard knot at injection site the next morning - pt was informed that was a listed side effect and to let us know the next day if it subsides or not.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Chest pain, Fatigue, Headache, Pyrexia
Clinical narrative: Grogginess, headache, chest pain, fever above 101 degrees, congestion, cough, exhaustion, abdominal cramping lasting more than 2 weeks.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Somnolence
Clinical narrative: Grogginess, headache, chest pain, fever above 101 degrees, congestion, cough, exhaustion, abdominal cramping lasting more than 2 weeks.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pharyngeal oedema
Clinical narrative: Swelling and redness in arm where Fluvirin and Pneumovax were administered. Patient also reports some swelling in throat. Advised to take diphenhydramine qid and seek MD today. Patient states her daughter will take her to MD today.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling, and pain at injection site.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Severe headache...still lasting today 11/09. Same thing happened last year after receiving flu shot.  Last year the headache lasted one month!!!
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Pt had fever and swollen red arm.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Hypoaesthesia, Hypoaesthesia oral, Nerve conduction studies abnormal, Paraesthesia
Clinical narrative: Recived the flu shot on 10/28/14. A couple hours later my left arm started going numb and continued to stay numb. Came to work 10/29/14 it still numb. But the numbness and the tingling started coming down my left ribs and up the left side of my face and my lips was numb on my way home that night. The next day the 10/30/14 I went to ER room. I was having facial drooping and completey numbness and tingling in my left upper body and arm and face. After ER dr had seen me and ordered blood work and conducted a neuro test he had determined my left side to be greatly decreased from my right side. He consulted my Primary and a Neuro Dr. They continued to watch me for a few hours and they had agreed it was a reaction to flu shot and had started me on prednisone for 10 day. I was to follow up with primary MD on Tuesday and if the tingling and numbness was not better by Tuesday I am to see a neuro Dr. and I was instructed to not lift with my left arm and if I got any burning or the symptoms I was having got worse to get back to the ER immediately.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis, Vaccination complication
Clinical narrative: Recived the flu shot on 10/28/14. A couple hours later my left arm started going numb and continued to stay numb. Came to work 10/29/14 it still numb. But the numbness and the tingling started coming down my left ribs and up the left side of my face and my lips was numb on my way home that night. The next day the 10/30/14 I went to ER room. I was having facial drooping and completey numbness and tingling in my left upper body and arm and face. After ER dr had seen me and ordered blood work and conducted a neuro test he had determined my left side to be greatly decreased from my right side. He consulted my Primary and a Neuro Dr. They continued to watch me for a few hours and they had agreed it was a reaction to flu shot and had started me on prednisone for 10 day. I was to follow up with primary MD on Tuesday and if the tingling and numbness was not better by Tuesday I am to see a neuro Dr. and I was instructed to not lift with my left arm and if I got any burning or the symptoms I was having got worse to get back to the ER immediately.