chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, the patient experienced herpes sine herpete following administration of ZOSTAVAX. The outcome of adverse event was unknown. The relatedness between adverse event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (dose, strength, frequency and route were not reported) lot # K010647, expiration date 30-OCT-2015 and lot # L002422, expiration date 23-APR-2016. No adverse effect reported. 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 referring to a patient of unknown age and gender. The patient's medical history and drug allergies were not reported. On 17-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K018183, expiration date of 04-MAY-2016, dose strength and route unknown). No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Anxiety, Bursitis, Mumps antibody test negative, Osteoporosis, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 60 year old female patient. The patient's pertinent medical history was not reported and was allergic to Penicillin. It was reported the patient does not know if she had received the MMR II in the past but that it was a possibility that she had received it. On an unknown date as the patient aged, she developed osteoporosis, anxiety, Achilles bursitis and vitamin D deficiency. On 28-JUL-2015, the patient had a blood test and results showed she had no immunity to rubella and mumps. On 06-AUG-2015, the patient was vaccinated with MMR II (lot # K011189 and expiration date 12-AUG-2016) (dose and route were not reported). Concomitant therapies included XANAX, LEXAPRO, EPIPEN and hydrocortisone suppositories. Action taken was not applicable. The outcome of events was reported as not recovered/not resolved. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Vitamin D deficiency
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 60 year old female patient. The patient's pertinent medical history was not reported and was allergic to Penicillin. It was reported the patient does not know if she had received the MMR II in the past but that it was a possibility that she had received it. On an unknown date as the patient aged, she developed osteoporosis, anxiety, Achilles bursitis and vitamin D deficiency. On 28-JUL-2015, the patient had a blood test and results showed she had no immunity to rubella and mumps. On 06-AUG-2015, the patient was vaccinated with MMR II (lot # K011189 and expiration date 12-AUG-2016) (dose and route were not reported). Concomitant therapies included XANAX, LEXAPRO, EPIPEN and hydrocortisone suppositories. Action taken was not applicable. The outcome of events was reported as not recovered/not resolved. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Blood test normal, Chills, Decreased appetite, Inflammation
Clinical narrative: 4/27/2015 - Appointment with Dr. Review cholesterol blood tests. Order for new blood tests given for Cholesterol/Prostate for 10/26/2015 appt. PREVNAR 13 (pneumonia) shot. 5/02/2015 - Started arm/shoulder joint and muscle pain. 5/06/2015 - Continuing arm/shoulder joint and muscle pain plus chills, appetite loss. Unable to lift both arms above waist. Started taking Ibuprofen for pain and inflammation. 5/08-10/2015 - Arm/shoulder joints and muscles extremely painful. 5/11-7/06/2015 - Unable to sleep in bed lying down. Sleeping in living room on couch and/or recliner. (Small naps 20-30 minutes). 5/11/2015 - Made appointment with Dr. for increasing pain. Order Blood tests and gave blood tests. 5/12/2015 - Test results all OK. 5/14/2015 - Dr. sent referral to Arthritis and Rheumatology for an appointment. 5/18/2015 - Dr. sent referral to Orthopedic for an appointment. 5/19/2015 - Made appointment with Dr. of Orthopedic for 5/29/2015. 5/20/2015 - Made appointment with Dr. of Arthritis and Rheumatology for 6/03/2015. 5/23/2015 - Made appointment with Dr. for increasing pain. Ordered more blood tests. Prescribed Indomethacin 50mg for pain. Told to reschedule appointment with Dr. of Orthopedic for 5/29/2015 to after appointment with Dr of Arthritis and Rheumatology for 6/03/2015. Gave blood tests and rescheduled appointment with Dr. of Orthopedic to 6/13/2015. 5/24-28/2015 - Still cannot sleep in bed due to severe upper arm, shoulder, and neck pain. 5/26-31/2015 - Swelling in left foot for unknown reason.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Mobility decreased, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: 4/27/2015 - Appointment with Dr. Review cholesterol blood tests. Order for new blood tests given for Cholesterol/Prostate for 10/26/2015 appt. PREVNAR 13 (pneumonia) shot. 5/02/2015 - Started arm/shoulder joint and muscle pain. 5/06/2015 - Continuing arm/shoulder joint and muscle pain plus chills, appetite loss. Unable to lift both arms above waist. Started taking Ibuprofen for pain and inflammation. 5/08-10/2015 - Arm/shoulder joints and muscles extremely painful. 5/11-7/06/2015 - Unable to sleep in bed lying down. Sleeping in living room on couch and/or recliner. (Small naps 20-30 minutes). 5/11/2015 - Made appointment with Dr. for increasing pain. Order Blood tests and gave blood tests. 5/12/2015 - Test results all OK. 5/14/2015 - Dr. sent referral to Arthritis and Rheumatology for an appointment. 5/18/2015 - Dr. sent referral to Orthopedic for an appointment. 5/19/2015 - Made appointment with Dr. of Orthopedic for 5/29/2015. 5/20/2015 - Made appointment with Dr. of Arthritis and Rheumatology for 6/03/2015. 5/23/2015 - Made appointment with Dr. for increasing pain. Ordered more blood tests. Prescribed Indomethacin 50mg for pain. Told to reschedule appointment with Dr. of Orthopedic for 5/29/2015 to after appointment with Dr of Arthritis and Rheumatology for 6/03/2015. Gave blood tests and rescheduled appointment with Dr. of Orthopedic to 6/13/2015. 5/24-28/2015 - Still cannot sleep in bed due to severe upper arm, shoulder, and neck pain. 5/26-31/2015 - Swelling in left foot for unknown reason.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: 4/27/2015 - Appointment with Dr. Review cholesterol blood tests. Order for new blood tests given for Cholesterol/Prostate for 10/26/2015 appt. PREVNAR 13 (pneumonia) shot. 5/02/2015 - Started arm/shoulder joint and muscle pain. 5/06/2015 - Continuing arm/shoulder joint and muscle pain plus chills, appetite loss. Unable to lift both arms above waist. Started taking Ibuprofen for pain and inflammation. 5/08-10/2015 - Arm/shoulder joints and muscles extremely painful. 5/11-7/06/2015 - Unable to sleep in bed lying down. Sleeping in living room on couch and/or recliner. (Small naps 20-30 minutes). 5/11/2015 - Made appointment with Dr. for increasing pain. Order Blood tests and gave blood tests. 5/12/2015 - Test results all OK. 5/14/2015 - Dr. sent referral to Arthritis and Rheumatology for an appointment. 5/18/2015 - Dr. sent referral to Orthopedic for an appointment. 5/19/2015 - Made appointment with Dr. of Orthopedic for 5/29/2015. 5/20/2015 - Made appointment with Dr. of Arthritis and Rheumatology for 6/03/2015. 5/23/2015 - Made appointment with Dr. for increasing pain. Ordered more blood tests. Prescribed Indomethacin 50mg for pain. Told to reschedule appointment with Dr. of Orthopedic for 5/29/2015 to after appointment with Dr of Arthritis and Rheumatology for 6/03/2015. Gave blood tests and rescheduled appointment with Dr. of Orthopedic to 6/13/2015. 5/24-28/2015 - Still cannot sleep in bed due to severe upper arm, shoulder, and neck pain. 5/26-31/2015 - Swelling in left foot for unknown reason.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medication, drug reactions or allergies were not reported. On 07-AUG-2015 the patient was vaccinated with an expired dose of GARDASIL 9, intramuscular, lot number reported as J011960, expiration date 06-AUG-2015, (anatomical location, dose and dose number were not reported). No adverse effects were reported. Lot number J011960 is an invalid lot number for GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (Lot# K004483, expiration date 16-AUG-2015; K004487; expiration date 21-AUG-2015) dose and route of administration were not provided. No adverse effect reported. This service request was first opened on 30-JUN-2015, when a pharmacist called to reported a vaccine temperature excursion but any adverse event was reported at that time. However, this adverse event was reported on 11-AUG-2015, during a call back by this healthcare worker. 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: This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (J012567, expiration date: 30-JAN-2016; K006682; 17-DEC-2015), dose and route of administration were not provided. No adverse effect reported. This service request was first opened on 30-JUN-2015, when a pharmacist called to report a vaccine temperature excursion but any adverse event was reported at that time. However, this adverse event was reported on 11-AUG-2015, during a call back by this healthcare worker. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Initial and follow up information was received from a nurse practitioner via company representative, regarding on a 26 year old female patient. Patient's medical history or concurrent conditions were not provided. On 04-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9, intramuscular (strength, lot number and expiration date not provided). There was no concomitant therapies reported. On 04-AUG-2015, the patient tired and drained few hours after the vaccination with GARDASIL 9. Then, 6 to 8 hours after vaccination, loss of appetite and body aches, 12 to 14 hours later, the patient felt headache and had a sore throat. It was reported that when the patient woke up, the morning of this report (05-AUG-2015), her condition had worsened. The patient contacted the nurse practitioner, and was advised to go to Emergency Room (ER) for treatment. It was unspecified whether the patient was admitted to the hospital from the unspecified emergency room. It was unspecified whether the patient intended to continue GARDASIL 9 series, due to these adverse effects. The relationship between decreased appetite, asthenia, fatigue, headache and oropharyngeal pain with GARDASIL 9 was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: Initial and follow up information was received from a nurse practitioner via company representative, regarding on a 26 year old female patient. Patient's medical history or concurrent conditions were not provided. On 04-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9, intramuscular (strength, lot number and expiration date not provided). There was no concomitant therapies reported. On 04-AUG-2015, the patient tired and drained few hours after the vaccination with GARDASIL 9. Then, 6 to 8 hours after vaccination, loss of appetite and body aches, 12 to 14 hours later, the patient felt headache and had a sore throat. It was reported that when the patient woke up, the morning of this report (05-AUG-2015), her condition had worsened. The patient contacted the nurse practitioner, and was advised to go to Emergency Room (ER) for treatment. It was unspecified whether the patient was admitted to the hospital from the unspecified emergency room. It was unspecified whether the patient intended to continue GARDASIL 9 series, due to these adverse effects. The relationship between decreased appetite, asthenia, fatigue, headache and oropharyngeal pain with GARDASIL 9 was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Peripheral swelling, Urticaria
Clinical narrative: This spontaneous report was received from a 71 year old female patient, reporting on herself. The patient had no pertinent concurrent conditions, medical history or drug reactions. On 14-AUG-2015, in a local pharmacy, the patient was vaccinated with a dose of ZOSTAVAX one time subcutaneous injection in the arm (dose and Lot No. were not reported). There were no concomitant medications. On 15-AUG-2015, the day after receiving vaccination, the patient experienced severe injection site pain. She had a welt on her arm that turned red and began to swell. The patient saw her physician, three days after receiving the ZOSTAVAX and was prescribed KEFLEX. No laboratory tests were performed. The outcome of urticaria, peripheral swelling, erythema and injection site pain was reported as recovering. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a 71 year old female patient, reporting on herself. The patient had no pertinent concurrent conditions, medical history or drug reactions. On 14-AUG-2015, in a local pharmacy, the patient was vaccinated with a dose of ZOSTAVAX one time subcutaneous injection in the arm (dose and Lot No. were not reported). There were no concomitant medications. On 15-AUG-2015, the day after receiving vaccination, the patient experienced severe injection site pain. She had a welt on her arm that turned red and began to swell. The patient saw her physician, three days after receiving the ZOSTAVAX and was prescribed KEFLEX. No laboratory tests were performed. The outcome of urticaria, peripheral swelling, erythema and injection site pain was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PEDVAXHIB (Lot# J011963, 20-JUN-2016; J013943, 14-AUG-2016; J015437, 09-OCT-2016; J016186, 24-OCT-2016; K002747, 09-DEC-2016) dose and route of administration were not provided. No adverse effect reported. This service request was first opened on 30-JUN-2015, when a pharmacist called to report a vaccine temperature excursion but any adverse event was reported at that time. However, this adverse event was reported on 11-AUG-2015, during a call back by this healthcare worker. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Weight bearing difficulty
Clinical narrative: Red, swollen, warm to touch and painful unable to bear weight on leg. (Right leg).
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of MMR II, lot number K018965, expiration date 15-OCT-2016, (dose and route were not reported). There was no concomitant medication reported. No adverse effect was reported. No product quality complaint was involved. It was unknown if the patients sought medical attention. 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: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 03-FEB-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms 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 a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 16-FEB-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a nurse referring to a 5 year old patient. On 11-AUG-2015, the patient was vaccinated with PROQUAD (dose, frequency and indication were not reported, lot # L009210 with exp. date 17-SEP-2017). Nurse reported that the patient received an unspecified amount of partial dose of PROQUAD due to a malfunction of a safety syringe. The patient had not experienced an adverse effect. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody, Mumps antibody test, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a health professional concerning a female patient of unknown age. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with MMR II (dose, route, frequency and lot no. unspecified). On an unspecified date, the patient had a serological testing for measles, mumps and rubella, and the titers came back negative for protection against rubella. It was also stated that the patient was going to see the physician on an unspecified date. The outcome of negative for protection against rubella was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse via a company representative referring to an 18 year old male patient. The patient's concurrent condition and medical history were not reported. On 13-AUG-2015 the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose and route were unknown) (it was not reported which dose in the vaccine series he was given). On 13-AUG-2015, the patient experienced syncope after receiving therapy with GARDASIL. The patient sought medical attention by office visit. The patient was given water, instructed to elevate his feet and lay down for 15 minutes. The outcome of syncope was reported as recovering/resolving. Additional information is not expected as the reporter asked not to be contacted.
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 patients of unknown age and gender. Medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with GARDASIL (lot # K011562 with expiration date of 08-APR-2017; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 40 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2015 the patient was vaccinated with expired doses of MMR II HSA, lot # J006953, (dose and route were not reported). This dose of MMR II had an expiration date of 07-JUN-2015. No adverse events were reported. This is one of several cases 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 Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of MMR II (HSA, lot# K001230 with expired date 27-JAN-2016, lot# K014833 with expired date of 14-SEP-2016, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 3 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2015 the patient was vaccinated with expired doses of MMR II HSA, lot # J006953, (dose and route were not reported). This dose of MMR II had an expiration date of 07-JUN-2015. No adverse events were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an 8 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2015 the patient was vaccinated with expired doses of MMR II HSA, lot # J006953, (dose and route were not reported). The dose of MMR II had an expiration date of 07-JUN-2015. No adverse events were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12 year old male patient. Pertinent medical history or drug allergies/drug reactions were not reported. On 19-AUG-2014, the patient was vaccinated with GARDASIL (dose, strength and route of administration were not reported). There was not concomitant medication reported. On 19 AUG-2014, after the patient received the vaccination, he fainted (syncope). The reporter stated that the patient sought medical attention (he was in doctors office). At the reporting time, the outcome of syncope was reported as recovered/resolved (date was not specified). Additional information is not expected as the reporter did not consent to contact the patient's physician.
Age: 2.0
Sex: F
Vaccine: FLU3, MMR, MMR
Symptoms: Alopecia, Arthritis, Breast swelling, Cough, Diarrhoea
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 2 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. The patient did not take any concomitant medication. On 13-FEB-2015, the patient was vaccinated with the first dose of M-M-R II lot # K003806, expiration date 13-MAR-2016, subcutaneous (exact dose was not reported). On 13-FEB-2015, in the evening, the patient experienced fever. On an unknown date in 2015 the patient developed a rash that looked like the measles covering her entire body. The patient was treated with ibuprofen and unspecified gel for her skin. On an unknown date in 2015, reported as "now" the patient experienced seizures and her hair was thinning out. In July 2015, the patient was hospitalized for a week. The patient underwent unspecified lab diagnostic studies but no results were provided. The patient's outcome was reported as not recovered. It was reported that therapy with M-M-R II was continued. Causality assessment was not provided. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU3, MMR, MMR
Symptoms: Dyspnoea, Infection, Local swelling, Measles, Pyrexia
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 2 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. The patient did not take any concomitant medication. On 13-FEB-2015, the patient was vaccinated with the first dose of M-M-R II lot # K003806, expiration date 13-MAR-2016, subcutaneous (exact dose was not reported). On 13-FEB-2015, in the evening, the patient experienced fever. On an unknown date in 2015 the patient developed a rash that looked like the measles covering her entire body. The patient was treated with ibuprofen and unspecified gel for her skin. On an unknown date in 2015, reported as "now" the patient experienced seizures and her hair was thinning out. In July 2015, the patient was hospitalized for a week. The patient underwent unspecified lab diagnostic studies but no results were provided. The patient's outcome was reported as not recovered. It was reported that therapy with M-M-R II was continued. Causality assessment was not provided. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU3, MMR, MMR
Symptoms: Rash generalised, Screaming, Seizure, Swelling face, Vomiting
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 2 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. The patient did not take any concomitant medication. On 13-FEB-2015, the patient was vaccinated with the first dose of M-M-R II lot # K003806, expiration date 13-MAR-2016, subcutaneous (exact dose was not reported). On 13-FEB-2015, in the evening, the patient experienced fever. On an unknown date in 2015 the patient developed a rash that looked like the measles covering her entire body. The patient was treated with ibuprofen and unspecified gel for her skin. On an unknown date in 2015, reported as "now" the patient experienced seizures and her hair was thinning out. In July 2015, the patient was hospitalized for a week. The patient underwent unspecified lab diagnostic studies but no results were provided. The patient's outcome was reported as not recovered. It was reported that therapy with M-M-R II was continued. Causality assessment was not provided. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU3, MMR, MMR
Symptoms: Alopecia, Laboratory test, Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 2 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. The patient did not take any concomitant medication. On 13-FEB-2015, the patient was vaccinated with the first dose of M-M-R II lot # K003806, expiration date 13-MAR-2016, subcutaneous (exact dose was not reported). On 13-FEB-2015, in the evening, the patient experienced fever. On an unknown date in 2015 the patient developed a rash that looked like the measles covering her entire body. The patient was treated with ibuprofen and unspecified gel for her skin. On an unknown date in 2015, reported as "now" the patient experienced seizures and her hair was thinning out. In July 2015, the patient was hospitalized for a week. The patient underwent unspecified lab diagnostic studies but no results were provided. The patient's outcome was reported as not recovered. It was reported that therapy with M-M-R II was continued. Causality assessment was not provided. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU3, MMR, MMR
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 2 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. The patient did not take any concomitant medication. On 13-FEB-2015, the patient was vaccinated with the first dose of M-M-R II lot # K003806, expiration date 13-MAR-2016, subcutaneous (exact dose was not reported). On 13-FEB-2015, in the evening, the patient experienced fever. On an unknown date in 2015 the patient developed a rash that looked like the measles covering her entire body. The patient was treated with ibuprofen and unspecified gel for her skin. On an unknown date in 2015, reported as "now" the patient experienced seizures and her hair was thinning out. In July 2015, the patient was hospitalized for a week. The patient underwent unspecified lab diagnostic studies but no results were provided. The patient's outcome was reported as not recovered. It was reported that therapy with M-M-R II was continued. Causality assessment was not provided. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Peripheral coldness, Raynaud's phenomenon, Systemic lupus erythematosus
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to a currently 17 year old female patient (daughter of the nurse). Patient's medical history, concomitant therapies or drug reactions/allergies were not reported. On 25-FEB-2009, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose and route of administration not provided). Other suspect therapies included an unspecified meningococcal vaccine and an unspecified Tdap vaccine, received on the same day. On 27-APR-2009, the patient was administered with her second dose of GARDASIL (lot #, expiration date, dose and route of administration not provided). On 27-AUG-2009, the patient was vaccinated with the third dose of GARDASIL (lot #, expiration date, dose and route of administration not provided). On an unknown date in 2010 (reported as 6 to 8 months after the last dose of GARDASIL), the patient started to experience cold and numbness in her feet and was diagnosed with Raynaud's syndrome. On an unspecified date (reported as recently), the patient was also diagnosed with lupus. The outcome of lupus and Raynaud's syndrome was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, lupus was determined to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: HPV #1 -HA and body aches x 1 d after injection. HPV #2 - HA, body aches, with n/v x 2d after injection. Self treated at home.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives 24 hours after injection over left arm (deltoid), hives generalized to the all body.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Swelling
Clinical narrative: Redness right atm at inj site 1/2 dollar sized no fever no streaking. Swelling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Culture negative, Electroencephalogram, Endotracheal intubation, Febrile convulsion, Generalised tonic-clonic seizure
Clinical narrative: Complex tonic-clonic seizure probably febrile / required intubation / med flight / PICU stay.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Intensive care, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Complex tonic-clonic seizure probably febrile / required intubation / med flight / PICU stay.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count, Mean platelet volume decreased, Petechiae, Platelet count normal, Somnolence
Clinical narrative: Right leg below the knee-many scattered, non-blanching petechiae, one on sole of foot. This occurred within 5 hours of vaccine. Parent stated that infant was sleepy and vomited bottle. temp of 98.2.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting, White blood cell count normal
Clinical narrative: Right leg below the knee-many scattered, non-blanching petechiae, one on sole of foot. This occurred within 5 hours of vaccine. Parent stated that infant was sleepy and vomited bottle. temp of 98.2.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pain
Clinical narrative: 5 days after receiving HPV 9, pt started with soreness in R deltoid muscle.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: RED SWOLLEN SIZE OF 3 SILVER DOLLAR COINS.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Erythema, Lethargy, Peripheral swelling, Pruritus
Clinical narrative: Per patient report via MY CHART (email): "Whole upper arm from shoulder to mid upper arm; significant swelling observable to the eye, red, hot, painful for three full days. Could not on that arm for three nights. After the second day, the very red parts of the reaction began to itch. Felt no appetite and lethargic for first two days. => I will not be taking any further pneumonia vaccinations. Had a similar but less allergic response to the flu vaccine in the past => I will not be taking any further flu shots.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Per patient report via MY CHART (email): "Whole upper arm from shoulder to mid upper arm; significant swelling observable to the eye, red, hot, painful for three full days. Could not on that arm for three nights. After the second day, the very red parts of the reaction began to itch. Felt no appetite and lethargic for first two days. => I will not be taking any further pneumonia vaccinations. Had a similar but less allergic response to the flu vaccine in the past => I will not be taking any further flu shots.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever and body aches especially in the legs the night of vaccine. Swelling, redness, and pain at the site of the injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: PATIENT IS EXPERIENCING RASH AND ITCHING AT THE INJECTION SITE. SHE IS NOT HAVING ANAPHYLAXIS REACTIONS, I RECOMMENDED TO TAKE BENADRYL AND CONTACT HER DR. I HAVE ALSO INFORMED HER DOCTOR ALSO AND WILL FOLLOW UP WITH HER LATER.
Sex: U
Vaccine: MMR
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 15-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: IPV, PNC13, TDAP
Symptoms: Decreased appetite, Erythema, Fatigue, Hypotension, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 72-years-old female patient received PREVNAR 13, via an unspecified route of administration in her right arm on 10Jun2015, single dose. On the same day, the patient concurrently received the Tdap IPV in her left arm. The patient was healthy and received PNEUMOVAX 23 in 2013. On 11Jun2015, the patient was admitted to the hospital with hypotension and fatigue, the next day, on 12Jun2015, she developed a fever of a 103 degrees, nausea, vomiting and a decreased appetite. On 13Jun2015 the patient experienced that the right arm was swollen and red, the reporter thought the patient had developed lymphadenitis, there was a 19 centimeter long rash towards the patient's lymphnodes. The reporter prescribed antibiotics, and prednisone. The patient was seen again on 19Jun2015, and everything was back to normal, except for that the injection site was still pink, but the swelling had subsided.
Age: 72.0
Sex: F
Vaccine: IPV, PNC13, TDAP
Symptoms: Lymphadenitis, Nausea, Peripheral swelling, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 72-years-old female patient received PREVNAR 13, via an unspecified route of administration in her right arm on 10Jun2015, single dose. On the same day, the patient concurrently received the Tdap IPV in her left arm. The patient was healthy and received PNEUMOVAX 23 in 2013. On 11Jun2015, the patient was admitted to the hospital with hypotension and fatigue, the next day, on 12Jun2015, she developed a fever of a 103 degrees, nausea, vomiting and a decreased appetite. On 13Jun2015 the patient experienced that the right arm was swollen and red, the reporter thought the patient had developed lymphadenitis, there was a 19 centimeter long rash towards the patient's lymphnodes. The reporter prescribed antibiotics, and prednisone. The patient was seen again on 19Jun2015, and everything was back to normal, except for that the injection site was still pink, but the swelling had subsided.
Age: 72.0
Sex: F
Vaccine: IPV, PNC13, TDAP
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 72-years-old female patient received PREVNAR 13, via an unspecified route of administration in her right arm on 10Jun2015, single dose. On the same day, the patient concurrently received the Tdap IPV in her left arm. The patient was healthy and received PNEUMOVAX 23 in 2013. On 11Jun2015, the patient was admitted to the hospital with hypotension and fatigue, the next day, on 12Jun2015, she developed a fever of a 103 degrees, nausea, vomiting and a decreased appetite. On 13Jun2015 the patient experienced that the right arm was swollen and red, the reporter thought the patient had developed lymphadenitis, there was a 19 centimeter long rash towards the patient's lymphnodes. The reporter prescribed antibiotics, and prednisone. The patient was seen again on 19Jun2015, and everything was back to normal, except for that the injection site was still pink, but the swelling had subsided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Pain, redness and swelling at the injection site. Unable to lift arm.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Pruritus, Respiratory tract congestion, Swelling face
Clinical narrative: 45 min post injection pt had facial and eye swelling, itching and congestion. Given 25mg BENADRYL with relief  in 1 hr, complete  recovery by 3 hrs.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Dyskinesia, Tic, Trismus
Clinical narrative: Vaccine administered 3/9-within a few days my son was making involuntary neck/shoulder movements. 2nd vaccination was on 5/27-started having involuntary jaw movements a few days later.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Injection site rash
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female physician of unknown age, who is the patient. No pertinent medical history or concurrent conditions were reported. The patient's allergies included reactions to unspecified allergens. On 13-AUG-2015 the patient was vaccinated with ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not provided). No concomitant medications were reported. On 15-AUG-2015, the patient experienced an anaphylactic reaction. No description of anaphylactic reaction was provided. As treatment, the patient administered herself epinephrine with an epi-pen. Then, the patient sought medical attention at the emergency room of an unspecified hospital. There the patient received unspecified treatment and was released to home. Also, on an unknown date, after the administration of ZOSTAVAX, the patient experienced a rash at the site of administration. The treatment for rash was unspecified. No product quality complaint was reported. The outcome of the anaphylactic reaction and administration site rash was reported as recovered, on an unspecified date in August 2015. The reporter did not assess the relationship between the events and the ZOSTAVAX. Upon internal review, the anaphylactic reaction was considered medically significant. Additional information is not expected because there is no permission to contact the physician.
Age: 46.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Mobility decreased, Musculoskeletal disorder, Pain
Clinical narrative: A day after shots my arm locked up and unable to use it, lift it. Its horrible pain and locks up at certain positions. Already a month gone by and I can move it a little more, not much. Went to chiropractor and got 2 electric stimulation sessions/
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable nurse manager (other HCP) and from a contactable medical assistant (other HCPs), who reported similar events for 3 patients. This is the second of three reports. A 72 year-old female patient received on 05Aug2015 PREVNAR 13 (lot number L77777, expiry date Jan2017, NDC number: 0005-1971-02) intramuscular on the left deltoid at 0.5 ml single. No vaccines were given four weeks prior or on the same date along with the suspect vaccine. Relevant medical history included rheumatoid arthritis, insomnia, chronic obstructive pulmonary disease, osteopenia, High blood pressure, chronic allergies (unspecified), gastrooesophageal reflux disease (GERD) or reflux all ongoing and hysterectomy in 1992. Concomitant medications included losartan (manufacturer unknown, tablet) oral at 100 mg, 1x/day, for blood pressure, methotrexate (manufacturer unknown, injection) subcutaneous at 1 mL/25mg once weekly for rheumatoid arthritis, Calcium + D (tablet) oral (Calcium 600mg]/[Vitamin D 200 units), at 1 dosage form daily as supplement, sulfasalazine (manufacturer unknown, tablet) oral at 1000 mg, 2x/day, for rheumatoid arthritis, temazepam (manufacturer unknown, capsule) oral, 15 mg one at night as needed for insomnia, DUONEB (nebulizer solution) at 0.5-2.5mg per 3mL solution, 3mLs or one vial every 6hrs as needed for shortness of breath and chronic obstructive pulmonary disease, folic acid (manufacturer unknown, tablet) oral at 1 mg, daily as supplement. The patient experienced localized cellulitis on unknown date and redness, itching and warm to touch on 13Aug2015 in the morning all events occurred at the site of injection. It was quite a large area of redness and it was warm to touch. The patient saw a nurse practitioner in their office on 13Aug2015 and cephalexin-at 500mg capsule, one capsule by mouth 4 times daily, treatment for 7 days was administered for cellulitis. It was unknown if the cellulitis was related to vaccine injection. Patient had not had cellulitis before. The outcome of cellulitis was unknown, the patient did not recover from the other reported events. Redness, itching and warm to touch was considered related to the vaccine. Medical assistant believed the events were related to the vaccine.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site streaking, Lymphadenopathy
Clinical narrative: Received immunizations Thursday afternoon Friday afternoon developed redness rx BENADRYL Saturday our redness increased and strek up (R) leg and only node (R) groin rx BACTRIM.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache
Clinical narrative: Headache and chills. Took TYLENOL and rested the entire day.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Cyanosis, Peripheral swelling, Pyrexia
Clinical narrative: Arm swell, 102F fever (4 hours after shot), shivering. Lips, fingers, toes turned slightly blue on 8/10/2015 at 3 PM. When he takes Ibuprofen slight blue color goes away.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to an approximately 15 year old male patient (16 year old at the reporting time). Information regarding relevant history and concurrent condition were not reported. "2 years ago", in approximately August 2013, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). "1 year ago", in approximately August 2014, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot # not reported) and at the reporting time of 13-AUG-2015, the patient would receive the third  dose of GARDASIL (dose, route and lot # not reported) (inappropriate schedule of drug administration). No adverse event was 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 patients of unknown age and gender. Medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with M-M-R II (lot # K005574 with expiration date of 17-APR-2016; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range(incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.11
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: erythema multiforme; developed 8/11-8/13 after vaccine given  8/3/2015.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: "Hot to touch", red, swollen, hard and itching.