chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Fear of injection, Full blood count, Human chorionic gonadotropin, Hypersensitivity, Hypoacusis
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13-year-old female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 23-MAR-2017, the patient was vaccinated with the third dose of properly stored GARDASIL 9 injection, lot # M017983 with expiry date on 30-MAY-2018 (dose and route of administration were not reported). On the same day, approximately 3 minutes after administration of the vaccine, the patient was seated in a chair and observed by her mother and the reporting medical assistant. The patient was sitting upright and rigid in the chair with her arms bent at the elbow, hands drawn up to her shoulders and her head "back". The medical assistant stated that the patient appeared unresponsive for about a minute and then became responsive and "seemed completely all right after that." At that time, the patient was examined by a physician, who recommended a further examination at the local emergency department. The physician, reporting medical assistant and the mother of the patient continued to observe the patient for following 17 minutes and the family of the patient and the physician felt comfortable enough to allow the patient to be transported via the family's car to the emergency department. It was reported that the patient sought a medical attention. The outcome of the event was considered as recovered/resolved on 23-MAR-2017. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of appearing unresponsive was considered to be medically significant. Additional information is not expected because there was no consent to contact the physician.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Hypotension, Metabolic function test, Rash, Restlessness, Seizure
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13-year-old female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 23-MAR-2017, the patient was vaccinated with the third dose of properly stored GARDASIL 9 injection, lot # M017983 with expiry date on 30-MAY-2018 (dose and route of administration were not reported). On the same day, approximately 3 minutes after administration of the vaccine, the patient was seated in a chair and observed by her mother and the reporting medical assistant. The patient was sitting upright and rigid in the chair with her arms bent at the elbow, hands drawn up to her shoulders and her head "back". The medical assistant stated that the patient appeared unresponsive for about a minute and then became responsive and "seemed completely all right after that." At that time, the patient was examined by a physician, who recommended a further examination at the local emergency department. The physician, reporting medical assistant and the mother of the patient continued to observe the patient for following 17 minutes and the family of the patient and the physician felt comfortable enough to allow the patient to be transported via the family's car to the emergency department. It was reported that the patient sought a medical attention. The outcome of the event was considered as recovered/resolved on 23-MAR-2017. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of appearing unresponsive was considered to be medically significant. Additional information is not expected because there was no consent to contact the physician.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Syncope, Tinnitus, Visual impairment
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13-year-old female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 23-MAR-2017, the patient was vaccinated with the third dose of properly stored GARDASIL 9 injection, lot # M017983 with expiry date on 30-MAY-2018 (dose and route of administration were not reported). On the same day, approximately 3 minutes after administration of the vaccine, the patient was seated in a chair and observed by her mother and the reporting medical assistant. The patient was sitting upright and rigid in the chair with her arms bent at the elbow, hands drawn up to her shoulders and her head "back". The medical assistant stated that the patient appeared unresponsive for about a minute and then became responsive and "seemed completely all right after that." At that time, the patient was examined by a physician, who recommended a further examination at the local emergency department. The physician, reporting medical assistant and the mother of the patient continued to observe the patient for following 17 minutes and the family of the patient and the physician felt comfortable enough to allow the patient to be transported via the family's car to the emergency department. It was reported that the patient sought a medical attention. The outcome of the event was considered as recovered/resolved on 23-MAR-2017. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of appearing unresponsive was considered to be medically significant. Additional information is not expected because there was no consent to contact the physician.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Muscle rigidity, Posture abnormal, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13-year-old female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 23-MAR-2017, the patient was vaccinated with the third dose of properly stored GARDASIL 9 injection, lot # M017983 with expiry date on 30-MAY-2018 (dose and route of administration were not reported). On the same day, approximately 3 minutes after administration of the vaccine, the patient was seated in a chair and observed by her mother and the reporting medical assistant. The patient was sitting upright and rigid in the chair with her arms bent at the elbow, hands drawn up to her shoulders and her head "back". The medical assistant stated that the patient appeared unresponsive for about a minute and then became responsive and "seemed completely all right after that." At that time, the patient was examined by a physician, who recommended a further examination at the local emergency department. The physician, reporting medical assistant and the mother of the patient continued to observe the patient for following 17 minutes and the family of the patient and the physician felt comfortable enough to allow the patient to be transported via the family's car to the emergency department. It was reported that the patient sought a medical attention. The outcome of the event was considered as recovered/resolved on 23-MAR-2017. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of appearing unresponsive was considered to be medically significant. Additional information is not expected because there was no consent to contact the physician.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Deafness, Loss of consciousness
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13-year-old female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 23-MAR-2017, the patient was vaccinated with the third dose of properly stored GARDASIL 9 injection, lot # M017983 with expiry date on 30-MAY-2018 (dose and route of administration were not reported). On the same day, approximately 3 minutes after administration of the vaccine, the patient was seated in a chair and observed by her mother and the reporting medical assistant. The patient was sitting upright and rigid in the chair with her arms bent at the elbow, hands drawn up to her shoulders and her head "back". The medical assistant stated that the patient appeared unresponsive for about a minute and then became responsive and "seemed completely all right after that." At that time, the patient was examined by a physician, who recommended a further examination at the local emergency department. The physician, reporting medical assistant and the mother of the patient continued to observe the patient for following 17 minutes and the family of the patient and the physician felt comfortable enough to allow the patient to be transported via the family's car to the emergency department. It was reported that the patient sought a medical attention. The outcome of the event was considered as recovered/resolved on 23-MAR-2017. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of appearing unresponsive was considered to be medically significant. Additional information is not expected because there was no consent to contact the physician.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 76-year-old female patient with primary biliary cholangitis, reflex sympathetic dystrophy and none drug reactions or allergies. The patient had shingles in approximately 1958 when the patient was 18 year-old. There was no concomitant medication reported. On 21-MAR-2017, the patient was vaccinated with a dose of with ZOSTAVAX, 0.65ml, subcutaneously, lot number M027348 with expiration date 27-JUL-2017 to prevent shingles. On approximately 22-MAR-2017 "24 hours" after vaccination, the patient developed a rash "from her mid-spine to mid-breast on her left side". The patient sought medical attention by seeing an unspecified healthcare worker on 27-MAR-2017 in regards to the reaction and was diagnosed with shingles (herpes zoster). The patient was prescribed with gabapentin and lidocaine (manufacturer unknown) as treatment for the event. None laboratory diagnostics were performed. At the time of the report, the patient did not recover from the herpes zoster. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 76-year-old female patient with primary biliary cholangitis, reflex sympathetic dystrophy and none drug reactions or allergies. The patient had shingles in approximately 1958 when the patient was 18 year-old. There was no concomitant medication reported. On 21-MAR-2017, the patient was vaccinated with a dose of with ZOSTAVAX, 0.65ml, subcutaneously, lot number M027348 with expiration date 27-JUL-2017 to prevent shingles. On approximately 22-MAR-2017 "24 hours" after vaccination, the patient developed a rash "from her mid-spine to mid-breast on her left side". The patient sought medical attention by seeing an unspecified healthcare worker on 27-MAR-2017 in regards to the reaction and was diagnosed with shingles (herpes zoster). The patient was prescribed with gabapentin and lidocaine (manufacturer unknown) as treatment for the event. None laboratory diagnostics were performed. At the time of the report, the patient did not recover from the herpes zoster. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Nausea, Pruritus generalised
Clinical narrative: Information was received from a 65 year old female patient referring to herself. The patient had a slight case of shingles years ago. Concurrent conditions included high blood pressure and high cholesterol. Concomitant therapies included pravastatin, benazepril and amlodipine. The patient did not have drug reactions/allergies. On 24-FEB-2017 (reported as "Friday"), the patient was vaccinated with a dose of ZOSTAVAX (lot, expiration date, concentration, frequency and route were unknown) in the left arm for prevention of Shingles. And then at the night of 24-FEB-2017, the patient did not want to eat. Subsequently on 25-FEB-2017 (reported as "Saturday"), the patient had the chills and nausea. She laid under an electric blanket for about 3 or 4 hours, but she could not get warm; after that she began to sweat profusely. The patient also believed she had a fever (date unspecified), but she did not take her temperature, so did not know for sure. On 27-FEB-2017 (reported as "today"), the patient had a rash all over her body, in her hair and on face from the top of her head to her ankles. The patient was concerned that the rash on her face would go into her eyes. Also, the patient reported she had itches everywhere. The patient did not seek medical attention. No lab diagnostics study was performed. At the time of reporting, the patient did not recovered from the events. The causality between events and ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Information was received from a 65 year old female patient referring to herself. The patient had a slight case of shingles years ago. Concurrent conditions included high blood pressure and high cholesterol. Concomitant therapies included pravastatin, benazepril and amlodipine. The patient did not have drug reactions/allergies. On 24-FEB-2017 (reported as "Friday"), the patient was vaccinated with a dose of ZOSTAVAX (lot, expiration date, concentration, frequency and route were unknown) in the left arm for prevention of Shingles. And then at the night of 24-FEB-2017, the patient did not want to eat. Subsequently on 25-FEB-2017 (reported as "Saturday"), the patient had the chills and nausea. She laid under an electric blanket for about 3 or 4 hours, but she could not get warm; after that she began to sweat profusely. The patient also believed she had a fever (date unspecified), but she did not take her temperature, so did not know for sure. On 27-FEB-2017 (reported as "today"), the patient had a rash all over her body, in her hair and on face from the top of her head to her ankles. The patient was concerned that the rash on her face would go into her eyes. Also, the patient reported she had itches everywhere. The patient did not seek medical attention. No lab diagnostics study was performed. At the time of reporting, the patient did not recovered from the events. The causality between events and ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 27-FEB-2017, the patient inadvertently administered an expired M-M-R II dose (dose and frequency: 0.5ml, "once", lot # L001336, expiry date: 13-JAN-2017) subcutaneously for prophylaxis. No adverse effect was noted. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-MAR-2017, the patient was subcutaneously vaccinated with an expired dose of ZOSTAVAX lot# L032397, expiry date 26-NOV-2016 (dose was not reported). There was no side effect reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Bedridden, Erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and the 64 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. The patient had penicillin allergy. Concomitant therapies included COVARYX HS and cyclobenzaprine hydrochloride. On 20-FEB-2017, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (anatomical location was not reported) (lot # M035147 and expiration date 25-OCT-2017) to prevent shingles. On the same date (reported as right after receiving ZOSTAVAX), the patient experienced soreness at the injection site and she recovered of it on an unspecified date. On 24-FEB-2017 (reported as 4 days after taking ZOSTAVAX), the patient had pain in her stomach which radiated to her back; additionally she had a fever and was bedridden. These symptoms lasted for four days and the patient recovered on 27-FEB-2017. Then, on an unspecified date in 2017, the patient had pain (pain in extremity), swelling and redness of both feet; she also had a knot on each leg above her ankles which were sore. These symptoms also lasted 4 days and then, the patient recovered on an unspecified date. The patient did not experience any rashes or blisters. She did not seek medical attention when she was experiencing any symptoms and neither received any treatment. None diagnostic laboratory studies were performed. On 15-MAR-2017, the patient no longer had symptoms. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and the 64 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. The patient had penicillin allergy. Concomitant therapies included COVARYX HS and cyclobenzaprine hydrochloride. On 20-FEB-2017, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (anatomical location was not reported) (lot # M035147 and expiration date 25-OCT-2017) to prevent shingles. On the same date (reported as right after receiving ZOSTAVAX), the patient experienced soreness at the injection site and she recovered of it on an unspecified date. On 24-FEB-2017 (reported as 4 days after taking ZOSTAVAX), the patient had pain in her stomach which radiated to her back; additionally she had a fever and was bedridden. These symptoms lasted for four days and the patient recovered on 27-FEB-2017. Then, on an unspecified date in 2017, the patient had pain (pain in extremity), swelling and redness of both feet; she also had a knot on each leg above her ankles which were sore. These symptoms also lasted 4 days and then, the patient recovered on an unspecified date. The patient did not experience any rashes or blisters. She did not seek medical attention when she was experiencing any symptoms and neither received any treatment. None diagnostic laboratory studies were performed. On 15-MAR-2017, the patient no longer had symptoms. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered
Clinical narrative: This solicited report was received from a physician, referring to a 16 year old male patient, who was enrolled in a Market Research. The patient's medical history, concomitant therapies and concurrent conditions were not provided. On an unknown date, the patient was accidentally given the 4th dose of GARDASIL (lot#, expiration date, concentration and route were unknown) for prophylaxis.The reporter was not sure if the patient was already gave 3 or 2 doses, and this dose was an extra dose. The reporter considered the adverse event was not serious. Additional information is not expected, because the reporter is not willing to discuss further.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: This spontaneous report was received from a physician, via company representative, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies and concomitant therapies were unknown by the reporter. On unknown dates, the patient was vaccinated with two series of RECOMBIVAX HB (strength, dose, route, lot number and expiration date were not reported) for hepatitis B. On an unspecified date, serum hepatitis B surface antibody screen was performed (reported as "titers were drawn") and showed that the patient did not convert (Hepatitis B surface antibody negative). The patient sought medical attention due to the event. It was unknown if treatment was given for the event, or if other laboratories or intervention to prevent serious criteria were performed. The outcome of the event was unknown at the time of reporting.  The reporter did not provide a causality assessment between the event and the suspect vaccine. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Infertility, Lethargy, Mood altered, Seizure
Clinical narrative: This spontaneous report was received from a physician's assistant via unspecified, multiple parents and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with  GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not reported). No information about the patients' concomitant therapies was provided. On unknown dates, the patients experienced mood changes, fertility issues, seizures and lethargy.     The outcome of the events and the causality between the events and GARDASIL 9 were not reported. Upon internal review the event of seizure was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates in 2017 (reported as beginning sometime in January 2017), the patients were vaccinated with improperly stored doses of VAQTA (lot # M033611, expiration date: 02-MAR-2018)(dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of  93.04 degrees Fahrenheit for 8 hours and 42 minutes on 24-JAN-2017. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012513: US-009507513-1703USA012514: US-009507513-1703USA012512:
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Injection site inflammation, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a female patient in her late 50's. None concurrent condition, medical history or drug reactions /allergies were reported. In early February 2017, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route and anatomical location were unknown) for prevention of shingles. On an unknown date in 2017, the patient experienced pain from her shoulder down to her elbow (pain in extremity). Also the physician noted that there was some inflammation that had developed at the patient's injection site and a rash along her abdominal area was observed soon after the patient was administered the ZOSTAVAX. The patient also complained of some armpit pain (axillary pain) as well. The shoulder and elbow pain was problematic enough where it was effecting the patient's ability to sleep (insomnia). At the time of reporting, the outcome of injection site inflammation, insomnia, axillary pain and rash was reported as recovered/resolved. The outcome of pain in extremity, pain in shoulder and pain in elbow was reported as not recovered/not resolved. The patient saw her physician recently on an unknown date for a follow up visit. No Product quality complaint (PQC) was involved. The reporting physician did not assess the causal relationship between the adverse events and the therapy with ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Sleep disorder
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a female patient in her late 50's. None concurrent condition, medical history or drug reactions /allergies were reported. In early February 2017, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route and anatomical location were unknown) for prevention of shingles. On an unknown date in 2017, the patient experienced pain from her shoulder down to her elbow (pain in extremity). Also the physician noted that there was some inflammation that had developed at the patient's injection site and a rash along her abdominal area was observed soon after the patient was administered the ZOSTAVAX. The patient also complained of some armpit pain (axillary pain) as well. The shoulder and elbow pain was problematic enough where it was effecting the patient's ability to sleep (insomnia). At the time of reporting, the outcome of injection site inflammation, insomnia, axillary pain and rash was reported as recovered/resolved. The outcome of pain in extremity, pain in shoulder and pain in elbow was reported as not recovered/not resolved. The patient saw her physician recently on an unknown date for a follow up visit. No Product quality complaint (PQC) was involved. The reporting physician did not assess the causal relationship between the adverse events and the therapy with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 24 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD subcutaneouslly, lot # M031942, expiration date on 27-DEC-2017 (strength, dose number and anatomical location were not provided) for prophylaxis. Other suspect therapies included sterile diluent(manufacturer unknown) (strength, dose number and anatomical location were not provided) for prophylaxis. No adverse event reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9, lot number M034437 with expiration date 03-FEB-2019. The vaccines were exposed to previous temperatures excursions; also on 07-MAR-2017, the vaccines were exposed to temperature of +32.3F (Fahrenheit) during 5 hours and 7 minutes. Additionally on 20-MAR-2017, the vaccines were exposed to +23.4F (Fahrenheit) during 9 hours and 53 minutes. Data logger was filled. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates in 2017 (reported as beginning sometime in January 2017), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M033583, expiration date: 14-APR-2019; lot# M030380, expiration date: 01-FEB-2019 and lot # M024261, expiration date: 30-JUL-2018) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 93.40 degrees Fahrenheit for 8 hours and 42 minutes on 24-JAN-2017. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012513: US-009507513-1703USA012514: US-009507513-1703USA011060.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates in 2017 (reported as beginning sometime in January 2017), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M037248, expiration date: 21-FEB-2019) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of  93.04 degrees Fahrenheit for 8 hours and 42 minutes on 24-JAN-2017. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012514: US-009507513-1703USA012512: US-009507513-1703USA011060:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates in 2017 (reported as beginning sometime in January 2017), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M031807, expiration date: 02-APR-2018) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of  93.04 degrees Fahrenheit for 8 hours and 42 minutes on 24-JAN-2017. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012513: US-009507513-1703USA011060: US-009507513-1703USA012512:
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to one of two 5 months old patients (twins) the gender was unknown. The patient's medical history or concurrent conditions were not reported. On 28-SEP-2016, on 28-OCT-2016 and on 27-MAR-2017, a day before the patient was 6 months old, the patient was vaccinated with the first, second an third respectively doses of RECOMBIVAX HB the route was not reported (which had the lot # M039642, expiration date 03-JUL-2019). On unknown dates, and also on 27-MAR-2017, the patient was vaccinated with the first, second and third doses of ROTATEQ orally (which had the lot # M042822, expiration date 19-JUN-2018 or M039068, expiration date 19-APR-2018) both vaccines for prophylaxis. No adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012679:
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to one of two 5 months old patients (twins) the gender was unknown. The patient's medical history or concurrent conditions were not reported. On 28-SEP-2016, on 28-OCT-2016 and on 27-MAR-2017, a day before the patient was 6 months old, the patient was vaccinated with the first, second an third respectively doses of RECOMBIVAX HB the route was not reported (which had the lot # M039642, expiration date 03-JUL-2019). On unknown dates, and also on 27-MAR-2017, the patient was vaccinated with the first, second and third doses of ROTATEQ orally (which had the lot # M042822, expiration date 19-JUN-2018 or M039068, expiration date 19-APR-2018) both vaccines for prophylaxis. No adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012538:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown dates, the patients each were vaccinated with improperly stored doses of ROTATEQ (strength, dose, lot #, expiration date were not reported) (incorrect product storage). No adverse event was reported. The vaccines had been exposed under temperature 48.7 degrees Fahrenheit for 1 hour 30 minutes. There was no previous excursion reported. Data logger was involved. The nurse stated that she was unable to provide any patient identifiers, lot numbers, expiration dates or dates of vaccination, as she had stated when she called into our National Service Center. This is one of several reports received from the same reporter. Additional information is not expected as further information is not available.; Sender's Comments: US-009507513-1702USA001497: US-009507513-1703USA012893:
Age: 30.0
Sex: F
Vaccine: PNC13
Symptoms: Crying, Stomatitis, Vomiting
Clinical narrative: This is a spontaneous report obtained from a contactable consumer that reported for herself. A 30 year old female patient received, on 23Mar2017, PREVNAR 13 single dose, for immunization. Relevant medical history included Ehlers-Danlos syndrome, Painful Os Peroneum Syndrome (POPS syndrome), arrhythmia, fatigue and pain. Concomitant medications included tramadol 300 mg, once daily, for pain; RITALIN 10 mg, twice daily, for fatigue; and nadolol 40 mg, once daily, for arrhythmia. On 23Mar2017, the patient experienced uncontrollable crying, vomiting and mouth sores. Vomiting was treated with ZOFRAN but did not work. The patient did not recover from the event at time of this report.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Early next morning after shot, my shoulder was in high pain while at rest and in use. I though the pain would go away, so I continued my normal activities and exercises, but the next day the pain intensified and I started losing strength and mobility in shoulder and arm movement. Dr. prescribed OTC anti inflammatory pills, topical rub, exercises. The Physical Therapist provided TENZ unit, exercise techniques and regimen, and cortisone electric pad treatment.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HBPV, HIBV, RV1
Symptoms: Autism spectrum disorder, Developmental delay, Fall, Inability to crawl, Infantile spasms
Clinical narrative: Low fever; red from knee to hip on right leg; knot at one of two injection sites on right leg; sleepy; started falling backwards when seated; stopped trying to crawl; staring;at the time we didn't realize he was starting with small seizures until it was obvious on 6/10/2015.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HBPV, HIBV, RV1
Symptoms: Injection site erythema, Injection site nodule, Posture abnormal, Pyrexia, Seizure
Clinical narrative: Low fever; red from knee to hip on right leg; knot at one of two injection sites on right leg; sleepy; started falling backwards when seated; stopped trying to crawl; staring;at the time we didn't realize he was starting with small seizures until it was obvious on 6/10/2015.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HBPV, HIBV, RV1
Symptoms: Somnolence, Staring
Clinical narrative: Low fever; red from knee to hip on right leg; knot at one of two injection sites on right leg; sleepy; started falling backwards when seated; stopped trying to crawl; staring;at the time we didn't realize he was starting with small seizures until it was obvious on 6/10/2015.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site, approximately 1 inch in diameter.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-MAR-2017, the patient was vaccinated with an expired dose of PROQUAD lot # L034932, expiry date 03-MAR-2017 (dose and route of administration were not reported), which was reconstituted with sterile water diluent. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, regarding an unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX subcutaneous injection as a single dose (strength was not reported) (lot # M025870, expiration date 24-MAY-2018; lot #: M032493, expiration date: 06-JUL-2018) for prophylaxis. The patients were also administered sterile diluent (strength, lot number and expiration date were not reported). According to the reporter, VARIVAX doses had been exposed the following temperatures excursions: 22 degrees Fahrenheit (F) for 1 hour daily, during defrost cycle. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information is not expected as the reporter refused additional contact.; Sender's Comments: US-009507513-1703USA013063:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit ; 32 to 35 degrees Fahrenheit for 64 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012527: US-009507513-1703USA012528: US-009507513-1703USA012526:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit ; 32 to 35 degrees Fahrenheit for 64 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012527: US-009507513-1703USA012528: US-009507513-1703USA010513:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit ; 32 to 35 degrees Fahrenheit for 64 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA010513: US-009507513-1703USA012528: US-009507513-1703USA012526.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit; 32 to 35 degrees Fahrenheit for 64 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012527: US-009507513-1703USA010513: US-009507513-1703USA012526.
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on the site of injection on an unspecified date with outcome of unknown.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC
Symptoms: Pyrexia, Rash generalised
Clinical narrative: The child ran a fever of 100-103 from 3/21/2017 to 3/24/2017 and was given baby motrin to bring it down, which helped. On 3/24/2017, a mild spotted rash appeared over the child's entire body and lasted until 3/29/2017.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pneumoccal 23 given at time of visit. No reaction noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Left upper arm red swollen (4.5" by 3"), warm to touch.  Very irritating to client.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blindness, Dizziness, Migraine
Clinical narrative: Dizziness followed by her Eyes sight spontaneously going completely to a blackout state. Migraines.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Redness and dime size wheal above injection site in left arm. Denied itching. Dr examined. Cold pack applied to site and BENADRYL given.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Blindness, Dizziness, Electrocardiogram, Electroencephalogram, Fatigue
Clinical narrative: Tiredness, fell asleep almost immediately afterwards Vaccination was given. He woke up with Ophthalmic Migraines, dizziness followed by his eyes sight spontaneously going completely black.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Migraine with aura, Somnolence
Clinical narrative: Tiredness, fell asleep almost immediately afterwards Vaccination was given. He woke up with Ophthalmic Migraines, dizziness followed by his eyes sight spontaneously going completely black.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site infection, Injection site reaction, Injection site vesicles, Wound
Clinical narrative: PER PATIENT AREA OF INJECTION STARTED AS BLISTER, TURNED INTO OPEN WOUND THAT THEN GOT INFECTED. SAW PCP, TREATED WITH ANTIBIOTICS. RESOLVEED IN 1 WEEK.
Age: 2.0
Sex: F
Vaccine: MENB, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: None noted after 1 hour of monitoring.  Mom given anticipatory guidance as well as previously given handout on the vaccination.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Pt stated he started to feel numbness and tingling in lips 5-10 minutes after receiving vaccine. Pt then started to feel dizzy around 3:46 PM and a provider was brought over to immunizations clinic to evaluate patient. Vital signs were taken over the course of events, and patient maintained normal vitals. Provider had patient remain in clinic until 4:15 when patient stated that symptoms were subsiding.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient. The patient had no medical history, drug reactions or allergies and did not take any concomitant therapies.  On 08-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscular injection in the left upper arm (lot #M038216 and expiration day: 09-MAY-2018). On the same day, an hour after receiving the vaccination the patient had induration, a little redness, and hard around the area of the injection on the left upper arm. The patient sought for the medical attention and contacted with a pharmacist. The pharmacist advised to the patient to treat the adverse effects with an ice pack, acetaminophen (TYLENOL), and diphenhydramine hydrochloride (BENADRYL) for itching if it occurs, and go to urgent care if needed. The outcome of the event and the relatedness between the event and PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician assistant and refers to a currently (at the time of reporting) 17 year old female patient. The patient's concurrent condition included asthma. The patient had no concomitant medication nor drug reactions or allergies. On 07-MAR-2017, the patient was vaccinated with a dose of VARIVAX, 0.5 ml, subcutaneously, lot # M031969, expiry date 30-JUN-2018, for prophylaxis. After the patient received VARIVAX, the patient's chart was "reviewed" and it was noted that the patient was pregnant at the time of the VARIVAX administration. The patient's last menstrual period (LMP) date and estimated date of delivery (EDD) were not reported. The pregnancy outcome was pending. There were no lab diagnostic studies performed. Additional information has been requested.