chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: HPV2
Symptoms: Malaise, Sleep disorder
Clinical narrative: This case was reported by a regulatory authority via regulatory authority and described the occurrence of malaise in a 40-year old female subject who received CERVARIX. In August 2010, the subject received the 1st dose of CERVARIX (intramuscular). In March 2011, the dose was an unknown dose. On an unknown date, unknown after receiving CERVARIX, the subject experienced malaise, constipation, arthralgia, sleep disorder, headache, low back pain and difficulty in walking. On an unknown date, the outcome of the malaise, constipation, arthralgia, sleep disorder, headache, low back pain and difficulty in walking were unknown. It was not reported if the reporter considered the malaise, constipation, arthralgia, sleep disorder, headache, low back pain and difficulty in walking to be related to CERVARIX.
Age: 16.0
Sex: F
Vaccine: MMR, VARCEL, FLU4, HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Migrant child came in for vaccines. Received MMR and Varicella then noted positive urine pregnancy test. Manufacturers were notified.
Age: 16.0
Sex: F
Vaccine: MMR, VARCEL, FLU4, HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Migrant child came in for vaccines. Received MMR and Varicella then noted positive urine pregnancy test. Manufacturers were notified.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site atrophy, Injection site discolouration, Injection site dryness, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 85 year old female patient. The patient's pertinent medical history was unknown and drug reactions/allergies were not reported. On 03-MAY-2016, the patient was vaccinated with ZOSTAVAX vial 19400 (batch # L094529, expiry date 09-FEB-2017 and dose was not reported) subcutaneously. Concomitant therapies included alprazolam, celecoxib and esomeprazole. On the same day, "the patient experienced injection site pain immediately following the vaccination". On 15-JUN-2015, the patient came in to the pharmacy to inquire about "a hard lump the size of 2 peanut M&Ms "(injection site induration)(onset approximately in 2016). It was noted that there was a nodular area under the skin at the injection site and indented on surface (onset approximately in 2016). The skin also appeared dry and purple (onset approximately in 2016). The outcome of the events were reported as not recovered/not resolved. The reporter did not provide the causality assessment for the adverse events. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site atrophy, Injection site discolouration, Injection site dryness, Injection site induration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 85 year old female patient. The patient's pertinent medical history was unknown and drug reactions/allergies were not reported. On 03-MAY-2016, the patient was vaccinated with ZOSTAVAX vial 19400 (batch # L094529, expiry date 09-FEB-2017 and dose was not reported) subcutaneously. Concomitant therapies included alprazolam, celecoxib and esomeprazole. On the same day, "the patient experienced injection site pain immediately following the vaccination". On 15-JUN-2015, the patient came in to the pharmacy to inquire about "a hard lump the size of 2 peanut M&Ms "(injection site induration)(onset approximately in 2016). It was noted that there was a nodular area under the skin at the injection site and indented on surface (onset approximately in 2016). The skin also appeared dry and purple (onset approximately in 2016). The outcome of the events were reported as not recovered/not resolved. The reporter did not provide the causality assessment for the adverse events. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 85 year old female patient. The patient's pertinent medical history was unknown and drug reactions/allergies were not reported. On 03-MAY-2016, the patient was vaccinated with ZOSTAVAX vial 19400 (batch # L094529, expiry date 09-FEB-2017 and dose was not reported) subcutaneously. Concomitant therapies included alprazolam, celecoxib and esomeprazole. On the same day, "the patient experienced injection site pain immediately following the vaccination". On 15-JUN-2015, the patient came in to the pharmacy to inquire about "a hard lump the size of 2 peanut M&Ms "(injection site induration)(onset approximately in 2016). It was noted that there was a nodular area under the skin at the injection site and indented on surface (onset approximately in 2016). The skin also appeared dry and purple (onset approximately in 2016). The outcome of the events were reported as not recovered/not resolved. The reporter did not provide the causality assessment for the adverse events. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with abnormal cholesterol and osteoporosis. No information about medical history, drug reactions or allergies was provided. On 14-JUN-2016, the patient was vaccinated with PNEUMOVAX 23, dose 0.5 ml, intramuscularly (lot number: L022795; expiration date 5-NOV-2016). Concomitant therapies included LIPITOR and EVISTA. On an unknown date in June 2016, reported as within 24 hours of vaccination, the patient's arm became black and blue with significant swelling. There was no treatment given for events. The patient sought medical attention and contacted with the pharmacist, who advised her to contact with her physician. The patient had a medical appointment scheduled later same day, on 15-JUN-2016. The outcome of arm became black and blue with significant swelling was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with abnormal cholesterol and osteoporosis. No information about medical history, drug reactions or allergies was provided. On 14-JUN-2016, the patient was vaccinated with PNEUMOVAX 23, dose 0.5 ml, intramuscularly (lot number: L022795; expiration date 5-NOV-2016). Concomitant therapies included LIPITOR and EVISTA. On an unknown date in June 2016, reported as within 24 hours of vaccination, the patient's arm became black and blue with significant swelling. There was no treatment given for events. The patient sought medical attention and contacted with the pharmacist, who advised her to contact with her physician. The patient had a medical appointment scheduled later same day, on 15-JUN-2016. The outcome of arm became black and blue with significant swelling was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site mass
Clinical narrative: Information has been received from a pharmacist referring to a 62 years old female patient. The patient's medical history included shingles (resolved on approximately 21-MAY-2016, reported as 30 days prior to receiving ZOSTAVAX). The patient was allergic to penicillin, sulfa medications, iodine, morphine, cephalosporins, methadone. On 20-JUN-2016 the patient was vaccinated with ZOSTAVAX 0.65 ml/1 vial (0.65ml, lot # L032402, expiration date 26-NOV-2016) subcutaneously. Concomitant therapies included amlodipine and metoprolol.  On 21-JUN-2016, the patient experienced "a lump" at the injection site (left deltoid) that had been getting worse. Pharmacist instructed the patient to use hydrocortisone cream and cold compresses on the affected area. No lab diagnostics test was performed. On 01-JUL-2016 the patient called pharmacist and stated "I found 4 blistery bumps under the left breast, they looked like previous shingles rash I had before." The patient was advised to see a physician and the physician prescribed acyclovir and triamcinolone cream. The outcome of the injection site mass was reported as not recovered; the outcome of blistery bumps was unknown. Reporter's causality was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site mass, Rash vesicular
Clinical narrative: Information has been received from a pharmacist referring to a 62 years old female patient. The patient's medical history included shingles (resolved on approximately 21-MAY-2016, reported as 30 days prior to receiving ZOSTAVAX). The patient was allergic to penicillin, sulfa medications, iodine, morphine, cephalosporins, methadone. On 20-JUN-2016 the patient was vaccinated with ZOSTAVAX 0.65 ml/1 vial (0.65ml, lot # L032402, expiration date 26-NOV-2016) subcutaneously. Concomitant therapies included amlodipine and metoprolol.  On 21-JUN-2016, the patient experienced "a lump" at the injection site (left deltoid) that had been getting worse. Pharmacist instructed the patient to use hydrocortisone cream and cold compresses on the affected area. No lab diagnostics test was performed. On 01-JUL-2016 the patient called pharmacist and stated "I found 4 blistery bumps under the left breast, they looked like previous shingles rash I had before." The patient was advised to see a physician and the physician prescribed acyclovir and triamcinolone cream. The outcome of the injection site mass was reported as not recovered; the outcome of blistery bumps was unknown. Reporter's causality was not reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Angiogram, Borrelia test, Clostridium test, Computerised tomogram, Decreased appetite
Clinical narrative: Initial local soreness and discomfort of bicep, went then radiating pain into (L) jaw, numbness of jaw, numbness of (L) calf, diarrhea, weight loss, nausea. Lasted about 1 month prior to abating.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Diarrhoea, Fatigue, Hypoaesthesia, Injection site pain, Laboratory test
Clinical narrative: Initial local soreness and discomfort of bicep, went then radiating pain into (L) jaw, numbness of jaw, numbness of (L) calf, diarrhea, weight loss, nausea. Lasted about 1 month prior to abating.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Initial local soreness and discomfort of bicep, went then radiating pain into (L) jaw, numbness of jaw, numbness of (L) calf, diarrhea, weight loss, nausea. Lasted about 1 month prior to abating.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Pyrexia, Thyroid function test, Vision blurred
Clinical narrative: Initial local soreness and discomfort of bicep, went then radiating pain into (L) jaw, numbness of jaw, numbness of (L) calf, diarrhea, weight loss, nausea. Lasted about 1 month prior to abating.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Diarrhoea, Hypoaesthesia, Musculoskeletal discomfort, Nausea, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial local soreness and discomfort of bicep, went then radiating pain into (L) jaw, numbness of jaw, numbness of (L) calf, diarrhea, weight loss, nausea. Lasted about 1 month prior to abating.
Age: 19.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Nuclear magnetic resonance imaging brain normal, Pain, Pain in jaw, Tendonitis, Weight decreased
Clinical narrative: Initial local soreness and discomfort of bicep, went then radiating pain into (L) jaw, numbness of jaw, numbness of (L) calf, diarrhea, weight loss, nausea. Lasted about 1 month prior to abating.
Age: 2.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain upper, Urticaria
Clinical narrative: This spontaneous report as received from Nurse practitioner via consumer (patient mother) refers to a 12 year old male patient. The patient pertinent medical history included seasonal allergy. The patient drug reactions or allergies were none. On 07-JUN-2016, the patient was vaccinated with GARDASIL 9, intramuscular (Lot # L048459, Expiry: 22-FEB-2018). On 07-JUN-2016, the patient experienced stomach cramps. On 11-JUN-2016, after 4 days after the vaccination, the patient experienced hives. On an unknown date in June 2016, the patient mother gave the patient an unspecified dose of BENADRYL. The outcome of the events was reported as recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, concerning a female patient between 60-61 years old reporting on herself. The patient's medical history and concurrent conditions were not provided. In approximately 2015 (reported as "about one year ago"), the patient was vaccinated with ZOSTAVAX, "one time vaccination" (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported). The patient had no concomitant therapies. In approximately 2015 (reported as "about one year ago"), the patient experienced a "swelling welt on the site of injection but went away a week later" (vaccination site swelling and vaccination site urticarial). The patient did not receive treatment for the events and it was unknown if the patient sought medical attention. No product quality complaint was involved. The patient's outcome of vaccination site swelling and vaccination site urticarial. The causal relationship between the events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, concerning a female patient between 60-61 years old reporting on herself. The patient's medical history and concurrent conditions were not provided. In approximately 2015 (reported as "about one year ago"), the patient was vaccinated with ZOSTAVAX, "one time vaccination" (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported). The patient had no concomitant therapies. In approximately 2015 (reported as "about one year ago"), the patient experienced a "swelling welt on the site of injection but went away a week later" (vaccination site swelling and vaccination site urticarial). The patient did not receive treatment for the events and it was unknown if the patient sought medical attention. No product quality complaint was involved. The patient's outcome of vaccination site swelling and vaccination site urticarial. The causal relationship between the events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact.
Sex: M
Vaccine: FLUX, MMR, FLUX, MMR, TD
Symptoms: Condition aggravated, Pneumonia, Sickle cell anaemia
Clinical narrative: Case number PHEH2016US016881, is an initial spontaneous report received from a nurse on 01 Jul 2016. This report refers to a male patient. Past medical history included measles at the age 6 years without any prior immunization. Concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported), MMR II (unknown manufacturer, batch number: not reported) and TD (unknown manufacturer, batch number: not reported); in Nov 2010 (date unspecified). After vaccination, in Dec 2010, he was hospitalized with relapse of sickle cell and pneumonia. He received the treatment with unspecified pneumococcal vaccine (manufacturer unknown) while hospitalized but no other hospitalization details were available. Nurse stated no immunologic testing was completed on patient but that may happen in the future. The patient was doing great. The outcome of the events was reported as complete recovery. The events were assessed as serious and causality were not reported.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Myalgia, Paraesthesia, Peripheral coldness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of numbness in a 35-year-old female patient who received RABAVRT (batch number 586011AA, expiry date January 2019). On 28th JUNE 2016, the patient received RABAVERT 1ml. On 28th JUNE 2016, less than a day after receiving RABAVERT, the patient experienced numbness and tingling. On an unknown date, the patient experienced cold hands. On an unknown date, the outcome of the numbness, tingling and cold hands were not recovered/not resolved. It was unknown if the reporter considered the numbness, tingling and cold hands to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. The coordinator reported that, the patient experienced numbness and tingling from left hand fingertips to left arm and cheek and left hand fingers cold after receiving RABAVERT. This case has been linked with case US2016084171, reported by the same reporter.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of numbness in a 35-year-old female patient who received RABAVRT (batch number 586011AA, expiry date January 2019). On 28th JUNE 2016, the patient received RABAVERT 1ml. On 28th JUNE 2016, less than a day after receiving RABAVERT, the patient experienced numbness and tingling. On an unknown date, the patient experienced cold hands. On an unknown date, the outcome of the numbness, tingling and cold hands were not recovered/not resolved. It was unknown if the reporter considered the numbness, tingling and cold hands to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. The coordinator reported that, the patient experienced numbness and tingling from left hand fingertips to left arm and cheek and left hand fingers cold after receiving RABAVERT. This case has been linked with case US2016084171, reported by the same reporter.
Sex: F
Vaccine: MENB, MENB
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of redness in a 10-year old female patient who received BEXSERO (batch number 151501, expiry date December 2016). On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 6 days after receiving BEXSERO, the patient experienced redness and itching. On an unknown date, the outcome of the redness and itching were unknown. It was unknown if the reporter considered the redness and itching to be related to BEXSERO. Additional details were provided as follows: The patient's age at vaccination was not reported. The reporter stated that, the patient after receiving BEXSERO experienced redness and itchiness. No further information was reported regarding the event.
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of redness in a 10-year old female patient who received BEXSERO (batch number 151501, expiry date December 2016). On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 6 days after receiving BEXSERO, the patient experienced redness and itching. On an unknown date, the outcome of the redness and itching were unknown. It was unknown if the reporter considered the redness and itching to be related to BEXSERO. Additional details were provided as follows: The patient's age at vaccination was not reported. The reporter stated that, the patient after receiving BEXSERO experienced redness and itchiness. No further information was reported regarding the event.
Age: 21.0
Sex: M
Vaccine: JEV1
Symptoms: Drug dispensed to wrong patient, Wrong drug administered
Clinical narrative: Patient was administered the wrong vaccine due to patient misidentification by staff member at approximately 1400 on July, 12, 2016.
Sex: U
Vaccine: HPV9
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. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 17-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 11-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with improperly stored PROQUAD batch# M010478, expiry date: 01-SEP-2017 (dose#, route and site of administration not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the six reports received from the same reporter.
Sex: U
Vaccine: HPV9
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. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 26-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported) (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 06-JUL-2016 the patient was inadvertently vaccinated with M-M-R II (lot # J006139 with expiration date 17-APR-2015, subcutaneous; therapy type and dose not reported) which was expired. Concomitant therapy was not provided. No adverse effect reported. 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 medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' current conditions, concomitant therapies or medical history provided. On unknown dates, patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB lot # L045117, expiration date 06-OCT-2018 (dose was not reported). There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion of 29 degree Fahrenheit for 1 hour on unknown date. Data logger was involved. This is several report received from the same source. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 16 unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD lot # M001152, expiry date: 05-JUL-2017 (also reported as 05-JUL-2107), (dose#, route and site of administration not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the six reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about patients' current conditions, concomitants therapies or medical history provided. On unknown dates, patient were administered unspecified number of improperly stored doses of GARDASIL 9, lot # M003659 expiration date 20-SEP-2017 (dose was not reported). There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion of 29 degree Fahrenheit for 1 hour on an unknown date. Data logger was involved. This is one of several reports reported by the same reporter. Additional information is not expected because there was no consent to contact physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a female patient of unknown age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details not provide) via subcutaneous route. Reporting physician stated that on an unknown date after vaccination, the patient developed severe pain at the injection site. The patient required medical attention and called her physician. It was unspecified if the patient received any treatment for the adverse event or not. Outcome of the event was reported as recovered. Reporting physician had not assessed the causality of the event with respect to therapy with ZOSTAVAX. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare administrator referring to a patient of unknown age and gender. On 23-JUN-2016 the patient was vaccinated with improperly stored oral ROTATEQ (lot# L048854, expiration date 31-AUG-2017, dose not reported) orally. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to as many as 30 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. In July 2016 (reported as "between 05-JUL-2016 and 09-JUL-2016"), the patients were each administered improperly stored doses of VAQTA lot # M009377, expiration date 17-JUN-2017 (dose and route of administration were not reported). The vaccines underwent a temperature excursion of 48 degrees Fahrenheit for 15 hours. Digital Data Logger was involved. There was no previous excursion. No adverse effects reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Diarrhoea, Musculoskeletal pain, Nausea, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with end stage renal disease. The patient's drug reactions or allergies were unknown by the reporter. On 17-JUN-2016 (also reported as on 17-JUN-2017), the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # M005727, once, route of administration and expiration date were not reported) for prevention of shingles. The patient's  concomitant medications were not provided. On approximately 19-JUN-2016 (reported as two to three days, after receiving the ZOSTAVAX, the patient experienced pain around the left shoulder blade, radiating to the back, unspecified swelling, nausea and diarrhea. No treatment was given for the adverse events. The patient contacted the pharmacist on 27-JUN-2016 to inform the pharmacist of adverse effects and reported symptoms were not improving, and had worsened. Causality assessment between the adverse events and the ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare administrator referring to a patient of unknown age and gender. On 23-JUN-2016 the patient was vaccinated with improperly stored ROTATEQ (lot # L048854, expiration date 31-AUG-2017, dose not reported) orally. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 4 month old, male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 25-APR-2016 at 12:15, the patient was vaccinated with improperly stored first dose of ROTATEQ lot # L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-JUN-2016, the patient was vaccinated with the second adult dose of RECOMBIVAX HB (dose, route of administration and lot # were not reported), that was expired in February 2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to two unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD lot # M003434, expiry date: 19-JUL-2017, (dose#, route and site of administration not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the six reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 18 unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L045993, expiry date: 17-NOV-2017, (dose#, route, and site of administration not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the six reports received from the same reporter.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Inappropriate schedule of drug administration, Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to an 18 year old female patient (daughter of nurse's friend). The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. Three years ago, in approximately 2013, the patient was vaccinated with the first dose of GARDASIL (dosage information, lot number and expiry date were not reported) intramuscularly. One year later, in approximately 2014, the patient received the second dose of GARDASIL (inappropriate schedule of drug administration). After each dose of GARDASIL, later in the day, the patient lost consciousness (onset dates approximated to 2013 and 2014). Right after receiving the second dose of GARDASIL, the patient developed an unspecified autoimmune disorder, in approximately 2014. Patient sought medical attention and she was hospitalized, on an unknown date. The outcome of the events was unknown. The reporter's causality assessment was not provided for the events, although the patient's mother claimed that, the autoimmune disorder was a direct result of vaccination with GARDASIL. The reporter considered autoimmune disorder to be serious due to hospitalization. Upon internal review, loss of consciousness and autoimmune disorder were determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from an office manager concerning an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of oral ROTATEQ (dose and route not reported, lot number L027070, expiration date: 30-APR-2017). The vaccines were stored in 33 Fahrenheit degrees for 5 hours. They were back in range. There was no previous temperature excursion. The report was made because of digital logger. There were no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from an office manager concerning an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (dose and route not reported, lot number reported as K011526 which was non valid for quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine, expiration date: 08-APR-2017). The vaccines were stored in 33 Fahrenheit degrees for 5 hours. They were back in range. There was no previous temperature excursion. The report was made because of digital data logger. There were no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of vaccination, lot # and expiration date not reported) as a shingles vaccination. On 04-JUL-2016, (reported as "week ago"), the patient had joint pain and their skin felt warm to touch. The outcome of the events were not reported. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Expired product administered
Clinical narrative: Information has been received from a pharmacist referring to a 45 years old female patient. The patient had no drug reaction/allergies. The patient's pertinent medical history was unknown by reporter. On 07-APR-2016 the patient was vaccinated with a dose of expired PNEUMOVAX 23 (lot # K010466, expiration date 23-MAR-2016, strength and dose were not reported) intramuscularly. Concomitant therapies included HUMIRA and IMURAN. On 28-JUN-2016 the patient's "titers" were drawn and the result of the lab work showed that "the patient's titers were not as high as they should be". There was no treatment given to the patient. The outcome of the event was unknown. Reporter's causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 3 unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L041207, expiry date: 20-OCT-2017 (dose#, route and site of administration not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the six reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare administrator referring to a patient of unknown age and gender. On 20-JUN-2016 the patient was vaccinated with improperly stored oral ROTATEQ (lot # L048854, expiration date 31-AUG-2017, dose not reported) orally. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cardiac electrophysiologic study normal, Condition aggravated, Heart rate increased, Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer concerning a 54 year old female patient with allergy (drug hypersensitivity) to sulfa and morphine. The patient's medical history included supraventricular tachycardia in 2008. On 25-MAY-2016, the patient was vaccinated with ZOSTAVAX (dose, dosage number, route of administration and expiration date were not reported). The concomitant therapies included: ZYRTEC-D, SINGULAIR, LEXAPRO and WELLBUTRIN and "DEXLIN". On 01-JUN-2016, 8 days after onset of therapy, she experienced SVT (supraventricular tachycardia) and she had to go to emergency room (ER) in the hospital. In the emergency room (ER), her heart rate went up to 170-180 (units not provided) for about an hour and she was treated with adenosine. Additionally, she experienced high blood pressure and was given unspecified medication as a treatment for elevated blood pressure. The patient stated that she stayed in the emergency room (ER) for about 3 hours and was released. Therefore, on an unknown date in 2016, she followed up with two separate cardiologists and a complete cardiac work-up and electrophysiology study were ordered and everything came back negative. On 06-JUL-2016, the patient reported that she went to get a massage and her massage therapist noticed two scratch marks on her back (right side); she did not think too much about it and came home, but the next day on 07-JUL-2016, she looked at scratches through mirror and she noticed vesicles on those scratches. After that on the same date, the patient went to see dermatologist and the physician confirmed that it was shingles (herpes zoster) and the physician prescribed VALTREX as a treatment. The outcome of supraventricular tachycardia and blood pressure increased was reported as recovered, on an unknown date in 2016. The outcome of herpes zoster was reported as not recovered. The patient did not believe that the supraventricular tachycardia and blood pressure increased were related with ZOSTAVAX administration. However, the relatedness between herpes zoster and ZOSTAVAX administration was not provided. Upon internal review supraventricular tachycardia was considered medically significant. Additional information is not expected as the reporter did not wish further contact.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Scratch, Supraventricular tachycardia
Clinical narrative: This spontaneous report was received from a consumer concerning a 54 year old female patient with allergy (drug hypersensitivity) to sulfa and morphine. The patient's medical history included supraventricular tachycardia in 2008. On 25-MAY-2016, the patient was vaccinated with ZOSTAVAX (dose, dosage number, route of administration and expiration date were not reported). The concomitant therapies included: ZYRTEC-D, SINGULAIR, LEXAPRO and WELLBUTRIN and "DEXLIN". On 01-JUN-2016, 8 days after onset of therapy, she experienced SVT (supraventricular tachycardia) and she had to go to emergency room (ER) in the hospital. In the emergency room (ER), her heart rate went up to 170-180 (units not provided) for about an hour and she was treated with adenosine. Additionally, she experienced high blood pressure and was given unspecified medication as a treatment for elevated blood pressure. The patient stated that she stayed in the emergency room (ER) for about 3 hours and was released. Therefore, on an unknown date in 2016, she followed up with two separate cardiologists and a complete cardiac work-up and electrophysiology study were ordered and everything came back negative. On 06-JUL-2016, the patient reported that she went to get a massage and her massage therapist noticed two scratch marks on her back (right side); she did not think too much about it and came home, but the next day on 07-JUL-2016, she looked at scratches through mirror and she noticed vesicles on those scratches. After that on the same date, the patient went to see dermatologist and the physician confirmed that it was shingles (herpes zoster) and the physician prescribed VALTREX as a treatment. The outcome of supraventricular tachycardia and blood pressure increased was reported as recovered, on an unknown date in 2016. The outcome of herpes zoster was reported as not recovered. The patient did not believe that the supraventricular tachycardia and blood pressure increased were related with ZOSTAVAX administration. However, the relatedness between herpes zoster and ZOSTAVAX administration was not provided. Upon internal review supraventricular tachycardia was considered medically significant. Additional information is not expected as the reporter did not wish further contact.
Age: 1.3
Sex: F
Vaccine: RV5
Symptoms: Constipation, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a infant female patient of unknown age. The patient's pertinent medical history and drug allergies were none. On 29-JAN-2016, the patient was vaccinated with oral, ROTATEQ 2 ml (lot # L026740 and expiry date: 16-APR-2017) via oral route. Concomitant medications were none. The patient experienced constipation for 2-3 days immediately after wards. The patient's mother sought medical attention by calling the physician's office on 02-FEB-2016 and a treatment of corn sugar syrup (KARO) syrup and water was prescribed. The reporter stated that on 02-FEB-2016, the following directions were given to the mother: That the mother should call back if the constipation does not resolve and no further contact was made to the physician's office by the patient's mother. The reporter also stated that another physician did not want to give the next dose in the series due to the adverse effect. The outcome of constipation was reported as recovered. The causality of the event was not reported. No product quality complaint (PQC) was reported for oral ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients (unknown age and gender). The patients current conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of ZOSTAVAX (lot # L046900 and expiry date 23-FEB-2017). No adverse effects were reported. Product quality complaint (PQC) was not involved. No further details were provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare administrator referring to a patient of unknown age and gender. On 27-JUN-2016 the patient was vaccinated with improperly stored oral ROTATEQ (lot # L048854, expiration date 31-AUG-2017, dose not reported) orally. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # L050560, expiry date: 14-DEC-2017, (dose#, route and site of administration not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the six reports received from the same reporter.
Age: 25.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Influenza like illness, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Shaking, muscle spasms, muscle pain. 7/9/2016- Injection side swelled to size of a nickel. 101 degree fever. Flu-like symptoms. Chills. Nausea. Injection site rash spreading, raise, hot, burning. Rash from shoulder to elbow. Extremely limited arm movement. 7/10/16- Injection sit rash spread further. Blotchy. Raised, hot. Fever continues 100 degrees. Extremely limited arm movement. 7/11/16- Injection site rash spread to bicep. Blotchy, raised, burning. No fever. Body aches.