chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Erythema, Rash, Wheezing
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13-year-old male patient. The patient's pertinent medical history included asthma. He was allergic to morphine, walnuts and pecans. Concomitant therapies included FLOVENT and VENTOLIN. On 26-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L038917, expiration date 20-FEB-2018, 0.5 ml; site and route of administration were not reported). On 30-MAY-2016, the patient had rash on face, chin area, mouth and neck, swelling, pain and redness to the left testicle. The symptoms subsided by 01-JUN-2016, when the patient was seen by the physician. On 01-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2018, site, dose and route of administration were not reported). The patient had the same symptoms as with the first dose but also experienced wheezing on an unspecified date in September 2016. The patient received treatment for the events, but no lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Follow up information has been received from the registered nurse/nursing supervisor on 11-NOV-2016. This report refers to the patient. The patient's concurrent conditions included wheezing. The patient was vaccinated intramuscularly into the right deltoid with the first and the second 0.5 ml doses of GARDASIL 9 according to schedule. On 30-MAY-2016, 4 days after the first dose of GARDASIL 9, the patient developed painful rash on chin and mouth, swelling around chin and also a pain, itching and swelling of testicular region. It was also reported that on that day, the patient experienced allergic reaction. The patient was treated with BENADRYL for these events. The above mentioned events resolved on an unknown date in 2016. On 05-SEP-2016, 4 days after the second dose of GARDASIL 9, the patient experienced wheezing, which was treated with the following inhalers: FLOVENT and VENTOLIN. On 07-SEP-2016, 6 days after the second dose of GARDASIL 9, the patient developed red painful rash on lower cheeks, chin and chest. The patient called to the doctor's office due all experienced events and was referred to an allergist. The events of wheezing and red painful rash on lower cheeks, chin and chest resolved on 09-SEP-2016. The relatedness between the events and the therapy with GARDASIL 9 was not reported. Additional information is not expected as all scheduled correspondence have been received. Sender's Comments: MERCK 1609USA005318: Mfr number.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Erythema, Oral mucosal eruption, Rash, Testicular pain, Testicular swelling
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13-year-old male patient. The patient's pertinent medical history included asthma. He was allergic to morphine, walnuts and pecans. Concomitant therapies included FLOVENT and VENTOLIN. On 26-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L038917, expiration date 20-FEB-2018, 0.5 ml; site and route of administration were not reported). On 30-MAY-2016, the patient had rash on face, chin area, mouth and neck, swelling, pain and redness to the left testicle. The symptoms subsided by 01-JUN-2016, when the patient was seen by the physician. On 01-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2018, site, dose and route of administration were not reported). The patient had the same symptoms as with the first dose but also experienced wheezing on an unspecified date in September 2016. The patient received treatment for the events, but no lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Follow up information has been received from the registered nurse/nursing supervisor on 11-NOV-2016. This report refers to the patient. The patient's concurrent conditions included wheezing. The patient was vaccinated intramuscularly into the right deltoid with the first and the second 0.5 ml doses of GARDASIL 9 according to schedule. On 30-MAY-2016, 4 days after the first dose of GARDASIL 9, the patient developed painful rash on chin and mouth, swelling around chin and also a pain, itching and swelling of testicular region. It was also reported that on that day, the patient experienced allergic reaction. The patient was treated with BENADRYL for these events. The above mentioned events resolved on an unknown date in 2016. On 05-SEP-2016, 4 days after the second dose of GARDASIL 9, the patient experienced wheezing, which was treated with the following inhalers: FLOVENT and VENTOLIN. On 07-SEP-2016, 6 days after the second dose of GARDASIL 9, the patient developed red painful rash on lower cheeks, chin and chest. The patient called to the doctor's office due all experienced events and was referred to an allergist. The events of wheezing and red painful rash on lower cheeks, chin and chest resolved on 09-SEP-2016. The relatedness between the events and the therapy with GARDASIL 9 was not reported. Additional information is not expected as all scheduled correspondence have been received. Sender's Comments: MERCK 1609USA005318: Mfr number.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Wheezing
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13-year-old male patient. The patient's pertinent medical history included asthma. He was allergic to morphine, walnuts and pecans. Concomitant therapies included FLOVENT and VENTOLIN. On 26-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L038917, expiration date 20-FEB-2018, 0.5 ml; site and route of administration were not reported). On 30-MAY-2016, the patient had rash on face, chin area, mouth and neck, swelling, pain and redness to the left testicle. The symptoms subsided by 01-JUN-2016, when the patient was seen by the physician. On 01-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2018, site, dose and route of administration were not reported). The patient had the same symptoms as with the first dose but also experienced wheezing on an unspecified date in September 2016. The patient received treatment for the events, but no lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Follow up information has been received from the registered nurse/nursing supervisor on 11-NOV-2016. This report refers to the patient. The patient's concurrent conditions included wheezing. The patient was vaccinated intramuscularly into the right deltoid with the first and the second 0.5 ml doses of GARDASIL 9 according to schedule. On 30-MAY-2016, 4 days after the first dose of GARDASIL 9, the patient developed painful rash on chin and mouth, swelling around chin and also a pain, itching and swelling of testicular region. It was also reported that on that day, the patient experienced allergic reaction. The patient was treated with BENADRYL for these events. The above mentioned events resolved on an unknown date in 2016. On 05-SEP-2016, 4 days after the second dose of GARDASIL 9, the patient experienced wheezing, which was treated with the following inhalers: FLOVENT and VENTOLIN. On 07-SEP-2016, 6 days after the second dose of GARDASIL 9, the patient developed red painful rash on lower cheeks, chin and chest. The patient called to the doctor's office due all experienced events and was referred to an allergist. The events of wheezing and red painful rash on lower cheeks, chin and chest resolved on 09-SEP-2016. The relatedness between the events and the therapy with GARDASIL 9 was not reported. Additional information is not expected as all scheduled correspondence have been received. Sender's Comments: MERCK 1609USA005318: Mfr number.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Erythema, Oral mucosal eruption, Pain, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13-year-old male patient. The patient's pertinent medical history included asthma. He was allergic to morphine, walnuts and pecans. Concomitant therapies included FLOVENT and VENTOLIN. On 26-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L038917, expiration date 20-FEB-2018, 0.5 ml; site and route of administration were not reported). On 30-MAY-2016, the patient had rash on face, chin area, mouth and neck, swelling, pain and redness to the left testicle. The symptoms subsided by 01-JUN-2016, when the patient was seen by the physician. On 01-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2018, site, dose and route of administration were not reported). The patient had the same symptoms as with the first dose but also experienced wheezing on an unspecified date in September 2016. The patient received treatment for the events, but no lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Follow up information has been received from the registered nurse/nursing supervisor on 11-NOV-2016. This report refers to the patient. The patient's concurrent conditions included wheezing. The patient was vaccinated intramuscularly into the right deltoid with the first and the second 0.5 ml doses of GARDASIL 9 according to schedule. On 30-MAY-2016, 4 days after the first dose of GARDASIL 9, the patient developed painful rash on chin and mouth, swelling around chin and also a pain, itching and swelling of testicular region. It was also reported that on that day, the patient experienced allergic reaction. The patient was treated with BENADRYL for these events. The above mentioned events resolved on an unknown date in 2016. On 05-SEP-2016, 4 days after the second dose of GARDASIL 9, the patient experienced wheezing, which was treated with the following inhalers: FLOVENT and VENTOLIN. On 07-SEP-2016, 6 days after the second dose of GARDASIL 9, the patient developed red painful rash on lower cheeks, chin and chest. The patient called to the doctor's office due all experienced events and was referred to an allergist. The events of wheezing and red painful rash on lower cheeks, chin and chest resolved on 09-SEP-2016. The relatedness between the events and the therapy with GARDASIL 9 was not reported. Additional information is not expected as all scheduled correspondence have been received. Sender's Comments: MERCK 1609USA005318: Mfr number.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Testicular pain, Testicular swelling
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13-year-old male patient. The patient's pertinent medical history included asthma. He was allergic to morphine, walnuts and pecans. Concomitant therapies included FLOVENT and VENTOLIN. On 26-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L038917, expiration date 20-FEB-2018, 0.5 ml; site and route of administration were not reported). On 30-MAY-2016, the patient had rash on face, chin area, mouth and neck, swelling, pain and redness to the left testicle. The symptoms subsided by 01-JUN-2016, when the patient was seen by the physician. On 01-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M009378, expiration date 23-APR-2018, site, dose and route of administration were not reported). The patient had the same symptoms as with the first dose but also experienced wheezing on an unspecified date in September 2016. The patient received treatment for the events, but no lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Follow up information has been received from the registered nurse/nursing supervisor on 11-NOV-2016. This report refers to the patient. The patient's concurrent conditions included wheezing. The patient was vaccinated intramuscularly into the right deltoid with the first and the second 0.5 ml doses of GARDASIL 9 according to schedule. On 30-MAY-2016, 4 days after the first dose of GARDASIL 9, the patient developed painful rash on chin and mouth, swelling around chin and also a pain, itching and swelling of testicular region. It was also reported that on that day, the patient experienced allergic reaction. The patient was treated with BENADRYL for these events. The above mentioned events resolved on an unknown date in 2016. On 05-SEP-2016, 4 days after the second dose of GARDASIL 9, the patient experienced wheezing, which was treated with the following inhalers: FLOVENT and VENTOLIN. On 07-SEP-2016, 6 days after the second dose of GARDASIL 9, the patient developed red painful rash on lower cheeks, chin and chest. The patient called to the doctor's office due all experienced events and was referred to an allergist. The events of wheezing and red painful rash on lower cheeks, chin and chest resolved on 09-SEP-2016. The relatedness between the events and the therapy with GARDASIL 9 was not reported. Additional information is not expected as all scheduled correspondence have been received. Sender's Comments: MERCK 1609USA005318: Mfr number.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Allergy to vaccine
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of drug allergy in a 43-year-old female patient who received Flu Seasonal TIV Dresden. Co-suspect products included fluticasone propionate, ADVAIR Diskus for an unknown indication and Aspirin unknown for an unknown indication. Concurrent medical conditions included drug allergy (the patient having allergy from Citric Acid, Asparaginase, Penicillins, Percocet) and food allergy (tomato). Concomitant products included ZANTAC, ADVIL, CYMBALTA, PROAIR HFA, SINGULAIR, NASACORT AQ, DITROPAN XL, vitamin D, DESYREL, ALIGN capsule, ZYRTEC P, stool softener, LUMIGAN, EPIPEN injection, tramadol, VIBRAMYCIN, NORCO tablet, ZOFRAN ODT and ZANAFLEX. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose, ADVAIR Diskus at an unknown dose and frequency and Aspirin at an unknown dose and frequency. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, ADVAIR Diskus and Aspirin, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to Seasonal Influenza vaccine, ADVAIR Diskus and Aspirin.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Drug hypersensitivity
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of drug allergy in a 43-year-old female patient who received Flu Seasonal TIV Dresden. Co-suspect products included fluticasone propionate, ADVAIR Diskus for an unknown indication and Aspirin unknown for an unknown indication. Concurrent medical conditions included drug allergy (the patient having allergy from Citric Acid, Asparaginase, Penicillins, Percocet) and food allergy (tomato). Concomitant products included ZANTAC, ADVIL, CYMBALTA, PROAIR HFA, SINGULAIR, NASACORT AQ, DITROPAN XL, vitamin D, DESYREL, ALIGN capsule, ZYRTEC P, stool softener, LUMIGAN, EPIPEN injection, tramadol, VIBRAMYCIN, NORCO tablet, ZOFRAN ODT and ZANAFLEX. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose, ADVAIR Diskus at an unknown dose and frequency and Aspirin at an unknown dose and frequency. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, ADVAIR Diskus and Aspirin, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to Seasonal Influenza vaccine, ADVAIR Diskus and Aspirin.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Affect lability, Condition aggravated, Immunoglobulin therapy, Plasmapheresis, Sydenham's chorea
Clinical narrative: Return of the Sydenham's Chorea symptoms, including chorea movements and emotional lability.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of VAQTA (lot # M032492, expiration date 02-MAR-2018; dose and route of administration were not reported) for prophylaxis. No previous excursion was reported.  The call was made because of the data logger. No adverse effects were reported. As of 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received form the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA005657: US-009507513-1610USA005658: US-009507513-1610USA005656:,MERCK 1610USA005157:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified) for prophylaxis. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 304 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information is not expected because follow-up request letter was returned by post office. Sender's Comments:  US-009507513-1608USA005743: MERCK 1610USA006401: Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On unknown dates, the patients were administered improperly stored doses of PROQUAD lots # M012986 and M021428 with expiration dates 12-SEP-2017 and 29-OCT-2017 respectively, (dosages and therapy routes were not provided), for prophylaxis. Concomitant therapies were not informed. The doses of measles, PROQUAD were exposed to a temperature of 21.3 degree centigrade and were out of range for 1 hour. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Follow up information has been received from the nurse on 17-NOV-2016. On unknown dates, an unspecified number of patients received improperly stored PROQUAD (lots # M012986 and M021428 with expiration dates 12-SEP-2017 and 29-OCT-2017 respectively, dose and route were not provided) for prophylaxis. No adverse effect was reported. More temperature excursion details were provided: the vaccines had been exposed under the temperature -16.0 degree centigrade for 5 hours and 46 minutes on 09-NOV-2016, -6.8 degree centigrade for 16 hours 34 minutes on 10-NOV-2016, -8.4 degree centigrade for 15 hours 35 minutes on 12-NOV-2016, -11.4 degree centigrade for 17 hours 38 minutes on 13-NOV-2016, -11.1 degree centigrade for 10 hours and 51 minutes on 14-NOV-2016, -16.2 degree centigrade for 22 minutes on 15-NOV-2016. Previous excursion included: on 12-SEP-2016, -8.7 degree centigrade for 9 hours 18 minutes; on 16-SEP-2016, -7.7 degree centigrade for 11 hours 39 minutes; on 23-SEP-2016, -9.5 degree centigrade for 9 hours 35 minutes; on 16-OCT-2016, -8.5 degree centigrade for 14 hours 48 minutes; on 25-OCT-2016, -6.8 degree centigrade for 10 hours 8 minutes; on 04-NOV-2016, -7.6 degree centigrade for 9 hours 45 minutes. Data logger issue was involved. Additional information has been requested. Reporter, adverse event information and narrative were updated. Sender's Comments:  US-009507513-1611USA004908: US-009507513-1611USA004924: US-009507513-1611USA004925: US-009507513-1611USA004926: US-009507513-1611USA004927: US-009507513-1611USA004928: US-009507513-1611USA004929: US-009507513-1611USA004931: US-009507513-1611USA013266: MERCK 1611USA004930: Mfr number.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Erythema, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a 66-year-old female patient who was reporting on herself. The patient did not take any concomitant medications and did not have any known drug reactions and allergies. There was no information about the patient's medical history provided. On 09-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23, 0.5 ml, intramuscularly in the right arm for prophylaxis (lot# and expiration date were not reported). Other suspect therapies included unspecified influenza virus vaccine administrated to the patient on 09-NOV-2016 in left arm. On 09-NOV-2016, reported as later the same evening, the patient felt pain in the right shoulder. She could not open car door or raise right arm past hips. Her arm was extremely painful, red and swollen, and she felt the pain circling from arms to shoulders. The patient could not roll over without experiencing terrible pain. The patient took TYLENOL for the pain and applied ice. The patient stated that the following day, reported as in the morning, she felt better and less pain. The patient called to the physician, on an unknown date and had unspecified laboratory diagnostic studies performed, on an unknown date (results were not provided). The outcome of the pain was reported as recovering. The outcome of the other events were reported as not recovered. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information is not expected because there was no consent to contact the physician.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a 66-year-old female patient who was reporting on herself. The patient did not take any concomitant medications and did not have any known drug reactions and allergies. There was no information about the patient's medical history provided. On 09-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23, 0.5 ml, intramuscularly in the right arm for prophylaxis (lot# and expiration date were not reported). Other suspect therapies included unspecified influenza virus vaccine administrated to the patient on 09-NOV-2016 in left arm. On 09-NOV-2016, reported as later the same evening, the patient felt pain in the right shoulder. She could not open car door or raise right arm past hips. Her arm was extremely painful, red and swollen, and she felt the pain circling from arms to shoulders. The patient could not roll over without experiencing terrible pain. The patient took TYLENOL for the pain and applied ice. The patient stated that the following day, reported as in the morning, she felt better and less pain. The patient called to the physician, on an unknown date and had unspecified laboratory diagnostic studies performed, on an unknown date (results were not provided). The outcome of the pain was reported as recovering. The outcome of the other events were reported as not recovered. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information is not expected because there was no consent to contact the physician.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist via a company representative concerning a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy information were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, strength, dose, frequency and route were not reported) for prevention of pneumonia. On an unknown date, after receiving PNEUMOVAX 23 the patient experienced pain at the injection site. No lab test was performed. The patient sought medical attention via contacting the pharmacist. The outcome of injection site pain was reported as recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No information about patients' medical histories, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route and site of vaccination unknown, lot number and expiry date were not reported). The patient also received vaccination with a dose of TRUMENBA. On an unknown date, the patient experienced syncope. The outcome of the events was unknown at the time of the report. The relationship between the events and vaccination with GARDASIL 9 was not reported. This case is linked with MARRS # 1612USA003795 (same reporter). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, after receiving GARDASIL, the patient experienced an unknown reaction. The patient's mother (hematologist researcher) documented this case in magazine journal, however, a copy of this article was unavailable at the time of this report. The outcome of adverse event was not reported. The relatedness between adverse event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported. Additional information is not expected because the reporter did not give permission to be contacted.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site paraesthesia
Clinical narrative: Information has been received from a 68 year old male patient (also reported as female) reporting on himself. The patient's pertinent medical history was not informed. Concurrent conditions included anxiety. On 16-NOV-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dosage and therapy route were not provided), to prevent shingles. Concomitant therapies were not informed. On 16-NOV-2016, the patient experienced a little tingly feeling at the site of the injection and a minor headache. The outcome of tingly feeling at the site of the injection and a minor headache was unknown at the time of the report. The causal relationship between ZOSTAVAX and the events was not reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not allow to contact him or his physician.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 49 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, subcutaneously (dose, lot# and expiration date were not reported) for prophylaxis. Following the vaccination, the patient experienced shooting pain at the injection site. The pain extended down the patient's entire arm. It was increasingly getting worse on 18-NOV-2016. The patient's arm pain was preventing her from sleeping at night. The patient sought the medical attention and called to the pharmacy. There was no treatment given. The outcome of injection site pain and sleep disorder was reported as not recovered.       The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concurrent conditions were not reported.  In November 2016 (reported as 15-NOV-2016 or 16-NOV-2016), the patient was vaccinated with a dose of ZOSTAVAX (Lot #, expiration date, strenght, dose, frequency and route were not reported) for prophylaxis. Other suspect therapies included M-M-R II which was administered on 17-NOV-2016, (Lot #, expiration date, strenght, dose, frequency and route were not reported) for prophylaxis and many other unspecified vaccines were administered for citizenship purposes in the last 48 to 72 hours. Additionally, it was reported that the patient's varicella vaccination history was unknown. No adverse events were reported. No product Quality Complaint (PQC) was involved. Additional information is not expected, since the physician wished not to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of GARDASIL 9 (dose and frequency unknown) (lot # L036301, expired date 20-DEC-2017; Lot# M017983, expired date 30-MAY-2018) were administered to the unspecified patients for prophylaxis. No adverse experience has been reported. The GARDASIL 9 was exposed to 35F for a time frame of 60 hours. No data logger and previous temperature excursion were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1611USA010289: US-009507513-1611USA010288.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of ROTATEQ (dose and frequency unknown) (lot # L046318, expired date 28-SEP-2017; Lot# M005732, expired date 19-OCT-2017; M007125, expired date 06-OCT-2017) were administered to the unspecified patients for prophylaxis. No adverse experience has been reported. The ROTATEQ was exposed to 35F for a time frame of 60 hours. No data logger and previous temperature excursion were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010289: US-009507513-1611USA010129.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning unspecified patients.  The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided.        On unspecified dates, improperly stored doses of with VAQTA (dose, frequency, lot# and expiration date were unknown) were administered to the unspecified patients for prophylaxis. No adverse experience has been reported. The VAQTA was exposed to 35F for a time frame of 60 hours. No data logger and previous temperature excursion were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1611USA010129: US-009507513-1611USA010288:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with 0.5 ml dose of improperly stored PEDVAXHIB intramuscularly (strength reported as "7.5 mcg", lot # K015463, expiration date: 09-JUL-2017) for prophylaxis. No adverse effects were reported. It was stated that vaccination with PEDVAXHIB was not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA008360: US-009507513-1609USA010831: US-009507513-1611USA012031: US-009507513-1611USA012032: US-009507513-1611USA007789.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with 0.5 ml dose of improperly stored PEDVAXHIB intramuscularly (strength reported as "7.5 mcg", lot # M025192, expiration date was not provided) for prophylaxis. No adverse effects were reported. It was stated that vaccination with PEDVAXHIB was not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1609USA008360: US-009507513-1611USA012030: US-009507513-1609USA010831: US-009507513-1611USA012032.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with 0.5 ml dose of improperly stored PEDVAXHIB intramuscularly (strength reported as "7.5 mcg", lot # K015463, expiration date: 09-JUL-2017) for prophylaxis. No adverse effects were reported. It was stated that vaccination with PEDVAXHIB was not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA008360: US-009507513-1611USA012030: US-009507513-1611USA012031: US-009507513-1609USA010831.
Sex: F
Vaccine: HPV9
Symptoms: Clonus, Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unspecified date the patient was vaccinated with GARDASIL 9, intramuscular, for prophylaxis (lot# not provided).  The nurse reported that on an unspecified date, "six months ago," the patient experienced fainting and clonic movements immediately after administration of her first dose of GARDASIL 9.  The patient recovered while in the office and did not require medical treatment.  No further information was provided.  The outcome of the events was reported as resolved. Additional information is not expected as the nurse did not consent to follow-up.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site movement impairment, Injection site pain, Injection site swelling, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 82 year old female patient. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On 01-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 in the right deltoid (dosage regimen, route of administration, lot # and expiry date unspecified) for prophylaxis. On an unknown date in November 2016, approximately one or two days after vaccination with PNEUMOVAX 23, the patient experienced pain, tenderness (injection site pain), swelling (injection site swelling), and stiffness around the injection site (injection site movement impairment). It was reported that the patient could barely move her arm (injected limb mobility decreased) and had consulted her primary physician who recommended supportive treatment, cold compresses and non-steroidal medications such as Ibuprofen, and offered a shot of cortisone as a possible option. The unspecified physician also recommended for the patient to see an orthopedist to evaluate her arm. The patient complied with the cold compresses and the non-steroidal medications such as Ibuprofen, but refused to get the cortisone shot. At the time of this report, the patient stated that she had scheduled an appointment with orthopedist next week. Patient also stated that she had received PREVNAR 13 approximately one year ago, and also received her flu shot approximately one or two months prior to the time of this report. She did not have any injection site reactions with either of those injections. At the time of this report, the patient stated that she was feeling a little better, but some stiffness remained in her arm. The outcome of injection site pain, injection site movement impairment, injected limb mobility decreased and injection site swelling was reported as recovering. Causality assessment was not provided by the reporter. No additional information was available. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as: M024678 with expiration date: 08-MAY-2018, lot # reported as: M000997 with expiration date: 07-JAN-2018, lot # reported as: L044524 with expiration date: 09-NOV-2017 and lot # reported as: L043622 with expiration date: 03-NOV-2017 (doses and routes of administration were not reported) for prophylaxis. There were no adverse effects reported. The administered doses of vaccine experienced a temperature excursion of maximum 15.2 Fahrenheit for 2 hours and 8 minutes. Data logger was involved and there was no previous temperature excursion reported. There was any Product Quality Complaint (PQC) involved. This is one of two reports received from the same reporter. Lot numbers M024678, M000997, L044524 and L043622 are invalid lot numbers for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. Additional information has been requested. Sender's Comments: US-009507513-1611USA007720: MERCK 1611USA014218:Mfr number.
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Dizziness, Joint stiffness, Mobility decreased
Clinical narrative: Information has been received from an office manager via company representative referring to a 67 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot# and expiration date were unknown) for prophylaxis. After administration of PNEUMOVAX 23, "a couple weeks ago", the patient's arm became "hot and painful" and she also experienced myalgia, high fever, chills, weakness dizziness and could not bending her fingers or lifting her arm. No treatment was given for the adverse events. Additional information is not expected as there was no consent for follow up.
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Information has been received from an office manager via company representative referring to a 67 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot# and expiration date were unknown) for prophylaxis. After administration of PNEUMOVAX 23, "a couple weeks ago", the patient's arm became "hot and painful" and she also experienced myalgia, high fever, chills, weakness dizziness and could not bending her fingers or lifting her arm. No treatment was given for the adverse events. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient age and gender unknown.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  The nurse reported that the patient received the third dose of GARDASIL 9, (route and lot # unknown) for prophylaxis on 29-NOV-2016 which was earlier then recommended.  No adverse event was reported.  The outcome of the event was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Hypersensitivity, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a certified medical assistant via a company representative refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, at the age of 11 year old, the patient was vaccinated with the second dose of unidentified Merck hpv vaccine (name, dose, expiration date and lot number not provided) (reporter was not sure if it was GARDASIL or GARDASIL 9 for human papillomavirus prevention. On an unknown date, the patient had an unspecified allergic reaction after the second dose of unidentified Merck hpv vaccine. On an unknown date, the patient developed a fever of 101 degrees and had aches. The outcome of the adverse events was unknown. The relatedness between the adverse events and unidentified Merck hpv vaccine was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner via medical records and refers to an 18 year old male patient. On 24-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. All available medical records will be provided upon request. This is one of several reports received from the same source. Additional information is not expected as all follow up information was received. Sender's Comments: US-009507513-1609USA007391: US-009507513-1610USA002333: US-009507513-1610USA002334: US-009507513-1612USA003507: US-009507513-1612USA003508: US-009507513-1612USA003509.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner via medical records and refers to a 15 year old female patient. On 24-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. All available medical records will be provided upon request. This is one of several reports received from the same source. Additional information is not expected as all follow up information was received. Additional information is not expected as all follow up information was received. Sender's Comments: US-009507513-1609USA007391: US-009507513-1610USA002333: US-009507513-1612USA003506: US-009507513-1610USA002334: US-009507513-1612USA003508: US-009507513-1612USA003509.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner via medical records and refers to a 16 year old male patient. On 25-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. All available medical records will be provided upon request. This is one of several reports received from the same source. Additional information is not expected as all follow up information was received. Sender's Comments: US-009507513-1609USA007391: US-009507513-1610USA002333: US-009507513-1612USA003506: US-009507513-1612USA003507: US-009507513-1612USA003509: US-009507513-1610USA002334.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner via medical records and refers to a 15 year old male patient. On 25-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. All available medical records will be provided upon request. This is one of several reports received from the same source. Additional information is not expected as all follow up information was received. Sender's Comments: US-009507513-1609USA007391: US-009507513-1610USA002333: US-009507513-1612USA003506: US-009507513-1612USA003507: US-009507513-1612USA003508: US-009507513-1610USA002334.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers 7 unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 06-DEC-2016, the patients were vaccinated with improperly stored VARIVAX (lot # L046888, expiry date: 23-NOV-2017) for prophylaxis. Medical assistant reported that the product underwent temperature excursion at 34.0F for 3 hours. No data logger was involved. There were no prior excursions. No adverse effects were reported. Additional information has been requested.