chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: DT
Symptoms: Extra dose administered, Inadequate aseptic technique in use of product
Clinical narrative: My son was being seen for his pre kindergarten exam. The lead pediatric nurse was training a med student during my sons exam. The student administered all of his shots. After administering several the lead nurse said the needle was dirty and she(the student) needed to repeat the dose again. They apologized for the additional poke and offered no information or concern of the effects of unsterile injections or repeated doses. They did offer an extra sticker.
Age: 12.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: A 12 year old young man received a 0.5 mg dose of KINRIX instead of a Tdap.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 18-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to separate temperature excursion (dates unspecified): lasting for 24, 136 and 32 hours, with the lowest recorded temperature of 34, 31 and 30 degrees Fahrenheit, respectively. No adverse effects were reported. there was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 72 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), third lasting for 88 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.11 degrees Celsius) and fourth lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius) for 136 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 89 year old female patient of unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. None drug reactions/allergies. The past drug included PREVNAR 13. On 11-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, injection (lot number/expiry date and dose not reported) intramuscularly in the left arm (as follow-up to PREVNAR 13). Approximately on unknown date in October-2016, the patient developed pain and redness in her left arm, which spread up to her shoulder "within hours" of being vaccinated. None lab diagnostics studies performed. The patient received an unspecified treatment. No Product Quality Complaint (PQC) was involved. The outcome of the events was recovering. The reporter did not provide any causality assessment between events and PNEUMOVAX 23. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth, Joint range of motion decreased
Clinical narrative: Given PPSV23 vaccine and presented the following day with no systemic symptoms but local area described as: Significant area of erythema and warmth to the entire medial deltoid area on the left side. She has edema but no fluctuance. No indication that this required I and D. Arms NV intact. Pt was treated for cellulitis. Cellulitis: erythema, warmth, edema, local pain, decreased ROM. Cephalexin 500 mg QID, Ibuprofen 600 mg tid.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Given PPSV23 vaccine and presented the following day with no systemic symptoms but local area described as: Significant area of erythema and warmth to the entire medial deltoid area on the left side. She has edema but no fluctuance. No indication that this required I and D. Arms NV intact. Pt was treated for cellulitis. Cellulitis: erythema, warmth, edema, local pain, decreased ROM. Cephalexin 500 mg QID, Ibuprofen 600 mg tid.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to multiple unspecified patients of unknown age and gender. The patients had no pertinent medical history, concurrent conditions and concomitant therapies. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot number L015460, expiration date 20-JUL-2017 (dose and route of administration were not reported). No adverse events were reported. There was not product quality complaint involved. This is one of several reports received from the same source. 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 physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-APR-2015, the patient was vaccinated with improperly stored dose of VAQTA pediatrician dose: 25U/0.5 ml (lot # J014584, expiration date: 16-JAN-2016; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 16 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 64 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative regarding a patient of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an unknown date the patient experienced shingles. The outcomes of herpes zoster was unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius) for 136 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to an unknown number of unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not provided. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9, lot number M018810, Expiration date 28-MAY-2018, (frequency, route and anatomical location were not reported). No adverse effects were reported in any patient. No digital data logger was involved. No product quality complain was involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-OCT-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius) for 64 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to multiple unspecified patients of unknown age and gender. The patients had no pertinent medical history, concurrent conditions and concomitant therapies. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot number L048854, expiration date 31-AUG-2017, orally (dose number was not provided). No adverse events were reported. There was not product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: DTAP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of adverse reaction in a 15-month-old male patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to DTaP vaccine. Additional details were provided as follows: This case was reported by the patient's father, who was also a physician. The age at vaccination was not reported. The patient experienced unknown reaction after vaccination with DTaP vaccine (unknown manufacturer). Limited details were available. This case has been linked with case US2016148523, reported by the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 30-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): lasting for 72 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-1.11 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. 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 was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of VARIVAX, injection, lot # M008173, expiration date: 16-FEB-2018, subcutaneously (in the back of the arm). Dose number of strength were not provided. The dose received by the patient had undergone a temperature excursion (experienced on an unknown date). The patient did not experienced any adverse event. It is unknown if there was any relevant laboratory data. 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 has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K009482, expiration date 06-MAR-2017, dose and route not reported). The doses of vaccine were improperly stored at 34 degrees Fahrenheit for 228.5 hours. There were no previous excursions. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient were inadvertently vaccinated with the expired doses of PNEUMOVAX 23 (lot # J005071, expiration date 19-JAN-2015; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-1.11 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 18-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 56, 136 and 24 hours, with the lowest recorded temperature of 30, 31 and 34 degrees Fahrenheit, respectively. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 24, 8, 136 and 88 hours, with the lowest recorded temperature of 34, 33, 31 and 30 degrees Fahrenheit, respectively. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L039141, expiration date 16-AUG-2017; lot # M004890, expiration date 10-NOV-2017, dose not reported) orally. The doses of vaccine were improperly stored at 34 degree Fahrenheit for 228.5 hours. There were no previous excursions. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 18-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 88, 136, 24 and 72 hours, with the lowest recorded temperature of 30, 31, 34 and 33 degrees Fahrenheit, respectively. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 30-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.55 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # M006139, expiration date 13-MAY-2017; lot # M005287, expiration date 08-OCT-2017, dose and route not reported). The doses of vaccine were improperly stored at 34 degree Fahrenheit for 228.5 hours. There were no previous excursions. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # K005958, expiration date 09-FEB-2017, dose and route not reported). The dose of vaccine were improperly stored at 34 degree Fahrenheit for 228.5 hours. There were no previous excursions. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 24, 136 and 56 hours, with the lowest recorded temperature of 34, 31 and 30 degrees Fahrenheit, respectively. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 03-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-1.11 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperatures excursion (date unspecified): lasting for 136, 24 and 80 hours, with the lowest recorded temperature of 30, 31 and 34 degrees Fahrenheit, respectively. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # K026246, expiration date 28-JAN-2017; lot # L019297, expiration date 18-AUG-2017; lot # K026247, expiration date 29-JAN-2017, dose and route not reported). The doses of vaccine were improperly stored at 34 degree Fahrenheit for 228.5 hours. There were no previous excursions. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 16 year old male patient. No information regarding the patient's pertinent medical history and concomitant therapies was provided. On 05-OCT-2016, the patient was vaccinated with a first dose of VARIVAX subcutaneously (lot # M006726; dose and expiration date were not reported). On the same day, the patient was vaccinated with a dose of PROQUAD (dose, lot# and expiration date were not provided). No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report as received from a nurse via physician refers to a 18 year old female pregnant patient. No medical history nor concomitant therapy was reported. On an unknown date in 2016, the patient was vaccinated with GARDASIL 9, 0.5 ml, intramuscular (lot# and expiration date were not reported). After a few days after being vaccinated with GARDASIL 9 the patient found out that she was 13 weeks pregnant. Last Menstrual Period (LMP) was calculated on 05-JUL-2016 and Estimated Due Date (EDD) on 11-APR-2017. The patient was exposure to GARDASIL 9 during the first trimester of pregnancy. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-1.11 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. 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: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 29-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K006447, expiry date 16-JUN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): one lasting for 24 hours, with the highest recorded temperature of 49 degrees Fahrenheit (9.44 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, since 19-AUG-2016, the patients received improperly stored doses of VARIVAX (lot # M002063 with expiration date 12-JAN-2018; lot # M004328 with expiration date 26-JAN-2018; lot # M009768 with expiration date 23-FEB-2018; lot # M014309 with expiration date 21-MAR-2018; dose and route were not reported). It was reported that the vaccine was improperly stored at -3.5 Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
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. On 16-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 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 event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old female patient. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was inadvertently vaccinated with VARIVAX (lot # M023380, expiry date: 11-MAY-2018), instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 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 event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
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. On 20-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 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 event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative regarding a patient of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an unspecified date the patient was vaccinated with ZOSTAVAX (lot, expiration date and dosing regimen were unspecified). On an unspecified date, after ZOSTAVAX administration, the patient had a mild case was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 28-year-old female patient who was the pharmacist's daughter. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of unspecified varicella virus vaccine (dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced shingles. The outcome of shingles was not reported. The relatedness between unspecified varicella virus vaccine and the shingles was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 04-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K006447, expiry date 16-JUN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): one lasting for 24 hours, with the highest recorded temperature of 49 degrees Fahrenheit (9.44 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored PEDVAXHIB (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the temperatures had reached below recommended temperatures. Specified temperature excursion details were unavailable at the time. This case is linked to case number 1610USA009568 and 1610USA011174 via same reporter link. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Gingival swelling, Malaise, Pyrexia, Varicella
Clinical narrative: Information has been received from a consumer referring to her 2 years old grandson. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date in June 1996, the patient was vaccinated with an unspecified chicken pox vaccine (dose 1, dose, route, lot number and expiration date were unknown) (the patient was approximately 2 years when vaccination). On an unknown date in September 1996, after receipt of the initial unspecified chicken pox vaccine, the patient became very sick. The patient developed the following symptoms: fevers over 40 centigrade degrees (reported as 104 degrees), swollen gums and broke out in pox all over the patient's body. The patient sought unspecified medical attention via office visit. No treatment was given for the adverse events. The patient's present status was reported as recovered (date unspecified). The causal relationship between the unspecified chicken pox vaccine and the events was unknown. Additional information is not expected as no consent was given to contact the reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ (incorrect product storage) (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the temperatures had reached below recommended temperatures. Specific temperature excursion details were unavailable at the time. This case is linked to case number 1610USA009568 and 1610USA011175 via same reporter link. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL 9  (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the temperatures had reached below recommended temperatures. Specific temperature excursion details were unavailable at the time. This case is linked to case number 1610USA011174 and 1610USA011175 via same reporter link. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: HEPAB
Symptoms: Antibody test negative, Serology negative, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 65-year-old female patient who received TWINRIX adult. Co-suspect products included TWINRIX adult and TWINRIX adult (batch number AHABB253BC, expiry date 13th July 2014). On an unknown date, the patient received the 1st dose of TWINRIX adult and the 2nd dose of TWINRIX adult. On 23rd July 2013, the patient received the 3rd dose of TWINRIX adult (intramuscular) 1 ml. On an unknown date, several years after receiving TWINRIX adult and TWINRIX adult and 3 years after receiving TWINRIX adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX adult, TWINRIX adult and TWINRIX adult. Additional details were provided as follows: The first two doses were administered at another facility. The patient received 3rd dose of TWINRIX adult on left arm. The reporter got the information from the patient's husband that the patient had a negative titer after receiving the TWINRIX series. It was not specified if it was for Hepatitis A, Hepatitis B or both. In 2016 (very recently), approximately several years after receiving the first two doses and approximately 3 years after receiving 3rd dose of TWINRIX series the negative titer was found, though the reporter did not know when specifically it was drawn. This case has been linked with US2016150946, reported by same reporter.
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 10-year-old female patient who received PEDIARIX (batch number 33E9E, expiry date unknown). On 23rd September 2016, the patient received the 1st dose of PEDIARIX (intramuscular) 0.5 ml. On 26th September, 3 days after receiving PEDIARIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to PEDIARIX. Additional details were provided as follows: The nurse reported that the injection site reaction was from left upper arm up to elbow.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M019691, expiration date 02-NOV-2017; lot # M031802, expiration date 09-NOV-2017, dose not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-MAR-2015, the patient was vaccinated with improperly stored dose of VAQTA pediatrician dose: 25U/0.5 ml (lot # J014584, expiration date: 16-JAN-2016; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius) for 16 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M005714, expiration date 03-OCT-2017; lot # M011117, expiration date 07-DEC-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Pain
Clinical narrative: 6 inch diameter erythema around injection area noticed after injection administered. Had pain for 2 days.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: Pt became very fatigued w/malaise, headache, mental "fogginess" as if a "concussion", muscle pain, dizziness while driving. No redness, no local reaction or fever. SX onset within 24 hours - 7 days similar complaints following first dose of TRUMENBA.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia
Clinical narrative: Pt became very fatigued w/malaise, headache, mental "fogginess" as if a "concussion", muscle pain, dizziness while driving. No redness, no local reaction or fever. SX onset within 24 hours - 7 days similar complaints following first dose of TRUMENBA.
Sex: M
Vaccine: HPVX
Symptoms: Psychotic disorder
Clinical narrative: This spontaneous report as received from a mother of a patient via a nurse practitioner, via a field representative refers to a male child of an unknown age. The patient's concurrent conditions and medical history were not reported. On an unspecified date (reported as recently), the patient was vaccinated with a dose of an unidentified Merck Human Papillomavirus (HPV) vaccine (name, lot number, expiration date and dose were not provided) intramuscularly. The nurse practitioner stated that the injection was not given in her office. Concomitant therapies were not reported. The nurse practitioner stated that the patient's mother informed her that after the injection, the child experienced a "psychotic episode" (onset date not specified). The patient's mother sought medical attention by visiting the provider's office. The outcome of the event was not reported. The reporters did not provide the causality assessment between the suspect therapy and the event. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Medical history, concurrent conditions and concomitant medical were not provided. On an unspecified date in 2015, the patient was vaccinated with the first dose of GARDASIL 9, injection, intramuscularly. (Dose, lot number and expiration date were not reported). In February 2016, the patient received her second dose of GARDASIL 9, injection, intramuscularly. (Dose, lot number and expiration date were nor reported). On 06-OCT-2016 the patient was vaccinated with the third dose of GARDASIL 9, injection, intramuscularly. (Dose, lot number and expiration date were nor reported). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 (intramuscular; dose, lot # and expiration date were not reported). On 09-JUN-2016, the patient was vaccinated with the second dose of GARDASIL 9 (intramuscular; dose, lot # and expiration date were not reported). On 03-AUG-2016, the patient was vaccinated with the third dose of GARDASIL 9 (intramuscular; dose, lot # and expiration date were not reported). It was reported that the last dose of GARDASIL 9 was given early and was meant to be scheduled for November 2016. No adverse effect was reported. Additional information has been requested.