chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L044917, expiration date 05-OCT-2018, lot # reported as L044878, expiration date 17-JAN-2018, lot # L016959, expiration date 12-MAR-2018 and lot # L006231 expiration date 06-OCT-2016 (given before expiration date) (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperatures and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M010486, expiration date 25-MAY-2017 and lot # L046893 expiration date 23-FEB-2017 (dose, route of administration and anatomical location were not provided). The vaccines were frozen and exposed to the following temperatures and time frames out of range: -3 Celsius degrees for 261 hours between 17-JUN-2016 and 24-JUN-2016, -6 Celsius degrees for 50 hours between 28-JUN-2016 and 30-JUN-2016, -1 Celsius degree for 191.5 hours between 30-JUN-2016 and 07-JUL-2016, -3 Celsius degrees for 336 hours between 08-JUL-2016 and 19-JUL-2016, -3 Celsius degrees for 166.5 hours between 19-JUL-2016 and 27-JUL-2016, 0 Celsius degrees for 84 hours between 29-JUL-2016 and 01-AUG-2016, -1 Celsius degree for 36 hours between 01-AUG-2016 and 03-AUG-2016, 1 Celsius degree for 193 hours between 03-AUG-2016 and 10-AUG-2016, -1 Celsius degree for 344.25 hours between 11-AUG-2016 and 25-AUG-2016, 0 Celsius degrees for 161.25 hours between 26-AUG-2016 and 31-AUG-2016, -3 Celsius degrees for 21 hours between 01-SEP-2016 and 02-SEP-2016, -2 Celsius degrees for 131 hours between 02-SEP-2016 and 07-SEP-2016, -2 Celsius degrees for 46.5 hours between 07-SEP-2016 and 09-SEP-2016, 0 Celsius degrees for 143.75 hours between 09-SEP-2016 and 15-SEP-2016, -1 Celsius degree for 110.25 hours between 15-SEP-2016 and 20-SEP-2016, -3 Celsius degrees for 57 hours between 20-SEP-2016 and 22-SEP-2016, 0 Celsius degrees for 136 hours between 22-SEP-2016 and 28-SEP-2016, 0 Celsius degrees for 71.5 hours between 27-SEP-2016 and 30-SEP-2016, and -2 Celsius degrees for 94 hours between 03-OCT-2016 and 05-OCT-2016 (summary time of excursions 2634.5 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a 77 years old female patient concerning herself. The patient's pertinent medical history was not informed. The patient's concurrent conditions included osteoarthritis and allergy penicillin, codeine, sulfa and environment (spring, mold, dust, fur). On 11-OCT-2016, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (lot #, expiration date, dosage and therapy route were not provided), administered in the right arm. Concomitant therapies included TYLENOL. It was reported that on 11-OCT-2016, reported as "since being administered the pneumococcal vaccine (manufacturer unknown)", the patient had had slight pain, but she attributed the pain to her osteoarthritis. The patient stated that it was hard to quantify exactly when the reaction began due to osteoarthritis. The patient also reported that on 18-OCT-2016, reported as "all day yesterday" she was in extreme pain. The same day (18-OCT-2016), reported as "last night", her right arm was killing her. She touched the area in the muscle where she had the shot and it was sensitive and sore. The patient did not seek medical attention, nor laboratory diagnostics studies where performed and no treatment for the adverse events was given. The outcome of injection site hypersensitivity was reported as not recovered due the patient's arm was still sore. The outcome of other adverse events was unknown at the time of the report. The causal relationship between pneumococcal vaccine (manufacturer unknown) and the adverse events was not reported. No product quality complaint (PQC) was involved. Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 22-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 single DS, 0.5 mLVls 10SDV, (lot number L035885, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 had a temperature excursion. The lowest temperature excursion was of 34 Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HEPAB
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 38-year-old male patient who received TWINRIX adult (batch number 3NK9A, expiry date 28th May 2017). Concomitant products included TWINRIX adult, Typhoid vaccine, Yellow Fever vaccine, DT+TD vaccine and multivitamin. On 11th May 2016 07:55, the patient received the 2nd dose of TWINRIX adult (intramuscular) 1 ml. On 11th May 2016 11:55, 4 hrs after receiving TWINRIX adult, the patient experienced itchy rash and pruritus. TWINRIX adult was interrupted. On an unknown date, the outcome of the itchy rash and pruritus were recovered/resolved. The reporter considered the itchy rash and pruritus to be almost certainly related to TWINRIX adult. Additional details were provided as follows: The reporter's office was not informed until the time of reporting, when the patient came in for his 3rd dose. On 13th April 2016, the patient received 1st dose of TWINRIX adult on the left deltoid, Typhoid vaccine and TD on the right deltoid manufactured by Sanofi Pasteur. The patient might have also received yellow fever vaccine from the health department during this time period. The patient received 2nd dose of TWINRIX adult on the left deltoid and experienced an itchy rash on his chest. The symptoms resolved within 48 hours.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 syringes, lot # L040181, expiration date 18-AUG-2017, lot # M005287, expiration date 18-OCT-2017, lot # M018766, expiration date 15-OCT-2017 and lot # M020521 expiration date 17-NOV-2017 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperature and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. 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 via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 960 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 26-MAR-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L026405, expiration date 15-JUL-2017 (dose, route of administration and anatomical location were not provided). The vaccines were frozen and exposed to the following temperatures and time frames out of range: -3 Celsius degrees for 261 hours between 17-JUN-2016 and 24-JUN-2016, -6 Celsius degrees for 50 hours between 28-JUN-2016 and 30-JUN-2016, -1 Celsius degree for 191.5 hours between 30-JUN-2016 and 07-JUL-2016, -3 Celsius degrees for 336 hours between 08-JUL-2016 and 19-JUL-2016, -3 Celsius degrees for 166.5 hours between 19-JUL-2016 and 27-JUL-2016, 0 Celsius degrees for 84 hours between 29-JUL-2016 and 01-AUG-2016, -1 Celsius degree for 36 hours between 01-AUG-2016 and 03-AUG-2016, 1 Celsius degree for 193 hours between 03-AUG-2016 and 10-AUG-2016, -1 Celsius degree for 344.25 hours between 11-AUG-2016 and 25-AUG-2016, 0 Celsius degrees for 161.25 hours between 26-AUG-2016 and 31-AUG-2016, -3 Celsius degrees for 21 hours between 01-SEP-2016 and 02-SEP-2016, -2 Celsius degrees for 131 hours between 02-SEP-2016 and 07-SEP-2016, -2 Celsius degrees for 46.5 hours between 07-SEP-2016 and 09-SEP-2016, 0 Celsius degrees for 143.75 hours between 09-SEP-2016 and 15-SEP-2016, -1 Celsius degree for 110.25 hours between 15-SEP-2016 and 20-SEP-2016, -3 Celsius degrees for 57 hours between 20-SEP-2016 and 22-SEP-2016, 0 Celsius degrees for 136 hours between 22-SEP-2016 and 28-SEP-2016, 0 Celsius degrees for 71.5 hours between 27-SEP-2016 and 30-SEP-2016, and -2 Celsius degrees for 94 hours between 03-OCT-2016 and 05-OCT-2016 (summary time of excursions 2634.5 hours). There were no adverse effects reported. There were no data logger and no prior excursions. 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 via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10Pk" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 30-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10Pk" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 08-MAR-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F -2.7 Celsius) for 1764. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-JAN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10Pk" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1584 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases 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 via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-MAR-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10 PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Secondary transmission, Varicella
Clinical narrative: Information has been received from an optometrist concerning a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not informed. In approximately 1996, reported as "about 20 years ago", the patient got chicken pox from another unspecified patient who on unknown date received a dose of ZOSTAVAX 19400 PFU, (lot #, expiration date, dose and route were not provided). Concomitant therapies were not informed. The outcome of the events was unknown at the time of the report. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Dysstasia, Feeling drunk
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of difficulty breathing in a adult female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, less than a day after receiving BOOSTRIX, the patient experienced difficulty breathing, light headedness, feeling drunk and difficulty in standing. On an unknown date, the outcome of the difficulty breathing, light headedness, feeling drunk and difficulty in standing were unknown. It was unknown if the reporter considered the difficulty breathing, light headedness, feeling drunk and difficulty in standing to be related to BOOSTRIX. Additional details were provided as follows: This case was received from nurse via the vaccine patient assistance program. The age at vaccination was not reported. It was reported, that the reporter directed to the patient to dial 911. The caller stated that, her mother just had been administered BOOSTRIX and it was totally out of it. She stated when asked if she was responsive that she was, but that she was like drunk, she was dizzy, lightheaded, could not stand and was having difficulty breathing.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: Information had been received on 12-OCT-2016 from an office manager who reported that the nurse who administered vaccines on 08-SEP-2016 confused PNEUMOVAX 23 (unspecified lot/unspecified expiration) with PREVNAR 13. Nurse administered PNEUMOVAX 23 (dose not reported) to patient (age and gender not reported) when patient should have received a dose of PREVNAR 13. No adverse effect reported. No additional information available. 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 via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok w Tip" which had a lot number of M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases 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 via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok wTip, which had a lot number of  M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 Celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases 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 via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-AUG-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok w Tip" which had a lot number of M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effect reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases 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 via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-AUG-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok w Tip" which had a lot number of M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases 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 via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-JUL-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok w Tip" which had a lot number of M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases 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, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 09-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events 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, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 25-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events 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 was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided. On an unknown dates, the unspecified patients were vaccinated with dose of ZOSTAVAX (Dose, route, lot # and expiration date were not reported). It was stated that the patients experienced shingles subsequently to vaccination. At the time of reporting, the outcome of herpes zoster was unknown. The causality assessment between herpes zoster and ZOSTAVAX was unknown. No product quality complain was involved. Additional information is not expected because the physician cannot be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PNEUMOVAX 23 (lot # L038669, expiration date 11-AUG-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL that were exposed to a fridge excursion on 21-JUL-2017 (lot # K010215 expiration date 05-MAY-2017, lot# L040459 expiration date 06-APR-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 that were exposed to a fridge excursion on 21-JUL-2017 (lot # L011846 expiration date 16-JUN-2017, lot# L040459 expiration date 08-MAY-2017, lot# 026602 expiration date 19-OCT-2017). This is one of the 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, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 23-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 272 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events 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, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 11-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events 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, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 04-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 25-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events 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 via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok w Tip" which had a lot number of M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effect reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases 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 certificated medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored ROTATEQ (lot # L038534, expiration date 19-AUG-2017, lot # reported as L0349638, expiration date 23-AUG-2017, lot # L046318, expiration date 28-SEP-2017, lot # M004542, expiration date 18-OCT-2017, lot # M007124, expiration date 05-OCT-2017; dose unknown), orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from an office manager refers to a female patient of unknown age with diabetes, hypertension, smoker, anxiety, fatty liver, and reflux disease. The office manager reported the patient who was vaccinated with 3 doses of RECOMBIVAX HB experienced injection site pain. The first and second dose of RECOMBIVAX HB (unknown lot # and expiration dates) were given on unspecified dates. The third dose of RECOMBIVAX HB (lot # L042846, unknown expiration) was given on 22-AUG-2016. Concomitant therapies included LIPITOR, Hydrochlorothiazide (+) Lisinopril and metformin. The patient experienced injection site pain after the first dose and the pain continued to linger one month after the third dose. The injection site was described to have redness and swelling. The patient cannot move her arm. The patient did not seek medical attention for the adverse reaction, however, she reported it to the physician during her regular visit on 11-OCT-2016. There were no lab diagnostics studies performed. The outcome of movement disorder, infusion site swelling, injection site erythema and injection site pain was reported as not recovered/not resolved. No further details were provided. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant therapies were not provided. On an unknown date, the patient was inadvertently administered a dose of VARIVAX (strength, dose number, route, lot # and expiration date were not reported), instead of ZOSTAVAX (wrong drug administered) and no adverse effects were reported. No product quality complaint (PQC) was involved in this report. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain around injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Basal cell carcinoma, Biopsy skin abnormal, Injection site reaction, Rash erythematous, Skin neoplasm excision
Clinical narrative: A year later I had a red circle skin rash that is at the site where I had the injection for shingles. Now that same spot has been removed and was basil cell carcinoma; Weight: 68.4 kg.
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. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 152, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. 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 registered nurse and refers to an unspecified number of patients of an unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored ROTATEQ, (route, anatomical location, dose and frequency were not reported), lot # reported as L029615, expiration date 15-MAY-2017, lot # M019706, expiration date 24-OCT-2017. The total cumulative temperature excursion was reported as 117 minutes in high temperature (49.1 Fahrenheit degrees) and 225 minutes, 4 cycles, in low temperature (34.1 Fahrenheit degrees). No adverse effects were reported and no product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concomitant medications, drug reactions and allergies was not provided. On 06-JUN-2016, the patient was vaccinated with a dose of improperly stored VAQTA 50U/1ml, lot number: L036878 with expiration date of 26-MAY-2017 (route of administration was not reported). The vaccine was stored at a highest recorded temperature of 49F (9.444444444 Celsius) for 128 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse event was reported. No Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX, HPVX
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a colleague of the company representative's daughter referring a their daughter, age not provided. Medical history, concomitant medications and concurrent conditions were not reported. On 19-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 or GARDASIL (dose, lot number and expiration date were not provided) and unspecified influenza virus vaccine (dose, lot number and expiration date were not provided) in the same time and in the same unspecified arm. On an unknown date, the patient started to experience pain in her legs. The reporter wanted to know if the event was a side effect of GARDASIL 9 or GARDASIL. At the time of the report the outcome of the event was unknown. The causal relationship between the event and GARDASIL 9 or GARDASIL was unknown. Additional information is not expected as the primary reporter did not provided details contact.
Age: 0.2
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, Speech disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of speech disorder in a 11-week-old female patient who received KINRIX. On 18th October 2016, the patient received the 1st dose of KINRIX. On 18th October 2016, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On 19th October 2016, the patient experienced speech disorder. On an unknown date, the outcome of the speech disorder, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. It was unknown if the reporter considered the speech disorder to be related to KINRIX. Additional details were provided as follows: This case was reported by the patient's mother. The reporter wanted her daughter to receive only DTaP, but her doctor convinced her to add poliovirus as well. As a result of this decision, KINRIX was chosen to administer the series and the patient received KINRIX at an age of 11 weeks. As a result of this decision, KINRIX was chosen to administer the series and the patient received KINRIX at an age of 11 weeks. Thus, it led to an inappropriate schedule of vaccine administered and an inappropriate age at vaccination. In morning of reporting date, the patient was not been babbling or cooing like usually does in the morning. The reporter declined to do the report.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 12-OCT-2016 from a licensed practical nurse who reported that multiple unspecified patients (gender and age not specified) received improperly stored vaccines on either 11-OCT-2016 or 12-OCT-2016. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 11-OCT-2016 or 12-OCT-2016, the patients received improperly stored VAQTA (Lot number M015290, expiration date 20-SEP-2017) (Lot number M032492, expiration date 02-MAR-2018). Temperature was reported as 34.8 degrees Fahrenheit. Time frame was reported as 5 hours 22 minutes. The vaccines were reported as administered. There was no previous temperature excursion. The Call was because of data logger. No adverse effects were reported. No additional information was available. No product quality complaint involved. This is one of several reports received from same source. Additional information has been requested.