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 physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-SEP-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), " TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 48 hours (Lowest recorded temperature was 0 F (0 Celsius); 24 hours (Lowest recorded temperature was -1 F (-1 Celsius); 48 hours (Lowest recorded temperature was 1 F (1 Celsius) and 72 hours (Highest recorded temperature was 9 F (9 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 09-MAR-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 17-JUN-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 88 hours with a lowest recorded temperature of 33 Fahrenheit (F) (0.55555556 Celsius(C)) and other one of 80 hours with a lowest recorded temperature of 34 F (1.111111111 C). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. 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 radiology technician/vaccine coordinator referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the unspecified numbers of patients were vaccinated with an improperly stored doses of ROTATEQ lot #M019708 exp. 25-OCT-2017, and M012495 exp. 09-OCT-2017 (dose and anatomical location were not reported), orally. No adverse effects were reported. Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. Data logger involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 mcg/0.5 ml, lot # L045117 and expiration date 06-OCT-2018 (administration route was not provided). No adverse effects were reported. The vaccine had two temperature excursions, both of 144 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius (C)) and for the other a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Contraindication to vaccination
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (lot#, total dose and route unknown). Concomitant therapies included methotrexate. The pharmacist reported that the patient was vaccinated with (Oka/Merck) VARIVAX while on maintenance dose of methotrexate 7.5 mg every other day for unspecified immunocompromised condition. The pharmacist was not aware of any adverse effect to the patient. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 16-APR-2016), " TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 80 hours (Lowest recorded temperature was 30 F (-1.111111111 Celsius); 1172 hours (Lowest recorded temperature was -3 (-3 Celsius); 168 hours (Highest 49 F(9.44444444 Celsius); 24 hours (Highest recorded temperature was 48 F (8.888888889 Celsius), 416 hours (Highest recorded temperature was 47 F (8.333333333 Celsius) and 336 hours (Highest recorded temperature was 59 F (15 Celsius). No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-MAY-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 16-APR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had six temperature excursions: 80 hours (Highest recorded temperature was 49 F (9.444444444 Celsius); 80 hours (Lowest recorded temperature was 30 F (-1.111111111 Celsius); 1172 hours (Lowest recorded temperature was -3 (-3 Celsius); 336 hours (Highest recorded temperature was 59 F (15 Celsius); 24 hours (Highest recorded temperature was 48 F (8.888888889 Celsius) and 393 hours (Highest recorded temperature was 47F (8.333333333 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". No product quality complaint was involved. This is one of several cases from the same reporter Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 12-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB . Lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 88 hours with a lowest recorded temperature of 33 Fahrenheit (F) (0.555555555 Celsius(C)) and other one of 80 hours with temperature of 34 F (1.111111111 C) and 16 hours with temperature 49 Fahrenheit (F) (0.555555556 Celsius (C). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site reaction, Skin lesion
Clinical narrative: Rash left upper outer thigh with 9 x 14 cm of mild erythema with a central area with mild induration about 4 x 4 cm with the punctate lesion in the superior central region. Right thigh with 12 x 15 mm of erythema with a central punctate lesion.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 11/1/2016 7:00 pm pt. noticed injection site is "inflamed", sore, warm, red and swelling. 11/2/16, 11:46 am. pt. called and informs of adverse reaction, pt. is advised to apply warm compress and TYLENOL as needed. 11/3/16 - Pt. is in office and examined symptoms improved. Pt. is in stable condition.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 11/1/2016 7:00 pm pt. noticed injection site is "inflamed", sore, warm, red and swelling. 11/2/16, 11:46 am. pt. called and informs of adverse reaction, pt. is advised to apply warm compress and TYLENOL as needed. 11/3/16 - Pt. is in office and examined symptoms improved. Pt. is in stable condition.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, IPV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Vaccines given 10/19/16 Week of 11/1/16 Lacy eruption on back and trunk.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Synovitis
Clinical narrative: Patient with transient synovitis of (L) hip noted 11/2/16, approximately 2 weeks after IPV injection in (L) thigh. Patient recovered well with ibuprofen.
Age: 1.1
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Gram stain negative, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Lateral aspect of upper left thigh localized non tender faintly erythematous from non fluctuating non mobile 10 cm in diameter swelling at site of immunization. Two smaller firm swelling purplish about 1cm in diameter firm non tender on lateral right upper thigh.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 03-MAR-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 mcg/0.5 ml, lot # L045117 and expiration date 06-OCT-2018 (administration route was not provided). No adverse effects were reported. The vaccine had two temperature excursions, both of 144 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius (C)) and for the other a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 48 hours (Lowest recorded temperature was 0 F (0 Celsius); 24 hours (Lowest recorded temperature was -1 F (-1 Celsius); 48 hours (Lowest recorded temperature was 1 F (1 Celsius) and 72 hours (Highest recorded temperature was 9 F (9 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAR-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (Lot No. K007263; expiration date 09-JUN-2016) "SDV;10 pack", (Route of administration and anatomical location were not reported). There was no concomitant therapy reported. On unspecified dates, the RECOMBIVAX HB had three temperature excursions: one of 16 hours, 168 hours and 896 hours. The lowest recorded temperature was 32 F and the highest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 13-FEB-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reports as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 19-APr-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 18-APR-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reports as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reaction or allergies, concurrent conditions and concomitant therapies were not reported. On 10-FEB-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 mcg/0.5 ml, lot # L045117 and expiration date 06-OCT-2018 (administration route was not provided). No adverse effects were reported. The vaccine had two temperature excursions, both of 144 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius (C)) and for the other a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B DNA assay negative, Hepatitis B antibody negative, Hepatitis B core antibody positive, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
Clinical narrative: Information has been received from the author of a published article, concerning a 61 year old female patient. The patient's medical history included end-stage liver disease secondary to hepatitis C genotype 1a liver cirrhosis and a deceased donor orthotopic liver transplant. On unspecified dates, the patient was vaccinated with the first, second and third doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lots # not provided). The patient acquired immunity to hepatitis B in March 2013, but lost her immunity to hepatitis B in February 2015 prior liver transplant. Upon follow up in transplant infectious disease clinic 1 month following her liver transplant, she was doing well. Interestingly enough, hepatitis B serology during that time showed positive HBsAB and HBcAb tests and negative HBsAg and HBV DNA. They continued to monitor recipient hepatitis B serology and found that her HBcAb which was positive became negative 9 months after the transplant and her HBsAB which was positive became negative 9 months following the transplant despite after receiving a hepatitis B booster dose in December 2015. The patient's monitoring laboratories were as follows: HBsAB pretransplant (10-FEB-2015): <10, HBcAb: negative and HBsAg: negative. HBsAB 1 month testing (21-SEP-2015): 237, HBcAb: positive, HBsAg: negative and HBV DNA: negative (9/10). HBcAb 3 month testing (09-NOV-2015): positive and HBsAg: negative. HBcAb 4 month testing (07-DEC-2015): positive and HBsAg: negative. HBcAb 5 month testing (05-JAN-2016): positive and HBsAg: negative. HBsAB 6 month testing (02-FEB-2016): 27, HBcAb: positive and HBsAg: negative. HBcAb 7 month testing (01-MAR-2016): positive and HBsAg: negative. HBsAB 9 month testing (09-MAY-2016): <5, HBcAb: negative and HBsAg: negative. At the time of the report, the patient's outcome regarding acquired immunity but lost it was recovered on an unspecified date and the outcome for HBcAb positive but became negative after 9 months following transplant despite after receiving hepatitis B booster dose was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: Information has been received from the author of a published article, concerning a 61 year old female patient. The patient's medical history included end-stage liver disease secondary to hepatitis C genotype 1a liver cirrhosis and a deceased donor orthotopic liver transplant. On unspecified dates, the patient was vaccinated with the first, second and third doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lots # not provided). The patient acquired immunity to hepatitis B in March 2013, but lost her immunity to hepatitis B in February 2015 prior liver transplant. Upon follow up in transplant infectious disease clinic 1 month following her liver transplant, she was doing well. Interestingly enough, hepatitis B serology during that time showed positive HBsAB and HBcAb tests and negative HBsAg and HBV DNA. They continued to monitor recipient hepatitis B serology and found that her HBcAb which was positive became negative 9 months after the transplant and her HBsAB which was positive became negative 9 months following the transplant despite after receiving a hepatitis B booster dose in December 2015. The patient's monitoring laboratories were as follows: HBsAB pretransplant (10-FEB-2015): <10, HBcAb: negative and HBsAg: negative. HBsAB 1 month testing (21-SEP-2015): 237, HBcAb: positive, HBsAg: negative and HBV DNA: negative (9/10). HBcAb 3 month testing (09-NOV-2015): positive and HBsAg: negative. HBcAb 4 month testing (07-DEC-2015): positive and HBsAg: negative. HBcAb 5 month testing (05-JAN-2016): positive and HBsAg: negative. HBsAB 6 month testing (02-FEB-2016): 27, HBcAb: positive and HBsAg: negative. HBcAb 7 month testing (01-MAR-2016): positive and HBsAg: negative. HBsAB 9 month testing (09-MAY-2016): <5, HBcAb: negative and HBsAg: negative. At the time of the report, the patient's outcome regarding acquired immunity but lost it was recovered on an unspecified date and the outcome for HBcAb positive but became negative after 9 months following transplant despite after receiving hepatitis B booster dose was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 16-APR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 80 hours (Lowest recorded temperature was 30 F (-1.111111111 Celsius); 1172 hours (Lowest recorded temperature was -3 (-3 Celsius); 168 hours (Highest 49 F (9.444444444 Celsius); 24 hours (Highest recorded temperature was 48 F (8.888888889 Celsius), 416 hours (Highest recorded temperature was 47 F (8.333333333 Celsius) and 336 hours (Highest recorded temperature was 59 F (15 Celsius). No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 29-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. Lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 88 hours with a lowest recorded temperature of 33 Fahrenheit (F) (0.555555556 Celsius (C)) and other one of 84 hours with a lowest recorded temperature of 34 F (1.111111111 C) and 16 hours at temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 15-APR-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 48 hours (Lowest recorded temperature was 0 F (0 Celsius); 24 hours (Lowest recorded temperature was -1 F (-1 Celsius); 48 hours (Lowest recorded temperature was 1 F (1 Celsius) and 72 hours (Highest recorded temperature was 9 F (9 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (reported also as radiology tech/vaccine coordinator) referring to an unspecified number of patients of unknown ages and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L048848 expiration date 09-AUG-2018) (lot # M006708 expiration date 02-JUN-2018) (dose and anatomical location were not reported). No adverse effects were reported. Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. With a data logger involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. K007263; expiration date 09-JUN-2016) "SDV; 10 pack", (Route of administration and anatomical location were not reported). There was no concomitant therapy reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursions: one of 16 hours and 480 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 18-JUN-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 micrograms/1 ml (Lot # J001183, expiration date 08-SEP-2014) route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the RECOMBIVAX HB had a temperature excursion for 4044 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was receive from a pharmacist and refers to a female patient on unknown age. The patient's medical history. drug reactions or allergies and concurrent conditions were not reported. On 20-FEB-2015, the patient was vaccinated with a dose of GARDASIL, then, on 15-JUL-2015, the patient was vaccinated for her second dose of GARDASIL 9; (dose, route, anatomical location, lot number and expiration date for the above vaccines were not reported). There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 13-FEB-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 684 hours with a lowest recorded temperature of -3 Fahrenheit (F) (-3 Celsius (C)) and other one of 336 hours with a highest recorded temperature of (-3 C). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions of allergies, concurrent conditions and concomitant therapies were not reported. On 06-APR-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10PK 0.5 mcg/0.5 ml SDLLolCap Ped" and lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as " in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was inadvertently vaccinated with a fourth dose of GARDASIL 9 (strength, dose, frequency, lot number and expiration date were unknown), intramuscularly. No adverse effects were reported. Additional information has been requested. Follow-up information was received on 05-OCT-2016 (initial information was 04-OCT-2016) from the medical assistant who reported the patient received the first dose of GARDASIL 9 (Lot number L014415, expiration date 25-JUL-2017) on 24-SEP-2016. The patient received the second dose of GARDASIL 9 (Lot number L024993, expiration date 17-OCT-2017) on 20-MAR-2016. The patient received the third dose of GARDASIL 9 (unspecified Lot number/unspecified expiration date) administered to patient on an unspecified date. The patient received a fourth dose of GARDASIL 9 (Lot number M011840, expiration date 01-FEB-2018) on 03-OCT-2016. The medical assistant explained that their "system shows patient received a total of four doses of GARDASIL)." No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 22-DEC-2014, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. Lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reaction or allergies, concurrent conditions and concomitant therapies were not reported. On 10-APR-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10PK 0.5 mcg/0.5 ml SDLLolCap Ped" and lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as " in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 08-JAN-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. Lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, 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 concurrent conditions and medical history were not reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursions of 24 hours each one. The lowest recorded temperature for one excursion was 34 F (1.111111111 Celsius) and 33 F (0.555555556) for the other one. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 10-JAN-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. Lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions once of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB with lot number K002327 with expiration date of 07-FEB-2016 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 34 F (1.111111111 Celsius). The sum of hours in excursion was 368 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion was reported as "Refrigerator(R)". No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-SEP-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB 10 mcg/1 ml "10X1 DS/V TF" with lot number K002327 with expiration date 07-FEB-2016 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 34 F (1.111111111 Celsius). The sum of hours in excursion was 512 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)".  No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Folliculitis, Herpes zoster, Infection parasitic, Rash generalised
Clinical narrative: Information has been received on 17-OCT-2019 from a consumer refers to a 71 year old female patient with sulfa allergy, penicillin allergy, x-ray dye allergy and drug allergies to LEVAQUIN, ZITHROMAX, DEMEROL, FLOXIN, and FERROCITE. The patient's medical history included herpes zoster. In the second week of June 2016, the patient was vaccinated with ZOSTAVAX, about seven months after having shingles. The patient requested the ZOSTAVAX so that she wouldn't get shingles again. Concomitant therapies included unspecified vitamins and supplements. About two to three weeks after the shot, the patient broke out all over her body. It started with one spot on her neck and her leg. The unspecified rash then spread all over her body - on her arms, under her breasts, on her stomach and down her legs. The patient says she looked like a zebra and had to wear long skirts to hide her legs. At an unspecified time in July, the patient visited an unspecified urgent care facility. The urgent care facility diagnosed her with an unspecified parasitic infection. The patient then went to her unspecified primary care provider. The primary care provider referred her to an unspecified dermatology office. In this dermatology office, the patient saw an unspecified physician assistant. The physician assistant diagnosed her with rash and bacterial folliculitis. The physician assistant referred the patient to an unspecified allergist who referred her back to the dermatologist. The patient then returned to the dermatology office a second time and saw an unspecified dermatologist who diagnosed her with shingles. The patient reported that the shingles were worse the second time after having ZOSTAVAX than they were the first time she experienced them. As of the date of this report, the patient reported that it still looks like she has "chicken pox on her stomach and arms" and is still applying unspecified steroid cream. No further information provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received on 17-OCT-2019 from a consumer refers to a 71 year old female patient with sulfa allergy, penicillin allergy, x-ray dye allergy and drug allergies to LEVAQUIN, ZITHROMAX, DEMEROL, FLOXIN, and FERROCITE. The patient's medical history included herpes zoster. In the second week of June 2016, the patient was vaccinated with ZOSTAVAX, about seven months after having shingles. The patient requested the ZOSTAVAX so that she wouldn't get shingles again. Concomitant therapies included unspecified vitamins and supplements. About two to three weeks after the shot, the patient broke out all over her body. It started with one spot on her neck and her leg. The unspecified rash then spread all over her body - on her arms, under her breasts, on her stomach and down her legs. The patient says she looked like a zebra and had to wear long skirts to hide her legs. At an unspecified time in July, the patient visited an unspecified urgent care facility. The urgent care facility diagnosed her with an unspecified parasitic infection. The patient then went to her unspecified primary care provider. The primary care provider referred her to an unspecified dermatology office. In this dermatology office, the patient saw an unspecified physician assistant. The physician assistant diagnosed her with rash and bacterial folliculitis. The physician assistant referred the patient to an unspecified allergist who referred her back to the dermatologist. The patient then returned to the dermatology office a second time and saw an unspecified dermatologist who diagnosed her with shingles. The patient reported that the shingles were worse the second time after having ZOSTAVAX than they were the first time she experienced them. As of the date of this report, the patient reported that it still looks like she has "chicken pox on her stomach and arms" and is still applying unspecified steroid cream. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-SEP-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB 10 mcg/1 ml "10X1 DS/V TF" with lot number K002327 with expiration date of 07-FEB-2016 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 34 F (1.111111111 Celsius). The sumo of hours in excursion was 96 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.