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 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 28-JUN-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 88 hours with a lowest recorded temperature of 33 Fahrenheit (F) (0.555555556 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: 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 excursion of 24 hours each one. The lowest recorded temperature for one of the excursions was 33 F (0.555555556) and 34 F (1.111111111 Celsius) 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, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the RECOMBIVAX HB had a temperature excursion of 48 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 23-OCT-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 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 date, the RECOMBIVAX HB had a temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 29-JUL-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: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial report was received from a office manager concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX, lot number was reported as M027348 with expiration date 27-JUL-2017 (dose, strength and route of administration were not provided). The temperature excursion lasted 4 hours at -10 Celsius and had a previous excursion that lasted 16 hours at -3.8 Celsius. No adverse effects were reported and no data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager and a physician concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in October 2016 (reported as "since 01-OCT-2016"), the patients were vaccinated with improperly stored VAQTA (dose and route were unknown; lot # L015460 with expiration date 20-JUL-2017 and lot # M015290 with expiration date 20-SEP-2017). The vaccines were exposed under temperature of 30.6 degrees Fahrenheit for 29 hours 30 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager and a physician concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in October 2016 (reported as "since 01-OCT-2016"), the patients were vaccinated with improperly stored ROTATEQ (dose and route were unknown; lot # L033693 with expiration date 31-MAY-2017 and lot # M012495 with expiration date 09-OCT-2017). The vaccines were exposed under temperature of 30.6 degrees Fahrenheit for 29 hours 30 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received 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 19-FEB-2016, 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 one temperature excursion of 1008 hours and the lowest recorded temperature was 34 F (1.111111111 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 representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-JAN-2016, 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: 24 hours (Lowest recorded temperature was -1 F (-1 Celsius); 72 hours (Highest recorded temperature was 9 F (9 Celsius); 48 hours (Lowest recorded temperature was 0 F (0 Celsius) and 48 hours (Lowest recorded temperature was 1 F (1 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 representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. K007263; expiration date 09-JUN-2016) (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 288 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 reported. On 09-SEP-2016, 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); 72 hours (Highest recorded temperature was 9 F (9 Celsius) and 48 hours (Lowest recorded temperature was 1 F (1 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.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Arm warm and reddish.
Sex: U
Vaccine: HEP, HEPA, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office administrator and refers to an unspecified amount of patients (age and gender unknown). The reporter stated that an unspecified number of improperly stored vaccines were administered to an unspecified number of patients. The vaccines were GARDASIL 9 (lot # L040054, expiration 26-DEC-2017), RECOMBIVAX HB (lot # M010671, expiration 02-JUN-2018), ROTATEQ (lot # M017514, expiration 07-NOV-2017 and VAQTA (lot # M027879, expiration 24-JAN-2018). 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 company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-SEP-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 72 hours (Highest recorded temperature was 9 F (9 Celsius); 48 hours (Lowest recorded temperature was 0 F (0 Celsius); 24 hours (Lowest recorded temperature was -1 F (-1 Celsius) and 48 hours (Lowest recorded temperature was 1 F (1 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 representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 25-MAR-2016), " TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had one temperature excursion of 1008 hours and the lowest recorded temperature was 34 F (1.111111111 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 representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 23-MAR-2016, 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: 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 21-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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager and a physician concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in October 2016 (reported as "since 01-OCT-2016"), the patients were vaccinated with improperly stored GARDASIL 9 (dose and route were unknown; lot # L026602 with expiration date 19-OCT-2017, lot # L036301 with expiration date 20-DEC-2017 and lot # M004116 with expiration date 12-OCT-2017). The vaccines were exposed under temperature of 30.6 degrees Fahrenheit for 29 hours 30 minutes. There were no previous temperature excursions. Data logger was involved. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received 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 11-DEC-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had two separate temperature excursions: 72 hours (Highest recorded temperature was 9 F (9 Celsius) and 48 hours (Lowest recorded temperature was 1 F ( 1 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 27-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 24 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 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 28-SEP-2015, 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 two temperature excursions: one of 16 hours,  and 120 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 reported. On 19-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 536 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 reported. On 30-OCT-2014, 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 one temperature excursion: 48 hours  and the lowest recorded temperature was 1 F (1Celsius). 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 representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-OCT-2014, 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 one temperature excursion of 48 hours and the lowest recorded temperature was 1 F (1 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 representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-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, 920 and 168 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.
Age: 27.0
Sex: F
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Hypersomnia, Incorrect route of drug administration, Myalgia, Neck pain
Clinical narrative: Information had been received on 12-OCT-2016 from a nurse practitioner who is also the patient. Patient has penicillin allergy. Patient received VARIVAX (lot# L021211, expiration date 10-JUN-2017) on 10-OCT-2016 via the intramuscular route. Patient also stated that she received influenza vaccine (unknown lot, expiration date and brand) during the same visit. Patient reported that the "next morning" she experienced "muscle aches and a sore neck". She also reported that she had been "sleeping a lot more than normal". Patient stated that this was the "fourth time" receiving the VARIVAX as she was already vaccinated on unspecified dates in 2001, 2009 and 2011. Patient stated that in 2015 on an unspecified date she had blood work drawn to "check varicella titers" and stated "I was still protected but was told that my titers were right on the border of not being protected. That is why I received another dose on 10-OCT-2016". Outcome of events were not reported. Patient did not seek medical attention and no treatment was given for adverse events. No additional information was provided. Call was disconnected before further details could be obtained. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Hypersomnia, Inappropriate schedule of drug administration, Myalgia, Nasal discomfort
Clinical narrative: Information had been received on 12-OCT-2016 from a nurse practitioner who is also the patient. Patient has penicillin allergy. Patient received VARIVAX (lot# L021211, expiration date 10-JUN-2017) on 10-OCT-2016 via the intramuscular route. Patient also stated that she received influenza vaccine (unknown lot, expiration date and brand) during the same visit. Patient reported that the "next morning" she experienced "muscle aches and a sore neck". She also reported that she had been "sleeping a lot more than normal". Patient stated that this was the "fourth time" receiving the VARIVAX as she was already vaccinated on unspecified dates in 2001, 2009 and 2011. Patient stated that in 2015 on an unspecified date she had blood work drawn to "check varicella titers" and stated "I was still protected but was told that my titers were right on the border of not being protected. That is why I received another dose on 10-OCT-2016". Outcome of events were not reported. Patient did not seek medical attention and no treatment was given for adverse events. No additional information was provided. Call was disconnected before further details could be obtained. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 19-OCT-2019 from an office manager. The office manager reported that an unknown number of patients may have been vaccinated with ZOSTAVAX (lot # L037790, expiration date 30-DEC-2016), subcutaneous on unspecified dates over the last month that had been improperly stored. No adverse effects reported. No further information was reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Erythema and itching at injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: 2 inch red rash appeared the day after injection. No pain or warmth or vesicles.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Electrocardiogram normal, Swollen tongue
Clinical narrative: Presented to PCP office c/o dizziness and feeling that tongue was swelling. Had received shingles vaccine at Pharmacy approx. 4 hrs prior. No SOB. EPIPEN administered. 911 called, transported to ER.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L034370, expiration date 08-SEP-2017; dose was unknown) via intramuscular injection. No adverse effects were reported. No product quality complaint (PQC) was involved. The excursion temperature was 29 Fahrenheit degree for 6 hours. There was no previous temperature excursion. No data logger was involved. This is one of several reports received 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 licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # reported as M029233, expiration date 09-AUG-2018; lot # M007763, expiration date 15-SEP-2017, dose and route not reported). The doses of vaccine were improperly stored at 48.9 degree Fahrenheit for 8 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacy student refers to an 81 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On 20-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, intramuscularly, once, lot # M00431 with expiry: 12-OCT-2017. Concomitant therapies included PREMARIN. Subsequently, shortly after vaccination, the patient experienced excessive swelling and redness at the injection site. On 22-OCT-2016, two day post vaccination, the patient sought medical attention - visited physician, and she was given treatment for the events. Outcome of the events and causality were not reported. The lot# M00431 has been verified to be invalid lot number for PNEUMOVAX 23. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses improperly stored PROQUAD (lot # M002055 with expiration date 11-JUL-2017, lot # M006104 with expiration date 01-AUG-2017; dose and route were unknown). The vaccines were exposed under temperature of 40.3 degrees Fahrenheit for 9 hours and 52 minutes. There were not previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses improperly stored VARIVAX (lot # L024252 with expiration date 30-JUN-2017; dose and route were unknown). The vaccines were exposed under temperature of 40.3 degrees Fahrenheit for 9 hours and 52 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates the patients each received an improperly stored doses of GARDASIL 9 (dose, route and frequency unknown) (lot # M023169, expired date 13-JUN-2018). No adverse effects reported. The GARDASIL 9 was exposed to 54.32F for a time frame of 8 hours. There were no previous temperature excursion and no data logger involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLUX, PNC13, VARZOS
Symptoms: Injection site pruritus, Injection site vesicles, Polymerase chain reaction, Varicella virus test
Clinical narrative: Information has been received from a pharmacist referring to a 69 year old female patient. On 12-OCT-2016 the patient was vaccinated with ZOSTAVAX (lot # M030139 with expiration date of 18-AUG-2017, subcutaneous in the left arm; once), as well as "a flu shot" and PREVNAR. The location of administration for the flu shot and PREVNAR was undetermined. On the same date, the patient experienced a small blister at the injection site of left upper arm and the patient stated it was not painful, but itchy. On 14-OCT-2016, the patient came to the pharmacy. No treatment was given for the events. The reporter accepted the Varicella Zoster Virus (VZV) packet. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Varicella Zoster Virus identification Polymerase Chain Reaction (PCR) test would be performed (result pending). The vents were recovering. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager regarding two patients of unknown age and gender. The patients pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the two patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 ( lot # M022947 and expiry date 12-NOV-2017) (dosing regimen were unknown). No adverse symptoms were reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPVX
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 20-JUL-2016, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown), VAQTA, and RECOMBIVAX HB (dose, route, lot number and expiration date were unknown for all the 3 vaccines), which experienced temperature excursion. This is one of several reports 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 03-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 444 hours with a lowest recorded temperature of -3 Fahrenheit (F) (-3 Celsius (C)) and other one of 336 hours with highest recorded temperature of 59 F (15 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: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Deafness unilateral
Clinical narrative: Hearing loss in left ear (same side as administration); has not worsened or gotten better since onset.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Started itching and breaking out in hives on upper torso area. By next morning it had spread to other parts of my body. Took BENADRYL regularly to help with the itch but the welts continued. 11/4 bottom lip extremely swollen, welts on face, scalp, body. Dr called in prescription for Prednisone and recommended continuing BENADRYL.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Feeling jittery, Flushing, Tachycardia
Clinical narrative: Within 5-10 mins of vaccination, started experiencing flushing, tachycardia, jitteriness, and slight confusion.
Age: 67.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Pain and swelling at the site upper left arm two weeks later still in pain penetrating down arm to fingers tingling and been to doctor five times arm is killing me.
Age: 67.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: Pain and swelling at the site upper left arm two weeks later still in pain penetrating down arm to fingers tingling and been to doctor five times arm is killing me.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Loss of consciousness, Nausea
Clinical narrative: GARDISAL 1ST SHOT-Sharp stomach pains and extremely nauseous. Lasted 12 hrs. Then dreamlike black out for 30 seconds 8:00 PM 24 hrs. AFTER receiving vaccine
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Urticarial, erythema type rash of the trunk & extremities; pt was already on daily CLARITIN. Also took BENADRYL and PEPCID which seemed to help. Per pt rash was greatly diminished at her visit on 11/4/16.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Injection site red rash 2 inches down and 4 inches across. Area slightly hard and hot to the touch. Slightly itchy. Recommended ice, TYLENOL or ibuprofen, hydrocortisone, and CLARITIN since patient is allergic to BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING, AND HOT TO THE TOUCH IN INJECTION AREA.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: REDNESS, SWELLING, AND HOT TO THE TOUCH IN INJECTION AREA.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed site tenderness, swelling, redness and warmth that started the day after the immunization was given, the symptoms gradually worsened, patient called the office back to report symptoms on 11/5/16 and was scheduled an appointment to be seen. Patient ordered AUGMENTIN antibiotic for treatment of reaction.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Malaise, Nausea, Pollakiuria
Clinical narrative: Patient stated that he became ill shortly after recieving the vaccine and is still ill. He states he is nauseated, is urinating more frequently than normal, and feels as though he has no energy.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Muscular weakness, Pallor, Platelet count normal, Red blood cell sedimentation rate normal
Clinical narrative: Patient received vaccine at 1001. Medical technician noted that the patient's face appeared pale. Patient was asked to sit in the chair and vitals were taken. BP was 110/80 and secondary reading was 102/76. Pulse was 86.  Patient was discharged and resumed normal daily activities including working out. At 1830, patient noted the appearance of hives present on back, bilateral arms, bilateral dorsum of feet, and neck. Patient woke up the next morning and noted that the hives have worsened in appearance. Patient also experienced generalized weakness with more pronounced weakness present in bilateral lower extremities. Patient followed up with physician 7 days after symptoms initially started and was given 10mg of prednisone.  Patient followed up on 11/04/2016 in regards to symptoms not improving. Was referred to urgent care by medical technician at clinic. Patient was then referred to emergency department where he received further care. Was given 60mg of prednisone and Benadryl however, noted that the Benadryl was making his chest feel "weird". Patient is currently on a prednisone taper and was prescribed zantac to take at home for abdominal discomfort due to taking the prednisone.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria, White blood cell count normal
Clinical narrative: Patient received vaccine at 1001. Medical technician noted that the patient's face appeared pale. Patient was asked to sit in the chair and vitals were taken. BP was 110/80 and secondary reading was 102/76. Pulse was 86.  Patient was discharged and resumed normal daily activities including working out. At 1830, patient noted the appearance of hives present on back, bilateral arms, bilateral dorsum of feet, and neck. Patient woke up the next morning and noted that the hives have worsened in appearance. Patient also experienced generalized weakness with more pronounced weakness present in bilateral lower extremities. Patient followed up with physician 7 days after symptoms initially started and was given 10mg of prednisone.  Patient followed up on 11/04/2016 in regards to symptoms not improving. Was referred to urgent care by medical technician at clinic. Patient was then referred to emergency department where he received further care. Was given 60mg of prednisone and Benadryl however, noted that the Benadryl was making his chest feel "weird". Patient is currently on a prednisone taper and was prescribed zantac to take at home for abdominal discomfort due to taking the prednisone.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: MODERATE BLEEDING FROM INJECTION SITE THEN A RAISED, HARD, QUARTER-SIZED KNOT PROTRUDED FROM THE SKIN ABOUT A HALF INCH.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called pharmacy on 11/03/2016 and stated her arm had been sore since her flu vaccine given on 10/14/2016.  She saw her CNP on 11/04/2016 and had a pea sized sore area on her arm.  Patient does not blame pharmacy and said her body reacts different to medicine.  She is fine with shot.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site warmth, Pain, Pain in extremity, Rash
Clinical narrative: Described crippling pain at beginning but nothing at injection site.  Saw her again on 11/5 and has rash, site warm to the touch, swelling and headache.  Pain has lessened in the arm and no difficulty in breathing.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: Described crippling pain at beginning but nothing at injection site.  Saw her again on 11/5 and has rash, site warm to the touch, swelling and headache.  Pain has lessened in the arm and no difficulty in breathing.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth on left upper arm.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Muscular weakness, Pain in extremity
Clinical narrative: Extreme pain/ weakness in left elbow and arm. No treatment yet. Going to facility next week.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient had an injection site reaction with swelling, pain, redness, heat, as well as tenderness under the arm starting the day after the injection. She subsequently awoke this morning with significant nausea and vertigo.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vertigo
Clinical narrative: Patient had an injection site reaction with swelling, pain, redness, heat, as well as tenderness under the arm starting the day after the injection. She subsequently awoke this morning with significant nausea and vertigo.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Erythema multiforme, Rash, Urticaria
Clinical narrative: Patient started to get rash, mom thought was hives and treated with Benadryl 6.25mg every 6 hours for 5 doses before taking back to Dr. office.  Hives were not showing improvement with Benadryl and Dr. diagnosed with Erythema Multiforme.  Acyclovir was prescribed and improvement was seen.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema, Mouth swelling
Clinical narrative: According to patient's MD, she experience angioedema all over her body, mouth swelled, went to ER [not sure when event occurred, but it was-not while patient at pharmacy].
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient has a red swollen itchy area at the site of the injection.
Age: 27.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Headache, Insomnia, Myalgia, Nasopharyngitis, Photophobia
Clinical narrative: Since administration of both the Hepatitis B vaccine and the Tdap vaccine, I have had visual disturbances, including more blurry vision and photophobia. Also, I have had a chronic headache since the occurence as well as a cough +productive, producing sputum as well as what feels to be a "head cold." I have also noticed an increase in insomnia as well as muscle aches and pains.
Age: 27.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Productive cough, Vision blurred, Visual impairment
Clinical narrative: Since administration of both the Hepatitis B vaccine and the Tdap vaccine, I have had visual disturbances, including more blurry vision and photophobia. Also, I have had a chronic headache since the occurence as well as a cough +productive, producing sputum as well as what feels to be a "head cold." I have also noticed an increase in insomnia as well as muscle aches and pains.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: Patient described reaction on right arm as "feeling like a bumpy rash, hot and warm to the touch, and hurting all the way around." Patient resolved the reaction by taking Ibuprofen to get the pain to subside.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Patient developed a round, 1-2 inch diameter, raised, rash that she described as warm and itchy. She said that it had increased in size from 11/3 to 11/5. She was advised to treat with Benadryl, Motrin and ice on 11/5 and to report back if any worse over the weekend.