chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Rt thigh with oblong area of erythematous patches, total area about 14 x 9 cm. in the center of this area, centered at site of MMRV, is approx 6cm circular area that is erythematous with multiple vesicles.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Chills, Dizziness, Hypoaesthesia, Laboratory test
Clinical narrative: Has had several instances of numbness, dizziness, passing out, paralysis, shaking, chills, nausea, back pain, muscle weakness and more. Symptoms started back in 2013 with the first fainting spell around August 2013.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Muscular weakness, Nausea, Paralysis, Syncope
Clinical narrative: Has had several instances of numbness, dizziness, passing out, paralysis, shaking, chills, nausea, back pain, muscle weakness and more. Symptoms started back in 2013 with the first fainting spell around August 2013.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Has had several instances of numbness, dizziness, passing out, paralysis, shaking, chills, nausea, back pain, muscle weakness and more. Symptoms started back in 2013 with the first fainting spell around August 2013.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Dizziness, Myalgia
Clinical narrative: Muscle aches, dizziness, weakness. Temperature of 103 degrees developed in the night. No treatment except aspirin and sleep.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Hot, swollen, and painful injection site.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Headache, Migraine
Clinical narrative: Severe headache/migraine continuing to this day.
Age: 1.62
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Mulitple episodes of vomiting.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Red, firm, swollen arm. Treated with steroids and antihistamines.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer regarding herself via sales representative refers to a 61 years (reported as 61 or 62) old female patient. No information about medical history, concurrent conditions were reported. Concomitant medication included unspecified flu shot (dosage/frequency/manufacturer unknown). On an unknown date (reported as on an unspecified date 5-6 years ago about 3 days) after the patient was vaccinated with PNEUMOVAX 23, dose/frequency 1 single shot, route subcutaneous the patient developed a fever, injection site was red and swollen. The outcome of fever and injection site was red and swollen was reported a recovered/resolved on an unknown date. No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient's drug allergies and pertinent medical history were not reported. On 27-MAY-2014 the patient was vaccinated with ZOSTAVAX, subcutaneously. Concomitant medications were not reported. On 27-MAY-2014, the patient was inadvertently administered ZOSTAVAX which expired was on 24-APR-2014. The pharmacist reported that it was supported. No adverse effects were reported. The outcome of patient was inadvertently administered ZOSTAVAX which expired on 24-APR-2014 and no adverse effects reported was unknown. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Local swelling, Skin warm, Urticaria
Clinical narrative: During the first week after the Tdap vaccine, my arm swelled up and became very hot in temperature.  During the second week after the shot, I developed hives all over my body, especially concentrated in the arm where the shot was administered.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Excessive eye blinking, Strabismus, Tic
Clinical narrative: Eye tics (excessive eye blinking and squinting) started the next morning and haven't stopped.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: Welts started to develop on opposite arm (Left) that turned into raised blisters then spread to right arm and upper torso. They are not painful but they are itchy. Patient went to doctor three times. Md took sample for testing on 05/27/2014.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RVX
Symptoms: Diarrhoea, Vomiting projectile
Clinical narrative: Severe diarrhea and projectile vomiting. No treatment.
Age: 20.0
Sex: M
Vaccine: FLUX, MNQ
Symptoms: Blood test, Catheterisation cardiac, Myocarditis, Pericarditis, X-ray
Clinical narrative: Myocarditis and pericarditis.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, RVX
Symptoms: Mass
Clinical narrative: She still has a lump in her leg after receiving the Pediarix vaccine.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Bone marrow transplant, Breast cancer female
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an approximately 23 year old female patient with non Hodgkin's lymphoma B cell stage 3 and no drug reactions/allergies. On an unspecified date the patient was vaccinated with first dose of GARDASIL (0.5ml, intramuscular) (lot number 660612/0229X, expired date 30-OCT-2010). On 22-OCT-2008, the patient was vaccinated with second dose of GARDASIL (0.5ml, intramuscular) (lot number 661044/0548X, expired date 29-NOV-2010). On 08-JAN-2009, the patient was vaccinated with third dose of GARDASIL (0.5ml, intramuscular) (lot number unspecified). The reason the patient received the GARDASIL series was for prevention as well as the patient had a "low grade pap smear" in 2007. The certified medical assistant reported that the patient was diagnosed with breast cancer in 2011. She stated that the patient was "in and out" of the hospital on unspecified dates at an unspecified hospital after she was diagnosed with the breast cancer. She also reported that the patient had been seen by an unspecified oncologist on unspecified dates. The certified medical assistant also reported that the patient "recently" had a bone marrow transplant on an unspecified date. She stated that the patient was re-administered all of her "childhood vaccines" (vaccines unspecified) on an unspecified date after her bone marrow transplant. The certified medical assistant reported that the patient's medication list "from October 2013" showed that the patient was on an unspecified birth control pill and ibuprofen. The certified medical assistant reported that she was unsure if the patient was still currently taking those medications. The outcome of the patient was unknown. The causality was not provided. Upon internal review, breast cancer and bone marrow transplant were considered to be other important medical events. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Erythema multiforme, Fungal infection, Inflammation, Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer regarding himself refers to a male patient of unknown age. The pertinent medical history of the patient included allergic rhinitis and GERD. Approximately on an unknown date in 2013 the patient was vaccinated with ZOSTAVAX (routed as about 1 year ago) (dose, route not reported) to prevent shingles. Other suspect therapies included BEXTRA and LAMISIL reported as BEXTRA and LAMISIL. Concomitant therapies included PROTONIX and SINGULAIR. The reporter stated that approximately on an unknown date in March 2014 (reported as 2 months ago) the patient experienced itchy rash from the back of the hip to the medial lower leg on just on of his leg and there are no open lesions or pustules and the patient went to the physician who gave him ECONAZOLE. It was also reported that the physician believed that the patient has a fungal infection and this treatment had no effect. The physician performed a biopsy of the rash (unknown date) which showed spongiform inflammation and the patient was then given clobetasol and Cutemol (manufacturers unspecified). The patient also stated that he had erythema minor on an unspecified date after BEXTRA and LAMISIL (manufacturers unspecified) use. The outcome of fungal infection and itchy rash was reported as not recovered/not resolved. The outcome of erythema minor was reported as recovered/resolved on an unknown date. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Received vaccine 2-3 days before visit at PCP office, site, of injection became red and tender to touch. Today in clinic dxd with cellulitis and tx'd with KEFLEX. Shot was for meningitis but mom doesn't recall which one. Pt seen on 5/24/14.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pruritus, Skin warm
Clinical narrative: Patient has a reaction the size of an egg that is feverish, hard, itchy.
Age: 38.0
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Patient administered VIVOTIF - typhoid oral vaccine - experienced vomiting.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Received ZOSTAVAX 5-30-14 at 12:30. Started itching that evening, increasingly over past 2 days, also swollen and erythematous (6 cm x 4 cm), warm to touch. No fever/chills, or body aches.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with VAQTA that were stored improperly. No adverse effect reported. This is one of several report received from the same reporter. Follow up information was from the same registered nurse who stated that patient identifiers and dates of administered were unavailable at this time; however, lot numbers and expiration dates were available, VAQTA (Pediatric) lot number: J000366, expiration date: 27-AUG-2015. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: This spontaneous report as received from a male consumer of unknown age refers to himself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. The patient reported that he received the ZOSTAVAX vaccine being immunosuppressed from CLL (Chronic lymphocytic leukemia) Leukemia was now needed X-rays for an unspecified reason. Additional information has been requested.
Age: 1.98
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 4 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX (Merck) Lot # H014074 (dose, route and frequency were not reported). The nurse reported that on 24-OCT-2013, VARIVAX (Merck) was stored for -13.9 C for 8 hours. On 29-OCT-2013, the VARIVAX (Merck) was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX (Merck) was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX (Merck) was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX (Merck) was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX (Merck) was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 4 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored  (Oka/Merck) VARIVAX Lot # H014074 (dose, route and frequency were not reported). The nurse reported that the on 24-OCT-2013, (Oka/Merck) VARIVAX was stored for -13.9 C for 8 hours. On 29-OCT-2013, the (Oka/Merck) VARIVAX was stored for -12.8 C for 4 hours. On 14-NOV-2013, the (Oka/Merck) VARIVAX was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the (Oka/Merck) VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the (Oka/Merck) VARIVAX was stored for -13.8 C for a total of 5 hours. Since the overall average for (Oka/Merck) VARIVAX was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case linked to the case 1405USA015833, 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405UA015839, 1405UA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 4 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX Lot # H014074 (dose, route and frequency were not reported). The nurse reported that the on 24-OCT-2014, (Oka/Merck) VARIVAX was stored for -12.8 C for 4 hours. On 14-NOV-2013, the (Oka/Merck) VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the (Oka/Merck) VARIVAX was stored for -13.8 C for a total of 5 hours. Since the overall average for (Oka/Merck) VARIVAX was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA15842 and 1405USA008798 (same reporter link). Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 13 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX (Merck) Lot # H014074 (dose, route and frequency were not reported). The nurse reported that on 24-OCT-2013, VARIVAX (Merck) was stored for -13.9 C for 8 hours. On 29-OCT-2013, the VARIVAX (Merck) was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX (Merck) was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX (Merck) was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX (Merck) was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX (Merck) was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA015841 and 1405USA008798 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-JUL-2013, the patient was vaccinated with the first dose of GARDASIL intramuscularly. Lot# was not provided. Reporter reported that patient was currently in the office, on 28-MAY-2014, to receive the second dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The nurse reported the patient might have received improperly stored ROTATEQ (lot # reported as J010985, exp 24-APR-2015) on an unknown date that was exposed to 52.1F for 188 hours. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age with no drug allergies, reaction and no concomitant medication reported. In 2010 ("4 years ago" as reported) the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular). On 21-MAY-2014 the patient was vaccinated with the second dose of GARDASIL (0.5 ml, intramuscular). No adverse effects reported. The outcome of the event was unknown. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 4 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX Lot # h014074 (dose, route and frequency were not reported). The nurse reported that the on 24-OCT-2013, (Oka/Merck) VARIVAX was stored for -13.9 C for 8 hours. On 29-OCT-2013, the (Oka/Merck) VARIVAX was stored for -12.8 C for hours. On 14-NOV-2013, the (Oka/Merck) VARIVAX was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the (Oka/Merck) VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the (Oka/Merck) VARIVAX was stored for -13.8 C for a total of 5 hours. Since the overall average for (Oka/Merck) VARIVAX was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015822, 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840 and 1405USA015841, 1405USA015842 (same reporter link). Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 4 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX (Merck) Lot # H014074 (dose, route and frequency were not reported). The nurse reported that on 24-OCT-2013, VARIVAX (Merck) was stored for -13.9 C for 8 hours. On 29-OCT-2013, the VARIVAX (Merck) was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX (Merck) was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX (Merck) was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX (Merck) was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX (Merck) was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with VAQTA that were stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Follow up information was from the same registered nurse who stated that patient identifiers and dates of administration were unavailable at this time; however, lot numbers and expiration dates were available, VAQTA (Adult) lot number: J007781, expiration date: 19-SEPT-2015. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 4 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX (Merck) Lot # H014074 (dose, route and frequency were not reported). The nurse reported that on 24-OCT-2013, VARIVAX (Merck) was stored for -13.9 C for 8 hours. On 29-OCT-2013, the VARIVAX (Merck) was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX (Merck) was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX (Merck) was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX (Merck) was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX (Merck) was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA0015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 18 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX (Merck) Lot # H014074 (dose, route and frequency were not reported). The nurse reported that on 24-OCT-2013, VARIVAX (Merck) was stored for -13.9 C for 8 hours. On 29-OCT-2013, the VARIVAX (Merck) was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX (Merck) was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX (Merck) was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX (Merck) was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX (Merck) was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015840, 1405USA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 16 yeare old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX Lot # H014074 (dose, route and frequency were not reported). The nurse reported that the on 24-OCT-2013, VARIVAX was stored for -13.9 C for 8 hours. On 29-OCT-2013, the VARIVAX was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015834, 1405USA015835, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 18 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX Lot # H014074 (dose, route and frequency were not reported). The nurse reported that the on 24-OCT-2013, (Oka/Merck) VARIVAX was stored for -13.9 C for 8 hours. On 29-OCT-2014, the (Oka/Merck) VARIVAX was stored for -12.8 C for 4 hours. On 14-NOV-2013, the (Oka/Merck) VARIVAX was stored for -11.4 c for 1.5 hours. On 26-MAR-2014, the (Oka/Merck) VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the (Oka/Merck) VARIVAX was stored for -13.8 for a total of 5 hours. Since the overall average for (Oka/Merck) VARIVAX was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. The case is linked to the case 1405USA015833, 1405USA015834, 1405USA015836, 1405USA015837, 1405USA014838, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405US008798 (same reporter link).
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 18 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored VARIVAX Lot # H014074 (dose, route and frequency were not reported). The nurse reported that on 24-OCT-2013, VARIVAX was stored for -13.9 C for 8 hours.On 29-OCT-2013, the VARIVAX was stored for -12.8 C for 4 hours. On 14-NOV-2013, the VARIVAX was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the VARIVAX was stored for -13.8 C for a total of 5 hours. Since the overall average for VARIVAX was below -15 C, these cumulative excursions of -11.4 C for 20 hours is supported. No adverse event has been reported. No further information was provided. This case is linked to the case 1405USA015833, 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015838, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405USA008798 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients. On unknown dates an unspecified number of patients were administered with doses of GARDASIL (lot #, strength, dose, frequency, route unknown) that were improperly stored. No adverse effects were reported. Follow-up information was received from the physician. The physician stated he would be able to share lot numbers and some expiration date numbers for the vaccines that experienced a temperature excursion. The physician was not sure all the Lot numbers were for Merck vaccines. Lot # J013324, exp. date 12-FEB-2016 for GARDASIL. The physician did not have any patient identifiers or dates of vaccination available at this time. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Fall, Head injury, Immediate post-injection reaction, Syncope, Tooth loss
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On 19-NOV-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) and a dose of influenza virus vaccine (manufacturer unknown) dose, route and lot # not reported). The physician reported that on 19-NOV-2010, the patient experienced a fainting episode, immediately following the GARDSAIL administration. The physician reported that the patient hit her head during the fall and knocked out one of her teeth. The patient did not receive treatment for the adverse events. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Dizziness, Fall, Haemorrhage, Head injury, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On 19-NOV-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) and a dose of influenza virus vaccine (manufacturer unknown) dose, route and lot # not reported). The physician reported that on 19-NOV-2010, the patient experienced a fainting episode, immediately following the GARDSAIL administration. The physician reported that the patient hit her head during the fall and knocked out one of her teeth. The patient did not receive treatment for the adverse events. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Laceration, Lip injury, Loss of consciousness, Mouth haemorrhage, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On 19-NOV-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) and a dose of influenza virus vaccine (manufacturer unknown) dose, route and lot # not reported). The physician reported that on 19-NOV-2010, the patient experienced a fainting episode, immediately following the GARDSAIL administration. The physician reported that the patient hit her head during the fall and knocked out one of her teeth. The patient did not receive treatment for the adverse events. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Tooth loss
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On 19-NOV-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) and a dose of influenza virus vaccine (manufacturer unknown) dose, route and lot # not reported). The physician reported that on 19-NOV-2010, the patient experienced a fainting episode, immediately following the GARDSAIL administration. The physician reported that the patient hit her head during the fall and knocked out one of her teeth. The patient did not receive treatment for the adverse events. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blood test, Herpes zoster, Pruritus
Clinical narrative: This spontaneous report was received from a 80 year old female patient referred to herself. The patient's current condition included penicillin allergy/drug reaction. There was no patient pertinent medical history. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # unspecified), single 0.65 ml shot, subcutaneous. Concomitant medication included unspecified blood pressure medication. The reporter stated that "on 12-APR-2014 my back began to itch and now I could not lie on my back because it was to painful after I received the ZOSTAVAX vaccine 04-NOV-2013." The reporter also reported that "my physician confirmed on 16-APR-2014 that I had Shingles." The patient was treated with VALTREX and DIPROLENE. "Blood work" was performed, results were not reported. The patient had sought medical attention by visiting physician. The patient did not recover from shingles. The relatedness between the event and ZOSTAVAX was not specified. The Follow up information was received from the physician and referred to a 80 year old female retired patient, who was retired with no pre-existing allergies, birth defects, medical conditions and illness at time of vaccination (previously reported as penicillin allergy/drug reaction). On 04-NOV-2013 the patient was vaccinated with first dose of ZOSTAVAX. There was no previous doses. On 16-APR-2014 (previously reported as 12-APR-2014) the patient experienced red, itchy, painful, pimple like lesions, a classic Shingles presentation. The patient did not recover. She was still experiencing pain. The patient required emergency room or doctor visit. According to the reporter the event resulted in persistent or significant disability or incapacity. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Back pain, Blood test, Erythema, Herpes zoster
Clinical narrative: This spontaneous report was received from a 80 year old female patient referred to herself. The patient's current condition included penicillin allergy/drug reaction. There was no patient pertinent medical history. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # unspecified), single 0.65 ml shot, subcutaneous. Concomitant medication included unspecified blood pressure medication. The reporter stated that "on 12-APR-2014 my back began to itch and now I could not lie on my back because it was to painful after I received the ZOSTAVAX vaccine 04-NOV-2013." The reporter also reported that "my physician confirmed on 16-APR-2014 that I had Shingles." The patient was treated with VALTREX and DIPROLENE. "Blood work" was performed, results were not reported. The patient had sought medical attention by visiting physician. The patient did not recover from shingles. The relatedness between the event and ZOSTAVAX was not specified. The Follow up information was received from the physician and referred to a 80 year old female retired patient, who was retired with no pre-existing allergies, birth defects, medical conditions and illness at time of vaccination (previously reported as penicillin allergy/drug reaction). On 04-NOV-2013 the patient was vaccinated with first dose of ZOSTAVAX. There was no previous doses. On 16-APR-2014 (previously reported as 12-APR-2014) the patient experienced red, itchy, painful, pimple like lesions, a classic Shingles presentation. The patient did not recover. She was still experiencing pain. The patient required emergency room or doctor visit. According to the reporter the event resulted in persistent or significant disability or incapacity. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pruritus, Skin lesion
Clinical narrative: This spontaneous report was received from a 80 year old female patient referred to herself. The patient's current condition included penicillin allergy/drug reaction. There was no patient pertinent medical history. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # unspecified), single 0.65 ml shot, subcutaneous. Concomitant medication included unspecified blood pressure medication. The reporter stated that "on 12-APR-2014 my back began to itch and now I could not lie on my back because it was to painful after I received the ZOSTAVAX vaccine 04-NOV-2013." The reporter also reported that "my physician confirmed on 16-APR-2014 that I had Shingles." The patient was treated with VALTREX and DIPROLENE. "Blood work" was performed, results were not reported. The patient had sought medical attention by visiting physician. The patient did not recover from shingles. The relatedness between the event and ZOSTAVAX was not specified. The Follow up information was received from the physician and referred to a 80 year old female retired patient, who was retired with no pre-existing allergies, birth defects, medical conditions and illness at time of vaccination (previously reported as penicillin allergy/drug reaction). On 04-NOV-2013 the patient was vaccinated with first dose of ZOSTAVAX. There was no previous doses. On 16-APR-2014 (previously reported as 12-APR-2014) the patient experienced red, itchy, painful, pimple like lesions, a classic Shingles presentation. The patient did not recover. She was still experiencing pain. The patient required emergency room or doctor visit. According to the reporter the event resulted in persistent or significant disability or incapacity. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old daughter with peanuts, peanut butter and salmon allergies. On 27-MAY-2014 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (strength unknown, intramuscular). Tuberculin (TB) test was administered the same day. Immediately the patient had a seizure and started convulsing for less than a minute. The patient was instructed by a healthcare professional's (unspecified) in the office, to lie down for 30 or 40 minutes and then was assisted by a wheelchair to her mother's car and sent home. The outcome of the events was reported as not recovered with nauseous and "wiped out". Upon internal review, seizure and convulsing for less than a minute is considered to be medically significant. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Fatigue, Immediate post-injection reaction, Nausea
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old daughter with peanuts, peanut butter and salmon allergies. On 27-MAY-2014 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (strength unknown, intramuscular). Tuberculin (TB) test was administered the same day. Immediately the patient had a seizure and started convulsing for less than a minute. The patient was instructed by a healthcare professional's (unspecified) in the office, to lie down for 30 or 40 minutes and then was assisted by a wheelchair to her mother's car and sent home. The outcome of the events was reported as not recovered with nauseous and "wiped out". Upon internal review, seizure and convulsing for less than a minute is considered to be medically significant. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Expanding redness, warmth and swelling at injection site, 3" diameter.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Somnolence, Vomiting
Clinical narrative: 104 fever, 2 episodes of vomiting and sleepiness all day.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Disturbance in attention, Hallucinations, mixed, Unresponsive to stimuli, Vision blurred
Clinical narrative: Patient began to have visual and audio hallucinations.  She was unable to focus on the conversation she was having.  The walls appeared to be moving.  Her eyes were unfocused and she was awake but not responsive.  This lasted for about 2 hours.
Age: 31.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Area vaccinated warm to touch, swelling, itching, redness, fever, vomitting, soreness.
Age: 31.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: Area vaccinated warm to touch, swelling, itching, redness, fever, vomitting, soreness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, soreness, swelling, hotness, itching at the site of injection which spread to about 6 inches or more down my arm. Infection set in had to go to the emergency room and was given RX for clindamycin (every 6 hours for 10 days).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Localised infection
Clinical narrative: Redness, soreness, swelling, hotness, itching at the site of injection which spread to about 6 inches or more down my arm. Infection set in had to go to the emergency room and was given RX for clindamycin (every 6 hours for 10 days).
Age: 21.0
Sex: F
Vaccine: ADEN_4_7, DTAP, FLUC3, HEPA, MNQ
Symptoms: Chest pain, Cough, Increased upper airway secretion, Wheezing
Clinical narrative: Chest pain, phlegm in throat, cough, wheezing. 50MG DIPHENEHYDRAMINE HCL at 1130 IM. 125mg Solu Medrol IM.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Diffuse rash - pruritic.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Started off with a fever on 05/29/2014 and then developed into vomiting on 06/01/2014; he is currently unable to hold any liquid down and we may need to go the the ER in the next day or two.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: (L) anterior thigh erythema, edema and warm to touch. 3x5 wide area with induration over entire area.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Localized reaction at injection site (R arm) from shoulder to elbow, pink slightly nodular rash, pain, itchiness. Treatment - supportive care and antibiotics PRN worsening.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Laboratory test abnormal, No adverse event, Wrong drug administered
Clinical narrative: No adverse event.  Wrong vaccination administered.  Menactra was given 05/21/14, had been previously given 03/27/13.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a 57 year old female patient and her husband via a company representative refers to the patient herself. There was no information about medical history/concurrent conditions and concomitant medication. On approximately 23-APR-2014 (reported as "about 2 and 1/2 weeks ago") the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous in the abdomen (lot# and dose unspecified). The patient stated that "it was administered as a 'deep subcutaneous injection'". In approximately April 2014 (reported as "within 24 hours after receiving ZOSTAVAX"), the patient developed an inch-size red circle around the injection site that was sore and there was no rash. The patient did not seek medical attention. The patient recovered in approximately April 2014 (reported as "3 to 5 days after the onset of her symptoms"). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 28-FEB-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J007854, expiration date 28-SEP-2014 (dose and route not reported) that was exposed to 38F for 576 hours, Dates of excursions: 01-FEB-2014 to 28-FEB-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 29-APR-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J013451, expiration date 24-JAN-2014 (dose and route not reported) with worst case exposure of 34F for 506 hours, Dates of excursions: 06-MAR-2014 to 29-APR-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 year old patient who had previously received 2 doses of VARIVAX (Merck) and M-M-R II. On 20-MAY-2014 the patient was inadvertently vaccinated with a third 0.5 ml dose of M-M-R II via subcutaneous route and VARIVAX (Merck) (captured in case #1405USA013780). No adverse effects were reported. No PQC. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date in 2014 the unspecified number of patients were vaccinated with GARDASIL. Concomitant medications were not reported. It was reported that the GARDASIL vaccine was exposed to 11 degree celsius (C) for 84.5 hours, and then for -2.5C for 47 hours in January 2014. These doses of GARDASIL are administered consistently throughout the period of January 2014 to May 2014. No adverse effects were reported. The outcome of administered vaccine exposed to 11c for 84.5 hours, and then for -2.5c for 47 hours and no adverse effects was unknown. This case was linked to 1406USA000392, 1406USA000393, 1406USA000394 and 1406USA000395 (same reporter link).
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Body temperature, Dizziness, Fatigue
Clinical narrative: My husband, is retired, after 31 years of public service. He walked 7 miles every day, up and down the steps, and in every kind of weather, plus dogs. Most days he would come home soaked to the skin and cold, and for years he never got so much as the sniffles. My husband was a saint to his many patrons on his daily route, and a teddy bear that talked to me. Later after he retired, he sailed right thru his heart by-pass and prostate cancer, and he remained very active since he tends to be practical and upbeat in all circumstances. He has always credited  his flu shots with the reason my husband remained untouched by the illnesses most people would talk about, making the rounds thru the years. I noticed when the next day after the flu shot he said he somehow did not feel good. The next morning he said he felt lousy and dizzy, and he had a temperature, and a stomach ache. He is not a complainer, and I was baffled, so I called the clinic. To my surprise they wanted patient to come in that very afternoon. I'm reading the newspaper when an ambulance pulls up and five big neck attendants walked to the back with a stretcher. I thought someone back there is in trouble. MD came to the waiting area and told me not to be alarmed, but she was sending patient to the hospital. She did not want me to drive him to the hospital since she wanted him to be monitored on oxygen, and a IV started, during the trip. Patient got out of the hospital nine days later. I expected him to be on the mend and be his old cheerful self, but weeks went by then months went by, and he was never the same person. The main result was an unfathomable and unrelenting decline in strength and stamina, not recovered, faster than general aging could account for. He put himself into physical therapy but even that finally proved to be too much for him, even using a cane. My husband turned quiet and now can barely move or lift his feet, without fatigue. My husband never took another flu shot. Some previous flu shots dates: 10-24-2011, 9-29-2010, 10-30-2009, 11-3-2008, 11-19-01, 11-9-1999.