chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Hypoaesthesia, Pain, Scar
Clinical narrative: Shingles-across left back/shoulder-down left arm-all fingers and hand-severe blistering/pain. I now have scaring and pain and no feeling in tips of fingers on left hand. Antiviral med taken.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Limb mass, Peripheral swelling, Pruritus
Clinical narrative: 9-15-16 bad headache-took Ibuprofen. 9-17-16 left arm started with lump and swelling and itch really bad. Took BENADRYL pills and a gel on skin. Did not work. Few day later blister came up. 9-26-16 6 blisters, swelling went my legs. Took Ibuprofen and put CALADRYL on and help. Oct. 9 it going away.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneous). The vaccines was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L003227 exp date 13-OCT-2016). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion was 8 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # L035105 exp date 14-MAY-2017 and lot # L043213 exp date 28-AUG-2017) (route and doses not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 804 hours with the lowest recorded temperature of -3 Fahrenheit degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 756 hours with the lowest recorded temperature of -3 Fahrenheit degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 96 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 120 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 120 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time o the second time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 21-SEP-2016, the patient was administered an improperly stored dose of VARIVAX (lot # M027346, expiration date 01-JUN-2018) 0.65 ml, subcutaneously. The vaccine was stored under temperature 47.1 Fahrenheit degree for 40 hours. There was no previous temperature excursion. Digital data logger was involved. The temperature had been back in range. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant referring to two patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients might have received an improperly stored dose of VARIVAX injection (lot # M024675, expiration date 01-JUN-2018; lot # M024675, expiration date 18-MAY-2018; dose unknown) subcutaneously. No adverse effects were reported. The vaccines were stored under the temperature 7.9 Fahrenheit degree for 40 minutes. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 108 hours with the lowest recorded temperature of -3 Fahrenheit degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain and decreased range of motion to arm vaccine given in.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Acute pain in left arm. No Swelling. No redness. 3 hours after left Pharmacy.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Pt. receive BOOSTRIX influenza at Flu Clinic. Experience itchiness raised bumps at site of injection. Subsided within 1-2 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Redness and knot at site of injection Hot and tender, approx. 3 1/2 in diameter. Mostly gone by day 5.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: About 4 hours after vaccine developed fever to 102, diarrhea, vomiting, full body pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Erythema, Skin lesion, Skin warm, Swelling
Clinical narrative: Patient received shingles vaccine at local pharmacy. Shot placed in wrong location on arm. Three days later pt seen in office by PCP w/6 cm x 5.5 cm lesion raised about 2 cm. Warm, red, tender (left deltoid).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient received shingles vaccine at local pharmacy. Shot placed in wrong location on arm. Three days later pt seen in office by PCP w/6 cm x 5.5 cm lesion raised about 2 cm. Warm, red, tender (left deltoid).
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Body temperature increased, Cough, Mobility decreased, Muscular weakness, Nausea
Clinical narrative: Pt received 3rd dose of HPV in left deltoid at 4pm later that evening had left arm pain which persisted slept fine. Today pain persists with nausea T=100.5 at 5:30pm. Unable to raise arm above shoulder level. Sl. cough, legs feel weak.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: Pt received 3rd dose of HPV in left deltoid at 4pm later that evening had left arm pain which persisted slept fine. Today pain persists with nausea T=100.5 at 5:30pm. Unable to raise arm above shoulder level. Sl. cough, legs feel weak.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Saturday morning woke up with extreme pain and swelling and redness, iced arm Saturday and Sunday and went to doctor Monday afternoon given antibiotic if not better by Thursday pt had to return.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea, nausea.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, lot # L038522, expiration date 11-AUG-2017, by intramuscular route in her arm, (frequency was not reported). On the same date, the patient was vaccinated with FLUZONE. At the time of vaccination, the patient had a concomitant therapies with hydrocodone and an unspecified stomach medication reported as "like for an ulcer". On approximately 07-OCT-2016, the patient experienced excessive soreness and inability to lift arm (pain in extremity and injected limb mobility decrease), the dose of hydrocodone was increased, however, the pain was still present after the vaccination. On approximately the same date, the patient fell out of bed (fall) for an unspecified reason but was unable to get up because of arm soreness. The reporter did not specified any treatment or if the patient sought medical attention regarding the fall. On 09-OCT-2016, the patient was better but still sore. At the time of reporting, the outcome of pain in extremity, injected limb mobility decreased and fall was reported as not recovered/not resolved, and, the relatedness between those events and the therapy with PNEUMOVAX 23 and FLUZONE was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, lot # L038522, expiration date 11-AUG-2017, by intramuscular route in her arm, (frequency was not reported). On the same date, the patient was vaccinated with FLUZONE. At the time of vaccination, the patient had a concomitant therapies with hydrocodone and an unspecified stomach medication reported as "like for an ulcer". On approximately 07-OCT-2016, the patient experienced excessive soreness and inability to lift arm (pain in extremity and injected limb mobility decrease), the dose of hydrocodone was increased, however, the pain was still present after the vaccination. On approximately the same date, the patient fell out of bed (fall) for an unspecified reason but was unable to get up because of arm soreness. The reporter did not specified any treatment or if the patient sought medical attention regarding the fall. On 09-OCT-2016, the patient was better but still sore. At the time of reporting, the outcome of pain in extremity, injected limb mobility decreased and fall was reported as not recovered/not resolved, and, the relatedness between those events and the therapy with PNEUMOVAX 23 and FLUZONE was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, lot # L038522, expiration date 11-AUG-2017, by intramuscular route in her arm, (frequency was not reported). On the same date, the patient was vaccinated with FLUZONE. At the time of vaccination, the patient had a concomitant therapies with hydrocodone and an unspecified stomach medication reported as "like for an ulcer". On approximately 07-OCT-2016, the patient experienced excessive soreness and inability to lift arm (pain in extremity and injected limb mobility decrease), the dose of hydrocodone was increased, however, the pain was still present after the vaccination. On approximately the same date, the patient fell out of bed (fall) for an unspecified reason but was unable to get up because of arm soreness. The reporter did not specified any treatment or if the patient sought medical attention regarding the fall. On 09-OCT-2016, the patient was better but still sore. At the time of reporting, the outcome of pain in extremity, injected limb mobility decreased and fall was reported as not recovered/not resolved, and, the relatedness between those events and the therapy with PNEUMOVAX 23 and FLUZONE was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, lot # L038522, expiration date 11-AUG-2017, by intramuscular route in her arm, (frequency was not reported). On the same date, the patient was vaccinated with FLUZONE. At the time of vaccination, the patient had a concomitant therapies with hydrocodone and an unspecified stomach medication reported as "like for an ulcer". On approximately 07-OCT-2016, the patient experienced excessive soreness and inability to lift arm (pain in extremity and injected limb mobility decrease), the dose of hydrocodone was increased, however, the pain was still present after the vaccination. On approximately the same date, the patient fell out of bed (fall) for an unspecified reason but was unable to get up because of arm soreness. The reporter did not specified any treatment or if the patient sought medical attention regarding the fall. On 09-OCT-2016, the patient was better but still sore. At the time of reporting, the outcome of pain in extremity, injected limb mobility decreased and fall was reported as not recovered/not resolved, and, the relatedness between those events and the therapy with PNEUMOVAX 23 and FLUZONE was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Fall, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, lot # L038522, expiration date 11-AUG-2017, by intramuscular route in her arm, (frequency was not reported). On the same date, the patient was vaccinated with FLUZONE. At the time of vaccination, the patient had a concomitant therapies with hydrocodone and an unspecified stomach medication reported as "like for an ulcer". On approximately 07-OCT-2016, the patient experienced excessive soreness and inability to lift arm (pain in extremity and injected limb mobility decrease), the dose of hydrocodone was increased, however, the pain was still present after the vaccination. On approximately the same date, the patient fell out of bed (fall) for an unspecified reason but was unable to get up because of arm soreness. The reporter did not specified any treatment or if the patient sought medical attention regarding the fall. On 09-OCT-2016, the patient was better but still sore. At the time of reporting, the outcome of pain in extremity, injected limb mobility decreased and fall was reported as not recovered/not resolved, and, the relatedness between those events and the therapy with PNEUMOVAX 23 and FLUZONE was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, lot # L038522, expiration date 11-AUG-2017, by intramuscular route in her arm, (frequency was not reported). On the same date, the patient was vaccinated with FLUZONE. At the time of vaccination, the patient had a concomitant therapies with hydrocodone and an unspecified stomach medication reported as "like for an ulcer". On approximately 07-OCT-2016, the patient experienced excessive soreness and inability to lift arm (pain in extremity and injected limb mobility decrease), the dose of hydrocodone was increased, however, the pain was still present after the vaccination. On approximately the same date, the patient fell out of bed (fall) for an unspecified reason but was unable to get up because of arm soreness. The reporter did not specified any treatment or if the patient sought medical attention regarding the fall. On 09-OCT-2016, the patient was better but still sore. At the time of reporting, the outcome of pain in extremity, injected limb mobility decreased and fall was reported as not recovered/not resolved, and, the relatedness between those events and the therapy with PNEUMOVAX 23 and FLUZONE was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV, FLUX, PPV, FLU4, PPV, FLU4, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Disability, Mobility decreased
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 75 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, lot # L038522, expiration date 11-AUG-2017, by intramuscular route in her arm, (frequency was not reported). On the same date, the patient was vaccinated with FLUZONE. At the time of vaccination, the patient had a concomitant therapies with hydrocodone and an unspecified stomach medication reported as "like for an ulcer". On approximately 07-OCT-2016, the patient experienced excessive soreness and inability to lift arm (pain in extremity and injected limb mobility decrease), the dose of hydrocodone was increased, however, the pain was still present after the vaccination. On approximately the same date, the patient fell out of bed (fall) for an unspecified reason but was unable to get up because of arm soreness. The reporter did not specified any treatment or if the patient sought medical attention regarding the fall. On 09-OCT-2016, the patient was better but still sore. At the time of reporting, the outcome of pain in extremity, injected limb mobility decreased and fall was reported as not recovered/not resolved, and, the relatedness between those events and the therapy with PNEUMOVAX 23 and FLUZONE was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV, FLU4, PPV, FLU4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 80 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, lot # L038522, expiration date 11-AUG-2017, by intramuscular route in the patient's arm, (frequency were not reported). At the same day, the patient received a dose of FLUZONE. The patient had a concomitant therapies with an unspecified thyroid medication and an unspecified glaucoma drops. On approximately 07-OCT-2016, the patient experienced excessive soreness and inability to lift arm. The patient was treated with ibuprofen, up to 800 mg, however, it did not help. On 09-OCT-2016, the patient was better but still sore, he could not lift arm without use of other arm and there was still soreness; the patient related it to where shots were administered. On 13-OCT-2016, the patient requested the pharmacist about what to do next like refer to a physician. No product quality complain was involved. At the time of reporting, the outcome of pain in extremity and injected limb mobility decreased was reported as not recovered/not resolved, and, the relatedness between those events and the therapies with PNEUMOVAX 23 or FLUZONE were unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV, FLU4, PPV, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 80 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, lot # L038522, expiration date 11-AUG-2017, by intramuscular route in the patient's arm, (frequency were not reported). At the same day, the patient received a dose of FLUZONE. The patient had a concomitant therapies with an unspecified thyroid medication and an unspecified glaucoma drops. On approximately 07-OCT-2016, the patient experienced excessive soreness and inability to lift arm. The patient was treated with ibuprofen, up to 800 mg, however, it did not help. On 09-OCT-2016, the patient was better but still sore, he could not lift arm without use of other arm and there was still soreness; the patient related it to where shots were administered. On 13-OCT-2016, the patient requested the pharmacist about what to do next like refer to a physician. No product quality complain was involved. At the time of reporting, the outcome of pain in extremity and injected limb mobility decreased was reported as not recovered/not resolved, and, the relatedness between those events and the therapies with PNEUMOVAX 23 or FLUZONE were unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV, FLU4, PPV, FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 80 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, lot # L038522, expiration date 11-AUG-2017, by intramuscular route in the patient's arm, (frequency were not reported). At the same day, the patient received a dose of FLUZONE. The patient had a concomitant therapies with an unspecified thyroid medication and an unspecified glaucoma drops. On approximately 07-OCT-2016, the patient experienced excessive soreness and inability to lift arm. The patient was treated with ibuprofen, up to 800 mg, however, it did not help. On 09-OCT-2016, the patient was better but still sore, he could not lift arm without use of other arm and there was still soreness; the patient related it to where shots were administered. On 13-OCT-2016, the patient requested the pharmacist about what to do next like refer to a physician. No product quality complain was involved. At the time of reporting, the outcome of pain in extremity and injected limb mobility decreased was reported as not recovered/not resolved, and, the relatedness between those events and the therapies with PNEUMOVAX 23 or FLUZONE were unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Discomfort, Injection site inflammation, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Child complained of sore arm on evening of 10/15.  50 mg Ibuprofen was administered at 8 PM.  Child ran fever of 100 the following morning.  200 mg Ibuprofen was administered at 7:45 AM on 10/16.  At 8:15 AM child complained that upper arm at the shot sight was "tight."  Observed that entire upper arm was approximately 50% larger in size than normal.  Clearly defined red rash surrounding the shot site was also observed.  Child was taken to urgent care at 8:45 AM, whereupon doctor assured parent that this was still within the realm of an unusual but "normal" local reaction.  Doctor advised to treat the symptoms (Ibuprofen for pain/aching due to swelling, fever and Benadryl for itching).  At 6:45 PM, rash had doubled in area, arm had doubled in size and swelling extended to forearm and shoulder.  At 10:45 AM on 10/17, parent observed that large, fluid-filled blisters were developing on child's upper arm, the arm had continued to swell, was extremely hot/inflamed, and VERY painful.  Swelling had extended to fingertips and across scapula and back.  Child was generally cranky, uncomfortable, and subdued during entire encounter.  11:15 AM on 10/17, child was again taken to urgent care.  Doctor advised that this was possibly and allergic reaction to the preservative in the vaccine.  A 5-day regimine of prednisone was prescribed (14mg 1x/day).
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site vesicles, Injection site warmth, Irritability, Local reaction, Peripheral swelling
Clinical narrative: Child complained of sore arm on evening of 10/15.  50 mg Ibuprofen was administered at 8 PM.  Child ran fever of 100 the following morning.  200 mg Ibuprofen was administered at 7:45 AM on 10/16.  At 8:15 AM child complained that upper arm at the shot sight was "tight."  Observed that entire upper arm was approximately 50% larger in size than normal.  Clearly defined red rash surrounding the shot site was also observed.  Child was taken to urgent care at 8:45 AM, whereupon doctor assured parent that this was still within the realm of an unusual but "normal" local reaction.  Doctor advised to treat the symptoms (Ibuprofen for pain/aching due to swelling, fever and Benadryl for itching).  At 6:45 PM, rash had doubled in area, arm had doubled in size and swelling extended to forearm and shoulder.  At 10:45 AM on 10/17, parent observed that large, fluid-filled blisters were developing on child's upper arm, the arm had continued to swell, was extremely hot/inflamed, and VERY painful.  Swelling had extended to fingertips and across scapula and back.  Child was generally cranky, uncomfortable, and subdued during entire encounter.  11:15 AM on 10/17, child was again taken to urgent care.  Doctor advised that this was possibly and allergic reaction to the preservative in the vaccine.  A 5-day regimine of prednisone was prescribed (14mg 1x/day).
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Rash erythematous, Swelling
Clinical narrative: Child complained of sore arm on evening of 10/15.  50 mg Ibuprofen was administered at 8 PM.  Child ran fever of 100 the following morning.  200 mg Ibuprofen was administered at 7:45 AM on 10/16.  At 8:15 AM child complained that upper arm at the shot sight was "tight."  Observed that entire upper arm was approximately 50% larger in size than normal.  Clearly defined red rash surrounding the shot site was also observed.  Child was taken to urgent care at 8:45 AM, whereupon doctor assured parent that this was still within the realm of an unusual but "normal" local reaction.  Doctor advised to treat the symptoms (Ibuprofen for pain/aching due to swelling, fever and Benadryl for itching).  At 6:45 PM, rash had doubled in area, arm had doubled in size and swelling extended to forearm and shoulder.  At 10:45 AM on 10/17, parent observed that large, fluid-filled blisters were developing on child's upper arm, the arm had continued to swell, was extremely hot/inflamed, and VERY painful.  Swelling had extended to fingertips and across scapula and back.  Child was generally cranky, uncomfortable, and subdued during entire encounter.  11:15 AM on 10/17, child was again taken to urgent care.  Doctor advised that this was possibly and allergic reaction to the preservative in the vaccine.  A 5-day regimine of prednisone was prescribed (14mg 1x/day).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal X-ray, Abnormal faeces, Asthenia, Blood thyroid stimulating hormone, C-reactive protein
Clinical narrative: Fatigue/ Weakness; Diarrhea followed by 2-4 days of pellet size stools; Nausea; weight Loss (8 pounds since taking vaccine).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Culture, Diarrhoea, Differential white blood cell count, Escherichia test, Fatigue
Clinical narrative: Fatigue/ Weakness; Diarrhea followed by 2-4 days of pellet size stools; Nausea; weight Loss (8 pounds since taking vaccine).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Full blood count, Giardia test, Helicobacter test, Laboratory test, Metabolic function test
Clinical narrative: Fatigue/ Weakness; Diarrhea followed by 2-4 days of pellet size stools; Nausea; weight Loss (8 pounds since taking vaccine).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Thyroxine, Weight decreased
Clinical narrative: Fatigue/ Weakness; Diarrhea followed by 2-4 days of pellet size stools; Nausea; weight Loss (8 pounds since taking vaccine).
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dysarthria, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Reported swelling and redness at injection site starting around 12:30 PM.  At 13:30 PM had a near-syncopal episode with slurred speech; remembers feeling hot and dizzy just prior to syncope.  Seen in ER; received IV Famotidine, Solu-Medrol, and Benadryl.  No airway compromise, no hives.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Presyncope
Clinical narrative: Reported swelling and redness at injection site starting around 12:30 PM.  At 13:30 PM had a near-syncopal episode with slurred speech; remembers feeling hot and dizzy just prior to syncope.  Seen in ER; received IV Famotidine, Solu-Medrol, and Benadryl.  No airway compromise, no hives.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site warmth, Oropharyngeal pain, Rhinorrhoea, Skin oedema
Clinical narrative: Initial unsolicited report received from a consumer on 29 Sep 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number expiration date, route of administration was not reported) on 27 Sep 2016. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergies were not reported. Concomitant medications were not reported. On unspecified date, following the vaccination, the patient had around site felt hot, itchy, had feeling of sniffles, sore throat, and had feeling like fluid was underneath her skin. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. The outcome of the events were unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. (Same source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLU SHOT (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient was sick for over a year. Patient's lab data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. (Same source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLU SHOT (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient was deadly sick for two year in row. Patient's lab data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient got sick. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza like illness, Malaise
Clinical narrative: Initial unsolicited report received from a consumer on 30-Sep-2016. This case was linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188849, 2016SA188850, 2016SA188851. This case involves a patient of (age, sex unknown), who was vaccinated with FLU SHOT (batch number, dose, expiry date, site of administration, route of administration unknown) on an unknown date. Medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced flu like symptoms; according to the patient it was reported that- "the only time I ever got a flu shot is the only time I ever had the flu/ thought I was going to die". Laboratory investigations and corrective treatment were not reported. The outcome for the events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited case received from consumer (patient) via social media on 10-Oct-2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188850, 2016SA188851. (Same source/site, same vaccine). This case involves a patient (age and gender unknown) who was vaccinated with a dose of FLU SHOT (manufacturer: unknown, batch number, expiry date, route, and dose in series: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient got sick. The patient reported that every time patient took flu shot, he got sick. Patient's lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.