chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 05-NOV-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot # L024997, expiration date: 06-OCT-2016), which were improperly stored for 43 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 12-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.67 ml, Lot#L011529, expiration date: 03-JUL-2016), which was improperly stored for 9 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 3 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 14-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot # 011529, expiration date: 03-JUL-2016), which were improperly stored for 11 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nursing referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 11-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 49 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 09-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 47 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 05-NOV-2015, the patients were vaccinated with ZOSTAVAX (0.5 ml, Lot#L024997, expiration date: 06-OCT-2016), which were improperly stored for 43 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 06-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot # L024997, expiration date: 06-OCT-2016), which was improperly stored for 44 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 06-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 44 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 04-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot# L024997, expiration date: 06-OCT-2016), which was improperly stored for 42 days (incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 30-OCT-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot # L024997, expiration date: 06-OCT-2016), which was improperly stored for 46 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 02-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 40 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Syncope
Clinical narrative: Syncope episode following administration of HPV and Hep A vaccines. Pt recovered within 5 min after episode.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 11-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 49 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 17-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot#L011529, expiration date: 03-JUL-2016), which were improperly stored for 14 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Lethargy, Nausea
Clinical narrative: Increased size from 1.5 in diam to 2.5 in diam. Feeling tired, lethargic, mild nausea. Pt had been alternating Ibuprofen and TYLENOL. Tried ice - didn't make a difference. Prescribed cephalexin 250 mg, 21, 1 tab(s) 3 times a day for 7 days. Got better after 24 hours of antibiotics.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Administered morning of 5/12/16 10:44 am. 5/13/16 pt called in afternoon and said it was red in a 3-3.5 inch circle around injection site, warm to touch and raised/swollen slightly 5/14/16 called pt and said 2as 3.5 - 4 inch circle; not as raised, less warm and feels better than yesterday. 5/16/16 - going away, not itchy, not raised, less warm.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Injection site warmth, Pruritus
Clinical narrative: Erythema, inflammation and warmth to the touch on RD, measuring 73mm in length and 90mm in height. Redness to left forearm where TB was administered, no induration. Erythema to LD where T-dap was administered. Pruritis to chest area. Pt took (2) BENADRYL 25mg tabs.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: Pt received vaccine at approx. 1:00 p.m. Pt received KINRIX, MMR, Varicella. Mother/father brought child in approx. 3:00 p.m. Child skin reddish color with welts approx. 1-2 cm throughout body. Child c/o itching throughout body. Child was not having breathing difficulties.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Severe chills, muscle and joint pain, of my whole body, headache, fatigue, decreased - no appetite for 36 hrs.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: Severe chills, muscle and joint pain, of my whole body, headache, fatigue, decreased - no appetite for 36 hrs.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Molluscum contagiosum, Rash
Clinical narrative: Pt has dx molluscum contagiosum. Hx of eczema and dry skin. Tx with apple cider vinegar. Seen in office approximately 1 wk after MMR vaccine with worsening rash -> refer to Derm ? reaction to MMR vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 16-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 54 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ROTATEQ lot # L022446/expiration date- 14-FEB-2017, lot # L026740/expiration date- 20-APR-2017, lot # L026741/expiration date- 18-MAY-2017, lot # L027719/expiration date- 28-APR-2017, lot # L039638/expiration date- 23-AUG-2017, lot # L035636/expiration date- 21-MAY-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion and time frame was 49F for 143 hours and 34F for 24 hours. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Breath holding, Dizziness, Eye movement disorder, Tremor
Clinical narrative: Child was nervous gave TDAP and MCV4 and she was doing ok said shots weren't as bad as she thought then gave HPV4 in Lt. Deltoid, she c/o dizziness, looked to be holding breath. Advised to breath. Then lip curved up, eyes crossed and upper body began shaking, laid her down and she came to called PCP and advised to go to ED. During shaking applied cool compress and elevated legs. BP 118/72 P75.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative referring to an elderly (reported as over the age of 65 years) female patient with neoplasm malignant. The patient's medical history was not provided. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (route, dose, frequency, lot number and expiration date were not reported). Concomitant medications were not provided. On an unknown date, (reportedly as approximately one year after vaccination), the patient developed shingles (herpes zoster). Furthermore, on an unknown date (reported as approximately one year after developing shingles) the patient saw the physician in the office and was administered the second dose of ZOSTAVAX. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of herpes zoster was unknown. The primary reporter did not provide the causal relationship between ZOSTAVAX and herpes zoster. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In May 2016, the patients were vaccinated with the improperly stored dose of VAQTA lot # L031196, expiration date on 05-FEB-2017, lot number reported as: M009377, expiration dates on 30-JUN-2017 and 17-JUN-2017; dose was not reported. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Redness, swelling at injection site. Also small fluid filled blister at site warm to touch, no pain, no fever, no infection.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 12-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.67 ml, Lot # L024997, expiration date: 06-OCT-2016), which was improperly stored for 50 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 12-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot # L011529, expiration date: 03-JUL-2016), which was improperly stored for 9 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 23-OCT-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 39 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 3 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 12-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot#L011529, expiration date: 03-JUL-2016), which were improperly stored for 9 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Skin exfoliation
Clinical narrative: Pt report 5/20/16 late afternoon stating that her skin is peeling off (injection site) after she got the shot the next day and it aches. She put alcohol on skin.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 13-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot # L011529, expiration date: 03-JUL-2016), which were improperly stored for 10 days. The outcome was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 11-AUG-2015, the patient was vaccinated with ZOSTAVAX (1 ml, Lot#L011529, expiration date: 03-JUL-2016), which was improperly stored for 8 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via a company representative concerning a patient of unknown age and gender. On unknown dates, the patient might was vaccinated with two doses of ZOSTAVAX (lot numbers, expiration dates and route unspecified), respectively. It was reported that each dose was administered on a separate unspecified date but within 5 years of each other (extra dose administered). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 lot # L016429/ expiration date 09-AUG-2017, lot no. L02660/ expiration date- 19-OCT-2017, lot # L026602/ expiration date- 19-OCT-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion and time frame was 49F for 143 hours and 34F for 24 hours. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored VAQTA lot # L032749/ expiration date- 04-NOV-2016, lot # L026600/ expiration date- 15-MAR-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion and time frame was 49F for 143 hours and 34F for 24 hours. There was no previous temperature excursion and call was not because of a data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB  lot # L038018/expiration date- 13-SEP-2017, lot # L044694/expiration date- 04-FEB-2018 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion and time frame was 49F for 142 hours and 34F for 24 hours. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not reported). On an unknown date, the patient developed a grapefruit size case of shingles at the ZOSTAVAX injection site. The outcome of the event was unknown. Relatedness between the event and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Cellulitis, Full blood count normal, Injection site erythema, Injection site infection, Injection site pruritus
Clinical narrative: 5/24: Received vaccine - did swim in lake that evening. 5/25: seen at acute care for increased redness and itching at vaccine site - started KEFLEX for sxn/infection. 5/26: seen at our clinic for rash spreading even more, dx bacterial cellulitus and added clindamycin with KEFLEX. 5/27: seen at clinic for recheck - improving.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: 5/24: Received vaccine - did swim in lake that evening. 5/25: seen at acute care for increased redness and itching at vaccine site - started KEFLEX for sxn/infection. 5/26: seen at our clinic for rash spreading even more, dx bacterial cellulitus and added clindamycin with KEFLEX. 5/27: seen at clinic for recheck - improving.
Age: 1.07
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives over most of body.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 101.3 day after imms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Skin discolouration, Urticaria
Clinical narrative: Hives on trunk, arms, legs onset day of vaccines. Initially treated with BENADRYL 5/23/16 Rx for hydroxyzine started 5/25/16 rash improving some purple areas. Rec allergy consult.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 23-OCT-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot # L024997, expiration date: 06-OCT-2016), which was improperly stored for 39 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been received.
Age: 27.0
Sex: M
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a 27 year old male patient who was a pharmacist and was reporting on himself. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with his last dose of GARDASIL 9 (dose, route of administration and lot # were not reported). On an unknown date, the patient was experiencing adverse effects from receiving GARDASIL 9. The patient stated that he might consider bringing this case to court. The patient's outcome was unknown. The reporter considered the event to be related to the therapy with GARDASIL 9 (reported as he was experiencing adverse effects experiencing from receiving GARDASIL 9). Additional information is not expected as there was no consent to contact a physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 3 unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On unspecified dates the patients were vaccinated with an improperly stored dose of GARDASIL (incorrect product storage) (lot # K008931, expiry date 04-MAR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the GARDASIL experienced a temperature of 27 degrees Fahrenheit for a time frame of 60 days (multiple cycles). It was reported that the GARDASIL was back in range. It was reported that the GARDASIL experienced no previous temperature excursion. This case was reported due to a data logger. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse who reported that multiple unspecified patients received unsecured doses of improperly stored PROQUAD (lot # L050909, expired date 14-JUN-2017 or lot # M002055, expired date 11-JUL-2017; rHA; dose and route not reported). These vaccines were under 9.5 F for 3 hours and 26 minutes and then under 13.1 F for 1 hour and 24 minutes. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 26-MAY-2016, the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (lot # K003414 and expiry date: 06-MAR-2016). No adverse effects were reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse who reported that multiple unspecified patients received unspecified doses of improperly stored ZOSTAVAX (lot # L023118 expired date 24-SEP-2016 or L017138 expired date 13-AUG-2016; dose and route not reported). These vaccines were under 9.5 F for 3 hours and 26 minutes. There was no previously temperature excursion. No adverse effects were reported. This is one of the several reports from the same reporter. 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 who reported that multiple unspecified patients received unspecified doses of improperly stored VARIVAX (lot # L045956, expired date 17-NOV-2017 or lot # L048463, expired date 02-DEC-2017; dose and route not reported). These vaccines were under 9.5 F for 3 hours and 26 minutes and then under 13.1 F for 1 hour and 24 minutes. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L038018/expiration date- 13-SEP-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion was 35 F and 52.5 F for unspecified time. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information is not expected as reporter dose not wants to get contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L019836/expiration date-24-MAR-2017. No adverse event was reported. The outcome of the event was unknown. Temperature excursion was 35 F and 52.5 F for unspecified time. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information is not expected as reporter does not wants to get contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL lot # L035105/expiration date-14-MAY-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion was 35 F and 52.5 F for unspecified time. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information is not expected as reporter does not wants to get contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 01-OCT-2015, the patient was vaccinated with ZOSTAVAX (0.67 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 17 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 3 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 20-OCT-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot # L024997, expiration date: 06-OCT-2016), which were improperly stored for 36 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 08-OCT-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 24 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 19-OCT-2015, the patient was vaccinate with ZOSTAVAX (0.5 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 35 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 07-OCT-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 23 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Throat tightness
Clinical narrative: This medically confirmed health authority report (initial receipt 26-Oct-2015) concerns a 48 year old female patient. The patient had no medical history or current illness. Her concomitant medications included atorvastatin, glibenclamide, rabeprazole, metformin and lisinopril/hydrochlorothiazide. On 30-Aug-2015, the patient received intramuscular AFLURIA injection (batch number U56406), intramuscular PNEUMOVAX (batch number: L003227) and intramuscular Tdap (batch number C4689AA). All three vaccines were given in the right arm. On 30-Aug-2015 around 10 pm, the patient developed anaphylaxis (throat swelling and closure). The outcome was as recovered. Reporter's comments: The reporter assessed the events as non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 50 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate reports sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 19-Sep-2015- unknown stop date, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml, site: Left arm. Additional suspect drug (s): PNEUMOVAX, Indication: not provided, site: right arm. Reaction (s))/event (s) and outcome: On 19-Sep-2015, 1 day after starting/treatment with AFLURIA the patient experienced Arm swollen (non serious, outcome: Unknown), Arm painful (non serious, outcome: Unknown). For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#. Reporter's assessment: The health authority assessed the events as non-serious. Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the events Arm swollen and Arm painful are unlisted events of AFLURIA. Case Causality: Possible.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Gingival swelling, Lip swelling, Sneezing, Swelling face
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a (n) Health Professional and concerns a (n) 54 years old male patient. Concurrent medical condition (s), medical and drug history: The patient has a medical history of High blood pressure, GERD and Allergic to tetracycline and penicillin. The following drug history information was reported: Tetracycline (Indication: -, Reaction: Allergy) and Penicillin (Indication: -, Reaction: Allergy). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s) /event (s): The patient received AFLURIA on 21-Sep-2015 - unknown stop date, Batch no: U55906, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s) /event (s) and outcome: On 21-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Swelling of [face,] tongue [, gums and lips] / Swollen tongue (non serious, outcome: Recovered / Resolved), Swelling of face [, tongue, gums and lips] / Swelling face (non serious, outcome: Recovered / Resolved), Swelling of [face, tongue,] gums [and lips] / Gingival swelling (non serious, outcome: Recovered / Resolved), Swelling of [face, tongue, gums and] lips / Lip swelling (non serious, outcome: Recovered / Resolved), Wheezing (non serious, outcome: Recovered / Resolved), Sneezing (non serious, outcome: Recovered / Resolved), Coughing (non serious, outcome: Recovered / Resolved). ER too busy to stay, symptoms were improving, went home and took second CLARITIN and two ADVIL. Event treatment: Took ADVIL at 15:45 and CLARITIN at 20:45. Took second loratadine after ER visit. Reporter's assessment: Non-serious. Case correction (10-Feb-2016): Upgraded to serious.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Swollen tongue, Wheezing
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a (n) Health Professional and concerns a (n) 54 years old male patient. Concurrent medical condition (s), medical and drug history: The patient has a medical history of High blood pressure, GERD and Allergic to tetracycline and penicillin. The following drug history information was reported: Tetracycline (Indication: -, Reaction: Allergy) and Penicillin (Indication: -, Reaction: Allergy). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s) /event (s): The patient received AFLURIA on 21-Sep-2015 - unknown stop date, Batch no: U55906, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s) /event (s) and outcome: On 21-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Swelling of [face,] tongue [, gums and lips] / Swollen tongue (non serious, outcome: Recovered / Resolved), Swelling of face [, tongue, gums and lips] / Swelling face (non serious, outcome: Recovered / Resolved), Swelling of [face, tongue,] gums [and lips] / Gingival swelling (non serious, outcome: Recovered / Resolved), Swelling of [face, tongue, gums and] lips / Lip swelling (non serious, outcome: Recovered / Resolved), Wheezing (non serious, outcome: Recovered / Resolved), Sneezing (non serious, outcome: Recovered / Resolved), Coughing (non serious, outcome: Recovered / Resolved). ER too busy to stay, symptoms were improving, went home and took second CLARITIN and two ADVIL. Event treatment: Took ADVIL at 15:45 and CLARITIN at 20:45. Took second loratadine after ER visit. Reporter's assessment: Non-serious. Case correction (10-Feb-2016): Upgraded to serious.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: This health authority report (initial receipt 23-Nov-2015) concerns a 35 year old female patient with no medical history or current illness. On 07-Oct-3015, the patient received AFLURIA  (batch U54506) via unknown route at site LA (site arm). On the same day the patient also received PNEUMOVAX (batch K007826) via unknown route at site LA (left arm). On 08-Oct-2015, the patient developed cellulitis. The event outcome was unknown. Reporter's assessment: The reporter considered events non serious.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 56 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug (s), timing and condition
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 57 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 14-Oct-2015- unknown stop date, Batch no: U58808, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 14-Oct-2015, 1 day after starting/treatment with AFLURIA the patient experienced Body aches (non serious, outcome: Recovered/Resolved), Fever (non serious, outcome: Recovered/Resolved), Chills (non serious, outcome: Recovered/Resolved), Headaches (non serious, outcome: Recovered/Resolved), Diarrhoea (non serious outcome: Recovered/ Resolved). The patient was treated with acetaminophen and the symptoms alleviated. For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate# Reporter's assessment: The health authority assessed the events as non-serious. Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the events Fever, Chills and Headaches are listed events of AFLURIA, the events Body aches and Diarrhoea are unlisted events of AFLURIA. Case Causality: Possible.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: This case report was received from a(n) Health Professional and concerns a(n) 48 years old female patient. Weight: not provided, Height: not provided. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Lupus in September. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 13-OCT-2015 - unknown stop date, Batch no: U58908, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s); No additional drugs suspected. Reaction(s)/event(s) and outcome: On 14-Oct-2015, 2 days after starting / treatment with AFLURIA the patient experienced numbness in Rt hand (fingers) non serious, outcome: Unknown). Event treatment: The patient was treated with acetaminophen which was helping. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The healthy authority assessed the events as non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 50 years old female patient. Weight: not provided, Height: not provided. For concomitant and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication. Indication not reported on 08-Oct-2015- unknown stop date, Batch no: 11549221A, Route of administration: Intramuscular, Site: left arm. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 09-Oct-2015, 2 days after starting/ treatment with AFLURIA the patient experienced Pain at injection site (non serious, outcome: Unknown), Bruising at injection site (non serious, outcome: Unknown), Warm to touch at injection site (non serious, outcome: Unknown), Swelling at injection site (non serious, outcome: Unknown).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Pain
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 58 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 07-Oct-2015- unknown stop date, Batch no: U56306, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 07-Oct-2015, 2 days after starting/treatment with AFLURIA the patient experienced Unable to move arm w/o intense pain (non serious, outcome: Not Recovered/Not Resolved), Bruise at injection site (non serious, outcome: Not Recovered/ Not Resolved), Injection site pain (non serious, outcome: Not Recovered/Not Resolved). The patient was starting to get better as of 13-Oct-2015. She had no fever or inflammation and was otherwise okay. For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate# Reporter's assessment: The health authority assessed the events as non-serious. Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the events Bruise at injection site and Injection site pain are listed events of AFLURIA, the event Unable to move arm w/o intense pain is a unlisted event of AFLURIA. Case Causality: Possible.