chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 20-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 01-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 25-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. Follow up information has been received from the C.M.A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 31-JUL-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 59 year old male patient. Concurrent or medical conditions were not reported. On 20-NOV-2015, the patient was vaccinated with VARIVAX (Merck) (dose, strength, route and lot number were not reported), instead of ZOSTAVAX due to a human error. No adverse effects reported. 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 healthcare worker refers to a 12 year old patient of unknown gender. On 10-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports 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 healthcare worker refers to a 12 year old patient of unknown gender. On 13-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 65 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 09-FEB-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics therapy start date, event onset date and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 20-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 12-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 18-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 22-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 30-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, subcutaneous, 0.5ml). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were unspecified by reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On an unknown date the patient experienced "a rash and blistering at the injection site". It was unspecified if a treatment was given for the events. The outcome of the events was reported as not recovered. The causality of the events was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were unspecified by reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On an unknown date the patient experienced "redness and blistering from elbow to armpit". It was unspecified if a treatment was given for the events. The outcome of the events was reported as not recovered. The causality of the events was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 20-NOV-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L016283, expiry date: 07-AUG-2016) (incorrect product storage). No adverse effects were reported. The outcome was unknown. No product quality complaint was involved. This case is also related to MARRS# 1511USA012683 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer concerning her daughter of unknown age. No concurrent conditions or pertinent medical history were reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose number, dose and lot number not provided). No concomitant therapies were reported. On an unknown date the patient experienced an unspecified adverse event. The outcome of the adverse event was unknown. It was unspecified if the patient sought medical attention. There was no product quality complaint (PQC) involved. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. Since 11-OCT-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L030591 and expiration date 10-FEB-2017, lot # L008353 and expiration date 11-SEP-2016, exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates approximately in 2015 (reported as "on unspecified dates since 18-NOV-2015") the patients were vaccinated with a doses of ROTATEQ lot # L00054 expiration date 30-NOV-2016, lot # L008057 expiration date 01-DEC-2016, lot # L009119 expiration 17-DEC-2016, orally which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Glycosylated haemoglobin increased, Type 2 diabetes mellitus
Clinical narrative: Information has been received from the authors of a published literature article. The authors discussed the effectiveness of exclusion of pre-existing and Day 0 diagnoses of Type 2 Diabetes Mellitus (T2DM) in excluding prevalent T2DM when using automated data in vaccine safety studies. Briefly, the study cohort was comprised of all 117,402 girls and young women ages 9-26 years, who received at least one dose of HPV4 (manufacturer unknown) (lot # and expiry date not reported) from August 2006 to March 2008. Potential incident T2DM cases were identified using ICD-9 code 250.xx associated with inpatient and emergency room visits during the 60 days following each HPV4 dose and excluding those with ICD-9 code 250.xx recorded in any healthcare setting prior to their first HPV4 dose. Elevated HbA1c was used as a marker for the detection and diagnosis of T2DM. Of 33 potential incidents T2DM cases identified using automated data, 19 cases were excluded that either did not have T2DM or had T2DM noted in the charts that pre-dated the first dose of vaccine. Hence, 14 cases of T2DM diagnosed after the date of first vaccination were identified, all with abnormal HbA1c. Of these, four cases were diagnosed with T2DM based on lab results obtained after the vaccination date. Author's medical record review found that 4 of 33 potential incident T2DM cases (12%) were confirmed to be new onset T2DM. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016)( dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the requested made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M. A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 10-JUN-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M. A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for the patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the reports received from the same reporter. Follow up information has been received from the C.M. A via other source of 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 29-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. On 10-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 1 1/2" X 1 1/2" area of redness and swelling at injection site.  No itching.  Aware of it with movement.  Edges marked with pen by RN, advised to see MD if redness or swelling increased.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt was given second Hep A shot 22 days too soon. First dose was given on 6/10/2015.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Hyperaesthesia, Influenza, Neck pain
Clinical narrative: Arm was "so painful" that night, took Advil.  Next morning woke up with flu symptoms - joint pain, arm pain, skin sensitivity.  Neck became "beet red", sore to the touch.  Took Chlortrimeton.  Had Fluzone High Dose last year also with no problems.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm was "so painful" that night, took Advil.  Next morning woke up with flu symptoms - joint pain, arm pain, skin sensitivity.  Neck became "beet red", sore to the touch.  Took Chlortrimeton.  Had Fluzone High Dose last year also with no problems.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Complains of arm pain for two weeks.  No numbness or tingling to extremity.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: After receving Varivax vaccine in left arm. Employee began feeling "off" within 3-4 hours.  Area below injection site red, warm to touch and swollen.  Has been applying cold compress to area.  Denies nausea, vomiting etc. Instructed to continue to apply compresses, apply topical Benadryl and take Benadryl po.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: RIGHT ARM SWOLLEN AFTER THE VACCINE ADMINISTRATION.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood test, Computerised tomogram, Ovarian cancer, Ovarian granulosa cell tumour
Clinical narrative: I was diagnosed with ovarian cancer, a juvenile granulosa cell tumor to be exact. It had been growing for approximately 10 months, which is very near the date when I received the final vaccine and my periods stopped coming. By the time the tumor was caught, it had burst and I was bleeding to death. I had a major surgery. I'm still in remission.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Surgery, Tumour haemorrhage, Tumour rupture, Ultrasound scan
Clinical narrative: I was diagnosed with ovarian cancer, a juvenile granulosa cell tumor to be exact. It had been growing for approximately 10 months, which is very near the date when I received the final vaccine and my periods stopped coming. By the time the tumor was caught, it had burst and I was bleeding to death. I had a major surgery. I'm still in remission.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 16 year old patient of unknown gender. On 13-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 01-DEC-2015, the patient was accidentally vaccinated with an expired dose of PROQUAD (Merck) lot # K007452, expiration date 21-NOV-2015 (strength, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 01-DEC-2015, the patient was inadvertently vaccinated with an expired dose of PROQUAD (Merck) (lot number K006771 and expiration date 07-NOV-2015, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects had been reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Oral discomfort, Rash pruritic, Swelling
Clinical narrative: Raised, itchy rash. Started middle of night on Sunday (11-29). Worse on Mon and Tues (11-30 and 12-1). Inside of mouth burns. Went to see Dr. (Dermatologist) on Wed (12-2-15).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown genders and ages. Patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of ROTATEQ, lot # L008054, expiration date 30-NOV-2016, oral, (route, anatomical place and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: (R) upper arm pain, headache and nausea, decreased appetite, fatigue. Mild erythema 2cm x 1 cm (R) deltoid without heat or drainage.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: (R) upper arm pain, headache and nausea, decreased appetite, fatigue. Mild erythema 2cm x 1 cm (R) deltoid without heat or drainage.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Skin 6 x 7 cm area of erythema and mild edema on extensor surface of right upper arm surrounding injected site.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Bradycardia, Erythema, Oxygen saturation decreased
Clinical narrative: Desaturation to 8 and bradycardia to 55. Required PPV to return to baseline. Noticed that finger tips and soles of feet as well as groin turned a bright, vivid red and palms were white. This reaction dissipated within 1 minute and infant color returned to normal.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Pain on injection, weakness and pain in L arm since injection.
Age: 31.0
Sex: F
Vaccine: FLUR3
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Employee seen in Occupational Health clinic today (12/03/2015) and reports having a spontaneous abortion.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Arm pain, soreness, tingling down to fingers, muscles aches, anxiety.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Insomnia, Mobility decreased, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: Fever, chills arm pain. OT for 3 weeks. Pain pills for 2 weeks.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Periarthritis, Pyrexia
Clinical narrative: Fever, chills arm pain. OT for 3 weeks. Pain pills for 2 weeks.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient had redness all around injection site, about 3 inches in diameter and skin was hot.  Patient was going to take Benadryl and watch closely.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Injection site rash, Pruritus, Skin warm
Clinical narrative: RASH AROUND INJECTION SITE, RADIATING ITCHING FROM INJECTION SITE TO FINGERTIPS. REDNESS, AND SKIN WARM TO THE TOUCH.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Patient stated pain became extreme around 3 am in the morning of 11/30 and was slowly progressing to that point during the day of the immunization. I can not pinpoint a definite time during that day in which the pain exactly started but it did become extreme around 3 o'clock in the morning.
Age: 1.42
Sex: F
Vaccine: DPP, DTPHEP, FLUX, MMRV
Symptoms: Breath odour, Dermatitis diaper, Lethargy, Onychoclasis, Pollakiuria
Clinical narrative: Increased unquenchable thirst, increased urination, severe diaper rashes unable to be cured by anything other than athletes foot fungus creams, brittle nails, more lethargic, occassional fruity breath, all classic symptoms of type 1 diabetes - taking patient to doctors on 12/4/15 for testing. Did not have these issues prior to this last set of vaccinations.
Age: 1.42
Sex: F
Vaccine: DPP, DTPHEP, FLUX, MMRV
Symptoms: Thirst, Type 1 diabetes mellitus
Clinical narrative: Increased unquenchable thirst, increased urination, severe diaper rashes unable to be cured by anything other than athletes foot fungus creams, brittle nails, more lethargic, occassional fruity breath, all classic symptoms of type 1 diabetes - taking patient to doctors on 12/4/15 for testing. Did not have these issues prior to this last set of vaccinations.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site a few hours after injection then erythema the morning after, which was 24 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple, unspecified patients of unknown age and gender. On unknown date the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot# reported as L001536 with expiration date of 03-JUL-2016, lot # L016283 with expiration date of 07-AUG-2016, dose, strength and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Headache, Pain, Peripheral swelling, Pruritus
Clinical narrative: One week ago pt received flu vax (R) arm, PCV 13 (L) arm. Next day felt onset of chills, headache and noted (L) arm swelling, pain, itchy. Taken to hospital ED. Referred back to PCP. Swelling has improved, but remains tender, itchy, swollen. Denies cough, SOB, wheezing.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Tenderness
Clinical narrative: One week ago pt received flu vax (R) arm, PCV 13 (L) arm. Next day felt onset of chills, headache and noted (L) arm swelling, pain, itchy. Taken to hospital ED. Referred back to PCP. Swelling has improved, but remains tender, itchy, swollen. Denies cough, SOB, wheezing.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Chills, Feeding disorder, Feeling abnormal, Injection site reaction
Clinical narrative: Same happened in 1991. Warm and heavy (R) shoulder 1-2 hours after injection. Evening felt lousy took TYLENOL, worked next day. Chills Fri PM, took TYLENOL. Could not eat following 3 days, could not get up from bed. Chills stopped on Sunday. Pain in bones all over.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Same happened in 1991. Warm and heavy (R) shoulder 1-2 hours after injection. Evening felt lousy took TYLENOL, worked next day. Chills Fri PM, took TYLENOL. Could not eat following 3 days, could not get up from bed. Chills stopped on Sunday. Pain in bones all over.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Large area of redness where vaccine was administered also raised rash (circle like) on area of vaccine administration. After 4 days rash still there and is itchy.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Local injection site reaction with bruising, mild swelling and warmth to the touch.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Right thigh swelling, pain and itching, started evening of administration. Seen in clinic next day - started BENADRYL, cool compress. Increased next day and started prednisone.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Back pain, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Experienced fever, slight headache, mild fatigue, nausea, back aches, mild dizziness, day after vaccine.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Experienced fever, slight headache, mild fatigue, nausea, back aches, mild dizziness, day after vaccine.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody positive, Arthralgia, Dyspepsia, Fatigue, Red blood cell sedimentation rate increased
Clinical narrative: Pain in joints - especially spine/neck; fatigue; indigestion started 11/14/15.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Rheumatoid factor positive
Clinical narrative: Pain in joints - especially spine/neck; fatigue; indigestion started 11/14/15.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site streaking, Limb discomfort, Pain in extremity
Clinical narrative: (R) arm pain/discomfort, redness/streaking at inj site spreading to axilla and breast area.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin disorder
Clinical narrative: (R) arm pain/discomfort, redness/streaking at inj site spreading to axilla and breast area.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Localized redness, itching all over.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Local reaction
Clinical narrative: Patient states "The whole front side of my arm from site of inj. down to my elbow became red. I had stinging sensation and itching in this area. Used CORTIZONE cream on arm and took BENADRYL 50mgs Q4 hours till red area went away. This lasted from 11-11-15 to 11-22-15." No hardness/firmness noted at site of extended localized reaction.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Pt received FLUZONE and PNEUMOVAX on the same arm on1.1.15 and developed redness on the arm on 12.2.15 PM. It was warm to touch and reported this on 12.3.15.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient complained that injection site swollen and red. Suggested checking with Dr. Dr stated no cellulitis recommended warm compresses.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given FLUVIRIN, which is indicated for 4 or over. Patient was only 3 yr 10 months. Patient's mother was ok with it on notification and did not want child revaccinated. There were no adverse events. Patient's physician was made aware as well and stated they were ok with not revaccinating as well.
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse (office manager) via a company representative referring to a female patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 24-NOV-2015, the patient was administered a dose of GARDASIL injection (lot # reported as 06501X with expiration date 19-FEB-2011; dose and route were not provided). The reporter stated that it was discovered after administration that it was expired. Treatment was not given and no adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 30-SEP-2014, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot number and expiry date unknown). On 23-NOV-2015, the patient was again vaccinated with of second dose of PNEUMOVAX 23 (lot no. # K020214, expiry date: 25-MAR-2016) which was shorter than the recommended dosing interval. No concomitant medications were reported. No other adverse events were reported. No product quality complaint was reported. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: DTAPHEPBIP, HEP, HPV4, MEN, MMR, DTAPHEPBIP, HEP, HPV4, MMR, MNQ
Symptoms: Drug administered to patient of inappropriate age, Injection site pain, Neck pain, Pyrexia
Clinical narrative: Case number PHEH2015US004130 is an initial spontaneous report from a medical assistant received on 02 Mar 2015. This report refers to a 26-year-old male patient. On 26 Feb 2015, he was vaccinated with MENVEO (batch number: A14082) intramuscularly along with PEDIARIX (other manufacturer, batch number: not reported), hepatitis B vaccine (other manufacturer, batch number: not reported), MMR vaccine (other manufacturer, batch number: not reported) and GARDASIL (other manufacturer, batch number: not reported). On 27 Feb 2015, she experienced fever, neck pain and pain at injection site. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 26.0
Sex: M
Vaccine: DTAPHEPBIP, HEP, HPV4, MEN, MMR, DTAPHEPBIP, HEP, HPV4, MMR, MNQ
Symptoms: Injection site pain, Neck pain, Pyrexia
Clinical narrative: Case number PHEH2015US004130 is an initial spontaneous report from a medical assistant received on 02 Mar 2015. This report refers to a 26-year-old male patient. On 26 Feb 2015, he was vaccinated with MENVEO (batch number: A14082) intramuscularly along with PEDIARIX (other manufacturer, batch number: not reported), hepatitis B vaccine (other manufacturer, batch number: not reported), MMR vaccine (other manufacturer, batch number: not reported) and GARDASIL (other manufacturer, batch number: not reported). On 27 Feb 2015, she experienced fever, neck pain and pain at injection site. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 16-year-old female patient who received MENVEO (batch number M15065, expiry date September 2015). On 10th November 2015, the patient received MENVEO .5 ml. On 13th November 2015, 3 days after receiving MENVEO, the patient experienced rash and shortness of breath. On an unknown date, the outcome of the rash and shortness of breath were unknown. The reporter considered the rash and shortness of breath to be unrelated to MENVEO. Additional details were provided as follows: The healthcare professional reported that on 13th November 2015, the patient experienced rash on both arms and legs and also had shortness of breath (SOB) after vaccination with MENVEO. On same day, the patient visited the emergency room. The healthcare professional did not believe that the vaccine was a cause of the adverse events.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 16-year-old female patient who received MENVEO (batch number M15065, expiry date September 2015). On 10th November 2015, the patient received MENVEO .5 ml. On 13th November 2015, 3 days after receiving MENVEO, the patient experienced rash and shortness of breath. On an unknown date, the outcome of the rash and shortness of breath were unknown. The reporter considered the rash and shortness of breath to be unrelated to MENVEO. Additional details were provided as follows: The healthcare professional reported that on 13th November 2015, the patient experienced rash on both arms and legs and also had shortness of breath (SOB) after vaccination with MENVEO. On same day, the patient visited the emergency room. The healthcare professional did not believe that the vaccine was a cause of the adverse events.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Myalgia, Nausea, Paraesthesia
Clinical narrative: We. 11/27/15 - began with severe headache, achiness, nausea, temp. 99.6 degrees; unable to eat/get out of bed until Sunday 11/29/15. 11/30/15 - began with diarrhea, muscle aches.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Diarrhoea, Feeding disorder, Headache, Mobility decreased
Clinical narrative: We. 11/27/15 - began with severe headache, achiness, nausea, temp. 99.6 degrees; unable to eat/get out of bed until Sunday 11/29/15. 11/30/15 - began with diarrhea, muscle aches.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: We. 11/27/15 - began with severe headache, achiness, nausea, temp. 99.6 degrees; unable to eat/get out of bed until Sunday 11/29/15. 11/30/15 - began with diarrhea, muscle aches.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, RVX
Symptoms: Erythema, Irritability, Pain in extremity, Swelling
Clinical narrative: Redness, swelling, irritability, pain in leg. Administered Tylenol.
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site reaction, Psoriasis
Clinical narrative: Psoriasis at injection site several weeks after injection.  Additional psoriasis spots have developed on my arms.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, IPV, RV1
Symptoms: Postictal state, Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: Seizure: generalized shaking of arms and legs bilaterally, unresponsive for less than one minute. Post-ictal after seizure. Occurred again at 3pm same day, generalized shaking of arms and legs with post-ictal period afterwards.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Food allergy, Skin test positive, Wrong drug administered
Clinical narrative: Developed a severe food allergy to green peas, chick peas and lentils.  He was eating a cereal that morning made of chickpeas and lentils and also had a pouch containing green peas shortly before being vaccinated, with the wrong vaccines (two hibs and a polio 3 years early).
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Seen 11/4 in ER. End of October developed numbness in hands and feet (seen 11/5 sx x 1 wk). Returned 11/9 with paresthesia - unable to walk - sent to ER and admitted to Medical Center. Diagnosed with Guillain-Barre Syndrome. Discharged to rehab 11/16 and released 11/25. Seen in office 12/3.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Haematoma, Injection site discolouration, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 59-year-old female patient. The current conditions of the patient included high blood pressure and high cholesterol. The patient had no drug allergies. On 18-NOV-2015, the patient was vaccinated with ZOSTAVAX (lot number # L024998 Expiry date: 06-OCT-2016) (strength and dosing regimen was unknown), via subcutaneous route. Concomitant therapies included PLAVIX and aspirin (manufacturer unknown) and some unspecified medication for high blood pressure. On 18-NOV-2015, in the evening time, after the patient was vaccinated with ZOSTAVAX, experienced a large, red, sore area around the injection site with a nod in it. On 23-NOV-2015, the patient visited the pharmacy and reported that the nod or the hematoma has disappeared, however, the site was still large (the size of her lower arm), red and black and sore and was also described the site as "black and blue" and the size of an orange. The patient was advised and encouraged to follow up with her primary health care physician. The outcome of the event "a large, red, sore area around the injection site" was reported as not recovered however the outcome for the event "the injection site with a nod" was reported as recovered. The relatedness of the events with ZOSTAVAX was unknown. No product quality complaint was reported. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea, emesis, nausea, stomach pain. Symptoms intermittently through 12/3/2015.
Age: 1.5
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an 18 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 07-OCT-2015, the patient was vaccinated with expired dose (third dose in the series) of RECOMBIVAX HB lot # J000722 and expiry date of 17-SEP-2015 (unknown strength and route). No adverse effects were reported. 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 of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 19-OCT-2015, the patient was vaccinated with a dose of VAIRVAX (Merck) (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.