chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.06
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient had no pertinent medical history, no concomitant medications and no drug reactions/allergies. On 25-AUG-2008 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, the first dose, site and route of administration, lot# and expiration date were not reported. On an unknown date, after receiving the first dose of (Oka/Merck) VARIVAX, the patient developed shingles. On an unknown date the patient recovered from shingles. Relatedness between use of (Oka/Merck) VARIVAX and the event of shingles was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with a dose ROTATEQ, orally (dose and lot # were not reported). This vaccine had been exposed to 32F for 2.5 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No information about medical history, drug reactions and allergies was specified. On 22-SEP-2014, patient was given the ZOSTAVAX (lot#, dose, route not reported). No concomitant medications were reported. The field representative reported that the pharmacist called in to report the events. The pharmacist reported that on 23-SEP-2014, the patient experienced adverse events of - site of injection swelling, redness, itchiness and soreness. The patient is now starting to have "tingling in other parts of her body" (the "other parts of her body" was unspecified by the field representative). She was unsure of where the tingling was located. The pharmacist said she recommended the patient to see her doctor and the patient will go in to see her doctor today. There was no product quality complaint. The outcome of the events was reported as not recovered. The causality of the events was not specified. Additional information has been requested.
Age: 0.47
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a child received her first dose of VAQTA on 10-JUL-2014 and her second dose of VAQTA on 16-SEP-2014. The child has not reported or demonstrated any adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 02-OCT-2014, the patient was vaccinated with expired dose of PNEUMOVAX 23, injection, 10 vials of 1, 0.5 ml, intramuscular (lot # J007059, expired date: 31-JUL-2014). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site anaesthesia
Clinical narrative: Patient said that arm feels as if it goes numb at injection site. The numbness comes and goes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dyspnoea, Erythema, Immediate post-injection reaction, Injection site erythema, Pain
Clinical narrative: 10:00 Varicella/KINRIX administered (L) arm, MMR administered (R) arm. Client immediately complained of itching/pain. (R) arm reddened around insertion site. 10:02 client's face reddened, hives present on (L) side, continues to complain of itching. 10:07 sent to ER via private vehicle, as client was leaving, he stated that "it is getting harder to breathe".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: 10:00 Varicella/KINRIX administered (L) arm, MMR administered (R) arm. Client immediately complained of itching/pain. (R) arm reddened around insertion site. 10:02 client's face reddened, hives present on (L) side, continues to complain of itching. 10:07 sent to ER via private vehicle, as client was leaving, he stated that "it is getting harder to breathe".
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient has a red, raised rash with itching that is present at site of injection that wraps around to back of arm - rash is still present 14 days later.
Age: 1.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Diarrhoea, Hypotonia, Unresponsive to stimuli
Clinical narrative: Pt went limp and was unresponsive 1030pm 10/7/14 and about 1030 am and 11am on 10/8/14. Perioral cyanosis with 1 episode. No fever. Has had diarrhea for about 6 days pre vaccine.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, strength, frequency and lot number were not reported). On an unknown date, the patient was vaccinated with a second dose of GARDASIL (dose, strength, frequency and lot number were not reported). Secondary and concomitant therapies were not reported. Medical assistant reported that the patient received her first dose of GARDASIL when she was 19 years old and the second dose of GARDASIL at 26 years old. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Off label use
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that on unspecified dates an unspecified number of patients were administered more than the recommended doses of PNEUMOVAX 23 INJ in a shorter time period than recommended in the prescribing information. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (RN) refers to a patient of unknown gender and age. The patient was respectively vaccinated with the first and second dose of RECOMBIVAX HB vial, (therapy type, lot number, route and dose were not provided) on 19-APR-2003 and 17-JUN-2005. There were no known adverse effects. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to his grandmother of unknown age. On an unknown date the patient may have vaccinated with a second dose of PNEUMOVAX 23 (lot#, expiration date, route and dose were unknown) because she was unsure if she ever received the first dose. No adverse effects was reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Malaise, Myalgia, Pain
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 69 year old female patient with drug reactions/allergies to MEDROL. The patient had no pertinent medical history. On 24-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, intramuscular, 0.5 ml, lot# was reported as K00773, expiration date 01-MAY-2015) as required. Concomitant therapies included FLONASE, BIEST, estriol, OTEZLA and metoprolol succinate. On 26-SEP-2014, the patient experienced red rash at the injection site and extreme muscle ache after taking PNEUMOVAX 23. The patient had been still feeling unwell and "sore" since 26-SEP-2014. The patient had sought for medical attention. Treatment included BACTRIM was given for the adverse event. No lab diagnostics study was performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Itching/redness, 6 to 8 hours after injection, ice hydrocortisone cream.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 05-FEB-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. The reporter reported that on an unknown date an unspecified number of patients were vaccinated with VARIVAX (Merck) (dose, frequency, dose number, product lot#, expiry date, route not reported) that was improperly stored. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Viral titre
Clinical narrative: This spontaneous report was received from a other registered nurse refers to an approximately 25 year old female patient with hypercholesteremia and mitral valve disorder. The patient's medical history included goitre. On an unknown date in 2005, the patient received dose one of (Oka/Merck) VARIVAX INJ (lot # was not reported) injection for vaccination, and on an unknown date in 2007, the patient received dose two of (Oka/Merck) VARIVAX (lot# 656078/0169U and expiration date was 17-JAN-2009) injection for vaccination. Concomitant medications were not reported. The patient had (Oka/Merck) VARIVAX INJ titers drawn on 19-AUG-2010 and these titers came back negative. On an unknown date in 2013, the patient was then administered a third dose of (Oka/Merck) VARIVAX INJ (lot# H009634 and expiration date was 09-MAY-2014) injection for vaccination and had titers drawn again on 24-SEP-2014 which showed negative results. The outcome of events was reported as not recovered/not resolved. Causality was not provided by the reporter. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to 4 patients of unknown age and gender. On an unknown date in 2014, the patients were inadvertently vaccinated with expired doses of PNEUMOVAX 23 (lot # J011651 exp 22-AUG-2014) intramuscularly. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age and gender. On 03-OCT-2014, the patient was vaccinated with an improperly stored 0.65 ml dose of ZOSTAVAX (lot # not reported) subcutaneously that was exposed to 20 F for 139 hours. No adverse effect was reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 58 year old female patient with depression, hypothyroidism, fibromyalgia, sulfa allergy and gastritis due to prednisone (manufacturer unknown) (MARRS#1410USA004118). On an unspecified date in 2005 the patient was vaccinated with PNEUMOVAX 23, intramuscular (dose and lot number were not reported). Concomitant therapies included CELEBREX, ZOLOFT, and ARMOUR THYROID TABLETS. In 2005, within 48 hours of receiving PNEUMOVAX 23 the patient developed pain, swelling and redness at the PNEUMOVAX 23 injection site. The patient took TYLENOL on unspecified dates. On an unspecified date about 2 weeks after PNEUMOVAX 23 injection, the patient recovered. No lab diagnostics studies were performed. The patient called the physician. This is one of two reports from the same patient. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Pharmacy Technician refers to a patient of unknown age and gender. Concomitant medication, medical history, drug reactions and allergies were not reported. On 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J002646 expiry date 11-MAR-2014 (dose and route were not reported). On 24-SEP-2014, the patient was administered an expired dose of PNEUMOVAX 23. No adverse events were reported. The outcome of was administered an expired dose of PNEUMOVAX 23 was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a female patient of unknown age. Concomitant medications, medical history, drug reactions and allergies were not reported. On unspecified dates between 15-SEP-2014 and 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J013555 expiry date 02-MAY-2015, intramuscular (dose was not reported. On the day, in September 2014 following to the vaccination with PNEUMOVAX 23 injection, the patient experienced hot area, red and painful at the site of injection. The patient sought medical attention went to see the physician. There were no laboratory diagnostic studies performed. On an unknown day, the patient received an unspecified antibiotic. The outcome of painful, red and hot area at the site of injection was reported as recovering. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a male patient of unknown age. Concomitant medications, medical history, drug reactions and allergies were not reported. On unspecified dates between 15-SEP-2014 and 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J013555 expiry date 02-MAY-2015, intramuscular (dose not reported). On the day in September 2014, following to the vaccination with PNEUMOVAX 23 injection, the patient experienced hot area, red and painful at the site of injection. The patient sought medical attention went to see the physician. There were no laboratory diagnostic studies performed. On an unknown day, the patient received an unspecified antibiotic. The outcome of painful, red and hot area at the site of injection was reported as recovering. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 02-SEP-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed within recommended storage temperature since then. The highest temperature the M-M-R II could have been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a female patient of unknown age. Concomitant medications, medical history, drug reactions and allergies were not reported. On unspecified dates between 15-SEP-2014 and 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J013555 expiry date 02-MAY-2015, intramuscular (dose was not reported). On the day in September 2014, following to the vaccination with PNEUMOVAX 23 injection, the patient experienced hot area, red and painful at the site of injection. The patient sought medical attention went to see the physician. There were no laboratory diagnostic studies performed. On an unknown day, the patient received an unspecified antibiotic. The outcome of painful red and hot area at the site of injection was reported as recovering. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a group of 3 patients of unknown age. Medical history, current conditions and concomitant medication were not reported. On an unknown date (In September 2014), the patients were vaccinated with VARIVAX (Merck) (Lot # and expiration date were not provided). On an unknown date (In September 2014), 3 patients received improperly stored with VARIVAX (Merck). No symptoms reported. No other details. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 27-AUG-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a Medical Assistant refers to a female patient of unknown age. Medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular (Lot # and expiration date were not provided). On an unspecified date, the patient became pregnant. The LMP and EDD were not known. The pregnancy outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to three patients of unknown age and gender. Medical history was not reported. The nurse informed that on 08-MAY-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed to 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from the patient's wife and the 78 year old male patient with high blood pressure, reporting on himself. The patient had no pertinent drug reactions/allergies. On an unspecified date in 2008 the patient was vaccinated with ZOSTAVAX, injection (dose and lot number were not provided). Concomitant medications included an unspecified blood pressure medicine. Reporter stated that the patient received the ZOSTAVAX vaccine 2008, and he came down with shingles on 12-SEP-2014. Reporter stated that he was in the third week of a wicked case of shingles. The outcome of wicked case of shingles was reported as not recovered/not resolved. Patient was prescribed steroids and pain killers as treatment. The relationship between ZOSTAVAX and the event was not reported. No lab diagnostics studies were performed. Patient had an doctor office visit. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a Licensed Vocational Nurse concerning 25 year old female patient. Medical history and concurrent conditions were not reported. On 25-JUL-2014, patient was vaccinated with the first dose of GARDASIL (Lot # K006095, expiration route 06-AUG-2015) (route not reported). On 26-SEP-2014, the patient was vaccinated with the second dose of GARDASIL (Lot # K006095, expiration date 02-FEB-2014) (route not reported). Co-suspect and concomitant therapies were not reported. The Licensed Vocational Nurse reported that after patient received her second dose on 26-SEP-2014, she sought consultation with another healthcare provider for contraception, and during that consultation, she was discovered to be pregnant. No adverse effects have been observed or reported. The last menstrual period (LMP) was reported as 01-SEP-2014, date of conception was approximately on 15-SEP-2014 and estimated delivery date would be on 08-JUN-2015. The pregnancy outcome was pending. Fetal outcome was unknown. The exposure was during the first trimester. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On 17-SEP-2014, the patients were administered with PNEUMOVAX 23 (single and multi dose vials) (Lot # J004387; Expiration date: 04-JAN-2015) (dose and route not reported), which underwent a temperature excursion. No adverse experiences/effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 14-JUL-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Current conditions and relevant medical history were not reported. On 04-OCT-2014 the patient was vaccinated with ZOSTAVAX (Subcutaneous injection; dose number, route, batch and lot # and expiration date not reported). Concomitant therapies were not reported. On an unspecified date in October 2014, after receiving the dose of ZOSTAVAX, the patient experienced "a little redness and soreness at the injection site. The patient sought medical attention by contacting the pharmacist. The outcome of the events was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 27-JUN-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On an unspecified date in August 2010, the patient received the first dose of GARDASIL intramuscular; in April 2013 the patient received the second dose of GARDASIL intramuscular and on 01-OCT-2014 the patient was in the office to receive the third dose intramuscular of GARDASIL. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 13-MAR-2014, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, (dose, route, lot number and expiration date not reported). On 04-OCT-2014 the patient received a second dose of ZOSTAVAX (dose, route, lot number and expiration date not reported). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional (certified Medical Assistant) refers to an unspecified number of patients of unknown age and gender. The reporter stated that an unspecified number of doses of PNEUMOVAX 23, 0.5 ml (route, Lot# and expiration date were not reported), which underwent a supported temperature excursion, may have been administered to unspecified patients on unspecified dates. No adverse experiences reported. It was unknown if the patients sought medical attention. Additional information is not expected, because the physician can not be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 08-APR-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a female consumer refers to a patient of unknown age with shingles. On an unknown date, the patient was vaccinated with ZOSTAVAX 1 single shot (dose, strength, frequency and lot number were not reported). Other suspect therapies included PNEUMOVAX 23 (dose, strength, frequency and lot number were not reported). Concomitant therapies included LYRICA. The patient reported that on an unknown date she received PNEUMOVAX 23 and 10 days later she received ZOSTAVAX and she had been experiencing unspecified side effect (not specified). Patient reported that she attributed this effects that she took herself off of LYRICA which she had used to treat a case of shingles that she had before receiving ZOSTAVAX. The patient did not sought medical attention. Additional information is not expected because no reporter details were provided.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: Severe muscle soreness day of injection. Patient took MOTRIN to alleviate pain.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Hyperhidrosis
Clinical narrative: Diarrhea, chills, perspiration.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Local swelling, Tenderness
Clinical narrative: Case number PHHY2014US112261, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 533452) website on 03 Sep 2014, and with a follow-up information received from Quality Assurance Department (reference number: 323709) on 06 Oct 2014. This report refers to an 11-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M13064, expiry date: Jan 2015) intramuscularly in the left arm, BOOSTRIX (other manufacturer, batch number: 17J44) intramuscularly in the left arm and GARDASIL (other manufacturer, batch number: J015378) intramuscularly into the right arm on 02 Jun 2014. On 04 Jun 2014, he experienced cellulitis, swelling, redness and mild tenderness on left arm. The outcome of the events was not reported. The seriousness of the events was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, MENVEO (batch number: M13064) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323709) on 08 Sep 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 323709) on 06 Oct 2014: Updated batch review report.
Age: 20.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, VARCEL, FLU3, HPV4, MNQ, VARCEL
Symptoms: Condition aggravated, Seizure like phenomena
Clinical narrative: Case number PHHY2014US111600, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 534609) website on 03 Sep 2014, and with a follow-up information received from Quality Assurance Department (reference number: 323430) on 03 Oct 2014. This report refers to a 20 year old male patient. His medical history included seizures. Concomitant medication included VIMPAT; Lamotrigine; Folic Acid; Levetiracetam and Lorazepam. He was vaccinated with FLUVIRIN (batch number: 1310101) intramuscular into left arm on 19 Feb 2014. On the same day he received GARDASIL (batch number: J012212, other manufacturer) IM into left arm, MENACTRA (batch number: U4593AB, other manufacturer) IM into right arm and VARIVAX (batch number: J006805, other manufacturer) subcutaneous into right arm. On the same day patient had an increased seizure activity. The patient's mother notified the clinic on 21 Jun 2014. The patient would discuss with neurology. The final outcome of the events was unknown. Seriousness and causality assessment was not reported. Based on the review performed, FLUVIRIN batch 1310101 was manufactured in accordance with the approved internal procedures and is in compliance with cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323430) on 05 Sep 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 323430) on 03 Oct 2014: Updated batch review report.
Age: 20.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, VARCEL, FLU3, HPV4, MNQ, VARCEL
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Case number PHHY2014US111600, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 534609) website on 03 Sep 2014, and with a follow-up information received from Quality Assurance Department (reference number: 323430) on 03 Oct 2014. This report refers to a 20 year old male patient. His medical history included seizures. Concomitant medication included VIMPAT; Lamotrigine; Folic Acid; Levetiracetam and Lorazepam. He was vaccinated with FLUVIRIN (batch number: 1310101) intramuscular into left arm on 19 Feb 2014. On the same day he received GARDASIL (batch number: J012212, other manufacturer) IM into left arm, MENACTRA (batch number: U4593AB, other manufacturer) IM into right arm and VARIVAX (batch number: J006805, other manufacturer) subcutaneous into right arm. On the same day patient had an increased seizure activity. The patient's mother notified the clinic on 21 Jun 2014. The patient would discuss with neurology. The final outcome of the events was unknown. Seriousness and causality assessment was not reported. Based on the review performed, FLUVIRIN batch 1310101 was manufactured in accordance with the approved internal procedures and is in compliance with cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323430) on 05 Sep 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 323430) on 03 Oct 2014: Updated batch review report.
Age: 14.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Injection site swelling, Local swelling, Pain, Swelling face
Clinical narrative: Case number PHHY2014US112520, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 535502-1) website on 03 Sep 2014, and with a follow-up information received from Quality Assurance Department (reference number: 323682) on 01 Oct 2014. This report refers to a 14 year old female patient. She had no known drug allergies. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M13030) into left arm on 03 Jun 2014. Swelling started on left arm at the injection site that PM 3 to 4 inch wide. On 04 Jun 2014, swelling was up whole arm into neck, face and tongue. Her physician reported cellulitis. Her parents were not satisfied with physician's diagnosis and took her to hospital emergency room. Diagnosed with cellulitis and informed to take prednisone dose pack. On 05 Jun 2014, she was doing better and the swelling going down. On 06 Jun 2014, swelling was much better and some pain noted. The final outcome of the events was completely recovered. Seriousness and causality assessment was not reported. However the case was internally upgraded as medically significant by the agency. Based on the investigation performed, the QA department stated that, MENVEO (batch number: M13030) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323682) on 08 Sep 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 323437) on 01 Oct 2014: Updated batch review report.
Age: 14.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Swollen tongue
Clinical narrative: Case number PHHY2014US112520, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 535502-1) website on 03 Sep 2014, and with a follow-up information received from Quality Assurance Department (reference number: 323682) on 01 Oct 2014. This report refers to a 14 year old female patient. She had no known drug allergies. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M13030) into left arm on 03 Jun 2014. Swelling started on left arm at the injection site that PM 3 to 4 inch wide. On 04 Jun 2014, swelling was up whole arm into neck, face and tongue. Her physician reported cellulitis. Her parents were not satisfied with physician's diagnosis and took her to hospital emergency room. Diagnosed with cellulitis and informed to take prednisone dose pack. On 05 Jun 2014, she was doing better and the swelling going down. On 06 Jun 2014, swelling was much better and some pain noted. The final outcome of the events was completely recovered. Seriousness and causality assessment was not reported. However the case was internally upgraded as medically significant by the agency. Based on the investigation performed, the QA department stated that, MENVEO (batch number: M13030) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323682) on 08 Sep 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 323437) on 01 Oct 2014: Updated batch review report.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood glucose decreased, Hypoglycaemia, Loss of consciousness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypoglycemia in a 52-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. Previously administered products included influenza vaccine without adverse event. (The subject reported herself as extremely healthy with no medical history that prevents her from getting flu vaccines. She has been getting flu vaccines for years and had never had adverse events before). On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 15 min after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria hospitalization and clinically significant/intervention required), injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness (serious criteria GSK medically significant), leg cramps and hungry. On an unknown date, the patient experienced product complaint. The patient was treated with EPIPEN and Dextrose. On 26th September 2014, the outcome of the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights and loss of consciousness were recovered/resolved. On an unknown date, the outcome of the leg cramps and hungry were recovered/resolved and the outcome of the product complaint was not reported. The reporter considered the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness, leg cramps and hungry to be probably related to FLUVIRAL. Additional details received: The patient had lunch at 12:40 and was vaccinated at 4:15 pm. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of the concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood glucose decreased, Blood potassium decreased, Confusional state, Disturbance in attention, Dizziness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypoglycemia in a 52-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. Previously administered products included influenza vaccine without adverse event. (The subject reported herself as extremely healthy with no medical history that prevents her from getting flu vaccines. She has been getting flu vaccines for years and had never had adverse events before). On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 15 min after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria hospitalization and clinically significant/intervention required), injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness (serious criteria GSK medically significant), leg cramps and hungry. On an unknown date, the patient experienced product complaint. The patient was treated with EPIPEN and Dextrose. On 26th September 2014, the outcome of the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights and loss of consciousness were recovered/resolved. On an unknown date, the outcome of the leg cramps and hungry were recovered/resolved and the outcome of the product complaint was not reported. The reporter considered the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness, leg cramps and hungry to be probably related to FLUVIRAL. Additional details received: The patient had lunch at 12:40 and was vaccinated at 4:15 pm. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of the concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dysgeusia, Fatigue, Headache, Hyperhidrosis, Irritability
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypoglycemia in a 52-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. Previously administered products included influenza vaccine without adverse event. (The subject reported herself as extremely healthy with no medical history that prevents her from getting flu vaccines. She has been getting flu vaccines for years and had never had adverse events before). On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 15 min after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria hospitalization and clinically significant/intervention required), injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness (serious criteria GSK medically significant), leg cramps and hungry. On an unknown date, the patient experienced product complaint. The patient was treated with EPIPEN and Dextrose. On 26th September 2014, the outcome of the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights and loss of consciousness were recovered/resolved. On an unknown date, the outcome of the leg cramps and hungry were recovered/resolved and the outcome of the product complaint was not reported. The reporter considered the hypoglycemia, injection site sting, funny taste in mouth, confusion, irritable, angry, disoriented, lightheaded, seeing black spots, lower voice, sweaty, flashing lights, loss of consciousness, leg cramps and hungry to be probably related to FLUVIRAL. Additional details received: The patient had lunch at 12:40 and was vaccinated at 4:15 pm. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of the concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.