chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLUN4
Symptoms: Sneezing
Clinical narrative: A report has been received from a Health Professional concerning a 57 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). Concomitant medications included vitamins and amlodipine, benazepril. FLUMIST quadrivalent (intranasal) started on 06-Nov-2014. The patient experienced FLUMIST given to a 57 year old which started on 06-Nov-2014, sneezing, redness in the eye, headache and congestion. The outcome of the event of sneezing, redness in the eye, headache, congestion and FLUMIST given to a 57 year old is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 14-Nov-2014 from health professional via spontaneous source: New events of headache, congestion, sneezing and redness in the eye were added. PQC was ticked. Strength of the suspect drug was added. Reporter's information was updated. Case was unsuppressed.
Age: 52.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 52 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that we inadvertently administered to patient of inappropriate age) which started on 05-Nov-2014. The outcome of the event of FLUMIST administered to a 52 year old patient is unknown. The report was considered to be non-serious.
Age: 60.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 60 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). Concomitant medication included METOPROLOL, FLUTICASONE, ATORVASTATIN, IBANDRONATE SODIUM and LORATADINE. FLUMIST (INTRANASAL) started on 05-Nov-2014. Patients over the age of 49 had administered FLUMIST. The outcome of the event of ADMINSITRATION TO PATIENTS OVER 49 YEARS OLD is unknown. The report was considered to be non-serious.
Age: 53.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 53 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that the patient experienced 53 year old received FLUMIST last year which started during 2013. The patient recovered from the event of 53 year old received FLUMIST last year on an unspecified date. The report was considered to be non-serious.
Age: 14.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 14 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 28-Oct-2014. It was reported that several patients received only a half dose of FLUMIST which started on 28-Oct-2014. The outcome of the event of MULTIPLE PATIENTS RECEIVED A HALF A DOSE OF FLUMIST is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 28-Oct-2014. Multiple patients received a half dose of FLUMIST which started on 28-Oct-2014. The outcome of the event of MULTIPLE PATIENTS RECEIVED A HALF DOSE OF FLUMIST is unknown. The report was considered to be non-serious.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Blood calcium, Blood gases, Blood magnesium, Blood phosphorus
Clinical narrative: Information has been received from pharmacy intern (Pharm. D.) referring to a 67 year old male patient. The patient's current condition included hypertension, diabetes, hyperlipidemia and non-ischemic cardiac myopathy. The patient had no known drug reactions/allergies. On 20-FEB-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose and route were unknown) at another unspecified facility. Concomitant therapies included aspirin, SYNTHROID, losartan potassium, metformin and STARLIX. On 23-FEB-2015, the patient ingested an unspecified amount of dietary whey protein by mouth and an unspecified amount of time after that, the patient experienced an anaphylactic episode on same day. The patient was transported by ambulance to a hospital on 23-FEB-2015, and he became non-verbal while in transport to the hospital. He was wheezing upon arrival to the hospital emergency department, with hives "from head to toe." The patient received 0.5 mL of epinephrine subcutaneously in the ambulance. He received 125 mg of SOLU-MEDROL intravenously, 25 mg of BENADRYL intravenously, and he was started on an epinephrine infusion and a fentanyl infusion. Calcium, Magnesium, Phosphate (CMP), Electrocardiogram (EKG) and Arterial Blood Gas (ABG) were performed while result not provided. The patient was hospitalized, intubated, and he was on a mechanical ventilator at the time of this report. The reporter considered the event anaphylactic episode to be medically significant and life threatening. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Electrocardiogram, Endotracheal intubation, Mechanical ventilation, Metabolic function test, Urticaria
Clinical narrative: Information has been received from pharmacy intern (Pharm. D.) referring to a 67 year old male patient. The patient's current condition included hypertension, diabetes, hyperlipidemia and non-ischemic cardiac myopathy. The patient had no known drug reactions/allergies. On 20-FEB-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose and route were unknown) at another unspecified facility. Concomitant therapies included aspirin, SYNTHROID, losartan potassium, metformin and STARLIX. On 23-FEB-2015, the patient ingested an unspecified amount of dietary whey protein by mouth and an unspecified amount of time after that, the patient experienced an anaphylactic episode on same day. The patient was transported by ambulance to a hospital on 23-FEB-2015, and he became non-verbal while in transport to the hospital. He was wheezing upon arrival to the hospital emergency department, with hives "from head to toe." The patient received 0.5 mL of epinephrine subcutaneously in the ambulance. He received 125 mg of SOLU-MEDROL intravenously, 25 mg of BENADRYL intravenously, and he was started on an epinephrine infusion and a fentanyl infusion. Calcium, Magnesium, Phosphate (CMP), Electrocardiogram (EKG) and Arterial Blood Gas (ABG) were performed while result not provided. The patient was hospitalized, intubated, and he was on a mechanical ventilator at the time of this report. The reporter considered the event anaphylactic episode to be medically significant and life threatening. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: Information has been received from pharmacy intern (Pharm. D.) referring to a 67 year old male patient. The patient's current condition included hypertension, diabetes, hyperlipidemia and non-ischemic cardiac myopathy. The patient had no known drug reactions/allergies. On 20-FEB-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose and route were unknown) at another unspecified facility. Concomitant therapies included aspirin, SYNTHROID, losartan potassium, metformin and STARLIX. On 23-FEB-2015, the patient ingested an unspecified amount of dietary whey protein by mouth and an unspecified amount of time after that, the patient experienced an anaphylactic episode on same day. The patient was transported by ambulance to a hospital on 23-FEB-2015, and he became non-verbal while in transport to the hospital. He was wheezing upon arrival to the hospital emergency department, with hives "from head to toe." The patient received 0.5 mL of epinephrine subcutaneously in the ambulance. He received 125 mg of SOLU-MEDROL intravenously, 25 mg of BENADRYL intravenously, and he was started on an epinephrine infusion and a fentanyl infusion. Calcium, Magnesium, Phosphate (CMP), Electrocardiogram (EKG) and Arterial Blood Gas (ABG) were performed while result not provided. The patient was hospitalized, intubated, and he was on a mechanical ventilator at the time of this report. The reporter considered the event anaphylactic episode to be medically significant and life threatening. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Irritability
Clinical narrative: Developed loose stools and fussiness next day after vaccines administered persisted for more than week.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 10/14 Client called and c/o sore arm, redness at injection site. Client instructed to place warm compress to site 4x a day to (R) arm. 2/6/15 telephoned to report continued pain and request VAERS report be filed.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 02-FEB-2015, unspecified patients were vaccinated with a dose of improperly stored ROTATEQ, oral (dose, lot number and expiry date were not reported. No adverse effects were reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from other, as part of a marketing research program, refers to a female patient of 33 year old. On an unknown date the patient was vaccinated with a dose of PCV23 (manufacturer unknown) (dose, route, lot# and expiration date were not reported). Concomitant therapy was not reported. On an unknown date the patient experienced hypersensitivity. The outcome of hypersensitivity was unknown. Relatedness between PCV23 (manufacturer unknown) and the adverse event was not provided. Upon internal review, hypersensitivity determined to be medically significant since the seriousness of the case was reported as unknown. Additional information is not expected because there is no contact information.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to some patients pf unknown age and gender, that were vaccinated, on an unknown date, with a dose of ROTATEQ, (dose, route of administration and lot # not reported). Information regarding concomitant therapy, concurrent conditions and medical history was not provided. The nurse reported that the ROTATEQ was administered to patients post supported excursion. No adverse effects noted by any patient. This is one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. It was reported that the patient was vaccinated with first dose in the series of GARDASIL (injection, lot#, dose, route were unspecified) on an unspecified date in 2008. The second dose was administered on an unspecified date in 2010 and third dose was administered on an unspecified date in 2014. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to a 65 year old patient. On 23-FEB-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J014568, expired date 18-FEB-2015. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 02-FEB-2015, unspecified patients were vaccinated with a dose of improperly stored VAQTA (dose, route, lot number and expiry date were not reported). No adverse effects were reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician referring to a 2 month old infant patient of unknown age. On 12-FEB-2015, the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (lot#, dose and route not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown gender and age. On 19-FEB-2015, the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX, (lot number) dose 1, 0.5 ml, subcutaneously. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown gender and age. On 19-FEB-2015, the patient was vaccinated with an improperly stored (Oka/Merck) VARICELLA (lot dose) dose 1, 0.5 ml, subcutaneously. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Information has been received from a registered nurse concerning an adult patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot#, expiration date, dose and route not provided). The reporter asked about the adverse reactions to patient after receiving an expired PNEUMOVAX23 or was it more or less potent. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Influenza A virus test positive, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: C/O clear runny nose x1 day. C/O fever 103-104. Fussy, positive influenza (A) positive.
Sex: U
Vaccine: MMR
Symptoms: Fine motor skill dysfunction, Immediate post-injection reaction, Motor dysfunction
Clinical narrative: Information has been received from a mother of a patient referring to her child of unknown age and unknown gender who was highly functional autistic. On unknown dates the patient was vaccinated with the first and the second dose of MMR II (lot#, expiration date, dose and route were unknown). And, after receiving the second dose of MMR II, the patient experienced a loss of all fine and gross motor skills immediately. The patient was recovered from the event after three weeks, on an unspecified date. Additional information is not expected as there is no reporter's contact information.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender who on an unknown dates were vaccinated with improperly stored doses of GARDASIL (dose, route, lot # and expiration date were not reported). 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: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age. Medical history and concurrent condition of the patient was not reported. On 24-FEB-2015 the patient was vaccinated with a dose of GARDASIL (lot # H010123, expiry date: 16-JAN-2015, 0.5 ml, intramuscularly). Other suspect and concomitant therapies were not reported. No symptoms reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker via field representative refers to a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date the patient experienced shingles (Herpes zoster) post vaccination. The reporter stated that the patient was not vaccinated at the physician's office where the healthcare worker works. The outcome od shingles was unknown. The causality of the event with zoster vaccine live was not reported, product quality issue was not involved. this case is linked to # 1502USA010983 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from the registered nurse refers to an unspecified number of patients of unknown gender and age. Information about the patients medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, dose number, lot/batch# and expiration dates were not reported) after being improperly stored. Information about concomitant medications was not provided. No product quality complaint (PWC) was involved. This is one of several reports from the same reporter. Additional information is not expected as no consent for contact was given.
Age: 27.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as receive from a pharmacist refers to a 27 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL. Dose, route, lot number and expiration date were not reported. No adverse effects were reported. Patient want to complete the GARDASIL vaccination series. Additional information has been requested. No allowed to contact physician.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old female patient. The patient had no pertinent medical history and no known drug reactions or allergies. On an unknown date, the patient was vaccinated with the second dose of PROQUAD (Merck) (route, lot # and expiration date were not provided). There was no concomitant medication. On an unknown date, 2 weeks after PROQUAD (Merck) administration, the patient was diagnosed with chickenpox. The nurse reported that the patient was covered from head to toe with varicella like lesions and that the patient had chickenpox really bad. The nurse stated that the patient was seen by an unspecified physician and the only treatment recommended was BENADRYL and oatmeal baths (also reported as no treatment was given for the adverse event). There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a 37 year old female patient reporting on herself, as part of a marketing research program conducted by the agency. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot#, dose and route not provided). On an unknown date the patient had a reaction (unspecified). At the time of the report, the patient's outcome was unknown. Additional information is not expected, as the patient did not give consent to disclose personal details.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site reaction
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age over 60 years old. Approximately in December 2014 (also reported as within the last two months) the patient was vaccinated with ZOSTAVAX (0.65 ml, once, subcutaneously, lot # not reported) and experienced an increased injection site reaction which resembled cellulitis and which measured about 6 inches in diameter after receiving ZOSTAVAX. Because cellulitis could not be ruled out, the patient was treated with an unspecified antibiotic and referred to an unspecified wound care facility where the patient was receiving treatment at the time of the report. The patient's outcome was reported as recovering. The patient sought medical attention and saw the physician. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research program, refers to a 22 year old, female patient. Patient's medical history and current conditions were not provided. On an unkonwn date the patient was vaccinated with a dose of pneumococcal vaccine, (manufacturer unknown) (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. On an unknown date the patient experienced the event of pneumococcal infection (unspecified) (described as "I got those diseases after being vaccinated"). The outcome of adverse event was unknown. The related between adverse event and pneumococcal vaccine, (manufacturer unkonwn) was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 66 year old female consumer refers to herself. Pertinent medical history included with allergies to sulfur and penicillin. On 16-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location and lot number was unknown). Concomitant therapies included atenolol and amlodipine. On an unknown date in 2015, the patient had a little itching at the injection site. On 22-FEB-2015, the patient experienced redness at the injection site. No treatment was given for the event. No lab studies were performed. Action taken with ZOSTAVAX was not reported. The outcome of itching at the injection site was unknown. The outcome of redness at the injection site was reported as not recovered/not resolved. The causal relationship between the events and ZOSTAVAX was unknown. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender who on an unknown dates were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, route, lot # and expiration date were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 02-FEB-2015, unspecified patients were vaccinated with a dose of improperly stored M-M-R II (dose, route, lot number and expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 02-FEB-2015, unspecified patients were vaccinated with a dose of improperly stored PNEUMOVAX 23 (dose, route, lot number and expiry date were not reported). No adverse effects were reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from the registered nurse refers to an unspecified number of patients of unknown gender and age. Information about the patient's medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of LIQUID PEDVAXHIB (dose, dose number, lot/batch# and expiration dates were not reported) after being improperly stored. Information about concomitant medications was not provided. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information is not expected as no consent for contact was given.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history and current conditions were reported. On 23-FEB-2015 the patient was vaccinated with expired ZOSTAVAX lot # J014812, Expiry: 20-FEB-2015, 0.65 ml, once subcutaneous. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to some patients of unknown age and gender, that were vaccinated, on an unknown date, with a dose of VAQTA, (dose, route of administration and lot # not reported). Information regarding concomitant therapy, concurrent conditions and medical history was not provided. The nurse reported that the VAQTA was administered to patients post supported excursion. No adverse effects noted by any patient. This is one of several reports from the same reporter source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker via field representative refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date the patient experienced shingles post vaccination. The reporter stated that the patient was not vaccinated at the physician's office where the healthcare worker works. The outcome of shingles was unknown. The causality of the event with zoster vaccine live was not reported. Product quality issue was not involved. This case is linked to # 1502USA012238 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Aphthous stomatitis
Clinical narrative: This spontaneous report as received from a registered nurse (reported as office manager) refers to a male patient of unknown age. The patient medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unkonwn date, 5 years after vaccination the patient experienced canker sores on his lips. The outcome of canker sores on his lips was unkonwn. The causality of canker sores on his lips was not reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from the registered nurse refers to an unspecified number of patients of unknown gender and age. Information about the patients medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of COMVAX (dose, dose number, lot/batch# and expiration dates were not reported) after being improperly stored. Information about concomitant medications were not provided. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information is not expected as no consent for contact was given.
Age: 0.8
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 month old male patient. Patient's concurrent conditions and relevant medical history was not reported. On 02-JAN-2003, 8 days before the patient's 12 month birthday, the patient was vaccinated with first dose of M-M-R II (lot number, dose, frequency and route unspecified) (inappropriate schedule of drug administration). Concomitant medications were not reproted. No adverse effects were reported. The outcome of the events was unkonwn. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to an unspecified number of patients of unknown age. On 25-FEB-2015 the patients was vaccinated with RECOMBIVAX HB (dose, lot number, was unknown), intramuscular, which was improperly stored. No adverse event was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. No additional information was reported. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of vaccine exposure during a pregnancy in a 35-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 17 September 2014, the subject received an unspecified dose of BOOSTRIX (unknown route and injection site, batch number not provided). Her last menstrual period was not provided but her estimated date of delivery was on 22 November 2014. The subject was exposed to the vaccine during the third trimester. No adverse event was reported. At the time of reporting, the pregnancy was ongoing. (Pregnancy Notes) On 26 January 2015, this case was considered lost to follow-up. Follow-up information received from the consumer on 23 February 2015. The consumer provided Healthcare professional details and reported that the pregnancy and the delivery were normal.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the unspecified patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX (Merck), subcutaneously (dose, lot number and expiry date were not reported). No adverse effect reported. There was no concomitant medication provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to an unspecified number of patients of unknown age. On 25-FEB-2015 the patients was vaccinated with VAQTA (dose, lot number, was unkonwn), intramuscularly which was improperly stored. No adverse effects were reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. No additional information was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from the registered nurse refers to an unspecified number of patients of unknown gender and age. Information about the patients medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (dose, dose number, lot/batch# and expiration dates were not reported) after being improperly stored. Information about concomitant medications was not provided. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information is not expected as no consent for contact was given.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to some patients of unknown age and gender, that were vaccinated, on an unknown date, with a dose of RECOMBIVAX HB, (dose, route of administration and lot # not reported). Information regarding concomitant therapy, concurrent conditions and medical history was not provided. The nurse reported that the RECOMBIVAX HB was administered to patients post supported excursion. No adverse effects noted by any patient. This is one of several reports from the same reporter source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test, Unevaluable event
Clinical narrative: Patient had miscarriage prior to vaccine, blood levels of patients post vaccine still indicate that she may be pregnant. Patient did not inform pharmacist of miscarriage/possible pregnancy, checked off "no" on questionnaire for pregnancy.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Asthma, Body temperature increased
Clinical narrative: This spontaneous report was received from a physician concerning a 12 year old male patient that has never being hospitalized for asthma. On an unknown date the patient was vaccinated with a dose of M-M-R II (Lot #, dose and route unknown). Other suspect therapies included DTaP (unspecified), Tetanus Toxoid. The patient's mother reported that her child developed asthma after he received the vaccines. Also, the mother reported that on an unknown date and during an unspecified period of time after the child received the M-M-R II, his temperature was 104F.The physician stated that the child's diagnosis of asthma was not confirmed by him or any other physician, and he did not think that any medical attention has been has been sought. The physician also mentioned that he does not think that the child developed asthma because he was vaccinated. The physician was busy and he did not have the specific patient's information available at the time of the report. The outcome of fever and asthma was not reported and the causality between fever and M-M-R II was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a female patient of unknown age, reporting on herself. On an unknown date in August 2014 the patient was vaccinated with ZOSTAVAX (route, dose number, dosage and lot number unknown). The patient reported that shortly after she received ZOSTAVAX, she developed pain in her arm. The patient sought medical attention (spoke with physician). The outcome of the event was reported as not recovered. Additional information is not expected because there is no contact information for the reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: Injection site inflammation, warm to touch.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to some patients of unknown age and gender, that were vaccinated, on an unknown date, with a dose of GARDASIL, 0.5 ml, intramuscular (lot # not reported). Information regarding concomitant therapy, concurrent conditions and medical history was not provided. The nurse reported that the GARDASIL was administered to patients post supported excursion. No adverse effects noted by any patient. This is one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with 0.5 ml doses of VARIVAX (Merck) (lot # not reported) subcutaneously that were improperly stored between November 2014 and January 2015. No adverse effects were reported. Additional information is not expected. There is no permission to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a ten unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 20-NOV-2014 (dates of administration were unspecified), ten unspecified patients were vaccinated with a dose of VARIVAX (Merck) which underwent a supported temperature excursion, lot number reported as K007973, expiry date 03-JUN-2016 and lot number K005182, expiry date 10-APR-2016 (dose and route were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Antinuclear antibody negative, Blood lactic acid normal, Diarrhoea, Electrophoresis protein normal, Gait disturbance
Clinical narrative: (B) numbness (no weakness) to LE which progressed up to chest. Started 2-3 days after injection. No F/C/SOB and pain/gait abnormalities/vomiting/diarrhea.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Hepatitis viral test negative, Hypoaesthesia, Pain, Red blood cell sedimentation rate normal, Treponema test negative
Clinical narrative: (B) numbness (no weakness) to LE which progressed up to chest. Started 2-3 days after injection. No F/C/SOB and pain/gait abnormalities/vomiting/diarrhea.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Vitamin B1, Vitamin B12 normal, Vomiting
Clinical narrative: (B) numbness (no weakness) to LE which progressed up to chest. Started 2-3 days after injection. No F/C/SOB and pain/gait abnormalities/vomiting/diarrhea.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a twenty unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 20-NOV-2014 (dates of administration were unspecified), twenty unspecified patients were vaccinated with a dose of PROQUAD (Merck) which underwent a supported temperature excursion, subcutaneously, lot number reported as K012918, expiry date 28-FEB2016 (dose was not reported). No adverse effects reported. There was no concomitant medications provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself. Medical history and concurrent conditions were not provided. On 09-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. On an unknown date, the patient experienced redness at the injection site. The patient did not seek medical attention. The outcome of redness at the injection site was unknown. Relatedness between the therapy with ZOSTAVAX and the redness at the injection site was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Lft. arm erythema with swelling; warm to touch extending 5-6 cm along back of arm.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: Red, warm, slightly raised, itchy, rash on right deltoid, 5-6 cm wide and about 9-10 cm up his arm-treatment was BENADRYL.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 2/26/15 Removed band aid, area red, warm, swollen, hard area. Mother contacted MD administering TYLENOL and use of ice as needed. Monitoring for injection. Left deltoid area.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: ZOSTAVAX given 2-11. H.Z.=symptom - Rt C.N. 5 - 1st branch vesicles onset 2-20. Rt trigeminal 1 distribution.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. No medical history, drug allergy, concurrent condition and concomitant medication was reported. On 25-FEB-2015, the patient was vaccinated with improperly stored M-M-R II (dose and lot number were not reported), subcutaneous. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as receive from a Registered Nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 02-FEB-2015, unspecified patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (dose, route, lot number and expiry date were not reported). No adverse effects were reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Rash, beginning on feet, ascending to include body to neck.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood lactic acid decreased, Cellulitis, Erythema, Induration, Pain in extremity
Clinical narrative: Right arm pain, firmness, redness and warmth. Diagnosis of cellulitis. Treatment with IV Vancomycin, PO BACTRIM and KEFLEX.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, White blood cell count increased
Clinical narrative: Right arm pain, firmness, redness and warmth. Diagnosis of cellulitis. Treatment with IV Vancomycin, PO BACTRIM and KEFLEX.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient (age and gender not reported) who on 04-FEB-2015, was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous. On 09-FEB-2015, the patient returned to the pharmacy with a prescription for a MEDROL dose pack lasting 6 days for an unspecified reason. The pharmacist state that he did not agree with "this being treated as an adverse event since nothing was reported" and the patient had not yet taken the MEDROL. The patient sought medical attention, but it was unspecified the reason for it. Patient's outcome of adverse event was not reported. Relationship between adverse event and ZOSTAVAX was not reported. Additional information is not expected as no consent for follow up was obtained.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red and warm to touch at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient reported reddish spots/rash at shoulder and back of shoulder recommended to see physician on as soon as possible basis.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient called 2/12/15 stated she had a rash under and over left breast wrapping around back that itched. Patient is in another state. Called primary care Dr. they wanted patient to visit a Dr. in the other state and then follow up Dr.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Soreness and ache in left arm for 3-4 days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender who on an unknown dates were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Mild loose stool.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Diarrhoea
Clinical narrative: Mild loose stool.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Low grade fever and soreness at injection site a few hours after immunizations were given.  I gave her Tylenol.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death
Clinical narrative: Low grade fever and soreness at injection site a few hours after immunizations were given.  I gave her Tylenol.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Eczema weeping, Hypersensitivity, Pruritus, Rash
Clinical narrative: Severe allergy with skin eruptions on arms and body with itchiness weeping eczema.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Hypersensitivity, Hypoaesthesia oral, Hypotension
Clinical narrative: Lips numb, hypotension with dizziness. Placed as allergy in medical record.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Itchy bubbly rash on hands, lasted almost a year
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Periarthritis
Clinical narrative: Severe adhesive capsulitis documented by MRI and physical exam.  (times and dates are approximate). Was fine until shot, then local pain that I thought was nothing, then pain moving shoulder that persisted.  Saw orthopedic surgeon, had one cortisone shot with little effect.  Have had ongoing physical therapy with no improvement in about 6 months.  May need surgery.  Radiologist said worst adhesive capsulitis ever seen.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Dysmenorrhoea, Endometriosis, Menorrhagia, Oophorectomy
Clinical narrative: Excessive menstral bleeding. Blood Transfusion required. Severe menstral cycles for years, with pain. Miscarriage. Ovarian cysts. Loss of ovary.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst, Transfusion
Clinical narrative: Excessive menstral bleeding. Blood Transfusion required. Severe menstral cycles for years, with pain. Miscarriage. Ovarian cysts. Loss of ovary.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Axillary mass
Clinical narrative: 2"-3" Lump in my left arm pit.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Photophobia, Pyrexia
Clinical narrative: High fever spikes between 102.5 and 103.9 and shivering and light sensitivity. Alternating Tylenol and Motrin every 4 hours. Fever will not go below 102.5. Have called Dr. office many times.
Age: 31.0
Sex: F
Vaccine: PPV, TD
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site warmth, Tremor
Clinical narrative: Redness around the injection site that continues to spread 2 days after vaccine and is hot to touch. Temp 103 after Tylenol and Ibuprofen. Chills with uncontrolled shaking x 1-2 hours.