chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 66 year old, male patient, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. The reporter stated that patient was 66 y/o and was administered FLUMIST. The outcome of the event of administered FLUMIST by elder age was unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Dermatitis contact, Dizziness, Headache
Clinical narrative: A consumer report has been received. The report concerns an 11 year old, male consumer, who received FLUMIST Quadrivalent (intranasal), 0.2 milliliters, during Oct-2015. Concomitant medications included GARDASIL and prednisone. The patient experienced felt dizzy, poison oak and headache. The outcome of the event of felt dizzy, poison oak and headache was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: A report has been received from a Health Professional concerning multiple patients of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. It was reported that an office staff is seeing an abnormally high number of children, at least 10 to 20 kids between the ages of 2 to 16 years of age with severe vomiting after receiving the FLUMIST Quadrivalent. This event has been happening for a week and a half or two weeks Oct-2015. Today 28-Oct-2015 another child was vomiting. The vomiting starts approximately one hour up to the next day after receiving the FLUMIST Quadrivalent. The patients are vomiting up to 6 times or more and throughout the night. The outcome of the event of severe vomiting was unknown. The report was considered to be non-serious. Follow-up of insignificant information receiving by AstraZeneca/MedImmune on 17-Nov-2015 from HCP: Reporter details were updated. Correction in database only. Formulation was updated from spray to nasal spray. Manufacturer was added.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza B virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent, (intranasal), 0.2 Millilitres, Once/Single administration. It was reported that the patient tested positive for Type B Flu. The outcome of the event of tested positive for Type B Flu was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a pharmacist concerning a subject of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. It was reported that patient received 2 doses. The outcome of the event of received 2 doses is unknown. The report was considered to be non-serious. Corrected report 13-Nov-2015: Relation to patient added. Reporter information added.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving nasal FLUMIST Quadrivalent 0.2 Millilitres. It was reported that FLUMIST Quadrivalent was refrigerated at 47 degrees Fahrenheit since 01-OCT-2015 which started on 01-Oct-2015. FLUMIST Quadrivalent (Intranasal) was discontinued during Oct-2015. The outcome of the event of FLUMIST QUADRIVALENT was refrigerated at 47 degrees Fahrenheit is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Rash pruritic
Clinical narrative: A report has been received from a Health Professional concerning a Child, subject of unknown gender, who received FLUMIST quadrivalent (intranasal), 0.2 Millilitres, Once/Single administration. FLUMIST quadrivalent (intranasal) started on an unknown date. The patient experienced itchy/rashy. The outcome of the event of itchy/rashy is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A report has been received from a pharmacist concerning a male subject who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on 28-Oct-2015. Pharmacist reports that boy received two doses of FLUMIST by mistake 10 days apart. FLUMIST Quadrivalent was continued. The outcome of the event of recd 2 doses 10 days apart is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. The patient had been administered the vaccine after it had been outside of the recommended storage range within the last 2 weeks in Oct2015. The outcome of the event of administered the vaccine after it had been outside of the recommended storage range within the last 2 weeks is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error, Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a male patient. No information was provided regarding the concomitant medications, concurrent diseases and medical history of the patient. The patient number eight received the FLUMIST vaccine (intranasal), 0.2 ml dose, one time intranasally, date of vaccination not provided. It was unknown if the dose of 0.1 ml was given in each nostril. The office refrigerator had a temperature excursion of 1.5 degrees C for a total of 17.5 hours. The temperature would be at recommended temperature range and then dip to 1.5 degrees C, then go back to original range. FLUMIST Quadrivalent was continued. The outcome of the events of patient number eight given FLUMIST vaccine that underwent a temperature excursion, and it is unknown if the dose of 0.1ml was given in each nostril was unknown. The report was considered to be non-serious by company physician.
Age: 53.0
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 53 year old, Female subject, who had been receiving FLUMIST quadrivalent, (intranasal), 0.2 Millilitres. FLUMIST quadrivalent started on an unknown date for Influenza. FLUMIST was administered to 53 year old female patient. The outcome of the event of outside indicated range is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A consumer report has been received. The report concerns a patient, female consumer, who had been receiving FLUMIST Quadrivalent (intranasal) 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. Reporter stated that the pregnant patient, 1 month to full-term, was administered FLUMIST. The outcome of he event of pregnant patient, 1 month to full-term, was administered FLUMIST is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters (frequency not reported). FLUMIST Quadrivalent started on an unknown date. The nurse reported that a consumer may or may not have received a dose of FLUMIST Quadrivalent after a temperature excursion when the FLUMIST was stored in the refrigerator and she did not know if they used the FLUMIST for a consumer after this temperature excursion happened or not. The outcome of the event of consumer may or may not have received dose of FLUMIST Quadrivalent after temperature excursion when FLUMIST was stored in refrigerator does not know if they used FLUMIST for consumer after this temperature excursion happened or not was unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Dysphagia, Respiratory tract congestion, Swelling face
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a female patient. Patient relevant history, concurrent disease and concomitant drugs were not provided. On 02-Oct-2015, patient received nasal FLUMIST (intranasal), 0.2 millilitres and 2 hours later the patient mother called the office to report her son's left side of the face was swollen and he was congested. Reporter enquired to Dr. responded that she rec BENADRYL but the patient was not experiencing difficulty swallowing. The outcome of events congested and left side of the face was swollen was unknown. The reporter considered events congested and left side of the face was swollen to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: A report from health professional via medical rep concerns a 3 year old, male patient. No information regarding relevant history, concomitant disease and concomitant medications was provided. The patient was administered FLUMIST Quadrivalent (intranasal), 0.2mL on 01-Oct-2015. The patient experienced a bloody nose after the administration. As treatment the staff applied pressure to his nose and the event resolved. The patient recovered from bloody nose on 01-Oct-2015. The company physician assessed bloody nose to be non serious.
Sex: U
Vaccine: FLUN4
Symptoms: Hypersensitivity
Clinical narrative: A report has been received from a health professional via medical representative concerning a patient of unknown age and gender. The patient's medical history, concomitant diseases and medications were not reported. On 02-OCT-2015, the patient was given dose of FLUMIST quadrivalent, (intranasal), 0.2 millilitres in once/single administration and developed allergic reaction. At the time of reporting, the outcome of the event of had an allergic reaction was unknown. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a health professional, concerning a patient of unknown gender. No concomitant medication or relevant history was provided. The patient received FLUMIST Quadrivalent (intranasal), 0.2 milliliters with unknown frequency. It was administered in single nostril. The outcome of the event of FLUMIST was administered in single nostril was unknown. The report was considered to be non-serious by a company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: A report has been received from a Pharmacist concerning a patient, subject of unknown gender, who received FLUMIST quadrivalent (intranasal), 0.2 Millilitres. FLUMIST quadrivalent (intranasal) started on an unknown date. The pharmacist administered the FLUMIST but stated that some of the medication ran down out of the patient's nose. The event of some of the medication ran down out of the patient's nose onto their mouth is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL), 0.2 Millilitres, Unknown. FLUMIST (INTRANASAL) started on an unknown date. It was reported that 4 doses of FLUMIST were given this morning. They had experienced a temperature excursion which started on 07-Oct-2016. The outcome of the event of 4 doses of FLUMIST were given this morning and medication given after having temperature excursion is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza like illness, Influenza virus test positive
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a female patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown, started during Oct-2015. The reporter stated that the patient had developed flu like symptoms and during Oct-2015 she had a positive nasal swab for influenza. FLUMIST quadrivalent was continued. The outcome of the events of positive for influenza and flu like symptoms was unknown. The company physician assessed the events of positive for influenza and flu like symptoms to be non serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a 2 year old, male patient. The patient had medical history of premature birth and twin. Patient received FLUMIST quadrivalent (intranasal), 0.2 milliliters. The patient experienced hives which started on 09-Oct-2015. Action taken with FLUMIST quadrivalent was unknown. The patient recovered from the event of hives on an unspecified date. The report was considered to be non-serious company physician.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Back pain
Clinical narrative: A report has been received from a physician concerning a 12 year old, female subject, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST quadrivalent started on 13-Oct-2015. The patient experienced back pain which started on 13-Oct-2015. The outcome of the event of back pain is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: U
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old unknown gender patient. No information was provided regarding the concomitant medications, concurrent diseases and medical history of the patient. Nurse reported patient developed hives after dose of last year FLUMIST quadrivalent (intranasal). Action taken with FLUMIST quadrivalent was unknown. The outcome of the event of hives was unknown. The report was considered to be non-serious by company physician.
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Cataplexy, Depression, Narcolepsy, Somnolence
Clinical narrative: A consumer report has been received concerning a 27 year old, Female patient. Reporter stated that in Feb-2014, nurse administered FLUMIST quadrivalent (intranasal), 0.2 milliliters, once/single administration, at her daughters pediatricians office. She received one dose, in one nostril. Within a month after getting FLUMIST she started falling asleep while she was driving. She went to facility and they thought she had depression. In Mar-2014, the second symptom developed, when she laughed or told a joke, her hand would fall, which was called cataplexy. She went back to the doctor in May-2014 and was referred to a neurologist. On 06-Jun-2014, she was diagnosed with narcolepsy. One of the medicines prescribed for narcolepsy blocked her birth control and she became pregnant in Apr-2015. She stated this pregnancy was a little rough. The outcome of falling asleep while she was driving, depression, cataplexy, narcolepsy and received one dose, in one nostril was unknown. The company physician assessed falling asleep while she was driving, depression, cataplexy, narcolepsy and received one dose, in one nostril to be non serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST quadrivalent started during Jan-2015. The patient experienced the pediatric practice manager reported that 40 doses of the FLUMIST were given through the month of Jan 2015 despite temperature excursions, and possible expired vaccine which started during Jan-2015. FLUMIST quadrivalent was continued. The outcome of the event of the pediatric practice manager reported that 40 doses of the FLUMIST were given through the month of Jan 2015 despite temperature excursions, and possible expired vaccine is unknown. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Epistaxis, Nasal discomfort, Nasal inflammation
Clinical narrative: A report has been received from a PSS via physician concerning a two child and this report was for second patient. No information regarding medical history and concomitant medicines was provided. The reporter called to report adverse event that was reported to her by Pediatrician HCP. HCP reported that he had two patients who received FLUMIST quadrivalent, 0.2 milliliters and developed severe nose bleed later that same day. One of the patients was seen the following day and the reporter reported that the childs mucosal tissue in the nares was inflamed and irritated. No specified date for FLUMIST for either child was given but a time frame of a week or two was given. The reporter reported that one patient got a severe nose bleed that night she got the FLUMIST and the other patient got a severe nose bleed five days later after getting the FLUMIST. The action taken to suspect drug was unknown. The outcome of the events of developed severe nose bleed and mucosal tissue in the nares was inflamed and irritated was unknown. The report was considered to be non-serious by company physician.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a 5 year old, Male consumer, Height: 110.0 Centimeters, Weight: 40.0 Pounds, who had been receiving FLUMIST quadrivalent, (intranasal). FLUMIST quadrivalent started on 12-Oct-2015. The patient experienced complained of a cough which stared on 15-Oct-2015, complained of a sore throat which started on 14-Oct-2016, her son had a fever on Tuesday morning which started on 13-Oct-2015 and had a headache Tuesday evening after administration of FLUMIST. FLUMIST quadrivalent was discontinued on 12-Oct-2015. The outcome of the event of her son had a fever on Tuesday morning, complained of a sore throat, complained of a cough and had a headache Tuesday evening after administration of FLUMIST is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: A report has been received from a Health Professional concerning a 13 year old, Female patient, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST quadrivalent started on an unknown date. The patient experienced moderate to severe abdominal cramping and moderate to severe diarrhea. FLUMIST quadrivalent was continued. The outcome of the event of moderate to severe abdominal cramping and moderate to severe diarrhea was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Epistaxis, Nasal discomfort, Nasal inflammation
Clinical narrative: A report has been received from a PSS via physician concerning a two child and this report was for first patient. No information regarding medical history and concomitant medicines was provided. The reporter called to report adverse event that was reported to her by pediatrician HCP. HCP reported that he had two patients who received FLUMIST quadrivalent (intranasal), 0.2 milliliters and developed severe nose bleed later that same day. One of the patients was seen the following day and the reporter reported that the childs mucosal tissue in the nares was inflamed and irritated. No specified date for FLUMIST for either child was given but a time frame of a week or two was given. The reporter reported that one patient got a severe nose bleed that night she got the FLUMIST and the other patient got a severe nose bleed five days later after getting the FLUMIST. The action taken to suspect drug was unknown. The outcome of the events of developed severe nose bleed and mucosal tissue in the nares was inflamed and irritated was unknown. The report was considered to be non-serious by company physician.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain, Pyrexia
Clinical narrative: Pain and numbness down arm and up to neck at time of administration, by 5-6 pm extreme pain in arm. Pt could not lift arm and was in pain all night. Pt. felt feverish and had headache. Next day and day after pt started to have less pain and more movement without pain. No additional fever.
Age: 5.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Child was prescribed Hep B vaccine #3 and Hib was inadvertently given. Child with no adverse reaction, no complications.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient received PREVNAR 13 (Pneumococcal conjugate) vaccination on Jan 22nd 2016, and approx. 1.5 hrs later she developed some redness at and around the injection site on her left upper arm (deltoid) the redness spread with itching and hot to the touch. Patient was seen on Jan 27th for skin rash and treated with KEFLEX for 7 days for skin infection/cellulitis. Rash (macular) extends from just below left shoulder to about 8 cm above the elbow. No joint swelling or fever or chills, sore to the touch.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Skin infection, Tenderness
Clinical narrative: Patient received PREVNAR 13 (Pneumococcal conjugate) vaccination on Jan 22nd 2016, and approx. 1.5 hrs later she developed some redness at and around the injection site on her left upper arm (deltoid) the redness spread with itching and hot to the touch. Patient was seen on Jan 27th for skin rash and treated with KEFLEX for 7 days for skin infection/cellulitis. Rash (macular) extends from just below left shoulder to about 8 cm above the elbow. No joint swelling or fever or chills, sore to the touch.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Muscle twitching, Syncope
Clinical narrative: Syncope < 1 minute with facial twitching.
Age: 38.0
Sex: M
Vaccine: PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: We are completing this form due to state specifics policies that state that due to age the PNEUMOVAX vaccine had to be administrated.  So far, the patient doesn't present any adverse event.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Injection site reaction, Injection site swelling, Malaise
Clinical narrative: Localized swelling raised macular popular area 9x7 cm over 6cm below injection site of PNEUMOVAX given 12 hours fever, chills, general malaise, general myalgia, arthralgia.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Rash maculo-papular
Clinical narrative: Localized swelling raised macular popular area 9x7 cm over 6cm below injection site of PNEUMOVAX given 12 hours fever, chills, general malaise, general myalgia, arthralgia.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: Severe local skin redness and induration that increased over 2 days after getting vaccine on 02/22/16. Likely early cellulitis.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Swelling, Tenderness
Clinical narrative: Gave pt 2 shots separated into each arm. Mom states started to see swelling after they got home; painful to touch; administered TYLENOL some help with pain, site was still red this morning.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Erythema, Rash macular
Clinical narrative: Child broke out with erythematous macules to entire body within 24 hours of receiving vaccines. No treatment required. Rash resolved within 48 hours.
Age: 23.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Blister, Rash, Rash erythematous, Varicella virus test, Wound secretion
Clinical narrative: Varicella vaccine administered on 2/18/16, returned to Employee Health on Monday, 2/22/16 stating rash on (R) upper arm (weeping, small pinhead sized vesicles) and (R) forearm - raised red rash - no vesicles - and (L) wrist - pinpoint flat healing spots - no vesicles.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: About 5 minutes after administering the BOOSTRIX Tdap shot, the patient fainted (syncope). The patient was able to recover in less than a minute.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (certified medical assistant) refers to patients of unknown age and gender. The patients medical history and concurrent conditions were not specified. The reporter stated that, multiple unspecified patients received improperly stored doses of M-M-R II (lot # L012479, expiry date 10-APR-2017, dose, strength, dose number, vaccination site and route not provided) on unspecified dates. Concomitant medications were not specified. Additionally 32 doses of M-M-R II were administered to these patients on unspecified dates. No adverse effects were reported. The vaccines were exposed to temperature of 50.03 F for a time period of 48 hours. There as no previous temperature excursions. No additional information was provided. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner regarding an unspecified patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2016 (also reported as unspecified dates since 27-JAN-2016) an unspecified patients was vaccinated with improperly stored doses ZOSTAVAX (lot # L032402, expiry date 26-NOV-2016) dosage regimen and route unknown. The nurse reported that the doses were exposed to several defrost cycles. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (Lot # L029631, exp. date: 14-AUG-2017). The product was stored in temperature of 50.2 F degrees for 1 hour 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Ear pain, Rash
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dosing regimen and lot # unspecified). The nurse reported that an unspecified patient developed an unspecified rash on an unspecified part of their body (unspecified date) as well as "ear pain" (unspecified ear/unspecified date) on unspecified time after receiving a dose of ZOSTAVAX. The nurse had to end the call and declined to provide any further information. No further information was provided. The outcome of both events was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 13-JAN-2016 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # L022447, exp date: 26-JUN-2017) orally. The product was exposed in temperature of 49.3 F degrees for 40 minutes. The temperature excursion was recorded by a data logger. The product had previously exposed to 50.2 F degrees for 1 hour 10 minutes. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients. On multiple unspecified dates the patients might have been vaccinated with PROQUAD (Merck) (lot # L002420, expiration date 23-JUL-2016), which were improperly stored at 4 centigrade for unspecified time frame. There was no previous temperature excursion. No adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to 2 anonymous patients of unknown age. On 13-JAN-2016 the patient was vaccinated with improperly stored VAQTA (lot # L039659 (also reported as L03659), exp: 15-MAR-2017) since last excursion. The product was exposed temperature of 49.3 F degrees for 40 minutes. The temperature excursion was recorded by a data logger. The product had been previously exposed to temperature of 50.2 F for 1 hour and 10 minutes. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored GARDASIL 9 (Lot # L017407, exp date: 15-AUG-2017) orally. The product was exposed to temperature of 50.2 F degrees for 1 hour 10 minutes. The temperature excursion was reported by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 with expired date 17-OCT-2017, dose and route were unknown). No concomitant therapy was reported. The reporter stated that the temperature excursion of the vaccine was 10.3 degrees Celsius for 30 minutes. No adverse effect was reported. This was one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. Information regarding relevant medical history and concurrent condition were not reported. On 19-FEB-2016 the patient was vaccinated with an adult dose of VAQTA (lot # L017757, expiration date 08-APR-2018, 50/1.0 U/ml, 1.0 ml, intramuscular) (accidental overdose). Information regarding concomitant medications was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L038501 with expired date 16-AUG-2018, dose and route were unknown). No concomitant therapy was reported. The reporter stated that the temperature excursion of the vaccine was 10.3 degrees Celsius for 30 minutes. No adverse effect was reported. There was 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: Information has been received from a nurse practitioner refrring to a patient of unknown age and gender. On 18-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 32 (lot # L014420 with expiration date of 23-FEB-2017; strength, dosage and frequency unspecified) (Incorrect product storage). No adverse effect was reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 59 year old male patient. The pharmacist did not have access to the patient's medical history. In approximately 2014 ("about 2 years ago"), the patient was vaccinated with ZOSTAVAX (lot# and expiry date unspecified). No concomitant medications were reported. The reporter stated that, since an unknown date, the patient got a rash every year and had one currently. The patient sought medical attention. Since approximately 2014, ("since the patient received the ZOSTAVAX about 2 years ago"), the rashes seemed to be lessening (unexpected therapeutic effect). No Product Quality Complaint (PQC) was reported. The outcome of rash was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product label confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 11-FEB-2016, the unspecified patient was inadvertently administered a dose of PROQUAD (Merck) (lot # L041627, expiration date: 20-APR-2017, dose and route of administration were not reported) instead of an intended dose of M-M-R II, concomitantly with VARIVAX (Merck) (lot # L039092, expiration date: 06-OCT-2017, dose and route of administration were not reported). Nurse stated that PROQUAD was mistaken for M-M-R II because of the label "measles, mumps, rubella" was listed first before "varicella". No adverse effect was reported. No dose of M-M-R II was administered. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Licensed Nurse Practitioner (L.P.N) referring to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 19-FEB-2016 the patient was inadvertently vaccinated with a dose of expired RECOMBIVAX HB (lot # J012567, expiration date 30-JAN-2016 (dose number, dose and route were not reported) in the immunization series. Concomitant drug was 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 physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-FEB-2016, the patient was vaccinated with the improperly stored dose of VARIVAX (Merck) (lot # L027288, expiration date 21-JUL-2017; dose and route were not reported). The vaccine was stored in 0.5 degrees of Celsius for 2 hours and 18 minutes and in 3.6 degrees of Celsius for 3 hours and 6 minutes. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of M-M-R II (lot # L015280 with expired date 30-APR-2017, dose and route were unknown). No concomitant therapy was reported. The reporter stated that the temperature excursion of the vaccine was 10.3 degrees Celsius for 30 minutes. No previous temperature excursion was found. No adverse effect was reported. This was one of several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to 32 year old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 18-FEB-2016, the patient was vaccinated with an expired dose VAQTA 50/1.0 U/ml, lot # K014696, expiration date 11-NOV-2015, (route, dose and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L027733, expiration date 13-SEP-2017, dose and route were not reported). The vaccine was exposed to the temperature of -9.5F for 15 hours. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX Lot # L036822, expiration date 24-DEC-2017) dose, route and anatomical location were not provided. No concomitant medications were reported. The ZOSTAVAX was stored at 0 C temperature for 8 hours, there was no previous temperature excursion. No adverse symptoms reported. No product quality complaint was involved. 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 (immunization official) refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. The healthcare worker reported that doses of VARIVAX (Merck) injection (lot # L029472, expiration date 06-AUG-2017, dose and route of administration were not provided), which were exposed to the temperatures outside of the recommended range (temperature 9.5 Fahrenheit degrees (F), time frame 1 hour 18 minutes) had been administered to unspecified patients approximately in 2016 (reported as on unspecified dates since 13-JAN-2016). No adverse effects were reported. There was no previous temperature excursion. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Pruritus, Rash, Rash erythematous, Tenderness
Clinical narrative: Pt states arm was tender for a few days and now it is "itchy" (10/15/15). Raised red rash 2" x 4" about 2" below injection site noted. PCV13 given on 10/07/15 to left deltoid. States the rash area started at injection site but now has "moved down arm". Encouraged her to take an antihistamine and use hot or cool packs as needed.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On 18-FEB-2016, the patient was vaccinated with an expired dose of ROTATEQ (Lot # K004795, expiration date: 11-FEB-2016), oral. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (certified medical assistant) refers to patients of unknown age and gender. The patients medical history and concurrent conditions were not specified. The reporter stated that, multiple unspecified patients received improperly stored doses of ROTATEQ orally (lot # L004466, expiry date 02-AUG-2016, dose, strength, dose number, vaccination site not provided) on unspecified dates. Concomitant medications were not specified. Additionally 7 doses of ROTATEQ were administered to these patients on unspecified dates. No adverse effects were reported. The vaccines were exposed to temperature of 50.03 F for a time period of 48 hours. There was no previous temperature excursions. No additional information was provided. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Injection site rash, Overdose
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site rash in a 6-year-old female patient who received HAVRIX 1440 (batch number X22P4, expiry date 16th October 2017). Concurrent medical conditions included drug allergy. On 29th June 2015, the patient received the 1st dose of HAVRIX 1440. On 29th June 2015, several hours after receiving HAVRIX 1440, the patient experienced injection site rash, overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the overdose and inappropriate age at vaccine administration were unknown. The reporter considered the injection site rash to be probably related to HAVRIX 1440. Additional details were provided as follows: This case was not reported previously. The patient had allergy to benzalkonium chloride. Two different dates of birth were reported. On 29th June 2015, the 6 year old patient received the 1st dose of HAVRIX 1440, leading to an overdose and an inappropriate age at vaccine administration. The patient experienced rash from the initial point of the injection on the upper left arm from the deltoid muscle approximately to the elbow, the night after receiving HAVRIX. Rash resolved on its own in a couple of days. The physician seek guidance for administering the second dose. The patient had denied permission to contact their physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of an unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 19-FEB-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot #: L013429, expiration date on 21-JUL-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. The Licensed Practical Nurse reported that the doses of GARDASIL 9 lot #: L013429 with expiration date on 21-JUL-2017, underwent a temperature of -5 degrees C during 2.5 hours. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 22-OCT-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, albumin status HSA, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports from the same reporter. Additional information is not expected as no further follow-up is required.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 30-NOV-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports from the same reporter. Additional information is not expected as no further follow-up is required.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner regarding 3 unspecified patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2016 (also reported as unspecified dates since 27-JAN-2016) 3 unspecified patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L009208, expiry date 17-SEP-2016 and L031602, expiry date 18-FEB-2017) dosage regimen and route unknown. The nurse reported that the doses were exposed to several defrost cycles. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) lot # K010211, expiry date 17-JAN-2016, dose, route of administration and anatomical location were not reported (lot # was also reported as D592C). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports from the same reporter. Additional information is not expected as no further follow-up is required.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner regarding 2 unspecified patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2016 (also reported as unspecified dates since 27-JAN-2016) 2 unspecified patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L013827, expiry date 21-APR-2017) dosage regimen and route unknown. The nurse reported that the doses were exposed to several defrost cycles. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.