chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: FLUN4
Symptoms: Adenovirus test positive, Empyema, Malaise, Pulmonary necrosis
Clinical narrative: A spontaneous report has been received from a Health Professional concerning a 4 year old patient of unknown gender. The relevant history and concurrent disease were not reported. Patient had received FLUMIST QUADRIVALENT (intranasal) 0.2 millilitres, yearly 5 days prior to hospital admission with critical illness, pneumococcal empyema, right lung necrosis, and a positive adenovirus test. The action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the events of pneumococcal empyema, positive adenovirus test, right lung necrosis and critical illness was unknown. The company physician identify pneumococcal empyema, right lung necrosis, critical illness and positive adenovirus test from narrative and assessed it to be serious due to important medical event and hospitalization.
Age: 63.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Chills, Cough, Influenza like illness, Pyrexia
Clinical narrative: Patient reported flu-like symptoms of chills, fever, cough.  All symptoms resolved on Saturday 3/12/16 except for the cough which patient reports still having on 3/15/16.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle spasms
Clinical narrative: Constant ache, on shot site - every day sometimes can't lift arm - at least 2x a wk - sometimes I get a really bad cramp and can't lift arm. Use a small vibrator till cramp stops take ibuprofen for ache.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Face oedema, Facial pain
Clinical narrative: Facial edema within 24 hrs (primarily around nose, painful).
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, warmth, itching, pain, and area hard to the touch at injection site.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site warmth
Clinical narrative: Redness, swelling, warmth, itching, pain, and area hard to the touch at injection site.
Age: 52.0
Sex: F
Vaccine: TYP
Symptoms: Extra dose administered
Clinical narrative: Pt accidentally got two doses of Typhim Vi injectable vaccine.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Cognitive disorder, Encephalitis, Epilepsy, Headache
Clinical narrative: Sxs started 4-5 days prior to admission with mild headache, malaise, fever (max T 104.1), followed by onset of seizures. Admitted to medical center: 9/17/15. Discharged 3/1/16. Primary dx, epilepsy, unspecified secondary dx, encephalitis. Discharge dx includes seizure disorder, impaired ADL, cognitive deficits, muscular deconditioning.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Muscular weakness, Pyrexia, Seizure
Clinical narrative: Sxs started 4-5 days prior to admission with mild headache, malaise, fever (max T 104.1), followed by onset of seizures. Admitted to medical center: 9/17/15. Discharged 3/1/16. Primary dx, epilepsy, unspecified secondary dx, encephalitis. Discharge dx includes seizure disorder, impaired ADL, cognitive deficits, muscular deconditioning.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given two PREVNAR doses 4 months apart by accident. Patient was notified.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Mild swelling at injection site <0.5 inch, denies redness, fever. Pain when patient touched injection site.
Age: 31.0
Sex: F
Vaccine: MUR
Symptoms: Memory impairment, Nausea, Night sweats, Pyrexia
Clinical narrative: Started feeling nauseous and laid down. After eating dinner I started to run a fever (temp unknown), I went to bed and woke up at 3:30am covered in sweat with soaked bedding. The evening before I had spoken on the phone as well as text messaged someone and have no memory of the events.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, pain and warm to touch at/around injection site. About 5 inches down the arm from Left Deltoid area where vaccines where administered.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient experience injection site reaction with redness, swelling, tenderness.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 30 December 2015. This case is a cluster of three cases and linked with 2015SA153209 and 2016SA003167 (same vaccine, different patient). This case involves a 37-year-old female patient who was vaccinated with a dose of Fluzone QIV (batch number: UI445AC, expiry date: 30 June 2016) in right deltoid on an unknown date. The patient medical history reported as allergic to egg or egg products, history of Guillain Barre syndrome, allergic to thiomersal, allergic to latex reported as no. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed aches, chills and fever. It was reported that the patient had not worked the day after but fine within 24 hours of vaccination. Laboratory data and corrective treatment was not reported. The patient was recovering from all the events. It was reported that the patient felt better 14 day later. List of documents held by sender: none. Follow up information received from a nurse on 29 February 2016. Patient had received Fluzone QIV intramuscularly on 30 September 2015. Patient had no other vaccination within four weeks prior to vaccination and illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as all-Biaxin (hives). On 30 September 2015, same day following the vaccination patient had experienced the events. On an unspecified date, patient had recovered.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Patient received both HPV 9 and meningococcal (MCV4P) immunizations in the same left deltoid. Later the same evening he developed redness over his entire deltoid along with warmth at the site, soreness, fever at home, headache.  He was given cool compress, ibuprofen.  No other treatment, took several days to resolve.
Age: 52.0
Sex: F
Vaccine: FLU3, HEP, HEPA, MMR, TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: RIGHT DELTOID SWELLING, REDNESS, HARDNESS AND HEAT AT VACCINE SIGHT. A SIZE OF 80MM CENTER OF SWELLING SHOWS DISCOLORATION, POSSIBLE SIGNS OF INFECTION.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Disorientation, Dizziness, Hyperhidrosis, Palpitations
Clinical narrative: EMPLOYEE FEELS DISORIENTED, DIZZY, ANXIETY, SWEATING, HEART PALPATIONS.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pruritus
Clinical narrative: Develop pruritic crop of vesicles on R flank.
Age: 0.85
Sex: M
Vaccine: IPV
Symptoms: Injection site urticaria
Clinical narrative: Hives around injection site.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema
Clinical narrative: Patient had chills starting on day 2 after receiving vaccine. Also had a large red spot (4" in length) on arm.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Generalised vaccinia
Clinical narrative: Generalized Vaccinia early stage.  May progress.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: FLU4
Symptoms: Drug hypersensitivity, Rash, Skin test positive
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a adult female patient who received FLUARIX QUADRIVALENT (batch number 397A7, expiry date 18th June 2016). On 25th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. In October 2015, 30 days after receiving FLUARIX QUADRIVALENT, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving. The reporter considered the rash to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a other healthcare professional, who herself was the patient. In October 2015, approximately 1 month after vaccination, the patient broke out in rash over face, arms and torso. The patient was not sure if it came from one of the GlaxoSmithKline Flu vaccines. She did not know if it was the FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT vaccine. In December, the patient underwent an allergy patch test that determined she was allergic to thimerosal. The reporter would call Medical Information after she verifies which flu vaccine was administered.
Sex: U
Vaccine: FLU4
Symptoms: Blister, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of blister in patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced blister and swelling. On an unknown date, the outcome of the blister and swelling were unknown. It was unknown if the reporter considered the blister and swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The other healthcare professional called to report that she did not like the FLUARIX QUADRIVALENT vaccine because 3 patients received the vaccine in 2014 and experienced blisters and swelling. The sales representative did not have any further information. This case has been linked to cases US2016GSK034531 and US2016GSK034532, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in unspecified number of patients who received FLULAVAL QUADRIVALENT (batch number 7754S, expiry date 30th June 2016). On an unknown date, the patients received FLULAVAL QUADRIVALENT. On an unknown date, several days after receiving FLULAVAL QUADRIVALENT, the patients experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were unknown. It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The nurse reported to internal GlaxoSmithKline employee that her office had several patients who experienced flu like symptoms a couple days after vaccination with FLULAVAL QUADRIVALENT. The patients also experienced pain in the arm at the injection site. The nurse did not provide any additional details or how many patients were affected. The nurse might follow up with GlaxoSmithKline with additional details after she speaks with her supervisor.
Sex: U
Vaccine: FLU4
Symptoms: Blister, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of blister in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced blister and swelling. On an unknown date, the outcome of the blister and swelling were unknown. It was unknown if the reporter considered the blister and swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The other healthcare professional called to report that she did not like the FLUARIX QUADRIVALENT vaccine because 3 patients received the vaccine in 2014 and experienced blisters and swelling. The sales representative did not have any further information. This case has been linked to cases US2016031743 and US2016GSK034531, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Blister, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of blister in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced blister and swelling. On an unknown date, the outcome of the blister and swelling were unknown. It was unknown if the reporter considered the blister and swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The other healthcare professional called to report that she did not like the FLUARIX QUADRIVALENT vaccine because 3 patients received the vaccine in 2014 and experienced blisters and swelling. The sales representative did not have any further information. This case has been linked to cases US2016031743 and US2016GSK034532, reported by the same reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient was administered KINRIX intramuscularly in the left thigh and PROQUAD subcutaneously on the right thigh on 8 Mar 2016. After vaccination, patient was seen in office on 10 Mar 2016 c/o swelling and redness at injection site left leg. Per Physician Assistant notation: Pt has large area of swelling to left mid thigh.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large area of swelling and redness noted on left mid thigh. Seen by NP. Instructed to use heat/cold compresses to area. BENADRYL cream for itching. Return on 3/11/16 for recheck.
Age: 3.0
Sex: M
Vaccine: DTAP, FLUN4, HEPA, MMRV
Symptoms: Blood culture, Differential white blood cell count, Ear infection, Febrile convulsion, Full blood count
Clinical narrative: Fever, resulted in febrile seizure. Went to ER via ambulance. Dx with febrile seizure, ear infection. Given AMOXIL 250mg/5mL, TYLENOL and MOTRIN.
Age: 3.0
Sex: M
Vaccine: DTAP, FLUN4, HEPA, MMRV
Symptoms: Metabolic function test, Pyrexia
Clinical narrative: Fever, resulted in febrile seizure. Went to ER via ambulance. Dx with febrile seizure, ear infection. Given AMOXIL 250mg/5mL, TYLENOL and MOTRIN.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, IPV, MMRV
Symptoms: Full blood count, Seizure
Clinical narrative: 48 hours post vaccination - witnessed spontaneous seizure activity lasting approximately 5 minutes.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist (patient's daughter) via a company representative regarding a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated two separate doses of ZOSTAVAX within a four month period (dose, route of administration, lot # and expiration date were not reported). On an unknown date (after the second injection of ZOSTAVAX), the patient experience a localized site reaction. The duration of the localized site reaction was not provided. On an unknown date, the patient recovered from localized site reaction (duration of the event was not provided). The relatedness between the event and the therapy with ZOSTAVAX was not provided. 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 healthcare worker refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K010224, expiry date: 13-MAY-2016) orally (start date and dosage not reported). No adverse effect reported. No further details provided This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a phlebotomist and refers to a 60 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 10-MAR-2016, the expired dose of ZOSTAVAX (lot # K023623, expiration date: 20-FEB-2016, dose, route of administration and injection site were not reported) was administered to the patient. The patient has not reported any adverse effects. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a unspecified number of patients of unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL Lot # K006960 (expiry date: 19-FEB-2017) at an unknown dosage. The temperature of the vaccine was 33.8 F and time frame was 96 hours. There was no data logger. No adverse reactions were reported. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number reported as L044475 and expiration date 12-MAY-2017, dose and route of administration were not reported). The temperature and the time frame of the excursion were 12.3 Celsius degrees for 83 hours and 40 minutes and -3.4 Celsius degrees for 105 hours and 50 minutes. There was no previous temperature excursion and it was stated it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history was not provided. It was reported that on unknown dates, the patients might have received doses of improperly stored PEDVAXHIB lot number L030872, expiration date 11-JUN-2018; lot number L035880, expiration date 11-AUG-2018; lot number reported as L019835, expiration date 23-MAR-2017; lot number reported as K019561, expiration date 20-APR-2016 (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 30.49F for 48 hours (the worst case scenario) at least 5 times. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was reported. On multiple unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of VARIVAX, lot number L013067, expiration date: 14-APR-2017, lot number L015045, expiration date: 29-APR-2017, lot number reported as K015968, expiration date: 23-SEP-2016 and lot number K010437, expiration date: 22-JUL-2016, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of -13.1 degrees Celsius for 40 hours. No previous temperature excursion was 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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. The patient's medical history was not provided. It was reported that on unknown dates, the patients might have received doses of improperly stored GARDASIL lot number J009243, expiration date 23-APR-2016 (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 3049F for 48 hours (the worst case scenario) at least 5 times. No adverse effects 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 an unspecified number of unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot number L019835 and expiration date 23-MAR-2017, dose and route of administration were not reported). The temperature and the time frame of the excursion were 12.3 Celsius degrees for 83 hours and 40 minutes and -3.4 Celsius degrees for 105 hours and 50 minutes. There was no previous temperature excursion and it was stated it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved This is one of several 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 a nurse practitioner regarding 2 unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX, lot # L011528, expiration date- 03-APR-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Time was 1 hour, temperature 34.7F and there was no previous excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with doses of improperly stored VAQTA (lot # L045713 with expiration date 14-JAN-2017, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a 44 year old female patient. The patient had no concurrent conditions, pertinent medical history or drug allergies/drug reactions. On 09-MAY-2008, the patient was vaccinated with the first dose of MMR II (lot reported as 0Q85U, expiration date 02-FEB-2009) (route, strength were not reported). Concomitant medications included VALTREX. On 28-AUG-2012, the patient was tested for titers, which were found to be negative for the mumps component (mumps antibody test negative). Therefore, on 31-AUG-2012, the patient was vaccinate with a second dose of MMR II (lot reported as 0447AA, expiration date 28-MAR-2013) (route, strength were not reported). On 08-MAR-2016, the patient was tested again for titers, which were found to be "negative for titers for the mumps component only"(mumps antibody test negative). The nurse reported that the patient came back to the office for another dose of MMR II as vaccination against mumps was a requirement for her nursing school. The reporter indicated that on 14-MAR-2016, the patient received a third dose of MMR II (lot reported as L027431, expiration date 22-JUL-2017) (route, strength were not reported). There was no product quality complaint involved. At the reporting time, the outcome of mumps antibody test negative (28-AUG-2012 and 08-MAR-2016) was reported as not recovered/not resolved. 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 registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was reported. On multiple unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of PROQUAD (Merck), lot number L023111, expiration date: 24-DEC-2016 and lot number reported as L050907, expiration date 14-JUN-2017, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of -13.1 degrees Celsius for 40 hours. No previous temperature excursion was 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: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a office manager via company representative refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with the dose of ZOSTAVAX via 19400 plaque-forming units (PFU), injection (dose, route of administration, lot# and expiration date were not reported). On an unspecified date, the patient experienced unspecified reaction to ZOSTAVAX. The outcome of the adverse event was not provided. The causality between the adverse event and ZOSTAVAX was assessed as related. This is one of the two reports from the same source. 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 healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 09-MAR-2016, the patient was vaccinated with a dose of MMR II, lot # L024266, expiry date 01-JUL-2017 (dose, route of administration and anatomical location were not specified). The administered dose of MMR II underwent temperature excursion under 11 Celsius degrees for 15.5 hours. No previous temperature excursions were reported. No adverse events were reported. Product quality complaint (PQC) was not involved. This is one of several case received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history was not provided. It was reported that on unknown dates, the patients might have received doses of improperly stored GARDASIL 9 lot number L019297, expiration date 18-AUG-2017; lot number L043213, expiration date 28-AUG-2017 (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 30.49F for 48 hours (the worst case scenario) at least 5 times. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-JUN-2011, the patient was vaccinated with a first dose of GARDASIL (lot# and exp. date were not reported). Subsequently on 31-AUG-2011 and on 24-OCT-2011 the patient was vaccinated with the second and the third dose of GARDASIL. The patient did not experience any adverse effect. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 18 month old patient. The patient's concurrent and historical conditions were not reported. On 14-MAR-2016, the patient was vaccinated with an expired dose of VAQTA (lot # K015827, exp.: 11-MAR-2016) (dose, frequency or anatomical location were not provided). Concomitant medications were not reported. No adverse effects reported. Additional information is not expected as no consent to contact HCP was informed.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant mediations was reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of GARDASIL 9, (dose, route of administration, injection site, lot number and expiration date were not provided), which had been drawn into and stored in a syringe for "15 to 20 minutes" prior to administration. The reporter also stated that it routinely occurred with "all of their (unspecified) vaccines". However, at the time of the report it could not be determined whether any other Merck vaccines were involved. No adverse effects were reported. 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 healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 09-MAR-2016, the patient was vaccinated with a dose of MMR II, lot # L024266, expiry date 01-JUL-2017 (dose, route of administration and anatomical location were not specified). The administered dose of MMR II underwent excursion at 11 Celsius degrees for 15.5 hours. No previous temperature excursions were reported. No adverse events were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age or gender. The patient's concurrent conditions, medical history or allergy/drug reactions were not reported. On 16-FEB-2015, the patient was vaccinated with the first dose of GARDASIL (dose, route, anatomical location and lot # were unspecified). On 13-APR-2015, the patient was vaccinated with the second dose of GARDASIL (dose, route, anatomical location and lot # were unspecified). Then, the patient was vaccinated, on 13-MAR-2016, with the third dose of GARDASIL (dose, route and anatomical location were unspecified). (Lot # K023432, exp: 18-JUN-2016). No adverse effects were informed. No product quality issues was informed. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding 2 unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L013827, expiration date- 21-APR-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Time was 1 hour, temperature 34.7F and there was no previous excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L030160, expiration date 11-AUG-2017). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, the patients were vaccinated with ZOSTAVAX (route of administration, dose, lot number, expiration date and indication were not reported). On an unknown dates, the pharmacist saw a lot of people who experienced injection site reactions to ZOSTAVAX. Some people experienced more severe reactions than others. The pharmacist requested information about "a correlation between the severity of injection site reactions and the efficacy or immune response to ZOSTAVAX." The outcomes of injection site reaction were unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored doses of GARDASIL (lot number K023432 and expiration date 18-JUN-2016, dose and route of administration were not reported). The temperature and the time frame of the excursion were 12.3 Celsius degrees for 83 hours and 40 minutes and -3.4 Celsius degrees for 105 hours and 50 minutes. There was no previous temperature excursion and it was stated it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 number of patients of unknown age and gender. The patients' medical history was not provided. It was reported that on unknown dates, the patients might have received doses of improperly stored PNEUMOVAX 23 lot number K021030, expiration date 22-JUN-2016 (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 30.49F for 48 hours (the worst case scenario) at least 5 times. 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 an unspecified number of unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored doses of M-M-R II (lot number L019989 and expiration date 01-JUN-2017, lot number L026553 and expiration date 16-JUL-2017, dose and route of administration were not reported). The temperature and the time frame of the excursion were 12.3 Celsius degrees for 83 hours and 40 minutes and -3.4 Celsius degrees for 105 hours and 50 minutes. There was no previous temperature excursion and it was stated it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, patients were vaccinated orally with improperly stored doses of ROTATEQ (lot number K009900 and expiration date 04-MAY-2016, dose was not reported). The temperature and the time frame of the excursion were 12.3 Celsius degrees for 83 hours and 40 minutes and -3.4 Celsius degrees for 105 hours and 50 minutes. There was no previous temperature excursion and it was stated it was a data logger. No adverse events were reported No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported). Concomitant medications were not reported. On an unknown date, a year after receiving ZOSTAVAX, the patient developed shingles. The outcome of shingles was reported as recovered on an unspecified date. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 16-OCT-2015 the patient was vaccinated with first dose of VAQTA (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On 02-MAR-2016 the patient inadvertently received the second dose of VAQTA immunization series (lot number L043209, expiry date unknown) one month too early. No adverse effects were reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. There was no product quality complaint reported. It a was also reported that the physician had completed a VAERS report for this incident. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was reported. On multiple unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of ZOSTAVAX, lot number L028284, expiration date: 28-OCT-2016 and lot number L029483, expiration date: 06-NOV-2016, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of -13.1 degrees Celsius for 40 hours. No previous temperature excursion was 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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L019297 with expiration date 18-AUG-2017, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a child male patient who received INFANRIX. Co-suspect products included BOOSTRIX. On an unknown date, the patient received INFANRIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX and not applicable after receiving BOOSTRIX, the patient experienced allergic reaction and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the allergic reaction and circumstance or information capable of leading to medication error were unknown. It was unknown if the reporter considered the allergic reaction to be related to INFANRIX. Additional details were provided as follows: This case was reported by the patient's grandmother. The patient had experienced an allergic reaction after vaccination with INFANRIX when he was a baby. The reporter stated that the patient was allergic to something in the vaccine. She also added that he is allergic to a certain food but could not recall the name. At the time of reporting, the patient was 7 years old and was prescribed BOOSTRIX vaccine in order to attend school, which led to circumstance or information capable of leading to medication error. The reporter initially inquired about ingredient because she could not locate them in the Product Information (PI). The reporter declined to provide additional information like address and adverse event information as she did not have the time.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient's husband (age unknown) was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, reported as 48 hours later (after her husband's vaccination), the patient developed shingles. There was no product quality complaint involved. The outcome of the event was not reported. The relatedness between ZOSTAVAX and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Keratitis
Clinical narrative: This spontaneous report as received from an unspecified reporter from an online article via company representative refers to an unspecified number of pediatric patients of unknown gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with zoster vaccine live (manufacturer unknown) (dose, route and site of administration were not reported) and varicella virus vaccine live (manufacturer unknown) (dose, route and site of administration were not reported), (also reported as varicella zoster virus vaccine or chickenpox and shingles vaccine). On unknown dates, patients experienced corneal inflammation. By studying case reports from national and international registries, unspecified number of pediatric patients (out of at least 20 cases which was found in both, children and adults) experienced keratitis within a month of administration of the chickenpox and shingles vaccine. Also, a review of a registry database and previously published reports found that for children symptoms of inflammation developed within 14 days of vaccination. The outcome of the adverse event was unknown. The article stated that a link was found between the zoster vaccine live (manufacturer unknown) and varicella virus vaccine live (manufacturer unknown) and corneal inflammation. Follow up information was received on 09-MAR-2016. A call was placed to physician in regards to article. Receptionist requested that all data requests should be submitting in writing. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: This spontaneous report as received from an office manager via company representative refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. Approximately in March 2016 (reported as unspecified time in the last week), the patient was vaccinated with a dose of ZOSTAVAX vial 19400 plaque-forming units (PFU), injection in the arm (dose, route of administration, lot# and expiration date were not reported). Approximately in March 2016, the patient's whole unspecified arm into which ZOSTAVAX was injected became numb down to the fingers. The patient was scheduled for a medical office visit, but was instructed to go to the emergency room if the reaction gets worse. The office manager could not remember which physician the patient saw in the practice. The outcome of the adverse event and the causality between the adverse event and ZOSTAVAX were not provided. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, clinic manager refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 11-MAR-2016 the patient was vaccinated with expired dose of VARIVAX (Merck) 1350 U (dosing details were not reported) lot # K003406 with an expiry date: 06-MAR-2016. The patient did not experience any adverse effects. No concomitant medications were reported. There was no product quality complaint involved. Additional information has been requested.