chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019330, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 25 Jun 2015 which was stored on incorrect temperature of (34.0 degrees Fahrenheit, and 50.2 degree Fahrenheit 48-120 hours). No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 25 November 2015: Previously administered products included MENVEO which was well tolerated. The patient's vaccination status was current. The patient details (height and weight) were provided. MENVEO was administered intramuscularly on the right deltoid.
Age: 0.16
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 8 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 11-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.15
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 8 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 11-SEP-2015 at 16:15 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 03-DEC-2015, patient was vaccinated with M-M-R II (strength, dose and route were not provided) lot # L011528 and expiration date 03-APR-2017, that were improperly storaged. No concomitant medications was reported. Symptoms Were Reported. No product quality complain was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 4 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015 at 10:10 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.12
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 6 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 10-SEP-2015, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 4 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015 at 10:45 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.15
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 7 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015 at 11:27 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019331, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 14 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 26 Jul 2015 which was stored at 34.0 degrees Fahrenheit and 50.2 degree Fahrenheit for 48-120 hours. No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 25 November 2015: The patient's vaccination status was current. The patient's details (height and weight) were provided. MENVEO was administered as initial application intramuscularly on the left deltoid.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019342, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 06 Aug 2015 and the vaccine administered was stored in (34.0 degrees Fahrenheit, and 50.2 degree Fahrenheit 48-120 hours). No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 25 November 2015: Previously administered products included MENVEO which was well tolerated. The patient's vaccination status was current. The patient's details (height and weight) were provided. MENVEO was administered intramuscularly on the right deltoid.
Age: 0.11
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 6 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 11-SEP-2015 at 10:44 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.32
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 3 months old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015, at 15:44 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.16
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 8 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.31
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 3 month-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015 at 10:11 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019327, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 14 Jul 2015 which was stored on incorrect temperature of 34.0 degrees Fahrenheit and 50.2 degree Fahrenheit at 48-120 hours. No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 25 November 2015: Previously administered products included MENVEO which was well tolerated. The patient's details (height and weight) were provided. The MENVEO batch number was changed to M14070. The vaccine was administered intramuscularly on the left deltoid.
Age: 0.23
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 12 weeks old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 12-SEP-2015, at 14:41 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. This is one of two reports received from the same reporter.
Age: 0.59
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 7 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 11-SEP-2015 at 16:45 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.21
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 10 weeks old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015, at 14:24 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.54
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 6 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 04-SEP-2015 at 14:46 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 3 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015, at 17:03 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 4 month old infant of unknown gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 16-SEP-2015 at 15:29 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to 4 patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L031069, expiration date: 18-AUG-2015 (dosage, dose no. and administration routes were not provided). No concomitant therapies were reported. No adverse effects reported. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 6 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015 at 11:18 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019364, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16 year old patient (gender unspecified). Past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 02 Aug 2015 and the vaccine administered was stored in (34.0 degrees Fahrenheit, and 50.2 degree Fahrenheit 48-120 hours). No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 25 November 2015: Previously administered products included MENVEO which was well tolerated. Concomitant products included GARDASIL received intramuscularly on 2nd August 2015. The patient's vaccination status was current. On 2nd August 2015, the male patient received the 2nd dose of MENVEO (intramuscular) .5 ml on left deltoid. The patient's details (height and weight) were provided.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2015US019017, is an initial spontaneous report received from a healthcare professional on 23 Sep 2015. This report refers to an 11-years-old female patient. Past medical history and concomitant medication were not reported. She received only MENVEO without being reconstituted with Men a component on 21 Sep 2015. No adverse event was reported following this administration error. Follow-up information received on 09 November 2015: The lot number of the MENVEO vaccine was X14136 (expiry date unknown). He was up to date for the vaccination. Concomitant products included ADACEL, given on 21 September 2015. The patient never had symptoms or complications after immunization. He received only the liquid portion of MENVEO.
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Night sweats, Pyrexia
Clinical narrative: Fever and rigors, night sweats. Influenza 0.5 ml once.
Age: 0.39
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 4 month old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 6 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015 at 14:58 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.44
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 5 month old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015 at 14:03 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 9 weeks old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015, at 11:33 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. The 9 weeks old patient was vaccinated with the second dose of ROTATEQ (inappropriate schedule of vaccine administered). No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 10 week old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 30-SEP-2015 at 09:42 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.65
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 7 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015 at 11:26 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 8 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015 at 10:24 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. The patients' medical history, concurrent condition, drug reactions and concomitant therapy were not reported. The reporter reported that an unspecified number of doses of improperly stored VARIVAX (Merck) (dose and route were not reported) were inadvertently administered to an unspecified number of unspecified patients since 17-SEP-2015. No adverse effects have been reported. Additional information has been requested. Lot number L015433 is an invalid lot number for VARIVAX (Merck).
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 6 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 16-SEP-2015 at 14:47 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 12-SEP-2015, at 16:24 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.32
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 3 month old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015, at 15:16 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.32
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 3 month-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 02-SEP-2015 at 10:12 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 4 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015, at 14:32 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.57
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 6 month old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015 at 16:06 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a 9 weeks old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015, at 15:24 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. The 9 weeks old patient was vaccinated with the second dose of ROTATEQ (inappropriate schedule of vaccine administered). No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 07-OCT-2015 (until the reporting time of 03-DEC-2015), the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L030592 with expiration date 12-FEB-2017, lot # L027634 with expiration date 21-JAN-2017, dose and route not reported). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 07-OCT-2015 (until the reporting time of 03-DEC-2015), the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L013067 with expiration date 14-APR-2017, lot # L017142 with expiration date 13-MAY-2017, dose and route not reported). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 31-DEC-2015 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (dose and route not reported, lot # K016322 with expiration date 24-DEC-2015). No adverse effects had been reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor, Peripheral coldness
Clinical narrative: Case number PHHY2014US148628, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540192) website on 13 Nov 2014. This report refers to a 48-year-old female patient. She had no known drug allergies. Concomitant medication included lorazepam. She was vaccinated with FLUVIRIN (batch number: 145002) and PNEUMOVAX (other manufacturer, batch number: K004207) both into right arm on an unknown date. On an unspecified date post vaccination, she became pale, felt dizzy, hands were cold, weak and had sweating. She had syncope but did not lose consciousness. Outcome of the events was reported as recovered. These events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of syncope, pale, sweating, felt dizzy, weak, cold hands was upgraded based on information in the source document.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US148628, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540192) website on 13 Nov 2014. This report refers to a 48-year-old female patient. She had no known drug allergies. Concomitant medication included lorazepam. She was vaccinated with FLUVIRIN (batch number: 145002) and PNEUMOVAX (other manufacturer, batch number: K004207) both into right arm on an unknown date. On an unspecified date post vaccination, she became pale, felt dizzy, hands were cold, weak and had sweating. She had syncope but did not lose consciousness. Outcome of the events was reported as recovered. These events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of syncope, pale, sweating, felt dizzy, weak, cold hands was upgraded based on information in the source document.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Allergy to vaccine, Infection, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Case number PHHY2014US150443, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541957) website on 13 Nov 2014. This report refers to a 60-year-old female patient. Medical history was not reported. Past medications included sulfa drugs, codeine and estrogens. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145223), along with ZOSTAVAX (batch number: K007848) into the left arm on 26 Aug 2014. On 29 Aug 2014, the patient developed large red wheal at injection site with hard knot. Wheal grew in size over 3 days. The patient called the MD and the patient went to the physician office. The physician said she was allergic to medicine (vaccine) and had developed an infection. She was given KEFLEX and prednisone as treatment. The physician told to the patient that she should recover. The outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Case number PHHY2014US150443, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541957) website on 13 Nov 2014. This report refers to a 60-year-old female patient. Medical history was not reported. Past medications included sulfa drugs, codeine and estrogens. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145223), along with ZOSTAVAX (batch number: K007848) into the left arm on 26 Aug 2014. On 29 Aug 2014, the patient developed large red wheal at injection site with hard knot. Wheal grew in size over 3 days. The patient called the MD and the patient went to the physician office. The physician said she was allergic to medicine (vaccine) and had developed an infection. She was given KEFLEX and prednisone as treatment. The physician told to the patient that she should recover. The outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Case number PHHY2014US150117, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542328) website on 13 Nov 2014. This report refers to a 28-year-old female patient. Medical history and concomitant medications were not reported. No illness at time of vaccination. She was vaccinated with FLUVIRIN (batch number: 1411201) intramuscularly into left arm on 02 Sep 2014. On the same day, after vaccination, she experienced shortness of breath, tightness of chest wall and possibly anaphylaxis. She went to emergency room due to these events. Outcome of the events was reported as recovered. These events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of anaphylaxis was upgraded based on the NVD key event list; shortness of breath, tightness of chest wall was upgraded based on information in source document.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal oedema
Clinical narrative: Case number PHHY2014US151173 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543504) website on 13 Nov 2014. This report refers to a 37 year old female patient. Medical history was not reported. Concurrent conditions included feeling of odd flu symptoms and asthma. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1411201) via intramuscular route on 02 Sep 2014. On 08 Sep 2014, the patient experienced anaphylaxis type reaction including difficulty breathing and throat swelling. The patient treatment included administration of epinephrine. Final outcome was complete recovery. The events were reported as non-serious. However, seriousness assessment of anaphylaxis type reaction was upgraded based on NVS-IME list. Causality was not reported.
Age: 82.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: Case number PHHY2014US151008 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543515) on 13 Nov 2014. This report refers to an 82-year-old female patient. Medical history was not reported. Concurrent conditions included hypertension, gout and thyroid. Concomitant medications included metoprolol, allopurinol, prednisone via ophthalmic route and unspecified medication for thyroid. She was vaccinated with FLUVIRIN (batch number: 1411001) intramuscularly in left arm and ZOSTAVAX (other manufacturer, batch number: K007985) subcutaneously both on 05 Sep 2014. On the same day after vaccination, she developed light tightness in throat, weakness, redness, heat, itch and soreness. Final outcome was reported as complete recovery. The events were reported as non-serious. However, seriousness assessment of tightness in throat was upgraded based on the information available in the source document. Causality was not reported.
Age: 82.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Throat tightness
Clinical narrative: Case number PHHY2014US151008 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543515) on 13 Nov 2014. This report refers to an 82-year-old female patient. Medical history was not reported. Concurrent conditions included hypertension, gout and thyroid. Concomitant medications included metoprolol, allopurinol, prednisone via ophthalmic route and unspecified medication for thyroid. She was vaccinated with FLUVIRIN (batch number: 1411001) intramuscularly in left arm and ZOSTAVAX (other manufacturer, batch number: K007985) subcutaneously both on 05 Sep 2014. On the same day after vaccination, she developed light tightness in throat, weakness, redness, heat, itch and soreness. Final outcome was reported as complete recovery. The events were reported as non-serious. However, seriousness assessment of tightness in throat was upgraded based on the information available in the source document. Causality was not reported.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US169483, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 543876) website on 29 Dec 2014 and with follow up information received from the quality assurance department (QA reference number: 344776) on 31 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 344776) on 02 Feb 2015. This report refers to a 16 year old female patient. Her medical history and concomitant medication were none. The patient was vaccinated with FLUVIRIN (batch number: 1411101) intramuscularly on 08 Sep 2014. On 09 Sep 2014, the patient developed Bell's palsy which was confirmed in an emergency room on 10 Sep 2014. Final outcome of the event was reported as condition unchanged. The event was reported as non-serious. Seriousness assessment of Bell's palsy was upgraded (medically significant) based on the NV-key event list. Causality of the event was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1411101) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 344776) on 31 Dec 2014: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 344776) on 02 Feb 2015: Updated FLUVIRIN vaccine batch review report.