chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patients of unknown age. On an unknown date, the patients was vaccinated with VARIVAX (lot # reported as N001527, N001527, N012134)  for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date, the patient experienced incorrect product storage and no adverse event.; Sender's Comments: US-009507513-1707USA011188:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history of the patient was not provided. Concomitant medication included properly stored sterile diluent (manufacturer unknown). On 23-JUN-2017, the patient was administered a dose of improperly stored VARIVAX (lot # N001528, expired date 13-JAN-2019; dose and route were not provided) for prophylaxis (incorrect product storage). The vaccine was exposure to  temperature excursion (range of 6 Fahrenheit degrees to 14 Fahrenheit degrees) for 12 hours. There was no previous temperature excursion. The dose of VARIVAX was reconstituted with properly stored sterile diluent (lot and expiration date not reported). Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009098: US-009507513-1707USA009102: US-009507513-1707USA009099: US-009507513-1707USA009100: US-009507513-1707USA009101:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history of the patient was not provided. Concomitant medication included properly stored sterile diluent (manufacturer unknown). On 29-JUN-2017, the patient was administered a dose of improperly stored VARIVAX (lot # N001528, expired date 13-JAN-2019; dose and route were not provided) for prophylaxis (incorrect product storage). The vaccine was exposure to  temperature excursion (range of 6 Fahrenheit degrees to 14 Fahrenheit degrees) for 12 hours. There was no previous temperature excursion. The dose of VARIVAX was reconstituted with properly stored sterile diluent (lot and expiration date not reported). Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009099: US-009507513-1707USA008903: US-009507513-1707USA009100: US-009507513-1707USA009101: US-009507513-1707USA009102:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history of the patient was not provided. Concomitant medication included properly stored sterile diluent (manufacturer unknown). On 06-JUL-2017, the patient was administered a dose of improperly stored VARIVAX (lot # N001528, expired date 13-JAN-2019; dose and route were not provided) for prophylaxis (incorrect product storage). The vaccine was exposure to  temperature excursion (range of 6 Fahrenheit degrees to 14 Fahrenheit degrees) for 12 hours. There was no previous temperature excursion. The dose of VARIVAX was reconstituted with properly stored sterile diluent (lot and expiration date not reported). Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009098: US-009507513-1707USA008903: US-009507513-1707USA009100: US-009507513-1707USA009101: US-009507513-1707USA009102:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history of the patient was not provided. Concomitant medication included properly stored sterile diluent (manufacturer unknown). On 22-JUN-2017, the patient was administered a dose of improperly stored VARIVAX (lot # N001528, expired date 13-JAN-2019; dose and route were not provided) for prophylaxis (incorrect product storage). The vaccine was exposure to  temperature excursion (range of 6 Fahrenheit degrees to 14 Fahrenheit degrees) for 12 hours. There was no previous temperature excursion. The dose of VARIVAX was reconstituted with properly stored sterile diluent (lot and expiration date not reported). Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009098: US-009507513-1707USA008903: US-009507513-1707USA009099: US-009507513-1707USA009101: US-009507513-1707USA009102:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history of the patient was not provided. Concomitant medication included properly stored sterile diluent (manufacturer unknown). On 28-JUN-2017, the patient was administered a dose of improperly stored VARIVAX (lot # N001528, expired date 13-JAN-2019; dose and route were not provided) for prophylaxis (incorrect product storage). The vaccine was exposure to  temperature excursion (range of 6 Fahrenheit degrees to 14 Fahrenheit degrees) for 12 hours. There was no previous temperature excursion. The dose of VARIVAX was reconstituted with properly stored sterile diluent (lot and expiration date not reported). Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009098: US-009507513-1707USA008903: US-009507513-1707USA009099: US-009507513-1707USA009100: US-009507513-1707USA009102:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history of the patient was not provided. Concomitant medication included properly stored sterile diluent (manufacturer unknown). On 18-JUL-2017, the patient was administered a dose of improperly stored VARIVAX (lot # N001528, expired date 13-JAN-2019; dose and route were not provided) for prophylaxis. The vaccine was exposure to temperature excursion (range of 6 Fahrenheit degrees to 14 Fahrenheit degrees) for 12 hours. There was no previous temperature excursion. The dose of VARIVAX was reconstituted with properly stored sterile diluent (lot and expiration date not reported). Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009098: US-009507513-1707USA008903: US-009507513-1707USA009099: US-009507513-1707USA009100: US-009507513-1707USA009101.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to 18 patients of unknown age and gender. Information regarding pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates in 2017, reported as from 29-MAR-2017 through 20-JUL-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX VIAL 19400 PFU, lot # M041085 with expiry date 03-JAN-2018 and lot # M042850 with expiry date 18-JAN-2018 (dose, route, anatomical location and dose number unknown) for prophylaxis. No adverse effects were reported. The administered doses of both lots experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degrees Fahrenheit to 14 degrees Fahrenheit for 3 hours 30 minutes. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse, refers to an unspecified patients of unknown ages and genders. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. Sender's Comments: US-009507513-1707USA011936.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M033212 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is VARIVAX.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician concerning a 22 month old female patient. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On an unknown date, the patient was inadvertently vaccinated with GARDASIL 9 (lot # N000326, expiration date: 14-OCT-2019, strength, dose, frequency and route were not reported) for prophylaxis (drug administered to patient of inappropriate age) during her well checking up. No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 22-JUN-2017 the patient was vaccinated with VARIVAX lot # N001530 with expiration date of 13-JAN-2019, 1 DF for prophylaxis. Concomitant therapies included sterile diluent. On 22-JUN-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA013239.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a lincenced nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 days (192 hours, worst case), and a temperature excursion of 47 to 77 degrees Fahrenheit for 1 hour, however it was reported that no previous temperature excursion was performed. The call was because of a "data logger". This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1707USA013301: US-009507513-1707USA013302: US-009507513-1707USA013303:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 27-JUN-2017 the patient was vaccinated with VARIVAX lot # N001530 with expiration date of 13-JAN-2019, 1 DF for prophylaxis. Concomitant therapies included sterile diluent. On 27-JUN-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA013067.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 days (192 hours, worst case), and a temperature excursion of 47 to 77 degrees Fahrenheit for 1 hour, however it was reported that no previous temperature excursion was performed. The call was because of a "data logger". This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA013302: US-009507513-1707USA013303: US-009507513-1707USA013214.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 days (192 hours, worst case), and a temperature excursion of 47 to 77 degrees Fahrenheit for 1 hour, however it was reported that no previous temperature excursion was performed. The call was because of a "data logger". This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009513507-1707USA013214: US-009513507-1707USA013301: US-009513507-1707USA013303.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (unknown albumin status) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 days (192 hours, worst case), and a temperature excursion of 47 to 77 degrees Fahrenheit for 1 hour, however it was reported that no previous temperature excursion was performed. The call was because of a "data logger". This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA013214: US-009507513-1707USA013301: US-009507513-1707USA013302.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # M026876, expiry date: 26-JUL-2017) reconstituted with sterile diluent (Manufacturer unknown) (lot# and expiry date unknown) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to 2 patients of unknown age. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, two patients were vaccinated with ZOSTAVAX, subcutaneous (dose, strength, lot # and expiry date not reported) for prophylaxis. The two patients developed shingles after receiving ZOSTAVAX. Both patients were not immunosuppressed. Outcome and causality not provided.      Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information on pertinent medical history and concurrent condition was not provided. On an unknown date in 2014, the patient was vaccinated with first dose of VAQTA (dose, route, strength, lot # and expiry date not reported) for prophylaxis. On an unknown date in 2016, the patient received second dose of VAQTA. On 27-JUL-2017, the patient was vaccinated with third dose of VAQTA (lot #: N005796 and expiry date: 26-MAY-2018). The nurse stated that the third dose of VAQTA was an event related to a documentation error and was not related to product confusion. No adverse effects were reported. Outcome not provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 28-JUL-2017, the patient was vaccinated with expired ZOSTAVAX (lot # M026878, expiry date: 27-JUL-2017), (route: subcutaneous) (expired vaccine used). The vaccine did not have any previous temperature excursions. No adverse symptoms reported. The outcome of the events was unknown. Additional information is not expected, as no consent to contact the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. Then the patient was administered a second dose of GARDASIL 9 "12 months and one day later" on an unknown date. No adverse effect reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Pain, Rhinorrhoea
Clinical narrative: Per patient report: Hives on face, temp 100F, body aches, runny nose, redness and pain at site x 3 days after injection.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Per patient report: Hives on face, temp 100F, body aches, runny nose, redness and pain at site x 3 days after injection.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients, names and other demographics unknown, who on unspecified dates received an improperly stored dose of ZOSTAVAX (lot # M040144, expiration date 26-DEC-2017) that was reconstituted with properly stored sterile water diluent (STERILE DILUENT) (lot # and expiration date were reported as unknown). The dose was stored at temperatures in the range of 6 degrees Fahrenheit to 14 degrees Fahrenheit for a time frame of 1 hour 30 minutes as identified by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old non-pregnant female patient. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient received a dose of RECOMBIVAX HB (lot numbers and expiration dates unspecified), intramuscularly, on 04-APR-1997, 05-MAY-1997, and 16-JAN-1998 as a vaccine. On 10-JUL-2017, the patient had a "blood draw" done where the surface antigen antibody quantitative was determined to be low. No treatment was provided. The outcome of the surface antigen antibody quantitative is unknown. No further details provided. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 27-JUL-2017, the patient was vaccinated with M-M-R II (rHA) lot # L008684 for prophylaxis. On 27-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date, the patient experienced no adverse event. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report has been received via a company employee from a consumer referring to two unspecified patients. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the two patients were vaccinated with the GARDASIL 9 (dose, route, lot number and expiration data were not reported) for prophylaxis. On an unknown date, the two patients passed out after vaccination. The outcome of the event was unknown. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA011284.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Poliomyelitis
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. An 89-year-old British and Norwegian female patient received PREVNAR 13 (NDC number: 00005-1971-02; UPC number: 0000028144), via an unspecified route of administration on 26Jul2017 at single dose for immunisation. Medical history included, trouble with her memory related to old age, osteoporosis, neck injury and spinal disorder as in the past she had a broken neck and a broken spine. The patient's concomitant medications were not reported however the patient took other medicines. The patient previously took polio vaccine ctv for immunisation and experienced poliomyelitis. The patient experienced can't lift right arm and can't lift anything, on 26Jul2017 with outcome of recovering. Therapeutic measures were taken as a result of the events and included menthol product, cold compress and lymph massage.
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Immediate post-injection reaction, Lethargy, Listless
Clinical narrative: Initial unsolicited report received from a nurse on 18-JUL-2017. This case involves a two-month-old female patient who was vaccinated with a first dose of PENTACEL a dose of PREVNAR (manufacturer: Wyeth) a dose of ROTAVAX (manufacturer: Merck) (for all the vaccines; batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 17-JUL-2017 (also reported as 18-JUL-2017). Patient's medical history and concomitant medications were not reported. On 17-JUL-2017 (also reported as 18-JUL-2017), immediately following the vaccination, the patient became listless and lethargic. Lab data and corrective treatment were not reported. On 17-JUL-2017 (also reported as 18-JUL-2017), the patient recovered from the event (it was reported that 'this lasted 15 minutes and then patient began acting normally'). List of documents held by sender: none.
Sex: M
Vaccine: UNK
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2017289069) on 19 Jul 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINE) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medication were not reported. On an unspecified date following the vaccination, the patient had allergy to vaccine. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: PNC13, RAB, YF, RAB
Symptoms: Anxiety, Dizziness, Nausea, Pain, Palpitations
Clinical narrative: Initial unsolicited report received from a healthcare professional on 19-Jul-2017. This case involves 23 years old male patient who was vaccinated with a first dose of IMOVAX (batch number: m12962M and expiry date was not reported) intramuscularly in right deltoid on an unspecified date. Patient's illness at time of vaccination includes stomachache in the AM. Pre-existing physician diagnosed allergies birth defects includes or medical condition includes extra heartbeat as per EE. Patient denies other medications. Any other vaccination within four weeks prior to the date includes vaccination of first dose of PREVENAR 13 (Batch number: R33239) intramuscularly in left deltoid and first dose of YELLOW FEVER VACCINE - US (YF) (Batch number: UI607AA and expiry date:07-NOV-2018) subcutaneously in right arm on 10 July 2017. On an unspecified date following vaccination patient had nausea, light headedness, heart raccing (heart racing) pain and it could be anxiety. Patient denies breakfast, do not eat lunch. Very warm day. Laboratory investigation includes blood pressure of 132/70, heart rate 64 and temperature of 98.3. Corrective treatment was not reported. Outcome of events was not reported. List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: PNC13, RAB, YF, RAB
Symptoms: Dizziness, Nausea, Palpitations
Clinical narrative: Initial unsolicited report received from a healthcare professional on 19-Jul-2017. This case involves 23 years old male patient who was vaccinated with a first dose of IMOVAX (batch number: m12962M and expiry date was not reported) intramuscularly in right deltoid on an unspecified date. Patient's illness at time of vaccination includes stomachache in the AM. Pre-existing physician diagnosed allergies birth defects includes or medical condition includes extra heartbeat as per EE. Patient denies other medications. Any other vaccination within four weeks prior to the date includes vaccination of first dose of PREVENAR 13 (Batch number: R33239) intramuscularly in left deltoid and first dose of YELLOW FEVER VACCINE - US (YF) (Batch number: UI607AA and expiry date:07-NOV-2018) subcutaneously in right arm on 10 July 2017. On an unspecified date following vaccination patient had nausea, light headedness, heart raccing (heart racing) pain and it could be anxiety. Patient denies breakfast, do not eat lunch. Very warm day. Laboratory investigation includes blood pressure of 132/70, heart rate 64 and temperature of 98.3. Corrective treatment was not reported. Outcome of events was not reported. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 21-Jul-2017. This case involves a 64-year-old male patient, who was vaccinated with second dose of ADACEL (batch number: U5702AA, expiry date: 20-Jun-2019; dose, route not reported) in right deltoid on 12-Jul-2017. Patient's illness at time of vaccination was none and pre-existing physician diagnosed allergies birth defects, medical conditions were reported as hypothyroidism. Concomitant medications were not reported. No other vaccinations within 4 weeks of vaccinations was given. On an unknown date, following the vaccination, the patient's arm still hurts. Patient required ER/doctor visit. No lab test was performed. As part of corrective treatment patient took NAPROXEN (ALLEVE) but did not helped. Patient did not recovered form the event. Documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Full blood count normal, Induration, Lymph node pain, Lymphadenopathy, Mononucleosis heterophile test negative
Clinical narrative: 4 days from injection, pain arose at left clavicle. 5 days after injection, enlarged lymph node was visible above left clavicle, causing acute pain when patient turned head or lifted left arm. Patient went to urgent care on day 5 for evaluation and was released (details under Item 19). 6 days after injection, lymph node was larger and harder. 8 days after injection, lymph node began to get smaller and mobility without pain returned to patient. 10 days after injection, patient returned to normal level of physical activity with only minor discomfort. 12 days after injection, patient followed up with primary care physician.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: 4 days from injection, pain arose at left clavicle. 5 days after injection, enlarged lymph node was visible above left clavicle, causing acute pain when patient turned head or lifted left arm. Patient went to urgent care on day 5 for evaluation and was released (details under Item 19). 6 days after injection, lymph node was larger and harder. 8 days after injection, lymph node began to get smaller and mobility without pain returned to patient. 10 days after injection, patient returned to normal level of physical activity with only minor discomfort. 12 days after injection, patient followed up with primary care physician.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Electrocardiogram normal, Eyelid oedema, Palpitations, Tenderness
Clinical narrative: 072817 AT ABOUT 9AM CLIENT STATED OVER THE PHONE SHE WOKE UP WITH HEART RACING, SWOLLEN LEFT EYELID, AND TENDER LEFT BROW. DIRECTED CLIENT TO GO TO ER/MD. SHE WENT TO MD. AT 11AM CLIENT LEFT MESSAGE SHE IS FINE, COMFORTABLE, OK. ABOUT 6PM CLIENT REPORTED VIA PHONE THAT AT ABOUT 10AM VITALS AND EKG RESULT NORMAL, TOLD BY MD NO REASON TO EXPERIENCE HEART RACING AGAIN, GIVEN OTC BENADRYL FOR FEW DAYS FOR SWOLLEN EYELID.  SHE REPEATED FEELING OK.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Biopsy, Gastrointestinal infection, Rash, Vasculitis
Clinical narrative: Had flu shot 9th Nov 16. Began breaking out in spots on legs and arms.  Diagnosed as IGA vasculitis-was in hospital for 4 nights with infected intestines. Was on morphine and other pain meds, steroids-Dapsone and Potassium Iodine.
Age: 11.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dizziness, Fatigue, Pallor, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Approximately 3-4 minutes after patient received vaccines, parent, sister, and child were sitting in seat and child "curled onto right side, with eyes open, but not responding to parent's voice." Parent states it lasted for 15-20 seconds. Parent pulled child into sitting position, and child stated she felt dizzy. Parent noticed child wet herself. Parent picked child up and brought her back into clinic.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt complained of arm at pain at injection site.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Balance disorder, Chest X-ray, Computerised tomogram, Diarrhoea
Clinical narrative: On day 2 following the vaccination, patient stated that she had a local reaction at the injection site of  left arm with redness, swelling, and hot to touch. On day 3, symptoms increased including diarrhea, headache, nausea, and abdominal cramping. On Day 4, she had dizziness and was unable to get out of bed. On day 6, she dizziness increased and she lost her balance and fell. As of 8/1/17, patient continues to have dizziness and balance instability.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Electrocardiogram, Fall, Injection site erythema, Injection site reaction
Clinical narrative: On day 2 following the vaccination, patient stated that she had a local reaction at the injection site of  left arm with redness, swelling, and hot to touch. On day 3, symptoms increased including diarrhea, headache, nausea, and abdominal cramping. On Day 4, she had dizziness and was unable to get out of bed. On day 6, she dizziness increased and she lost her balance and fell. As of 8/1/17, patient continues to have dizziness and balance instability.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth, Laboratory test, Local reaction, Mobility decreased
Clinical narrative: On day 2 following the vaccination, patient stated that she had a local reaction at the injection site of  left arm with redness, swelling, and hot to touch. On day 3, symptoms increased including diarrhea, headache, nausea, and abdominal cramping. On Day 4, she had dizziness and was unable to get out of bed. On day 6, she dizziness increased and she lost her balance and fell. As of 8/1/17, patient continues to have dizziness and balance instability.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea
Clinical narrative: On day 2 following the vaccination, patient stated that she had a local reaction at the injection site of  left arm with redness, swelling, and hot to touch. On day 3, symptoms increased including diarrhea, headache, nausea, and abdominal cramping. On Day 4, she had dizziness and was unable to get out of bed. On day 6, she dizziness increased and she lost her balance and fell. As of 8/1/17, patient continues to have dizziness and balance instability.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, site of administration, lot number and expiration date were not provided) for prophylaxis while the patient was concomitantly taking valacyclovir (VALTREX). Other suspect therapies included sterile diluent (STERILE DILUENT) (lot # and expiration date were not provided). The pharmacist reported that the valacyclovir (VALTREX) medication was not stopped for two weeks prior to the patient receiving the ZOSTAVAX vaccine. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients, names and other demographics unknown, who since MAR-2017 have been administered doses of VAQTA lot # M039202, expiration date 11-MAR-2018, RECOMBIVAX HB lot # M035487, expiration date 23-FEB-2019, ROTATEQ lot # M040270, expiration date 29-APR-2018 and GARDASIL 9 lot # M041212, expiration date 21-JUN-2019 which were improperly stored. The doses were stored at temperatures in the range of 32 degrees Fahrenheit to 35 degrees Fahrenheit (34 Fahrenheit) for a time frame of 4 hours; 36 degrees Fahrenheit to 46 degrees Fahrenheit (35.8 Fahrenheit) for a time frame of 12 hours. Previous temperature excursions was reported as NA. The call was not because of a data logger. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 11-JUL-2017 from a registered nurse who was reporting on a 4 year old patient of unknown gender. No medical history or concomitant medications were reported. On 11-JUL-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot N008824, expires 28-AUG-2018) that was reconstituted with properly stored sterile diluent MRK (lot number expiration unknown). No adverse effects were reported. The vaccine PROQUAD was at a temperature of 5.9 degrees F. for 18 minutes, as per a data logger. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 11-JUL-2017 from a pharmacist who was reporting on a patient of unknown age and gender. No medical history or concomitant medication was reported, The pharmacist reported that on 10-JUL-2017, the patient received an expired dose of ZOSTAVAX (lot M015926, expired 28-JUN-2017) that was inadvertently administered to the patient. Indication was for prophylaxis. It was unknown if the sterile diluent was expired (no lot or expiration reported). No adverse effects. No further information to report. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 12-JUL-2017 from a registered nurse who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. The nurse reported that on 10-JUL-2017, an unspecified patient received a dose of improperly stored ROTATEQ (lot M039061, expires 28-APR-2018) (dose, route and site not reported) for prophylaxis. No adverse effects were reported. No further information was provided. The temperature was 47 degrees F. to 77 degrees F. for 13 hours. There has been no previous temperature excursion. This call was not as a result of a data logger. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and a nurse referring to a 13 years old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-MAY-2015, the patient was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date not reported) for prophylaxis. Then the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot # and expiration date not reported) for prophylaxis on 22-JUL-2016(interchange of vaccine products and inappropriate schedule of vaccine administered). The patient was currently (in approximately July 2017) in the office to receive another dose of GARDASIL 9(inappropriate schedule of vaccine administered). No adverse effect was reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA010344.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and a nurse referring to a 14 years old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-MAY-2015, the patient was vaccinated with a dose GARDASIL (dose, route, lot # and expiration date not reported) for prophylaxis. Then the patient was vaccinated with GARDASIL 9 (dose, route, lot # and expiration date not reported) for prophylaxis on 22-JUL-2016 (interchange of vaccine products and inappropriate schedule of vaccine administered). No adverse effect was reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA009952.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse a via company representative refers to a 59 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, lot# and expiration date were not reported) for prophylaxis. On an unknown date, one week after vaccination, the patient developed shingles.  The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant via a field representative concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, a dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported) was "drawn up into a plastic syringe, stored in the refrigerator for 4 hours and then administered to the patient" (wrong technique in product usage process). It was outside the recommendations per GARDASIL 9 prescribing information. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 27-JUL-2017 the patient was vaccinated with VARIVAX lot # N000683 with expiration date of 06-JAN-2019, 1 DF for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On 27-JUL-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. It was stated that the vaccin underwent a temperature excursion of 6-14 degrees Fahrenheit for 6 hours. No previous temperature excursion was performed.  The call was because of a "data logger". Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. She was not administered any concomitant medications. On 28-JUL-2017, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX lot# M039453, expiration date 19-DEC-2017 (dose was not reported) for prevention of shingles. The vaccine was reconstituted with sterile diluent (DILUENT MRK) lot# M014921, expiration date 30-NOV-2018. On 29-JUL-2017, the patient began experiencing redness and itching at the injection site. The patient presented at pharmacy. There was no treatment given for the events. No laboratory diagnostic studies were performed. The outcome of redness and itching at the injection site was reported as not recovered at the time of report. The relatedness between redness and itching at the injection site and ZOSTAVAX was not reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: 102-103 fever for a week after vaccine with no other symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Same day - extreme arm soreness and burning at vaccine site; 2nd day - whole body aches and pains, vaccine site started swelling, itching and burning, turning red; 3rd day - continued swelling and redness about 2 inches all around vaccine site with dark red at specific vaccine site; this is 6th day since injection, arm is still sore, swollen and red around vaccine site.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Bruxism, Dyskinesia, Eye movement disorder, Fall, Head injury
Clinical narrative: Dr. did not explain any potential side effects of the vaccines. She gave a vaccine in each deltoid and then the GARDASIL 9 vaccine in his hip. Then let him walk right out of the treatment room to check out. He passed out/ lost consciousness in the hallway from the treatment room fell and hit the back of his head on the tile floor and had a 15-2o second seizure where his arms and legs got stiff, his eyes rolled back in his head and his head was tilted back to the right and he was jerking violently with his jaws clinched tight.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Seizure
Clinical narrative: Dr. did not explain any potential side effects of the vaccines. She gave a vaccine in each deltoid and then the GARDASIL 9 vaccine in his hip. Then let him walk right out of the treatment room to check out. He passed out/ lost consciousness in the hallway from the treatment room fell and hit the back of his head on the tile floor and had a 15-2o second seizure where his arms and legs got stiff, his eyes rolled back in his head and his head was tilted back to the right and he was jerking violently with his jaws clinched tight.
Age: 2.0
Sex: M
Vaccine: HIBV, PNC13, UNK
Symptoms: Vaccination complication
Clinical narrative: Advrs effect of pertuss vaccine, inc combin w pertuss, subs on 2017-07-28.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-07-28.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site joint pain, Muscular weakness, Pain in extremity
Clinical narrative: LEFT ARM WAS REASONABLY SORE, FOR 2 DAYS. THEN MOVED UNDER LEFT ARM AND AROUND TO TOP OF LEFT SHOULDER AND IN COLLAR AREA. CAN'T MOVE ARM UP OR I DON'T HAVE ANY STRENGTH IN MY ARM. NO TREATMENT STARTED.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a Medical Assistant regarding a female patient of unknown age who inadvertently was administered one expired dose of (MMRII) injection (lot L024264, exp. 01-JUL-2017) which was reconstituted with sterile diluent (lot # M019490, exp. 09-OCT-2018). Concomitant medication, medical history and concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: Information was received 13-JUL-2017 via a phone call from a female consumer who reported that her son experienced an adverse event after receiving an MMR vaccine a couple of years ago (Lot # and expiration date not provided). Description and outcome of the event and age of her son were not provided. The reporter opted not to provide any further information. Additional information is not expected.