chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Neck pain, Rotator cuff syndrome, Tendon disorder, X-ray normal
Clinical narrative: My arm burned to the hand before bedtime.  I could not move normally in the morning, and had to leave the bed by crawling on my knees on the floor and then pulling myself up.  The pain moved to my right shoulder and neck.  I ended up needing x-rays and PT.  Arthritis, tendons and rotater cuff all seemed to get set off from the shot.  I am still needing PT, and possibly a shot of cortisone.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Blood test, Computerised tomogram, Hypertension
Clinical narrative: Joint, neck & back pain. Muscle spasms, pain and swelling at injection location. 12/13/16 - Urgent Care for High Blood Pressure, joint and muscle pain. 12/18/16 - ER - High Blood Pressure, joint and muscle pain. 12/25/16 - ER High Blood Pressure, joint and muscle pain.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Muscle spasms, Myalgia, Neck pain
Clinical narrative: Joint, neck & back pain. Muscle spasms, pain and swelling at injection location. 12/13/16 - Urgent Care for High Blood Pressure, joint and muscle pain. 12/18/16 - ER - High Blood Pressure, joint and muscle pain. 12/25/16 - ER High Blood Pressure, joint and muscle pain.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Joint, neck & back pain. Muscle spasms, pain and swelling at injection location. 12/13/16 - Urgent Care for High Blood Pressure, joint and muscle pain. 12/18/16 - ER - High Blood Pressure, joint and muscle pain. 12/25/16 - ER High Blood Pressure, joint and muscle pain.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Muscle atrophy
Clinical narrative: Exact time and date unknown as to when patient noticed the muscle atrophy.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Eyelid oedema, Swelling face
Clinical narrative: Woke up with facial swelling a day after administration of influenza vaccine. No difficulty breathing and no fever. Seen 5 days later and still has lower eyelid swelling but facial swelling has subsided. Mother states this is the second such episode with influenza vaccine. Does not have this reaction with the intranasal vaccine.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Asthenia, Decreased appetite, Pain in extremity, Rash, Weight decreased
Clinical narrative: LEG PAIN, LACK OF APPETITE WEIGHT LOSS, RASH, SPENT 3 DAYS IN BED, NO ENERGY.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Fatigue
Clinical narrative: LEG PAIN, LACK OF APPETITE WEIGHT LOSS, RASH, SPENT 3 DAYS IN BED, NO ENERGY.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Joint swelling, Myalgia, Rash
Clinical narrative: LEG PAIN, LACK OF APPETITE WEIGHT LOSS, RASH, SPENT 3 DAYS IN BED, NO ENERGY.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Pain in extremity
Clinical narrative: LEG PAIN, LACK OF APPETITE WEIGHT LOSS, RASH, SPENT 3 DAYS IN BED, NO ENERGY.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Rash, Vomiting, Weight decreased
Clinical narrative: LEG PAIN, LACK OF APPETITE WEIGHT LOSS, RASH, SPENT 3 DAYS IN BED, NO ENERGY.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Rash pruritic
Clinical narrative: Small pruritic rash on L thigh and pruritic poorly circumscribed rash covering the anterior and lateral aspects of R thigh with a small area of nontender induration.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Complex regional pain syndrome, Disturbance in attention, Fibromyalgia, Gait disturbance, Hemiplegia
Clinical narrative: Case number PHEH2016US033874, is an initial spontaneous report received from a consumer (patient also a nurse) via pharmaceutical company (Pfizer reference number: 2016574499) on 28 Dec 2016. This report refers to a 37 years old female patient. Past medical history was not reported. Historical medication included as LYRICA. Concomitant medications included as LEXAPRO for depression and anxiety, LAMICTAL for bipolar, KLONOPIN for anxiety and trouble sleeping, AMBIEN, Vitamin B12 injection for critical vitamin B12 and Vitamin D for Vitamin D deficiency. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) in Oct 2014. On an unspecified date in Oct 2014, the patient had allergic reaction to flu shot. The patient also received with gabapentin for fibromyalgia at a dose of 50 mg three times a day in Nov 2014. The patient had a neurological symptoms from the flu shot in Nov 2014. The patient started gabapentin from 200mg, 300 mg to 600 mg and was maxed out to 800 mg a day dose. The dosage was so high, the patient felt very sedated, could not concentrate on an unspecified date in 2014. When patient sat down would be asleep in five minutes but the dose was decreased, it was not benefiting her physically and eventually was taking off of it. On an unknown date in 2014, the patient had rapid weight gain, within four months had put in 10 lbs. As the doses were increased the weight gain continued, thinks her depression was because she was gaining weight. Patient taking prednisone for weight gain but it did not help her. When patient got off the gabapentin she lost 15 lbs, dose was slowly titrated stopped taking in summer of 2015. On an unknown date, the patient had left side paralysis in left shoulder and arm where the injection was given and in left leg. Patient still having trouble with left leg, gait was not right still trips a lot. Patient also diagnosed with regional sympathetic dystrophy in left shoulder in Nov 2015. The outcome of the events sedation, could not concentrate, rapid weight gain and dose was decreased was not benefiting physically was reported as complete recovery on an unknown date and rest of events was not reported. The seriousness of the events was not reported. The causality of the events was not reported. Seriousness assessment of hemiplegia was upgraded to serious (medically significant) based on the NVS IME list. Seriousness assessment of the events sedation, complex regional pain syndrome, was upgraded to serious (medically significant) based on the information available in the source document.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Neurological symptom, Sedation, Weight decreased, Weight increased
Clinical narrative: Case number PHEH2016US033874, is an initial spontaneous report received from a consumer (patient also a nurse) via pharmaceutical company (Pfizer reference number: 2016574499) on 28 Dec 2016. This report refers to a 37 years old female patient. Past medical history was not reported. Historical medication included as LYRICA. Concomitant medications included as LEXAPRO for depression and anxiety, LAMICTAL for bipolar, KLONOPIN for anxiety and trouble sleeping, AMBIEN, Vitamin B12 injection for critical vitamin B12 and Vitamin D for Vitamin D deficiency. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) in Oct 2014. On an unspecified date in Oct 2014, the patient had allergic reaction to flu shot. The patient also received with gabapentin for fibromyalgia at a dose of 50 mg three times a day in Nov 2014. The patient had a neurological symptoms from the flu shot in Nov 2014. The patient started gabapentin from 200mg, 300 mg to 600 mg and was maxed out to 800 mg a day dose. The dosage was so high, the patient felt very sedated, could not concentrate on an unspecified date in 2014. When patient sat down would be asleep in five minutes but the dose was decreased, it was not benefiting her physically and eventually was taking off of it. On an unknown date in 2014, the patient had rapid weight gain, within four months had put in 10 lbs. As the doses were increased the weight gain continued, thinks her depression was because she was gaining weight. Patient taking prednisone for weight gain but it did not help her. When patient got off the gabapentin she lost 15 lbs, dose was slowly titrated stopped taking in summer of 2015. On an unknown date, the patient had left side paralysis in left shoulder and arm where the injection was given and in left leg. Patient still having trouble with left leg, gait was not right still trips a lot. Patient also diagnosed with regional sympathetic dystrophy in left shoulder in Nov 2015. The outcome of the events sedation, could not concentrate, rapid weight gain and dose was decreased was not benefiting physically was reported as complete recovery on an unknown date and rest of events was not reported. The seriousness of the events was not reported. The causality of the events was not reported. Seriousness assessment of hemiplegia was upgraded to serious (medically significant) based on the NVS IME list. Seriousness assessment of the events sedation, complex regional pain syndrome, was upgraded to serious (medically significant) based on the information available in the source document.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Arm around administration site red, warm, and tender.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site nodule, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Right upper arm with round, red, raised area of vaccine site. Per employee "given too high", "knot" sensation warm and painful 2/10.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient came in on 12/31 with large rash on arm with white bumpy rash in center and pink irritated rash surrounding.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site hypersensitivity, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Allergic reaction at injection site left arm. Itching and swelling. Pain also was experienced by patient. Allergic reaction related to PREVNAR 13.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Syncope, Tooth fracture
Clinical narrative: Pt. received ADACEL, MENACTRA and GARDASIL 9 vaccines. Within 1-2 minutes after last vaccine pt. had a syncope episode and fell off the exam table hitting the tall garbage can on the way down. She was unconscious about 30 seconds. Dr examined her. Pt. chipped 2 teeth. After about 15 minutes her mom took her home.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Hypopnoea, Pain in extremity, Paraesthesia oral, Peripheral swelling
Clinical narrative: Swelling in arm, Pain in the arm for 2 weeks (Inside the arm), Tingling in the tongue, shallow breathing. - Not 100% recovered.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Severe myalgias.
Age: 0.25
Sex: F
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Hepatitis A vaccine instead of receiving an Hepatitis B vaccine.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Pin and Needles sensation in Hands.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Peripheral swelling
Clinical narrative: Patient states arm is still swollen and area is hard.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a pharmacy technician concerning a 60 year old female patient. Information about the patient's concurrent condition, concomitant medication, drug reactions/allergies and medical history were unknown. On 01-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX (strength unknown, 0.65 ml once, lot # M020902 with expiration date 18-JUL-2017) intramuscularly for prevention of shingles (Subcutaneous injection formulation administered by other route). On 02-DEC-2016, the second day post vaccination, the patient started experienced pain. The patient received treatment for the event. This pain "stabbing pain in both arms", had not completely resolved (also reported as recovering). The causality assessment between "stabbing pain in both arms" and ZOSTAVAX was not provided. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella rash 2 weeks after varicella vaccine.
Age: 0.92
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Injection site erythema, Injection site rash, Irritability, Pyrexia
Clinical narrative: Fever of 102, rash at injection site, redness at injection site, fussiness.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Decreased appetite, Fatigue, Injection site rash, Irritability
Clinical narrative: Rash at injection site, fussy, extra tired, drastic decrease in appetite.
Age: 64.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Mass, Mobility decreased, Pain
Clinical narrative: Immediate pain.  I said ouch out loud it hurt so badly.  By next day I had a large lump.  It seemed shot hit nerve or bone and was up too high.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma, Therapeutic procedure
Clinical narrative: This spontaneous report has been received from a nurse practitioner via company representative referring to a 13 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unknown. Approximately in 2006 (reported as 10 years ago), the patient was vaccinated with all the three doses of GARDASIL via intramuscular route, for prophylaxis. The nurse reported that after receiving the third dose, patient began having plantar warts on her feet; 9 on 1 foot, 13 on the other (skin papilloma). The patient required medical attention. The nurse reported that they burned off the plantar warts. The outcome of the event was unknown. The causality between the event and GARDASIL was unknown. Follow up information has been received from the nurse on 02-NOV-2016 concerning the white patient. There was no pre-existing allergies, birth defects or medical conditions. There were no adverse events following prior vaccination. There was no illness at time of vaccination. It was reported that on 11-MAR-2007 the patient started the first dose of GARDASIL (lot# reported as 0188u). On 21-MAY-2007 the patient started the second dose of GARDASIL (lot# reported as 0188u).  On 21-AUG-2013 the patient started the third dose of GARDASIL (lot# reported as 04177BA) (Inappropriate schedule of vaccine administered). There was no relevant diagnostic test and laboratory data. At the time of reporting, the patient was recovered from the event on an unknown date. Lot number 4177BA is an invalid lot number for GARDASIL. Lot number 0657006 (batch 0188U) has been verified to be a valid lot number for GARDASIL. Lot number 0657622 (batch 0388U) has been verified to be a valid lot number for GARDASIL. Additional information is not expected as all the correspondences have been received. Report, Patient, Product, Event and Narrative have been updated.; Sender's Comments: MERCK 1609USA010366:Mfr number.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 23-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose and route unknown, lot # K010523, expiration date: 25-FEB-2016) for prophylaxis. No adverse effects were reported. Follow-up information has been received on 03-JAN-2017. This report refers to an 83 years old female patient. On 22-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (route: intramuscular, left deltoid). Additional information has been requested. Patient information, product information, event information and narrative were updated. Sender's Comments: MERCK 1609USA013565:Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patents' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses improperly stored PROQUAD (lot # M002055 with expiration date 11-JUL-2017, lot # M006104 with expiration date 01-AUG-2017; dose, dose number and route were unknown), for prophylaxis. The vaccines were exposed under temperature of 40.3 degrees Fahrenheit for 9 hours and 52 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Follow up information has been received on 28-DEC-2016, the nurse stated that he would fax the patient identifiers and dates of vaccination. Additional information has been requested.; Sender's Comments: US-009507513-1611USA001695:,MERCK 1610USA011829:Mfr number.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 22 year old male patient. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 18-DEC-2012, the patient was vaccinated with the first dose of GARDASIL (dose, route, anatomical location, lot # and expiration date were not reported). Then, on 20-DEC-2013, the patient received the second dose of GARDASIL (dose, route, anatomical location, Lot # and expiration date were not reported) for prophylaxis. The reporter stated that the patient received (also reported as would receive) on 01-NOV-2016 a dose of GARDASIL 9 (lot # L038503, expiration date 18-DEC-2017, dose, route and anatomical location were not reported). No adverse effect was reported. Additional information has been requested.; Sender's Comments: , MERCK 1611USA000896:Mfr number.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist via Poison & Drug Center (MRF# US16-057657) refers to several patients of unknown age.   This pharmacist reported that an unknown number of patients of unknown sex and age were administered one vial of ZOSTAVAX ( lot # M019646, EXP18-JUL-2017, once, subcutaneous) on unknown dates within the past 6 months in 2016 for prevention of shingles. Concomitant medications, relevant laboratory data, and past medical history were unknown for all patients. The pharmacist reported several patients complaining of itching, tingling, numbness, and a ring around the injection site after she administered ZOSTAVAX. It was unknown if the itching, tingling, numbness and ring around the injection site was treated but it did resolve for all of the patients. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 13-DEC-2016,  the patient was vaccinated with an expired dose of ROTATEQ orally (lot # L008997 expiration date: 04-DEC-2016)  for prophylaxis. The reporter stated that the vaccine was always stored properly and there were no adverse effects reported. Additional information is not expected as the reporter did not want to be contacted.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a licensed practical nurse referring to a 13 year old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On 09-SEP-2016, the patient received a dose of PROQUAD (lot #, expired date, dose and route were unknown)  for prophylaxis (inappropriate age at vaccine administration). On 12-OCT-2016, this patient then received a dose of M-M-R II and a dose of VARIVAX (dose, route, lot# and expiration unspecified) for prophylaxis (drug use for unapproved schedule). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning 6 unspecified patients of unknown age and gender. Information about concurrent condition, concomitant therapy, drug reactions/allergies and medical history was not provided. On unknown dates, the patients were each vaccinated with a dose of improperly stored VARIVAX (dose and route were unknown, lot # M003440 with expiration date 20-JAN-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 10.5 Fahrenheit for 1 hour 24 minutes and there was no previous excursion. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Pertinent medical history and drug allergies were not provided. On an unspecified date, the patient was vaccinated with RECOMBIVAX HB (route, strength, dose, lot#, expire date and frequency were unknown) for dose 2 within 48 hours after the dose 1 for prophylaxis (Inappropriate schedule of vaccine administered). Concomitant medication was not provided. No adverse effect reported. The outcome of inappropriate schedule of drug administration was unknown. Causality was not reported. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant, via Pfizer (2016560639, 3TZW1MBU) referring to a 9 year old female patient. The patient's concomitant therapies, medical history, family medical history and relevant test were unknown. The patient did not have neither medical conditions nor adverse event following prior vaccinations. On 24-OCT-2016, when the patient was 9 years of age, she was vaccinated with an incorrect storage dose of PEDVAXHIB intramuscular, in the left arm, dose was not reported (lot # L051122, expiration date 12-OCT-2018), for prophylaxis. Other suspect therapy included INFANRIX intramuscularly, anatomical location and dose were not reported (Lot # 2M527, expiration date 07-MAY-2017). The freezer reached a maximum temperature of 47.85 degrees Fahrenheit for a maximum of eight hours. The excursion occurred on 21-JUN-2016. The practice was aware of the temperature excursion before these doses were administered.  The practice thought that "everything was okay" because the product returned to within normal range within one to two hours after the temperature was reset, also because "the vaccine was not over the maximum temperature". Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (dose, route, lot and expiration date unknown) for prophylaxis. The details of the storage were two occurrences when the temperature of the freezer reached 29 Fahrenheit degree for 30 minutes on each of the two occasions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1701USA001058: US-009507513-1701USA001057.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L048848 with expiration date 09-AUG-2018, dose unknown) intramuscularly for prophylaxis. The vaccines were exposed to 8.8 degree Celsius for 60 minutes. There was no previous temperature excursion. No adverse effects were reported. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 21-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot# and expiration date were not reported, 0.5 mL, intramuscular) for prophylaxis. On 30-DEC-2015, the patient was vaccinated with the second dose of GARDASIL 9 (lot# and expiration date were not reported, 0.5 mL, intramuscular). On 10-MAR-2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot # K010215 (non-valid), expiration date unknown, 0.5 mL, intramuscular) (Product use issue). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 20-DEC-2016, the patient was vaccinated with an expired dose of VAQTA lot # L030442 with expiry date 19-DEC-2016 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The dose had never been improperly stored. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011133.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 05-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 11-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609: US-009507513-1701USA000676: US-009507513-1701USA000677: US-009507513-1701USA000678: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No symptoms; patient received improperly stored VARIVAX; This spontaneous report as received from a medical assistant refers to an 16-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 12-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1610USA004609: US-009507513-1701USA000677: US-009507513-1701USA000678: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 12-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1701USA000676: US-009507513-1610USA004609: US-009507513-1701USA000678: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 14-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1701USA000676: US-009507513-1701USA000677: US-009507513-1610USA004609: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 26-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1701USA000676: US-009507513-1701USA000677: US-009507513-1701USA000678: US-009507513-1610USA004609: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 01-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1701USA000676: US-009507513-1701USA000677: US-009507513-1701USA000678: US-009507513-1701USA000679: US-009507513-1610USA004609: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 03-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1701USA000676: US-009507513-1701USA000677: US-009507513-1701USA000678: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1610USA004609: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 04-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1701USA000676: US-009507513-1701USA000677: US-009507513-1701USA000678: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1610USA004609: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700:
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 15 month old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 07-OCT-2016, the patient was vaccinated with improperly stored and expired dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609:Original Case : 1610USA004609.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 11-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 5 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 20-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609.