chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot#, dose, and frequency were unspecified) for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No adverse effects reported. No product quality complaint was involved. The vaccines were exposed to a temperature excursion of 51 Fahrenheit degrees for a time frame of 1.5 hours, identified because of a digital data logger. There was no previous temperature excursion. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA007978: US-009507513-1709USA008156: US-009507513-1709USA008154:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No adverse effects reported. No product quality complaint was involved. The vaccines were exposed to a temperature excursion of 51 Fahrenheit degrees for a time frame of 1.5 hours, identified because of a digital data logger. There was no previous temperature excursion. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA008155: US-009507513-1709USA007978: US-009507513-1709USA008154:
Age: 19.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 19 years old patient of unknown gender. The patient's pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On 13-JUL-2017, the patient was administered with M-M-R II (albumin status rHA, lot # M042846, with expiration date 21-OCT-2018) or VARIVAX (lot# N014366, expiration date 09- MAY-2019) (dose, dose#, route of administration and anatomical location were not reported for both of the vaccines) for prophylaxis, which was reconstituted with sterile diluent (lot # N003192 with expiration date at 05-JUL-2019). The administered doses of vaccine were exposed to a temperature excursion between 47 degrees Fahrenheit (F) and 77 degrees Fahrenheit (F) on 09-JUL-2017, which lasted for a 12 hours and 10 minutes. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009993: US-009507513-1707USA002673: US-009507513-1709USA004444.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). The patients received improperly stored doses of GARDASIL 9 (dose, frequency and route were unknown, lot # L024993, expiration date: 17-OCT-2017, lot # reported as L04475, expiration date: 12-MAY-2017, lot # reported as M03770, expiration date: 01-JUN-2019) for prophylaxis on multiple unknown dates between 01-JAN-2017 to 01-AUG-2017. The temperature excursion was at 32 Fahrenheit Degree to 35 Fahrenheit Degree for 24 hours and 47 Fahrenheit Degree to 77 Fahrenheit Degree for 32 hours. The previous temperature excursion was reported as yes. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008435: US-009507513-1709USA008436: US-009507513-1708USA013804.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). The patients received improperly stored doses of M-M-R II (dose, frequency and route were unknown, lot # L028273, expiration date: 28-JUL-2017, lot # L039613, expiration date: 08-OCT-2017) for prophylaxis on multiple unknown dates between 01-JAN-2017 to 01-AUG-2017. The temperature excursion was at 32 Fahrenheit Degree to 35 Fahrenheit Degree for 24 hours and 47 Fahrenheit Degree to 77 Fahrenheit Degree for 32 hours. The previous temperature excursion was reported as yes. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA013804: US-009507513-1709USA008436: US-009507513-1709USA008434.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). The patients received improperly stored doses of ROTATEQ (dose, frequency and route were unknown, lot # M039061, expiration date: 28-APR-2018, lot # M042821, expiration date: 14-JUN-2018, lot # M005732, expiration date: 19-OCT-2017) for prophylaxis on multiple unknown dates between 01-JAN-2017 to 01-AUG-2017. The temperature excursion was at 32 Fahrenheit Degree to 35 Fahrenheit Degree for 24 hours and 47 Fahrenheit Degree to 77 Fahrenheit Degree for 32 hours. The previous temperature excursion was reported as yes. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008435: US-009507513-1708USA013804: US-009507513-1709USA008434.
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 number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies and concomitant therapies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (albumin status, exact dose, dose number, route of administration, lot # and expiration date were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No adverse effects were reported. The administered doses of PROQUAD experienced a temperature excursion between 15 and 46 Fahrenheit degrees for 1 hour. Digital data logger was used to capture the temperature excursion. Previous temperature excursions occurred on, but no details were provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008478: US-009507513-1709USA008479: US-009507513-1709USA004743.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies and concomitant therapies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered doses of ZOSTAVAX experienced a temperature excursion between 15 and 46 Fahrenheit degrees for 1 hour. Digital data logger was used to capture the temperature excursion. Previous temperature excursions occurred, but no details were provided. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA004743: US-009507513-1709USA008479: US-009507513-1709USA008477:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies and concomitant therapies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (albumin status, exact dose, dose number, route of administration, lot # and expiration date were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No adverse effects were reported. The administered doses of M-M-R II experienced a temperature excursion between -58 and 46 (21 Fahrenheit) Fahrenheit degrees for 1 hour. Digital data logger was used to capture the temperature excursion. Previous temperature excursions occurred, but no details were provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008478: US-009507513-1709USA008477: US-009507513-1709USA004743:
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Injection site abscess, Rash erythematous
Clinical narrative: Initial unsolicited report received from a pharmacist on 08-Sep-2017. This case involves a 65-year-old female patient who was vaccinated with first injection of FLUZONE HD (Batch number: UI845AB, expiration date, dose and site of administration were not reported) intramuscularly on an unspecified date a few days ago. The patient did not have any pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination. Concomitant medications were not reported. On 09-Aug-2017, after the vaccination, the patient developed two lumps which were size of a small palm that were red and hot to the touch, one under the arm and the other at the elbow on the injection side and the area was connected by a diffuse red rash. The reported stated that the patient was not a cooperative patient and moved during the injection. The patient was advised to seek medical attention this A.M. over the phone and the reporter came in for her to evaluate it this afternoon and had yet to seek medical attention but, would advise it again. The patient required emergency room (ER)/ doctor visit. Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of all the events was reported as not recovered. List of documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Posture abnormal, Pulse abnormal, Staring
Clinical narrative: Patient's response was suspected to be more directly related to her daughters reaction see VAERS #124194. I treated pt as though it was a reaction to the vaccine. PT received her vaccine approximately 4:35pm and assisted with her daughters vasovagal syncope episode but began to feel lightheaded and faint herself. Pt was able to seat herself and slumped backward in the chair.  Eyes were open and fixed. Pulse was weak in the right wrist and upon evaluation was estimated around 50. We the automatic BP cuff was able to assess PT's vitals the BP was 90/70 and pulse 58.  Pt began to look and interact with the staff after 3-5 minutes and was alert to place and time.  A second evaluation with the automatic BP kit was recorded with 101/79 and pulse of 65. PT noted the lightheaded feeling was going away and was feeling better. At 5:15pm the patient was able to leave on her own without an assistance. At 6:30pm the pharmacy make contact with Pt and discussed the event. No further follow-up with pt was needed or requested.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Pruritus, Rash, Throat irritation
Clinical narrative: Rash developed on hands, arms, chest, throat; itching arms and face; feeling flushed and a little scratchy in throat but not tight or trouble breathing.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Febrile convulsion, Pyrexia, Seizure like phenomena
Clinical narrative: Temp of 104 and febrile seizure about 12 hrs after vaccine was administered. 3 more seizure-like episodes within the next 24-hour period.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Visual impairment
Clinical narrative: Pt received shot in morning, took nap, and woke a few hours later. Patient's daughter called in asked about adverse reactions and the patient not being able to see well. Patient's daughter was instructed it may be a reaction to the shot, although rare, and to seek medical care at urgent care if symptoms continue. This pharmacist has been notified that the patient had body aches the next morning that precipitated a visit to ER where it was thought that the high dose flu shot was responsible and the er staff recommend patient no longer receive high dose flu shots.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING, PAIN, REDNESS, WARM TO TOUCH ON THIGHS BILATEALLY 3 IN X IN CIRCULAR LESIONS ON BOTH THIGHS. TREATMENT GIVEN WAS BENADRYL.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: Presented to ED 9/14 with C/O skin rash, erythema and itching on face and back. Swelling at injection site of varicella-zoster virus immunization that was given the day prior. Was given Rx for cephalexin and told to take BENADRYL (received first doses in ED) and stay home from school next day.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cyclic vomiting syndrome, Impaired work ability, Weight decreased
Clinical narrative: I am reporting as the mother of my daughter, who began suffering severe cyclic vomiting, sometime after receiving the HPV (GARDASIL) vaccine. She has episodes of bi-weekly to monthly, and she vomits all day; it subsides by early evening: They last from days to beyond a week. I am at a loss at this time because there has been NO diagnosis to date. She has been to the ER >25 times since c.2011 and her health as well as her ability to earn a living has been seriously, adversely affected. I was responsible for my daughter at the time she received the vaccine and I placed my trust in doctors as well as the drugs that are released/approved for use on patients. My daughter has lost too much weight and there is no way to know what damage she has sustained internally. Please contact her going forward as she is an adult and I have no authority beyond expressing my deep concern for her health.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to two unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On 30-AUG-2017, the patients were vaccinated with doses of improperly stored PROQUAD (dose and frequency were unknown; lot # N008826 with expiration date 12-SEP-2018) subcutaneously for prophylaxis, which were exposed to temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 114 hours. There were no previous temperature excursions. DILUENT was stored properly. No 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. Sender's Comments: US-009507513-1709USA000580.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Death, Irritability, Respiratory arrest, Resuscitation
Clinical narrative: My baby quit breathing, was not able to be revived through CPR and passed away. Irritability in the weeks prior.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Malaise
Clinical narrative: I felt ill for 3 days, with extreme fatigue and malaise.
Age: 39.0
Sex: M
Vaccine: DTAP
Symptoms: Product packaging confusion, Wrong drug administered
Clinical narrative: Patient was to received a TDaP vaccine at an Urgent Care Center after repair of a laceration. Due to similar packaging of the TDaP and DTaP vaccines located in the medication refrigerator, the patient inadvertently received the DTaP which is intended for those <7 y/o. After the event it was noted the two prefilled syringes both have the same color green on the syringe label which may have contributed to the error.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation, Pain in extremity, Pyrexia, Rash, Vaccination complication
Clinical narrative: Patient wanted to report how she had a severe reaction to a pneumococcal vaccination. She ended getting a high fever, severe pain in the arm injected, with a severe inflamed rash that was all across half of her arm.
Age: 5.0
Sex: F
Vaccine: DTP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Itching, puffy, red, hot to touch 8/24/17 placed ice pack on her right thigh, took patient to the emergency room because of high fever, 102 degrees on 8/25/17.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Patient broke out in hives and got itchy rashes. Reaction started at the feet and worked it's way up.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Altered state of consciousness, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Vaccines administered at 10:00 AM. Initially did not complain of any adverse side effects but 2-3 minutes after injections, stated he felt that he was going to pass out. Became diaphoretic and pale but was able to answer questions appropriately. Lost consciousness at 10:05 AM and was transferred to cot, supine position, with legs elevated. Cold packs placed to bilateral axila and posterior neck. Fan placed on client. At 10:20 AM, client stated he was feeling better. At 10:26 AM, assisted to sitting position on cot. At 10:32 AM, assited to walk to bathroom as he felt need to urinate. At 10:40 AM, assisted to car, gait steady.
Age: 5.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Blister, Discomfort, Gianotti-Crosti syndrome, Inflammation, Pruritus
Clinical narrative: On the night of the 26th of August my son broke out in a rash on his legs and arms. As the days progressed the rash spread to his face and lower abdomen and also got progressively worse. I took pictures as the rash went from pimple like places to blister like places all over his arms, legs, face, ears, and lower abdomen. It was very enflamed and he stayed itchy and uncomfortable with a good number of the blisters popping open on their own or from scratching leaving scars on his legs and arms. I had to keep him slathered in Caladryl lotion and change his clothes twice a day and wash his sheets daily. He was given Benadryl to help with the itching and to keep him comfortable. He also took an oatmeal bath every night before bed. He had the rash from August 26th and still to this day, September 18th, has a few places left on his arms and legs. It peaked for two weeks but started to go away/lessen around the 8th of September.
Age: 5.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Rash, Scar, Viral infection
Clinical narrative: On the night of the 26th of August my son broke out in a rash on his legs and arms. As the days progressed the rash spread to his face and lower abdomen and also got progressively worse. I took pictures as the rash went from pimple like places to blister like places all over his arms, legs, face, ears, and lower abdomen. It was very enflamed and he stayed itchy and uncomfortable with a good number of the blisters popping open on their own or from scratching leaving scars on his legs and arms. I had to keep him slathered in Caladryl lotion and change his clothes twice a day and wash his sheets daily. He was given Benadryl to help with the itching and to keep him comfortable. He also took an oatmeal bath every night before bed. He had the rash from August 26th and still to this day, September 18th, has a few places left on his arms and legs. It peaked for two weeks but started to go away/lessen around the 8th of September.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Epistaxis, Gingival bleeding, Haemorrhage subcutaneous, Immune thrombocytopenic purpura
Clinical narrative: Severe bleeding, gums, nose, bruises all over and pinpoint bleeding up and down legs and arms. Diagnosed with ITP (Idiopathic Thrombocytopenia) on 11-18-16. My platelet count was only 1,000 and is supposed to be 150,000 to 500,000. Hospitalized 3 times. My I T P Doctor was MD. But my flu shot was at clinic. My Doctor there was Dr. whom I know longer see.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count decreased
Clinical narrative: Severe bleeding, gums, nose, bruises all over and pinpoint bleeding up and down legs and arms. Diagnosed with ITP (Idiopathic Thrombocytopenia) on 11-18-16. My platelet count was only 1,000 and is supposed to be 150,000 to 500,000. Hospitalized 3 times. My I T P Doctor was MD. But my flu shot was at clinic. My Doctor there was Dr. whom I know longer see.
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypotonia, Malaise, Musculoskeletal stiffness, Pallor, Posture abnormal
Clinical narrative: AFTER VACCINES CLIENT STATED HE DID NOT FEEL WELL. NOTED COLOR WAS PALE. CLIENT'S HEAD WAS LOWERED BETWEEN LEGS, AMMONIA CAPSULE WAS PLACED UNDER CLIENT NOSE. NOTED CLIENT BECAME LIMP AND HIS HANDS AND FEET TURN INWARD AND STIFFENED AND EYE PUPILS FIXED. 911 WAS CALLED AND ICE PACK PLACED TO BACK OF NECK. CLIENT BECAME ALERT AND LAID DOWN WITH LEGS ELEVATED. B/P 120/80. EMS EVALUATED CLIENT B/P 139/72. CLIENT GRANDPARENTS DECLINED TO SEND CLIENT TO HOSPITAL. CLIENT STATED HE FELT BETTER AND AMBULATED OUT OF CLINIC
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pupil fixed
Clinical narrative: AFTER VACCINES CLIENT STATED HE DID NOT FEEL WELL. NOTED COLOR WAS PALE. CLIENT'S HEAD WAS LOWERED BETWEEN LEGS, AMMONIA CAPSULE WAS PLACED UNDER CLIENT NOSE. NOTED CLIENT BECAME LIMP AND HIS HANDS AND FEET TURN INWARD AND STIFFENED AND EYE PUPILS FIXED. 911 WAS CALLED AND ICE PACK PLACED TO BACK OF NECK. CLIENT BECAME ALERT AND LAID DOWN WITH LEGS ELEVATED. B/P 120/80. EMS EVALUATED CLIENT B/P 139/72. CLIENT GRANDPARENTS DECLINED TO SEND CLIENT TO HOSPITAL. CLIENT STATED HE FELT BETTER AND AMBULATED OUT OF CLINIC
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Severe bruising at and around injection site. Pain.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: Patient stated she had a small rash at the injection site.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M042858, expiration date 21-OCT-2018, dose and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion -9 degrees Celsius to 8 degrees Celsius for 6 hours and 18 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA008698.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 24-AUG-2017 from a nurse regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 23-AUG-2017 and 24-AUG-2017 doses of improperly stored PNEUMOVAX 23 lot # N010106, expiration 15-NOV-2018 unknown route were administered to unspecified patients for prophylaxis. No adverse effects were reported. The vaccines were stored at the temperature of 20 degrees Fahrenheit for the time frame of 24 hours. There was no previous temperature excursion. The call was not made due to a data logger. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: Information was received on 25-AUG-2017 from a 41-year-old female consumer via voicemail who received a dose of MMR II vaccine for prophylaxis on an unknown date (Lot # and expiration not reported). Concomitant medications and medical history were not reported. The patient reported she had an unknown reaction to MMR II vaccine when she was 18 months old. Patient recovered from the event. Causality were not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an other health professional refers to a 12 month old male patient. The patient had no medical/drug history, concurrent conditions and concomitant medication. On 05-SEP-2017, the patient received a first dose of VARIVAX (lot # N008829, expiry date: 16-MAR-2019) 0.5ml injection for prophylaxis that underwent temperature excursion (incorrect product storage). Date of excursion was reported as 01-SEP-2017 and 02-SEP-2017, with total time in the range 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees Celsius (C) to -10 degrees C) of 1 hour, Total time in the range 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) of 3 hours. Data logger was involved and these vaccine vials (20vials) had a previous temperature excursion on 30-AUG-2017, 14.35 degrees C for 30 minutes. No adverse event reported after receiving the vaccine. It was reported that the patient will receive a booster of this vaccine at the age of 4. No relevant lab tests were performed. The reporting healthcare professional also stated that vaccines M-M-R II (lot# M045101 with expiry of 10-NOV-2018 and lot# M045391 with expiry 14-NOV-2018) and PROQUAD (lot# N002325 with expiry 19-JUL-2018 and lot#N010866 with expiry 01-OCT-2018) underwent temperature excursions involving digital data logger but were not administered to patients. This is one of several reports from the same reporter.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 77-year-old male patient. The patient's concurrent conditions, concomitant medications and pertinent medical history were not provided. The patient had no drug reactions or allergies. On 05-SEP-2017, the patient was vaccinated with one dose of PNEUMOVAX 23 injection, intramuscularly, lot # N011305 with expiration date on 20-JAN-2019, for prevention of pneumonia. In September 2017 (reported as "a few days later"), the patient had to go to an unspecified hospital due to cellulitis in the arm that the PNEUMOVAX 23 was injected into. The patient was prescribed unspecified antibiotics for the cellulitis. The outcome of the event was reported as not recovered at the time of this report. The relatedness between the event and the suspect therapy was not provided by the reporter. The event was reported as life threatening. Upon internal review, the event of cellulitis was determined to be medically significant. A lot check was requested by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA004760.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple 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 RECOMBIVAX HB injection, lot # M006708, expiration date: 02-JUN-2018 (dose and route of administration were not reported) for prophylaxis. The vaccines were stored in the temperature of 47 to 77 degrees Fahrenheit for 63.25 hours. There was no previous temperature excursion. "Digital data logger" was involved. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacy student and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-SEP-2017, the patient was vaccinated with expired dose of ZOSTAVAX 19400 plaque forming units (PFU), expiration date 18-AUG-2017 (dose, route of administration and lot # were not reported). No adverse effects were reported. No product quality complaint has been filled. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA008689.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse and refers to unspecified patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK) (lot # unknown), The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 24-AUG-2017 from a nurse regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 22-AUG-2017 and 24-AUG-2017 doses of improperly stored VAQTA lot # N016805, expiration 04-SEP-2018 intramuscular were administered to unspecified patients for prophylaxis. No adverse effects were reported. The vaccines were stored at the temperature of 20 degrees Fahrenheit for the time frame of 24 hours. There was no previous temperature excursion. The call was not made due to a data logger. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Injection site pain
Clinical narrative: Mother states that patient complained about soreness at injection site and later the next day stated that her armpit was also hurting. Mother did not ask what type of pain or if it was radiating/how long.
Age: 11.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Mother states that patient complained about soreness at injection site and later the next day stated that her armpit was also hurting. Mother did not ask what type of pain or if it was radiating/how long.
Age: 79.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site rash, Injection site urticaria, Injection site vesicles, Pain in extremity
Clinical narrative: Blister and rash, hives below site. Hives around mouth. Pain in R UE and decreased AROM R UE only.
Age: 79.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Urticaria
Clinical narrative: Blister and rash, hives below site. Hives around mouth. Pain in R UE and decreased AROM R UE only.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Complication associated with device, Gait inability, Impaired work ability, Inflammation, Joint prosthesis user
Clinical narrative: See Report Info: I have 2 knee implants and that was what was affected. They were so swollen and inflamed and swollen that I could not walk or get up out of a chair. I had to miss work the next day and had to use knee braces and an cane to walk. This lasted for two days. I called the Dr. and they said that this should not happen. I was in pain for 4 days and then it started to get better.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Joint swelling, Orthosis user, Pain, Walking aid user
Clinical narrative: See Report Info: I have 2 knee implants and that was what was affected. They were so swollen and inflamed and swollen that I could not walk or get up out of a chair. I had to miss work the next day and had to use knee braces and an cane to walk. This lasted for two days. I called the Dr. and they said that this should not happen. I was in pain for 4 days and then it started to get better.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: 19 hours after getting the vaccination, my son presented with a skin rash on both arms and on his face. The rash continued to spread over the past week, at times getting better, and then worse again. He was given an oral steroid, as well as a steroid injection. It is now one week after the vaccination and he still has hives/rash.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator that was at a temperature greater than recommended (due to loss of power during hurricane). Patient without any adverse side effects from vaccine.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, PPV
Symptoms: Cellulitis, Rash, Rash erythematous, Skin warm
Clinical narrative: Rash on arm warm and red dr said it is cellulitis put patient on clindamycin 300 mg cap.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, PPV
Symptoms: Erythema, Lethargy, Skin warm
Clinical narrative: Rash on arm warm and red dr said it is cellulitis put patient on clindamycin 300 mg cap.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO REACTION REPORTED BY FAMILY, WRONG DOSE WAS GIVEN TO PATIENT. FLUARIX IS FOR 3 YEARS AND OLDER THIS CHILD IS 2 YEARS OLD AND 8 MONTHS.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral, Lacrimation increased
Clinical narrative: Received shot about 12:00 noon on 9/14/17. "Senior dose". Took 2 Ibuprofen about 12:30 anticipating sore arm. About 3:30 started to develop discomfort in throat: like a sore throat or a constriction. By 6:00 pm had the following symptoms: Sore/constricted throat: Could still breathe ok, but drank a lot of water to soothe it. Numbness about lips and cheeks: Found myself leaking water when I took a drink. Bloodshot watery eyes: Tearing, itchy. Took 2 more Ibuprofen about 6:00. As the evening went on I developed a "thick head". I lay down and tried to read until bedtime. Couldn't sleep initially, took 2 more Ibuprofen about midnight, and was able to sleep. Did not feel well enough to go to my normal 6:00am workout class. Most symptoms dissipated by morning (9/15) except the following (although improved): Slight constriction in throat, Bloodshot eyes, Fuzzy head. Continuing to take 2 Ibuprofen every 6 hours. 9/17/17 life is normal.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Ocular hyperaemia, Oropharyngeal pain, Throat tightness
Clinical narrative: Received shot about 12:00 noon on 9/14/17. "Senior dose". Took 2 Ibuprofen about 12:30 anticipating sore arm. About 3:30 started to develop discomfort in throat: like a sore throat or a constriction. By 6:00 pm had the following symptoms: Sore/constricted throat: Could still breathe ok, but drank a lot of water to soothe it. Numbness about lips and cheeks: Found myself leaking water when I took a drink. Bloodshot watery eyes: Tearing, itchy. Took 2 more Ibuprofen about 6:00. As the evening went on I developed a "thick head". I lay down and tried to read until bedtime. Couldn't sleep initially, took 2 more Ibuprofen about midnight, and was able to sleep. Did not feel well enough to go to my normal 6:00am workout class. Most symptoms dissipated by morning (9/15) except the following (although improved): Slight constriction in throat, Bloodshot eyes, Fuzzy head. Continuing to take 2 Ibuprofen every 6 hours. 9/17/17 life is normal.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt said after receiving her Flu vaccine, she noticed the injection area became hot, red rash (about size of fist), hard muscle, some swelling, and pain (5-6 if touched, 3 if not touched), pain with movement. She said she did go see a doctor about it, and they say to take diphenhydramine.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash erythematous
Clinical narrative: Pt said after receiving her Flu vaccine, she noticed the injection area became hot, red rash (about size of fist), hard muscle, some swelling, and pain (5-6 if touched, 3 if not touched), pain with movement. She said she did go see a doctor about it, and they say to take diphenhydramine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient presented with a red, itchy patch on skin on the back of the left arm at the injection site. It was about the size of a half dollar. It started the day after the vaccine and lasted about 4 days.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Immediate post-injection reaction, Injection site pain, Injection site warmth, Loss of personal independence in daily activities
Clinical narrative: I do not know the exact time as I wasn't watching the clock. However right after the injection I felt heat radiate from my left shoulder up, it felt like the injection was right on the shoulder rather than about 1-2 inches down from where I felt the heat and slight pain. I also had a bad taste in my mouth, similar to metallic taste that lasted a very long time however no time frame. Little by little I felt more itching and rash symptoms which really progressed on my drive home between 5-6 pm. Along with the rash were some bumps. I itched inside out. I also had digestive issues which caused pain and itchiness when going to the bathroom including rash. Also loss of focus as mentioned in another email in which I went home halfway through the following day.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pruritus, Rash, Vision blurred
Clinical narrative: I do not know the exact time as I wasn't watching the clock. However right after the injection I felt heat radiate from my left shoulder up, it felt like the injection was right on the shoulder rather than about 1-2 inches down from where I felt the heat and slight pain. I also had a bad taste in my mouth, similar to metallic taste that lasted a very long time however no time frame. Little by little I felt more itching and rash symptoms which really progressed on my drive home between 5-6 pm. Along with the rash were some bumps. I itched inside out. I also had digestive issues which caused pain and itchiness when going to the bathroom including rash. Also loss of focus as mentioned in another email in which I went home halfway through the following day.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L038132, expiration date 01-OCT-2017 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). There was no adverse effect reported.  Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 54 minutes. There was no previous temperature excursion. Digital data logger was involved. The outcome of the event was not reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1709USA008502: US-009507513-1709USA008504: US-009507513-1709USA008503:
Sex: U
Vaccine: VARZOS
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: Information has been received from a registered pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, concomitant medication or drug reactions/allergies. On 09-SEP-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU lot # M035694, expiry date 07-NOV-2017, reconstituted with sterile diluent (MRK) lot # M020945, expiry date 05-DEC-2018 for prophylaxis (dose, route of administration were not reported). During the administration there was a leak from the syringe where some of the reconstituted vaccine dripped on the patient's arm and patient did not receive a full dose of ZOSTAVAX (underdose). The pharmacist stated that the syringe may not have been fully secured. No adverse effects being reported.
Sex: F
Vaccine: HPV9
Symptoms: Coma, Terminal state
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an adult female patient who was currently in her 20's. The concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date ("within 24 hours of receiving GARDASIL 9, the patient "went into a coma" for an unknown reason and for unknown length, and on an unknown date, she was admitted to a hospital for the coma; additionally, it was reported, that at the time of reporting the patient "was dying". The outcome of coma was unknown, and the outcome of terminal state was not recovered/not resolved. The causal relationship between the events and GARDASIL 9 was not reported. The reporter considered the events of coma and terminal state as life threatening, and the event of coma as a disabling event, and upon internal review, the event of terminal state was considered to be as medically significant.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# N009802, expiration date 19-DEC-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 54 minutes. There was no previous temperature excursion. Digital data logger was involved. The outcome of the event was not reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA004753: US-009507513-1709USA008504: US-009507513-1709USA008503:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot# N013268, expiration date 25-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 54 minutes. There was no previous temperature excursion. Digital data logger was involved. The outcome of the event was not reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004753: US-009507513-1709USA008502: US-009507513-1709USA008504.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# M043669, expiration date 15-JUN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 54 minutes. There was no previous temperature excursion. Digital data logger was involved. The outcome of the event was not reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004753: US-009507513-1709USA008502: US-009507513-1709USA008503.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PROQUAD (lot # N014758, expiration date 08-NOV-2018) (dose and route were not reported) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine was exposed from -14 degree Celsius (°C) to -10 degree Celsius (°C) for 4 hours and 45 minutes. There was previous temperature excursion from -9°C to 8°C for 6 hours and 26 minutes. The call was made because there was a "data logger". No adverse effects reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA008045.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69-year-old male patient received PREVNAR 13 (lot S35324, expiry date Aug2018, NDC number 00005-1971-02) on 06Sep2017, in left arm, at single dose, for immunization. Medical history and concomitant medications were not reported. Since 06Sep2017 the patient was having swelling in the arm where he received vaccination and pain. Since an unspecified date in Sep2017 he was not having any appetite. The reporter stated that the daughter of the patient thought the swelling would diminish but it did not, she described the swelling kept coming up and getting worse, not going down. The daughter of the patient stated that the patient's pain kept coming up. The patient has been using TYLENOL to treat pain. Reporter advised the daughter of the patient to add cold compress to it along with taking TYLENOL or MOTRIN to see if it helped and to call patient's primary care provider to let them know. Reporter explained that she has not seen the patient but from the way his daughter described the event, maybe swelling was medically significant. Reporter stated that pain was from a medically significant to disabling event. Reporter did not know the seriousness of appetite lost. Swelling had not resolved at the time of report. The outcome of the other events was unknown. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "swelling in the arm where he received vaccination and pain" cannot be fully excluded considering the known adverse event profile of PREVNAR 13 and close time association.