chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received SHINGRIX. Concomitant products included Levothyroxine, Nitroglycerin, Vitamin B12, Vitamin D3, allopurinol, Isosorbide, (NOS) PROTONIX and PREMARIN. On 15th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th April 2018, several hours after receiving SHINGRIX, the patient experienced muscle pain, joint pain, chills and injection site pain. On 18th April 2018, the patient experienced extensive swelling of vaccinated limb, chest pain, muscle pain, joint pain, chills, injection site pain, injection site erythema, injection site leaking, jaw pain and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient had episodes of heart attack like reactions to medications in the past. On 15th April 2018 Sunday, at 13:00 hours, the patient received SHINGRIX on right arm and that evening she had extreme muscle and joint pain, chills and soreness at injection site. On 16th April 2018 and 17th April 2018 Monday and Tuesday, the patient was fine. On 18th April 2018, Wednesday, the patient's arm was swollen from shoulder to elbow, there was a lot of redness and the injection site was weeping. On 19th April 2018 and 20th April 2018, Thursday and Friday, the patient experienced episodes of crushing chest pain with jaw pain and excessive sweating. Both times the patient had to treat the chest pain with two nitroglycerin tablets. Emergency room (ER) or doctor visit was required for the events sweating, jaw pain and chest pain, injection site weeping, and swelling. On 21st April 2018, by Saturday, the symptoms were started to improve and all had resolved by the time the patient had called. The caller stated that her pharmacy had reported these symptoms, but she did not know if it was GlaxoSmithKline or Vaccine Adverse Event Reporting System (VAERS).
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chest pain, Chills, Extensive swelling of vaccinated limb, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received SHINGRIX. Concomitant products included Levothyroxine, Nitroglycerin, Vitamin B12, Vitamin D3, allopurinol, Isosorbide, (NOS) PROTONIX and PREMARIN. On 15th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th April 2018, several hours after receiving SHINGRIX, the patient experienced muscle pain, joint pain, chills and injection site pain. On 18th April 2018, the patient experienced extensive swelling of vaccinated limb, chest pain, muscle pain, joint pain, chills, injection site pain, injection site erythema, injection site leaking, jaw pain and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient had episodes of heart attack like reactions to medications in the past. On 15th April 2018 Sunday, at 13:00 hours, the patient received SHINGRIX on right arm and that evening she had extreme muscle and joint pain, chills and soreness at injection site. On 16th April 2018 and 17th April 2018 Monday and Tuesday, the patient was fine. On 18th April 2018, Wednesday, the patient's arm was swollen from shoulder to elbow, there was a lot of redness and the injection site was weeping. On 19th April 2018 and 20th April 2018, Thursday and Friday, the patient experienced episodes of crushing chest pain with jaw pain and excessive sweating. Both times the patient had to treat the chest pain with two nitroglycerin tablets. Emergency room (ER) or doctor visit was required for the events sweating, jaw pain and chest pain, injection site weeping, and swelling. On 21st April 2018, by Saturday, the symptoms were started to improve and all had resolved by the time the patient had called. The caller stated that her pharmacy had reported these symptoms, but she did not know if it was GlaxoSmithKline or Vaccine Adverse Event Reporting System (VAERS).
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site extravasation, Injection site pain, Myalgia, Pain in jaw
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received SHINGRIX. Concomitant products included Levothyroxine, Nitroglycerin, Vitamin B12, Vitamin D3, allopurinol, Isosorbide, (NOS) PROTONIX and PREMARIN. On 15th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th April 2018, several hours after receiving SHINGRIX, the patient experienced muscle pain, joint pain, chills and injection site pain. On 18th April 2018, the patient experienced extensive swelling of vaccinated limb, chest pain, muscle pain, joint pain, chills, injection site pain, injection site erythema, injection site leaking, jaw pain and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient had episodes of heart attack like reactions to medications in the past. On 15th April 2018 Sunday, at 13:00 hours, the patient received SHINGRIX on right arm and that evening she had extreme muscle and joint pain, chills and soreness at injection site. On 16th April 2018 and 17th April 2018 Monday and Tuesday, the patient was fine. On 18th April 2018, Wednesday, the patient's arm was swollen from shoulder to elbow, there was a lot of redness and the injection site was weeping. On 19th April 2018 and 20th April 2018, Thursday and Friday, the patient experienced episodes of crushing chest pain with jaw pain and excessive sweating. Both times the patient had to treat the chest pain with two nitroglycerin tablets. Emergency room (ER) or doctor visit was required for the events sweating, jaw pain and chest pain, injection site weeping, and swelling. On 21st April 2018, by Saturday, the symptoms were started to improve and all had resolved by the time the patient had called. The caller stated that her pharmacy had reported these symptoms, but she did not know if it was GlaxoSmithKline or Vaccine Adverse Event Reporting System (VAERS).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Swelling, Ultrasound scan abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, mass, tiredness, tenderness and febrile cold (excl flu like illness). On an unknown date, the outcome of the injection site pain, muscle pain, mass, tiredness, tenderness and febrile cold (excl flu like illness) were unknown. It was unknown if the reporter considered the injection site pain, muscle pain, mass, tiredness, tenderness and febrile cold (excl flu like illness) to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine 3 days before the reporting date and she had a very sore arm at the site, on day 2 she felt flu like tiredness and muscle pain. At the day of reporting she noticed a tender, movable lump on her collarbone, and she guessed it as a lymph node.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Mass, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, mass, tiredness, tenderness and febrile cold (excl flu like illness). On an unknown date, the outcome of the injection site pain, muscle pain, mass, tiredness, tenderness and febrile cold (excl flu like illness) were unknown. It was unknown if the reporter considered the injection site pain, muscle pain, mass, tiredness, tenderness and febrile cold (excl flu like illness) to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine 3 days before the reporting date and she had a very sore arm at the site, on day 2 she felt flu like tiredness and muscle pain. At the day of reporting she noticed a tender, movable lump on her collarbone, and she guessed it as a lymph node.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nasopharyngitis, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, mass, tiredness, tenderness and febrile cold (excl flu like illness). On an unknown date, the outcome of the injection site pain, muscle pain, mass, tiredness, tenderness and febrile cold (excl flu like illness) were unknown. It was unknown if the reporter considered the injection site pain, muscle pain, mass, tiredness, tenderness and febrile cold (excl flu like illness) to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine 3 days before the reporting date and she had a very sore arm at the site, on day 2 she felt flu like tiredness and muscle pain. At the day of reporting she noticed a tender, movable lump on her collarbone, and she guessed it as a lymph node.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Reported hives on trunk and face with extreme itching.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: At 3:00 AM for 2 hours I experienced extreme shivering, muscle ache and headache. I took 2 TYLENOL.
Age: 21.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Antibody test normal, Impaired healing, Product administered at inappropriate site, White blood cell count normal
Clinical narrative: 21 yr old male without a history of a primary, secondary immunodeficiency, or eczema presents to A/I clinic with concern for a possible adverse reaction to his recent smallpox vaccination - administered in an atypical location 15 days ago. He reports that he has been compliant with keeping the lesion clean and dry despite its location on his upper left back. Patient has not had systemic symptoms. He has not had distant lesions. The patients concern was the size and the slower healing time than expected. He was seen in clinic today by Allergist, Immunizations nurse and the Dermatologist. There is no reason at this time to suspect that he has a 2ndary bacterial infection. Although progressive vaccinia is on the Ddx there doesn't appear to be necrosis at this time, he has what appears to be a ring of granulation tissue (new skin), his WBC is within normal limits, he has demonstrated positive titers to other vaccines (indicating that at least he has humoral immunity). The likely explanation: Poor wound healing due to the location of vaccine. Pictures were obtained with the patients consent. Plan at time of visit - Have patient monitor the lesions - Return to clinic or come to the ER this weekend and contact Allergist who is on call always,  if the skin or center of ulceration becomes discolored, fevers occur, new lesions occur elsewhere. Additionally, he will return on Monday for a re-check, to measure the size and monitor for changes (ideally it will be smaller, show more signs of healing). Should there be signs that this is progressive vaccinia we will inquire about obtaining  Vaccinia IG and begin immunodeficiency w/u. Case d/w (who agrees with above): MSN FNP-BC, Immunization Healthcare Branch.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a 66 year old male physician referring to himself. With concurrent conditions of asthma, hypertension, increased blood cholesterol, congenital spinal stenosis and seasonal allergy, additionally the patient was vaccinated with PREVENAR 13, 14 months ago. No other medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 19-APR-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N003993, expiration date 20-OCT-2018, (strength was not reported) in the left arm for prophylaxis. On the same date, within a few hours after the vaccine, the patient reported he began to experience pain, warmth, swelling and redness in the left arm within a few hours after receiving the PNEUMOVAX 23, and 5 to 6 hours after receiving the vaccination the symptoms extended to his left bicep. On 20-APR-2018, the patient experienced fatigue. The reporter stated that the pain, redness, swelling at the injection site "progressed from the antecubital fossa to the anterior, medial aspect" of his left elbow on 21-APR-2018. On the same date, the physician reported the pain from his left shoulder to the left clavicle. The pain from his left clavicle extended to the mediastinum that increased in severity when he was lying down. The physician reported he began to experience chills and esophageal discomfort that made it difficult to eat and drink. On 21-APR-2018, the patient took 80 mg of prednisone (unknown manufacturer) and on 22-APR-2018, he took 60 mg of prednisone (unknown manufacturer). No lab tests were performed to the patient. The outcome of generalized pain, oesophageal discomfort, fatigue, injection site warmth, swelling and erythema was reported as recovering, "reported as symptoms improved by 50%". The outcome of chills was reported as recovered. The reporter considered the events to be serious due to disability. The causality between the events and the therapy was not reported.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Oesophageal discomfort, Pain
Clinical narrative: This spontaneous report was received from a 66 year old male physician referring to himself. With concurrent conditions of asthma, hypertension, increased blood cholesterol, congenital spinal stenosis and seasonal allergy, additionally the patient was vaccinated with PREVENAR 13, 14 months ago. No other medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 19-APR-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N003993, expiration date 20-OCT-2018, (strength was not reported) in the left arm for prophylaxis. On the same date, within a few hours after the vaccine, the patient reported he began to experience pain, warmth, swelling and redness in the left arm within a few hours after receiving the PNEUMOVAX 23, and 5 to 6 hours after receiving the vaccination the symptoms extended to his left bicep. On 20-APR-2018, the patient experienced fatigue. The reporter stated that the pain, redness, swelling at the injection site "progressed from the antecubital fossa to the anterior, medial aspect" of his left elbow on 21-APR-2018. On the same date, the physician reported the pain from his left shoulder to the left clavicle. The pain from his left clavicle extended to the mediastinum that increased in severity when he was lying down. The physician reported he began to experience chills and esophageal discomfort that made it difficult to eat and drink. On 21-APR-2018, the patient took 80 mg of prednisone (unknown manufacturer) and on 22-APR-2018, he took 60 mg of prednisone (unknown manufacturer). No lab tests were performed to the patient. The outcome of generalized pain, oesophageal discomfort, fatigue, injection site warmth, swelling and erythema was reported as recovering, "reported as symptoms improved by 50%". The outcome of chills was reported as recovered. The reporter considered the events to be serious due to disability. The causality between the events and the therapy was not reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 01-MAR-2018, the patient was vaccinated with RECOMBIVAX HB for prophylaxis, lot number N022563 with expiration date of 10-MAY-2020 (dose and route of administration were not reported). The patient was inadvertently administered the dialysis dose and the patient was not on dialysis and was not considered to be pre-dialysis. No adverse effects were reported.
Sex: M
Vaccine: PPV
Symptoms: Antibody test abnormal, Bronchitis, Staphylococcal infection
Clinical narrative: This spontaneous report was received from an approximately 43 year old male patient. The patient did not have drug reactions/allergies. The patient's pertinent medical history included L4/L5/S1 disk injury and methicillin resistant staphylococcal infection (MRSA). Concomitant therapies included SINGULAIR, ALLEGRA, AMBIEN, FLEXERIL, naproxen and vancomycin. On an unknown date in 2014 (reported as about 4 years ago), the patient was vaccinated with PREVNAR 13 (dose, route, lot and expiry date not reported) for the prevention of pneumonia. On an unknown date in 2016 (reported as about 2 years ago), the patient was vaccinated with PNEUMOVAX 23 (dose, unit, route, frequency, expiration date and lot number not specified) for the prevention of pneumonia. On an unknown date in 2017 (reported as an year ago), the patient experienced methicillin resistant staphylococcal infection. The patient reported that the patient just had his antibodies tested and they came back low. Types 1, 9, 18c, 20, 22 all came back low on unspecified date. It was reported that the patient received unspecified treatment for the events. The patient reported that in 2018 (reported as recently), he experienced bronchitis on unspecified date and was currently being treated with vancomycin (manufacturer unknown). The outcome of the events bronchitis, antibody test abnormal and staphylococcal infection was reported as not recovered/not resolved. The reporter did not assess the causality of the events with suspect therapies. Product quality complaint was not involved. Upon internal review, the event methicillin resistant staphylococcal infection was determined to be medically significant.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a 4 month old male patient. The patient did not have pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 07-APR-2018, the patient was vaccinated with the second dose of ROTATEQ by oral route (strength, dose, lot number and expiration date were not provided) for vaccination. Approximately on 09-APR-2018 (reported as "within two days of receiving the vaccine"), the patient developed a "bloody streak in his stool, which was very mucous-like". Although medical attention was sought, none laboratory studies were performed and no treatment was given. The outcome of haematochezia was reported as not resolved. The causality assessment between therapy with ROTATEQ and the event was not reported. Upon internal review, haematochezia was determined to be medically significant. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1805USA000914.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a nurse prescriber via field reporter and refers to a 2 month old patient. The patient did not have any pertinent medical history, drug reactions or allergies and concomitant therapies. On 17-APR-2018 the patient was vaccinated with first dose of ROTATEQ orally, as a part of the schedule, for prophylaxis(lot # N022173, expiration date on 15-MAR-2019; exact dose and site of administration were not reported). The patient received regularly scheduled (unspecified) vaccines at the same time when he/she received ROTATEQ. On 17-APR-2018, within 1 hour of receiving ROTATEQ, the patient was vomiting. The patient sought medical attention, by office visit. The patient was treated with unspecified fluids to prevent dehydration. There were no lab diagnostic studies performed. The outcome of vomiting was reported as recovered, the vomiting continued for about one day and then subsided, approximately on 18-APR-2018. The relatedness between the event and ROTATEQ was not reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000703:
Age: 1.83
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an officer manager referring to a currently 2 year old female patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 26-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000921: US-009507513-1805USA000924:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a female patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified date in 2016 (reported as "two years ago"), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, anatomical location, lot number and expiration date were not provided) by intramuscular route for prophylaxis. On 30-APR-2018, the patient was vaccinated with the second dose of GARDASIL 9 (lot # N003703 with expiration date of 29-OCT-2019) dose 2, by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of drug administration). No adverse events were reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an officer manager referring to a currently 1 year old male patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 30-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA000841: US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000924:
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an officer manager referring to a currently 1 year old female patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 30-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000841: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000921: US-009507513-1805USA000924:
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an officer manager referring to a currently 1 year old female patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 26-FEB-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA000841: US-009507513-1805USA000922: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000921: US-009507513-1805USA000924:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an officer manager referring to a currently 4 year old female patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 14-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA000841: US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000921:
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an officer manager referring to a currently 1 year old male patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 30-MAR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA000841: US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000921: US-009507513-1805USA000924:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an officer manager referring to a currently 1 year old male patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 06-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000841: US-009507513-1805USA000923: US-009507513-1805USA000922: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000927: US-009507513-1805USA000921: US-009507513-1805USA000924:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an officer manager referring to a currently 4 year old female patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 24-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000841: US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000921: US-009507513-1805USA000924:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an officer manager referring to a currently 4 year old female patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 16-FEB-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000841: US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000921: US-009507513-1805USA000924:
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea
Clinical narrative: This spontaneous report was received from a pharmacist referring to a non-pregnant female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (route, dose, frequency, and anatomical location, were unknown) with lot # N010497 and expiration date 13-JAN-2020 for vaccination. Pharmacist stated that 10 minutes after administration of the GARDASIL 9, the patient stated she was experiencing headaches, and 2 and a half hours after administration of the GARDASIL 9 she experienced nausea. Pharmacist stated there was no treatment provided to the patient, and no laboratory diagnostics or studies were performed. At the time of the report, the outcome of headache and nausea was reported as not recovered. The pharmacist  did not mention the causality assessment between headache and nausea, and GARDASIL 9.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 02-MAY-2018 the patient was vaccinated with an improperly stored dose of ZOSTAVAX for prophylaxis; dose, strength, frequency and route of administration were unknown;  lot # N025704 and expiration date 16-DEC-2018. ZOSTAVAX was reconstituted with a properly stored sterile diluent. The patient experienced no adverse events. ZOSTAVAX had a temperature excursion of 24 hours; there were no previous temperature excursions. Data logger was not involved.
Age: 69.0
Sex: F
Vaccine: FLUX, YF, FLUX, YF
Symptoms: Arthralgia, Fatigue, Headache, Joint range of motion decreased, Paraesthesia
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 26-Apr-2018. This case involves a 69-year-old female patient (age was not reported), who was vaccinated with 0.5 ml single dose of YF-VAX (Batch number, expiration date and dose in series were not reported) via subcutaneous route in left deltoid on 04-Apr-2018. The patient had a medical history of glaucoma, high cholesterol and no known drug allergy. It was reported that the patient had cortisone shots previously and did not experience such discomfort. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced hip was very painful and having trouble moving the joint (On a scale from 1 to 10 her pain level is an 8), not any redness or swelling to the area and having a headache. Lab data was not reported. Patient received CORTISONE SHOTS on 19-Apr-2018 as a corrective treatment. The patient was not yet recovered/resolved from all the events. List of documents held by sender: none; Sender's Comments: This case concerns an adult patient who developed paresthesia of limbs, fatigue and throat irritation after vaccination with FLUQUADRI. The time to onset is compatible with the role of vaccine. However, there is no information provided regarding patient's past history, medical condition at the time of vaccination and lab tests ruing out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 69.0
Sex: F
Vaccine: FLUX, YF, FLUX, YF
Symptoms: Throat irritation
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 26-Apr-2018. This case involves a 69-year-old female patient (age was not reported), who was vaccinated with 0.5 ml single dose of YF-VAX (Batch number, expiration date and dose in series were not reported) via subcutaneous route in left deltoid on 04-Apr-2018. The patient had a medical history of glaucoma, high cholesterol and no known drug allergy. It was reported that the patient had cortisone shots previously and did not experience such discomfort. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced hip was very painful and having trouble moving the joint (On a scale from 1 to 10 her pain level is an 8), not any redness or swelling to the area and having a headache. Lab data was not reported. Patient received CORTISONE SHOTS on 19-Apr-2018 as a corrective treatment. The patient was not yet recovered/resolved from all the events. List of documents held by sender: none; Sender's Comments: This case concerns an adult patient who developed paresthesia of limbs, fatigue and throat irritation after vaccination with FLUQUADRI. The time to onset is compatible with the role of vaccine. However, there is no information provided regarding patient's past history, medical condition at the time of vaccination and lab tests ruing out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX, YF, FLUX, YF
Symptoms: Arthralgia, Fatigue, Headache, Joint range of motion decreased, Paraesthesia
Clinical narrative: Initial unsolicited report received from consumer on 26-Apr-2018. This case involves patient (Age and gender was not reported) who was vaccinated with dose of YF-VAX (batch number, expiry date, route and site of administration were not reported) on 04 Apr 2018 and CORTISONE injection on 19 Apr 2018. The patient's medical history and concomitant medication were not reported. On 19 Apr 2018, 15 days' post vaccination and at the time of cortisone injection it was very painful and can not move the hip joint. On an unspecified date, post vaccination patient had headache. Previously patient had other cortisone injections with no problem. Laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. Patient was very concerned about this adverse reaction. Patient was reported that due to the YF-VAX. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who developed paresthesia of limbs, fatigue and throat irritation after vaccination with FLUQUADRI. The time to onset is compatible with the role of vaccine. However, there is no information provided regarding patient's past history, medical condition at the time of vaccination and lab tests ruing out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX, YF, FLUX, YF
Symptoms: Throat irritation
Clinical narrative: Initial unsolicited report received from consumer on 26-Apr-2018. This case involves patient (Age and gender was not reported) who was vaccinated with dose of YF-VAX (batch number, expiry date, route and site of administration were not reported) on 04 Apr 2018 and CORTISONE injection on 19 Apr 2018. The patient's medical history and concomitant medication were not reported. On 19 Apr 2018, 15 days' post vaccination and at the time of cortisone injection it was very painful and can not move the hip joint. On an unspecified date, post vaccination patient had headache. Previously patient had other cortisone injections with no problem. Laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. Patient was very concerned about this adverse reaction. Patient was reported that due to the YF-VAX. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who developed paresthesia of limbs, fatigue and throat irritation after vaccination with FLUQUADRI. The time to onset is compatible with the role of vaccine. However, there is no information provided regarding patient's past history, medical condition at the time of vaccination and lab tests ruing out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Abnormal behaviour, Acne, Asthenia, Communication disorder, Crying
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 6-month-old female patient who received PEDIARIX (batch number FF723, expiry date unknown). On 21st November 2013, the patient received the 1st dose of PEDIARIX (intramuscular) .5 ml. On 21st November 2013, less than a day after receiving PEDIARIX, the patient experienced injection site rash and injection site erythema. On 22nd November 2013, the patient experienced crying, fontanel bulging and fever. On 23rd November 2013, the patient experienced weakness, behavior abnormal, communication disorder, difficulty sleeping and yeast infection. On 28th November, the patient experienced diaper rash and eating disorder. On 29th November 2013, the patient experienced seizure (serious criteria GSK medically significant), ear infection, sore throat and diarrhea. On 18th December 2013, the patient experienced restlessness, acne and skin eruption. On 1st March 2016, the patient experienced eczema and food allergy. PEDIARIX was discontinued (Dechallenge was unknown). Rechallange with PEDIARIX was unknown. In November 2014, the outcome of the injection site rash and injection site erythema were recovered/resolved. On an unknown date, the outcome of the seizure, crying, fontanel bulging, weakness, behavior abnormal, communication disorder, difficulty sleeping, yeast infection, diaper rash, eating disorder, ear infection, sore throat, diarrhea, restlessness, acne, skin eruption, eczema, food allergy and fever were unknown. It was unknown if the reporter considered the seizure, injection site rash, injection site erythema, crying, fontanel bulging, weakness, behavior abnormal, communication disorder, difficulty sleeping, yeast infection, diaper rash, eating disorder, ear infection, sore throat, diarrhea, restlessness, acne, skin eruption, eczema, food allergy and fever to be related to PEDIARIX. Additional details were provided as follows: The patient was administered PEDIARIX in the left thigh. On 22nd November 2013, 1 day after receiving vaccination, the patient experienced crying, fontanel bulging and fever and body temperature was recorded as 103 degree. On 23rd November 2013, 2 days after receiving vaccination, the patient experienced weakness, behavior abnormal, communication disorder, difficulty sleeping and yeast infection. On 28th November 2013, 7 days after receiving vaccination, the patient experienced diaper rash and eating disorder. On 29th November 2013, 8 days after receiving vaccination, the patient experienced seizure (serious criteria GSK medically significant), ear infection, sore throat and diarrhea. On 18th December 2013, 27 days after receiving vaccination, the patient experienced restlessness, acne and skin eruption. On 1st March 2016, 831 days after receiving vaccination, the patient experienced eczema and food allergy.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Dermatitis diaper, Diarrhoea, Ear infection, Eating disorder, Eczema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 6-month-old female patient who received PEDIARIX (batch number FF723, expiry date unknown). On 21st November 2013, the patient received the 1st dose of PEDIARIX (intramuscular) .5 ml. On 21st November 2013, less than a day after receiving PEDIARIX, the patient experienced injection site rash and injection site erythema. On 22nd November 2013, the patient experienced crying, fontanel bulging and fever. On 23rd November 2013, the patient experienced weakness, behavior abnormal, communication disorder, difficulty sleeping and yeast infection. On 28th November, the patient experienced diaper rash and eating disorder. On 29th November 2013, the patient experienced seizure (serious criteria GSK medically significant), ear infection, sore throat and diarrhea. On 18th December 2013, the patient experienced restlessness, acne and skin eruption. On 1st March 2016, the patient experienced eczema and food allergy. PEDIARIX was discontinued (Dechallenge was unknown). Rechallange with PEDIARIX was unknown. In November 2014, the outcome of the injection site rash and injection site erythema were recovered/resolved. On an unknown date, the outcome of the seizure, crying, fontanel bulging, weakness, behavior abnormal, communication disorder, difficulty sleeping, yeast infection, diaper rash, eating disorder, ear infection, sore throat, diarrhea, restlessness, acne, skin eruption, eczema, food allergy and fever were unknown. It was unknown if the reporter considered the seizure, injection site rash, injection site erythema, crying, fontanel bulging, weakness, behavior abnormal, communication disorder, difficulty sleeping, yeast infection, diaper rash, eating disorder, ear infection, sore throat, diarrhea, restlessness, acne, skin eruption, eczema, food allergy and fever to be related to PEDIARIX. Additional details were provided as follows: The patient was administered PEDIARIX in the left thigh. On 22nd November 2013, 1 day after receiving vaccination, the patient experienced crying, fontanel bulging and fever and body temperature was recorded as 103 degree. On 23rd November 2013, 2 days after receiving vaccination, the patient experienced weakness, behavior abnormal, communication disorder, difficulty sleeping and yeast infection. On 28th November 2013, 7 days after receiving vaccination, the patient experienced diaper rash and eating disorder. On 29th November 2013, 8 days after receiving vaccination, the patient experienced seizure (serious criteria GSK medically significant), ear infection, sore throat and diarrhea. On 18th December 2013, 27 days after receiving vaccination, the patient experienced restlessness, acne and skin eruption. On 1st March 2016, 831 days after receiving vaccination, the patient experienced eczema and food allergy.