chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pyrexia, Rash, Tenderness, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX (batch number X5XY4, expiry date 2nd July 2021) for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, chills, tremor, swollen glands and headache. On 12th March 2019, the patient experienced red rash, painful rash, raised rash and heat rash. On an unknown date, the outcome of the injection site pain, fever, chills, tremor, swollen glands and headache were recovered/resolved and the outcome of the red rash, painful rash, raised rash and heat rash were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever, chills, tremor, swollen glands, headache, red rash, painful rash, raised rash and heat rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. Post vaccination that evening she experienced soreness at injection site, high fever, chills, uncontrollable shaking, left side headache, and her left side body glands were swollen from waist up. The next day after vaccination she broke out in a circular rash 3 inches across the injection site on the left arm accompanied with red, pain, hot, and raised area. The rash had lessened but it was still present. The soreness at injection site, high fever, chills, uncontrollable shaking, left side headache, and her left side body glands were swollen from waist up was lasted for about 2 days. On 13th March 2019, the patient visited her physician, but she had to see the physician assistant since her physician was not there. The patient was tested for Lyme disease and Rocky Mountain spotted fever. The results came back on the date of reporting and she was negative for the Lyme disease and Rocky Mountain spotted fever. The reporter consented to follow up. No further details were provided.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Borrelia test negative, Chills, Headache, Immunology test, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX (batch number X5XY4, expiry date 2nd July 2021) for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, chills, tremor, swollen glands and headache. On 12th March 2019, the patient experienced red rash, painful rash, raised rash and heat rash. On an unknown date, the outcome of the injection site pain, fever, chills, tremor, swollen glands and headache were recovered/resolved and the outcome of the red rash, painful rash, raised rash and heat rash were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever, chills, tremor, swollen glands, headache, red rash, painful rash, raised rash and heat rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. Post vaccination that evening she experienced soreness at injection site, high fever, chills, uncontrollable shaking, left side headache, and her left side body glands were swollen from waist up. The next day after vaccination she broke out in a circular rash 3 inches across the injection site on the left arm accompanied with red, pain, hot, and raised area. The rash had lessened but it was still present. The soreness at injection site, high fever, chills, uncontrollable shaking, left side headache, and her left side body glands were swollen from waist up was lasted for about 2 days. On 13th March 2019, the patient visited her physician, but she had to see the physician assistant since her physician was not there. The patient was tested for Lyme disease and Rocky Mountain spotted fever. The results came back on the date of reporting and she was negative for the Lyme disease and Rocky Mountain spotted fever. The reporter consented to follow up. No further details were provided.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX (batch number X5XY4, expiry date 2nd July 2021) for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, chills, tremor, swollen glands and headache. On 12th March 2019, the patient experienced red rash, painful rash, raised rash and heat rash. On an unknown date, the outcome of the injection site pain, fever, chills, tremor, swollen glands and headache were recovered/resolved and the outcome of the red rash, painful rash, raised rash and heat rash were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever, chills, tremor, swollen glands, headache, red rash, painful rash, raised rash and heat rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. Post vaccination that evening she experienced soreness at injection site, high fever, chills, uncontrollable shaking, left side headache, and her left side body glands were swollen from waist up. The next day after vaccination she broke out in a circular rash 3 inches across the injection site on the left arm accompanied with red, pain, hot, and raised area. The rash had lessened but it was still present. The soreness at injection site, high fever, chills, uncontrollable shaking, left side headache, and her left side body glands were swollen from waist up was lasted for about 2 days. On 13th March 2019, the patient visited her physician, but she had to see the physician assistant since her physician was not there. The patient was tested for Lyme disease and Rocky Mountain spotted fever. The results came back on the date of reporting and she was negative for the Lyme disease and Rocky Mountain spotted fever. The reporter consented to follow up. No further details were provided.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Miliaria, Pyrexia, Rash, Rash erythematous, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX (batch number X5XY4, expiry date 2nd July 2021) for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, chills, tremor, swollen glands and headache. On 12th March 2019, the patient experienced red rash, painful rash, raised rash and heat rash. On an unknown date, the outcome of the injection site pain, fever, chills, tremor, swollen glands and headache were recovered/resolved and the outcome of the red rash, painful rash, raised rash and heat rash were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever, chills, tremor, swollen glands, headache, red rash, painful rash, raised rash and heat rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. Post vaccination that evening she experienced soreness at injection site, high fever, chills, uncontrollable shaking, left side headache, and her left side body glands were swollen from waist up. The next day after vaccination she broke out in a circular rash 3 inches across the injection site on the left arm accompanied with red, pain, hot, and raised area. The rash had lessened but it was still present. The soreness at injection site, high fever, chills, uncontrollable shaking, left side headache, and her left side body glands were swollen from waist up was lasted for about 2 days. On 13th March 2019, the patient visited her physician, but she had to see the physician assistant since her physician was not there. The patient was tested for Lyme disease and Rocky Mountain spotted fever. The results came back on the date of reporting and she was negative for the Lyme disease and Rocky Mountain spotted fever. The reporter consented to follow up. No further details were provided.
Age: 72.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Ophthalmic herpes zoster, Rash
Clinical narrative: Feb. 26, 2019 shingle injection; very swollen left arm. Feb 26. 2019 had headache started in the mid evening; headache intensified-saw Dr on afternoon of 28th of Feb. Saw eye Ophthalmologist diagnosed shingles in right eye. Given many prescrips; saw Ophthalmologist March 8th and he admitted me to hospital for 2 days March 12th told to see Cornea Specialist (saw Dr March 13th). Shingles lesions effected right half of face, eye, eyebrows, hairline, hair, head with pain throbbing to all. The prescriptions given on March 1st, 2019 may have saved my eyesight still working to get any and all my eyesight back.
Age: 72.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Blood test, Headache, Herpes zoster, Injection site swelling, Ophthalmic herpes zoster
Clinical narrative: Feb. 26, 2019 shingle injection; very swollen left arm. Feb 26. 2019 had headache started in the mid evening; headache intensified-saw Dr on afternoon of 28th of Feb. Saw eye Ophthalmologist diagnosed shingles in right eye. Given many prescrips; saw Ophthalmologist March 8th and he admitted me to hospital for 2 days March 12th told to see Cornea Specialist (saw Dr March 13th). Shingles lesions effected right half of face, eye, eyebrows, hairline, hair, head with pain throbbing to all. The prescriptions given on March 1st, 2019 may have saved my eyesight still working to get any and all my eyesight back.
Age: 72.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Ophthalmological examination, Pain, Peripheral swelling, Visual impairment
Clinical narrative: Feb. 26, 2019 shingle injection; very swollen left arm. Feb 26. 2019 had headache started in the mid evening; headache intensified-saw Dr on afternoon of 28th of Feb. Saw eye Ophthalmologist diagnosed shingles in right eye. Given many prescrips; saw Ophthalmologist March 8th and he admitted me to hospital for 2 days March 12th told to see Cornea Specialist (saw Dr March 13th). Shingles lesions effected right half of face, eye, eyebrows, hairline, hair, head with pain throbbing to all. The prescriptions given on March 1st, 2019 may have saved my eyesight still working to get any and all my eyesight back.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Facial pain, Fatigue, Feeling of body temperature change
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left side. The patient experienced nearly all the side effects over the weekend. Less than a day, the patient was sick. Less than a week after, the patient experienced sore arm and flu like symptoms. The patient had one side effect the reporter not sure of or it might be something else. After 1 day the patient had swelling and soreness just under my left cheek bone. In a muscle or tissue from under cheek bone across to ear.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Influenza, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left side. The patient experienced nearly all the side effects over the weekend. Less than a day, the patient was sick. Less than a week after, the patient experienced sore arm and flu like symptoms. The patient had one side effect the reporter not sure of or it might be something else. After 1 day the patient had swelling and soreness just under my left cheek bone. In a muscle or tissue from under cheek bone across to ear.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rhinorrhoea, Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left side. The patient experienced nearly all the side effects over the weekend. Less than a day, the patient was sick. Less than a week after, the patient experienced sore arm and flu like symptoms. The patient had one side effect the reporter not sure of or it might be something else. After 1 day the patient had swelling and soreness just under my left cheek bone. In a muscle or tissue from under cheek bone across to ear.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Facial pain, Influenza like illness, Malaise, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left side. The patient experienced nearly all the side effects over the weekend. Less than a day, the patient was sick. Less than a week after, the patient experienced sore arm and flu like symptoms. The patient had one side effect the reporter not sure of or it might be something else. After 1 day the patient had swelling and soreness just under my left cheek bone. In a muscle or tissue from under cheek bone across to ear.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left side. The patient experienced nearly all the side effects over the weekend. Less than a day, the patient was sick. Less than a week after, the patient experienced sore arm and flu like symptoms. The patient had one side effect the reporter not sure of or it might be something else. After 1 day the patient had swelling and soreness just under my left cheek bone. In a muscle or tissue from under cheek bone across to ear.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Facial pain, Feeling abnormal, Feeling hot
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left side. The patient experienced nearly all the side effects over the weekend. Less than a day, the patient was sick. Less than a week after, the patient experienced sore arm and flu like symptoms. The patient had one side effect the reporter not sure of or it might be something else. After 1 day the patient had swelling and soreness just under my left cheek bone. In a muscle or tissue from under cheek bone across to ear.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nasal congestion, Nasopharyngitis, Pyrexia, Rhinorrhoea, Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia were unknown. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, sickness, facial swelling, facial pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left side. The patient experienced nearly all the side effects over the weekend. Less than a day, the patient was sick. Less than a week after, the patient experienced sore arm and flu like symptoms. The patient had one side effect the reporter not sure of or it might be something else. After 1 day the patient had swelling and soreness just under my left cheek bone. In a muscle or tissue from under cheek bone across to ear.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Facial pain, Fatigue, Feeling of body temperature change
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a male patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received SHINGRIX. On 16th March 2019, less than a day after receiving SHINGRIX, the patient experienced facial swelling, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion. On 17th March 2019, the patient experienced feels awful. On an unknown date, the outcome of the facial swelling and facial pain were not recovered/not resolved and the outcome of the feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy and nasal congestion were recovered/resolved. It was unknown if the reporter considered the facial swelling, feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who himself was a Pharmacist. The age at vaccination was not reported. On Sunday from the reporting date, the patient received a dose of SHINGRIX. The patient experienced a swollen facial area around left jaw and cheek area, basic side effects, feeling terrible, swelling and soreness just under his left facial check and radiating across to ear area, very painful, fever, chills, hit then cold, runny nose congestion, and loss of energy. The patient had the basic side effects on Saturday night and Sunday felt terrible. The patient woke up on Sunday morning with swelling and soreness just under his left facial cheek and radiating across to war area and was very painful. The patient had not any trauma to that area. The patient did have fever and chills. Hit then cold. Runny nose congestion and loss of energy through yesterday a day before the date of reporting. Better the day of reporting, except face.  The patient wants to know if the facial swelling around his left cheek could be caused by SHINGRIX since it happened morning after shot. It was not the type swelling due to allergic reaction.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Influenza, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a male patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received SHINGRIX. On 16th March 2019, less than a day after receiving SHINGRIX, the patient experienced facial swelling, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion. On 17th March 2019, the patient experienced feels awful. On an unknown date, the outcome of the facial swelling and facial pain were not recovered/not resolved and the outcome of the feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy and nasal congestion were recovered/resolved. It was unknown if the reporter considered the facial swelling, feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who himself was a Pharmacist. The age at vaccination was not reported. On Sunday from the reporting date, the patient received a dose of SHINGRIX. The patient experienced a swollen facial area around left jaw and cheek area, basic side effects, feeling terrible, swelling and soreness just under his left facial check and radiating across to ear area, very painful, fever, chills, hit then cold, runny nose congestion, and loss of energy. The patient had the basic side effects on Saturday night and Sunday felt terrible. The patient woke up on Sunday morning with swelling and soreness just under his left facial cheek and radiating across to war area and was very painful. The patient had not any trauma to that area. The patient did have fever and chills. Hit then cold. Runny nose congestion and loss of energy through yesterday a day before the date of reporting. Better the day of reporting, except face.  The patient wants to know if the facial swelling around his left cheek could be caused by SHINGRIX since it happened morning after shot. It was not the type swelling due to allergic reaction.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rhinorrhoea, Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a male patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received SHINGRIX. On 16th March 2019, less than a day after receiving SHINGRIX, the patient experienced facial swelling, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion. On 17th March 2019, the patient experienced feels awful. On an unknown date, the outcome of the facial swelling and facial pain were not recovered/not resolved and the outcome of the feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy and nasal congestion were recovered/resolved. It was unknown if the reporter considered the facial swelling, feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who himself was a Pharmacist. The age at vaccination was not reported. On Sunday from the reporting date, the patient received a dose of SHINGRIX. The patient experienced a swollen facial area around left jaw and cheek area, basic side effects, feeling terrible, swelling and soreness just under his left facial check and radiating across to ear area, very painful, fever, chills, hit then cold, runny nose congestion, and loss of energy. The patient had the basic side effects on Saturday night and Sunday felt terrible. The patient woke up on Sunday morning with swelling and soreness just under his left facial cheek and radiating across to war area and was very painful. The patient had not any trauma to that area. The patient did have fever and chills. Hit then cold. Runny nose congestion and loss of energy through yesterday a day before the date of reporting. Better the day of reporting, except face.  The patient wants to know if the facial swelling around his left cheek could be caused by SHINGRIX since it happened morning after shot. It was not the type swelling due to allergic reaction.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Facial pain, Influenza like illness, Malaise, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a male patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received SHINGRIX. On 16th March 2019, less than a day after receiving SHINGRIX, the patient experienced facial swelling, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion. On 17th March 2019, the patient experienced feels awful. On an unknown date, the outcome of the facial swelling and facial pain were not recovered/not resolved and the outcome of the feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy and nasal congestion were recovered/resolved. It was unknown if the reporter considered the facial swelling, feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who himself was a Pharmacist. The age at vaccination was not reported. On Sunday from the reporting date, the patient received a dose of SHINGRIX. The patient experienced a swollen facial area around left jaw and cheek area, basic side effects, feeling terrible, swelling and soreness just under his left facial check and radiating across to ear area, very painful, fever, chills, hit then cold, runny nose congestion, and loss of energy. The patient had the basic side effects on Saturday night and Sunday felt terrible. The patient woke up on Sunday morning with swelling and soreness just under his left facial cheek and radiating across to war area and was very painful. The patient had not any trauma to that area. The patient did have fever and chills. Hit then cold. Runny nose congestion and loss of energy through yesterday a day before the date of reporting. Better the day of reporting, except face.  The patient wants to know if the facial swelling around his left cheek could be caused by SHINGRIX since it happened morning after shot. It was not the type swelling due to allergic reaction.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a male patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received SHINGRIX. On 16th March 2019, less than a day after receiving SHINGRIX, the patient experienced facial swelling, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion. On 17th March 2019, the patient experienced feels awful. On an unknown date, the outcome of the facial swelling and facial pain were not recovered/not resolved and the outcome of the feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy and nasal congestion were recovered/resolved. It was unknown if the reporter considered the facial swelling, feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who himself was a Pharmacist. The age at vaccination was not reported. On Sunday from the reporting date, the patient received a dose of SHINGRIX. The patient experienced a swollen facial area around left jaw and cheek area, basic side effects, feeling terrible, swelling and soreness just under his left facial check and radiating across to ear area, very painful, fever, chills, hit then cold, runny nose congestion, and loss of energy. The patient had the basic side effects on Saturday night and Sunday felt terrible. The patient woke up on Sunday morning with swelling and soreness just under his left facial cheek and radiating across to war area and was very painful. The patient had not any trauma to that area. The patient did have fever and chills. Hit then cold. Runny nose congestion and loss of energy through yesterday a day before the date of reporting. Better the day of reporting, except face.  The patient wants to know if the facial swelling around his left cheek could be caused by SHINGRIX since it happened morning after shot. It was not the type swelling due to allergic reaction.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Facial pain, Feeling abnormal, Feeling hot
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a male patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received SHINGRIX. On 16th March 2019, less than a day after receiving SHINGRIX, the patient experienced facial swelling, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion. On 17th March 2019, the patient experienced feels awful. On an unknown date, the outcome of the facial swelling and facial pain were not recovered/not resolved and the outcome of the feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy and nasal congestion were recovered/resolved. It was unknown if the reporter considered the facial swelling, feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who himself was a Pharmacist. The age at vaccination was not reported. On Sunday from the reporting date, the patient received a dose of SHINGRIX. The patient experienced a swollen facial area around left jaw and cheek area, basic side effects, feeling terrible, swelling and soreness just under his left facial check and radiating across to ear area, very painful, fever, chills, hit then cold, runny nose congestion, and loss of energy. The patient had the basic side effects on Saturday night and Sunday felt terrible. The patient woke up on Sunday morning with swelling and soreness just under his left facial cheek and radiating across to war area and was very painful. The patient had not any trauma to that area. The patient did have fever and chills. Hit then cold. Runny nose congestion and loss of energy through yesterday a day before the date of reporting. Better the day of reporting, except face.  The patient wants to know if the facial swelling around his left cheek could be caused by SHINGRIX since it happened morning after shot. It was not the type swelling due to allergic reaction.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nasal congestion, Nasopharyngitis, Pyrexia, Rhinorrhoea, Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a male patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received SHINGRIX. On 16th March 2019, less than a day after receiving SHINGRIX, the patient experienced facial swelling, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion. On 17th March 2019, the patient experienced feels awful. On an unknown date, the outcome of the facial swelling and facial pain were not recovered/not resolved and the outcome of the feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy and nasal congestion were recovered/resolved. It was unknown if the reporter considered the facial swelling, feels awful, fever, chills, feeling hot, cold, runny nose, loss of energy, facial pain and nasal congestion to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who himself was a Pharmacist. The age at vaccination was not reported. On Sunday from the reporting date, the patient received a dose of SHINGRIX. The patient experienced a swollen facial area around left jaw and cheek area, basic side effects, feeling terrible, swelling and soreness just under his left facial check and radiating across to ear area, very painful, fever, chills, hit then cold, runny nose congestion, and loss of energy. The patient had the basic side effects on Saturday night and Sunday felt terrible. The patient woke up on Sunday morning with swelling and soreness just under his left facial cheek and radiating across to war area and was very painful. The patient had not any trauma to that area. The patient did have fever and chills. Hit then cold. Runny nose congestion and loss of energy through yesterday a day before the date of reporting. Better the day of reporting, except face.  The patient wants to know if the facial swelling around his left cheek could be caused by SHINGRIX since it happened morning after shot. It was not the type swelling due to allergic reaction.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site rash
Clinical narrative: Pt reported a rash on the right shoulder, upper arm a few hours following the shot. No medical appt after the reaction. Resolved on it's own.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event, Inappropriate schedule of product administration
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to 23 adolescent patients of unknown gender. The patients' medical history, concurrent condition and concomitant therapy were unknown. The purpose of this longitudinal study was to identify individual and interpersonal factors associated with human papillomavirus (HPV) vaccine series completion in a sample of low-income adolescent girls and boys. On an unknown date patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose, frequency, route, batch/lot number and expiration date were not provided) for prophylaxis (product origin unknown). Within 1 year of initiation, the patients received only the initial dose or two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). On an unknown date, patients experienced side effects of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). The outcome of the event was unknown. The event was considered to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). Findings highlight important opportunities for improving completion of the HPV vaccine series among adolescents. Intervention efforts should involve health care providers and parent-adolescent dyads and prioritize evidence-based strategies for reducing missed opportunities for series completion. This is one of three reports regarding the same literature (linked case# 1903USA008996 and 1903USA008997). Sender's Comments: US-009507513-1903USA008996: US-009507513-1903USA008997.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This spontaneous non-valid report as received from a pharmacist refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided. On 25-FEB-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (exact dose, route of administration, lot number, expiration date and site of injection were not provided). On 25-FEB-2019, the patient experienced reaction, described as "red, swollen, warm, red ring lower than the injection site and sore". The patient was given a treatment for the events. The patient did not sought medical attention. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not provided. This case is non-valid due to lack of patient's identifiers.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event, Incomplete course of vaccination
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to 17 adolescent patients of unknown gender. The patients' medical history, concurrent condition and concomitant therapy were unknown. The purpose of this longitudinal study was to identify individual and interpersonal factors associated with human papillomavirus (HPV) vaccine series completion in a sample of low-income adolescent girls and boys. On an unknown date patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose, frequency, route, batch/lot number and expiration date were not provided) for prophylaxis (product origin unknown). On an unknown date, patients experienced side effects of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). The outcome of the event was unknown. The event was considered to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). Findings highlight important opportunities for improving completion of the HPV vaccine series among adolescents. Intervention efforts should involve health care providers and parent-adolescent dyads and prioritize evidence-based strategies for reducing missed opportunities for series completion. This is one of three reports regarding the same literature (linked case# 1902USA011603 and 1903USA008997). Sender's Comments: US-009507513-1902USA011603: US-009507513-1903USA008997.
Sex: U
Vaccine: HPVX
Symptoms: Incomplete course of vaccination
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to 46 adolescent patients of unknown gender. The patients' medical history, concurrent condition and concomitant therapy were unknown. The purpose of this longitudinal study was to identify individual and interpersonal factors associated with human papillomavirus (HPV) vaccine series completion in a sample of low-income adolescent girls and boys. On an unknown date patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose, frequency, route, batch/lot number and expiration date were not provided) for prophylaxis (product origin unknown). Within 1 year of initiation, patients received only the initial dose or two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (inappropriate schedule of product administration). Findings highlight important opportunities for improving completion of the HPV vaccine series among adolescents. Intervention efforts should involve health care providers and parent-adolescent dyads and prioritize evidence-based strategies for reducing missed opportunities for series completion. This is one of three reports regarding the same literature (linked case# 1902USA011603 and 1903USA008996). Sender's Comments: US-009507513-1902USA011603: US-009507513-1903USA008996.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (lot # R015745, expiry date 02-DEC-2019, dose, strength, route, vaccination site unspecified) for prophylaxis (product storage error). The vaccine was stored at a temperature between minus (-9) degree centigrade to 8 degree centigrade, (-4 degree centigrade) for time frame of 2 hours and 11 minutes. There was no previous temperature excursion reported. No adverse effects were reported. Digital data logger was involved.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an approximately 12 years old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was possibly vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient possibly received the second dose of GARDASIL 9 2 years later. No adverse effects were reported.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 25-OCT-2016, at age 66, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug hypersensitivity, Rash
Clinical narrative: This spontaneous report was received from a physician via Pfizer refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) for prophylaxis (dosing details, lot/batch# not reported). On 06-JAN-2015, it was noted that, the patient experienced rash which was a drug hypersensitivity reaction. The outcome of rash and drug hypersensitivity was unknown. The reporter considered rash and drug hypersensitivity to be related to varicella virus vaccine live(manufacturer unknown). This is one of the two reports received from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported, but was selected as adult as per vaccine indication. The patient received 1st dose of SHINGRIX approximately 1 month ago from the date of reporting and experienced significant pain. The patient wanted to re-administer the SHINGRIX. No further information was provided. Contact for additional information was not allowed. Any follow up information received by Merck would be forwarded upon receipt.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: This case was reported by an other health professional via call center representative and described the occurrence of shoulder pain in an unspecified number of patients who received BEXSERO (batch number ABX6C1AA, expiry date 31st August 2019) for prophylaxis. On an unknown date, the patients received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patients experienced shoulder pain, injection site pain, joint range of motion decreased and radiating pain. On an unknown date, the outcome of the shoulder pain, injection site pain, joint range of motion decreased and radiating pain were unknown. It was unknown if the reporter considered the shoulder pain, injection site pain, joint range of motion decreased and radiating pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable for this report. The medical assistant reported that the patients experienced shoulder and injection site pain, limited range of motion and pain radiating into the neck after receiving BEXSERO. The reporter could not provide patient demographics or lot number and expiration dates. This case has been linked with case US2019051642, reported by the same reporter.