chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Feeling of body temperature change, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE VACCINE for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and FLUZONE VACCINE (intramuscular) .5 ml. In August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain. On 30th August 2018, the patient experienced muscle pain and feeling hot and cold. SHINGRIX was continued with no change. On an unknown date, the outcome of the muscle pain and feeling hot and cold were not recovered/not resolved and the outcome of the injection site muscle pain was unknown. It was unknown if the reporter considered the muscle pain, feeling hot and cold and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient received FLUZONE on left arm. Less than a day after receiving, SHINGRIX, the patient experienced muscle soreness and it was all over her body and at the injection sites. The patient planned to follow-up with her physician or pharmacist on an unknown date. It was unknown if the reporter considered the muscle pain, feeling hot and cold and injection site muscle pain to be related to FLUZONE as well.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia, malaise, loss of energy, injection site pain, tiredness, headache, fever, decreased appetite and feeling abnormal. On an unknown date, the outcome of the myalgia, malaise, loss of energy, injection site pain, tiredness, headache, fever, decreased appetite and feeling abnormal were recovering/resolving. It was unknown if the reporter considered the myalgia, malaise, loss of energy, injection site pain, tiredness, headache, fever, decreased appetite and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient experienced weakness, low appetite and no energy. The patient also experienced pain at the injection site. The patient did not feel like doing much of anything over the next 2 days. The patient felt better on the day of reporting, but not fully recovered.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia, malaise, loss of energy, injection site pain, tiredness, headache, fever, decreased appetite and feeling abnormal. On an unknown date, the outcome of the myalgia, malaise, loss of energy, injection site pain, tiredness, headache, fever, decreased appetite and feeling abnormal were recovering/resolving. It was unknown if the reporter considered the myalgia, malaise, loss of energy, injection site pain, tiredness, headache, fever, decreased appetite and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient experienced weakness, low appetite and no energy. The patient also experienced pain at the injection site. The patient did not feel like doing much of anything over the next 2 days. The patient felt better on the day of reporting, but not fully recovered.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 46-year-old female patient who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. On 12th July 2016, the patient received the 1st dose of ENGERIX B. On 8th August 2016, the patient received the 2nd dose of ENGERIX B. On 23rd January 2017, the patient received the 3rd dose of ENGERIX B. In January 2018, not applicable after receiving ENGERIX B and ENGERIX B, not applicable after receiving ENGERIX B and ENGERIX B and unknown after receiving ENGERIX B, the patient experienced drug dose administration interval too long. On 21st August 2018, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The patient received 3rd dose later than the recommended interval, which led to lengthening of vaccination schedule. On 21st August 2018, the patient underwent for serology test of hepatitis B antibody and came up with non-reactive. The healthcare professional did not have information on lot and expiration dates of the vaccines that were administered.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Dysgeusia, Fatigue, Flushing, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, several days after receiving SHINGRIX, the patient experienced tingling and appetite lost. On 23rd August 2018, the patient experienced headache and sinus headache. On 24th August 2018, the patient experienced taste metallic, numbness oral, swollen mouth, fever, facial flushing and fatigue. The patient was treated with ibuprofen. On an unknown date, the outcome of the headache, fatigue, sinus headache, tingling and appetite lost were unknown and the outcome of the taste metallic, numbness oral, swollen mouth, fever and facial flushing were recovered/resolved. It was unknown if the reporter considered the headache, taste metallic, numbness oral, swollen mouth, fever, facial flushing, fatigue, sinus headache, tingling and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she experienced headache which started on the first day post vaccination. On the second day, the patient experienced metallic taste in the mouth, numbness and swelling in the mouth, fever, flushing of the face, and fatigue. Later at night, the patient visited the emergency room and kept there for couple hours, monitored and then discharged. The patient was mentioned that she took an ibuprofen before going in to the emergency room. Couple days later, the patient noticed that she had loss of appetite. Approximately about three days ago from the date of reporting, the patient had tingling on the left side of the face and the neck in the evening. The patient had recovered from everything except fatigue and loss of appetite. The patient had a sinus headache on the left side on the date of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia oral, Mouth swelling, Paraesthesia, Pyrexia, Sinus headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, several days after receiving SHINGRIX, the patient experienced tingling and appetite lost. On 23rd August 2018, the patient experienced headache and sinus headache. On 24th August 2018, the patient experienced taste metallic, numbness oral, swollen mouth, fever, facial flushing and fatigue. The patient was treated with ibuprofen. On an unknown date, the outcome of the headache, fatigue, sinus headache, tingling and appetite lost were unknown and the outcome of the taste metallic, numbness oral, swollen mouth, fever and facial flushing were recovered/resolved. It was unknown if the reporter considered the headache, taste metallic, numbness oral, swollen mouth, fever, facial flushing, fatigue, sinus headache, tingling and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she experienced headache which started on the first day post vaccination. On the second day, the patient experienced metallic taste in the mouth, numbness and swelling in the mouth, fever, flushing of the face, and fatigue. Later at night, the patient visited the emergency room and kept there for couple hours, monitored and then discharged. The patient was mentioned that she took an ibuprofen before going in to the emergency room. Couple days later, the patient noticed that she had loss of appetite. Approximately about three days ago from the date of reporting, the patient had tingling on the left side of the face and the neck in the evening. The patient had recovered from everything except fatigue and loss of appetite. The patient had a sinus headache on the left side on the date of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Mouth swelling, Pharyngeal oedema, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, several days after receiving SHINGRIX, the patient experienced tingling and appetite lost. On 23rd August 2018, the patient experienced headache and sinus headache. On 24th August 2018, the patient experienced taste metallic, numbness oral, swollen mouth, fever, facial flushing and fatigue. The patient was treated with ibuprofen. On an unknown date, the outcome of the headache, fatigue, sinus headache, tingling and appetite lost were unknown and the outcome of the taste metallic, numbness oral, swollen mouth, fever and facial flushing were recovered/resolved. It was unknown if the reporter considered the headache, taste metallic, numbness oral, swollen mouth, fever, facial flushing, fatigue, sinus headache, tingling and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she experienced headache which started on the first day post vaccination. On the second day, the patient experienced metallic taste in the mouth, numbness and swelling in the mouth, fever, flushing of the face, and fatigue. Later at night, the patient visited the emergency room and kept there for couple hours, monitored and then discharged. The patient was mentioned that she took an ibuprofen before going in to the emergency room. Couple days later, the patient noticed that she had loss of appetite. Approximately about three days ago from the date of reporting, the patient had tingling on the left side of the face and the neck in the evening. The patient had recovered from everything except fatigue and loss of appetite. The patient had a sinus headache on the left side on the date of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Dysgeusia, Fatigue, Flushing, Headache
Clinical narrative: I got the SHINGRIX vaccine as recommended by my doctor. Within 8 hours my arm was sore at the injection site and I had a bad headache. The following night I got a fever, flushed face, metallic taste in my mouth and felt like mouth and throat beginning to swell. I went to ER and was kept for two hrs for observation. I took ibuprofen which helped. It has been a week today and I'm still having fatigue and lack of appetite. I will not be getting the 2nd dose.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia oral, Mouth swelling, Paraesthesia, Pyrexia, Sinus headache
Clinical narrative: I got the SHINGRIX vaccine as recommended by my doctor. Within 8 hours my arm was sore at the injection site and I had a bad headache. The following night I got a fever, flushed face, metallic taste in my mouth and felt like mouth and throat beginning to swell. I went to ER and was kept for two hrs for observation. I took ibuprofen which helped. It has been a week today and I'm still having fatigue and lack of appetite. I will not be getting the 2nd dose.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Mouth swelling, Pharyngeal oedema, Pyrexia
Clinical narrative: I got the SHINGRIX vaccine as recommended by my doctor. Within 8 hours my arm was sore at the injection site and I had a bad headache. The following night I got a fever, flushed face, metallic taste in my mouth and felt like mouth and throat beginning to swell. I went to ER and was kept for two hrs for observation. I took ibuprofen which helped. It has been a week today and I'm still having fatigue and lack of appetite. I will not be getting the 2nd dose.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Wrong technique in product usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 75-year-old female patient who received SHINGRIX (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis. On 20th July 2018, the patient received SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 20th July 2018, the patient experienced wrong injection technique. In July 2018, the outcome of the injected limb mobility decreased was recovered/resolved. On an unknown date, the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that, the patient received the SHINGRIX, high on the deltoid and might have hit the bone, which led to wrong injection technique. The patient could not move her hand for 2 to 3 days after vaccination.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis. On 22nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 2 days after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hives 48 hours after getting SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: Reporter was a patient. The age at vaccination was not reported. The patient denied permission to contact their physician.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 30th August 2018 16:00, the patient received the 2nd dose of SHINGRIX. In August 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain, general body pain, muscle weakness and mobility decreased. On an unknown date, the outcome of the injection site pain, muscle weakness and mobility decreased were not recovered/not resolved and the outcome of the general body pain was unknown. It was unknown if the reporter considered the injection site pain, general body pain, muscle weakness and mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The patient was vaccinated with SHINGRIX on the left deltoid. The patient was vaccinated with SHINGRIX at a local pharmacy. Approximately 4 hours later after vaccination with SHINGRIX, the patient experienced injection site pain, muscle weakness that is inability to lift arm above elbow. The patient also complained of body aches.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 16th June 2018, the patient received the 1st dose of SHINGRIX. On 29th June 2018, 13 days after receiving SHINGRIX, the patient experienced itchy upper limbs and rash. The patient was treated with Corticosteroids Nos and dermatologicals (Cream (Nos)). On an unknown date, the outcome of the itchy upper limbs and rash were recovered/resolved. It was unknown if the reporter considered the itchy upper limbs and rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in unknown deltoid. Two weeks after the patient received SHINGRIX vaccination, he developed a reaction on his upper right arm, on the skin between his elbow and shoulder that was itching and felt like mosquito bites. On 3rd July 2018, the patient was prescribed with a cream but it did not relieve the condition. On 6th July 2018, the patient took a corticosteroid that did resolve the issue.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female 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 year after receiving SHINGRIX, the patient experienced injection site erythema and injection site inflammation. On an unknown date, the outcome of the injection site erythema and injection site inflammation were unknown. It was unknown if the reporter considered the injection site erythema and injection site inflammation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX 2 months before the reporting date.The patient experienced redness and inflamed reaction at the site. The reporting pharmacist declined demographics of the patient and completion of adverse event (AE) report.
Sex: U
Vaccine: TDAP
Symptoms: Fatigue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than a year after receiving dTpa vaccine, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient received an unknown brand of Tdap a few months before the reporting date. This was reportedly already submitted by a sales representative, but no record of case could be found in CAMEL search. This was possible repeat report.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male 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 year after receiving SHINGRIX, the patient experienced fever and general body pain. SHINGRIX was discontinued. On an unknown date, the outcome of the fever and general body pain were unknown. It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter is a nurse practitioner reporting an adverse event on behalf of the patient. The patient experienced body aches and fever after receiving the 1st dose of SHINGRIX. The patient did not want to get the 2nd dose. The reporter had limited information regarding this event and the patient at the time of the call. This case has linked to case US2018158758, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a female 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 year after receiving SHINGRIX, the patient experienced fever and general body pain. SHINGRIX was discontinued. On an unknown date, the outcome of the fever and general body pain were unknown. It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter is a nurse practitioner reporting an adverse event on behalf of the patient. The patient experienced body aches and fever after receiving the 1st dose of SHINGRIX. The patient did not want to get the 2nd dose. The reporter had limited information regarding this event and the patient at the time of the call. This case has linked to case US2018158757, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Product preparation error
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported, but the patient's age was in the range of 50 to 60. The patient received the dose of SHINGRIX without diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not agree to be followed up. Follow up information was received from nurse on 28th August 2018: The patient's demographic details were updated. On an unknown date, less than a year after vaccination, the patient experienced hurt like hell for 3 days.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Blood test normal, Hypersensitivity, Pruritus, Rash erythematous
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Zoster vaccine with an associated reaction of herpes zoster (had the original Zoster vaccine in 2010 and contracted Shingles in 2014). On 15th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, 3 days after receiving SHINGRIX, the patient experienced allergic reaction, pruritus, itchy rash and varicella. On an unknown date, the outcome of the allergic reaction and varicella were unknown and the outcome of the pruritus was not recovered/not resolved and the outcome of the itchy rash was recovered/resolved. The reporter considered the allergic reaction, pruritus, itchy rash and varicella to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX shot from his health provider. About three days after receiving this last SHINGRIX shot the patient began suffering severe itching, starting on the palms of my hands and moving to my feet and other parts of my body. At one point for a week or so he had red itching bumps on his back resembling chicken pox, but the dermatologist did a biopsy and it concluded it was some allergy to a medication, but the patient was not taking any that could have caused that. The patient stated, that did clear up, but he was having frequent itching on his hands, feet, arms and so on other areas at the time of reporting. After several visits to the dermatologist, allergist and the patient's primary internist, he had not received any definite cause or effective relief from his itching. In the week before reporting the patient's internist did a very thorough blood test and abdominal sonogram and did not find anything abnormal in it. All the physicians did not believe that the patient's symptoms could have been caused by the SHINGRIX vaccine, but, since they were so close to the Shingles that he had in 2014 and started so soon after the SHINGRIX shots it seemed like more than a coincidence to him. The patient thought he would just contact the company to see if they could confirm if there could be any possibility of a reaction or not. The patient appreciated the representative's attention and did appreciate the development of the product SHINGRIX to greatly decrease the occurrence of the very painful Shingles disease for so many in the future.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Ultrasound abdomen normal, Varicella
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Zoster vaccine with an associated reaction of herpes zoster (had the original Zoster vaccine in 2010 and contracted Shingles in 2014). On 15th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, 3 days after receiving SHINGRIX, the patient experienced allergic reaction, pruritus, itchy rash and varicella. On an unknown date, the outcome of the allergic reaction and varicella were unknown and the outcome of the pruritus was not recovered/not resolved and the outcome of the itchy rash was recovered/resolved. The reporter considered the allergic reaction, pruritus, itchy rash and varicella to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX shot from his health provider. About three days after receiving this last SHINGRIX shot the patient began suffering severe itching, starting on the palms of my hands and moving to my feet and other parts of my body. At one point for a week or so he had red itching bumps on his back resembling chicken pox, but the dermatologist did a biopsy and it concluded it was some allergy to a medication, but the patient was not taking any that could have caused that. The patient stated, that did clear up, but he was having frequent itching on his hands, feet, arms and so on other areas at the time of reporting. After several visits to the dermatologist, allergist and the patient's primary internist, he had not received any definite cause or effective relief from his itching. In the week before reporting the patient's internist did a very thorough blood test and abdominal sonogram and did not find anything abnormal in it. All the physicians did not believe that the patient's symptoms could have been caused by the SHINGRIX vaccine, but, since they were so close to the Shingles that he had in 2014 and started so soon after the SHINGRIX shots it seemed like more than a coincidence to him. The patient thought he would just contact the company to see if they could confirm if there could be any possibility of a reaction or not. The patient appreciated the representative's attention and did appreciate the development of the product SHINGRIX to greatly decrease the occurrence of the very painful Shingles disease for so many in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Product supply issue
Clinical narrative: This case was reported by a consumer and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced general body pain, fatigue and product supply issue. On an unknown date, the outcome of the general body pain, fatigue and product supply issue were unknown. It was unknown if the reporter considered the general body pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Six month before the reporting date, the patient received a dose of SHINGRIX. The patient had body aches, fatigue and she was unable to get out of bed for a half day after the vaccination. The patient was asking when did the SHINGRIX vaccines would be shipped. There was no availability of the vaccine in their area that she had found for receiving the 2nd dose. This case has been linked to the US2018GSK162777, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was an older gentleman. The patient developed severe rash all the way under his arm pit.
Sex: U
Vaccine: VARZOS
Symptoms: Presyncope
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vasovagal reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vasovagal reaction. On an unknown date, the outcome of the vasovagal reaction was unknown. It was unknown if the reporter considered the vasovagal reaction to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional reported that she was copied on email notifying her of patient who had vasovagal reaction following administration of SHINGRIX. The reporter was unable to provide any information on patient, vaccine administration, vaccine lot number and expiration date or information about the event. Agency offered to complete adverse event report. The health care professional stated she did not know if adverse event report was filed but they usually file them on their own.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that she had the patient whom presented with a severe rash 2 to 3 days after receiving a dose of SHINGRIX. The two patient experienced rash and one patient's rash looked similar to shingles (refer case US2018GSK157610). The patient received the vaccine at local pharmacy and neither could be attributed to anything else. The reporter did not agree to contact for follow up. This case has been linked with case US2018GSK157610, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vesicular rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.  It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that she had the patient whom presented with a severe rash 2 to 3 days after receiving a dose of SHINGRIX. The patient experienced rash looked similar to shingles. The patient received the vaccine at local pharmacy and neither could be attributed to anything else. The reporter did not agree to contact for follow up. This case has been linked with case US2018GSK157609, reported by the same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Constipation, Pyrexia, Tremor
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of chills in a 57-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of myalgia (1st dose received on 3rd April 2018, for tolerance see case US2018GSK162440). On 24th August 2018, the patient received the 2nd dose of SHINGRIX. On 25th August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, tremor, fever, abdominal pain and constipation. The patient was treated with FAMVIR, gabapentin and LORTAB. On an unknown date, the outcome of the chills, tremor, fever, abdominal pain and constipation were unknown. It was unknown if the reporter considered the chills, tremor, fever, abdominal pain and constipation to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX and went to emergency room (ER) on Saturday (25th August 2018) and Sunday (26th August 2018) for shaking, chills, fever over 100 and abdominal pain. The physician treated the patient with LORTAB on Saturday and gabapentin PERCOCET and FAMVIR on Sunday. The patient was back in physician office on Monday (27th August 2018) to be treated for left side abdominal pain. On the day of reporting the patient called back with abdominal pain. The physician gave him medication for constipation. This case has been linked with case US2018GSK162440 (same patient) reported by the same reporter. The reporter agreed to be contacted for follow up.
Age: 15.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a 15-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and MENACTRA at an unknown dose. On an unknown date, 1 day after receiving BEXSERO, the patient experienced fever and general body pain. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever and general body pain were recovered/resolved. It was unknown if the reporter considered the fever and general body pain to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO and MENACTRA on the same day. The patient had body aches and fever of 103 degree Fahrenheit the day after immunizations. The nurse had them alternate ADVIL and TYLENOL to manage fever and the patient was fine after next day. Lab Comments: Lab test was done on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Influenza like illness, Injection site erythema, Injection site oedema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male 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 year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, muscle pain, joint pain, distress gastrointestinal, injection site pain, injection site edema, injection site erythema and injection site warmth. On an unknown date, the outcome of the influenza-like symptoms, fever, muscle pain, joint pain, distress gastrointestinal, injection site pain, injection site edema, injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, muscle pain, joint pain, distress gastrointestinal, injection site pain, injection site edema, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The reporter said he already reported this adverse event to the company in the past. He could not remember the details anymore. In 2018, the patient vaccinated with a dose of SHINGRIX. It took him about 2 weeks to recovered from the symptoms. The symptoms were intestinal distress, red spot that was tender to the touch at the injection site, elevated temperature at the injection site. The reporter said that the symptoms went away after about 2 weeks.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male 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 year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, muscle pain, joint pain, distress gastrointestinal, injection site pain, injection site edema, injection site erythema and injection site warmth. On an unknown date, the outcome of the influenza-like symptoms, fever, muscle pain, joint pain, distress gastrointestinal, injection site pain, injection site edema, injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, muscle pain, joint pain, distress gastrointestinal, injection site pain, injection site edema, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The reporter said he already reported this adverse event to the company in the past. He could not remember the details anymore. In 2018, the patient vaccinated with a dose of SHINGRIX. It took him about 2 weeks to recovered from the symptoms. The symptoms were intestinal distress, red spot that was tender to the touch at the injection site, elevated temperature at the injection site. The reporter said that the symptoms went away after about 2 weeks.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be probably related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The case was reported by the dentist. The event lasted for several days. The events experienced by the patient did not cause any hospitalization overnight or also did not prolonged an existing hospitalization. The reporting healthcare professional did not consider the events experienced by the patient to be life threatening. The events had not resulted into any persistent or significant disability. The events had not required any surgical or medical intervention. The events had not resulted in any sort of congenital anomaly or birth defect. The reporter stated that he can be contacted for more information about the reaction he had experienced with the vaccination.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a patient who received MENVEO for prophylaxis. Co-suspect products included BOOSTRIX for prophylaxis. On an unknown date, the patient received MENVEO at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, less than a day after receiving MENVEO and BOOSTRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to MENVEO and BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced allergic reaction after receiving both MENVEO and BOOSTRIX on the same day. The reporter was trying to obtain a sample of both to test the patient to.
Sex: F
Vaccine: MENB
Symptoms: Induration
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of induration in a 18-year-old female patient who received BEXSERO for prophylaxis. On 18th July 2018, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a month after receiving BEXSERO, the patient experienced induration. On an unknown date, the outcome of the induration was not recovered/not resolved. It was unknown if the reporter considered the induration to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported but it could be 17 or 18 years. The patient received the BEXSERO in an unknown arm. Approximately 6 weeks post administration of the 1st dose, the patient still has induration greater than 1mm and nearly 3 inches. The reporter agreed to follow up. This case has linked to case US2018GSK162744, reported by the same reporter for same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for himself. The age at vaccination was not reported. The patient experienced a sore arm for 3 days but no other reactions. The patient still intended to receive the 2nd dose. The reporter denied for follow up. This case has been linked with case US2018GSK160167, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced a sore arm for 3 days but no other reactions. The patient still intended to receive the 2nd dose. The reporter denied for follow up. This case has been linked with case US2018GSK160166, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
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 for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the upper arm. After receiving SHINGRIX, the patient experienced pain in upper arm. The patient was asking about medication to treat the same.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fatigue in a 54-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Vitamin B12, FERREX, DEPLIN, ESTRACE, zoledronic acid, calcium and magnesium. In June 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue and general body pain. On an unknown date, the outcome of the fatigue and general body pain were unknown. The reporter considered the fatigue and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was taking some medications at the time she was given the vaccine, FERREX 150 Forte Plus 50-100 mg capsule, DEPLIN 15 15-90.314 mg capsule, Vitamin B12 100 mcg tablet, ESTRACE 0.1 mg/gm cream, Zoledronic acid 5mg/100ml solution (given months before the vaccine), calcium 600mg tablet, magnesium 300mg tablet. The patient was seen by physician about 6 weeks after receiving SHINGRIX, for continued fatigue and general body aches. Both reporter and patient think that her symptoms were due to the vaccine.