chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Headache, Incomplete course of vaccination, Influenza like illness, Miliaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (had history of chicken pox). Previously administered products included Flu vaccine with an associated reaction of headache (Received flu vaccine in the past refer case US2018GSK185831). On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 21st March 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and headache. On 24th March 2018, the patient experienced itchy rash, sunburn-like rash and heat rash. On an unknown date, the patient experienced bedridden and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, general body pain, headache, bedridden and itchy rash were recovered/resolved and the outcome of the sunburn-like rash, heat rash and incomplete course of vaccination were unknown. It was unknown if the reporter considered the influenza-like symptoms, general body pain, headache, bedridden, itchy rash, sunburn-like rash and heat rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX on 20th March 2018. The patient has not yet received the 2nd dose of SHINGRIX, which led to incomplete course of vaccination and was not sure if she would be getting the 2nd dose. The patient stated that the day after she received the 1st dose of SHINGRIX, she experienced, flu-like symptoms, headache, body aches and felt like a truck had hit her. The patient stated that she was bedridden for 1 day and then the symptoms resolved a few days later. The patient stated that on 24th March 2018, she developed a hot itchy rash that was on her upper left arm a few inches below the injection site, the size of the rash was larger than her hand, it was bright red, felt hot to the touch, and felt like a severe sunburn. The patient stated that the rash lasted for approximately 1 week. The patient stated that she had received flu vaccines (unknown manufacturer) in the past and after receiving them, she has experienced body soreness and headache (Refer case US2018GSK185831) the patient stated that the soreness that she felt after the flu vaccine was different than the body aches that she experienced following the SHINGRIX vaccine. The patient stated that she had not received a flu vaccine in at least 5 or 6 years. The patient did not have any additional details regarding the adverse reactions that she experienced after receiving the flu vaccines.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (had history of chicken pox). Previously administered products included Flu vaccine with an associated reaction of headache (Received flu vaccine in the past refer case US2018GSK185831). On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 21st March 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and headache. On 24th March 2018, the patient experienced itchy rash, sunburn-like rash and heat rash. On an unknown date, the patient experienced bedridden and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, general body pain, headache, bedridden and itchy rash were recovered/resolved and the outcome of the sunburn-like rash, heat rash and incomplete course of vaccination were unknown. It was unknown if the reporter considered the influenza-like symptoms, general body pain, headache, bedridden, itchy rash, sunburn-like rash and heat rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX on 20th March 2018. The patient has not yet received the 2nd dose of SHINGRIX, which led to incomplete course of vaccination and was not sure if she would be getting the 2nd dose. The patient stated that the day after she received the 1st dose of SHINGRIX, she experienced, flu-like symptoms, headache, body aches and felt like a truck had hit her. The patient stated that she was bedridden for 1 day and then the symptoms resolved a few days later. The patient stated that on 24th March 2018, she developed a hot itchy rash that was on her upper left arm a few inches below the injection site, the size of the rash was larger than her hand, it was bright red, felt hot to the touch, and felt like a severe sunburn. The patient stated that the rash lasted for approximately 1 week. The patient stated that she had received flu vaccines (unknown manufacturer) in the past and after receiving them, she has experienced body soreness and headache (Refer case US2018GSK185831) the patient stated that the soreness that she felt after the flu vaccine was different than the body aches that she experienced following the SHINGRIX vaccine. The patient stated that she had not received a flu vaccine in at least 5 or 6 years. The patient did not have any additional details regarding the adverse reactions that she experienced after receiving the flu vaccines.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (as a child). Previously administered products included ZOSTAVAX. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 27th September 2018, the patient experienced muscle pain, fatigue, headache, shivering, injection site erythema and injection site swelling. On 29th September 2018, the patient experienced injection site rash. On 2nd October 2018, the patient experienced injection site itching. On an unknown date, the patient experienced injection site lump. On an unknown date, the outcome of the injection site pain and injection site swelling were recovering/resolving and the outcome of the muscle pain, fatigue, headache and shivering were recovered/resolved and the outcome of the injection site itching, injection site erythema and injection site lump were not recovered/not resolved and the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site pain, muscle pain, fatigue, headache, shivering, injection site itching, injection site erythema, injection site swelling, injection site rash and injection site lump to be related to SHINGRIX. Additional details were provided as follows: At 13:00, the patient received SHINGRIX on the left arm. On the same day the patient experienced sore arm. One day after receiving SHINGRIX, the patient experienced redness and swelling (like large hive) a little below the injection site. The patient also had headache, muscle aches, shivering and fatigue. On 28th September 2018, the redness and swelling at the injection site was more. On 29th September 2018 (3 days after vaccination), the swelling started gone down, but it was still red and the redness looked like rash instead of just bright red. On the day of reporting (6 days after vaccination), she developed itching at the site. The soreness was improved but it hurts if the patient touched it. The swelling went down but there was still a lump (less than a week after vaccination) and the redness was about 2 by 4 inches.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (as a child). Previously administered products included ZOSTAVAX. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 27th September 2018, the patient experienced muscle pain, fatigue, headache, shivering, injection site erythema and injection site swelling. On 29th September 2018, the patient experienced injection site rash. On 2nd October 2018, the patient experienced injection site itching. On an unknown date, the patient experienced injection site lump. On an unknown date, the outcome of the injection site pain and injection site swelling were recovering/resolving and the outcome of the muscle pain, fatigue, headache and shivering were recovered/resolved and the outcome of the injection site itching, injection site erythema and injection site lump were not recovered/not resolved and the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site pain, muscle pain, fatigue, headache, shivering, injection site itching, injection site erythema, injection site swelling, injection site rash and injection site lump to be related to SHINGRIX. Additional details were provided as follows: At 13:00, the patient received SHINGRIX on the left arm. On the same day the patient experienced sore arm. One day after receiving SHINGRIX, the patient experienced redness and swelling (like large hive) a little below the injection site. The patient also had headache, muscle aches, shivering and fatigue. On 28th September 2018, the redness and swelling at the injection site was more. On 29th September 2018 (3 days after vaccination), the swelling started gone down, but it was still red and the redness looked like rash instead of just bright red. On the day of reporting (6 days after vaccination), she developed itching at the site. The soreness was improved but it hurts if the patient touched it. The swelling went down but there was still a lump (less than a week after vaccination) and the redness was about 2 by 4 inches.
Age: 74.0
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 injection site pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (as a child). Previously administered products included ZOSTAVAX. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 27th September 2018, the patient experienced muscle pain, fatigue, headache, shivering, injection site erythema and injection site swelling. On 29th September 2018, the patient experienced injection site rash. On 2nd October 2018, the patient experienced injection site itching. On an unknown date, the patient experienced injection site lump. On an unknown date, the outcome of the injection site pain and injection site swelling were recovering/resolving and the outcome of the muscle pain, fatigue, headache and shivering were recovered/resolved and the outcome of the injection site itching, injection site erythema and injection site lump were not recovered/not resolved and the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site pain, muscle pain, fatigue, headache, shivering, injection site itching, injection site erythema, injection site swelling, injection site rash and injection site lump to be related to SHINGRIX. Additional details were provided as follows: At 13:00, the patient received SHINGRIX on the left arm. On the same day the patient experienced sore arm. One day after receiving SHINGRIX, the patient experienced redness and swelling (like large hive) a little below the injection site. The patient also had headache, muscle aches, shivering and fatigue. On 28th September 2018, the redness and swelling at the injection site was more. On 29th September 2018 (3 days after vaccination), the swelling started gone down, but it was still red and the redness looked like rash instead of just bright red. On the day of reporting (6 days after vaccination), she developed itching at the site. The soreness was improved but it hurts if the patient touched it. The swelling went down but there was still a lump (less than a week after vaccination) and the redness was about 2 by 4 inches.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pyrexia, Tremor, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-year-old female patient who received SHINGRIX (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received, on an unknown date). On 1st October 2018 11:30, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st October 2018 22:30, 11 hrs after receiving SHINGRIX, the patient experienced fever, chills, joint pain and tremor. Rechallenge with SHINGRIX was positive. On 3rd October 2018 02:00, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the chills, joint pain and tremor were recovered/resolved. It was unknown if the reporter considered the fever, chills, joint pain and tremor to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left deltoid. The patient experienced fever, violent shaking, chills and severe joint pain around 10:30 PM the evening after receiving her dose of SHINGRIX. Her normal temperature was 96.8 degrees Fahrenheit and her fever reached 102 degrees Fahrenheit. The patient's fever broke around 2 PM on 3rd October 2018.  She was feeling better the night before the day of reporting. The patient informed the pharmacist that she experienced a similar experience after her first dose of SHINGRIX for tolerance see case US2018GSK186293.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Dyspepsia, Erythema, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (The every year the patient gets the flu vaccine and she gets a sore arm). On 28th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 10 hrs after receiving SHINGRIX, the patient experienced headache, stomach pain and stomach burning sensation of. On 28th September 2018, the patient experienced pain in arm. On 29th September 2018, the patient experienced fatigue, fever and weakness. On 30th September 2018, the patient experienced swelling arm, skin warm, erythema of extremities and itchy upper limbs. The patient was treated with EXCEDRIN unknown. On an unknown date, the outcome of the pain in arm, fatigue and fever were recovering/resolving and the outcome of the headache, weakness, skin warm, erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the stomach pain, stomach burning sensation of and swelling arm were recovered/resolved. It was unknown if the reporter considered the pain in arm, headache, stomach pain, stomach burning sensation of, fatigue, fever, weakness, swelling arm, skin warm, erythema of extremities and itchy upper limbs to be related to SHINGRIX. Additional details were reported as follows: At 16:00, the patient got 1st dose of SHINGRIX on 28th September 2018. The patient arm was sore that day. The patient woke up around 2 am on 29th September 2018 with a headache and stomach pain. It felt like her stomach burned inside. Later that morning on 29th September 2018, when the patient woke up for the day, her stomach felt better, but the headache was worse. The patient treated it with 1/2 an EXCEDRIN tablet and treated it continuously for the next day or two. That day on 29th September 2018 she also had fatigue, fever and weakness. On Sunday morning (30th September 2018) she noticed her arm was starting to turn pink and by that evening there was a large pink area, and her arm was swollen and warm to the touch. It was also a little itchy in the red area. The patient had started feeling better, but most of the symptoms had not completely resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (The every year the patient gets the flu vaccine and she gets a sore arm). On 28th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 10 hrs after receiving SHINGRIX, the patient experienced headache, stomach pain and stomach burning sensation of. On 28th September 2018, the patient experienced pain in arm. On 29th September 2018, the patient experienced fatigue, fever and weakness. On 30th September 2018, the patient experienced swelling arm, skin warm, erythema of extremities and itchy upper limbs. The patient was treated with EXCEDRIN unknown. On an unknown date, the outcome of the pain in arm, fatigue and fever were recovering/resolving and the outcome of the headache, weakness, skin warm, erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the stomach pain, stomach burning sensation of and swelling arm were recovered/resolved. It was unknown if the reporter considered the pain in arm, headache, stomach pain, stomach burning sensation of, fatigue, fever, weakness, swelling arm, skin warm, erythema of extremities and itchy upper limbs to be related to SHINGRIX. Additional details were reported as follows: At 16:00, the patient got 1st dose of SHINGRIX on 28th September 2018. The patient arm was sore that day. The patient woke up around 2 am on 29th September 2018 with a headache and stomach pain. It felt like her stomach burned inside. Later that morning on 29th September 2018, when the patient woke up for the day, her stomach felt better, but the headache was worse. The patient treated it with 1/2 an EXCEDRIN tablet and treated it continuously for the next day or two. That day on 29th September 2018 she also had fatigue, fever and weakness. On Sunday morning (30th September 2018) she noticed her arm was starting to turn pink and by that evening there was a large pink area, and her arm was swollen and warm to the touch. It was also a little itchy in the red area. The patient had started feeling better, but most of the symptoms had not completely resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (The every year the patient gets the flu vaccine and she gets a sore arm). On 28th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 10 hrs after receiving SHINGRIX, the patient experienced headache, stomach pain and stomach burning sensation of. On 28th September 2018, the patient experienced pain in arm. On 29th September 2018, the patient experienced fatigue, fever and weakness. On 30th September 2018, the patient experienced swelling arm, skin warm, erythema of extremities and itchy upper limbs. The patient was treated with EXCEDRIN unknown. On an unknown date, the outcome of the pain in arm, fatigue and fever were recovering/resolving and the outcome of the headache, weakness, skin warm, erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the stomach pain, stomach burning sensation of and swelling arm were recovered/resolved. It was unknown if the reporter considered the pain in arm, headache, stomach pain, stomach burning sensation of, fatigue, fever, weakness, swelling arm, skin warm, erythema of extremities and itchy upper limbs to be related to SHINGRIX. Additional details were reported as follows: At 16:00, the patient got 1st dose of SHINGRIX on 28th September 2018. The patient arm was sore that day. The patient woke up around 2 am on 29th September 2018 with a headache and stomach pain. It felt like her stomach burned inside. Later that morning on 29th September 2018, when the patient woke up for the day, her stomach felt better, but the headache was worse. The patient treated it with 1/2 an EXCEDRIN tablet and treated it continuously for the next day or two. That day on 29th September 2018 she also had fatigue, fever and weakness. On Sunday morning (30th September 2018) she noticed her arm was starting to turn pink and by that evening there was a large pink area, and her arm was swollen and warm to the touch. It was also a little itchy in the red area. The patient had started feeling better, but most of the symptoms had not completely resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Influenza like illness, Pain, Pain in jaw
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, jaw pain, influenza-like symptoms, fever, swelling, rash, erythema of extremities and numbness. On an unknown date, the outcome of the pain, jaw pain, influenza-like symptoms, fever, swelling, rash, erythema of extremities and numbness were unknown. It was unknown if the reporter considered the pain, jaw pain, influenza-like symptoms, fever, swelling, rash, erythema of extremities and numbness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The reporting pharmacist stated that she had seen many adverse effects after SHINGRIX. The reporter did not have additional information, including patient information or how many affected patients there were. This case has been linked to US2018GSK185943, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, jaw pain, influenza-like symptoms, fever, swelling, rash, erythema of extremities and numbness. On an unknown date, the outcome of the pain, jaw pain, influenza-like symptoms, fever, swelling, rash, erythema of extremities and numbness were unknown. It was unknown if the reporter considered the pain, jaw pain, influenza-like symptoms, fever, swelling, rash, erythema of extremities and numbness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The reporting pharmacist stated that she had seen many adverse effects after SHINGRIX. The reporter did not have additional information, including patient information or how many affected patients there were. This case has been linked to US2018GSK185943, reported by the same reporter.
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 21st September 2018, the patient received SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 27th September 2018, 6 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional information was reported as follows: The age at vaccination was not reported. The patient was also vaccinated with a Flu vaccine at the same time of vaccination with SHINGRIX. No additional information was provided by the reporter. The doctors' office was contacted by GlaxoSmithKline and waited for a call back.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 mg. On 24th September 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and pain in arm. On 1st October 2018, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the chills, fever and pain in arm were unknown. It was unknown if the reporter considered the rash, chills, fever and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient received SHINGRIX in the left arm. Seven days after receiving SHINGRIX, the patient experienced rash on his face, neck, and ears. The reporter did not want to answer any further questions, but was willing to be contacted by GlaxoSmithKline Safety. This case has been linked with case US2018180183, reported by same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 mg. On 26th September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue. On 27th September 2018, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: The caller reported that she did not wanted to answer any further questions, but was willing to be contacted by GlaxoSmithKline Safety.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Antibody test, Chills, Diarrhoea, Dysarthria, Dyspnoea
Clinical narrative: Diarrhea, fatigue, chills, throat constriction, swelling of tongue (slurred speech) shortness of breath.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Full blood count, Swollen tongue, Throat tightness
Clinical narrative: Diarrhea, fatigue, chills, throat constriction, swelling of tongue (slurred speech) shortness of breath.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Groin pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain 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, 3 days after receiving SHINGRIX, the patient experienced shoulder pain, groin pain, joint range of motion decreased, pain in hip and muscle pain. The patient was treated with TYLENOL and anti-inflammatory/antIrheumatic products (Anti-Inflammatory). On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the groin pain, joint range of motion decreased, pain in hip and muscle pain were unknown. It was unknown if the reporter considered the shoulder pain, groin pain, joint range of motion decreased, pain in hip and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The events had been persisting for almost 3 months, bilateral shoulder pain resulting in the inability to lift either arm upwards, and hip or groin pain. The provider reported that the patient was unable to distinguish between muscle or joint pain. The patient had been using anti-inflammatories and TYLENOL with limited relief. Blood work was inconclusive. The healthcare professional did not have lot number or expiry number or exact vaccination date.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain 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, 3 days after receiving SHINGRIX, the patient experienced shoulder pain, groin pain, joint range of motion decreased, pain in hip and muscle pain. The patient was treated with TYLENOL and anti-inflammatory/antIrheumatic products (Anti-Inflammatory). On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the groin pain, joint range of motion decreased, pain in hip and muscle pain were unknown. It was unknown if the reporter considered the shoulder pain, groin pain, joint range of motion decreased, pain in hip and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The events had been persisting for almost 3 months, bilateral shoulder pain resulting in the inability to lift either arm upwards, and hip or groin pain. The provider reported that the patient was unable to distinguish between muscle or joint pain. The patient had been using anti-inflammatories and TYLENOL with limited relief. Blood work was inconclusive. The healthcare professional did not have lot number or expiry number or exact vaccination date.
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pneumonia 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, several months after receiving SHINGRIX, the patient experienced pneumonia (serious criteria GSK medically significant). On an unknown date, the outcome of the pneumonia was unknown. The reporter considered the pneumonia to be unrelated to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced pneumonia months after receipt a dose of SHINGRIX. Only the patient's gender was collected. The healthcare professional stated that the pneumonia was not related to SHINGRIX.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Eye pain, Eyelid ptosis, Facial paralysis, Lacrimation increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a 79-year-old patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix about 4 months ago). On 7th August 2018, the patient received the 2nd dose of Shingrix. On 7th August 2018, less than a day after receiving Shingrix, the patient experienced Bell's palsy (serious criteria GSK medically significant), pain in arm, runny nose, eye pain and eyes tearing. On 8th August 2018, the patient experienced ptosis. On an unknown date, the outcome of the Bell's palsy, ptosis, runny nose, eye pain and eyes tearing were recovering/resolving and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the bell's palsy, pain in arm, ptosis, runny nose, eye pain and eyes tearing to be related to Shingrix. Additional details were provided as follows: The patient received 1st dose of Shingrix 4 months before the reporting date and experienced no side effects. After 2nd dose vaccination, the patient experienced a sore arm that hurt and had a runny nose. Just before he went to bed, he experienced both his eyes hurting and tearing up. The next morning, his wife noted that he his left eye was drooping, and thought he had a stroke.  The patient went to the emergency room and was diagnosed with Bell's Palsy. The patient also had a CT scan which was negative. The patient was discharged from emergency the same day. At the time of report, the patient was noticing an improvement in his Bell's Palsy symptoms. The contact details of the physician was provided, phone number was not available but was okay to send patient letter.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a 79-year-old patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix about 4 months ago). On 7th August 2018, the patient received the 2nd dose of Shingrix. On 7th August 2018, less than a day after receiving Shingrix, the patient experienced Bell's palsy (serious criteria GSK medically significant), pain in arm, runny nose, eye pain and eyes tearing. On 8th August 2018, the patient experienced ptosis. On an unknown date, the outcome of the Bell's palsy, ptosis, runny nose, eye pain and eyes tearing were recovering/resolving and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the bell's palsy, pain in arm, ptosis, runny nose, eye pain and eyes tearing to be related to Shingrix. Additional details were provided as follows: The patient received 1st dose of Shingrix 4 months before the reporting date and experienced no side effects. After 2nd dose vaccination, the patient experienced a sore arm that hurt and had a runny nose. Just before he went to bed, he experienced both his eyes hurting and tearing up. The next morning, his wife noted that he his left eye was drooping, and thought he had a stroke.  The patient went to the emergency room and was diagnosed with Bell's Palsy. The patient also had a CT scan which was negative. The patient was discharged from emergency the same day. At the time of report, the patient was noticing an improvement in his Bell's Palsy symptoms. The contact details of the physician was provided, phone number was not available but was okay to send patient letter.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a 80-year-old male patient who received Shingrix for prophylaxis. On 8th October 2018 12:30, the patient received the 1st dose of Shingrix. On 8th October 2018, less than an hour after receiving Shingrix, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was not recovered/not resolved. It was unknown if the reporter considered the bell's palsy to be related to Shingrix. Additional details were reported as follows: The reporter was the patient's wife. This case was previously reported to the physician. The patient received Shingrix in right arm. At 1:30 PM, on the same day, the patient was in the emergency room being treated for Bell's palsy.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever 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 year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The case was reported by nurse for herself. The age at vaccination was not reported. The age group was not reported, but was captured as adult as per vaccine indication. The patient experienced fever of 101 degrees Fahrenheit which lasted 2 days. No additional information were provided. After 2nd dose of SHINGRIX the patient experienced fever for tolerance refer case US2018GSK185871.  Lab Comments: On an unspecified date, the patient's body temperature was measured.
Sex: F
Vaccine: FLUX
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 Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a week after receiving Flu vaccine, 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 Flu vaccine. Additional information was reported as follows: The age at vaccination was not reported. The patient stated that she always reponded to the shots by experiencing a sore arm within 24 to 48 hours after vaccination. This case was linked with US2018179211 case reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Malaise, Pain in extremity, Rash generalised, Respiratory symptom
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received Shingrix for prophylaxis. Previously administered products included Shingles vaccine (vaccinated a few years ago before the date of reporting, the patient had no reaction to the same). On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced allergic reaction (serious criteria life threatening), feeling unwell, generalized rash, pain in arm and respiratory symptom. The patient was treated with Benadryl and prednisone. On an unknown date, the outcome of the allergic reaction, feeling unwell, generalized rash, pain in arm and respiratory symptom were unknown. It was unknown if the reporter considered the allergic reaction, feeling unwell, generalized rash, pain in arm and respiratory symptom to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient stated that she became very ill after vaccination with Shingrix. The patient stated that she had a near death allergic reaction. The patient stated that she could show the picture of rash that covered her body. She thought the reaction experienced by her was normal as the literature stated a rash might be accompanied with the vaccination. The pain in her arm was agonizing but she thought that it was normal. The patient was away from home and far from the health care unit, so the patient took Benadryl considering it was an allergic reaction, but nothing helped. On the second or the third day after the vaccination, the reaction moved to her lungs so they drove to a critical care location, where the patient had used an inhaler until they arrived to the critical care location. The patient was immediately administered Prednisone their. The patient stated that, she knew she cannot get the second shot of Shingrix. The patient lastly inquired that what could be the ingredient from the vaccine, that caused the allergic reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date for tolerance see case US2018GSK178839). 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 fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever was recovered/resolved.  It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The case was reported by nurse for herself. The age at vaccination was not reported. The age group was not reported, but was captured as adult as per vaccine indication. The patient experienced fever of 101 degrees Fahrenheit which lasted 2 days. No additional information were provided. Lab Comments: On an unspecified date, the patient's body temperature was measured.
Sex: U
Vaccine: FLU4
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 patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that, with every flu shot, the patient experienced a very sore arm. This case has been linked with case US2018GSK178901, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of malaise in a 64-year-old 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 malaise. On an unknown date, the outcome of the malaise was recovered/resolved. It was unknown if the reporter considered the malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. For tolerance to 2nd dose refer linked case US2018152727 for the same patient.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for three patients. This is the first of three reports. An adolescent patient of an unspecified age and gender received TRUMENBA, intramuscular on an unspecified date at a single dose as protection from meningitis B. The patient's medical history and concomitant medications were not reported. The patient experienced pain, redness, and swelling at the injection site on an unspecified date. It was reported that the patient was given meningococcal group B rlp2086 one day and the very next day the patient came back with the reactions. Outcome of the events was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018405600 same reporter, events, suspect product; different patient;US-PFIZER INC-2018405601 same reporter, events, suspect product; different patient.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for three patients. This is the second of three reports. An adolescent patient of an unspecified age and gender received TRUMENBA, intramuscular on an unspecified date at a single dose as protection from meningitis B. The patient's medical history and concomitant medications were not reported. The patient experienced pain, redness, and swelling at the injection site on an unspecified date. It was reported that the patient was given meningococcal group B rlp2086 one day and the very next day the patient came back with the reactions. Outcome of the events was unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018405597 same reporter, events, suspect product; different patient.;US-PFIZER INC-2018405601 same reporter, events, suspect product; different patient.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for three patients. This is the third of three reports. An adolescent patient of an unspecified age and gender received TRUMENBA, intramuscular on an unspecified date at a single dose as protection from meningitis B. The patient's medical history and concomitant medications were not reported. The patient experienced pain, redness, and swelling at the injection site on an unspecified date. It was reported that the patient was given meningococcal group B rlp2086 one day and the very next day the patient came back with the reaction. Outcome of the events was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018405597 same reporter, events, suspect product; different patient;US-PFIZER INC-2018405600 same reporter, events, suspect product; different patient.