chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of musculoskeletal pain (1st dose received on 18th June 2018, refer case US2018227685). In August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, 1 day after receiving SHINGRIX, the patient experienced shoulder pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose of SHINGRIX in the right shoulder. The patient claimed that after about a day or two of receiving the injection, he experienced a feeling like someone punched him on his shoulder. The patient claimed that, at the time of reporting the feeling was still unresolved and it would become agitated if he moves a certain way or lies down on that side of his body. There was a consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Axillary pain, Fatigue, Hyperaesthesia, Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms 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 influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, fatigue, pain in arm, axillary pain and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, pain in arm and mobility decreased were recovered/resolved and the outcome of the fatigue and axillary pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, fatigue, pain in arm, axillary pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had severe arm pain up to axillary area and down side. The patient also had more severe pain in same areas of arm/axillary. The patient was unable to raise arm for 3 days. For tolerance of next dose see case US2018183663.  Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Mobility decreased, Nausea, Pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms 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 influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, fatigue, pain in arm, axillary pain and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, pain in arm and mobility decreased were recovered/resolved and the outcome of the fatigue and axillary pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, fatigue, pain in arm, axillary pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had severe arm pain up to axillary area and down side. The patient also had more severe pain in same areas of arm/axillary. The patient was unable to raise arm for 3 days. For tolerance of next dose see case US2018183663.  Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms 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 influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, fatigue, pain in arm, axillary pain and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, pain in arm and mobility decreased were recovered/resolved and the outcome of the fatigue and axillary pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, fatigue, pain in arm, axillary pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had severe arm pain up to axillary area and down side. The patient also had more severe pain in same areas of arm/axillary. The patient was unable to raise arm for 3 days. For tolerance of next dose see case US2018183663.  Lab Comments: Lab test was done on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash herpetiform in a 59-year-old male patient who received SHINGRIX) for prophylaxis. The patient's past medical history included shingles (outbreak prior to receive SHINGRIX). In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 30 days after receiving SHINGRIX, the patient experienced rash herpetiform. On an unknown date, the patient experienced localized erythema and pain. On an unknown date, the outcome of the rash herpetiform was recovering/resolving and the outcome of the localized erythema and pain were unknown.  It was unknown if the reporter considered the rash herpetiform, localized erythema and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About one month after receiving SHINGRIX, the patient developed a shingles like rash across his back that was similar in location to where he had a previous shingles outbreak. The patient reported that this outbreak was not as severe as previous and he still has a red area on his back and some slight pain but had not seen his doctor about the event. The patient consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Pigmentation disorder, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash aggravated in a 73-year-old male patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. Concurrent medical conditions included rash and shingles. On 4th December 2018, the patient received SHINGRIX. On 5th December 2018, 1 days after receiving SHINGRIX, the patient experienced rash aggravated, blister and spot pigmented. On an unknown date, the outcome of the rash aggravated and blister were not recovered/not resolved and the outcome of the spot pigmented was unknown. It was unknown if the reporter considered the rash aggravated, blister and spot pigmented to be related to SHINGRIX. Additional details were reported as follows: The patient had the rash before the SHINGRIX, but the rash got worse the day after receiving the vaccine and the patient was diagnosed with shingles by his doctor. The blisters looked like they had little black spots at the top, like the blood was not circulating. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 14th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 14th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site inflammation. On 15th December 2018, the patient experienced nausea and fever. On 16th December 2018, the outcome of the injection site erythema, nausea, fever and injection site inflammation were recovered/resolved. It was unknown if the reporter considered the injection site erythema, nausea, fever and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. After receiving SHINGRIX, the patient experienced redness and inflammation at injection site. Next day, she experienced fever of 100 degrees F and nausea. All symptoms were resolved. She never had any type of reaction to vaccines in the past. Batch number was not provided. The reporter did gave consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Eye pain, Eye swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 57-year-old female patient who received Shingrix for prophylaxis. On 9th September 2018, the patient received the 1st dose of Shingrix (intramuscular). In September 2018, 1 days after receiving Shingrix, the patient experienced fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling. In September 2018, the outcome of the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling were recovered/resolved. It was unknown if the reporter considered the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling to be related to Shingrix. Additional details were provided as follows: This case was reported by the physician who herself was the patient. The patient received Shingrix on left arm. The patient experienced shivering (chills) and periorbital bone pain and swelling under eyes after vaccination. The symptoms resolved after 2.5 days. The reporter had consented to follow up. For tolerance to next dose, refer case US2018GSK232142.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 57-year-old female patient who received Shingrix for prophylaxis. On 9th September 2018, the patient received the 1st dose of Shingrix (intramuscular). In September 2018, 1 days after receiving Shingrix, the patient experienced fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling. In September 2018, the outcome of the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling were recovered/resolved. It was unknown if the reporter considered the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling to be related to Shingrix. Additional details were provided as follows: This case was reported by the physician who herself was the patient. The patient received Shingrix on left arm. The patient experienced shivering (chills) and periorbital bone pain and swelling under eyes after vaccination. The symptoms resolved after 2.5 days. The reporter had consented to follow up. For tolerance to next dose, refer case US2018GSK232142.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 79-year-old male patient who received Shingrix for prophylaxis. On 18th June 2018, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, 1 day after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved. It was unknown if the reporter considered the shoulder pain to be related to Shingrix. Additional details were provided as follows: The patient received the 1st dose of Shingrix in the right shoulder. The patient claimed that after about a day or two of receiving injection, he experienced a feeling like someone punched him on his shoulder. There was a consent for follow up. For tolerance with 2nd dose of Shingrix, refer linked case US2018GSK231617.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Endoscopy abnormal, Feeling abnormal, Positron emission tomogram normal, Small intestinal obstruction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of small intestine adenocarcinoma in a 70-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included decreased white cell count and lymphoma. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a month after receiving SHINGRIX, the patient experienced small intestine obstruction (serious criteria hospitalization and GSK medically significant) and feeling miserable. On 26th November 2018, the patient experienced small intestine adenocarcinoma (serious criteria hospitalization and GSK medically significant). In August 2018, the outcome of the feeling miserable was recovered/resolved. On an unknown date, the outcome of the small intestine adenocarcinoma was recovering/resolving and the outcome of the small intestine obstruction was unknown. It was unknown if the reporter considered the small intestine adenocarcinoma, small intestine obstruction and feeling miserable to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left arm. The patient first experienced intestine blockage on a trip in August 2018, and he had four days of misery due to the blockage. When the patient returned, he continued to have regular screenings for lymphoma through Computerized tomogram (cat scans) and Positron emission tomogram (PET) and his most recent cat scan was in December 2017, which was showed nothing. They were doing lymphoma routine scans. On 26thNovember 2018, 98 days after vaccination, the patient was officially diagnosed with adenocarcinoma of the small intestine, through an endoscopy after suffering from some intestine blockage by the tumor. The patient had surgery to remove the tumor and was hospitalized starting on 3rd December 2018 for eight days. The patient did not know when the tumor started but believed that somewhere between December 2017 and November 2018. He was scheduled for chemotherapy in January 2019.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Small intestine adenocarcinoma, Tumour excision
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of small intestine adenocarcinoma in a 70-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included decreased white cell count and lymphoma. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a month after receiving SHINGRIX, the patient experienced small intestine obstruction (serious criteria hospitalization and GSK medically significant) and feeling miserable. On 26th November 2018, the patient experienced small intestine adenocarcinoma (serious criteria hospitalization and GSK medically significant). In August 2018, the outcome of the feeling miserable was recovered/resolved. On an unknown date, the outcome of the small intestine adenocarcinoma was recovering/resolving and the outcome of the small intestine obstruction was unknown. It was unknown if the reporter considered the small intestine adenocarcinoma, small intestine obstruction and feeling miserable to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left arm. The patient first experienced intestine blockage on a trip in August 2018, and he had four days of misery due to the blockage. When the patient returned, he continued to have regular screenings for lymphoma through Computerized tomogram (cat scans) and Positron emission tomogram (PET) and his most recent cat scan was in December 2017, which was showed nothing. They were doing lymphoma routine scans. On 26thNovember 2018, 98 days after vaccination, the patient was officially diagnosed with adenocarcinoma of the small intestine, through an endoscopy after suffering from some intestine blockage by the tumor. The patient had surgery to remove the tumor and was hospitalized starting on 3rd December 2018 for eight days. The patient did not know when the tumor started but believed that somewhere between December 2017 and November 2018. He was scheduled for chemotherapy in January 2019.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye haemorrhage, Headache, Retinal haemorrhage, Vision blurred, Visual impairment
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of retinal bleeding in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 4 to 5 years before the reporting date). On 14th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th December 2018, 1 days after receiving SHINGRIX, the patient experienced retinal bleeding (serious criteria GSK medically significant), eye hemorrhage (serious criteria GSK medically significant), eye floaters and headache. On 18th December 2018, the patient experienced blurred vision and visual impairment. The patient was treated with Aspirin and TYLENOL. On 18th December 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the retinal bleeding, eye hemorrhage, eye floaters, blurred vision and visual impairment were not recovered/not resolved. It was unknown if the reporter considered the retinal bleeding, eye hemorrhage, eye floaters, headache, blurred vision and visual impairment to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in left deltoid. The nurse reported that she experienced headache the next morning when she awoke around 7 am and she took an Aspirin. The patient had a few dark squiggly lines in her eye. The patient had a headache again on 16th December 2018 and she took TYLENOL and it resolved. On 18th December 2018, 4 days after receiving vaccination, the patient had dark squiggly cobwebs or floaters in her left eye from 5:30 to 7 am and it was blurry and hard for her to see out of that eye. The patient went to an ophthalmologist and he claimed that she had a retinal bleed or hemorrhage in her eye. The ophthalmologist told her that blood was causing the floaters which was obstructing her vision. The patient felt like the left eye was underwater and she cannot see out of it. The patient was planning to return for a follow-up doctor appointment on 28th December 2018. The reporter was a nurse and does 24 hour nurse shifts. The patient also reported that she was healthy and had a 105/69 blood pressure with no previous issues. The reporter had consented to follow up and had provided physician's contact details.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vitreous floaters
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of retinal bleeding in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 4 to 5 years before the reporting date). On 14th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th December 2018, 1 days after receiving SHINGRIX, the patient experienced retinal bleeding (serious criteria GSK medically significant), eye hemorrhage (serious criteria GSK medically significant), eye floaters and headache. On 18th December 2018, the patient experienced blurred vision and visual impairment. The patient was treated with Aspirin and TYLENOL. On 18th December 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the retinal bleeding, eye hemorrhage, eye floaters, blurred vision and visual impairment were not recovered/not resolved. It was unknown if the reporter considered the retinal bleeding, eye hemorrhage, eye floaters, headache, blurred vision and visual impairment to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in left deltoid. The nurse reported that she experienced headache the next morning when she awoke around 7 am and she took an Aspirin. The patient had a few dark squiggly lines in her eye. The patient had a headache again on 16th December 2018 and she took TYLENOL and it resolved. On 18th December 2018, 4 days after receiving vaccination, the patient had dark squiggly cobwebs or floaters in her left eye from 5:30 to 7 am and it was blurry and hard for her to see out of that eye. The patient went to an ophthalmologist and he claimed that she had a retinal bleed or hemorrhage in her eye. The ophthalmologist told her that blood was causing the floaters which was obstructing her vision. The patient felt like the left eye was underwater and she cannot see out of it. The patient was planning to return for a follow-up doctor appointment on 28th December 2018. The reporter was a nurse and does 24 hour nurse shifts. The patient also reported that she was healthy and had a 105/69 blood pressure with no previous issues. The reporter had consented to follow up and had provided physician's contact details.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event (serious criteria hospitalization). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter heard that, an unknown patient had to be hospitalized due to SHINGRIX dose. No other details were available.
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Fibromyalgia, Myalgia, Oropharyngeal pain, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves a 55 years old male patient who experienced muscle pain, sore throat almost like he has acid reflux and feels the need to keep clearing his throat, chronic fatigue and fibromyalgia, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immune system disorder. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious muscle pain (myalgia), sore throat almost like he has acid reflux and feels the need to keep clearing his throat (throat irritation), chronic fatigue (fatigue) and fibromyalgia, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This case is accessed as serious due to medically significant event. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. Relevant tests were not reported. Final diagnosis was fibromyalgia. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender's Comments: This case involves a 55 years old patient who experienced fibromyalgia with muscle pain, sore throat almost like he has acid reflux, chronic fatigue post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown and fibromyalgia is not expected following FLUZONE HD. Additionally, vaccine was administered out of recommended age leading to overdose. Patient has ongoing Immune system disorder. Further information regarding patient's medical history, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information, the role of the vaccines cannot be assessed.
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves a 55 years old male patient who experienced muscle pain, sore throat almost like he has acid reflux and feels the need to keep clearing his throat, chronic fatigue and fibromyalgia, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immune system disorder. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious muscle pain (myalgia), sore throat almost like he has acid reflux and feels the need to keep clearing his throat (throat irritation), chronic fatigue (fatigue) and fibromyalgia, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This case is accessed as serious due to medically significant event. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. Relevant tests were not reported. Final diagnosis was fibromyalgia. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender's Comments: This case involves a 55 years old patient who experienced fibromyalgia with muscle pain, sore throat almost like he has acid reflux, chronic fatigue post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown and fibromyalgia is not expected following FLUZONE HD. Additionally, vaccine was administered out of recommended age leading to overdose. Patient has ongoing Immune system disorder. Further information regarding patient's medical history, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information, the role of the vaccines cannot be assessed.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Exposure via skin contact, Product quality issue, Syringe issue, Underdose
Clinical narrative: This spontaneous case, initially received (combinedly processed with follow-up received on 02-Oct-2018) on 28-Sep-2018, from a pharmacist, concerns a 72-year-old, elderly, female patient. It was reported that the needle was attached to the syringe which seems to be looser on the other side (explicitly coded as needle issue). On 28-Sep-2018, the patient received partial dose of FLUAD (TIV) [ dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250799 and expiry date: 31-May-2019] (explicitly coded as incomplete dose administered), as the vaccine was leaked out through the patient's arm when the plunger was pressed (explicitly coded as syringe leak and exposure via skin contact). This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested ant the corresponding product technical complaint (PTC) reference number was 1033865. The reporter assessed the case as non-serious. Non-significant follow-up received from a pharmacist on 01-Nov-2018: No new information obtained. It was reported that the primary reporter no longer works in the pharmacy. Hence, they do not have further information on the case to provide.
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Occupational exposure to product, Product quality issue, Syringe issue
Clinical narrative: This non-serious spontaneous case, initially received from pharmacist on 26-Sep-2018, concerns a male patient of unspecified age. On an unspecified date, when trying to administer the FLUAD (TIV) [batch number: 250788, expiry date: 13-Apr-2019] to the patient, the syringe got leaked around the Luer-Lok (explicitly coded as syringe leak). It was reported that the health care professional (pharmacist) exposed to the vaccine (explicitly coded as occupational exposure while administering product). No vaccine was administered to the patient. No adverse events were experienced after the vaccine exposure. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding reference number was (number: 1033569).
Age: 16.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received on 12-Sep-2018, reported by other health professional (nurse), concerning a 16-year-old, female patient adolescent patient. The patient's historical condition included irritable bowel syndrome (IBS) and the current conditions included anxiety and depressive disorder (reported as medical history). The patient's concomitant medications included sertraline and PROAIR inhaler for unknown indications. On 10-Sep-2018, the patient (under age of 65 years) was inadvertently administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250789 and expiry date: 30-Apr-2019]. It was reported that, the patient did not experience any adverse events after vaccination. The reporter assessed the case as non-serious. Non-significant follow up report received on 08-Oct-2018: The nurse confirmed that, the patient did not experience any adverse events after vaccination.
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous case, initially received on 03-Oct-2018, reported by a pharmacist, concerns a female patient of unspecified age. The patient's historical condition was unknown. The patient's current condition included cancer. The patient's medication at the time of vaccination was unknown. On an unspecified date between 2017 and 2018 (reported as, sometime during the 2017-2018 influenza season), the patient was administered suspect vaccine FLUAD (TIV) [dose: reported as three-fourths of a 0.5 mL dose, frequency, route of administration, anatomical location, batch number and expiry date: not reported] (explicitly coded as incomplete dose administered). It was reported that the patient was administered only a partial dose (three-fourths of the total dose) because of her cancerous condition (as per her doctor). It was reported that medication error occurred in the previous year with the 2017-2018 formulation of FLUAD. At the time of this report, no adverse events were reported. The reporter assessed this case as non-serious. Update received on 30-Oct-2018: Non-significant case correction (03-Oct-2018): The phrase 'It was reported that medication error occurred in the previous year with the 2017-2018 formulation of FLUAD' was changed to 'It was considered as medication error' in the case comment. No changes were made in the narrative.
Age: 51.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received on 13-Sep-2018, reported by other healthcare professional, concerns a 51-year-old, adult, male patient. On an unspecified date, the patient (less than 65 years of age) was administered suspect vaccine FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed this case as non-serious.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional on 04-Sep-2018, concerns a 79-year-old, elderly, female patient. The patient's current conditions included hypertension, chronic obstructive pulmonary disease and anxiety (reported as medical history). The patient's concomitant medications included Losartan w/Hydrochlorothiazide and acebutolol for hypertension, albuterol, SINGULAIR, ANORO for chronic obstructive pulmonary disease and WELLBUTRIN XL for anxiety. It was reported that, vaccines bring to the pharmacy at room temperature (first time excursion). On 04-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, batch number: 250791, expiry date: 30-Apr-2019, route of administration and anatomical location: not reported] which underwent temperature excursion. No adverse event was experienced after vaccine administration. The reporter assessed the case as non-serious.
Age: 61.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 04-Sep-2018, concerns a 61-year-old, adult, male patient. The patient did not have any relevant medical history. The patient did not receive any concomitant medications. On 04-Sep-2018, the patient (under age 65 years) was accidentally administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250783, expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). The Seqirus confirmed that, batch number (250783) was a valid FLUAD NH1819 TIV PFS LL 10X1 batch number. The patient did not complain of any adverse events. The reporter assessed the case as non-serious. This case was cross-linked with the case 201803731 reported by the same reporter. Update received on 07-Sep-2018: Non-significant case correction (IRD: 04-Sep-2018): The Seqirus confirmed that, batch number (250783) was a valid FLUAD NH1819 TIV PFS LL 10X1 batch number. Hence, the batch number (250783) of the suspect product was added in the product tan and the narrative was amended accordingly.
Age: 54.0
Sex: F
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received from a pharmacist on 27-Sep-2018, concerns a 54-year-old, adult female patient. On an unspecified date, the patient (under age of 65 years) was administered FLUAD (TIV) [dose, route of administration, anatomical location, batch number and expiry date: not reported]. Follow-up received from the pharmacist on 16-Oct-2018: The patient's age was confirmed as 54-year and gender was updated as female. No other information was obtained.
Age: 58.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received on 01-Oct-2018, reported by other health professional (pharmacist), concerning a 58-year-old, adult, female patient. The patient's medical history and concomitant medications were unknown. On 01-Oct-2018, the patient (under age of 65 years) was administered FLUAD TIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250797 and expiry date: 31-May-2019). At the time of report, there were no adverse reactions. The reporter assessed the case non-serious.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 24-Sep-2018, concerns a 76-year-old, elderly, female patient. The patient was allergic to neomycin and several other antibiotics. On an unspecified date, the patient was administered influenza vaccine (dose, frequency, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported) which contained neomycin. No adverse event was reported. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: This non-serious spontaneous case, initially received on 05-Oct-2018 reported by other non-health professional and concerns a female patient of an unspecified age. The patient's current condition included high blood pressure. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported]. On an unspecified date, after vaccination, the patient experienced dizziness. The reporter stated that, the event may not be related to the suspect vaccine because she has high blood pressure which can cause it. At the time of this report, the outcome of the event was not reported. Update received on 30-Oct-2018: Non-significant case correction (IRD: 05-Oct-2018): The phrase 'was unassessable' was changed to is assessed as unassessable' in the case comment. No changed were made in the narrative.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Impaired work ability
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of chills in a 68-year-old female patient who received Shingrix for prophylaxis. On 27th November 2018, the patient received the 2nd dose of Shingrix .5 ml. On 27th November 2018, less than a day after receiving Shingrix, the patient experienced chills, fatigue and headache. On an unknown date, the outcome of the chills, fatigue and headache were recovered/resolved. It was unknown if the reporter considered the chills, fatigue and headache to be related to Shingrix. Additional details were reported as follows: The patient experienced extreme chills or fatigue, could not get out of bed and extreme headache ultimately missed 1 day of work. The symptoms lasted for approximately 1 and half day. The reporter did not agree upon follow up from GlaxoSmithKline.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a unspecified number of infant patients who received PEDIARIX for prophylaxis. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, unknown after receiving PEDIARIX, the patients 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 PEDIARIX. Additional details were not not provided as follows: The age at vaccination was not provided for the patients. The physician stated that, generally infants seems to experienced injection site pain with PEDIARIX.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Eye pain, Eye swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 57-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pyrexia (and also experienced chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling after receiving 1st dose on 9th september 2018, refer case US2018227676). On 13th December 2018, the patient received the 2nd dose of Shingrix (intramuscular). In December 2018, 14 hrs after receiving Shingrix, the patient experienced fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling. The patient was treated with BENADRYL and TYLENOL. Rechallenge with Shingrix was positive. On 16th December 2018, the outcome of the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling were recovered/resolved. It was unknown if the reporter considered the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on left arm. The patient took Benedryl and two Tylenol after getting the 2nd dose at about 8 PM on Thursday. Around 10:00 am in the next morning, the patient experienced fever, chills, shivering, myalgia, arthralgia, weakness, pain in periorbital bones and swelling under the eyes. The reporter had consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 57-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pyrexia (and also experienced chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling after receiving 1st dose on 9th september 2018, refer case US2018227676). On 13th December 2018, the patient received the 2nd dose of Shingrix (intramuscular). In December 2018, 14 hrs after receiving Shingrix, the patient experienced fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling. The patient was treated with BENADRYL and TYLENOL. Rechallenge with Shingrix was positive. On 16th December 2018, the outcome of the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling were recovered/resolved. It was unknown if the reporter considered the fever, chills, myalgia, arthralgia, weakness, periorbital pain and eye swelling to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on left arm. The patient took Benedryl and two Tylenol after getting the 2nd dose at about 8 PM on Thursday. Around 10:00 am in the next morning, the patient experienced fever, chills, shivering, myalgia, arthralgia, weakness, pain in periorbital bones and swelling under the eyes. The reporter had consented to follow up.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site pain, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old patient who received Shingrix for prophylaxis. Concomitant products included Shingrix. On 13th December 2018, the patient received the 2nd dose of Shingrix (intramuscular). In December 2018, less than a week after receiving Shingrix, the patient experienced injection site pain, general body pain and feeling cold. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, general body pain and feeling cold were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain and feeling cold to be related to Shingrix. Additional details were provided as follows: The patient had received both doses of Shingrix. After each dose he had some pain at the injection site, but his whole body ached like he got beat up and he felt very cold as well. The symptoms resolved after a day and a half. The consent was provided for follow-up. For tolerability of the first dose of Shingrix, refer case US2018227663.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Extensive swelling of vaccinated limb
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received Shingrix (batch number K2ZY4, expiry date 13th April 2021) for prophylaxis. On 14th December 2018, the patient received the 2nd dose of Shingrix (intramuscular). In December 2018, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and burning sensation. On an unknown date, the outcome of the extensive swelling of vaccinated limb and burning sensation were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and burning sensation to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix vaccine on unknown deltoid. The reporter stated that the patient developed a 6 inch by 4 inch area of swelling in the vaccinated arm after receiving Shingrix vaccine. The patient also mentioned that she had a burning feeling in her arm. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a elderly female patient who received Shingrix (batch number 27J4P, expiry date 12th April 2021) and (batch number 3977A, expiry date 9th May 2021) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site rash, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site rash and injection site erythema were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient received Shingrix subcutaneously, it reported that patient received 5 - 6 inches below bicep/couple inches above elbow - there was no muscle in this area so patient received the vaccine subcutaneously, this led to intramuscular formulation administered by other route. The patient also experiences large red rash around injection site lasting for some time and took a while to go away - the reaction at this time had recovered per pharmacist. The batch number of Shingrix was reported as 2734P or 2754P, which was corrected to 27J4P as per sales data sheet. The batch number of Shingrix excipient was reported as 3977A.