Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia, Product administered at inappropriate site
Clinical narrative: This is a spontaneous case, reported by other non-health professional (consumer) to VAERS (VAERS ID: 772849) and initially retrieved on 15-Jan-2019, concerning 59-year old adult male patient. In past, the patient had received flu shots for unknown indication and experienced minimal side effects (unspecified). The relevant medical history of the patient included tinnitus and high cholesterol. The patient had a cyst in his left arm (since unspecified date). The concomitant medications of the patient included Vitamin (not specified) and Omega 3-6-9 (linum usitatissimum seed oil) for unknown indications. The patient was allergic to pollen, dust and rodents. On 01-Oct-2018, the patient was administered INN Flu Vaccine Seasonal (anatomical location: left arm, route of administration: injection NOS (reported as syringe) dose, batch number, expiry date, trade name, manufacturer: not reported) at work for an unknown indication. It was reported that the patient was administered the flu shot more in the triceps than on the side of the arm (explicitly coded as vaccine administered at inappropriate site). Since the patient had a cyst in his left arm, the patient always pointed out while receiving a shot. They usually just move a bit to the side. The person who administered the vaccine went more under the arm, thus the triceps location (explicitly coded as vaccine administered at inappropriate site). It was administered more in the tricep than on the side of the arm and it was unusual. On 01-Oct-2018, after vaccination, the patient experienced localized edema. On an unspecified date in Oct-2017 after vaccination, patient experienced moderate localized soreness and it diminished over the first week, but crept down his left arm, almost to his hand. Over the 2nd week, the soreness gradually diminished, changing to a numbness and tingling that crept further down, into his pinky and ring fingers. On an unknown date, the patient felt the same numbness and tingling radiate up to the left side of my face, but that lasted less than a day. On an unknown date in Sep-2018, 11 months after vaccination, the patient still had the numbness and tingling down his arm into the pinky and ring fingers. It varied from day to day. The range was from mild to barely noticeable. On the date of reporting, it was on the upper end of his normal range, and he noticed a very mild numbness on the left side of his face as well. On an unknown date in Sep-2018, at the time of reporting (reported as last night and today), the patient experienced symptoms of a head cold that had run through his office. In general the impact had not gone beyond the numbness and tingling. Other than the first two weeks, the patient felt that his range of motion, strength and grip were nearly normal. As the patient wrote, he even noticed a tingle in his other two fingers, he was hyper-aware today or just an unusually tingly day that he did not know. The outcome of the events (numbness, localised oedema, pain in hand, tingling and head cold) was not recovered and of the event (vaccine administered at inappropriate site) was unknown. The reporter assessed this case as non-serious. This case is linked with 201900508 due to same patient. Reporter's Comments: A 59-year-old male patient experienced numbness, localised oedema, pain in hand, tingling and head cold after administration of INN Flu Vaccine Seasonal and had vaccine administered at inappropriate site. The company assessed the causality of the events (numbness, localised oedema, pain in hand and tingling) as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events. The company assessed the causality of the event (head cold) as not related to the suspect vaccine due to implausible temporal relationship between the suspect vaccine and the event since it occurred 11 months after vaccination. The company assessed the causality of the event (vaccine administered at inappropriate site) as not related to the suspect vaccine due to accidental nature of the event.