Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Eye irritation, Headache, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE HIGH-DOSE for prophylaxis. Previously administered products included ZOSTAVAX. Concomitant products included SHINGRIX. On 1st October 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular) and FLUZONE HIGH-DOSE (intramuscular). On 1st October 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 1st October 2018 19:00, the patient experienced chills, throat tightness, headache, runny nose, eye red, eye irritation, nasal congestion, injection site pain, fever and generalized muscle aches. The patient was treated with acetylsalicylic acid (Aspirin), ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the chills, headache, runny nose, eye red, eye irritation, nasal congestion, injection site pain, fever and generalized muscle aches were recovering/resolving and the outcome of the throat tightness was recovered/resolved and the outcome of the drug dose administration interval too short was unknown. The reporter considered the chills, throat tightness, headache, runny nose, eye red, eye irritation, nasal congestion, injection site pain, fever and generalized muscle aches to be unrelated to SHINGRIX. Additional details were reported as follows: On 16th August 2018, the patient stated that she received the 1st dose of SHINGRIX into left arm, concomitantly. The patient states that she did not realize that the SHINGRIX injection was 2 weeks early (inappropriate schedule of vaccine) until after she had already received the a dose of SHINGRIX, which led to shortening of the vaccination schedule. The patient received FLUZONE (manufacturer: Sanofi) in the right arm at the same time as SHINGRIX. The patient experienced pain during the SHINGRIX injection and the pain was better on the reporting date, however, when she lifts her left arm, it feels a little sore. The patient received both vaccine around 3pm and by 7pm she started to have experience the headache, fever, chills, tightness in the throat, nasal congestion, runny nose, muscle aches (all over the body), eye redness and eye irritation. The patient took baby aspirin, ibuprofen and Benadryl. The patient believed that the symptoms (other than injection site pain) came from the flu vaccine. The patient was certain that SHINGRIX was not causing her symptoms. She was relating it to the flu shot. It was unknown if the reporter considered headache, fever, chills, tightness in the throat, nasal congestion, runny nose, muscle aches (all over the body), eye redness and eye irritation to be related to FLUZONE HIGH DOSE 2018-2019 years. The patient did not want any follow up at all and specifically asked that she should not receive any mailing. The patient denied permission to contact. This case has been linked to the US2018GSK186061, reported by the same reporter.