Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Dizziness, Flatulence, Headache, Malaise
Clinical narrative: I thought the shot go in but the needle did not retracked, so it was sticking out / She took it out on my arm, it was sticking up. It did not go back in / the needle for syringe was faulty; she doesn´t feel that good; little headache; stomach is upset. Gassy and funky; Gassy and funky; I am kind of dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (dose number unknown, single), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 23Oct2023, outcome "unknown", described as "I am kind of dizzy"; FLATULENCE (non-serious) with onset 24Oct2023, outcome "unknown", described as "Gassy and funky"; HEADACHE (non-serious) with onset 24Oct2023, outcome "unknown", described as "little headache"; MALAISE (non-serious) with onset 24Oct2023, outcome "unknown", described as "she doesn´t feel that good"; ABDOMINAL DISCOMFORT (non-serious) with onset 24Oct2023, outcome "unknown", described as "stomach is upset. Gassy and funky"; NEEDLE ISSUE (non-serious), outcome "unknown", described as "I thought the shot go in but the needle did not retracked, so it was sticking out / She took it out on my arm, it was sticking up. It did not go back in / the needle for syringe was faulty".  The reporter considered "i thought the shot go in but the needle did not retracked, so it was sticking out / she took it out on my arm, it was sticking up. it did not go back in / the needle for syringe was faulty" not related to bnt162b2 omi xbb.1.5. Causality for "i thought the shot go in but the needle did not retracked, so it was sticking out / she took it out on my arm, it was sticking up. it did not go back in / the needle for syringe was faulty" was determined associated to device constituent of bnt162b2 omi xbb.1.5 (malfunction).  Additional information: Patient just got a Pfizer shot for the Covid. She stated that "this is my I get all the shot but they've been most Moderna and this is my first Pfizer. As I was having the shot the druggist said hold and I thought what's this all about and I thought the shot go in but the needle did not retracked, so it was sticking out and he said that's the first time that happened". Patient said if she did get the vaccine and he said yes but he said patient have to be cautious because he did not want to 'prick' the patient. He said the needle did not retracked back into the syringe. Patient concern was did she get the vaccine and why would that happen, the needle did not retracked. She stated that "what I want to know exactly is did I get the vaccine and why would the needle not back into the syringe and am I in danger because that happened with a faulty syringe.". She said that it does not go back in. It was sticking out, she saw it. She took it out on her arm, it was sticking up. The syringe was faulty, he said that she got the vaccine but her question is how can she get the vaccine if the needle did not go back in. She asked if she got the vaccine or not, because the needle for syringe was faulty by Pfizer, never seen that happen. On 24Oct2023, patient reported that she went to get Comirnaty yesterday. However, when the technician pulled the syringe out, the needle did not retract. The caller was afraid she didn't get the complete dose. Asked if she got the complete dose. Patient mentioned that today she doesn´t feel that good. She has a little headache and her stomach is upset, "Gassy and funky". The reporter asked if what she was experiencing is normal and how long would it last.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.