Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperexplexia, Insomnia, Nervousness
Clinical narrative: Medical Information Potential AE; feel very depressed; had a headache; my body was tired but I couldn't sleep and take my normal nap; I woke with a jerk and a start; fuzzy/very disappointed; couldn't sleep; felt jittery/nervous and easily startled with any quick noise; felt jittery/nervous and easily startled with any quick noise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 93 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 93 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "Medical Information Potential AE"; FEELING ABNORMAL (non-serious) with onset 08Apr2021, outcome "unknown", described as "fuzzy/very disappointed"; INSOMNIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "couldn't sleep"; FATIGUE (non-serious) with onset 09Apr2021, outcome "unknown", described as "my body was tired but I couldn't sleep and take my normal nap"; DYSKINESIA (non-serious) with onset 09Apr2021, outcome "unknown", described as "I woke with a jerk and a start"; DEPRESSED MOOD (non-serious) with onset 10Apr2021, outcome "unknown", described as "feel very depressed"; HEADACHE (non-serious) with onset 10Apr2021, outcome "unknown", described as "had a headache"; NERVOUSNESS (non-serious), HYPEREXPLEXIA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "felt jittery/nervous and easily startled with any quick noise".  Additional information: The patient received her first Pfizer Covid vaccine on 08Apr2021. That evening, she went to bed and stated "my head felt a little different, fuzzy, she could not sleep that well at night. She woke up the next morning and felt high as a kite. She stated that this lasted all day and said, her body was tired, but she could not sleep and take her normal nap. She could not sleep at night; she woke with a jerk and a start. This happened 3 times that night. One 10Apr2021, she started to feel very depressed, and she had a headache. A couple days ago, the depression lifted but then she felt jittery/nervous and easily startled with any quick noise. She stated that she remains easily startled and wants to know what the vaccine was doing to her body that would cause this side effect. She reported to her MD, and they did not recommend anything. The patient was referred caller to HCP for further discussion. Provided off-label disclaimer. Informed that Pfizer as unable to make treatment recommendations. Information was provided from attached documents-what are the risks of the vaccine and RA -How long side effects last final. The patient stated that she was not sure about getting the second dose of the vaccine with her side effects from the first. The patient was referred to speak with her HCP regarding treatment recommendations. Information was provided from attached document -who should not get the vaccine and reiterated the contraindications to getting the second dose of the vaccine. The patient stated that she would not go through another vaccination. She was very disappointed, and she would never take another vaccination. The patient was apologized and reiterated the reported side effects of the vaccine and referred to her HCP for further discussion. The patient was thanked for providing her side effect information. The patient asked where Pfizer was located and was provided response from Regulatory Authority and made aware that headquarters are located in Regulatory Authority.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.