Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Sinus headache, Tinnitus
Clinical narrative: ringing of the ears; numbness and tingling (nerve sensation tingling) of the feet that scattered over her ankles, thighs and hands; numbness and tingling (nerve sensation tingling) of the feet that scattered over her ankles, thighs and hands; pounding of the heart/Heart racing/pounding of the heart (at times, her heart rate are elevated but not all of the time, mainly a strong heartbeat).; slight sinus headache between the eyes; was not able to get any sleep because of having nerve pain/pain was almost like with someone who has neuropathy or shingles pain/nerve sensitivity is very alarming; she was not able to sleep because of the side effects she experienced; she was not able to sleep because of the side effects she experienced/ankle and both feet, hands, calves, and from the thighs the pain was severe enough that she could not sleep because of it; 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 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 14:30 (Lot number: FA7484, Expiration Date: 30Sep2021) at the age of 61 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 03Aug2021, outcome "not recovered", described as "ringing of the ears"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset Aug2021, outcome "not recovered" and all described as "numbness and tingling (nerve sensation tingling) of the feet that scattered over her ankles, thighs and hands"; PALPITATIONS (non-serious) with onset Aug2021, outcome "not recovered", described as "pounding of the heart/Heart racing/pounding of the heart (at times, her heart rate are elevated but not all of the time, mainly a strong heartbeat). "; SINUS HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "slight sinus headache between the eyes"; NEURALGIA (non-serious) with onset Aug2021, outcome "not recovered", described as "was not able to get any sleep because of having nerve pain/pain was almost like with someone who has neuropathy or shingles pain/nerve sensitivity is very alarming"; INSOMNIA (non-serious) with onset Aug2021, outcome "unknown", described as "she was not able to sleep because of the side effects she experienced"; PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "she was not able to sleep because of the side effects she experienced/ankle and both feet, hands, calves, and from the thighs the pain was severe enough that she could not sleep because of it". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior Vaccinations any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. No prior vaccinations reported. Other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: None. No family history reported. She also stated that she would probably no longer take the 2nd dose of the vaccine due to these side effects. Age: 61 Years Old. Gender: Female.Query: We received 3 delayed reports today with an awareness date of 02Aug2021. In addition to the one noted below, it seem there are 2 clones with AER # and #. Please confirm the awareness date for these and provide a reason for the delay in transmission. Thank you in advance. Response: the PRD of the report and the corresponding clone reports is 09Aug2021.  No follow-up attempts are possible. No further information is expected.