Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Sluggishness, Temporomandibular joint syndrome, Tonic clonic movements, Underdose
Clinical narrative: feel "overwhelmed"; fatigue/tired; elevated troponin levels; little foggy; Sluggish; seizure; Subluxation of TMJ; Tonic clonic with no loss of consciousness; she might have a touch of pericarditis; Dose: she didn't feel it exactly. She would say about 0.1ml by the size of syringe.; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration,  administered in right deltoid on 29Sep2021 14:15 (Batch/Lot number was not reported), at the age of 64-years-old, as dose 3, 0.1 ml single for Covid-19 immunisation. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine, liothyronine (NP THYROID) taken for thyroid disorder from an unspecified start date and ongoing (11 years been on it). The patient has no prior vaccinations no AEs following prior vaccinations within 4 weeks. No family medical history, as everyone is healthy. The patient previously received dose 1 of BNT162B2 on 18Dec2020 (lot number: EJ1685) and dose 2 on 08Jan2021, both administered in right deltoid for Covid-19 immunisation. On 29Sep2021, last week, Wednesday, patient got booster dose of Pfizer COVID Vaccine. Patient stated she didn't feel it exactly. She would say about 0.1ml by the size of syringe. On Friday morning, she went to emergency room because she had seizures on 01Oct2021. She is still feeling very overwhelmed about getting booster and what she went through in the ER. She was going to work. Seizures took like an hour because they screened her for a stroke first. Then they had her cleared in about an hour because they gave her medication to stop it. She felt very overwhelmed. Her troponin levels were very elevated. They asked if she had chest pain, but she did not have that. The seriousness criteria was very severe. She never had loss of consciousness and she knew everything going on. The CAT scan was able to show subluxation of TMJ on an unspecified date. They were tonic clonic with no loss of consciousness. It lasted for about an hour. The patient confirmed she thought it was medically significant and very severe. She is still a little foggy from all that stuff. Investigation included she had labs and bloodwork done on 01Oct2021. Her troponins were elevated and CAT scan caught subluxation of TMJ. Emergency Room was Yes. Patient is feeling really tired and her theory is that she might have a touch of pericarditis. She walks all the time and has good arteries. She thinks she has a very good cardiac status. Her troponins were elevated so something happened. She understands that especially with youngsters with pericarditis and myocarditis. No one knows like the ER doctor said they don't have answers. How long will she be feeling overwhelmed and tired? She truly believes because she is strong and healthy woman. The flu vaccine is coming soon too. Now, she is so concerned with the flu vaccine. When will she takes it and she doesn't want to take it on that day. Causality: A friend is a neurosurgeon that knows her too well. He said it is the vaccine and because she had cardiac reserve she didn't go into something major. All her friends are so afraid because caller is so healthy. Therapeutic measures were taken as a result of seizure (seizure). The reporter causality for the event seizure was related. The outcome of the events of subluxation of TMJ and tonic clonic with no loss of consciousness was recovered on 01Oct2021, feel overwhelmed, little foggy and sluggish was not recovered, while other events were unknown.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events ,  Seizure, Temporomandibular joint syndrome , Tonic clonic movements, Pericarditis and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.