Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Pain, Pain in extremity, Paraesthesia oral
Clinical narrative: 7PM at night, things got worse; convulsions; Is not thinking very clearly right now; soreness in the arm; like it got tighter in her body involuntary muscle spasms/Facial spasms/had tightness in thoracic area, it just spasmed; like it got tighter in her body involuntary muscle spasms; her jaw started to turn to the side as it was going. Her jaw was straining and pushing to one side; her teeth were clicking; Her tongue went down; Didn't sleep at all; couldn't get comfortable; She was very cold, icy cold; Was really miserable,; she had the normal aching; feeling fatigued; it is more Flu-like; tightness in her chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 07:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (ongoing), notes: Indication for use in the case: Eczema. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 07Oct2022 at 06:30 as unk unk, single; DUPIXENT taken for eczema, start date: 2022 (ongoing). Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot number: EM9809, Expiration date: unknown, Anatomical location: injection in her arm), administration date: 10Feb2021, when the patient was 72-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF2590, Expiration date: unknown, Anatomical Location: injection in her arm), administration date: 07Oct2021, when the patient was 73-year-old, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3247, Anatomical Location: injection in her arm, Expiration date: unknown, Vaccine administration date: Either 20Jan2021 or 29Jan2021), administration date: Jan2021, when the patient was 72 years old, for COVID-19 immunisation. The following information was reported: INSOMNIA (non-serious) with onset 10Oct2022, outcome "unknown", described as "Didn't sleep at all"; PARAESTHESIA ORAL (non-serious) with onset 10Oct2022, outcome "unknown", described as "Her tongue went down"; THINKING ABNORMAL (non-serious) with onset 10Oct2022, outcome "unknown", described as "Is not thinking very clearly right now"; FEELING COLD (non-serious) with onset 10Oct2022, outcome "not recovered", described as "She was very cold, icy cold"; FEELING ABNORMAL (non-serious) with onset 10Oct2022, outcome "unknown", described as "Was really miserable,"; SEIZURE (medically significant) with onset 10Oct2022, outcome "unknown", described as "convulsions"; DISCOMFORT (non-serious) with onset 10Oct2022, outcome "unknown", described as "couldn't get comfortable"; FATIGUE (non-serious) with onset 10Oct2022, outcome "not recovered", described as "feeling fatigued"; JOINT STIFFNESS (non-serious) with onset 10Oct2022, outcome "not recovered", described as "her jaw started to turn to the side as it was going. Her jaw was straining and pushing to one side"; BRUXISM (non-serious) with onset 10Oct2022, outcome "unknown", described as "her teeth were clicking"; INFLUENZA LIKE ILLNESS (non-serious) with onset 10Oct2022, outcome "unknown", described as "it is more Flu-like"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 10Oct2022, outcome "not recovered", described as "like it got tighter in her body involuntary muscle spasms"; MUSCLE SPASMS (non-serious) with onset 10Oct2022, outcome "not recovered", described as "like it got tighter in her body involuntary muscle spasms/Facial spasms/had tightness in thoracic area, it just spasmed"; PAIN (non-serious) with onset 10Oct2022, outcome "unknown", described as "she had the normal aching"; PAIN IN EXTREMITY (non-serious) with onset 10Oct2022, outcome "not recovered", described as "soreness in the arm"; CHEST DISCOMFORT (non-serious) with onset 10Oct2022, outcome "unknown", described as "tightness in her chest"; CONDITION AGGRAVATED (non-serious) with onset 10Oct2022 at 19:00, outcome "not recovered", described as "7PM at night, things got worse". The patient underwent the following laboratory tests and procedures: Weight: 112lbs or 115lbs, notes: Weight: about 112lbs or 115lbs. Therapeutic measures were taken as a result of seizure, thinking abnormal, pain in extremity, muscle spasms, musculoskeletal stiffness, joint stiffness, bruxism, paraesthesia oral, insomnia, discomfort, feeling cold, feeling abnormal, pain, fatigue, influenza like illness, chest discomfort, condition aggravated. Additional information: It was reported that the patient just received the Pfizer bivalent COVID-19 Vaccine on Monday at 7am, had very odd side effects. Also had the regular flu shot for older people on that Friday, but did not have side effects except swelling in the arm. Is not thinking very clearly right now Very odd side effects: Initially was fine had soreness in the arm. The patient had the shot at 7AM on 10Oct2022. As the day went on, started to feel like it got tighter in her body. Started to notice that she was having almost like involuntary muscle spasms. By later that evening, after 7PM, her jaw started to turn to the side as it was going. Her jaw was straining and pushing to one side, her teeth were clicking. Her tongue went down. Her jaw went one way and her face went another. Then had tightness in thoracic area, it just spasmed. When she tried to move her arm became really sore. Taken Tylenol, but that did not seem to relieve it. Did not sleep at all couldn't get comfortable, couldn't get comfortable. She was very cold, icy cold. Happened all within the 24 hour period. She would say she had the normal aching and then feeling fatigued, but that all was regular and doesn't matter. It was by dinner time, 7PM at night, things got worse. She was out of work yesterday. Was really miserable, it is more Flu-like. Still had tightness in her jaw, but jaw wasn't going one way and face another. Had tightness in her chest. Facial spasms have subsided. The overall fatigue seems to be the same. Arm was still sore but not all the way down to the wrist. Soreness is just from the elbow and up, it is normal soreness. Still having the coldness, but that's fine. Just feels very off. She had this severe reaction with a drug happen before, but it was a long time ago. Product name is unknown, it was probably 50 years ago. Treatment included taking Tylenol Extra strength caplets; 500mg per caplet, Dose: two caplets every 6-7 hours by mouth. Probably should have called her doctor when she was having the convulsions. Was not thinking very clearly. Tylenol didn't relieve her symptoms including soreness of the injection arm. Recognized the symptoms of her jaw turning and was very nervous of that. She was diligent, had her son check on her quite often. Could not tell if maybe getting the Flu shot on Friday might have been too soon. But she just had soreness in the arm from the Flu shot Its the one they give for seniors She has gotten all of the other COVID-19 Vaccines. Told Dupixent would not interfere with Bivalent COVID-19 Vaccine. The reporter wanted to know are there any other medical conditions that we should know about. Does not think anything was relevant. She does not generally take aspirin. Family Medical History Relevant to adverse event included None. Felt more like a reaction to her. Felt like the drug reaction she had, maybe twenty years ago. Remembered that off feeling and the symptoms with her jaw and teeth cracking on each other. Previously the drug reaction happened probably 50 years ago. It did feel like muscular spasms, not shortness of breath. She has had every one of the COVID-19 vaccine shots, this is the first one that she had a bit of problems with.