Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Muscle spasms, SARS-CoV-2 test
Clinical narrative: She states on Saturday she had terrific leg cramps in one leg; She states she has had 2 of Pfizer COVID-19 vaccines and the COVID-19 booster and she is 74 years old/She states on Sunday her and her husband both tested positive for COVID; She states on Sunday her and her husband both tested positive for COVID/cough/runny nose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 24Feb2021 as dose 2, single (Lot number: EL3247), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Arthritis throughout her body and everything else is good; 10 years ago; "Anxiety" (unspecified if ongoing); "chills and nausea" (unspecified if ongoing), notes: she had chills and nausea.; "chills and nausea" (unspecified if ongoing), notes: she had chills and nausea.; "deep cough" (unspecified if ongoing), notes: very deep cough which she has once a year. The patient's family history included: "his body was on fire and a thousand needles sticking" (unspecified if ongoing), notes: her son's COVID vaccine. Concomitant medication(s) included: AMOXICILLIN, start date: 27Apr2022, stop date: 01May2022; BENZONATATE taken for cough, start date: 27Apr2022, stop date: 30Apr2022; PROZAC taken for anxiety; NAPROXEN taken for arthritis. Vaccination history included: Flu vaccine (Flu Shot many years ago), for Immunization. The following information was reported: COVID-19 (medically significant) with onset 01May2022, outcome "unknown", described as "She states on Sunday her and her husband both tested positive for COVID/cough/runny nose"; DRUG INEFFECTIVE (medically significant) with onset 01May2022, outcome "unknown", described as "She states she has had 2 of Pfizer COVID-19 vaccines and the COVID-19 booster and she is 74 years old/She states on Sunday her and her husband both tested positive for COVID"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "She states on Saturday she had terrific leg cramps in one leg". The events "she states she has had 2 of pfizer covid-19 vaccines and the covid-19 booster and she is 74 years old/she states on sunday her and her husband both tested positive for covid", "she states on sunday her and her husband both tested positive for covid/cough/runny nose" and "she states on saturday she had terrific leg cramps in one leg" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative, notes: Wednesday; (01May2022) Positive, notes: Sunday. Clinical Information: The patient took no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The facility type was not pharmacy vaccine administration at Facility. No vaccines were administered on same date with the Pfizer vaccine considered suspect. Onset Age: unknown Vaccine/Brand Name: Shingles vaccine/ unknown name Vaccination Date: unknown. Caller (patient) stated she started taking Prozac brand 22 years ago and she started taking Naproxen about 8 years ago. Onset Age: unknown Vaccine/Brand Name: Shingles vaccine/ unknown name Vaccination Date: unknown. she doesn't really remember but she had chills and nausea. The patient stated she was sick but doesn't really remember just stated she was ill. The patient stopped taking Benzonatate on Saturday because she wasn't coughing any more. The patient stated that a week ago on Monday she started having COVID symptoms with coughing and runny nose but she never ran a fever. Caller states she took a COVID test but was negative. She stated she has had 2 of Pfizer COVID-19 vaccines and the COVID-19 booster and she is 74 years old. She states she went to the doctor and had a very deep cough which she has once a year. She states the doctor gave her antibiotics of Amoxicillin for bronchitis. She stated by Friday she was much better. She states on Saturday she had terrific leg cramps in one leg. She states on Sunday her and her husband both tested positive for COVID. Caller stated on Saturday her deep cough and runny nose was gone but her husband ran a fever. She states on Sunday she asked her doctor for Paxlovid. She states she is a healthy 74-year-old but was able to get Paxlovid because of her age. She states she is very healthy but because of her age her doctor said she should take Paxlovid. She stated she took one dose Sunday night and 2 doses on Monday. Concomitant Medications: Amoxicillin: Caller stated she was prescribed on 27Apr2022. She stated what the doctor gave her and what she was taking were 2 different things. She stated she has prescribed 875 mg but has only taken half of that twice a day because she knew what her body can handle. She stated she stopped Amoxicillin on Sunday because she tested positive for COVID. She took 1 dose Wednesday then 2 doses Thursday, Friday and Saturday and 1 dose Sunday morning. No Adverse events required a visit to Emergency Room.