Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Covid/sick badly with cold like symptoms/ fever/ nauseous/ equilibrium was off/ weak/ sneezing/ muscular pain/ rigors and chills/ head feels congested; Covid/sick badly with cold like symptoms/ fever/ nauseous/ equilibrium was off/ weak/ sneezing/ muscular pain/ rigors and chills/ head feels congested; This is a spontaneous report received from a Nurse.  A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Nov2024 as dose 1, single (Lot number: LM2216, Expiration Date: 31Mar2025) at the age of 68 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid", start date: 2009 (unspecified if ongoing), notes: for 15 years, doesn't have thyroid; "osteoporotic" (unspecified if ongoing); "sleep" (unspecified if ongoing); "trying to get off sleep medications and needs something for relaxation" (unspecified if ongoing); "for bones" (unspecified if ongoing); "good for skin, collagen repair, cells and over all good for you" (unspecified if ongoing); "good for skin, collagen repair, cells and over all good for you" (unspecified if ongoing); "cardio protective and for lipid control" (unspecified if ongoing); "cardio protective and for lipid control" (unspecified if ongoing); "Covid-19", start date: Jan2023 (unspecified if ongoing), notes: for the first time; "better for muscle relaxation" (unspecified if ongoing); "muscle spasms in her feet" (unspecified if ongoing); "menopause" (unspecified if ongoing); "hot flashes" (unspecified if ongoing); "vaginal dryness/dried up from menopause" (unspecified if ongoing); "vasovagal reactions to stress" (unspecified if ongoing); "Near syncopal" (unspecified if ongoing); "overactive parasympathetic system" (unspecified if ongoing); "palpitations" (unspecified if ongoing), notes: had echos, a Holter monitor; "oxidation of cells" (unspecified if ongoing); "TSH" (ongoing), notes: went to doctor for a checkup, goes every 6 months for TSH. Patient Details: when queried height stated she shrunk from osteoporosis. She is osteopenic left femoral neck. It's lumbar. Had her 4th Dexa scan 2 weeks ago. It's L1-L3. Had been on Alendronate for 19 months. Height is 4 feet 11 and a half inches. Tuesday went to doctor for a checkup. She went every 6 months for TSH because she doesn't have thyroid. She was well. Clarified she has hypothyroid for 15 years. Concomitant medication(s) included: INFLUENZA VACCINE, on 12Oct2024 as unk, single; LEVOTHYROXINE oral taken for hypothyroidism, start date: 2009 (ongoing); ALENDRONATE oral taken for osteoporosis, start date: Apr2023 (ongoing); QUETIAPINE taken for sleep disorder, start date: Jun2023 (ongoing); MAGNESIUM GLYCINATE taken for feeling of relaxation, muscle spasms, hypotonia, start date: 2024 (ongoing); FISH OIL taken for cardiac disorder, lipid metabolism disorder (ongoing); ESTRADIOL taken for vulvovaginal dryness (ongoing); LIPOSOMAL VITAMIN C [ASCORBIC ACID;SODIUM ASCORBATE] taken for skin disorder, collagen disorder, start date: 2022 (ongoing); SUPER R LIPOIC ACID, start date: 2019 (ongoing); NYQUIL; EQUATE NITETIME COLD & FLU. The patient also took other concomitant therapy, included Bone restore elite calcium supplemet with Vit K2, started taking about 5 years ago, ongoing, dosage: 4 a day for bones; Multi vitamin: started taking at least 8-9 years ago, ongoing, twice a day called 2 per day high potency multi vitamin and mineral for overall health. Past drug history included: Diltiazem, notes: generic, was on meds 2 years ago for almost a year; Metoprolol, notes: generic, was on meds 2 years ago for almost a year. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE), for Covid-19 immunization; Rsv, for Immunization, reaction(s): "terrible reaction". For concomitant products: Levothyroxine: Started taking 15 years ago; For Alendronate: States this is her 20th month taking it; For Quetiapine: started taking she would say 18 months ago. Generic for Seroquel. Didn't take it the last 4 nights. For magnesium glycinate: started taking a few months ago; For Life extension super R lipoic acid: started taking 5 years ago; For Extended liposomal Vitamin C 24 hour extended release: started taking 2 years ago; For Omega fish oil: started taking at least 6-7 years ago. For Estradiol vaginal cream: started using would say 5-6 years ago. Stated she didn't take her Quetiapine the last 4 nights. She tried Nyquil generic because has doxylamine sleeping aide in it. She took 2 pills of Nighttime cold and flu equate ( Has dextromethorphan, acetaminophen, and doxylamine.) Stated on Wednesday, Thursday, Friday, Saturday and Sunday nights she took 2 tablets to go to sleep. Estradiol vaginal cream -it's for all dried up from menopause. She was on estrogen post menopause years ago. She had hot flashes and vaginal dryness and couldn't take it. 3-4 years she had the patch and the doctor said no more because it may be linked to cancer so her doctor said to get a GYN and use this locally if she needs it. Medical History: once in a while she got vasovagal reactions to stress sometimes embarrassing moments is almost syncopal. Near syncopal. She was checked out years ago and was told nothing wrong just overactive parasympathetic system. She has had echos, a Holter monitor. When she left work she was getting palpitations before left filling out paperwork. When she came home she saw cardiologist 3 times and was on meds 2 years ago for almost a year she took generic diltiazem and generic metoprolol. Does not have manufacturer, NDC, lot or expiry to provide. Stated they didn't make a difference because sometimes it still happened. They thought it was anxiety and needed counseling. Everything checked out physically there was nothing wrong. Stated that everything goes downhill when retired.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2024, outcome "recovering" and all described as "Covid/sick badly with cold like symptoms/ fever/ nauseous/ equilibrium was off/ weak/ sneezing/ muscular pain/ rigors and chills/ head feels congested". The events "covid/sick badly with cold like symptoms/ fever/ nauseous/ equilibrium was off/ weak/ sneezing/ muscular pain/ rigors and chills/ head feels congested" required physician office visit. The patient underwent the following laboratory tests and procedures: Body height: (2024) shrunk from osteoporosis; Body temperature: (2024) rebounded; (2024) 100.8; (2024) came down; (2024) on and off; (Nov2024) under 101 temperature, notes: night Wednesday; Bone densitometry: (2024) Unknown results; (2024) Unknown results; (2024) Unknown results; (Nov2024) L1-L3, notes: 2 weeks ago; SARS-CoV-2 test: (Nov2024) Unknown results, notes: Thursday morning. Clinical course: Caller stated she has been sick all week with Covid. Caller was a retired nurse and this was her 7th vaccination and 2nd time getting Covid. She got sick badly on Wednesday with cold like symptoms. Thursday she tried to get her ahold of her doctor. She got the flu vaccine the week before that on 12Oct2024 for over 65. Name of vaccine, manufacturer and lot unknown. Stated she had a fever for 24 hours or a day and a half. She was nauseous, her equilibrium was off. Wednesday, Thursday, Friday. She was not good. Stated she saved the lot number. She would call the CDC to report also. She had a terrible reaction from RSV when she took that. Product name unknown, manufacturer, lot unknown. She called the CDC and reported that. It was 7 hours later very high temp with rigors. No trouble breathing or constitutional problems, had fevers on and off for would say a good 14-16 hours. Fever rebounded. Stated she wanted to let us know it didn't work for her. Stated she won't hold it because if you're going to get it you will. She called the doctor and said don't have that bad symptoms, she had a fever 100.8 and came down and fine after that but just is not in a good way. Her head felt congested. Felt stupid to get on Paxlovid because wouldn't have gotten it until Friday. Wednesday, she was sneezing very badly and went to the gym and had muscular pain that she thought was from when she went Monday and did too much. Had rigors and chills into the night Wednesday and just under 101 temperature. Then she knew. Seriousness criteria: just concerned about vaccination efficacy. She knows you can get it. 2% of the population will get it and she did. She was weak and nauseous. No throwing up. No problem with intake of fluids. Listless. Her head today, she was walking around and wanted to go outside before sun went down. She could't be like sitting in bed all day. Aches were all gone. She attributed those to extra heavy stuff Monday. Back, scapula and traps like she did too much upper body. Sneezing. Daughter said maybe Covid. Thursday morning tested. She didn't believe in getting vaccinations together. In her mind she always figures if you have a reaction you won't know what gave you the reaction. Investigations: She concerned about her bones. Does 3 times a week weight training. Was in bed for 2 days straight not moving. Went out yesterday to get moving. Didn't have dates or lot numbers of previous Pfizer Covid vaccines to provide. She is just disgusted. Concerned about vaccination efficacy.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.