Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Investigation, Myalgia, Night sweats, Tremor
Clinical narrative: Breasts feeling sore; She is so weak; Tender breasts; Muscles and bones hurting; Muscles and bones hurting; Night sweats; Chills; Severe shaking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2022 10:00 (Lot number: FK9894) at the age of 78 years as dose 4 (booster), single for covid-19 immunisation; tamoxifen (TAMOXIFEN) (Lot number: BK4844658, Expiration Date: 20Dec2022) at 20 mg 1x/day for breast cancer. Relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer; "Asthma" (unspecified if ongoing), notes: Asthma; "Drug sensitive" (unspecified if ongoing), notes: Drug sensitive; "Immune compromised" (unspecified if ongoing), notes: Immune compromised, has breast cancer; "Irregular heart beat" (unspecified if ongoing), notes: Irregular heart beat; "COVID-19", start date: 2020 (unspecified if ongoing), notes: She knows that beginning of 2020 all of this came down and she had Covid. Clarified that she had Covid prior to getting the Covid vaccines.; "She didn't have was the taste and smell", start date: 2020 (unspecified if ongoing), notes: The only thing she didn't have was the taste and smell.; "She didn't have was the taste and smell", start date: 2020 (unspecified if ongoing), notes: The only thing she didn't have was the taste and smell.; "Brain fog", start date: Feb2020 (unspecified if ongoing), notes: she has brain fog too which she has had since she got it in Feb2020; "Ill" (unspecified if ongoing), notes: She was ill and in bed for 3 weeks; "Osteoporosis" (unspecified if ongoing), notes: she has to take Prolia every 6 months for osteoporosis; "Sleep" (unspecified if ongoing), notes: Sleep. Concomitant medication(s) included: PRADAXA; METOPROLOL TARTRATE taken for heart rate irregular; SINGULAIR taken for asthma; ADVAIR; REMERON taken for sleep disorder; FLUTICASONE; PROLIA. Vaccination history included: Covid-19 vaccine (Dose: 1, LOT: EL9261, MANUFACTURER UNKNOWN, Route, Anatomical Location: left arm, below the shoulder), administration date: 24Jan2021, when the patient was 77 years old, for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, LOT: EN6701 or EN6201, MANUFACTURER UNKNOWN, Route, Anatomical Location: left arm, below the shoulder), administration date: 15Feb2021, when the patient was 77 years old, for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, First Booster, LOT: 301556A, MANUFACTURER UNKNOWN, Route, Anatomical Location: left arm, below the shoulder), administration date: 04Oct2021, when the patient was 78 years old, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: NIGHT SWEATS (non-serious) with onset 31Mar2022 21:00, outcome "not recovered", described as "Night sweats"; CHILLS (non-serious) with onset 31Mar2022 21:00, outcome "recovering", described as "Chills"; TREMOR (non-serious) with onset 31Mar2022 21:00, outcome "unknown", described as "Severe shaking"; BREAST PAIN (non-serious), outcome "unknown", described as "Breasts feeling sore"; ASTHENIA (non-serious), outcome "unknown", described as "She is so weak"; BREAST TENDERNESS (non-serious), outcome "unknown", described as "Tender breasts"; BONE PAIN (non-serious), MYALGIA (non-serious), outcome "recovered" and all described as "Muscles and bones hurting". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for tamoxifen was unknown. Therapeutic measures were not taken as a result of night sweats, chills, breast pain, asthenia, breast tenderness. Therapeutic measures were taken as a result of tremor, bone pain, myalgia. Additional information : Product Note : Additional Information for Other medicines Metoprolol Tartrate: Start Date: Unknown, when she went to the ER, and everything happened, she had to have these 2 medicines and had atrial fibrillation. RMH Covid-19 note : She knows that beginning of 2020 all of this came down and she had Covid. Clarified that she had Covid prior to getting the Covid vaccines. Caller states she had the fourth vaccine, the booster, last Thursday and she is very drug sensitive. When she had the third one, she had similar side effects but it wasn't that terrible. Her husband had it and nothing happened to him. She had night sweats and just had the chills. She woke up for 3 and a half, our days, ringing out wet hair and her sheets. She was just concerned about the chills and the shaking. Clarified that the vaccine, booster being referred to is the Pfizer Covid vaccine booster. Patient Details: Age adverse event(s) started: Caller states she is 78, 78 and is going to be 79.  Weight: 156. Caller states she has to lose 10 pounds before her big trip. Caller states she is going to call him next and find out why she has been having this. She had these night sweats for so long and she had breast cancer and is also taking Tomaxafin. She is just wondering if that might have something to do with this. She has been getting tender breasts and has been taking this medication for a year and hasn't had that before. She states that if someone is going to get something, it is going to be her. She is so drug sensitive. Caller states that the telephone number for this provider is the number for (Facility withheld), and states that she does not have his direct number. Event Details: Night sweats, chills, shaking: Caller states she had her booster Thursday and states they started that night. She had the shot at 10 in the morning, or so. About 9:00pm that night, she just started with severe shaking. She went to bed that night and when she woke up, her hair was all wet, as well as her sheets. Today is the first day it has gotten better. She still has the night sweats but the chills have gotten better. Caller states that Thursday night, Friday and Saturday, she had these symptoms. Last night, she had the sweats but they were not as severe as the night before. Treatment: No, because of the severe shaking and muscles and bones hurting, she took 2 Tylenol. She states she is very careful and took just 2 extra strength Tylenol, only on that Thursday night. Clarified she is not experiencing the muscle and bones hurting anymore. Concomitant Products/medical conditions: Caller states she is just old and is just loaded with those darn pills. She knows they are for her health.  She knows that beginning of 2020 all of this came down and she had Covid. The only thing she didn't have was the taste and smell. Clarified that she had Covid prior to getting the Covid vaccines.  Suspect Products: Tamoxifen: Caller states this is her cancer medication that she will have to take for 5 years. Clarified that she thinks this might have been the Tomoxifen because, her breasts were feeling sore and states this medication is hormonal and stops the hormones. Start Date: Caller states she started taking it one year ago. LOT: Caller provides the number BK4844658, stating it might be the lot number. NDC: Unknown EXP: Caller provides discard by date of 20Dec 2022 Clarified this medication is in pharmacy prescription bottle. Manufacturer Name: Unknown Caller states that is just states it is generic for Nolvadex. Clarified she is taking the generic medication, the Tamoxifen. Caller states it is a hormone receptor. Caller states there are 2 other medications she takes at night. She knows that it had to do with Covid. That is when she started taking most of this stuff. She states she has brain fog too which she has had since she got it in Feb2020. She was ill and in bed for 3 weeks and was on nebulizers. Clarified she was referring to when she actually had Covid and not regarding the Covid vaccine. Tests: Caller states she has to take Prolia every 6 months for osteoporosis. She just had it a few months ago and has had no problems at all.