Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Pain assessment, Pain in extremity
Clinical narrative: Bone pain everywhere; Chest pain/chest discomfort; Chills/shivers; Even feels pain in old incision sites; chest scar started hurting again; Arthritis has worsened (swelling of knuckles); Tenderness and pain in her breasts, groins, and armpits; Tenderness and pain in her breasts, groins, and armpits; Tenderness and pain in her breasts, groins, and armpits; Lymph nodes under arms and groin are swollen and painful; lymph node pain in breast and armpit; Lymph nodes under arms and groin are swollen and painful; Surgical scar worsened in appearance; armpit swelling worsened; HearVcardiac changes, her heart went wacko; Bounding heart beat; Headaches; Fatigue; Dizziness; Pain in her stomach around injection site; symptoms on left side are worse; Vertigo; Rapid heart rate; Abrupt incidences of pain in her hands and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Nurse). Other Case identifier(s): 2022US002147.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; abaloparatide (TYMLOS), from 19Apr2022 (Batch/Lot number: unknown) to May2022 at 80 ug 1x/day, subcutaneous for senile osteoporosis. The patient's relevant medical history included: "Sulfonamide allergy" (ongoing); "Itching" (ongoing); "Skin lesion" (ongoing); "Redness" (ongoing); "Chest mass NOS" (unspecified if ongoing); "Mass excision" (unspecified if ongoing); "Surgical scar" (ongoing); "Cardiac dysrhthmias", start date: 07Apr2021 (ongoing); "Skin irritation" (unspecified if ongoing); "blisters" (unspecified if ongoing); "Frequent PVCs and PACs", start date: 07Apr2021 (ongoing); "Frequent PVCs and PACs", start date: 07Apr2021 (ongoing); "Sores" (ongoing). Concomitant medication(s) included: OXCARBAZEPINE; PYRIDOXINE HCL; CALCIUM; VITAMIN C [ASCORBIC ACID]; PROLIA; CANNABIDIOL; TERIPARATIDE; METOPROLOL SUCCINATE. Past drug history included: Fosamax, reaction(s): "Allergies: Fasomax"; Dilantin, reaction(s): "Drug allergy"; Lamictal, reaction(s): "Allergies: Lamictal"; Keppra, reaction(s): "Allergies: Keppra"; Aspirin, reaction(s): "Allergies: Aspirin"; Thimerosal, reaction(s): "Allergies: Thimerosal"; Topamax, reaction(s): "Allergies: Topamax"; Bactrim, reaction(s): "Allergies: Bactrim"; Sulfadiazine, reaction(s): "Allergies: Sulfadiazine". Vaccination history included: BNT162b2 (Dose number: 1, Cardiac Dysrhythmias appeared after both immunization.), administration date: 07Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "Cardiac Dysrhythmias"; BNT162b2 (Dose number: 2, Cardiac Dysrhythmias appeared after both immunization.), administration date: 28Apr2021, for COVID-19 Immunization, reaction(s): "Cardiac Dysrhythmias". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2022, outcome "unknown", described as "Abrupt incidences of pain in her hands and feet"; ARTHRITIS (non-serious) with onset Apr2022, outcome "unknown", described as "Arthritis has worsened (swelling of knuckles)"; BONE PAIN (medically significant) with onset Apr2022, outcome "unknown", described as "Bone pain everywhere"; PALPITATIONS (non-serious) with onset Apr2022, outcome "not recovered", described as "Bounding heart beat"; CHEST PAIN (non-serious) with onset Apr2022, outcome "not recovered", described as "Chest pain/chest discomfort"; CHILLS (non-serious) with onset Apr2022, outcome "unknown", described as "Chills/shivers"; DIZZINESS (non-serious) with onset Apr2022, outcome "not recovered"; SCAR PAIN (non-serious) with onset Apr2022, outcome "not recovered", described as "Even feels pain in old incision sites; chest scar started hurting again"; FATIGUE (non-serious) with onset Apr2022, outcome "not recovered"; HEADACHE (non-serious) with onset Apr2022, outcome "not recovered", described as "Headaches"; CARDIAC DISORDER (non-serious) with onset Apr2022, outcome "unknown", described as "HearVcardiac changes, her heart went wacko"; LYMPHADENOPATHY (non-serious) with onset Apr2022, outcome "unknown", described as "Lymph nodes under arms and groin are swollen and painful"; LYMPH NODE PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "Lymph nodes under arms and groin are swollen and painful; lymph node pain in breast and armpit"; INJECTION SITE PAIN (non-serious) with onset Apr2022, outcome "not recovered", described as "Pain in her stomach around injection site; symptoms on left side are worse"; HEART RATE INCREASED (non-serious) with onset Apr2022, outcome "unknown", described as "Rapid heart rate"; CONDITION AGGRAVATED (non-serious) with onset Apr2022, outcome "unknown", described as "Surgical scar worsened in appearance; armpit swelling worsened"; BREAST TENDERNESS (non-serious), GROIN PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset Apr2022, outcome "unknown" and all described as "Tenderness and pain in her breasts, groins, and armpits"; VERTIGO (non-serious) with onset Apr2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Blood pressure increased: (Apr2021) Increased; Electrocardiogram ambulatory: (04Jun2021) Results not provided; (05Jun2021) Results not provided; (06Jun2021) Results not provided; (07Jun2021) Results not provided; (08Jun2021) Results not provided; (09Jun2021) Results not provided; (10Jun2021) Results not provided; (11Jun2021) Results not provided; Pain assessment: (unspecified date) 10, notes: reference range not provided. The action taken for abaloparatide was dosage permanently withdrawn in May2022. Therapeutic measures were taken as a result of cardiac disorder. The patient also noted heart and cardiac changes (unspecified) after Tmlos and was now on Metoprolol. Treatment information for the remaining events was not provided.    Additional information: The patient experienced severe chills (duration 3 days). The patient was blessed on heart monitor. The patient stated she needs to sleep with a sports bra due to swelling under her armpits. The patient stated the armpit swelling started after COVID vaccination and got worse after taking Timlos. Patient experienced allergy to Tymlos added up on follow up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.