Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Polychondritis, Red blood cell sedimentation rate increased, Sacral pain, Tinnitus
Clinical narrative: Relapsing Polychondritis/ Perichondritis of pinna, right; Polychondritis/ nasal chondritis; SI pain; Losing weight; does not eat as much as used to eat; chronic APR elevations; UTI; pulsatile tinnitus; headache; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "history of Allergic" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Chronic pain disorder" (unspecified if ongoing); "Colon polyp" (unspecified if ongoing); "Combined form of senile cataract of both eyes" (unspecified if ongoing); "Deep vein thrombosis" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing); "Geographic tongue" (unspecified if ongoing); "GERD (gastroesophageal reflux disease)" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Laryngopharyngeal reflux (LPR)" (unspecified if ongoing); "Multiple thyroid nodules" (unspecified if ongoing), notes: Multiple thyroid nodules (23Nov2022); "Osteopenia" (unspecified if ongoing); "Preoperative clearance" (unspecified if ongoing); "Primary osteoarthritis of both first carpometacarpal joints" (unspecified if ongoing); "right thumb tendon transfer" (unspecified if ongoing); "hot flashes" (unspecified if ongoing); "night sweats" (unspecified if ongoing); "tibial plateau stress fracture" (unspecified if ongoing); "swelling" (unspecified if ongoing); "redness" (unspecified if ongoing); "pain" (unspecified if ongoing); "nasal bridge became swollen" (unspecified if ongoing), notes: nasal bridge became swollen. wider, painful; "wider" (unspecified if ongoing), notes: nasal bridge became swollen. wider, painful; "painful" (unspecified if ongoing), notes: nasal bridge became swollen. wider, painful; "redness develop under the right eye" (unspecified if ongoing), notes: redness develop under the right eye; "osteoporosis" (unspecified if ongoing); "problems with stomach" (unspecified if ongoing), notes: Caused problems with stomach and heartburn; "heartburn" (unspecified if ongoing), notes: Caused problems with stomach and heartburn. The patient's concomitant medications were not reported. Past drug history included: Prolia, start date: 17Dec2021, stop date: 17Dec2021. Vaccination history included: BNT162b2 (Dose 1, Site and Route of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: EL1283), administration date: 21Jan2021, when the patient was 74-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Site and Route of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: EM9809), administration date: 11Feb2021, when the patient was 74-year-old, for Covid-19 immunization; BNT162b2 (Dose 3 (BOOSTER), Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: FF8839), administration date: 06Oct2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "UTI", "Relapsing polychondritis", "perichondritis of pinna, right/polychondritis", "Chronic APR elevations"; BNT162b2 (Dose 4 (BOOSTER), Site and Route of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: FM0173), administration date: 02Jun2022, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "UTI", "ear perichondritis/perichondritis of pinna/polychondritis", "Chronic APR elevations", "mild TTP at right ear"; hepatitis b, administration date: 07May1996, when the patient was 49-year-old, for Immunization; hepatitis b, administration date: 02Apr1996, when the patient was 49-year-old, for Immunization; hepatitis b, administration date: 12Nov1996, when the patient was 50-year-old, for Immunization; pneumococcal conjugate, administration date: 04Dec2015, when the patient was 69-year-old, for Immunization; pneumococcal polysaccharide 23-valent (pneumovax23), administration date: 16Feb2012, when the patient was 65-year-old, for Immunization; td, unspecified, administration date: 01Apr2007, when the patient was 60-year-old, for Immunization; tdap, administration date: 20Mar2015, when the patient was 68-year-old, for Immunization; zostavax (live zoster vaccine), administration date: 14Sep2012, when the patient was 66-year-old, for Immunization; influenza, administration date: 21Oct1993, when the patient was 47-year-old, for Immunization; influenza, administration date: 04Nov1994, when the patient was 48-year-old, for Immunization; influenza, administration date: 31Oct1995, when the patient was 49-year-old, for Immunization; influenza, administration date: 10Nov1998, when the patient was 52-year-old, for Immunization; influenza, administration date: 19Oct1999, when the patient was 53-year-old, for Immunization; influenza, administration date: 03Nov2000, when the patient was 54-year-old, for Immunization; influenza, administration date: 17Nov2009, when the patient was 63-year-old, for Immunization; influenza, administration date: 19Sep2015, when the patient was 69-year-old, for Immunization; influenza, administration date: 15Oct2016, when the patient was 70-year-old, for Immunization; influenza, administration date: 30Nov2017, when the patient was 71-year-old, for Immunization; influenza, administration date: 20Oct2018, when the patient was 72-year-old, for Immunization; influenza, administration date: 08Oct2019, when the patient was 73-year-old, for Immunization; influenza, administration date: 11Oct2019, when the patient was 73-year-old, for Immunization; influenza, administration date: 20Sep2020, when the patient was 74-year-old, for Immunization; influenza (Vaccine Name: Flu, Anatomical Site of Injection: Arm, Date: Sep2021), administration date: 14Sep2021, when the patient was 75-year-old, for Immunization; influenza, administration date: 17Sep2022, when the patient was 76-year-old, for Immunization. The following information was reported: POLYCHONDRITIS (medically significant), outcome "unknown", described as "Relapsing Polychondritis/ Perichondritis of pinna, right; Polychondritis/ nasal chondritis"; SACRAL PAIN (non-serious), outcome "unknown", described as "SI pain"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Losing weight"; EATING DISORDER (non-serious), outcome "unknown", described as "does not eat as much as used to eat"; AST TO PLATELET RATIO INDEX INCREASED (non-serious), outcome "unknown", described as "chronic APR elevations"; URINARY TRACT INFECTION (non-serious), outcome "recovered", described as "UTI"; TINNITUS (non-serious), outcome "unknown", described as "pulsatile tinnitus"; HEADACHE (non-serious), outcome "unknown". The events "relapsing polychondritis/ perichondritis of pinna, right; polychondritis/ nasal chondritis", "pulsatile tinnitus" and "headache" required physician office visit. The patient underwent the following laboratory tests and procedures: Anti-complement antibody: (unspecified date) normal; Antineutrophil cytoplasmic antibody: (unspecified date) Negative; Antinuclear antibody: (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; AST to platelet ratio index increased: (unspecified date) chronic APR elevations; C-reactive protein: (Mar2023) 20.7; Double stranded DNA antibody: (unspecified date) Negative; Electrophoresis protein: (unspecified date) Monoclonal; Heart rate: (unspecified date) normal; APS: (unspecified date) Negative; (unspecified date) Negative; (unspecified date) normal; Red blood cell sedimentation rate increased: (Mar2023) 33; Ultrasound thyroid: (07Mar2023) unknown results; Weight: (unspecified date) lost 8, notes: Has lost 8 pounds. Therapeutic measures were taken as a result of sacral pain, urinary tract infection. Suspect Relapsing Polychondritis. Declines any treatment, now considering MTX. Diagnosis, prognosis, and treatment options of RP discussed at length and in detail. Patient declined to start any treatment for RP. Her reported history of recurrent pinna erythema, swelling, and pain that spares the lobe is very consistent. She also reports symptoms consistent with nasal chondritis. Denies any dyspnea or dysphagia. Denies cardiac or neurologic symptoms. ANA-, SSA/SSB-, RNP/smith-, dsDNA-, ANCA-, APS-, cyros-, complements normal, SPEP with possible monoclonal. Modest chronic APR elevations: CRP 20.7, sed rate 33 in Mar2023. Current exam is normal now. Chronic APR Elevations. Suspect due to untreated RP. Had first ever headache behind right eye. No pain at temples or occiput. No GCA or PMR symptoms and temporal artery exam is normal today without dilation or tenderness and with pulses 2+ bilaterally. Raynaud's: Recent onset at right index finger only, normal exam and pulses . Previous SI pain but resolved with PT/HEP. Still walking 2 miles a day. Losing weight, does not eat as much as used to eat. Pain/pressure inside right ear, but gone today. No episodes of ear swelling or redness for about 2 years. No trouble with swallowing or breathing. No new symptoms. Still has pulsatile tinnitus, saw audiologist and ENT. Had MRA brain which was normal. Interval UTI, finished Abx about 2 or so weeks ago, but still some mild symptoms The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300744 same patient/drug, different events/dose number;US-PFIZER INC-202400032937 same patient/vaccine, different dose (dose 5)/events;