Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight increased, X-ray, X-ray of pelvis and hip
Clinical narrative: Pelvic pain; Diarrhea; Arm injury; constipation; Joint range of motion decreased; arm soreness; felt dizzy and lightheaded; Upper respiratory infection; Blood pressure high; Pain in arm; shoulder fracture; BOWEL MOVEMENT THAT WAS UNLIKE OTHER ONES SHE HAD; Neuropathy; HEART FAILURE; Chills; Sweating; Joint range of motion decreased; Arm injury; Abnormal stools; Weight gain; Congestive heart failure; Pneumonia; Lumbar spinal stenosis; cataract; Celiac disease; This is a solicited report from a non-Pfizer-sponsored program (marketing program name not available) based on the information received by Pfizer (manufacturer control number 20K-163-3609696-00) from a contactable consumer. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number: EN5318, Expiry date: unknown) dose 2, intramuscular on 11Feb2021 (at the age of 72-years-old) as dose 2, single for COVID-19 immunisation. Medical history included vitamin D deficiency, high cholesterol, depression, congestive heart failure, blood pressure, osteoporosis, acid reflux, adrenal insufficiency, small bowel resection, abstain from alcohol and non-smoker, cataract from 2011, coeliac disease from 2008, neuropathy from 2017, pneumonia from 2017, congestive heart failure from 2017, nerve compression from 2017, arthralgia from 2017, broken arm and healed fracture on the left shoulder from 2017, back pain from 2017, weight increased since 2020, upper respiratory infection, lumber stenosis since 2017, cough from acid reflux from Jan2021 which was resolved on an unspecified date in 2021. Concomitant medications included ongoing adalimumab (HUMIRA, Solution for injection in pre-filled pen, subcutaneous) for moderate to severe adult Crohn's Disease from 2006, tramadol, furosemide (LASIX) for congestive heart failure, omeprazole for acid reflux, duloxetine hydrochloride (CYMBALTA) for depression, amlodipine for blood pressure, calcium for osteoporosis, bupropion hydrochloride (WELLBUTRIN) for depression, lisinopril for blood pressure, carvedilol for congestive heart failure, mirtazapine for depression, atorvastatin for high cholesterol, ergocalciferol (VIT D) for vitamin d deficiency and hydrocortisone for adrenal insufficiency. Past drug history included TALWIN and experienced vomiting and disorientation and cephalosporins and experienced vomiting/abdominal cramping and diarrhoea and took oxycodone and experienced side effects. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number: EL8982, Expiry date: unknown), dose 1 intramuscular as dose 1, single on 21Jan2021 for COVID-19 immunisation and experienced arm soreness which was recovered on 23Jan2021. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Feb 2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. In Feb2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech. Oxycodon (oxycodone hydrochloride) was also considered suspect. In Feb2021, the patient experienced felt dizzy and lightheaded, blood pressure high and upper respiratory infection. On 11Feb2021, the patient experienced arm soreness. Upon follow up the patient reported that she experienced chills and sweating on an unspecified date in 2021. In Jan2021, the patient experienced blood pressure was acting up/higher. In 2008, the patient experienced celiac disease. in 2011, the patient experienced cataract. In 2017, the patient experienced congestive heart failure, pneumonia, lumbar stenosis, neuropathy, pinched nerve, sacroiliac joint/hip pain and back pain. in 2017, the pneumonia resolved. in 2018, the patient experienced cough from acid reflux. In 2020, the patient experienced gained 30 pounds during covid 19 pandemic. In Dec2020, the patient experienced cough from acid reflux. in 2020, the cataract resolved. In 2017, the patient was hospitalized for five days due to pneumonia and unknown Intravenous antibiotics was given to her. She was confirmed that lumbar stenosis was getting worse, so physician changed her medication. She had celiac disease and gained 25 pounds during covid 19. She gained weight because of broken arm. She was taking Lyrica first for back pain, switched to Tramadol then Oxycodone for pain, not sure hips, or pelvis pain. She was also taking Tylenol as needed. At times could not bend over or stand, went to emergency room. In Aug 2020, the first outpatient procedure of the cataract surgery and second one was in Sep 2020. On 03 Jan 2021, she went to hospital due to her broken arm and left shoulder fracture and had to stay overnight and put on an arm sling. She was healing slowly and had to use walker to assist her in moving around. On 26 Feb 2021, she started physical therapy for her healed broken arm and healed fracture on the left shoulder. She had unspecified blood tests done during her hospitalization. She had heart failure, taking five medications. After injecting Humira, second day she had a bowel movement that was unlike the other ones she had. She clarified that bowel movement she mentioned in previous report meant that her diarrhoea and constipation which were symptoms of her Crohns disease improves after every injection of Humira and lasts for two days from the time of the injection. The patient underwent lab tests and investigations which included: basic metabolic panel: high result and congestive heart failure, chest computed tomography scan: confirmed pneumonia, chest Xray: pneumonia in 2017, blood pressure: acting up/higher on an unknown date, body weight: gained 25 pound in 2020, computed tomography scan: lumbar stenosis in Sep2020, shoulder Xray: broken shoulder and fracture was healed on 16Feb2021, x-ray of entire arm: fracture-crack below right shoulder, x-ray of hips and pelvis: normal on 03Jan2021. The patient was treated with Lisinopril, Tylenol, Oxycodone, Tramadol and Lyrica. The outcome of the events felt dizzy and lightheaded was recovered in Feb2021 and upper respiratory infection was recovered on an unspecified date, of the event arm soreness recovered on 13Feb2021 and of chills and sweating was recovering. The outcome of the events Shoulder fracture and Arm fracture lasted for 44 days since 03Jan2021 and was recovered on 16Feb2021 and of heart failure was unknown. The outcome of the events cataract and pneumonia was recovered on an unspecified date in 2017, dizziness was recovered on an unspecified date in Feb2021, cough was recovered on an unspecified date in Jan2021, pain in arm was recovered on 23Jan2021, of acid reflux, neuropathy, pinched nerve, painful joints, back pain, celiac disease and blood pressure high was not recovered, of fall, congestive heart failure, constipation, and diarrhoea was recovering, of abnormal stools, pelvic pain, neuropathy peripheral, lumbar spinal stenosis, weight gain, joint range of motion decreased and arm injury was unknown.  The reporter's causality for the event(s) was no reasonable possibility. Opinion is that there is no reasonable possibility that the events of cataract, fracture on left shoulder, broke arm near shoulder/moving hurts arm onset 03Jan2021, congestive heart failure, constipation, celiac disease, lumbar stenosis, gained 30 pound during covid 19 pandemic, at times cannot bend over or stand, broke arm near shoulder/moving hurts arm unknown onset, bowel movement that was unlike other ones she had, felt dizzy and lightheaded, cough from acid reflux onset in Dec2020, cough from acid reflux onset in 2018, neuropathy, pinched nerve, fell, sacroiliac joint/hip pain, pelvis pain, back pain, blood pressure was acting up/higher, arm soreness, recurred arm soreness, diarrhoea, neuropathy from back/toes are hurting and big toe numb and oxycodone had side effects are related to Humira 40mg/0.4ml(adalimumab). Opinion is that there is a reasonable possibility that the events of pneumonia and upper respiratory infection are related to Humira 40mg/0.4ml(adalimumab).  Follow-Up(29Mar2021): Follow-up attempts are completed. No further information is expected.  Follow-up(28Sep2021)- This is a follow-up solicited report based on the information received by Pfizer regulatory authority (Manufacturer Report Number: 21K-163-4092895-00). Age of the patient, new events with its outcome, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, laboratory/diagnostic procedures and narrative description was updated.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.