Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Osteopenia, Pain, Pain in extremity, Poor quality sleep, Red blood cell sedimentation rate increased
Clinical narrative: skin changes; hair loss; Nausea; did not sleep well due to achyness and muscle spasms; Legs seemed to get weak, wobbly and achy; intermittent headache; was awake during the night with increased leg pain and achyness; severe body aches; joint pain; Legs very painful- cant stand anything touching legs; brain fog; legs heavy; bilateral leg muscle spasms; 2 falls; Dizziness; metallic taste in mouth; when walking legs had visible shaking; Injury; hypotension; BP variation; HTN; standing and walking for more than a short distance caused extreme fatigue, weakness and some dizziness; standing and walking for more than a short distance caused extreme fatigue; standing and walking for more than a short distance caused extreme fatigue, weakness and some dizziness; bilateral tinnitus; anxiety; stress; hearing distortion; difficulty going from one computer monitor to the other/ difficulty walking; Difficulty standing- mild; mid vertigo; neurogenic pain of lower extremity, left; osteopenia; insomnia due to medical condition; essential hypertension, benign; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 23Aug2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable other HCP (health care profession) reported for herself via physician. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9261), via intramuscular route, administered in left deltoid on 25Jan2021 (at the age of 58-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypotension, Anxiety and depression from 18Oct2016, Arthropathy unspecified in knees and hands, asthma from 30Nov2011, Cardiac dysrhythmias, chronic sinusitis, complication of anesthesia, dysautonomia, GERD (gastrooesophageal reflux disease), hypothyroidism, menopause from 15Oct2012, migraines, morbid obesity with BMI (body mass index) of 40.0 44.9, adult from 19Oct2016, motion sickness, osteopenia, cardiovascular disease, pneumonia, unspecified visual loss, alcohol use, heart disease unspecified, orthostatic hypotension, headache, exercise intolerance, heart palpitation, hyperlipidemia, irregular heartbeat, AFib, OSA (obstructive sleep apnea), tends to be tachycardiac, hole in heart, post-menopausal syndrome, allergies to adhesive tape, allergy to suture; red dye; penicillin; sulfonamide, alcohol use, non smoker and COVID-19. The patient's concomitant medications were not reported. The patient previously took metoclopramide, azithromycin, cetirizine, iodine Budesonide metoprolol succinate (TOPROL) and solifenacin succinate (VESICARE) and experienced allergy for all of them. The patient had the family history as such: her mother was having cataract, macular degeneration, cancer of colon, pancreas and liver, her father had cataract, glaucoma, heart disease, heart bypass, atrial fibrillation, had pacemaker, diabetes and other Wolfe Parkinson white while her brother had lung cancer and orthostatic hypotension. On 28Jan2021, the patient had difficulty standing- mild and had difficulty while going from one computer monitor to the other. In Jan2021, the patient had mild vertigo. On 30Jan2021, hearing distortion and by 01Feb2021 standing and walking for more than a short distance caused extreme fatigue, weakness and some dizziness. very hard work. On 02Feb21 BP (blood pressure) variations, HTN (hypertension) and hypotension- send to ED (Emergency department) from work head CT (Computerized tomogram) done and it was negative, no clear etiology found in ED. On 03Feb2021 symptoms evolved, had 2 falls when walking legs had visible shaking. Started using a walker. Symptoms at this point: difficulty walking, legs heavy, hearing distortion, metallic taste in mouth, bilateral leg muscle spasms, dizziness, brain fog, very fatigue and weak 04Feb2021-same symptoms as 03Feb2021 but leg shaking was more pronounced and CRP (C-reactive protein) was 18.725. On 05Feb2021, additional symptoms were the patient woke up in the night with severe body aches and joint pain. No fever no cough. Legs were very painful- couldn't stand. Seemed weaker overall. COVID test and antibody test recommended and both came back negative on the same day of 05Feb2021. 07Feb2021-leg shakiness only if up walking, rest of symptoms from 06Feb2021 were the same. Leg/foot pumps were added. On 08Feb2021-body aches and leg pain got some better. No change in other symptoms. Patient had long talk with doctor and the doctor felt that symptoms were due to COVID vaccine. On 09Feb2021-no changes seen in symptoms, doctor added vitamin D3 10,000 IU, zinc 50 mg twice daily, vitamin C 1000 mg twice daily and Quercitin 500 mg twice daily and Lipo- Flavonnid plus ear health 2 tabs twice daily. On 10Feb2021-same symptoms occurred but tried adding legs lifts to foot pumps and hourly walks around the house assisted by walker which made legs ached more. Legs felt weaker but the patient did them anyway. On 11Feb2021, patient was awake during the night with increased leg pain and achiness. It was reported that the patient will try leg lifts every other hour instead of hourly. Symptoms were as of 11Feb2021: hearing distortion, intermittent headache, intermittent muscle spasms of the legs and arms, intermittent weakness and leg pain, brain fog, metallic taste in mouth, general feeling of weakness and fatigue. Tried to do leg lifts but legs too painful. On 12Feb2021-did leg lifts 3 times today, it was better day today. Patient informed she will try shower tomorrow with a shower chair. On 13Feb2021 the patient did shower today, had leg shaking mostly in left leg but overwhelming feeling of fatigue and weakness. But the patient still did the leg lifts x3. Left leg much harder to do than right. Had increased muscle spasms and cramping. On 14Feb2021-seemed to have increased hearing distortion and craft had to stop due to weakness and needed a nap. Overall, the patient was not feeling well. 15Feb2021, the patient tried to do things but seemed to "hit" a wall after a short time. Legs seemed to get weak, wobbly and achy. The patient was still doing leg lifts 3 times a day with foot pumps. Left leg was still worse. Metallic taste in mouth got better, ears no change, the patient tried a little walking without the walker and still it was not safe as the patient reported. On 16Feb202, the patient did not sleep well due to achiness and muscle spasms. Headache got back today and legs were heavy/wobbly on 16Mar2021. On 10Mar2021, Physical therapy ordered. On 11Mar2021, physical therapy started once weekly through 02Apr2021, minimal improvement. On 24Mar2021-went back to work remotely as unable to walk without walker still. On 03April2021, the symptoms were brain fog which made it extremely difficult to work, an example was typing and cut a word the first letter is correct and the rest was jumbled. Hearing distortion-sometimes volume got loud, intermittent beeping in hearing which made her sometimes had vertigo and nausea, legs were shaky but after being up for a longer amount of time. Half day at work was very difficult due to hitting a wall had extreme fatigue and brain fog got worse as the day goes on. Additional symptoms were hair loss and skin changed. As on 06May2021, the patient was taking olmesartan (BENICAR) 20 mg tablet, potassium chloride 20 mEq tablet, sucralfate (CARAFATE) 1 g tablet, valacyclovir (VALTREX) 500 mg tablet, vitamin coral, vitamin D2 oral, zinc oral. It was considered that the patient was having fatigue, unspecified type, brain fog, neurogenic pain of lower extremity, essential hypertension, benign, osteopenia, unspecified location, hair loss. The treatment with paracetamol (TYLENOL), alendronate-cholecalciferol (FOSAMAX PLUS D) 70 mg-2,800 unit per tablet and spironolactone (ALDACTONE) 50 mg tablet were started. The patient was put on a trail of Aldactone for hair loss and the pain medication was refilled and the patient was called for follow up after 3 months. It was reported that the patient understood and agreed of the treatment plan and will follow as directed. It was noticed that her symptoms had improved on the gabapentin, but pain persisted. fatigue and brain fog also persisted. she had started to lose hair, previous bone density shows osteopenia. sucralface (CARAFATE), gabapentin (NEURONTIN), buspirone hcl (BUSPAR), CANNABIDIOL C80, extract, albuterol (ACCUNEB), estradiol (ESTRACE), Melatonin, olmesartan (BENICAR), potassium chloride (KLOR-CON M20), levothyrine (SYNTHROID), montelukast (SINGULAIR), lisinopril (PRINIVIL, ZESTRIL), zinc, ascorbic acid (VITAMIN C) biofav lemonivit Bcomp,C (LIPOFLAVONOID PLUS ORAL), valaciclovir hydrochloride (VALTREX), esomeprazole magnesium (NEXIUM), diltazem (CARDIZEM), calcium carbonatevitamin D2 (CALCIUM VITAMIN D), ciclosporin (RESTASIS), Magnesium, Lactobacillus acidophilus, ergocalciferol, vitamin d2, multi-vitamin were given to patient. Patient's system was reviewed, and it was found that patient denied fever, chills, nausea, vomiting, diarrhea, constipation, chest pain, shortness of breath, light headedness, dizziness, changed in vision, muscle pain, weakness, numbness, or tingling other than that noted above. Objective: general well developed, well nourished, in no apparent distress. skin warm, no pallor, head: normocephalic, atraumatic, neck: neck supple without adenopathy, lungs clear to auscultation, breath sounded equal bilaterally, cardio regular rate and rhythm without murmurs, abdomen: abdomen soft, nontender, bowel sounds normal. Again the patient presented with brain fog, bilateral tinnitus, neurogenic pain of lower extremity, left, insomnia due to medical condition, essential hypertension, benign. The patient reported that she was having daily "brain fog", leg pain/weakness, distorted hearing-sometimes vertigo, extreme fatigue, stress and wanted another opinion. Primary diagnosis was Leg weakness, bilateral. Patent's leg weakness was very unclear to the etiology. It was not identified whether this conversion reaction from stress and anxiety of issues at work or this was the side effect from the coronavirus vaccine which was unusual. The doctor didn't see no signs of her pots syndrome causing this nor on other neurological symptoms. Individual muscle were normal reflexes were normal and sensation was normal. When the patient tried to stand she shook, encouraged her and she stated she was going fall down. She stated she had fallen at home. She was using a walker to get around which seems to be helpful. This did not not seem to be a cauda equina or spinal stenotic type of syndrome. It was getting better and so at this point time with the injury her symptoms better and the weakness was somewhat better and she was able to walk with a walker will be monitored. Dizzy spells: the sounds to be inner ear in nature was is resolving she still had tinnitus type of symptomatology. Physical exam was normal no indication for further imaging work-up CAT scan was normal also. She did describe some inner ear but not true vertiginous type of symptoms. And this also seemed to be improving. Patient states that 1 week ago she did her COVID test and checked for the first time. Last Tuesday she started to feel just off in the head. She had a hard time thinking. She was still at work. She stated that when she looked from screen to screen that's when she became somewhat dizzy but not true vertiginous. Over the next couple of days she had had distortion of the ears such as static type of tinnitus. And she became progressively weaker to the point where she felt was fallen twice. she could not stand without using a walker without shakiness and weakness in the legs bilaterally. There was no focal deficit noted. Arms were fine but there was a slight tremor noted she had been very stressed at work and overwhelmed recently. ENT: Tinnitus type symptoms with mild vestibular symptoms. Neuro: generalized lower extremity weakness when she tried to stand and had some shaking and tremor. As corrective treatment valaciclovir hydrochloride (VALTREX), Esomeprazole Magnesium (NEXIUM), buspirone (BUSPAR), nitroglycerin (NITROSTAT), Olmesartan (BENICAR), estradiol (ESTRACE), diltiazem (CARDIZEM CD) , calcium carbonate/vitamin D2 (CALCIUM-VITAMIN D ORAL), cyclosporine (RESTASIS), lisinopril (PRINIVIL, ZESTRIL), montelukast (SINGULAIR), sucralfate (CARAFATE), levothyroxine (SYNTHROID), potassium chloride (KLOR- CON M20), estradiol (ESTRACE), Acyclovir 5% cream , albuterol (PROVENTIL HFA, VENTOLIN HFA, PROAIR), magnesium, lactobacillus acidophilus, ERGOCALCIFEROL, VITAMIN D2. (VITAMIN D ORAL) MULTI-VITAMIN, Melatonin, montelukast (SINGULAIR) was ongoing for the patient. The patient underwent lab tests and procedures which included blood pressure measurement: BP variation on 02Feb2021, blood test: negative on 08Feb2021, computerized tomogram: negative on 02Feb2021 negative, no clear etiology found in ED, c-reactive protein: 18.725 (high) on 09Feb2021, c-reactive protein: 110.258-high on 14Feb2021, red blood cell sedimentation rate: 30-high on 14Feb2021 , SARS-COV-2 antibody test: negative on 08Feb2021 and SARS-COV-2 test: negative on 08Feb2021. The outcome was recovering for hearing distortion, brain fog, Legs very painful- cant stand anything touching legs, standing and walking for more than a short distance caused extreme fatigue, weakness and some dizziness, legs heavy, bilateral leg muscle spasms, standing and walking for more than a short distance caused extreme fatigue, joint pain, Dizziness, Difficulty standing- mild, neurogenic pain of lower extremity, left, Legs seemed to get weak, wobbly and achy, mild vertigo, standing and walking for more than a short distance caused extreme fatigue, weakness and some dizziness, severe body aches. The outcome was not recovered for bilateral tinnitus, when walking legs had visible shaking and recovered for skin changes and nausea in 2021, whereas the outcome was unknown for rest of the events.  Follow up (23Aug2021) New spontaneous report received from a contactable other HCP (health care professional). This other HCP (patient) reported in response to HCP letter [sent to physician] via follow-up letter which includes: New events added, seriousness criteria updated, case was assessed as serious and valid.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including audiogram at baseline, counteractive treatment measures and concomitant medications.    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.