Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoventilation, Investigation, Mean arterial pressure, Oxygen saturation, Physical examination
Clinical narrative: progressive shortness of breath; hypoventilation; dysphagia; severe asthenia; mild upper abdominal pain; inability to eat; This is a spontaneous report from a contactable physician. An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 14Feb2021 (at the age of 83-years-old) as a single dose for COVID-19 immunization. Medical history included right partial nephrectomy for renal cell carcinoma (RCC) in the remote past, hypertension, obstructive sleep apnea, hypothyroidism, morbid obesity, motion sickness, unspecified allergy as the patient cannot tolerate anything but paracetamol (TYLENOL), acute on chronic respiratory failure secondary to centrilobular emphysema. Ongoing concomitant medications included levothyroxine sodium (LEVOXYL) tablet, meclizine hcl tablet for motion relief and hydrochlorothiazide/ triamterene (DYAZIDE) capsule. The patient previously took paracetamol (TYLENOL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247) on 22Jan2021 (at the age of 83-years-old) in the left arm and experienced difficulty breathing, ground glass opaque lung problem, weak, nausea, "pain on rt.side waist around to back, down to lower belly", slight temp almost 100. On an unspecified date in Feb2021, the patient presented to the hospital with progressive shortness of breath and inability to eat for two days. The patient reportedly received the second dose of BNT162B2 four days prior to coming to the emergency room (ER). In the ER, the patient reported severe asthenia, mild upper abdominal pain and dysphagia, all as of an unspecified date. The patient underwent a CTA in the ER, on Feb2021, which showed no acute pulmonary embolism, or no ground glass infiltrates. The patient was admitted to the hospital on 21Feb2021 at 17:51 for management of worsening shortness of breath. Due to the patient's acute on chronic respiratory failure secondary to centrilobular emphysema and obesity, hypoventilation (as of an unspecified date in Feb2021) was further complicated by obstructive sleep apnea, thus, the patient was admitted to "MedSurg". The patient did not present with COVID-19 or COPD. The BMP was 226 at the time of admission. The patient was started on supplemental oxygen and additionally started on CPAP at night. She was seen by a pulmonologist who recommended Salmeterol Xinaf/ fluticasone (ADVAIR). Pulmonology also recommended to work-up any underlying unaddressed coronary artery disease contributing to the patient's shortness of breath. The patient underwent an echocardiogram on Feb2021 with regadenoson (LEXISCAN) for her shortness of breath which was within normal limits. As the patient additionally reported dysphagia at the time of admission, she was evaluated by a speech and swallow evaluation specialist as well as a gastroenterologist. A GI swallow series was recommended which the patient underwent on Feb2021 and was found to have no active signs of oropharyngeal or esophageal dysphagia. The patient additionally underwent a physical exam on 24Feb2021 at 08:00 with the following results. Vital signs: Temp: 98.2, Pulse: 69, Resp: 17, B/P (MAP): 98/62 (74), Pulse Ox: 96, O2 Delivery: Nasal cannula, O2 flow rate:2.00. HEENT: Pupils equal round reactive light accommodation, no lymphadenopathy noted, neck vens were apple. CVS: S1-S2 normal, no appreciable murmur rub or gallop noted. Respiratory: Good Inspiratory effort, good air entry bilaterally, no rhonchi, Rales or wheezes heard. Gl: Abdomen soft, nontender nondistended, bowel sounds heard, no organomegaly detected. Extremities: Bilateral lower extremities Shaw no edema, bilateral dorsalis pedis 2+, skin appeared intact. Neurological: Patient alert and oriented x3, strength 5x5 in all 4 extremities, no signs of focal neurological deficits. Skin: No clear breakdown or rashes noted. The patient was being discharged home on 24Feb2021 at 08:04 with a CPAP machine. The patient was prescribed Cefuroxime axetil (CEFTIN) 250mg Tablet orally twice a day; Salmeterol Xinaf/ fluticasone (ADVAIR) 250-50 diskus 1 puff twice a day for progressive shortness of breath and hypoventilation. The patient had been advised to follow-up with a pulmonologist for an outpatient pulmonary function test. The clinical outcome of progressive shortness of breath, hypoventilation, inability to eat, dysphagia, severe asthenia and mild upper abdominal pain was unknown. The reporting physician considered that BNT162B2 had no causal effect on the events reported.  Information on the lot/batch number has been requested.; Sender's Comments: In agreement with the HCP reporter, the reported events  do not appear to be related to the subject vaccine. The events likely represent intercurrent medical conditions, possibly associated with the patient's history of  emphysema. This case will be reassessed upon receipt of follow-up information.  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.