Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Asthma, Dysphonia
Clinical narrative: Loss of voice; Asthma; her voice became extremely hoarse; This is a spontaneous report from a contactable nurse. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Mar2021 09:15 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. Family history included sore arm. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (lot number: EN6198) on 23Feb2021 in the right arm for COVID-19 immunization. About 3-4 days after (as reported), her voice became extremely hoarse, in which she lost a voice for 3 weeks. She mentioned that she was diagnosed with Asthma on 23Mar2021 and was started with a Breo Ellipta inhaler. The Breo had a listed side effect of hoarseness of voice in which she started a week after receiving the vaccine, to which her hoarseness became worse. She mentioned that according to the paperwork she received from Pfizer, hoarseness of the voice was also listed as a side effect. She consulted with her Pulmonologist who determined that the inhaler was working pretty well and would like to continue her on it and wanted to see if the hoarseness is still there by May. As of calling, she already has some of her voice back, but the hoarseness was still continuing, which gets worse in the afternoon or evening. She would like to know if this has been reported and for how long it will last. She had the injection/vaccine and hoarseness started about a week before she started on the Breo Ellipta inhaler (NDC: 01730859-10 Lot: UL4F Expiration: 10/2022 Dose: 100mcg/25mcg). She stated they both can cause the same thing with hoarseness. She clarified that when she lost her voice, it was just above a whisper. It had gotten progressively worse since it started a week prior. It lasted almost 3 weeks. Now she has started to get her voice back, but still has the hoarseness and this was as good as her voice gets, it gets worse in the afternoon and by 2:00 P.M. it was back down to no voice. She went down to see the pulmonary specialist and prescribed her 2 different inhalers. The specialist said it was an unusual hoarseness, but he couldn't tell what one it was from. The patient clarified she experienced the hoarseness first from the Pfizer Covid Vaccine after the second vaccine, and then a week later she started on the Breo Ellipta, and the hoarseness got worse. The doctor wants to wait until 19May2021 and see if she still has the hoarseness and then he might switch, but it was working so well, he didn't want to switch her yet. The patient was prescribed Breo Ellipta and Albuterol but she hasn't used the Albuterol. The patient reported that she considers the event as medically significant because hoarseness can cause cancer and she doesn't want it to get worse. No other vaccines administered on the same date of the BNT162B2 and no prior vaccination. The event hoarseness started on 18Mar2021 and loss of voice on 23Mar2021. The events did not require a visit to the emergency room. The outcome of the event hoarseness was not recovered, Loss of voice recovered on 13Apr2021 and asthma was unknown. The events hoarseness and loss of voice was reported as serious-medically significant.  Follow attempts are possible. Further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Hoarse voice and Loss of voice cannot be excluded.  The case will be reassessed if additional information becomes available.  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.