Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain, Chest pain, Cough
Clinical narrative: chest pain; Also have pain discomfort around breast implants; Also have pain discomfort around breast implants; Persistent cough; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (21Sep2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Deltoid Right on 18Mar2021 13:30 (Batch/Lot Number: EN6204) (at the age of 76 years old) as single dose for Covid-19 immunisation. Medical history included cancer, swelling of tongue (allergic reaction), swelling of lips (allergic reaction), blister, shingles, Breast implant rupture in Jun2014 (Silicone implants, old smooth implants ruptured in 2014), breast cancer from 17Mar1986 and from 02Jul2014 (2 X Breast cancer survivor), Scar tissue from 2nd cancer surgery, Modified radical Mastectomy in 1986, Tumor removal on 24Aug2014, and Radiation 33 days from Oct2014 to Nov2014. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 25Feb2021 13:40, intramuscular in right lateral deltoid (at the age of 75 years old) for Covid-19 immunisation. The patient had Flu vaccine on an unknown date for immunization. Patient do get flu vaccine every fall; definitely was more than 4 weeks before, probably 4 or 5 months before BNT162B2. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTECSET) oral, taken for allergy from 1980 and ongoing; paracetamol (TYLENOL) oral, as needed taken for pain from 1960 and ongoing; levothyroxine, oral, 75 mg, 1x/day taken for under active thyroid from 2000 and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY), oral, as needed, taken for allergies from 1980 and ongoing. No immediate adverse reaction, no immediate symptoms at all after the second dose. However, on an unspecified date, the patient has now persistent cough, chest pain occasionally, and she also have pain discomfort around breast implants but that was probably due to patterned implants used this time after old smooth implants ruptured in 2014 and scar tissue from 2nd cancer surgery. On 11Jul2021, the patient went to the emergency room due to the events. The patient did not receive any treatment. Patient reported that chest pain was probably not an adverse effect to vaccine. The patient was going for ultrasound on 16Sep2021. Outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the Limited information in the case, the event Chest pain is assessed as Unrelated to the vaccine BNT162B2 and is probably due to the breast implant. All other events were assessed as Related for reporting purposes. 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.