Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Weight
Clinical narrative: swelling in her left armpit; moderate joint pain in her left shoulder blade/  pain in her back or shoulder on the left side; fever of 101.6 degrees Fahrenheit; tiredness; Body ache; feeling bad; soreness under her arm; pain in her back or shoulder on the left side; This is a spontaneous report received from contactable reporter consumer or other non HCP from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (Lot Number / Expiry Date: EL9265 or EL9263, she can't tell/ Unknown Route, Anatomical Location: Left arm), administration date: 28Jan2021, for COVID-19 Immunization, reaction(s): "some tiredness, pain where the shot was and maybe chills", "some tiredness, pain where the shot was and maybe chills", "some tiredness, pain where the shot was and maybe chills"; Pfizer covid vaccine (Lot Number / Expiry Date:EN6200/ Unknown, Route, Anatomical Location: Left dose), administration date: 24Feb2021, for COVID-19 Immunization, reaction(s): "some tiredness, pain where the shot was and maybe chills", "some tiredness, pain where the shot was and maybe chills"; Pfizer covid vaccine (Lot Number / Expiry Date:EN6200/ Unknown, Route, Anatomical Location: Left dose), administration date: 24Feb2001, for COVID-19 Immunization, reaction(s): "some tiredness, pain where the shot was and maybe chills". The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Sep2021, outcome "not recovered", described as "swelling in her left armpit"; ARTHRALGIA (non-serious) with onset Sep2021, outcome "not recovered", described as "moderate joint pain in her left shoulder blade/ pain in her back or shoulder on the left side"; PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "fever of 101.6 degrees Fahrenheit"; FATIGUE (non-serious) with onset Sep2021, outcome "recovered", described as "tiredness"; PAIN (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Body ache"; FEELING ABNORMAL (non-serious) with onset Sep2021, outcome "unknown", described as "feeling bad"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "unknown", described as "soreness under her arm"; BACK PAIN (non-serious) with onset Sep2021, outcome "unknown", described as "pain in her back or shoulder on the left side". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, arthralgia, pyrexia, fatigue, pain.   Additional information:-Patient Weight (kg) was 81.65 and Height (cm) was150 and The caller's states with the first two Pfizer COVID vaccines, she had some tiredness, pain where the shot was and maybe chills the next day. She states she never had any swelling. .Received a transfer call from agent PRIVACY NTID# Report# private. Caller is a 66 year-old female who received the booster dose of the Pfizer Covid-19 vaccine on 28SEP2021 and started to have complains of swelling in her left armpit, moderate joint pain in her left shoulder blade, fever of 101.6 degrees Fahrenheit, tiredness and body ache. Caller stated that she had complaints of tiredness and body ache with the second dose of the Pfizer Covid-19 vaccine. Caller stated that she has taken Tylenol and Ibuprofen after the third dose of the Pfizer Covid-19 vaccine and her temperature is 98.0 degrees Fahrenheit, that the tiredness and body ache has resolved but she still has complaints of swelling in her left armpit and moderate pain of her left shoulder blade. Caller is asking if the armpit swelling, shoulder joint pain, and fever have been reported as side effects of the booster dose of the Pfizer Covid-19 vaccine. Response referred to HCP and vaccination provider. Reviewed EUA PI LAB-1457-14.0 Revised: 22 September 2021 and PI LAB-1448-1.0 License No. 2229. Spoke from EUA PI LAB-1457-14.0 Revised: 22 September 2021 under 6.1 Clinical Trials Experience under Table 8 for Fever >38.4 Celsius to 38.9 Celsius and New or worsened joint pain for Any and Moderate as well as unsolicited Adverse Events overall, the 306 participants who received a booster dose, had a median follow-up time of 2.6 months after the booster dose to the cut-off date (June 17, 2021).In an analysis of all unsolicited adverse events reported following the booster dose, through 1 month after the booster dose, in participants 18 through 55 years of age (N = 306), those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (n = 16, 5.2%).Request Name was REQ-524889 and Product: COMIRNATY Question from Caller stated that the safety agent requested her lot number of the booster dose of the Pfizer Covid-19 vaccine. Caller stated that the lot number is handwritten and illegible on her vaccination card provided by vaccination site.Caller provided the lot number as 3C14 then a 5 or a S followed by an R or an 8 and ends with OA. Spoke with Customer Service agent and provided her with the above information; agent unable to verify a Pfizer Covid-19 vaccine number with multiple possible combinations and got a call back at 2:59 PM 30SEP2021.Response Referred to vaccination provider to confirm lot number that was written by vaccination site on vaccination card. Informed Caller that Customer Service could not verify lot number and tried various combinations of lot numbers with the possible characters provided.Caller mentions she is a patient caretaker for dialysis.When probed to determine the actual name of the booster shot she is referring to the caller states its whatever one they are giving out. She was given all these papers. She clarifies she is referring to the Pfizer COVID vaccine. She sees Pfizer but she can hardly tell what is written beside it. She sees the first two shots on her card and then the booster says other. The caller confirms she received her booster shot on Tuesday, 28 Sep 2021. She initially states she sees C145RA, but then states she doesn't know. She can't read it due to the handwriting. She doesn't know what the first thing says but it maybe reads CI4, the next digit may be 3 or a 5, it's not really clear. She confirms after the booster shot she had pain in her shoulder blade area and then under her arm is swollen some. Her left arm is where she got the shot at and it's swollen underneath. She states this pain and swelling started yesterday. Yesterday, is when she started feeling bad, tired. She took some Ibuprofen and got a little better. Yesterday evening, it came down on her again and she knew she had a fever and she checked it. The caller states the swelling under her arm she has never had before. She states she can feel the soreness under her arm. She looked at it in the mirror and felt it, she can sees it's swollen some and she has tenderness from the swelling. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. Patient had not visited physician office visit and emergency room.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.