Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Mammogram, Pain in extremity, Ultrasound scan
Clinical narrative: Caller had a little pain after receiving each dose, couldn't extend arm for 24 hours, that's one side effect caller got from all doses caller received of the vaccine. This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 58-year-old female patient received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, 0.3 ml single (Lot number: EK5730, Expiration Date: 19Dec2020) intramuscular, on 08Jan2021 as dose 2, single (Lot number: EL1284) and on 16Jan2022 at 17:45 as dose 3 (booster), 0.5 ml single (Lot number: FL3197, Expiration Date: 30Jun2022) at the age of 58 years intramuscular, in left deltoid for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller had a little pain after receiving each dose, couldn't extend arm for 24 hours, that's one side effect caller got from all doses caller received of the vaccine.". Relevant laboratory tests and procedures are available in the appropriate section. Started having pinpoint under her armpit, a shooting pain under her armpit, pain was spreading under caller's armpit  What was the dose, dosage units, formulation, route of administration and frequency when the adverse event occurred? 3rd dose, booster dose; intramuscular in left deltoid, dose unknown, thinks 0.5ml Indication Healthcare worker; Additional Information: Caller is calling about the Pfizer covid-19 vaccine booster dose. Caller is a Registered Nurse. Caller received the 1st and 2nd dose of the vaccine and was doing a traveling assignment in (withheld), and caller was requested to get the booster dose, which caller received 16Jan2022 in caller's left arm. Caller confirmed this was her 3rd dose of the vaccine. In Feb2022 caller started having pinpoint under her armpit, a shooting pain under her armpit. Came back in Mar2022 to start a new job and the pain was spreading under caller's armpit. Caller has a job and insurance, brought this up to the doctor, had an ultrasound of her left armpit and mammogram of left breast. HCP information: Caller saw the doctor once, doesn't remember the name of HCP, knows HCP is with (withheld). HCP address, phone number, email address: Unknown. Event details: Only reason caller is calling is when she went to get the ultrasound and mammogram they asked caller if caller got the vaccine and if caller got the booster dose of the vaccine. Then caller looked at the date she got the vaccine and the date she had the pain. Caller went online this morning and saw where there was mentioned that some people are having swollen lymph nodes after the booster, says some people when they go do mammograms, think it is cancer, doctors say no, they are saying the swollen lymph nodes should disappear in 4-6 weeks but caller's pain has not, caller doesn't think her lymph node is swollen. Caller can feel where the pain has initially started and the pain is spreading under caller's armpit. Caller didn't know about this, did the mammogram and ultrasound yesterday and the technician kept asking caller the same questions about the vaccine booster so caller went to see when she received the booster dose and when she stated having the pain, caller received the booster dose 16Jan2022 and then the pain started Feb2022. Started having pinpoint under her armpit, a shooting pain under her armpit, pain was spreading under caller's armpit: Start date of adverse event: Unknown specific date, sometime in Feb2022. Stop date of adverse event: The dull pain is ongoing, but the shooting pain is not constant. Seriousness criteria: Very dull pain, a 1 or 2, can feel the discomfort, but sometimes the pain can increase like a shooting pain. When the pain is shooting, the pain goes towards caller's breast. Caller confirms the pain is under caller's armpit on the left side. COVID-19 vaccine: All 3 doses caller received were the Pfizer COVID-19 vaccine. 1st dose: Date: 19Dec2020, NDC number, lot number, expiration date: Says Pfizer COVID-19 vaccine, 0.3ml, says BUD1500, expiration date: 19Dec2020, lot number: EK5730. Dose and route: 0.3ml, intramuscular in deltoid but doesn't say that on the card. 2nd dose: Date: 08Jan2021, NDC number, lot number, expiration date: Lot number: EL1284, this one does not have an expiration date written on the card. Dose and route: No dose written on the card. 3rd dose, booster dose: Date: 16Jan2022 NDC number, lot number, expiration date: Says Pfizer COVID-19 vaccine BNT162B2, lot number: FL3197, expiration date: 30Jun2022. Dose and route: Intramuscular in left deltoid, dose unknown, thinks 0.5ml. Causality: Thinks so, because didn't have any pain before and when caller went for tests the technician asked caller if caller received the booster dose, that's when caller put 1 and 1 together and read about it online. If caller had known caller wouldn't have taken the booster dose, had to take the booster dose for job. The pain doesn't go away. Tests: Caller did the ultrasound, mammogram, and chest x-ray, hasn't gone to the doctor yet. Said they don't see anything when caller had the tests done, maybe caller needs as CT scan to see what's going on. Confirmed caller didn't see the doctor yet, the person who did the tests said they don't see anything and that caller needs to go to the doctor to have other things done. Caller had a little pain after receiving each dose, couldn't extend arm for 24 hours, that's one side effect caller got from all doses caller received of the vaccine. Vaccine Supplemental Form: 1. Patient Details: Patient Last Name: (name withheld) First Name: (name withheld) Address: withheld Phone: # 2. Patient Age at Time of Vaccination in Months: or Years: 58 3. Pfizer Suspect Vaccine and Vaccination Details: NDC number, lot number, expiration date: Says Pfizer COVID-19 vaccine BNT162B2, lot number: FL3197, expiration date: 30Jun2022. Dose and route: Intramuscular in left deltoid, dose unknown, thinks 0.5ml. Time the Vaccination Was Given: About 5:45PM Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left deltoid 4. Only: Vaccination Facility Type: Hospital, Vaccine Administered at Military Facility? : No Vaccination Facility Address: Facility Name: (withheld) Address: Unknown Phone: Unknown 5. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): All 3 doses caller received were the Pfizer COVID-19 vaccine. 1st dose: Date: 19Dec2020, NDC number, lot number, expiration date: Says Pfizer COVID-19 vaccine, 0.3ml, says BUD1500, expiration date: 19Dec2020, lot number: EK5730. Dose and route: 0.3ml, intramuscular in deltoid but doesn't say that on the card. 2nd dose: Date: 08Jan2021, NDC number, lot number, expiration date: Lot number: EL1284, this one does not have an expiration date written on the card. Dose and route: No dose written on the card. Route, Anatomical Location: Caller thinks she alternated deltoids for previous doses because caller had a little pain after receiving each dose, couldn't extend arm for 24 hours, that's one side effect caller got from all doses caller received of the vaccine. 6. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: No 7. Adverse Event (AE) Details: Provide the time of onset of AE(s): Adverse Event: Started having pinpoint under her armpit, a shooting pain under her armpit, pain was spreading under caller's armpit. Confirmed caller's left armpit. 8. Additional Information: Did any AE(s) require a visit to: Emergency Room? No Physician Office? Was on traveling assignment, when caller got a new job and came back that's when caller went to the doctor. 9. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No 10. AE(s) following prior vaccinations: Had a little pain after receiving each dose, couldn't extend arm for 24 hours, that's one side effect caller got from all doses caller received of the vaccine. 11. Patients Medical History (including any illness at time of vaccination)? None 12. Family Medical History Relevant to AE(s): Not provided 13. Relevant Tests: Caller did the ultrasound, mammogram, and chest x-ray, hasn't gone to the doctor yet. Said they don't see anything when caller had the tests done, maybe caller needs as CT scan to see what's going on. Confirmed caller didn't see the doctor yet, the person who did the tests said they don't see anything and that caller needs to go to the doctor to have other things done.