Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Menstrual disorder, Pain in extremity, Vaccination site pain
Clinical narrative: Pain in left arm injection site, left breast and left ovary; Pain in left arm injection site, left breast and left ovary; Pain in left arm injection site; Headaches; but she did not feel well for a week after first dose; arm pain; exhausted and tired; Dizziness; Menstrual cycle was off and it took a few months to regulate again.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 43-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Apr2021 (Lot number: EW0162, Expiration Date: 31Jul2021) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "surgery on her left ovary" (unspecified if ongoing), notes: Years ago, she had surgery on her left ovary and left breast.; "surgery on her left ovary and left breast" (unspecified if ongoing); "Pain" (unspecified if ongoing); "anaemia" (unspecified if ongoing), notes: she has extreme pelvic pain with period and anaemia; "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aleve, reaction(s): "Allergy to some medications", notes: Allergy to some medications: Aleve, Naproxin Sodium, Ibuprofen and Ampicillin.; Naproxen sodium, reaction(s): "Allergy to some medications"; Ibuprofen for Dental surgery, reaction(s): "Allergy to some medications"; Ampicillin, reaction(s): "Allergy to some medications". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovering", described as "Menstrual cycle was off and it took a few months to regulate again."; VACCINATION SITE PAIN (non-serious) with onset 25Apr2021, outcome "recovering", described as "Pain in left arm injection site"; HEADACHE (non-serious) with onset Apr2021, outcome "recovering", described as "Headaches"; DIZZINESS (non-serious) with onset 2021, outcome "recovering", described as "Dizziness"; BREAST PAIN (non-serious), ADNEXA UTERI PAIN (non-serious) all with onset 25Apr2021, outcome "recovering" and all described as "Pain in left arm injection site, left breast and left ovary"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "but she did not feel well for a week after first dose"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm pain"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "exhausted and tired". Relevant laboratory tests and procedures are available in the appropriate section. Additional information Time the Vaccination Was Given: 13:00 but not sure. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Adverse Event (AE) Details: Provide the time of onset of AE(s) was Unknown for times for all adverse events. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. AE(s) following prior vaccinations was none. Illness/AE: Allergy to some medications: Aleve, Naproxin Sodium, Ibuprofen and Ampicillin. No manufacturer, lot or expiration for any of them. She has not taken any in years. Onset Date: Years ago. Was Unknown. It was so many years ago. She was given Ibuprofen for Dental surgery and she had a reaction. With the Aleve, it was after birth of third son in 2014 that she had reaction to it. Family Medical History Relevant to AE(s) was none. Relevant Tests was none.  He has a consumer on the line regarding the Pfizer BioNtech COVID 19 vaccine with an adverse event to report. He and wife both received vaccine series and stated for him, he experienced residual pain in arm that lasted greater than 2 1/2 months. Now it radiates into the bone and upper muscle of arm into his back. This was after 2nd dose of vaccine as with 1st dose, he did not experience it. He went to his doctor about it and doctor said it could be bursitis and could be related to injection technique. They could have hit a nerve in his arm. He called initially to ask questions, but they were not pertinent to this adverse event. He did not report anything with his wife. Reporter clarified information above. Within 2 weeks behind him, his wife she did have some noticeable difference in her cycle and some uncoordination being weak. She feels like she has some uncoordinating actions. This report is to capture information for her. Wife came on the line and reported for herself. Call recording notification provided. She did not have an email for prescriber. She did call her OB -GYN office after this because she wanted it to be documented. Initially, she read report with women who have reports with Menstrual cycle. She has close friends and online reports. They did experience increased pain and lack of cycle and it did come back. She feels like it affects hormone levels. She confirmed that she did not have any specific people to complete report for Years ago, she had surgery on her left ovary and left breast. So both the left breast and left ovary, she had a lot of pain in.  Her doctor stopped her period because she has extreme pelvic pain with period and anemia. This was prior to getting vaccine. She got her period after 2nd dose of vaccine. It was probably within a few days of getting the vaccine. It has resolved now, but it was close to 3 months or so that she had the off balance. She had first dose on 25Apr2021, and second dose on 16May2021. She did not start getting cycle back on track until mid Jul2021. It started with 1st dose and increased with second dose.  After first dose she had pain in left arm at injection site and same side she had breast pain and ovarian pain where she had previous surgery. Start date was 25Apr2021. It has improved.  Pain in left breast and left ovary started a few days after the first dose. It has improved.  Lack of menstrual cycle and off-balance issue was relative to change in hormones. It was the cycle and sometimes she felt dizzy. It is because it is a domino effect and it threw off hormone and because of shift in hormones, she had headaches and dizziness.  Headaches - started within a day or two of getting first dose. Symptoms are milder. Dizziness was not so much with first dose, but with second dose more. It started 27Apr2021, or 28Apr2021. Some of it was immediate. It was mostly arm pain, but she did not feel well for a week after first dose. The arm pain has improved. Second dose hit her hard. She felt 3-4 days after first dose, she just had arm pain. Then after second dose, she felt like she had the flu. She was really exhausted and tired. That started afternoon of the first dose, and she really felt it more with second dose. It has improved.  Overall, she does not feel like herself. She feels achy all over and does not feel 100% but can still function. She does not know this long after vaccine that it should still feel it. She said maybe it is just lifestyle or vaccine. Before she had the vaccine, she was tested for inflammation and had blood test and they were good. Both doses given in the left arm in the muscle. 2nd dose given on 16May2021 Lot EW0170 Expiration 31Aug2021. Unknown for NDC, dose, formulation. She does not take any other medications and has no other medical conditions or test results. The adverse event did not result in Emergency Room nor Physician Office.  No follow-up attempts are possible. No further information is expected.