Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Back pain, Blood pressure abnormal, Blood pressure measurement
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021344687 (Pfizer). A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 15:00 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single and administered in arm left, administration date 20Mar2021 17:00 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "lots of pain in the muscles"; ASTHENIA (non-serious) with onset 01Mar2021, outcome "not recovered", described as "feel weak / Weakness"; FATIGUE (non-serious) with onset 01Mar2021, outcome "recovering", described as "Fatigue"; PAIN IN EXTREMITY (non-serious), ABDOMINAL PAIN UPPER (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "pain / pain in her legs, stomach and back"; GAIT DISTURBANCE (non-serious) with onset Mar2021, outcome "not recovered", described as "has difficulty walking"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "she continues to have high blood pressure"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "she woke and her legs were asleep"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Event: Pain was reported as worsened". The events "lots of pain in the muscles", "feel weak / weakness", "fatigue", "pain / pain in her legs, stomach and back", "pain / pain in her legs, stomach and back", "pain / pain in her legs, stomach and back", "has difficulty walking", "she continues to have high blood pressure", "she woke and her legs were asleep" and "event: pain was reported as worsened", were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reason for no lot number: of COVID Vaccine: Other: Consumer stated, "EN6205, I don't it is ENG6205 or EN6205 not." Investigation Assessment: Yes. Consumer stated, "I put my vaccine the day of 27Feb and I am having side effects. I have lots of pain in the muscles, in the muscles and I am feeling weak." When confirmed Vaccine name if it is Pfizer COVID Vaccine.: Consumer stated, "Yes." When confirmed for the vaccination date if it is 27Feb2021: Consumer stated, "Yes." Prescribing healthcare professional details: LOT#, Expiration date, NDC# and UPC#: Consumer stated, "EN6205, I don't it is ENG6205 or EN6205 not." Treatment: Consumer stated, "Yesterday I went to emergency you know I went to the emergency yesterday." Lab work: Consumer stated, "Yes they give a blood test off course yes (name was not confirmed over the call hence not captured)." Reassurance: Consumer stated, "They are going to call me from nurse or someone. Someone is going to call me nurse or someone. I called because I want help". Caller received the second dose of the Covid-19 vaccine on 20Mar2020. She has had a lot of pain. She received the first dose on 27Feb2021. Clarifies that she started having pain after the first dose. She first said it lasted for several days but it is ongoing. She went to the emergency room but was sent home. She also has had fatigue and weakness. She had a lot of pain yesterday. She has had pain in her legs, stomach and back. The fatigue has gotten better. She is unable to clearly read Lot number that is on the card. It is either ENG205 or EN6205. She received the second dose of the vaccine on 02Mar2021. Lot is EP7534, or EP1534. Unable to clearly identify. Expiry and NDC were not provided on the vaccine card. She received the first dose in her left arm at 15:00. She received the second dose also in her left arm at 17:00. She also went to the emergency room after the first dose because she was so weak. She was checked and was told ok and sent her home. They told it a was a reaction from the vaccine. She was fine but had blood pressure was high. Now she continues to have high blood pressure. Every week she goes to the doctor. She is scared because of the pain in her body. She is asking is the pain going to pass. She also went to the emergency because she woke and her legs were asleep. She was scared. She called her doctor and they had a video call. Her doctor sent her to the emergency room. Pfizer Suspect Vaccine and Vaccination Details: Vaccine Lot Number: She is unable to clearly read Lot number that is on the card. It is either ENG205 or EN6205. Time the Vaccination Was Given (24 hour clock): 15:00. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left arm. History of all previous immunization with the Pfizer vaccine considered as suspect: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Did any AE(s) require a visit to: Emergency Room yes, Physician Office yes. Prior Vaccinations (within 4 weeks): None. Patient's Medical History (including any illness at time of vaccination): None. Family Medical History Relevant to AE (s): None. Relevant Tests: None. PQC Present: No. Caller received both doses of the Pfizer-BioNTech COVID-19 Vaccine (First dose last 27Feb2021 & Second dose on 20Mar2021). Caller reported to have "a lot of pain in body", fatigue, weakness, and difficulty to walk. Caller asked if this would go away from Safety, documenting possible duplicate AE, e-transmitting report for review (49 years old, Female). No follow-up attempts are possible; information about lot/batch number cannot be obtained.