Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain
Clinical narrative: Could not sleep, after the second vaccine; Headache, after the second vaccine; Body hurt, and she was in a lot of pain, after the second vaccine; This is a spontaneous report from a contactable consumer (the patient). A 32-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196) via an unspecified route of administration, in left arm on 19Jun2021 18:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation (reported as to protect herself from Covid) at pharmacy. Medical history included anxiety. Concomitant medication included paroxetine taken as anti-anxiety from an unspecified start date (reported as long time ago, 6 months ago) and ongoing. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 0509) via an unspecified route of administration, in left arm on 28May2021 16:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation at pharmacy. No additional vaccines administered on same date of the Pfizer vaccine. No prior vaccinations (within 4 weeks). On 19Jun2021 (reported as after 18:00), the patient experienced body hurt, and she was in a lot of pain, after the second vaccine. On 19Jun2021 22:00, the patient experienced could not sleep, after the second vaccine, headache, after the second vaccine. It was reported that Caller is a consumer who is complaining of insomnia ever since she received the Pfizer Covid vaccine. Caller stated that for the first two days, her body hurt, and she was in a lot of pain. She took Tylenol, every 4 hours, and reclarified, that it was helpful. From Monday to Friday, she could not sleep at all. She took Melatonin, to sleep, and only slept a total of 5 hours. Melatonin helped a little bit. Caller reported that usually, she would sleep for 12 hours a night, without any medication. Caller agrees to file a safety report. Adverse Event: Body hurt, a lot of pain: Time: after 18:00 and reports that she is in no pain right now. Outcome: caller answers as she is recovered with a headache, because she could not sleep. Could not sleep: Time: 22:00 Headache: Time: 22:00. Outcome: caller answers as it got better, when she took Tylenol, but she still has a headache. Caller asks if not being able to sleep, has been reported. Response: A review of the Prescribing Information did not find information regarding adverse reaction. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take. Are you guys going to give me medications or what do I do. Response: Beyond what is described in the prescribing Information, Pfizer does not provide any recommendations regarding the management or treatment of potential adverse events/reactions/symptoms that a patient /consumer may experience. Caller asks, should she go to the emergency room. Adverse events did not require a visit to Emergency Room and Physician Office. Therapeutic measures were taken as a result of could not sleep, after the second vaccine, body hurt, and she was in a lot of pain, headache, after the second vaccine. The outcome of event body hurt, and she was in a lot of pain, after the second vaccine was recovered on 21Jun2021 and outcome of other events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.