Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Insomnia, Stress
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient. A 76-year-old female patient received BNT162b2 (BNT162B2), on 16Jun2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 76 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Thyroid; "She had panic disorder for 35 years" (unspecified if ongoing), notes: She had panic disorder for 35 years; "Literally no sleep" (unspecified if ongoing), notes: In those years she would have literally no sleep because panic was so, severe.; "She is stressed and anxious" (unspecified if ongoing), notes: she is stressed and anxious; "She is stressed and anxious" (unspecified if ongoing), notes: she is stressed and anxious. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. Vaccination history included: Moderna (I took first three  Covid vaccines with Moderna, Dose 1, LOT: 004M20A), administration date: 09Feb2021, when the patient was 74-year-old, for COVID-19 Immunization; moderna (I took first three  Covid vaccines with Moderna, Dose 2, LOT: 025A21A), administration date: 09Mar2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "Aches and the pains", "Fevers", "Little chills"; moderna (I took first three  Covid vaccines with Moderna, Dose 3, LOT: 037C21A), administration date: 16Nov2021, when the patient was 75-year-old, for COVID-19 Immunization. The following information was reported: ANXIETY (non-serious) with onset Jun2022, outcome was unknown, described as anxious; STRESS (non-serious) with onset Jun2022, outcome was unknown, described as stressed; INSOMNIA (non-serious) with onset 16Jun2022, outcome was not recovered, described as Insomnia/ I am desperate without much sleep. The event insomnia/ i am desperate without much sleep required emergency room visit. Therapeutic measures were taken as a result of insomnia, anxiety, stress. Additional information: I took first three COVID vaccines with Moderna. The second booster with Pfizer. I know the insomnia I am having (6 nights already) is an uncommon side effect. I have read that many others have this Pfizer uncommon side effect. I read that It could go on for weeks or forever. I am desperate without much sleep, if any, and I am taking holistic and prescription meds. Caller endorsed inquiry Caller reported that she read online that 71% did not recover from the insomnia they were experiencing. She is also taking wholistic and prescription medications. She read online that other people have experienced this side effect and that 71% of those did not recover. Caller confirmed details provided by transfer agent. These people she read about are suffering longer than her. She is desperate to know if she will have this forever or if it will go away. She is asking everyone. HCP information: Her doctor is with (Withheld). Caller states she is calling a lot of people and not getting nowhere. She went to Urgent Care today, 22Jun2022. Event Details was 16Jun2022 is when she got the Comirnaty vaccine and the same night insomnia started. The insomnia is ongoing. Outcome of Event: it is hard to say. It depends on how much medication she has to dose herself with. She has been taking natural stuff, homeopathic, and herbal over the counter, and prescription and none of it is working all that well. Caller clarified those things are supposed to help her fall asleep. Comirnaty: Dose: What she read is Pfizer is 30 mcg or whatever unit it is and that seems to be the same. The Moderna the booster was half, the booster was 25. The Pfizer was 30 unknown units. She received it in her right arm. Moderna Vaccine: For the booster it has on the card: MRNA, Moderna-50mcg. That was supposed to be the booster and she thought the booster was supposed to be half. The booster was given on 16Nov2021, EXP: unknown, NDC: unknown The second dose of Moderna Vaccine was given on 09Mar2021. It just says EXP: unknown, NDC: unknown. The first dose of Moderna Vaccine was given on 09Feb2021, EXP: unknown. NDC: unknown. Additional Information Did any AE(s) require a visit to: Emergency Room? No, she was going to go to the emergency room, but her husband said no. She went to Urgent Care. When she was on the phone her doctor's office called and said they would call her back. Prior Vaccinations (within 4 weeks) If applicable: She doesn't know if allergy shots are considered vaccines. She has been getting allergy shots for a lot of years. On 07Jun2022 had regular allergy shots. AE(s) following prior vaccinations: Not insomnia, just the aches and the pains. Little chills and fevers the next day kind of thing. After the second Moderna vaccine, after a week and half she had 5 weeks of a reaction. It was not insomnia though. Caller clarified the adverse events of aches, pains, chills, and fevers she mentioned were all with the Moderna Vaccine. Patient's Medical History Something else to add. She had panic disorder for 35 years. She knows the difference between stress and anxiety and what she can take and the difference between insomnia and when she can't shut her mind off to sleep when anxious and stressed out. Panic disorder is so acute it won't let her body go to sleep. If she would take proper medication, it would put her to sleep. She takes a quarter of the lowest dose pill because she has a sensitive system and that would stop it. In those years she would have literally no sleep because panic was so severe. Lorazepam would calm her down enough it would knock her out. She can't take any of those kinds of things and walk and talk during the day like some people who take Xanax and function. Caller can't. This time with the insomnia the Lorazepam is not doing very well. That is how she knows the difference. Of course, she is stressed and anxious because this is happening, but that is coming later. She can take things to help her relax and she is calm and still can't sleep. It is not because of racing thoughts. Lorazepam: in a pharmacy bottle. Next to barcode there is a number but it doesn't say what that number is. Strength: 0.5mg and she only takes one quarter of that. Caller doesn't have NDC/LOT/EXP to provide. She might take it once every 8 or 10 years. That is how often she doesn't take it. That is something she keeps on her the shelf. It normally puts her to sleep, but this time it is not doing job well. It relaxes her completely but doesn't turn off her brain. She emailed and the previous agent called her back. Is there a phone number? She has called CDC and talked to pharmacist and doctors and is not getting answers. Most don't even know about the insomnia. They will read something that she already knows about. She needs to talk to a lab or research person that knows the product. She needs to talk to a medical professional. Everyone doesn't know. The doctor and pharmacist they don't know. Whoever is creating the Pfizer is who she needs to talk to. She had fear this would happen, no one would know anything. They are just saying take prescription pill. Caller informed that for product specific information she could speak. The caller was provided with phone number of #, option 3, and hours of operation of Monday through Friday, 8AM to 9PM, prior to warm transfer to (Name withheld), Description of Product Complaint: Experiencing 6 nights of insomnia. She has been taking natural stuff, homeopathic, and herbal over the counter, and prescription and none of it is working all that well. Caller clarified those things are supposed to help her fall asleep. She had panic disorder for 35 years. In those years she would have literally no sleep because panic was so severe. I took first three COVID vaccines with Moderna. The second booster with Pfizer. I know the insomnia I am having (6 nights already) is an uncommon side effect. I have read that many others have this Pfizer uncommon side effect. I read that it could go on for weeks or forever. I am desperate without much sleep, if any, and I am taking holistic and prescription meds. Please I need to know if the insomnia will ever stop. Caller is a consumer that states she received the Moderna COIVD-19 vaccine as her primary series and her first booster dose but then received her second booster dose with the Pfizer COIVD 19 vaccine and now is complaining of having insomnia. Caller has been sending emails and talking to the CDC as well as her doctor and pharmacist and no one knows anything about insomnia and the Pfizer COIVD 19 vaccine. She states she went online and saw that other people are having the same problem after the Pfizer vaccine am she is getting no information about is this, like is it going to continue all her life or will it stop? She states it's not one of the common side effects but it needs to be discussed with someone who is medical, can this vaccine cause insomnia? Because according to people on line it has been going for weeks and months. One thing she did print out was from a website and it was a 26Feb2022 study on how many people did have this side effect and talking about clinical trial and publications, and they are doing a study. No follow-up attempts are possible. No further information is expected.