Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Body temperature increased, Crying, Emotional disorder
Clinical narrative: a low grade fever; worried; emotional basket case; she experienced emotional side effects stating she felt paranoid and was crying.; she experienced emotional side effects stating she felt paranoid and was crying.; Body temperature running 2 degrees high; Headache; Arm site injection pain; Broke out into a couple of drenching sweats; This is a spontaneous report from a contactable consumer.   A contactable 63-year-old female consumer(patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0186) via an unspecified route of administration on 21May2021 on left arm as a single dose for COVID-19 immunization. The patient's medical history included Asperger's syndrome (From: Unspecified To: Ongoing), she was diagnosed with Asperger's at age 57 and has had this type of reaction with other drugs and foods in the past. She says she has taken antidepressants in the past which caused this type of reaction which included having suicidal thoughts. She had history of high blood pressure (From: Unspecified To: Ongoing) since she was 32 years old. The patient reported that she developed high blood pressure during pregnancy with her first child. She reported that she was never given a chance by her physician to see if her blood pressure would recover on its own after pregnancy, she just put on blood pressure medications, penicillin allergy (From: Unspecified To: Ongoing), she was overweight and had depression and suicidal thoughts with certain medications (From: Unspecified To: Unspecified). The patient reported that almost all antidepressant drugs and certain pain killers for arthritis caused her to have depression and suicidal thoughts. She did not provide details regarding which medications caused her to experience depression or suicidal thoughts. She had sensitivities to medications (From: Unspecified To: Ongoing). She reported that she cannot take any generic form of Imitrex, she can only take the brand name. Also reported that the medication sensitivity runs in her family. Her daughter was allergic to penicillin and had a moderate to severe reaction to the pertussis vaccine at 6 months old. The patient reported that her daughter could not take anything with the ingredients in that vaccine. She reported that her mother also almost died from anaphylactic shock from a penicillin drug. The medication sensitivities run right down the female family line. She did not provide details for medication that resulted in her mother's anaphylactic shock. The historical vaccine of the patient included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0167) via an unspecified route of administration on 30Apr2021 on left arm as 1st dose, single dose for COVID-19 immunization. It was reported that the patient did not receive any prior Vaccinations (within 4 weeks): and did not report any adverse events following prior vaccinations. The concomitants medications included lisinopril and hydrochlorothiazide (Start: Unspecified Stop: Ongoing). The patient reported that she has been taking lisinopril and hydrochlorothiazide since she was 32 years old for blood pressure. The patient reported that she was aware of all the side effects and everything, and kind of knew what to expect. After the second dose on 21May2021 caller reported that much to her surprise at 21:00 hours, her physical side were extremely mild. Body temperature running 2 degrees higher at 98.8 or 99.2 and she still felt ok. She reported that her body temperature normally runs a little low, 97.2 degrees F or 97.6degrees F. The same day she experienced arm site injection pain, she applied Aspercreme and CBD oil. The same day patient also experienced headache. She reported that she does not have a primary care physician. She was drenching sweat she experienced told her that she was running a low-grade fever. She reported that the elevated temperature continued through the night and into the morning of 22May2021. She reported that her body temperature returned to normal after she had the second episode of drenching sweat around 2:00 PM on 22May2021. She reported that she was done with the paranoia and was worried about if the paranoia was coming back, she would not think it was funny. She reported that she got the Covid-19 vaccine because she does not have health insurance and she is also 63, overweight, and has high blood pressure. She stated why would you not get the Covid- 19 vaccine if there was no charge for it and it could save your life and keep you out of the hospital. She stated that the pros of the Covid-19 vaccine outweigh the cons. She does not want other people that have the same issues with the Covid-19 vaccine affecting their mental health to get caught by surprise and think that it was permanent. She woke up the next morning on 22May2021 and did not even think about the arm pain. All the physical stuff was a walk in the park. She did not expect and what took her by surprise was that she was an emotional basket case on the morning of Saturday, 22May2021. She reported that she has had this side effect with various other drugs in the past. At first she did not put two and two together because thats how far removed it has been since she had this reaction to the other drugs. She inquired if becoming an emotional basket case was a known side effect of the Covid-19 vaccine and inquired if mental impact of the Covid- 19 was part of the study and if mental health questions were part of the surveys completed by patients. She reported that emotional changes for her can be associated with certain medications that she takes. She reported that antidepressants in particular will send her into a tailspin. She was encouraged to continue taking antidepressants in the past but stopped when she began feeling suicidal. She did not provide product details for the antidepressants that she experienced adverse events with while taking. She reported that she was basically on a 100% raw organic diet. After she had the second episode of drenching sweats, all of her side effects left. She stated that people may want to know that mental side effects of the Covid-19 vaccine are temporary and that it might happen. On 22May2021, she experienced emotional side effects stating she felt paranoid and was crying. She stated that this had been reported or evaluated for in the trials. The outcome of the events was crying, a low-grade fever and worried was unknown and rest of the events recovered on 22May2021. It was reported that the patient did not require emergency room or physician office visit.  Information on Lot/Batch number was available. Additional information has been requested.