Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: headache; malaise; she was exhausted for 4 days and with the second shot, it was the same thing/ a little confused and tired; a little confused and tired; a little confused and tired; felt dizzy; tired for 4 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Pregnancy" (unspecified if ongoing), notes: Pregnancy 22 weeks, 5 months pregnant; "She broke out into hives all over her body" (unspecified if ongoing); "allergic to amoxicillin and penicillin" (unspecified if ongoing), notes: allergic to amoxicillin and penicillin She broke out into hives all over her body., LOT, EXP: Unknown. The patient's concomitant medications were not reported. Past drug history included: Allergic to amoxicillin and penicillin, notes: allergic to amoxicillin and penicillin She broke out into hives all over her body., LOT, EXP: Unknown. The following information was reported: DIZZINESS (non-serious) with onset Apr2021, outcome "recovered", described as "felt dizzy"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered", described as "tired for 4 days"; HEADACHE (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "she was exhausted for 4 days and with the second shot, it was the same thing"; CONFUSIONAL STATE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "a little confused and tired".  Additional information: The reporter stated that she had a first and second dose. She states she is getting her first booster shot and when she got her first shot, which was just the regular ones. She states she was forced to get it at work as a requirement. This will be her first time taking the booster shot today and she has a lot of concerns. She is calling to get a professional opinion about this. The reporter was concerned because she noticed with the 1st COVID shot she went through an episode where she had gotten upset about something, felt dizzy and was very tired for 4 days. She wanted to get her booster shot but she was worried as she was 22 weeks pregnant, 5 months and does not want it to affect the baby if she would be feeling like this. She wants to know if she should wait. She noted that "My primary care provider, when I mentioned to him I was extremely tired for 4 days. In the beginning after vaccine, I was fine, but then I got upset about something, phone call from mother who made me upset, and I felt like a headache and got dizzy so I sat down. I calmed down and it did go away but I did feel dizzy after for 1 hour." She states that her symptoms sound like malaise, so reported side effect. Her provider said "Oh, if you had severe symptoms that your body can't handle it, you shouldnt get the booster." He wrote a letter, as she works in the medical field, "that its not mandatory due to the symptoms she had. Her Gynecologists encouraged her to get the booster due to concerns of the "new virus." So she had one provider telling her to not do so and has wrote a letter excusing her and then the other provider advising to get it. She called Pfizer to determine if the product was safe during pregnancy. She wants to know if there had been any reports of miscarriages'. She wants to know if the animals tested were pregnant during testing. Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Pfizer and BioNTech performed a study in animals. Female rats were given an injection into their muscle. The injection included the same amount of mRNA and other ingredients as a single human dose of COMIRNATY. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. Recommendations from the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices are available to your healthcare provider to inform this discussion. The reporter wanted to know if this was a common symptom of the vaccine, for them to feel tired and weak as malaise describes exactly what she experienced. She was concerned as she felt she was "back to square one, as she felt she has not got the answer nor any help. She was working in an optometry office as an optician. She was being around lot of people and it was a requirement. The patient did not receive prior vaccinations within 4 weeks.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.