Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pain in extremity, Paraesthesia, Respiratory rate increased
Clinical narrative: experienced pain and soreness to her arm; extreme tiredness and fatigue; heavy breathing; tingling/right ear and the ear started itching and tingling; slanting to the left when she walks; extreme tiredness and fatigue/felt drained immediately and was very extremely tired; she had the booster dose; itching in my right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Oct2021 (Lot number: FF8839) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pollen allergy" (unspecified if ongoing), notes: she is maybe having a slight reaction to the weather and maybe pollen is high so she overlooked that. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose , Lot number: EN6200, vaccine were administered into her top of the right arm), administration date: 22Feb2021, when the patient was 71 years old, for COVID-19 Immunization, reaction(s): "she was falling asleep in the car and it almost caused her to get in an accident so she pulled over and had to sleep for a while and then drive home."; Bnt162b2 (2nd dose , Lot number: EN6206, vaccine were administered into her top of the right arm), administration date: 16Mar2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Oct2021, outcome "unknown", described as "she had the booster dose"; EAR PRURITUS (non-serious) with onset Oct2021, outcome "unknown", described as "itching in my right ear"; PAIN IN EXTREMITY (non-serious) with onset 03Oct2021, outcome "unknown", described as "experienced pain and soreness to her arm"; FATIGUE (non-serious) with onset 03Oct2021, outcome "not recovered", described as "extreme tiredness and fatigue"; RESPIRATORY RATE INCREASED (non-serious) with onset 03Oct2021, outcome "unknown", described as "heavy breathing"; PARAESTHESIA (non-serious) with onset 03Oct2021, outcome "unknown", described as "tingling/right ear and the ear started itching and tingling"; BALANCE DISORDER (non-serious) with onset 03Oct2021, outcome "unknown", described as "slanting to the left when she walks"; FATIGUE (non-serious) with onset 03Oct2021, outcome "unknown", described as "extreme tiredness and fatigue/felt drained immediately and was very extremely tired". The events "itching in my right ear", "experienced pain and soreness to her arm", "extreme tiredness and fatigue", "heavy breathing", "tingling/right ear and the ear started itching and tingling", "slanting to the left when she walks" and "extreme tiredness and fatigue/felt drained immediately and was very extremely tired" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of respiratory rate increased.  Additional information: Patient took the Pfizer Covid booster dose on a Sunday morning and at 9-10:00am her husband and she both did that at withheld and her symptoms did not happen immediately but she came home 2-3 miles from her house and by the time she got to the house which may be 10-15 minutes from the time she was administered the booster shot she immediately felt like someone had poured water on the wicked witch and she withered away and felt drained immediately and was very extremely tired and it was like she immediately dropped like a drug in her face and it was a drug and told her husband she was so tired. Caller states she had a similar reaction after the 1st dose of the Pfizer Covid vaccine when she took it which required her to stay overnight close to the facility where she had it administered because coming home she was falling asleep in the car and it almost caused her to get in an accident so she pulled over and had to sleep for a while and then drive home. States with her 2nd dose of the Pfizer Covid vaccine this did not completely happen but with the booster vaccine the fatigue was so advanced and is ongoing very much and as a result of this people are asking has this impacted the callers other functions and what she ends up doing now is she gets up and walks and she walks to a slant and no one figured out that maybe it is something going on with her like the itching or something and she did have itching maybe 3-4 weeks ago and went to the allergist and they did not find anything wrong. States she has had heavy breathing and they told her to keep taking her nebulizer and she is on that but they said to continue to take the nebulizer and she is maybe having a slight reaction to the weather and maybe pollen is high so she overlooked that.   As per product complaint information vaccine supplemental form completed in additional context. Caller states she is calling about the Pfizer Booster and just needed to find out whether or not after taking the booster shot she immediately had side effects and should say an hour into it and since this time she has continued to have side effects. States she has had heavy breathing and they told her to keep taking her nebulizer and she is on that but they said to continue to take the nebulizer and she is maybe having a slight reaction to the weather and maybe pollen is high so she overlooked that. Caller states for the nebulizer to keep in mind she is wondering whether or not she was administered the nebulizer prior to the covid vaccine and maybe she was but the name is a doozy for the long name and it is Fornoterol-Budesonide-Pratropium and does not have the dosage of strength of it but just has that information on it and then she is supposed to mix it with fluid that is in some kind of plastic tube and the nebulizer is weak enough that they can give it to babies when they need nebulizer treatments and for the NDC she sees there are 5 threes in it and the NDC is # and says discard after 18May2022, has her name and Rx number on the label and states she does not see anything else other than the number and the name of her pharmacy and no lot or expiry date located.  No follow-up attempts are possible. No further information is expected.