Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: muscle ache; that every morning when she wakes up at 6  that she is laying in bed and feeling dizzy when she gets up/ light-headedness; allergic reaction to the vaccine or side effect; has a hard time sleeping/causing trouble sleeping; smelling the fumes, exhaust fumes /smell follows her all over the place; fever; headache; chills; she also lost her sense of smell; Body ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101418177 (Pfizer).  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 17Sep2021 (Lot number: FC3183) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAROSMIA (non-serious) with onset 22Sep2021, outcome "not recovered", described as "smelling the fumes, exhaust fumes /smell follows her all over the place"; PYREXIA (non-serious) with onset 18Sep2021, outcome "recovered" (2021), described as "fever"; HEADACHE (non-serious) with onset 18Sep2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 18Sep2021, outcome "recovered" (21Sep2021), described as "chills"; SLEEP DISORDER (non-serious) with onset 22Sep2021, outcome "not recovered", described as "has a hard time sleeping/causing trouble sleeping"; ANOSMIA (non-serious) with onset 18Sep2021, outcome "not recovered", described as "she also lost her sense of smell"; PAIN (non-serious) with onset 18Sep2021, outcome "recovered" (21Sep2021), described as "Body ache"; MYALGIA (non-serious), outcome "recovered", described as "muscle ache"; DIZZINESS (non-serious), outcome "recovering", described as "that every morning when she wakes up at 6  that she is laying in bed and feeling dizzy when she gets up/ light-headedness"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction to the vaccine or side effect". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:Caller was calling on behalf of his mother. Caller stated after the first vaccine, his mother experienced smelling exhaust fumes and asks if this has been reported, and if it has been reported, what is the recommendation or plan of action to take that the family physician has not been aware of to help her overcome this? Caller states she did consult with a family physician and they recommended to reach out to Pfizer, she doesnt know what could cause this. Caller states his mother took the first dose 5 months after recovering from Covid and had some fever, headache, and chills that went away. Caller states that five days after being vaccinated the first time she started smelling the fumes, exhaust fumes and was passing by a property where there were landscapers and started up a lawnmower that produced the smell and now the smell follows her all over the place. Caller stated she smells it outside his place where there are no cars running and everywhere. Caller stated she smells it when she is asleep and wakes up smelling it and wakes up in the night because of the smell. Caller stated there has been cases online that they have reported similar instances during Covid and not the vaccine. Caller stated she took the first dose about 20 days ago. Caller stated he and his Mothers doctor is suspecting that she is having an allergic reaction to the vaccine or side effect. Caller stated his mother had an ongoing smell of exhaust fumes for the past 7 or 8 days. Caller stated she always can smell the exhaust fumes and it did not go away. Caller stated when she took the vaccine, she also lost her sense of smell and it was replaced by exhaust fumes. Caller stated her smell had not been great, as she is recovering from Covid which she had 5 months ago before her vaccine.  Smell of exhaust fumes, which is causing trouble sleeping (From On day 5 after the vaccine), Loss of smell (From Caller thinks the next day after the vaccine). Caller stated the loss of smell was taken over by the exhaust smell, but she still could not smell. Fever(From the next day after the vaccine) and lasted 3 days on and off, Headache (From: the next day after the vaccine) but it is still on and off. It was periodic, Chills (From next day after the vaccine) it lasted for 3 days, Body ache (From next day after the vaccine) and lasted for 3 days. Caller reported previously after receiving first dose that his mom was feeling dizzy when she got up. DSU states this happened once or twice a day. DSU states she experienced a constant smell of exhaust fumes that would not go away, fever, headache, muscle aches, and loss of smell for three days. DSU states she provided caller with Pfizer Legal's address and fax number regarding reimbursement inquiry. DSU states she explained the process of safety data reporting and follow-up to the caller. Caller states, " mother had been experiencing exhaust fumes smell for a few weeks since her first dose of the Pfizer Covid vaccine. She also has been experiencing light-headedness early in the morning between 6AM and 7AM when she wakes up. She is still lying down when she is experiencing this, and she has to slowly sit up and recover. This happens several times during the day but not as severe." Caller asking for recommendations/medical advice on what to do for these symptoms as well as what kind of doctor to see. Caller asking if Pfizer is responsible for paying for his mother's treatment and office visits. Caller asking why Pfizer has not followed up yet with his mother's doctor after his previous report to DSU. Caller asking if there is guidance from Pfizer on who should not get the second dose of the vaccine and if Pfizer can provide a medical exemption for his mother. Caller requested Fact Sheet for Recipients and Caregivers be sent to provided email address.Caller stated that a week or two ago that he reported side effects of the Covid vaccine for mother. Stated there was missing information that he was able to obtain and there was another side effect. Stated that he reported previously that she started having constant smell of exhaust fumes that does not go away and is 24/7. Stated that he reported previously that when she took the vaccine that she had fever, headache, muscle ache and loss sense of smell for three days. Stated that she took the Covid test to make sure she did not have Covid and it came back negative. Provided a lot number of FC3183 that was not provided previously. Stated that she is reporting that every morning when she wakes up at 6 that she is laying in bed and feeling dizzy when she gets up. Stated that she has to sit up slowly. Stated that it slightly goes away and happens once or twice during the day. Wanted to know why they had not followed up with her or the doctor. Stated that the first dose 17Sep2021 was the date missing from the initial report. Provided a previous report reference number of #. Stated that her doctor told her not proceed with the second dose because she was having adverse reactions to this. Wanted to see what is being recommended once experiencing this type of side effect, if this common and next step to deal with it to overcome should she go to a specialist, is the cost regarding office visit and procedures will they be covered by insurance, out of pocket or will Pfizer be responsible for the cost. Wanted documentation exempting her from second dose due to her having allergic reaction to vaccine or should she contact physician's office. Phone Out 16:34, 2nd attempt by phone to HCP to obtain mailing information. Phone out to HCP. Phone answered by an assistant (name not provided) who provided the physician's mailing address.  Follow-up (08Oct2021), Follow-up (21Oct2021) and Follow-up (27Oct2021) : This is a follow-up spontaneous report from a contactable consumer.  Follow-Up (02Nov2021): Follow-up attempts are completed. No further information is expected