Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Investigation, Laboratory test, Rash
Clinical narrative: Wiped out; tired; Headache; Rash; Flushed; Redness; Warmth; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 (at the age of 70-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing asthma Has had for years, ongoing diabetes Has had for 4 years, allergies with medications, Penicillin causes an anaphylactic reaction and this is when she was ten years old , urticaria With Sulfas she gets hives. She was on these various Sulfa medications when she was in her 30s-40s, she takes it to protect kidney due to diabetes. Concomitant medication included ongoing glipizide (2.5mg with dinner ) taken for diabetes mellitus; Ongoing fluoxetine hydrochloride (PROZAC) (20mg once a day) taken for depression; dulaglutide (TRULICITY) 1x/day (1.5 injected once a week) taken for diabetes mellitus from an unspecified start date and ongoing; valsartan (40mg) taken for renal disorder from an unspecified start date and ongoing. The patient reported Valsartan is a blood pressure medication, but she takes it to protect kidney due to diabetes. The patient previously took flu vaccine in Sep2020 for influenza immunisation and experienced pain in extremity, morphine [morphine sulfate] and experienced rash, flushing and burning sensation. She had the Pneumonia vaccine and had no problems with that. In 1990 IV Morphine was given to her after surgery and it was discontinued. On 05Feb2021, the patient experienced headache, rash, flushed, redness, warmth, wiped out; tired on 06Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: okay on 05Feb2021, investigation: they were clear on 05Feb2021, laboratory test: unknown result. The patient had her first injection last Friday afternoon. She mentioned she has a history of allergies with medications. Therefore, she stayed in the staging area for 30 minutes instead of waiting for 15 minutes. After getting the vaccine she left and went to her already scheduled Endocrinologist appointment. The Endocrinologist appointment was also in the same hospital where she got the vaccine. She went to the Endocrinologist appointment and it was noted one hour after the injection she started to feel warm while in the waiting room. She thought to herself it's possible the waiting room was warm, but when she was called back to have her blood pressure take she had to take her sweater off. When she took her sweater off for blood pressure to be checked it was noted she had a broken out in a rash all over. She could not see her face, but she had a rash there too. She had a rash all over her body. The doctor came in and listened to her lungs and they were clear. Her blood pressure was okay. Caller stated since her Endocrinologist appointment was also located in same facility where got the vaccine she should go back there to be checked out. The sheet she has indicates a rash can occur. The rash is indicative of a severe reaction. She could breathe okay. It took four hours for the rash to gradually get lighter and lighter in color. It appears that the rash has gone away. She also experienced a headache. Saturday, she felt total wiped out. It is like she had no "umph" to do anything. She also mentioned she saw her PCP on Monday. That appointment was already scheduled on the books for a regular check up. The doctor was concerned about if she should get the second dose injection or not. The doctor is hoping it would be okay. The patient wanted to know if it is okay to get the second dose, if so, would it be possible to get the same reaction or could it be worse. She also mentioned this week she has talked to a couple of people and they indicate they know someone who has gotten the rash after the COVID shot, but it was after the second shot. She further clarified and explained she got the COVID 19 Vaccine on 05Feb2021. It was one hour after getting the vaccine she noticed the rash, redness, flush feeling, warmth. The rash, redness, flush feeling, warmth were all gone totally by the next day.  Attempted to clarify if recovered completely or with lasting effects and caller only able to state she guesses she is okay. She also added, that Friday the headache started . She does not know if it was from the vaccine or something else. It is not as bad now as it was on Friday and Saturday. It is more of an aggravation. She had a couple hours after injection. Stated may have noticed while in doctor's office. She confirmed she is still tired, but not wiped out like she was this weekend. Saturday it was like she forget about even thinking about trying to do anything. She had her regular lab work done prior to her doctor appointments. None were done specifically due to events that occurred.Time the vaccination was given was around 1:35PM. When she was in the observation area the clock said 1:39 PM on their clock. Then she had to wait half an hour there. Vaccination Facility Type was Hospital. History of all previous immunizations with the Pfizer vaccine not considered as suspect except this the first dose. No additional vaccines administered on same date of Pfizer Suspect. The events did not cause Emergency Room visit. She was seen by the doctor and mentioned details, but she already had these appointments scheduled. Prior vaccinations within 4 weeks was none. She then went on to add, she does not know if it is one of the fillers that may be in her ongoing or past medications that causes the reactions. Stated these fillers could potentially be in the COVID vaccine. She confirmed she has no lot/exp/NDC to provide for the Flu shot, Penicillin, IV Morphine, or Sulfa mediations. Outcome of the events headache and fatigue were recovering, and the outcome of the other events were recovered on 06Feb2021  Follow-up (12May2021): Follow-up attempts completed. No further information expected.