Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache
Clinical narrative: Major nosebleed; Headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself).  A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown, Expiration Date: unknown), via an unspecified route of administered in Arm Left on 03Jun2021 08:00 (at the age of 46-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus Verbatim: Diabetic (She takes medication.Caller stated she probably was diagnosed 25 years ago.  It's been a while), allergy (she took the shot because of her allergies), peripheral swelling (Her arm swelled up 3 times), compromised immune status, respiratory illness, genetic, chromosomal abnormalities, Endocrine abnormalities (endocrine abnormalities, including diabetes and obesity) from an unknown date and unknown if ongoing verbatim. The patient concomitant medications were not reported. The patient previously took epinephrine and experienced drug hypersensitivity. smallpox vaccine, vaccination Date: 1969. Her daughter was getting her smallpox vaccination at the same time. The caller had never had a smallpox vaccination. They decided to give it to her and her daughter at the same time. Her arm swelled all up again to the point her daughter took her to the emergency room. patient took Tetanus vaccine in 1996 and experienced allergy to vaccine, they told the caller she was allergic to the tetanus. She now wears a bracelet. Hopefully no one will give her a tetanus shot. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Caller stated she probably was diagnosed 25 years ago. Caller stated she does take diabetic medication. Vaccination Facility Type caller stated the clinic is connected to the hospital. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reporter stated, She had her first shot. She was advised to be near a hospital when she took the shot because of her allergic to the Epinephrine. she took the shot there. On 03Jun2021, patient experienced headache. she didn't had a headache before the shot. By noon, she was felt this headache. Caller stated she still has a little bit of it right above her left eye. the headache didn't go away with the Tylenol. The Tylenol doesn't seem to help much. She had to go buy some Tylenol. She had a major nosebleed on 05Jun2021 14:35 Saturday. Her headache kept getting worse. Reporter stated she did go to the physician office to get the packing removed from her nose. She went to the Emergency Room on Saturday. They had to cauterize her nose and packed it. She had no idea if it was from the shot or if the shot contributed to it. She hasn't had a nosebleed like that in years. It has been a long time since she had a bad nosebleed. She just wanted to let Pfizer know what's going on with her because it may help someone else. Her daughter was in healthcare and said caller should call and let Pfizer know. What good was it going to do to continue with the report. Reporter stated she still has a little bit headache on right above her left eye. It's not quite as bad as it was. It's there. She can tell it's there.  Reporter stated she has no idea about dose. Caller stated she was not hospitalized. The outcome of the event major nosebleed was reported as recovered on 08Jun2021 and the headache was recovering.   Description of complaint: Caller was reporting an AE to the Pfizer Covid Shot. Caller reports taking Tylenol for a headache and the headache did not go away. Caller reports the Tylenol doesn't seem to help much. Product strength and count size dispensed: Caller confirmed that it is 500 mg of Acetaminophen. She only took 2 like the instructions tell you. Count size is 60 tablets in the bottle. Packaging sealed and intact: absolutely.  Information on the lot/batch number has been requested.