Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pain in extremity, Paraesthesia, Parosmia
Clinical narrative: then the second dose, the sore arm started in the evening/ severe pain on Left arm; mild headache; smelling smoke happened after the second vaccine; metallic taste; Pain, tingling, numbness in left arm - radiated down into her left leg; Pain, tingling, numbness in left arm - radiated down into her left leg/tingle on left side of the body; Pain, tingling, numbness in left arm - radiated down into her left leg; experienced multiple GI issues; Most intense pain in her breasts, especially left side/ severe pain on Left arm and Left breast/severe intense pain in her left breast; Indigestion; diarrhea; ear clogged on one side of the head; had tingling, numbness, mostly in her breast area; mild to moderate symptoms upon 1st dose - intensified upon 2nd dose; Second shot, her vaccine was given 18 days later which she called the hospital when they said it was okay to give the 17th-21 days; Second shot, her vaccine was given 18 days later which she called the hospital when they said it was okay to give the 17th-21 days; This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting for his wife.  A 72-year-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular route of administration in arm left on 23Feb2021 (lot number: EL9266, expiry date: 31May2021, at the age of 72-year-old) as single dose for COVID-19 immunization. Medical history included asthma diagnosed 8-10 year ago, has always had seasonal allergies, heart valve calcification diagnosed 12 years ago. Concomitant medication(s) included losartan taken for blood pressure measurement, simvastatin (ZOCOR) taken for blood cholesterol, omeprazole (PROTONIX [OMEPRAZOLE]) and budesonide (PULMICORT) taken for asthma. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular route of administration in arm left on 05Feb2021 at 14:30 (lot number: EN9581, expiry date: unknown, at the age of 72-year-old) as single dose for COVID-19 immunization at vaccine hospital and experienced heavy and sore arm, mild headache, wide awake, left sided pain, persisting smell smoke, metallic taste, ulcers in her mouth, ocular migraine, abdominal pain, indigestion, heartburn, anxious, diarrhea and no appetite. On 05Feb2021, after receiving her first dose of the vaccine the patient didn't feel the needled at all. It felt very heavy, the patient had a sore arm, that was in the afternoon. In the evening the patient had a mild headache. The patient was up the entire night, wide awake. In the morning, the patient had a very bad pain running down the whole side of her body from the left arm, left breast, left hip, it lasted the entire day. The patient still had the pain in her left breast. That day, the patient had abdominal pain, heartburn, indigestion, she felt very anxious and edgy, no appetite, then she started with gurgling from her throat to her stomach. This was all for several days. Then the patient started with some diarrhea. The patient then started smelling smoke, every day for about 5 days she smelled smoke in different rooms in her house, but her husband could not smell it. Then the patient developed 3 ulcers inside of her mouth. Then the patient developed an ocular migraine. The patient had a metallic taste every afternoon around 4:00 and then she would try to eat something then it would come back in the evening that lasted for 5. Second shot, her vaccine was given 18 days later which she called the hospital when they said it was okay to give the 17th-21 days. The patient wanted to know if it was okay that she got her vaccines 18 days apart. The sore arm only happened with the first dose, the patient had a sore arm with the second one but nothing like the first one. The patient mentioned it to the nurse when she was receiving the second dose of the vaccine and the nurse administered the vaccine slowly. The patient's arm hurt for 3 days with the first dose, then the second dose, the sore arm started in the evening. The patient hasn't recovered completely from her mild headache. The patient's diarrhea went away after 5 days because she took Imodium. The gurgling, cramping pain is still there. The gastrointestinal stuff the patient has almost completely recovered from. After the second shot it, the left side pain went up into the neck and chest, not in the armpit but near the breast on the left. The smelling smoke happened after the second vaccine, same with the metallic taste. Reporter stated that patient had mild to moderate symptoms upon 1st dose - intensified upon 2nd dose. Pain, tingling, numbness in left arm - radiated down into her left leg. Most intense pain in her breasts, especially left side. Additionally, experienced multiple GI issues. She said she experienced side effects which are the following: sore arm, severe pain on Left arm and Left breast, tingle on left side of the body, indigestion, diarrhea, metallic taste on mouth, smell smoke for several days and ear clogged on one side of the head. It was reported that she had severe pain in her right arm which was the site of administration in her left deltoid and it radiated down to her arm and to her leg. She had severe intense pain in her left breast. She had tingling, numbness, mostly in her breast area. Additionally, she had experienced gastro-intestinal issues. The outcome of the events Pain, tingling, numbness in left arm, breast pain and multiple GI issues was recovering, and rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.