Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Stridor, Swelling
Clinical narrative: Stridor; Difficulty breathing / Dyspnea as well as persistent SOB plus DOE; Generalized erythema; chest, upper airway tightness; Sensation of throat closure; Dermatological/ Mucosal; Diarrhea; Nausea; States with the 1st one her arm was sore; Extremely red at injection site; Unresolved Swelling; Large lump at injection site that will not go away; Painful at times; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 21Dec2020 (Lot number: EN9899) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy of Tranvpore tape" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol; Losartan; Hctz; Protonix.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Dec2020, outcome "not recovered", described as "States with the 1st one her arm was sore"; VACCINATION SITE ERYTHEMA (non-serious) with onset 21Dec2020, outcome "not recovered", described as "Extremely red at injection site"; SWELLING (non-serious) with onset 21Dec2020, outcome "not recovered", described as "Unresolved Swelling"; VACCINATION SITE MASS (non-serious) with onset 21Dec2020, outcome "not recovered", described as "Large lump at injection site that will not go away"; PAIN (non-serious) with onset 21Dec2020, outcome "not recovered", described as "Painful at times"; STRIDOR (non-serious), outcome "not recovered", described as "Stridor"; DYSPNOEA (non-serious), outcome "not recovered", described as "Difficulty breathing / Dyspnea as well as persistent SOB plus DOE"; ERYTHEMA (non-serious), outcome "not recovered", described as "Generalized erythema"; CHEST DISCOMFORT (non-serious), outcome "not recovered", described as "chest, upper airway tightness"; THROAT TIGHTNESS (non-serious), outcome "not recovered", described as "Sensation of throat closure"; MUCOSAL DISORDER (non-serious), outcome "not recovered", described as "Dermatological/ Mucosal"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrhea"; NAUSEA (non-serious), outcome "not recovered", described as "Nausea". Therapeutic measures were not taken as a result of pain in extremity, vaccination site erythema, swelling, vaccination site mass, pain.  Additional information: The patient stated she received her vaccine back in Jan2021 and has had both shots. Stated with the 1st one her arm was sore and with the 2nd one her arm was really sore and became really bright red. The patient stated she developed a lump and showered her doctor. Stated that you can see it, it looked like she has been working out with that arm from the shoulder down you can see it and feel it. Stated it's like a fatty muscle and her other arm is flat. The patient stated she did not think she should get the booster in that arm, she doesn't know if it will penetrate that lump. She was in a sleeveless dress and can see a lump. The patient declined to make a report. Stated she didn't have a bad experience. Stated she was a nurse has a license. States she never took the flu shot so she thought it was her body reacting kind of in shock. The patient states she had a temperature and woke up cold and she is usually hot. States she got the vaccine on Saturday and on Sunday she took Tylenol and her arm was really sore. The patient did not require medical intervention, the patient was not seen in the Emergency Department, the patient was not hospitalized, the patient was not admitted to an Intensive Care Unit. Other symptoms: The event did not require the initiation of new medication or other treatment or procedure. Patient's outcome following the potential anaphylactic reaction not recovered, the patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported.  No follow-up attempts are possible. No further information is expected.