Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth, Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 76 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 28Sep2021 14:00 (Lot number: FC3184) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2017 (unspecified if ongoing), notes: lumpectomy Antiestrogen drug; "lumpectomy" (unspecified if ongoing); "stomach issues", start date: 2017 (unspecified if ongoing); "bile/acid reflux", start date: 2009 (ongoing), notes: bile/acid reflux, botox during endoscopy (Jun2021); "Achalasia", start date: 2018 (ongoing), notes: botox during endoscopy (Jun2021); "AAA repair", start date: 2004 (ongoing), notes: AAA repair, Repair-2006; "current aneurysm", start date: 2011 (ongoing), notes: Repair-2006; "fibromyalgia", start date: 1994 (ongoing); "schwannoma", start date: 2018 (ongoing), notes: only nerve root, displacing carotid monitoring for growth. There were no concomitant medications. Past drug history included: Keflex for phlebitis, reaction(s): "her stomach was not good"; Celebrex for cellulitis; Celebrex for phlebitis; Keflex for cellulitis, reaction(s): "her stomach was not good". Vaccination history included: Bnt162b2 (Dose: 2nd, 15:00, left arm, Intramuscular, lot number: EM9809), administration date: 09Feb2021, when the patient was 75 years old, for Covid-19 immunization, reaction(s): "Headache", "a low grade fever"; Bnt162b2 (Dose: 1st, 15:00, left arm, Intramuscular, lot number: EL0142), administration date: 19Jan2021, when the patient was 75 years old, for Covid-19 immunization; Flu shot (administered in the left arm), administration date: 23Sep2021, when the patient was 76 years old, for immunization. The following information was reported: MOBILITY DECREASED (non-serious) with onset 2021, outcome "unknown", described as "she turned her head and can't bend down"; PAIN (non-serious) with onset 29Sep2021, outcome "unknown", described as "body aches"; ABDOMINAL PAIN UPPER (non-serious) with onset 30Sep2021 03:00, outcome "unknown", described as "stomach pain/severe stomach pain"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) with onset 29Sep2021 20:00, outcome "unknown", described as "horrible contractions"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 29Sep2021, outcome "recovered" (Oct2021), described as "was fire red and 5 days later"; VACCINATION SITE INDURATION (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 29Sep2021, outcome "recovered" (Oct2021) and all described as "hot, hard, big, painful"; ABDOMINAL DISCOMFORT (non-serious) with onset 29Sep2021, outcome "unknown", described as "her stomach was not good"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "recovered" (2021), described as "swollen"; ABDOMINAL DISTENSION (non-serious) with onset 29Sep2021, outcome "unknown", described as "the next day felt very full"; PYREXIA (non-serious) with onset 29Sep2021, outcome "recovered" (03Oct2021), described as "had a fever of 102"; VOMITING (non-serious) with onset 29Sep2021 20:00, outcome "recovered" (2021), described as "throwing up/severe vomiting"; NAUSEA (non-serious) with onset 29Sep2021 20:00, outcome "unknown", described as "nausea"; MALAISE (non-serious) with onset 29Sep2021, outcome "unknown", described as "she isn't feel well"; HEADACHE (non-serious) with onset 29Sep2021, outcome "not recovered", described as "terrible headache/severe headache"; VACCINATION SITE SWELLING (non-serious) with onset 29Sep2021, outcome "unknown", described as "3-4 inches and was a goose egg"; ILLNESS (non-serious) with onset 29Sep2021, outcome "recovering", described as "really sick for 4-5 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper, vaccination site discolouration, vaccination site induration, peripheral swelling, pyrexia, vaccination site warmth, vaccination site pain, vaccination site swelling. Additional information: The patient wished that she was a little better. She stated that she did have stomach issues and had on hand a GI cocktail that was Mylanta with Lidocaine thankfully and took that and about 30 minutes later got relief. Stated the next two days she was still just a mess and was so shocked, booster was too much for her system. Stated she can't take it if the headache were worse. She reported that Botox was put in her esophagus because she was diagnosed with possible Achalasia and food was getting stuck and they did Botox. The patient took Tylenol, ice pack for 102 fever for 4 days following 3rd dose and ice pack for swollen, red, hot, hard, knot in arm. Follow-up attempts are completed. No further information is expected.