Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect route of product administration, Limb mass, Pyrexia, Vaccination site haemorrhage
Clinical narrative: She thinks it may have been because it went into a vein; a large drop of blood after the needle came out; a large red lump and 3-4 inches long on her right arm that she had the vaccine in; having a fever; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 03Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pneumonia" (unspecified if ongoing), notes: She has been social distancing for 2 years and had Pneumonia 2 years ago in 1 lung and found she doesn't have the proper antibodies to protect from Pneumonias. Her antibodies were tested in Aug and Sep 6 months after receiving her 2 initial COVID-19 Vaccines and she had a tiny improvement in the Pneumonia area and had a good response in the other area.; "GERD" (unspecified if ongoing); "ulcer in her esophagus" (unspecified if ongoing), notes: ulcer in her esophagus; "Osteoporosis" (unspecified if ongoing); "autoimmune deficiency" (unspecified if ongoing); "Allergic to sulfa" (unspecified if ongoing), notes: she is allergic for years; "Diabetes" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "To maintain her cholesterol" (unspecified if ongoing); "Headache" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for headache; PANTOPRAZOLE taken for gastrooesophageal reflux disease, oesophageal ulcer; LIPITOR taken for blood cholesterol abnormal; ALENDRONATE oral taken for osteoporosis; ATORVASTATIN CALCIUM taken for blood cholesterol abnormal; METFORMIN taken for diabetes mellitus; JANUVIA taken for diabetes mellitus; VITAMIN D NOS (ongoing). Past drug history included: Zantac for an ulcer in her esophagus, notes: Found in her 40's she had an ulcer in her esophagus. Has been on Zantac or something since her 40's. Vaccination history included: BNT162b2 (DOSE: 1, Lot number: Pfizer EL9263 , NDC/EXP: Unknown, Route, Anatomical Location: left arm), administration date: 28Jan2021, when the patient was 80-year-old, for Covid-19 immunization, reaction(s): "they didn't aspirate either", "had a slight feeling of something going into her arm", "blood on her arm"; BNT162b2 (DOSE: 2,, Lot Number / Expiry Date: EL926F/ unknown, NDC/EXP: Unknown, Route, Anatomical Location: left arm), administration date: 18Feb2021, when the patient was 80-year-old, for Covid-19 immunization, reaction(s): "they didn't aspirate either"; BNT162b2 (DOSE: 2,, Lot Number / Expiry Date: EL926F/ unknown, NDC/EXP: Unknown, Route, Anatomical Location: left arm), administration date: 18Feb2021, when the patient was 80-year-old, for COVID-19 immunization, reaction(s): "had a slight feeling of something going into her arm"; BNT162b2 (DOSE: 2,, Lot Number / Expiry Date: EL926F/ unknown, NDC/EXP: Unknown, Route, Anatomical Location: left arm), administration date: 18Feb2021, when the patient was 80-year-old, for Covid-19 Immunization, reaction(s): "blood on her arm". The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Sep2021, outcome "unknown", described as "She thinks it may have been because it went into a vein"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 03Sep2021, outcome "unknown", described as "a large drop of blood after the needle came out"; LIMB MASS (non-serious) with onset Sep2021, outcome "recovered", described as "a large red lump and 3-4 inches long on her right arm that she had the vaccine in"; PYREXIA (non-serious) with onset Sep2021, outcome "recovered", described as "having a fever"; HEADACHE (non-serious) with onset Sep2021, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of incorrect route of product administration, vaccination site haemorrhage, limb mass, pyrexia, headache.  Additional information: It was reported that patient was having trouble finding someone in her area who knows how to aspirate when giving the second booster Pfizer Covid 19 Vaccine. Per caller she is finding that pharmacy are not trained to aspirate. Patient would like to find someone in the area who can administer the second booster with the prescription she has from her doctor that aspirates. She had the first booster in Sep at pharmacy. She noticed that a drop of blood came out on her arm. She realized from her own studies what they do in other country from the doctors and those involved with Covid that it's important that you aspirate by pulling back on the plunger to see if there's blood there. Which means you have hit an artery or vein instead of a muscle. If there is blood you retract the needle and squeeze the blood out and then stick back in hoping to get a muscle and not a vein. Continued....