Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Intercepted product administration error, Limb discomfort, Needle issue, SARS-CoV-2 test
Clinical narrative: Patient experienced very very slight discomfort in the left arm; There was blood flowing from the injection site; Potential administration error: Patient felt vaccine was not properly injected and full dose was not given; Patient felt a fluid flowing until the elbow and the nurse told him it was alcohol from the swab but he thought maybe the needle leaked and the full dosage was not given to him; he thought maybe the needle leaked and the full dosage was not given; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Patient experienced very very slight discomfort in the left arm), VACCINATION SITE HAEMORRHAGE (There was blood flowing from the injection site), INTERCEPTED PRODUCT ADMINISTRATION ERROR (Potential administration error: Patient felt vaccine was not properly injected and full dose was not given), NEEDLE ISSUE (Patient felt a fluid flowing until the elbow and the nurse told him it was alcohol from the swab but he thought maybe the needle leaked and the full dosage was not given to him) and INCORRECT DOSE ADMINISTERED (he thought maybe the needle leaked and the full dosage was not given) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Lasted for 1 week) on 08-Jul-2022. Previously administered products included for Product used for unknown indication: Flu shot (Flu shot given last week). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Drug allergy (Bentyl).    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced LIMB DISCOMFORT (Patient experienced very very slight discomfort in the left arm), VACCINATION SITE HAEMORRHAGE (There was blood flowing from the injection site), INTERCEPTED PRODUCT ADMINISTRATION ERROR (Potential administration error: Patient felt vaccine was not properly injected and full dose was not given), NEEDLE ISSUE (Patient felt a fluid flowing until the elbow and the nurse told him it was alcohol from the swab but he thought maybe the needle leaked and the full dosage was not given to him) and INCORRECT DOSE ADMINISTERED (he thought maybe the needle leaked and the full dosage was not given). At the time of the report, LIMB DISCOMFORT (Patient experienced very very slight discomfort in the left arm) had not resolved and VACCINATION SITE HAEMORRHAGE (There was blood flowing from the injection site), INTERCEPTED PRODUCT ADMINISTRATION ERROR (Potential administration error: Patient felt vaccine was not properly injected and full dose was not given), NEEDLE ISSUE (Patient felt a fluid flowing until the elbow and the nurse told him it was alcohol from the swab but he thought maybe the needle leaked and the full dosage was not given to him) and INCORRECT DOSE ADMINISTERED (he thought maybe the needle leaked and the full dosage was not given) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         Patient previously taken first booster dose of Moderna COVID-19 vaccine on 06-Dec-2021 with batch no. 027H21B, 2nd Dose on 09-Apr-2021 with batch no. 031B21A and First dose on 12-Mar-2021 with batch no. 022M20A. No concomitant medications were reported. No Acute and Chronic illnesses at the time of vaccination.  The patient did not experience a similar event in the past. Patient reported with bivalent booster patient explained he felt like the vaccine was not properly injected because he felt a fluid flowing until the elbow and the nurse told him it was alcohol from the swab, but he thought maybe the needle leaked and the full dosage was not given to him, also there was blood flowing from the injection site. After bivalent dose patient was experiencing only very slight discomfort in the left arm. No treatment was given for any symptoms. Patient was not under any concomitant or regular medication.   This case was linked to MOD-2022-658087 (Patient Link).