Sex: M
Vaccine: SMALL
Symptoms: Injection site discharge, Mobility decreased, Muscle spasms, Nasal congestion, Nausea
Clinical narrative: Flu-like symptoms; Could not move his neck from left to right; Muscular cramps; Continuous body aches; Experienced itching; Dry throat; Nasal congestion; Chills; Feeling nauseous; Dizziness; Experienced arm aching in the injection arm; Loss of vision; Blurriness; Excessive draining out of the wound; This initial spontaneous case report was received on 15MAY2024 from the company manager regarding two male patient of unknown age who "experienced arm aching in the injection arm" (PT: Pain in extremity), "could not move his neck from left to right" (PT: Musculoskeletal stiffness), had "continuous body aches" (PT: Malaise), "excessive draining out of the wound" (PT: Injection site discharge, "muscular cramps" (PT: Muscle cramps), "flu-like symptoms" (PT: Influenza like illness ) which included "feeling nauseous" (PT: Nausea), "chills" (PT: Chills), "dizziness" (PT: Dizziness)", "nasal congestion" (PT: Nasal congestion) and "dry throat" (PT: Dry throat), "experienced itching" (PT: Pruritus), had "loss of vision and " (PT: Blindness transient) and "blurriness" (PT: Vision blurred) following the administration of ACAM2000 (smallpox vaccine, live, lot number: unknown) for immunisation.  This case report corresponds to the first case.   The patient's medical history, concomitant medications, or known allergies were not reported.  On 05APR2024, the patient received ACAM2000 and after 3 weeks, the patient experienced an ache in the injection arm, had continuous body aches, was not able to move his neck from left to right, had excessive draining out of the wound and muscular cramps. The patient also had flu-like symptoms which included chills, dizziness, nasal congestion, dry throat, and was feeling nauseous all the time. The patient had itching, but the location of itching was unspecified. Further, the patient had temporal loss of vision and blurriness.  The patient was sent back to the occupational health center where occupational health consultants who had administered the vaccine examined the patient.  The patient had not recovered from reported events at the time of report.  Based on the available information in the source document, two individual case safety reports (24000070 and 24000071) were created and linked in the database as it was reported by same reporter.  Company Medical comment: Because the information provided is limited, the sequence of the events is difficult to understand. in normal circumstances, after vaccination, there is a formation of a pustule within 2-5 days, which becomes vesicular, then pustular within at 8-10 days after vaccination. Once the pustule dries, there is a formation of a scab, which usually separates within 14-21 days, leaving a pitted scar and is asymptomatic. If a vaccination develops complications, in addition to local reactions, general reactions occur in the first 15 days and are associated to an exaggerated local reaction. For this patient to develop onset of reaction three weeks after vaccination, must had been symptomatic before, that were not disclosed. It is understandable that injection site discharge could also show inflammation that could cause pain in the arm, or if there was lymphadenopathy may cause stiffness in the neck or even symptoms that resemble influenza may be present and caused by the vaccination; however, temporary vision loss and blurred vision are not a known phenomenon and there is not temporal relationship to be considered related. The case does not meet the seriousness criteria of medical important event and considered unlisted.  More information will be sought. Assessment may change.; Sender's Comments: Because the information provided is limited, the sequence of the events is difficult to understand. in normal circumstances, after vaccination, there is a formation of a pustule within 2-5 days, which becomes vesicular, then pustular within at 8-10 days after vaccination. Once the pustule dries, there is a formation of a scab, which usually separates within 14-21 days, leaving a pitted scar and is asymptomatic. If a vaccination develops complications, in addition to local reactions, general reactions occur in the first 15 days and are associated to an exaggerated local reaction. For this patient to develop onset of reaction three weeks after vaccination, must had been symptomatic before, that were not disclosed. It is understandable that injection site discharge could also show inflammation that could cause pain in the arm, or if there was lymphadenopathy may cause stiffness in the neck or even symptoms that resemble influenza may be present and caused by the vaccination; however, temporary vision loss and blurred vision are not a known phenomenon and there is not temporal relationship to be considered related. The case does not meet the seriousness criteria of medical important event and considered unlisted. More information will be sought. Assessment may change. US-EMERGENT BIOSOLUTIONS-24000071:Linked case- same reporter