Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Groin pain, Incorrect route of product administration, Lymph node pain, Lymphadenopathy, Mobility decreased
Clinical narrative: Pain moved into groin; Swelling of lymph glands on left side of body/lymph glands were swollen; Lymph glands were painful; Vaccine being injected into the nerve plexus instead of muscle; Decreased fine motor skills; Decreased arm strength; Limited range of motion; Poor left hand coorination; Left arm tremors; Pain moved up neck into jaw and ear; Pain moved up neck into jaw and ear; Pain moved up neck into jaw and ear; Swelling moved up neck into jaw and ear/swelling have moved into groin; Swelling moved up neck into jaw and ear/swelling have moved into groin; Swelling moved up neck into jaw and ear/swelling have moved into groin; This spontaneous case from the Health Authority (reference number: SEQW20-00285) from other non-health professional on 13-Apr-2020, concerning a 30-year-old, male patient.   The patient's historical condition included flu in Jan-2020.   The patient did not use concomitant medications. The patient did not receive flu vaccine in the past.  On 29-Feb-2020, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: P100142910, expiry date: not reported] for influenza prophylaxis. The physicians feel the vaccine was being injected into the nerve plexus instead of muscle (explicitly coded as 'Product administration error').  On 02-Mar-2020, within a couple of days after vaccination, the patient experienced swelling of lymph glands on left side of body where vaccine was administered. Lymph glands were painful and swollen.   On an unspecified date in 2020, pain and swelling moved up neck into jaw and ear. The patient visited primary care physician who prescribed a course of unspecified antibiotics with no improvement. The physician then prescribed a course of prednisone which also did not help.  On 13-Apr-2020, reported as now, the swelling and pain moved into groin. The patient was supposed to visit emergency room today.  On an unspecified date in 2020, the patient also experienced left arm tremors, poor left hand coordination, limited range of motion, decreased arm strength, and decreased fine motor skills.  At the time of initial reporting on 13-Apr-2020,  the patient had not recovered from the events 'neck pain', 'jaw pain', 'ear pain', 'swelling', 'swelling of jaw angle', 'ear swelling and 'groin pain'.  At the time of follow up reporting on 16-Nov-2020, the patient was recovering from the events 'swollen glands' and 'lymph node pain', but the patient had not recovered from the events 'fine motor skill dysfunction', 'muscle strength abnormal', 'mobility decreased', 'coordination impaired' and 'tremor of hands'.   The outcome of the event 'product administration error' was not reported.  The reporter assessed the case as non-serious.     The reporter assessed the events 'swollen glands', 'lymph node pain', 'fine motor skill dysfunction', 'muscle strength abnormal', 'mobility decreased', 'coordination impaired' and 'tremor of hands' to be related to Afluria Quadrivalent. The patient had seen several physicians and they feel it was related to the vaccine being injected into the nerve plexus instead of muscle. The reporter did not provide a causality assessment for all other events.  Additional information received on 16-Nov-2020 from other non-health professional: Additional events added. Outcome changed from not recovered to recovering for swelling and pain in lymph glands. Causality provided. The narrative was amended accordingly.  Company comment: A 30-year-old male patient was administered Afluria Quadrivalent. The patient developed lymphadenopathy, lymph node pain, neck pain, pain in jaw, ear pain, swelling, swelling in face, ear swelling and groin pain after vaccination with the suspect product Afluria Quadrivalent. Within a couple of days after vaccination the events started to emerge. On an unspecified date in 2020, the patient also experienced left arm tremors, poor left hand coordination, limited range of motion, decreased arm strength, and decreased fine motor skills. Reportedly, the vaccine was administered in the left deltoid and the physicians feel the vaccine was being injected into the nerve plexus instead of muscle, which is considered Product administration error and may have contributed to development of the events. The patient's historical condition included flu in Jan-2020.  The patient did not use concomitant medications. More information regarding diagnostic findings and corrective treatment is needed. With information presented, causality is assessed as possibly related for all events. Product administration error is assessed as not related per company's conventions.; Reporter's Comments: The patient had seen several physicians and they feel it was related to the vaccine being injected into the nerve plexus instead of muscle.; Sender's Comments: A 30-year-old male patient was administered Afluria Quadrivalent. The patient developed lymphadenopathy, lymph node pain, neck pain, pain in jaw, ear pain, swelling, swelling in face, ear swelling and groin pain after vaccination with the suspect product Afluria Quadrivalent. Within a couple of days after vaccination the events started to emerge. On an unspecified date in 2020, the patient also experienced left arm tremors, poor left hand coordination, limited range of motion, decreased arm strength, and decreased fine motor skills. Reportedly, the vaccine was administered in the left deltoid and the physicians feel the vaccine was being injected into the nerve plexus instead of muscle, which is considered Product administration error and may have contributed to development of the events. The patient's historical condition included flu in Jan-2020.  The patient did not use concomitant medications. More information regarding diagnostic findings and corrective treatment is needed. With information presented, causality is assessed as possibly related for all events. Product administration error is assessed as not related per company's conventions.