Age: 68.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Mental impairment, Peripheral swelling, Pyrexia
Clinical narrative: Pressure on the side of her face radiating into temple; Right arm and shoulder swelling; Right arm and shoulder swelling; Wasn't able to bent the arm; Trouble thinking; She felt she couldn't breath; Fatigue; Allergic reaction within 1-2 hours of receiving the vaccines; Fever; She felt the medicine was trapped in the tissue of her arm; Sharp pains at the injection site; The patient was administered both vaccines in the right arm; This spontaneous case was received on 27-Jan-2021 from other health professional via Med Communications (reference number: SEQW21-00323) and concerned a 68-year-old, female patient.  The patient's concurrent conditions included 22 allergies including allergy to dog and cat hair. The patient stated she had allergy alert and the allergies were listed in their computer. The patient's past medical history included anaphylaxis. The patient's concomitant medications included levothyroxine, Singulair (montelukast sodium) and sucralfate, all used for unreported indications.  On 13-Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right deltoid, route of administration: not reported) (explicitly coded as 'Product administration error') for influenza prophylaxis. The batch number reported was 283852 and expiry date was 30-Jun-2021.   On the same day, the patient was vaccinated with non-company co-suspect pneumococcal vaccine (brand not specified, anatomical location: right arm, dose, route of administration, indication and batch number: not reported).  On the same day, one to two hours after receiving Flucelvax Quadrivalent and pneumococcal vaccine, the patient had an allergic reaction. The patient started having fever, pressure on the side of her face radiating into temple, right arm and shoulder swelling, and fatigue. She was not able to bent the arm, and she had trouble thinking. At night the patient felt she couldn't breath and had to get up and walk around. The patient felt that the medicine was trapped in the tissue of her arm. The patient also had sharp pains at the injection site. The patient called the physician's office and was told he was not available. She was advised to come into the office, but she was a private duty medical assistant (MA) and was taking care of a patient and unable to leave. The patient had drunk detox tea and kept the injection site warm.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 68-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company co-suspect pneumococcal vaccine. On the same day, after receiving vaccines, the patient had an allergic reaction. The patient started having pyrexia, pressure on the side of her face radiating into temple, right arm and shoulder swelling, and fatigue. She was not able to bent the arm, and she had trouble thinking. At night the patient felt she couldn't breath and had to get up and walk around. The patient felt that the medicine was trapped in the tissue of her arm (Feeling abnormal) The patient also had vaccination site pain. Causal role of the suspect vaccine is assessed as possibly related for head discomfort, joint swelling, peripheral swelling, pyrexia, hypersensitivity, injected limb mobility decreased, bradyphrenia, dyspnoea, fatigue, and vaccination site pain. The patient was administered both vaccines in the right arm. Feeling abnormal is assessed as not related to the suspect vaccine. Product administration error is assessed as not related based on company's conventions. Brighton Collaboration criteria could not be assessed, due to lack of information.; Sender's Comments: A 68-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company co-suspect pneumococcal vaccine. On the same day, after receiving vaccines, the patient had an allergic reaction. The patient started having pyrexia, pressure on the side of her face radiating into temple, right arm and shoulder swelling, and fatigue. She was not able to bent the arm, and she had trouble thinking. At night the patient felt she couldn't breath and had to get up and walk around. The patient felt that the medicine was trapped in the tissue of her arm (Feeling abnormal) The patient also had vaccination site pain. Causal role of the suspect vaccine is assessed as possibly related for head discomfort, joint swelling, peripheral swelling, pyrexia, hypersensitivity, injected limb mobility decreased, bradyphrenia, dyspnoea, fatigue, and vaccination site pain. The patient was administered both vaccines in the right arm. Feeling abnormal is assessed as not related to the suspect vaccine. Product administration error is assessed as not related based on company's conventions. Brighton Collaboration criteria could not be assessed, due to lack of information.