Age: 61.0
Sex: M
Vaccine: COVID19, FLUC3, PNC20
Symptoms: Pain in extremity, Product administration error, Product storage error
Clinical narrative: Swollen lymph nodes; Painful lymph nodes; Body aches; Weak; Arm soreness; Tired; The patient received Fucelvax that was exposed to a temperature excursion; Flucelvax was stored at 57 degrees Fahrenheit for approximately 48 hours; This spontaneous case was received on 12-Jan-2023 from Other Health Professional via Communications (reference number: SEQW23-00214), and from Seqirus on 16-Jan-2023 (being processed together), and concerned a 61-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On an unspecified day, in Dec-2022, between 02-Dec-2022 and 05-Dec-2022, Flucelvax Quadrivalent (influenza vaccine inact sag 4v, subunit) had a temperature excursion lasting approximately 48 hours with a maximum temperature of 57 degrees Fahrenheit (explicitly coded as 'Product storage error temperature too high'). The batch number reported was 353556 and expiry date: 30-Jun-2023.  On 05-Dec-2022, after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent (dose: not reported, route of administration: intramuscular, anatomical location: left deltoid, and indication: not reported) (explicitly coded as 'Product administration error').  On the same date, the patient was vaccinated with non-company, co-suspect Prevnar 20 (pneumococcal vaccine conj 20v (crm197); dose: not reported, route of administration: intramuscular, anatomical location: right deltoid, and indication: not reported). The batch number reported was GD8455.  On an unspecified date, the patient was vaccinated non-company, co-suspect Covid-19 vaccine (brand not specified; anatomical location: left arm, dose, route of administration, and indication: not reported). The batch number was not reported.  On an unknown date, an unspecified amount of time after receiving Flucelvax, Previnar 20 and Covid-19 vaccine, the patient experienced swollen and painful lymph nodes, weakness, tiredness, body aches and arm soreness.     The outcome of 'swollen lymph nodes', 'lymph node pain', 'ache', 'weakness', 'tiredness', and 'pain in arm' was not reported.     The reporter did not provide a causality assessment.  Company comment: A 61-year-old male patient was vaccinated with Flucelvax Quadrivalent, after it suffered a temperature excursion, and non-company, co-suspect Prevnar 20, on the same day (explicitly coded as 'Product administration error' and 'Product storage error temperature too high'). Reportedly, the temperature excursion reached a maximum temperature of 57 degrees Fahrenheit. In addition, on an unknown day, patient was vaccinated with non-company, co-suspect Covid-19 vaccine. An unknown amount of time following vaccination and on an unknown day, patient reported fatigue, pain in extremity, asthenia, pain, lymph node pain, and lymphadenopathy. Considering limited information provided, lack of information regarding the events onset date, and unclear temporal relationship, causality of the suspect vaccine is unassessable. Product administration error and product storage error temperature too high are assessed as not related per company's conventions.; Sender's Comments: A 61-year-old male patient was vaccinated with Flucelvax Quadrivalent, after it suffered a temperature excursion, and non-company, co-suspect Prevnar 20, on the same day (explicitly coded as 'Product administration error' and 'Product storage error temperature too high'). Reportedly, the temperature excursion reached a maximum temperature of 57 degrees Fahrenheit. In addition, on an unknown day, patient was vaccinated with non-company, co-suspect Covid-19 vaccine. An unknown amount of time following vaccination and on an unknown day, patient reported fatigue, pain in extremity, asthenia, pain, lymph node pain, and lymphadenopathy. Considering limited information provided, lack of information regarding the events onset date, and unclear temporal relationship, causality of the suspect vaccine is unassessable. Product administration error and product storage error temperature too high are assessed as not related per company's conventions.