Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Full blood count, Hypertension, Malaise, Neoplasm malignant
Clinical narrative: Cancer; Blood Pressure; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 16-Oct-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen. On 23-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced MALAISE (Not feeling well). On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant) and HYPERTENSION (Blood Pressure). At the time of the report, NEOPLASM MALIGNANT (Cancer), MALAISE (Not feeling well) and HYPERTENSION (Blood Pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High. On an unknown date, Full blood count: High.         It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The patient received the first dose of Moderna Covid-19 vaccine on 16-Feb-2021 intramuscularly. The patient received the second dose of Moderna Covid-19 vaccine on 18-Mar-2021 intramuscularly. The patient received the first booster dose of Moderna Covid-19 vaccine on 21-Aug-2021 intramuscularly. On 23-Oct-2022, the patient received the Second booster. On 27-Oct-2022, patient was not feeling well felt like crap and thought that patient's blood pressure was up, and patient had a high blood count.  Patient had flu shot and on 25-Oct-2022, had cancer treatment.  The reporter's causality for the events of blood Pressure, high blood count, cancer with Adalimumab solution for injection was not provided and for not feeling well was reported as no reasonable possibility.  The other manufacturer's causality with Adalimumab solution for injection for the event of cancer was reported as no reasonable possibility and for the events blood Pressure, high blood count, for not feeling well was reported as not assessable.  The other manufacturer's alternative etiology for cancer with Adalimumab solution for injection was more likely a pre-existing malignancy.  The assessment results of Humira by non-HCP (global introspection) for the events cancer, full blood count increased, blood pressure abnormal was not reported, for feeling unwell was not related and by Authority (global introspection) for the events cancer was no reasonable possibility, for feeling unwell, full blood count increased, blood pressure abnormal was not assessable.  Treatment medication was not provided.  Company comment: This spontaneous case concerns a 62-year-old, male patient with history of co-suspect administration of Humira (adalimumab) for Psoriatic Arthritis and history of concomitant administration of Influenza vaccine, who experienced the unexpected, serious (medically significant) event of neoplasm malignant, and other unexpected, non-serious events. The non-serious event malaise occurred 11 days after receiving Humira and 4 days after receiving the second booster dose (fourth dose in the COVID-19 vaccination series) of the mRNA-1273 bivalent BA.4/BA.5 vaccine. The start dates of the other events were not provided, hence, the onset latency could not be assessed. On an unspecified date, the patient received the Flu shot and it was reported that 2 days after receiving the second booster dose of the mRNA-1273 bivalent BA.4/BA.5 vaccine, the patient had cancer treatment (unspecified). No further details were provided. After 2 days, the patient felt unwell described as 'felt like crap'. On unspecified dates, the patient thought his blood pressure (BP) was up and he had a high blood count. However, the BP measurement and results of the blood count were not provided. Treatment information was also not provided. The outcomes of the events were unknown at the time of the report. The concomitant administration of Influenza vaccine remains a confounder for the events malaise and hypertension which are known adverse effects of the vaccine. The history of co-suspect administration of Humira also remains a confounder for the reported events. The benefit-risk relationship of the mRNA-1273 bivalent BA.4/BA.5 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old, male patient with history of co-suspect administration of Humira (adalimumab) for Psoriatic Arthritis and history of concomitant administration of Influenza vaccine, who experienced the unexpected, serious (medically significant) event of neoplasm malignant, and other unexpected, non-serious events. The non-serious event malaise occurred 11 days after receiving Humira and 4 days after receiving the second booster dose (fourth dose in the COVID-19 vaccination series) of the mRNA-1273 bivalent BA.4/BA.5 vaccine. The start dates of the other events were not provided, hence, the onset latency could not be assessed. On an unspecified date, the patient received the Flu shot and it was reported that 2 days after receiving the second booster dose of the mRNA-1273 bivalent BA.4/BA.5 vaccine, the patient had cancer treatment (unspecified). No further details were provided. After 2 days, the patient felt unwell described as 'felt like crap'. On unspecified dates, the patient thought his blood pressure (BP) was up and he had a high blood count. However, the BP measurement and results of the blood count were not provided. Treatment information was also not provided. The outcomes of the events were unknown at the time of the report. The concomitant administration of Influenza vaccine remains a confounder for the events malaise and hypertension which are known adverse effects of the vaccine. The history of co-suspect administration of Humira also remains a confounder for the reported events. The benefit-risk relationship of the mRNA-1273 bivalent BA.4/BA.5 vaccine is not affected by this report.