Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination failure
Clinical narrative: Pain in right side of stomach/ Recurred pain in Stomach; Blood pressure high; Blood pressure fluctuation; Itchy spot in wrist to thumb; Redness on skin; Wrists painful/Wrist issues/Hands painful; Hands swollen; Wrists swollen; Fell on left side; Blued up of shoulder; Elbow to hands swelling; Elbow to hands swelling; Tiny lump on neck; Nervous; Weakness; Vaccination failure; Covid infection; Could not use left hand; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure high) and ABDOMINAL PAIN UPPER (Pain in right side of stomach/ Recurred pain in Stomach) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010a21a and 012m18) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukaemia.    The patient's past medical history included Swelling of elbows (Elbow to hands swelling) on 28-Mar-2021, Hand swelling (Elbow to hands swelling) on 28-Mar-2021, Non-smoker, Abstains from alcohol, Contusion (Blued up of shoulder) and Thyroidectomy (Thyroid removal) in 2011. Previously administered products included for Drug use for unknown indication: Penicillin and Flu shot (Received Flu shots). Past adverse reactions to the above products included Allergy with Penicillin; and No adverse event with Flu shot. Concurrent medical conditions included Hypothyroidism since 2011, Angioma of skin since 2012, Penicillin allergy (Manifestated by turned purple) and Chronic lymphocytic leukaemia (Chronic lymphocytic leuk of b-cell type not achieve remis). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 milligram. In 2022, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 280 milligram. In April 2021, the patient experienced MUSCULOSKELETAL DISORDER (Could not use left hand). In December 2021, the patient experienced ASTHENIA (Weakness), VACCINATION FAILURE (Vaccination failure) and COVID-19 (Covid infection). In March 2022, the patient experienced ABDOMINAL PAIN UPPER (Pain in right side of stomach/ Recurred pain in Stomach) (seriousness criterion hospitalization). On 28-Mar-2022, the patient experienced CONTUSION (Blued up of shoulder), JOINT SWELLING (Elbow to hands swelling) and PERIPHERAL SWELLING (Elbow to hands swelling). On 02-May-2022, the patient experienced HYPERTENSION (Blood pressure high) (seriousness criterion hospitalization). In 2022, the patient experienced NECK MASS (Tiny lump on neck) and NERVOUSNESS (Nervous). On 21-Jun-2022, the patient experienced FALL (Fell on left side). On 13-Aug-2022, the patient experienced PERIPHERAL SWELLING (Hands swollen), JOINT SWELLING (Wrists swollen) and ARTHRALGIA (Wrists painful/Wrist issues/Hands painful). On 14-Aug-2022, the patient experienced ERYTHEMA (Redness on skin). On 15-Aug-2022, the patient experienced PRURITUS (Itchy spot in wrist to thumb). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure fluctuation). The patient was hospitalized on 02-May-2022 due to HYPERTENSION. The patient was treated with AMLODIPINE for Blood pressure high, at a dose of 5 milligram once a day; FAMOTIDINE at an unspecified dose and frequency; FUROSEMIDE at an unspecified dose and frequency; LEVOTHYROXINE at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. In 2022, ABDOMINAL PAIN UPPER (Pain in right side of stomach/ Recurred pain in Stomach), NERVOUSNESS (Nervous) and MUSCULOSKELETAL DISORDER (Could not use left hand) had resolved. In August 2022, JOINT SWELLING (Elbow to hands swelling), JOINT SWELLING (Wrists swollen), PRURITUS (Itchy spot in wrist to thumb) and ARTHRALGIA (Wrists painful/Wrist issues/Hands painful) had resolved. At the time of the report, HYPERTENSION (Blood pressure high), BLOOD PRESSURE FLUCTUATION (Blood pressure fluctuation) and VACCINATION FAILURE (Vaccination failure) outcome was unknown, CONTUSION (Blued up of shoulder), PERIPHERAL SWELLING (Elbow to hands swelling), ERYTHEMA (Redness on skin), FALL (Fell on left side), ASTHENIA (Weakness) and COVID-19 (Covid infection) had resolved, NECK MASS (Tiny lump on neck) had not resolved and PERIPHERAL SWELLING (Hands swollen) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, Blood pressure measurement: Elevated Blood Pressure. On 02-May-2022, Blood pressure measurement: 215/72 mmHg. On an unknown date, Blood pressure measurement: 178/75 mmHg and 219/60 mmHg.         Company comment: This case concerns a 78-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Hospitalization) events of Hypertension and Abdominal pain upper and unexpected, non-serious AESI of COVID-19. The event Vaccination failure was also reported. The events COVID-19 and Abdominal pain upper occurred approximately 9 months after administration of second dose of mRNA-1273 and the event Hypertension occurred 425 days after administration of second dose of mRNA-1273, the first dose of mRNA-1273 was administered 28 days prior to the second dose. It has been reported that approximately after administration of second dose of mRNA-1273, the patient experienced bluish discoloration of her shoulders and upper extremities, but it was concluded that it was a sequela of her current medical condition of Chronic lymphocytic leukemia. 14 months after administration of second dose of mRNA-1273, patient was rushed to an institution due to elevated blood pressure, she was admitted for three days until her blood pressure became normal. Patient was also hospitalized due to abdominal pain, upon work-up, patient was advised to have a heart catheter inserted or replacement of stent, but the patient refused. The events Abdominal pain upper and COVID-19 have resolved while the outcome of the event Hypertension is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.; Sender's Comments: This case concerns a 78-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Hospitalization) events of Hypertension and Abdominal pain upper and unexpected, non-serious AESI of COVID-19. The event Vaccination failure was also reported. The events COVID-19 and Abdominal pain upper occurred approximately 9 months after administration of second dose of mRNA-1273 and the event Hypertension occurred 425 days after administration of second dose of mRNA-1273, the first dose of mRNA-1273 was administered 28 days prior to the second dose. It has been reported that approximately after administration of second dose of mRNA-1273, the patient experienced bluish discoloration of her shoulders and upper extremities, but it was concluded that it was a sequela of her current medical condition of Chronic lymphocytic leukemia. 14 months after administration of second dose of mRNA-1273, patient was rushed to an institution due to elevated blood pressure, she was admitted for three days until her blood pressure became normal. Patient was also hospitalized due to abdominal pain, upon work-up, patient was advised to have a heart catheter inserted or replacement of stent, but the patient refused. The events Abdominal pain upper and COVID-19 have resolved while the outcome of the event Hypertension is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.