Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Hypoaesthesia, Peripheral coldness, SARS-CoV-2 test, Skin discolouration
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (She could not feel her 3 left fingers (index, middle and ring)), CARDIAC DISORDER (Surgery for a heart stent), SKIN DISCOLOURATION (Finger tips went black) and PERIPHERAL COLDNESS (Hand looks "frost field like when is cold") in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination. Patient had no allergies and chronic illnesses. The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: J&J vaccine (First dose Lot number: 042A21K1) on 12-Apr-2021. Past adverse reactions to the above products included No adverse event with J&J vaccine. Concurrent medical conditions included Hypertension. On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2022, the patient experienced HYPOAESTHESIA (She could not feel her 3 left fingers (index, middle and ring)) (seriousness criteria hospitalization and disability). On an unknown date, the patient experienced CARDIAC DISORDER (Surgery for a heart stent) (seriousness criterion hospitalization), SKIN DISCOLOURATION (Finger tips went black) (seriousness criteria hospitalization and disability) and PERIPHERAL COLDNESS (Hand looks "frost field like when is cold") (seriousness criteria hospitalization and disability). The patient was treated with WARFARIN for Pain in arm, at a dose of UNK, qd; Surgery (Finger amputation) for Hypoaesthesia and Surgery (heart stent) for Cardiac disorder. At the time of the report, HYPOAESTHESIA (She could not feel her 3 left fingers (index, middle and ring)), CARDIAC DISORDER (Surgery for a heart stent), SKIN DISCOLOURATION (Finger tips went black) and PERIPHERAL COLDNESS (Hand looks "frost field like when is cold") outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPOAESTHESIA (She could not feel her 3 left fingers (index, middle and ring)) and CARDIAC DISORDER (Surgery for a heart stent) to be related. No further causality assessments were provided for SKIN DISCOLOURATION (Finger tips went black) and PERIPHERAL COLDNESS (Hand looks "frost field like when is cold"). Patient had to check her blood every week. High blood pressure unspecified medicine was reported as concomitant medication. It was reported that patient tested positive for Covid-19 before it became a worldwide urgent news and before getting her first vaccine. Her Doctor said adverse events happened because of the booster dose. Company Comment: This spontaneous case concerns a 48-year-old, female patient with concurrent hypertension, who experienced the unexpected, serious (hospitalized, disability) events of Hypoaesthesia, Skin discolouration and Peripheral coldness, and the unexpected, serious (hospitalized) event of Cardiac disorder. The patient also received a dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) approximately 8 months prior to mRNA-1273. The event of hypoaesthesia occurred approximately 1.5 months after receiving mRNA-1273 as booster dose, while rest of the events occurred on unspecified dates after vaccination. The patient initially noted numbness of the 3 digits (index, middle and ring) of her left hand which prompted medical consult. Diagnosis was not provided for the symptom, although it was mentioned that the patient was eventually hospitalized and underwent cardiac stenting. The patient also noted that her fingertips went black and had her left index finger amputated on an unspecified date. She was then prescribed with warfarin and undergoes unspecified blood tests weekly. The patient's concurrent hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 48-year-old, female patient with concurrent hypertension, who experienced the unexpected, serious (hospitalized, disability) events of Hypoaesthesia, Skin discolouration and Peripheral coldness, and the unexpected, serious (hospitalized) event of Cardiac disorder. The patient also received a dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) approximately 8 months prior to mRNA-1273. The event of hypoaesthesia occurred approximately 1.5 months after receiving mRNA-1273 as booster dose, while rest of the events occurred on unspecified dates after vaccination. The patient initially noted numbness of the 3 digits (index, middle and ring) of her left hand which prompted medical consult. Diagnosis was not provided for the symptom, although it was mentioned that the patient was eventually hospitalized and underwent cardiac stenting. The patient also noted that her fingertips went black and had her left index finger amputated on an unspecified date. She was then prescribed with warfarin and undergoes unspecified blood tests weekly. The patient's concurrent hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.