Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Inappropriate schedule of product administration, Nail growth abnormal, Thrombotic stroke
Clinical narrative: A blood clot traveled to her head leading to stroke; fingernail growing out of fingertips/so she has to keep them trimmed; walking up and down stairs gets her short-winded; Patient got 5 April 2021 and second shot on 13 May 2021; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOTIC STROKE (A blood clot traveled to her head leading to stroke), NAIL GROWTH ABNORMAL (fingernail growing out of fingertips/so she has to keep them trimmed) and DYSPNOEA (walking up and down stairs gets her short-winded) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0246212 and 644DLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no medications, food and other products allergies. Patient had not tested COVID positive or diagnosis ever.  The patient's past medical history included Hypertension. Concomitant products included CLOPIDOGREL BISULFATE (CLOPIGEL) for Hypertension.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 5 April 2021 and second shot on 13 May 2021). On 26-May-2021, the patient experienced THROMBOTIC STROKE (A blood clot traveled to her head leading to stroke) (seriousness criteria hospitalization, disability and medically significant), NAIL GROWTH ABNORMAL (fingernail growing out of fingertips/so she has to keep them trimmed) (seriousness criterion hospitalization) and DYSPNOEA (walking up and down stairs gets her short-winded) (seriousness criterion hospitalization). The patient was hospitalized from 26-May-2021 to 29-May-2021 due to DYSPNOEA, NAIL GROWTH ABNORMAL and THROMBOTIC STROKE. At the time of the report, THROMBOTIC STROKE (A blood clot traveled to her head leading to stroke), NAIL GROWTH ABNORMAL (fingernail growing out of fingertips/so she has to keep them trimmed) and DYSPNOEA (walking up and down stairs gets her short-winded) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 5 April 2021 and second shot on 13 May 2021) outcome was unknown.            Patient stated that 13 days after the second shot, she had a stroke on 26 May 2021 and had to go to the hospital for 4 days. When she woke up, she thought her arm fell asleep and she lost control of her leg and then lost control of her face. A blood clot traveled to her head and now she had permanent numbness in the face, numbness in left arm, numbness in left hand, minor difficulty walking up stairs with left leg. walking up and down stairs gets her short-winded. She had to quit working. She was now on long-term disability. Her left arm felt like a tuning fork all the time. Her left hand felt like the bone sticking out of palm, fingernail growing out of fingertips, so she had to keep them trimmed. Patient was put on blood thinners.  Company Comment This is a spontaneous case concerning a 61-year-old female patient with relevant medical history of Hypertension, who experienced the unexpected serious (disability, medically significant) adverse event of special interest Thrombotic stroke and unexpected serious events of Dyspnoea and Nail growth abnormal, which led to hospitalization, 13 days after receiving the second dose of mRNA-1273 vaccine. Inappropriate schedule of vaccine administered, described as patient received 2 doses of mRNA-1273 vaccine with 38 days interval, was also reported as an additional non-serious event. Patient reported that a blood clot traveled to her head which resulted to inability to control her arm, leg and face. Patient also experienced permanent numbness of the face, left arm, left hand, minor difficulty walking up stairs with left leg and shortness of breath when walking up and down the stairs. Patient also noticed that her left arm feels like a tuning fork all the time, her left hand feels like the bone sticking out of palm, and her fingernail growing out of fingertips and she has to keep them trimmed. These led to a long-term disability and patient had to quit working. Patient was put on blood thinners in the hospital. No further details about the diagnostic procedures and treatments were provided. Patient reported that the events were not yet resolved. The medical history of Hypertension could be a risk factor for the event Thrombotic stroke. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-566820, MOD-2022-566822, MOD-2022-566813, MOD-2022-566828, MOD-2022-566808, MOD-2022-566814, MOD-2022-566821 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Events added. Seriousness of events updated. Suspect Product code updated from (Spikevax) to (Moderna CoviD-19 Vaccine).; Sender's Comments: This is a spontaneous case concerning a 61-year-old female patient with relevant medical history of Hypertension, who experienced the unexpected serious (disability, medically significant) adverse event of special interest Thrombotic stroke and unexpected serious events of Dyspnoea and Nail growth abnormal, which led to hospitalization, 13 days after receiving the second dose of mRNA-1273 vaccine. Inappropriate schedule of vaccine administered, described as patient received 2 doses of mRNA-1273 vaccine with 38 days interval, was also reported as an additional non-serious event. Patient reported that a blood clot traveled to her head which resulted to inability to control her arm, leg and face. Patient also experienced permanent numbness of the face, left arm, left hand, minor difficulty walking up stairs with left leg and shortness of breath when walking up and down the stairs. Patient also noticed that her left arm feels like a tuning fork all the time, her left hand feels like the bone sticking out of palm, and her fingernail growing out of fingertips and she has to keep them trimmed. These led to a long-term disability and patient had to quit working. Patient was put on blood thinners in the hospital. No further details about the diagnostic procedures and treatments were provided. Patient reported that the events were not yet resolved. The medical history of Hypertension could be a risk factor for the event Thrombotic stroke. The benefit-risk relationship of mRNA-1273 is not affected by this report.