Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Computerised tomogram, Interchange of vaccine products, Magnetic resonance imaging
Clinical narrative: Suspected brain stem TIA; Suspected brain stem TIA; COVID-19; patient received three doses of the Pfizer/BioNTech COVID-19 vaccine & 2nd booster dose of the Moderna COVID-19 vaccine; patient received three doses of the Pfizer/BioNTech COVID-19 vaccine & 2nd booster dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of the first episode of TRANSIENT ISCHAEMIC ATTACK (Suspected brain stem TIA) and the second episode of TRANSIENT ISCHAEMIC ATTACK (Suspected brain stem TIA) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (dose 1 with batch number EL8982, route intramuscular, location: arm) on 20-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (dose 2 with batch number EN6201, route intramuscular, location: arm) on 10-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (dose 3 with batch number 30145BA, route intramuscular and location: arm) on 24-Sep-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included MGUS since 2019, Hypertension since 1990, Osteoarthritis since 1990 and Allergy to antibiotic (Cipro allergy). Concomitant products included DILTIAZEM for Blood pressure high.    On 10-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2022, the patient experienced COVID-19 IMMUNISATION (patient received three doses of the Pfizer/BioNTech COVID-19 vaccine & 2nd booster dose of the Moderna COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (patient received three doses of the Pfizer/BioNTech COVID-19 vaccine & 2nd booster dose of the Moderna COVID-19 vaccine). On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the first episode of TRANSIENT ISCHAEMIC ATTACK (Suspected brain stem TIA) (seriousness criteria hospitalization and medically significant). On 09-Jul-2022, the patient experienced COVID-19 (COVID-19). On 10-Jul-2022, the patient experienced the second episode of TRANSIENT ISCHAEMIC ATTACK (Suspected brain stem TIA) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized for 2 days due to TRANSIENT ISCHAEMIC ATTACK, and then for 4 days due to TRANSIENT ISCHAEMIC ATTACK. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-Jul-2022 to 17-Jul-2022 for COVID-19 treatment, at an unspecified dose and frequency; ATORVASTATIN CALCIUM (LIPITOR) (oral) ongoing from 24-May-2022 for TIA, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] (oral) ongoing from 24-May-2022 for TIA, at an unspecified dose and frequency and CLOPIDOGREL BISULFATE (PLAVIX) (oral) ongoing from 11-Jul-2022 for TIA, at an unspecified dose and frequency. On 16-Jul-2022, COVID-19 (COVID-19) had resolved. At the time of the report, last episode of TRANSIENT ISCHAEMIC ATTACK (Suspected brain stem TIA) was resolving and COVID-19 IMMUNISATION (patient received three doses of the Pfizer/BioNTech COVID-19 vaccine & 2nd booster dose of the Moderna COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (patient received three doses of the Pfizer/BioNTech COVID-19 vaccine & 2nd booster dose of the Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, Computerised tomogram: No clear evidence of stroke. Small vessel ischemic disease. On 23-May-2022, Magnetic resonance imaging: No clear evidence of stroke. Small vessel ischemic disease.. On 10-Jul-2022, Computerised tomogram: No clear evidence of stroke. Small vessel ischemic disease.. On 10-Jul-2022, SARS-CoV-2 test: (Positive) Positive. On 13-Jul-2022, Magnetic resonance imaging: No clear evidence of stroke. Small vessel ischemic disease.. On 19-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         The patient was taking any other medications or products within 2 weeks of starting COVID-19 treatment. The patient previously received COVID-19 Vaccine.  After taking Paxlovid, it was reported that patient's symptoms initially resolved fully by day 8 of infection. Paxlovid was taken days 4 to 9. Then patient tested positive again on day 11 with symptoms congestion, cough, etc.  It was unknown if the patient had underwent specific relevant test for the thromboembolic events with thrombocytopenia. On 23 May 22, the patient was suspected brain stem TIA associated with nausea, vomiting, dizzy, double vision, nystagmus, unable to walk and slurred speech. Hospitalized for 2 days, treated with Liptor and Aspirin.  On 08 Jul 22, the patient became symptomatic with COVID. On 09 Jul 22, the patient had tested positive for COVID. On 10 Jul 22, the patient was suspected brain stem TIA associated with dizzy, double vision, fell, unable to walk and slurred speech due to which was hospitalized for 4 days. Treated with Plavix. The patient required skilled nursing facility (SNF) 8 more days. Patient took 5-day course of Paxlovid from 12 Jul 22 to 17 Jul 22.  On 18 Jul 22 the patient had possible paxlovid rebound, the patient again tested positive and became symptomatic for 2 days. Patient was still in recovery. On 28 Jul 22 , the patient initiated care with physician who was the stroke neurologist and still tried to determine the cause of TIA. Currently on 2-week heart monitor.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-627328 (Patient Link).   Reporter did not allow further contact  Company Comment: This spontaneous case concerns an 88-year-old, male patient with medical history of Hypertension (1990s) and Monoclonal Gammopathy of Undetermined Significance (2019), and past drug history of administration of three doses of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, serious (hospitalization and medically significant) AESI of transient ischaemic attack, the unexpected, serious (hospitalization, disability and medically significant) AESI of transient ischaemic attack, and the unexpected, non-serious AESI of COVID-19. The event transient ischaemic attack (first episode) occurred almost 8 months after receiving the third dose (first booster dose) of the Pfizer/BioNTech COVID-19 mRNA vaccine and approximately 1 month after receiving a dose (second booster dose/fourth dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine products). The event transient ischaemic attack (second episode) occurred approximately 9 months after receiving the third dose (first booster dose) of the Pfizer/BioNTech COVID-19 mRNA vaccine and 3 months after receiving a dose (second booster dose/fourth dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine. The event COVID-19  occurred approximately 9 months after receiving the third dose (first booster dose) of the Pfizer/BioNTech COVID-19 mRNA vaccine and almost 3 months after receiving a dose (second booster dose/fourth dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine. Approximately 1 month after receiving the mRNA-1273 vaccine, it was reported that the patient experienced nausea, vomiting, dizziness, double vision, nystagmus, inability to walk and slurred speech. He was hospitalized for 2 days for suspected Brainstem Transient Ischemic Attack (TIA). The Computerized Tomogram (CT) scan and Magnetic Resonance Imaging (MRI) showed 'small vessel ischemic disease, no clear evidence of stroke'. The patient was started on Lipitor (atorvastatin) and aspirin of unspecified dose, frequency and duration. It was reported that the event was resolving, until 3 months after receiving the mRNA-1273 vaccine, the patient again experienced dizziness, double vision, inability to walk and slurred speech, and the patient also had a fall. He was hospitalized for 4 days for suspected Brainstem TIA. Repeat CT scan and MRI still showed 'small vessel ischemic disease, no clear evidence of stroke'. The patient was started on Plavix (clopidogrel) of unspecified dose, frequency and duration. It was reported that the patient was recovering but he has weakness and memory impairment. Two weeks after the patient was discharged, he was seen by a Stroke neurologist and the patient was placed on a 2-week cardiac monitoring to determine the cause of the TIAs. It was also reported that 2 days before the second episode of TIA, the patient became symptomatic with COVID-19 (symptoms were not reported). The following day, he tested positive for SARS-CoV-2. After 3 days, he took and completed a 6-day course of Paxlovid (nirmatrelvir, ritonavir). It was reported that the symptoms initially resolved fully by day 8 of the infection (1 day before completion of Paxlovid treatment). However, 1 day after the Paxlovid treatment, the patient experienced congestion and cough, and was symptomatic for 2 days. The patient again tested positive for SARS-CoV-2. No additional details were provided regarding the possible COVID-19 rebound infection. The medical history of Hypertension, which is a known risk factor for Transient Ischemic Attack and COVID-19, remains a confounder for the reported events. The medical history of Monoclonal Gammopathy of Undetermined Significance, a blood disorder that causes accumulation of the abnormal monoclonal protein (M protein) in the blood which may reduce the body's ability to fight infections, remains a confounder for the event COVID-19. The patient's advanced age (high risk for TIA and infections) also remains a confounder for the reported events. The administration of three doses of the Pfizer/BioNTech COVID-19 mRNA vaccine also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2022: Live Follow Up : Patient information added / AE added / Case upgraded. On 10-Aug-2022: Follow Up : No new information; Sender's Comments: This spontaneous case concerns an 88-year-old, male patient with medical history of Hypertension (1990s) and Monoclonal Gammopathy of Undetermined Significance (2019), and past drug history of administration of three doses of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, serious (hospitalization and medically significant) AESI of transient ischaemic attack, the unexpected, serious (hospitalization, disability and medically significant) AESI of transient ischaemic attack, and the unexpected, non-serious AESI of COVID-19. The event transient ischaemic attack (first episode) occurred almost 8 months after receiving the third dose (first booster dose) of the Pfizer/BioNTech COVID-19 mRNA vaccine and approximately 1 month after receiving a dose (second booster dose/fourth dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine products). The event transient ischaemic attack (second episode) occurred approximately 9 months after receiving the third dose (first booster dose) of the Pfizer/BioNTech COVID-19 mRNA vaccine and 3 months after receiving a dose (second booster dose/fourth dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine. The event COVID-19  occurred approximately 9 months after receiving the third dose (first booster dose) of the Pfizer/BioNTech COVID-19 mRNA vaccine and almost 3 months after receiving a dose (second booster dose/fourth dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine. Approximately 1 month after receiving the mRNA-1273 vaccine, it was reported that the patient experienced nausea, vomiting, dizziness, double vision, nystagmus, inability to walk and slurred speech. He was hospitalized for 2 days for suspected Brainstem Transient Ischemic Attack (TIA). The Computerized Tomogram (CT) scan and Magnetic Resonance Imaging (MRI) showed 'small vessel ischemic disease, no clear evidence of stroke'. The patient was started on Lipitor (atorvastatin) and aspirin of unspecified dose, frequency and duration. It was reported that the event was resolving, until 3 months after receiving the mRNA-1273 vaccine, the patient again experienced dizziness, double vision, inability to walk and slurred speech, and the patient also had a fall. He was hospitalized for 4 days for suspected Brainstem TIA. Repeat CT scan and MRI still showed 'small vessel ischemic disease, no clear evidence of stroke'. The patient was started on Plavix (clopidogrel) of unspecified dose, frequency and duration. It was reported that the patient was recovering but he has weakness and memory impairment. Two weeks after the patient was discharged, he was seen by a Stroke neurologist and the patient was placed on a 2-week cardiac monitoring to determine the cause of the TIAs. It was also reported that 2 days before the second episode of TIA, the patient became symptomatic with COVID-19 (symptoms were not reported). The following day, he tested positive for SARS-CoV-2. After 3 days, he took and completed a 6-day course of Paxlovid (nirmatrelvir, ritonavir). It was reported that the symptoms initially resolved fully by day 8 of the infection (1 day before completion of Paxlovid treatment). However, 1 day after the Paxlovid treatment, the patient experienced congestion and cough, and was symptomatic for 2 days. The patient again tested positive for SARS-CoV-2. No additional details were provided regarding the possible COVID-19 rebound infection. The medical history of Hypertension, which is a known risk factor for Transient Ischemic Attack and COVID-19, remains a confounder for the reported events. The medical history of Monoclonal Gammopathy of Undetermined Significance, a blood disorder that causes accumulation of the abnormal monoclonal protein (M protein) in the blood which may reduce the body's ability to fight infections, remains a confounder for the event COVID-19. The patient's advanced age (high risk for TIA and infections) also remains a confounder for the reported events. The administration of three doses of the Pfizer/BioNTech COVID-19 mRNA vaccine also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.