Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Myalgia, Respiratory rate, Seizure
Clinical narrative: chills; body aches; Fatigue; Resident reported weakness; seizures or seizure like activity; hypo or hypertension; chest pains; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills), MYALGIA (body aches), FATIGUE (Fatigue), ASTHENIA (Resident reported weakness) and SEIZURE (seizures or seizure like activity) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acute respiratory failure (UNSPECIFIED WHETHER WITH HYPOXIA OR HYPERCAPNIA). Previously administered products included for COVID-19 prophylaxis: Moderna (dose 1) on 04-Mar-2021, Moderna (dose 2) on 17-Mar-2021, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (dose 4 and lot AS7163B (Expiry date: 28-Oct-2022)) on 06-Oct-2022; for Product used for unknown indication: Pfizer (Dose 3) on 16-Mar-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna, Moderna and Pfizer. Concurrent medical conditions included Wheezing, Parkinson's disease (WITHOUT DYSKINESIA, WITHOUT MENTION OF FLUCTUATIONS), Vitamin D deficiency, Vitamin B12 deficiency, Cough, Type 2 diabetes mellitus (TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS), Shortness of breath, Hypothyroidism (unspecified), Essential hypertension, Drug allergy (Diltiazem), Drug allergy (Pramipexole), Allergy to antibiotic (Vancomycin), Drug allergy (Celebrex), Drug allergy (NSAIDs), Food allergy (Chocolate), Gastrooesophageal reflux disease (GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS), Constipation, Acute bronchitis, Muscle weakness (MUSCLE WEAKNESS (GENERALIZED)), Major depressive disorder, single episode, Urinary tract infection, Obstructive sleep apnea syndrome, Dementia (UNSPECIFIED SEVERITY, WITHOUT BEHAVIORAL DISTURBANCE, PSYCHOTIC DISTURBANCE, MOOD DISTURBANCE, AND ANXIETY), Depression, Insomnia, Schizoaffective disorder and Morbid obesity (MORBID (SEVERE) OBESITY DUE TO EXCESS CALORIES). Concomitant products included MACROGOL 4000, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM SULFATE (POLYETHYLENE GLYCOL ELECTROLYTE POWDER(I)) for Constipation, GUAIFENESIN for Cough, INSULIN LISPRO (HUMALOG) and INSULIN GLARGINE for Diabetes, PANTOPRAZOLE SODIUM ANHYDROUS for GERD, LISINOPRIL for Hypertension, LEVOTHYROXINE SODIUM for Hypothyroidism, CARBIDOPA, LEVODOPA (CARBIDOPA-LEVODOPA-B) for Parkinson's disease, ASCORBIC ACID for Routine health maintenance, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (IPRATROPIUM/ALBUTEROL) for Shortness of breath, CYANOCOBALAMIN for Vitamin B12 deficiency, CHOLECALCIFEROL for Vitamin deficiency, ALBUTEROL SULFATE for Wheezing, ACETAMINOPHEN for an unknown indication.    On 08-Nov-2023 at 12:03 PM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Nov-2023 at 2:58 PM, the patient experienced CHILLS (chills) (seriousness criterion hospitalization), MYALGIA (body aches) (seriousness criterion hospitalization), FATIGUE (Fatigue) (seriousness criterion hospitalization), ASTHENIA (Resident reported weakness) (seriousness criterion hospitalization), SEIZURE (seizures or seizure like activity) (seriousness criterion medically significant), BLOOD PRESSURE FLUCTUATION (hypo or hypertension) and CHEST PAIN (chest pains). The patient was hospitalized for 2 days due to ASTHENIA, CHILLS, FATIGUE and MYALGIA. At the time of the report, CHILLS (chills), MYALGIA (body aches), FATIGUE (Fatigue) and ASTHENIA (Resident reported weakness) had not resolved and SEIZURE (seizures or seizure like activity), BLOOD PRESSURE FLUCTUATION (hypo or hypertension) and CHEST PAIN (chest pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 139/70. On an unknown date, Heart rate: 85. On an unknown date, Respiratory rate: 30.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient's age was reported as 79 years and 6 months.  It was reported that 9 patients who had adverse events after getting the Spikevax vaccine had common adverse events - chest pains, hypo or hypertension and seizures or seizures like activity.  No treatment medication information was reported.  Company Comment: This is a Spontaneous case concerning a 79-year-old, female patient with current condition of Parkinson's disease, Type 2 diabetes mellitus, Essential hypertension, different drug allergies, Major depressive disorder, muscle weakness previously vaccinated with other Moderna vaccines, who experienced the unexpected serious (medically significant) AESI of seizure and the serious (hospitalization) unlisted events of fatigue, chills, myalgia and asthenia among other non-serious events. One day after the administration of SPIKEVAX 2023-2024 vaccine, used as a fifth dose, the patient experienced fatigue, chills, myalgia and asthenia. He had BP 139/70 Pulse 85 and a Resp rate of 30 and he was admitted to hospitalization for 2 days. No further information on clinical course, investigations and treatment received was available in the report. Patient mentioned current condition are confounders for the events. With the available information its unclear if the patient experienced seizure or not. Further information is being requested. The benefit-risk relationship of SPIKEVAX 2023-2024Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749133, US-MODERNATX, INC.-MOD-2023-749386, US-MODERNATX, INC.-MOD-2023-749388, US-MODERNATX, INC.-MOD-2023-749389, US-MODERNATX, INC.-MOD-2023-749390, US-MODERNATX, INC.-MOD-2023-749391, US-MODERNATX, INC.-MOD-2023-749226, US-MODERNATX, INC.-MOD-2023-749191, US-MODERNATX, INC.-MOD-2023-749724 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2023: Significant follow-up received. Lot number updated. Reference number added. On 10-Nov-2023: Live follow-up received with significant information with vaccine details. On 10-Nov-2023: Significant Live follow up received and patient demographic, concomitant medications, events added. On 13-Nov-2023: Follow-up received that contains non-significant information: Reporter and Reference IDs updated. On 13-Nov-2023: Significant follow up added. Reporter and LRM was added. Patient age group added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749133:Patient 2 (AE-00078387/C-Int-0009067) US-MODERNATX, INC.-MOD-2023-749226:Patient 4 (AE-00078391/C-Int-0009069) US-MODERNATX, INC.-MOD-2023-749391:Patient 9 US-MODERNATX, INC.-MOD-2023-749389:Patient 7 US-MODERNATX, INC.-MOD-2023-749388:Patient 6 US-MODERNATX, INC.-MOD-2023-749390:Patient 8 US-MODERNATX, INC.-MOD-2023-749386:Patient 5 US-MODERNATX, INC.-MOD-2023-749191:Patient 3 (AE-00078390/C-Int-0009068) US-MODERNATX, INC.-MOD-2023-749724:Non retained case/Deleted case