Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Somnolence, Vision blurred
Clinical narrative: Constipation; Blured vision; Dizzy; losing conscious; Brain fog; pain in backhead; Staying awake only for 3hrs or 4 to 6hrs a day / feels like she have to lay down; weakness; Extreme fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONSTIPATION (Constipation), VISION BLURRED (Blured vision), DIZZINESS (Dizzy), LOSS OF CONSCIOUSNESS (losing conscious), ASTHENIA (weakness), FEELING ABNORMAL (Brain fog), HEADACHE (pain in backhead) and SOMNOLENCE (Staying awake only for 3hrs or 4 to 6hrs a day / feels like she have to lay down) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic since 1991, Hyperthyroidism since 1991, Breast cancer since 2001, Drug allergy (Anaphylaxis), Drug allergy (Anaphylaxis), Drug allergy (Stopped breathing), Drug allergy (Hives and Itching. Patient had septra before and she had no problems), Drug allergy (Hives - can only take brand name Levoxyl as she is severly allergic to brand name Synthroid and does not want to take generic levothyroxine).), Drug allergy (Stiff joints and joint aches), Iodine allergy (Hives), Drug allergy (combative) and Drug allergy. Concomitant products included INSULIN DEGLUDEC (TRESIBA), LEVOTHYROXINE SODIUM (LEVOXYL) from an unknown date to 29-May-2021, ALENDRONATE SODIUM (ALENDRONATE), ACYCLOVIR [ACICLOVIR], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), SELENIUM, COLECALCIFEROL, MENAQUINONE-7 (VITAMIN D3 K2), FISH OIL, CALCIUM, COLECALCIFEROL (CALCIUM +D3), MAGNESIUM, CHOLINE, SILICON (BIOSIL), INSULIN ASPART (FIASP FLEXTOUCH), MULTIVITAMIN ACTIVE WOMAN, CLOBETASOL PROPIONATE (CORMAX), ESTRADIOL (VAGIFEM) and METHYLSULFONYLMETHANE (MSM [METHYLSULFONYLMETHANE]) for an unknown indication.    On 01-May-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced ASTHENIA (weakness) (seriousness criterion hospitalization), SOMNOLENCE (Staying awake only for 3hrs or 4 to 6hrs a day / feels like she have to lay down) (seriousness criterion hospitalization) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced CONSTIPATION (Constipation) (seriousness criterion hospitalization), VISION BLURRED (Blured vision) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (losing conscious) (seriousness criteria hospitalization and medically significant), FEELING ABNORMAL (Brain fog) (seriousness criterion hospitalization) and HEADACHE (pain in backhead) (seriousness criterion hospitalization). The patient was hospitalized from 24-May-2021 to 27-May-2021 due to ASTHENIA, CONSTIPATION, DIZZINESS, FEELING ABNORMAL, HEADACHE, LOSS OF CONSCIOUSNESS, SOMNOLENCE and VISION BLURRED. The patient was treated with MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE (DELTASONE [PREDNISONE]) (oral) for Adverse event, at a dose of 2 dosage form once a day; PREDNISONE (DELTASONE [PREDNISONE]) (oral) for Adverse event, at a dose of 1 dosage form once a day; PREDNISONE (DELTASONE [PREDNISONE]) (oral) for Adverse event, at a dose of .5 dosage form once a day; PREDNISONE (DELTASONE [PREDNISONE]) (oral) for Adverse event, at a dose of 3 dosage form once a day and ONDANSETRON (ZOFRAN [ONDANSETRON]) (oral) ongoing since an unknown date for Nausea and Vomiting, at a dose of 1 dosage form as necessary. At the time of the report, CONSTIPATION (Constipation), VISION BLURRED (Blured vision), DIZZINESS (Dizzy), LOSS OF CONSCIOUSNESS (losing conscious), ASTHENIA (weakness), FEELING ABNORMAL (Brain fog) and HEADACHE (pain in backhead) had not resolved and SOMNOLENCE (Staying awake only for 3hrs or 4 to 6hrs a day / feels like she have to lay down) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included alcohol swabs pads, onetouch ultra blue test strip, BD ultra fine micro pen needle, accu-check fastclix lancet drum, accu-chek fastclix lancing dev kit and acetone (urin) test strip.  It was difficult to completely understand some parts of the hand written answers.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added allergies, concomitant medications, treatment drugs and 7 new serious events. Case was upgraded to serious with the addition of serious events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events Further information has been requested.