Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia, Sinusitis, Urinary incontinence, Vomiting
Clinical narrative: could not get out of bed; could not breathe; Has only 60% back of her bladder control; began vomiting; cough; lost control of her bladder; Earache; lost her smell; lost her taste; severe headaches/The headache, it was intense, her head felt like it was a fire ball inside, felt like she had acid inside her brain.; has not been able to sleep more than 2 hours a day at night; Lack of efficacy; Positive for COVID/she got COVID; Felt like she had a sinus infection/she had a severe sinus infection.; felt like she was going to get a fever/low grade fever, always at 100.5; she felt like something breaking through a shield in her body, like if her body had a shield of some kind and she felt something broke through that shield. She knew right away something was off.; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (she felt like something breaking through a shield in her body, like if her body had a shield of some kind and she felt something broke through that shield. She knew right away something was off.), SINUSITIS (Felt like she had a sinus infection/she had a severe sinus infection.), COVID-19 (Positive for COVID/she got COVID), DRUG INEFFECTIVE (Lack of efficacy) and EAR PAIN (Earache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included TIA in 2019. Previously administered products included for Product used for unknown indication: Modafil (she would have since 2019 when she had a TIA) since 2019. Concomitant products included VITAMINS NOS and VITAMIN C [ASCORBIC ACID] for Smell loss, MODAFINIL (MODAFIL) for TIA.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (she felt like something breaking through a shield in her body, like if her body had a shield of some kind and she felt something broke through that shield. She knew right away something was off.). On 26-Aug-2021, the patient experienced SINUSITIS (Felt like she had a sinus infection/she had a severe sinus infection.) and PYREXIA (felt like she was going to get a fever/low grade fever, always at 100.5). On 27-Aug-2021, the patient experienced COVID-19 (Positive for COVID/she got COVID). 27-Aug-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy). On 28-Aug-2021, the patient experienced EAR PAIN (Earache), ANOSMIA (lost her smell), AGEUSIA (lost her taste), INSOMNIA (has not been able to sleep more than 2 hours a day at night) and HEADACHE (severe headaches/The headache, it was intense, her head felt like it was a fire ball inside, felt like she had acid inside her brain.). On 03-Sep-2021, the patient experienced COUGH (cough), URINARY INCONTINENCE (lost control of her bladder) and VOMITING (began vomiting). On 16-Sep-2021, the patient experienced URINARY INCONTINENCE (Has only 60% back of her bladder control). On an unknown date, the patient experienced HYPOKINESIA (could not get out of bed) and DYSPNOEA (could not breathe). The patient was treated with BUTALBITAL on 31-Aug-2021 for Headache, at a dose of 50 mg four times per day; ACETAMINOPHEN on 31-Aug-2021 for Headache, at a dose of 325 mg four times per day; CAFFEINE on 31-Aug-2021 for Headache, at a dose of 40 mg four times per day; CODEINE on 03-Sep-2021 for Cough, at a dose of 1 dosage form; APIXABAN (ELIQUIS) on 03-Sep-2021 for Clot blood, at a dose of 1 dosage form and FLUTICASONE (nasal) in September 2021 at a dose of 1 dosage form. On 05-Sep-2021, COUGH (cough) had resolved. On 10-Sep-2021, ANOSMIA (lost her smell) had resolved. At the time of the report, FEELING ABNORMAL (she felt like something breaking through a shield in her body, like if her body had a shield of some kind and she felt something broke through that shield. She knew right away something was off.), SINUSITIS (Felt like she had a sinus infection/she had a severe sinus infection.), COVID-19 (Positive for COVID/she got COVID), DRUG INEFFECTIVE (Lack of efficacy), EAR PAIN (Earache), AGEUSIA (lost her taste), URINARY INCONTINENCE (lost control of her bladder), HYPOKINESIA (could not get out of bed), DYSPNOEA (could not breathe), INSOMNIA (has not been able to sleep more than 2 hours a day at night), URINARY INCONTINENCE (Has only 60% back of her bladder control), HEADACHE (severe headaches/The headache, it was intense, her head felt like it was a fire ball inside, felt like she had acid inside her brain.) and VOMITING (began vomiting) outcome was unknown and PYREXIA (felt like she was going to get a fever/low grade fever, always at 100.5) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 100.5 (High) low grade fever. In August 2021, Oxygen saturation: 82 to 85 (Low) oxygen went down to 82-85.. On 26-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. On 12-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.         The action taken with mRNA-1273 with the event was considered as not applicable.  Company Comment: This case concerns a 43 -year-old female patient with  relevant medical history of TIA , who experienced  unexpected events of  Drug ineffective. Feeling abnormal , Sinus infection, COVID-19,Ear pain  Anosmia, Aguesia, Cough , bladder incontinence , movement reduced , dyspnea  and insomnia with other expected events of fever, headache and vomiting .   These events occurred  approximately 6 months after vaccination with the 2nd dose of Moderna  and outcome of events were reported to have resolved. The benefit-risk relationship of Moderna is not affected by this report.; Sender's Comments: This case concerns a 43 -year-old female patient with  relevant medical history of TIA , who experienced  unexpected events of  Drug ineffective. Feeling abnormal , Sinus infection, COVID-19,Ear pain  Anosmia, Aguesia, Cough , bladder incontinence , movement reduced , dyspnea  and insomnia with other expected events of fever, headache and vomiting .   These events occurred  approximately 6 months after vaccination with the 2nd dose of Moderna  and outcome of events were reported to have resolved. The benefit-risk relationship of Moderna is not affected by this report.