Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19 (Illness, Asthenia, Chills, Oropharyngeal pain, Odynophagia, Sinusitis, Headache, Malaise and Feeling abnormal)), TREMOR (tremors/shakes), PALPITATIONS (pinging and throbbing on her lower right side), CYSTITIS (may have bladder infection) and FUNGAL INFECTION (yeast infection) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in March 2020 and Sinus infection. Previously administered products included for COVID-19 vaccination: Janssen (Dose number 1 Lot number: 1808980) on 30-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Drug allergy (Biaxin), Blood pressure high (Start Date: 10 years ago), High cholesterol (Start Date: 10 years ago), Bipolar disorder (Start date: 1980s), Depression (Start date: 1980s) and Stress symptoms (Start date: 1980s). Concomitant products included LEVOCETIRIZINE for Allergy, LISINOPRIL for Blood pressure high, MEDROXYPROGESTERONE for Night sweats, LORAZEPAM, COLECALCIFEROL (VITAMIN D3), ATORVASTATIN CALCIUM, QUETIAPINE FUMARATE (SEROQUEL), CARBAMAZEPINE (TEGRETOL), ESTRADIOL, DULOXETINE HYDROCHLORIDE (CYMBALTA) and CALCIUM, COLECALCIFEROL (CALCIUM + D3 [CALCIUM; COLECALCIFEROL]) for an unknown indication. On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Jan-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for COVID (Illness, Asthenia, Chills, Oropharyngeal pain, Odynophagia, Sinusitis, Headache, Malaise and Feeling abnormal)). On 27-Feb-2022, the patient experienced VOMITING (vomited bile). On an unknown date, the patient experienced TREMOR (tremors/shakes), PALPITATIONS (pinging and throbbing on her lower right side), CYSTITIS (may have bladder infection), FUNGAL INFECTION (yeast infection) and INTERCHANGE OF VACCINE PRODUCTS (Interchange change of vaccine product). The patient was treated with PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ALKA SELTZER PLUS COLD AND SINUS [PARACETAMOL; PSEUDOEPHEDRINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID (Illness, Asthenia, Chills, Oropharyngeal pain, Odynophagia, Sinusitis, Headache, Malaise and Feeling abnormal)), TREMOR (tremors/shakes), PALPITATIONS (pinging and throbbing on her lower right side), CYSTITIS (may have bladder infection) and VOMITING (vomited bile) had not resolved, FUNGAL INFECTION (yeast infection) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange change of vaccine product) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medication included probiotics and Vitamin B12 drugs used for the unknown indication. It was reported by the patient that She had no energy and used to feel horrible. Further she stated that she was unable to function correctly in her daily life at all. She did not knew whether this was due to the COVID-19 infection, or Moderna booster, or a combination of both at the same time. She had not experienced any fever so far. It was reported by the patient that she does not feel good and said that she shouldn't be feeling that way. Further she stated that whenever she closes her eyes, she feels like she will not wake up and her symptoms had been very unpredictable. She stated that one day she would feel really good and get up to take a shower, do the dishes, and cook and then the next 3 days, she would feel awful again. She stated further that there were no good days. It was reported by her that her condition was not changing and in fact was only getting worse. It was reported by her that her son has been cooking, cleaning, grocery shopping, and walking her dogs. It was reported by her that she had not walked her dogs in 2 months and does not leave the house. Further it was stated by her that she had cancelled all her doctors appointments as she did not had the strength to drive herself. It was reported by her that she felt like her life was on hold due to this. It was reported that patient did not seek medical care for the adverse events caused but occasionally spoke on phone with the doctor for events of sore throat, burning when swallowing, and sinus infection. Company Comment: This spontaneous case concerns a 59-years-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 and other non-serious events which occurred 7 days after booster dose of mRNA 1273 Vaccine. It was reported that patient received the Janssen COVID-19 vaccine on 30-MAR-2021 and developed contracting COVID-19 and became very sick with it for 2 months and out of work for that time. Patient received booster dose of the Moderna COVID-19 vaccine on 3-JAN-2022. Her son got sick during the first weekend in JAN-2022 and tested positive for COVID-19. 5 days later even patient was tested positive for COVID -19. Inter change of vaccine product is noted in this case with patient receiving a dose of Janssen Covid-19 9 months 4 days prior to current vaccination. However, the lab reports, clinical course and treatment information are not provided. The patient's son contracting COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 59-years-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 and other non-serious events which occurred 7 days after booster dose of mRNA 1273 Vaccine. It was reported that patient received the Janssen COVID-19 vaccine on 30-MAR-2021 and developed contracting COVID-19 and became very sick with it for 2 months and out of work for that time. Patient received booster dose of the Moderna COVID-19 vaccine on 3-JAN-2022. Her son got sick during the first weekend in JAN-2022 and tested positive for COVID-19. 5 days later even patient was tested positive for COVID -19. Inter change of vaccine product is noted in this case with patient receiving a dose of Janssen Covid-19 9 months 4 days prior to current vaccination. However, the lab reports, clinical course and treatment information are not provided. The patient's son contracting COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.