Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain in extremity, Vomiting
Clinical narrative: Severe dizziness; Heavy vomiting; Chills; Soreness in the arm; A spontaneous report was received from a consumer who was an 81-year-old female patient who experienced heavy vomiting, severe dizziness, chills and arm is still sore.   The patient's medical history included thyroid disorder and elevated cholesterol.  Products known to have been used by the patient, within two weeks prior to the event, included rosuvastatin calcium, levothyroxine sodium, vitamins, calcium and fish oil. Additional suspected products included denosumab injections.   On 06-Jan-2021, almost 12 hours prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (LOT 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 06-Jan-2021 at 1430. On 07-Jan-2021 at 0130, she woke up with vomiting and severe dizziness. Patient stated that the room was spinning for approximately 20 minutes and the dizziness lasted at least 30 minutes. Patient reported that her husband had to hold her and that she was very scared. Additionally, patient endorsed chills and arm soreness. It was not indicated when the chills and arm soreness started or stopped. Patient had an appointment scheduled to receive the second dose of mRNA-1273, however, she wanted to know whether or not to get it.   Treatment for the event included paracetamol for arm soreness and a pill for vomiting.   Action taken with mRNA-1273 in response to the events, heavy vomiting, severe dizziness, chills and arm is still sore, was not provided.    The events, severe dizziness and heavy vomiting were considered recovered/resolved.     The outcome of the events, chills and arm is still sore, were not reported. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Severe dizziness), VOMITING (Heavy vomiting), CHILLS (Chills) and PAIN IN EXTREMITY (Soreness in the arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and High cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, DENOSUMAB (PROLIA), VITAMINS NOS, CALCIUM and FISH OIL for an unknown indication.    On 06-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VOMITING (Heavy vomiting), CHILLS (Chills) and PAIN IN EXTREMITY (Soreness in the arm). On 07-Jan-2021 at 1:30 AM, the patient experienced DIZZINESS (Severe dizziness). On 07-Jan-2021, VOMITING (Heavy vomiting), CHILLS (Chills) and PAIN IN EXTREMITY (Soreness in the arm) had resolved. On 07-Jan-2021 at 2:00 AM, DIZZINESS (Severe dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-02633 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.