Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: She was diagnosed with Bell's palsy/she felt the left side of the face and neck cramping and numbness, numb bottom lip, smile one-sided; For the 1st 2 doses she only experienced a little fiver and little achy but nothing major.; to feel numbness and then pain in the left upper arm, the shoulder and joints; pain in the left upper arm, the shoulder and joints; had a big swelling under the left armpit; high fever/For the 1st 2 doses she only experienced a little fiver and little achy but nothing major.; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (She was diagnosed with Bell's palsy/she felt the left side of the face and neck cramping and numbness, numb bottom lip, smile one-sided) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21A, 001A21A and 047A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Naproxen) and Drug allergy (General anesthesia).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (She was diagnosed with Bell's palsy/she felt the left side of the face and neck cramping and numbness, numb bottom lip, smile one-sided) (seriousness criterion medically significant), PAIN (For the 1st 2 doses she only experienced a little fiver and little achy but nothing major.), HYPOAESTHESIA (to feel numbness and then pain in the left upper arm, the shoulder and joints), ARTHRALGIA (pain in the left upper arm, the shoulder and joints), LYMPHADENOPATHY (had a big swelling under the left armpit) and PYREXIA (high fever/For the 1st 2 doses she only experienced a little fiver and little achy but nothing major.). At the time of the report, BELL'S PALSY (She was diagnosed with Bell's palsy/she felt the left side of the face and neck cramping and numbness, numb bottom lip, smile one-sided), HYPOAESTHESIA (to feel numbness and then pain in the left upper arm, the shoulder and joints), LYMPHADENOPATHY (had a big swelling under the left armpit) and PYREXIA (high fever/For the 1st 2 doses she only experienced a little fiver and little achy but nothing major.) was resolving, PAIN (For the 1st 2 doses she only experienced a little fiver and little achy but nothing major.) outcome was unknown and ARTHRALGIA (pain in the left upper arm, the shoulder and joints) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Arteriogram carotid: Doctors made a CT scan, angiogram of the carotid, and blood tests. She was diagnosed with Bell's palsy probably caused by the vaccine.. On an unknown date, Blood test: Doctors made a CT scan, angiogram of the carotid, and blood tests. She was diagnosed with Bell's palsy probably caused by the vaccine.. On an unknown date, Computerised tomogram: Doctors made a CT scan, angiogram of the carotid, and blood tests. She was diagnosed with Bell's palsy probably caused by the vaccine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BELL'S PALSY (She was diagnosed with Bell's palsy/she felt the left side of the face and neck cramping and numbness, numb bottom lip, smile one-sided) to be related. No further causality assessments were provided for PAIN (For the 1st 2 doses she only experienced a little fiver and little achy but nothing major.), HYPOAESTHESIA (to feel numbness and then pain in the left upper arm, the shoulder and joints), ARTHRALGIA (pain in the left upper arm, the shoulder and joints), LYMPHADENOPATHY (had a big swelling under the left armpit) and PYREXIA (high fever/For the 1st 2 doses she only experienced a little fiver and little achy but nothing major.).    No relevant concomitant medications were reported. Patient mentioned that when 1st booster was administered on her left arm, she noticed it was an inexperienced HCP and felt like she receive more than the dose needed. A couple of days after 1st booster, patient started to feel numbness and then pain in the left upper arm, the shoulder and joints, had a big swelling under the left armpit, she had high fever, and she felt the left side of the face and neck cramping and numbness, numb bottom lip, smile one-sided. Currently symptoms still ongoing were pain in the shoulder and numbness in her face. No treatment medication reported.  Company Comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the expected, serious (medically significant) adverse event of special interest of Bell's palsy, approximately 2 days after receiving the third dose of mRNA-1273 vaccine. The patient started to feel numbness and then pain in the left upper arm, the shoulder and joints, had a big swelling under the left armpit, had high fever and felt the left side of the face and neck cramping and numbness, numb bottom lip, smile one-sided. CT scan, angiogram of the carotid and blood tests were performed but no results were provided. The patient was diagnosed with Bell's palsy. Treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the expected, serious (medically significant) adverse event of special interest of Bell's palsy, approximately 2 days after receiving the third dose of mRNA-1273 vaccine. The patient started to feel numbness and then pain in the left upper arm, the shoulder and joints, had a big swelling under the left armpit, had high fever and felt the left side of the face and neck cramping and numbness, numb bottom lip, smile one-sided. CT scan, angiogram of the carotid and blood tests were performed but no results were provided. The patient was diagnosed with Bell's palsy. Treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.