Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral discomfort, Oral mucosal eruption, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: Mouth swelling; face was starting to droop,feel paralysis in face; symptoms of a stroke; Bell's Palsy; woke up with feeling of "swish and sip" in mouth,tingling in lips; tongue stuck out crooked; crick in neck on the left side; pain behind ear that kinda burned on the left side; mouth inflamed; Felt like lips on fire; Lips were swollen; rash around the edges of mouth; Corners of mouth dry, cracked and uncomfortable; mouth was really stiff; couldn't keep her lips lubricated; lips were really painful; Bad rash all over body; Hardness at injection site; Redness at injection site; swelling of the lymph nodes in the same arm of the injection; Injection site pain,tenderness; Swelling at injection site; Fatigue; Headache; Muscle Pain; Joint Pain; Chills; Nausea; Fever; Swelling of her face; Dizziness; Swelling throat; Fast heart beat; Weakness; Injection site felt hot; felt pretty sick for the first couple of days; This spontaneous case was reported by a patient and describes the occurrence of FACIAL PARALYSIS (face was starting to droop,feel paralysis in face), CEREBROVASCULAR ACCIDENT (symptoms of a stroke) and BELL'S PALSY (Bell's Palsy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polycythemia vera (a form of blood cancer, for which she is on aspirin once a day. Patient initially diagnosed approximately 3 years ago.), Hypothyroidism, Allergy and Asthma ("a little" asthma due to environmental allergies.). Concomitant products included MONTELUKAST for Environmental allergy and Asthma, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ASPIRIN [ACETYLSALICYLIC ACID] for Polycythemia vera.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DIZZINESS (Dizziness), SWELLING FACE (Swelling of her face), PHARYNGEAL SWELLING (Swelling throat), HEART RATE INCREASED (Fast heart beat), ASTHENIA (Weakness), VACCINATION SITE WARMTH (Injection site felt hot), ILLNESS (felt pretty sick for the first couple of days), RASH (Bad rash all over body), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in the same arm of the injection), VACCINATION SITE PAIN (Injection site pain,tenderness), VACCINATION SITE SWELLING (Swelling at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). On 17-Apr-2021, the patient experienced LIP SWELLING (Lips were swollen), ORAL MUCOSAL ERUPTION (rash around the edges of mouth), ORAL DISCOMFORT (Corners of mouth dry, cracked and uncomfortable), ORAL DISCOMFORT (Felt like lips on fire), LIP PAIN (lips were really painful), INFLAMMATION (mouth inflamed), MUSCULOSKELETAL STIFFNESS (mouth was really stiff) and LIP DRY (couldn't keep her lips lubricated). On 12-Jul-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (crick in neck on the left side) and EAR PAIN (pain behind ear that kinda burned on the left side). On 14-Jul-2021, the patient experienced FACIAL PARALYSIS (face was starting to droop,feel paralysis in face) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (symptoms of a stroke) (seriousness criterion medically significant), BELL'S PALSY (Bell's Palsy) (seriousness criteria disability and medically significant), PARAESTHESIA ORAL (woke up with feeling of "swish and sip" in mouth,tingling in lips) and TONGUE DISCOMFORT (tongue stuck out crooked). On an unknown date, the patient experienced MOUTH SWELLING (Mouth swelling). The patient was treated with PREDNISONE for Bell's palsy, at a dose of 4 dosage form once a day; PREDNISONE for Bell's palsy, at a dose of 2 dosage form once a day; PREDNISONE ongoing since an unknown date for Bell's palsy, at a dose of 1 dosage form once a day; VALACYCLOVIR [VALACICLOVIR] on 14-Jul-2021 for Bell's palsy, at a dose of 1 dosage form (evening) and VALACYCLOVIR [VALACICLOVIR] for Bell's palsy, at a dose of UNK, tid. On 06-Apr-2021, DIZZINESS (Dizziness), SWELLING FACE (Swelling of her face), HEART RATE INCREASED (Fast heart beat), ASTHENIA (Weakness), RASH (Bad rash all over body), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PAIN (Injection site pain,tenderness), VACCINATION SITE SWELLING (Swelling at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown, VACCINATION SITE WARMTH (Injection site felt hot) had resolved. On 21-Jul-2021, ORAL MUCOSAL ERUPTION (rash around the edges of mouth) and LIP PAIN (lips were really painful) had resolved, LIP DRY (couldn't keep her lips lubricated) outcome was unknown. At the time of the report, FACIAL PARALYSIS (face was starting to droop,feel paralysis in face), CEREBROVASCULAR ACCIDENT (symptoms of a stroke), BELL'S PALSY (Bell's Palsy), LIP SWELLING (Lips were swollen), ORAL DISCOMFORT (Corners of mouth dry, cracked and uncomfortable), ORAL DISCOMFORT (Felt like lips on fire), PHARYNGEAL SWELLING (Swelling throat), ILLNESS (felt pretty sick for the first couple of days), PARAESTHESIA ORAL (woke up with feeling of "swish and sip" in mouth,tingling in lips), TONGUE DISCOMFORT (tongue stuck out crooked), INFLAMMATION (mouth inflamed), MOUTH SWELLING (Mouth swelling), MUSCULOSKELETAL STIFFNESS (mouth was really stiff) and VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in the same arm of the injection) outcome was unknown and MUSCULOSKELETAL STIFFNESS (crick in neck on the left side) and EAR PAIN (pain behind ear that kinda burned on the left side) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Heart rate: fast (High) Fast.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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. Very limited information has been reported at this time. Further information is t expected.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow up case: Additional events, concomitant medications and medical history was added.; 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. Very limited information has been reported at this time. Further information is t expected.