Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Mass, Periorbital swelling, Product dose omission issue, Rash
Clinical narrative: red,hard knot on it; Rashes and hives all over the body; Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow; He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles; Patient was wondering who he should to go to, so someone can can write "Do not give the second dose; Upper lip was really swollen; Upper lip was really swollen; Puffiness around the eyes; burning sensation on his upper lip on the inside; Felt pressure on his face; Swollen eyes; Feeling exhausted; Swollen face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of LIP SWELLING (Upper lip was really swollen), PERIORBITAL SWELLING (Puffiness around the eyes), BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face), EYE SWELLING (Swollen eyes), MASS (red,hard knot on it), SWELLING FACE (Swollen face), the second episode of LIP SWELLING (Upper lip was really swollen), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow), FATIGUE (Feeling exhausted), GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (he had a mild stroke 2 years ago on August 27th and his right arm, right leg, and right foot were paralyzed.). Previously administered products included for No adverse event: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced EYE SWELLING (Swollen eyes), SWELLING FACE (Swollen face) and FATIGUE (Feeling exhausted). On 15-Apr-2021, the patient experienced the first episode of LIP SWELLING (Upper lip was really swollen), PERIORBITAL SWELLING (Puffiness around the eyes), BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face) and the second episode of LIP SWELLING (Upper lip was really swollen). On an unknown date, the patient experienced MASS (red,hard knot on it), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow), GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency; DIPHENHYDRAMINE at an unspecified dose and frequency; FAMOTIDINE (FAMOTIDINE ACID REDUCER) at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. On 15-Apr-2021, PERIORBITAL SWELLING (Puffiness around the eyes) had resolved. At the time of the report, BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face), EYE SWELLING (Swollen eyes), MASS (red,hard knot on it), SWELLING FACE (Swollen face), the last episode of LIP SWELLING (Upper lip was really swollen), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow) and FATIGUE (Feeling exhausted) was resolving and GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other non drug treatment include Ice pack to alleviate the Rash. The patient experienced just felt different. The patient rang his HCP who advised him to go to emergency room. The patient was discharged a few hours later.Patient mentioned that he is not allergic to anything and found it strange that he would have severe allergic reactions from the vaccine.During the month of May, there were a couple of times where his face was swollen, upper lip was swollen, rashes and hives on the upper arms and upper thighs. On 07 Jun 2021, his face was swollen again. Patient noticed there were rashes under his arms about two inches long and on the left arm inside of the elbow, there was a very red, hard knot on it. Patient put a cold compression to alleviate the rash. Patient is concerned because he had never been allergic to anything in his life until this incident happened. He received other vaccines like the flu vaccine and he did not experience any side effects from the vaccine. Patient also reported that he has been feeling exhausted everyday.He has not taken any allergy medications since his last allergic reactions. He was currently not experiencing any symptoms.Patient is concerned about exhaustion and the swollen face that he had woken up to three times from 14 Apr 2021- 07 Jun 2021.  Healthcare professional advised patient not to take the Second dose.   Company comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received, Updated events outcome to recovering and Seriousness criteria in events tab,reporter information updated, Historical vaccine in other relevant history updated,Vaccine route of administration updated in events tab and added event (Gait inability) and reporter information.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded