Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pharyngeal swelling, Product dose omission issue, Pruritus
Clinical narrative: More than 36 days since first dose, has not received 2nd dose; Body aches; Feverish, but not elevated; Headache; Within 15 minutes, moderate itching all over body; Developed hives/5 hives; Slight itching in the back of the throat; Mild tongue swelling; Mild swelling of lips and throat; Mild swelling of lips and throat; Aches and pains; Felt like her wrists and ankles were sprained; Acute allergic reaction to the first dose of the vaccine; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Within 15 minutes, moderate itching all over body), URTICARIA (Developed hives/5 hives), THROAT IRRITATION (Slight itching in the back of the throat), SWOLLEN TONGUE (Mild tongue swelling) and LIP SWELLING (Mild swelling of lips and throat) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Hypothyroidism. Concomitant products included AMLODIPINE for Hypertension, THYROID (ARMOUR THYROID) for Hypothyroidism.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRURITUS (Within 15 minutes, moderate itching all over body), URTICARIA (Developed hives/5 hives), THROAT IRRITATION (Slight itching in the back of the throat), SWOLLEN TONGUE (Mild tongue swelling), LIP SWELLING (Mild swelling of lips and throat), PHARYNGEAL SWELLING (Mild swelling of lips and throat), PAIN (Aches and pains), LIGAMENT SPRAIN (Felt like her wrists and ankles were sprained), HYPERSENSITIVITY (Acute allergic reaction to the first dose of the vaccine), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), PYREXIA (Feverish, but not elevated) and HEADACHE (Headache). On 19-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days since first dose, has not received 2nd dose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. In July 2021, PRURITUS (Within 15 minutes, moderate itching all over body), URTICARIA (Developed hives/5 hives), THROAT IRRITATION (Slight itching in the back of the throat), SWOLLEN TONGUE (Mild tongue swelling), LIP SWELLING (Mild swelling of lips and throat), PHARYNGEAL SWELLING (Mild swelling of lips and throat), PAIN (Aches and pains), LIGAMENT SPRAIN (Felt like her wrists and ankles were sprained), HYPERSENSITIVITY (Acute allergic reaction to the first dose of the vaccine), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), PYREXIA (Feverish, but not elevated) and HEADACHE (Headache) had resolved. On 19-Aug-2021, PRODUCT DOSE OMISSION ISSUE (More than 36 days since first dose, has not received 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that the events were mild that she did not feel any obstruction nor did she feel that her breathing was impaired.   On 19 Aug 2021, she was scheduled for second dose and her physician said that he could not give the second dose because of the acute allergic reaction she experienced from the first dose, though patient said that it was non anaphylactic reaction. Physician recommended to get Johnson vaccine but patient did not want to get it.  Patient stated that the allergist also recommended not to take dose-2 Moderna Vaccine, but when the patient is adamant to get the second dose, allergist recommended to get hospitalized in case needs treatment for a reaction.   Patient took Aspirin for a few days, then she for breakthrough bleeding so she stopped it.