Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: developed pneumonia in left lung; little red dots and by night, turned into big red blotches/Rash all over the body/Rash is on scalp; Couldn't get out of bed the next day due to muscle and neck pain; Felt knocked to the ground; Neck pain; Muscle pain; Fatigue; really bad night sweats; sores in his mouth; Red welts; Red lesions all over neck, torso, arms buttocks and it is getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (developed pneumonia in left lung), FEELING ABNORMAL (Felt knocked to the ground), SKIN LESION (Red lesions all over neck, torso, arms buttocks and it is getting worse), NECK PAIN (Neck pain) and URTICARIA (Red welts) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 002B21A and CR7M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Biopsy (on his left lower back) on 17-Nov-2021. Concomitant products included MULTIVITAMIN [VITAMINS NOS], ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D3) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue). On 10-Nov-2021, the patient experienced FEELING ABNORMAL (Felt knocked to the ground), NECK PAIN (Neck pain), BEDRIDDEN (Couldn't get out of bed the next day due to muscle and neck pain) and MYALGIA (Muscle pain). On 12-Nov-2021, the patient experienced RASH MACULAR (little red dots and by night, turned into big red blotches/Rash all over the body/Rash is on scalp). On 15-Nov-2021, the patient experienced PNEUMONIA (developed pneumonia in left lung). In November 2021, the patient experienced SKIN LESION (Red lesions all over neck, torso, arms buttocks and it is getting worse), URTICARIA (Red welts), NIGHT SWEATS (really bad night sweats) and STOMATITIS (sores in his mouth). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Skin lesion, at an unspecified dose and frequency. On 12-Nov-2021, BEDRIDDEN (Couldn't get out of bed the next day due to muscle and neck pain) had resolved. At the time of the report, PNEUMONIA (developed pneumonia in left lung), FEELING ABNORMAL (Felt knocked to the ground), SKIN LESION (Red lesions all over neck, torso, arms buttocks and it is getting worse), NECK PAIN (Neck pain), URTICARIA (Red welts), RASH MACULAR (little red dots and by night, turned into big red blotches/Rash all over the body/Rash is on scalp), NIGHT SWEATS (really bad night sweats), STOMATITIS (sores in his mouth), FATIGUE (Fatigue) and MYALGIA (Muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took antibiotics for Pneumonia. On 17-Nov-2021, Biopsy was performed on his left lower back. They were testing for Erythema multiforme and Steven-Johnson syndrome. They recommended that if it does not improve, the patient should go back to the Emergency Room.  Company comment: This case concerns a 69-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious events of rash macular, stomatitis and pneumonia, among others. Patient developed rash macular 3 days after second dose of mRNA-1273 vaccine which is why he went to the emergency room 6 days from vaccination and discovered he had pneumonia in left lung, was prescribed antibiotics and 8 days after vaccination reported stomatitis and that he went through a biopsy on his left lower back to be tested for Erythema multiforme and Steven-Johnson syndrome. The rechallenge was not applicable, as no information about further dosing is disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The patient stated that he had no reactions either to first nor second dose of mRNA-1273. Event Pneumonia was automatically upgraded as a Serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious.   This case was linked to MOD-2021-386839 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Upgraded to serious. Added events Pneumonia, Red blotches On 17-Nov-2021: Added events Night sweats, Mouth pain; Sender's Comments: This case concerns a 69-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious events of rash macular, stomatitis and pneumonia, among others. Patient developed rash macular 3 days after second dose of mRNA-1273 vaccine which is why he went to the emergency room 6 days from vaccination and discovered he had pneumonia in left lung, was prescribed antibiotics and 8 days after vaccination reported stomatitis and that he went through a biopsy on his left lower back to be tested for Erythema multiforme and Steven-Johnson syndrome. The rechallenge was not applicable, as no information about further dosing is disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The patient stated that he had no reactions either to first nor second dose of mRNA-1273. Event Pneumonia was automatically upgraded as a Serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious.