Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Erythema, Feeling abnormal, Headache
Clinical narrative: right arm is extremely stiff, specially the upper part, as well as her neck and back; Arm is "really swollen"; Arm is is "really red/really angry red spot"; Patient stated that she is also itching "really bad" in the back, head, arms, face, and legs. She said she is "itching everywhere" but it seems to be worse on the upper body.; "itching everywhere" but it seems to be worse on the upper body/Trouble breathing - worse; scab on the top of her shoulder/Scab now is "yucky"; Scab is peeling; she doesn't feel good/feels "really bad"/She feels miserable/"really messed her up.; feels worn out/lethargic; hardness in her arm; "fever in the location of the injection"; Trouble breathing - worse; hoarse voice; ongoing bladder infection; "really nervous" for the second shot; Arm, neck and back are still painful; Arm, neck and back are still painful; rash that it's not too bad; muscle pain/achiness; joint pain; Flu shot arm is swollen all the way around and underneath/Flu shot arm - "It's really big"./both arms have blown up; Flu shot arm is hard; huge knot on her upper arm/Knot - still can feel it, but it has gone down/Lower arm has another knot, like a painful bug bite; got sick; dizzy; slept all day long; right arm started to hurt "really bad"/lower arm is "really painful"/Arm, neck and back are still painful; headache "really bad"; nauseous; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), DIZZINESS (dizzy), HYPERSOMNIA (slept all day long), PAIN IN EXTREMITY (right arm started to hurt "really bad"/lower arm is "really painful"/Arm, neck and back are still painful) and MASS (huge knot on her upper arm/Knot - still can feel it, but it has gone down/Lower arm has another knot, like a painful bug bite) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Patient has has trouble breathing and severe asthma.), Autoimmune disorder, Allergy (Patient has many allergies.), Bladder infection and Stomach function disorder (Patient had diseases of stomach). Concomitant products included LORATADINE for Allergy, HYDROXYZINE for Allergy and Sleepiness, DOMPERIDONE (PERIDIUM) for Bladder pain, OXYCODONE, ATORVASTATIN, PROPRANOLOL, FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), MAGNESIUM, CLOBETASOL PROPIONATE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced ILLNESS (got sick), DIZZINESS (dizzy), HYPERSOMNIA (slept all day long), PAIN IN EXTREMITY (right arm started to hurt "really bad"/lower arm is "really painful"/Arm, neck and back are still painful), HEADACHE (headache "really bad"), NAUSEA (nauseous) and PYREXIA (fever). On 19-Sep-2021, the patient experienced MASS (huge knot on her upper arm/Knot - still can feel it, but it has gone down/Lower arm has another knot, like a painful bug bite). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (right arm is extremely stiff, specially the upper part, as well as her neck and back), PERIPHERAL SWELLING (Arm is "really swollen"), ERYTHEMA (Arm is is "really red/really angry red spot"), PRURITUS (Patient stated that she is also itching "really bad" in the back, head, arms, face, and legs. She said she is "itching everywhere" but it seems to be worse on the upper body.), CONDITION AGGRAVATED ("itching everywhere" but it seems to be worse on the upper body/Trouble breathing - worse), SCAB (scab on the top of her shoulder/Scab now is "yucky"), SKIN EXFOLIATION (Scab is peeling), FEELING ABNORMAL (she doesn't feel good/feels "really bad"/She feels miserable/"really messed her up.), LETHARGY (feels worn out/lethargic), INDURATION (hardness in her arm), VACCINATION SITE WARMTH ("fever in the location of the injection"), DYSPNOEA (Trouble breathing - worse), DYSPHONIA (hoarse voice), CYSTITIS (ongoing bladder infection), NERVOUSNESS ("really nervous" for the second shot), BACK PAIN (Arm, neck and back are still painful), NECK PAIN (Arm, neck and back are still painful), RASH (rash that it's not too bad), MYALGIA (muscle pain/achiness), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (Flu shot arm is swollen all the way around and underneath/Flu shot arm - "It's really big"./both arms have blown up) and VACCINATION SITE INDURATION (Flu shot arm is hard). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, ILLNESS (got sick), PAIN IN EXTREMITY (right arm started to hurt "really bad"/lower arm is "really painful"/Arm, neck and back are still painful), MUSCULOSKELETAL STIFFNESS (right arm is extremely stiff, specially the upper part, as well as her neck and back), PERIPHERAL SWELLING (Arm is "really swollen"), ERYTHEMA (Arm is is "really red/really angry red spot"), PRURITUS (Patient stated that she is also itching "really bad" in the back, head, arms, face, and legs. She said she is "itching everywhere" but it seems to be worse on the upper body.), CONDITION AGGRAVATED ("itching everywhere" but it seems to be worse on the upper body/Trouble breathing - worse), SCAB (scab on the top of her shoulder/Scab now is "yucky"), SKIN EXFOLIATION (Scab is peeling), FEELING ABNORMAL (she doesn't feel good/feels "really bad"/She feels miserable/"really messed her up.), LETHARGY (feels worn out/lethargic), INDURATION (hardness in her arm), VACCINATION SITE WARMTH ("fever in the location of the injection"), DYSPNOEA (Trouble breathing - worse), DYSPHONIA (hoarse voice), CYSTITIS (ongoing bladder infection), NERVOUSNESS ("really nervous" for the second shot), BACK PAIN (Arm, neck and back are still painful), NECK PAIN (Arm, neck and back are still painful), RASH (rash that it's not too bad), MYALGIA (muscle pain/achiness), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (Flu shot arm is swollen all the way around and underneath/Flu shot arm - "It's really big"./both arms have blown up), VACCINATION SITE INDURATION (Flu shot arm is hard) and HEADACHE (headache "really bad") had not resolved, DIZZINESS (dizzy), HYPERSOMNIA (slept all day long), NAUSEA (nauseous) and PYREXIA (fever) had resolved and MASS (huge knot on her upper arm/Knot - still can feel it, but it has gone down/Lower arm has another knot, like a painful bug bite) was resolving.        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.   Patient had the lungs of 80y/o.  Concomitant product also included Medical marihuana for pain under the tongue drops very little, Medicine for nausea Occasionally, Antibiotic Twice a week for ongoing bladder infection, Inhalers Only if she can't breathe,Headache medicine Twice a day, Nasal spray.  Patient had lots of injuries after three car accidents.; Sender's Comments: This case concerns a 60-year-old female patient with relevant medical history of Autoimmune disorder and Cystitis, who experienced the unexpected non-serious events of Illness, Dizziness, Hypersomnia, Pain in extremity, Mass, Musculoskeletal stiffness, Peripheral swelling, Erythema, Pruritus, Condition aggravated, Scab, Skin exfoliation, Feeling abnormal, Lethargy, Induration, Vaccination site warmth, Dyspnoea, Dysphonia, Cystitis, Nervousness, Back pain, Neck pain and non-serious expected events of Rash, Myalgia, Arthralgia, Vaccination site swelling, Vaccination site induration, Headache, Nausea, Pyrexia. The event occurred within a period from 1 day to unknown after the first dose of  Moderna COVID-19 Vaccine administration. The rechallenge was unknown since information on the second dose was not available. The benefit-risk relationship is not affected by this report.