Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Inappropriate schedule of product administration, Influenza like illness, Nasal congestion, Nasal oedema
Clinical narrative: Dizziness; Bad cramps like menstrual cramps; Back ache/ back pain; Felt flu-like; Super sweaty; Acid reflux; Feeling fuzzy headed; Big and warm knot at the injection site; Excess sleeping; Congestion; Swollen nose; Big and warm knot at the injection site; Chills at night; Joint pain/ pain in knees; Fever; Pain at the injection site; Exhausted; Headache; Deviation from dosing schedule (more then 35 days between 1st and 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSMENORRHOEA (Bad cramps like menstrual cramps), BACK PAIN (Back ache/ back pain), INFLUENZA LIKE ILLNESS (Felt flu-like) and HYPERHIDROSIS (Super sweaty) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced DIZZINESS (Dizziness), DYSMENORRHOEA (Bad cramps like menstrual cramps), BACK PAIN (Back ache/ back pain), INFLUENZA LIKE ILLNESS (Felt flu-like), HYPERHIDROSIS (Super sweaty), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), FEELING ABNORMAL (Feeling fuzzy headed), VACCINATION SITE MASS (Big and warm knot at the injection site), HYPERSOMNIA (Excess sleeping), NASAL CONGESTION (Congestion), NASAL OEDEMA (Swollen nose), VACCINATION SITE WARMTH (Big and warm knot at the injection site), CHILLS (Chills at night), ARTHRALGIA (Joint pain/ pain in knees), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Exhausted), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from dosing schedule (more then 35 days between 1st and 2nd dose)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of extra strength. On 05-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from dosing schedule (more then 35 days between 1st and 2nd dose)) had resolved. At the time of the report, DIZZINESS (Dizziness), DYSMENORRHOEA (Bad cramps like menstrual cramps), BACK PAIN (Back ache/ back pain), INFLUENZA LIKE ILLNESS (Felt flu-like), HYPERHIDROSIS (Super sweaty), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), FEELING ABNORMAL (Feeling fuzzy headed), VACCINATION SITE MASS (Big and warm knot at the injection site), HYPERSOMNIA (Excess sleeping), NASAL CONGESTION (Congestion), NASAL OEDEMA (Swollen nose), VACCINATION SITE WARMTH (Big and warm knot at the injection site), CHILLS (Chills at night), ARTHRALGIA (Joint pain/ pain in knees), PYREXIA (Fever), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Exhausted) and HEADACHE (Headache) outcome was unknown.            No concomitant medication listed.   This case was linked to MOD-2021-254078 (Patient Link).