Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypoaesthesia, Inappropriate schedule of product administration, Interstitial lung disease, Muscular weakness
Clinical narrative: auto immune disorder; suspected reaction from covid vaccine; felt it was a dermatitis; intermittent numbness in fingers; difficulty breathing, winded; both hands are weak; Redness of both hands; Dry persistent cough/ cough; both hands are painful; interstitial lung disease; Pneumonia suspect; low grade fever; swelling in her hands equally on the right and left with tingling/swelling of both hands/hands inflamed; swelling in her hands equally on the right and left with tingling/prickling/ tingling; had her first dose of Moderna vaccine on 7Jan21 and had that 2nd dose on 19Feb21; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (auto immune disorder), INTERSTITIAL LUNG DISEASE (interstitial lung disease) and PNEUMONIA (Pneumonia suspect) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 021L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (mild), Penicillin allergy (rash and chills), Osteopenia and Contrast media allergy (Rash). Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS and CALCIUM for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had her first dose of Moderna vaccine on 7Jan21 and had that 2nd dose on 19Feb21). On 13-Mar-2021, the patient experienced PARAESTHESIA (swelling in her hands equally on the right and left with tingling/prickling/ tingling) and PERIPHERAL SWELLING (swelling in her hands equally on the right and left with tingling/swelling of both hands/hands inflamed). On 18-Apr-2021, the patient experienced PYREXIA (low grade fever). On 27-Apr-2021, the patient experienced PNEUMONIA (Pneumonia suspect) (seriousness criterion medically significant). On 24-Jun-2021, the patient experienced INTERSTITIAL LUNG DISEASE (interstitial lung disease) (seriousness criterion medically significant). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (auto immune disorder) (seriousness criterion medically significant), VACCINATION COMPLICATION (suspected reaction from covid vaccine), DERMATITIS (felt it was a dermatitis), HYPOAESTHESIA (intermittent numbness in fingers), DYSPNOEA (difficulty breathing, winded), MUSCULAR WEAKNESS (both hands are weak), ERYTHEMA (Redness of both hands), COUGH (Dry persistent cough/ cough) and PAIN IN EXTREMITY (both hands are painful). The patient was treated with PREDNISONE at a dose of 1 dosage form; DOXYCYCLINE at a dose of 1 dosage form and AZITHROMYCIN on 18-Apr-2021 for Bronchitis, at an unspecified dose and frequency. On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had her first dose of Moderna vaccine on 7Jan21 and had that 2nd dose on 19Feb21) had resolved. At the time of the report, AUTOIMMUNE DISORDER (auto immune disorder), INTERSTITIAL LUNG DISEASE (interstitial lung disease), PNEUMONIA (Pneumonia suspect), VACCINATION COMPLICATION (suspected reaction from covid vaccine), DERMATITIS (felt it was a dermatitis), PARAESTHESIA (swelling in her hands equally on the right and left with tingling/prickling/ tingling), DYSPNOEA (difficulty breathing, winded), MUSCULAR WEAKNESS (both hands are weak), PERIPHERAL SWELLING (swelling in her hands equally on the right and left with tingling/swelling of both hands/hands inflamed), COUGH (Dry persistent cough/ cough) and PYREXIA (low grade fever) outcome was unknown and HYPOAESTHESIA (intermittent numbness in fingers), ERYTHEMA (Redness of both hands) and PAIN IN EXTREMITY (both hands are painful) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 test: negative (Negative) negative. On 27-Apr-2021, Chest X-ray: pulmonary infiltrates at base of lungs. Pneumonia suspect. On 12-May-2021, Chest X-ray: pulmonary infiltrates still present but improved. On 26-May-2021, Chest X-ray: pulmonary infiltrates unchanged. On 08-Jun-2021, Antinuclear antibody: inconclusive (Inconclusive) inconclusive. On 08-Jun-2021, Computerised tomogram: pulmonary infiltrates present. On an unknown date, Antinuclear antibody: positive (Positive) positive Suspect reaction from covid vaccine.. On an unknown date, Blood pressure measurement: inconclusive (Inconclusive) inconclusive. On an unknown date, Body temperature: inconclusive (Inconclusive) inconclusive. On an unknown date, Heart rate: inconclusive (Inconclusive) inconclusive. On an unknown date, Respiratory rate: inconclusive (Inconclusive) inconclusive.         Patient allergic to contrast results in delayed while  body rash Treatment for the events included Zpak for bronchitis and nebulizer .Action taken with mRNA-1273 in response to the events was not Applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-065219 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Patient demographics, medical history, laboratory data, concomitant medications, treatment medications  were updated. Additional serious and non serious events and reporter details were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-065219:Dose 1