Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Paraesthesia, Tachycardia, Throat tightness, Tinnitus
Clinical narrative: muscle weakness; overall tension; lack of appetite; high tachycardia which occurred once; soreness in both arms; feeling neuropathy in both of her feet/feeling neuropathy in both of her ankles/patient reports feeling neuropathy in both of her feet.; fatigue; patient reports muscle pain in her arms and quad muscles; felt achy; flu like symptoms; felt feverish right after her second shot.; This spontaneous case was reported by an other health care professional and describes the occurrence of NEUROPATHY PERIPHERAL (feeling neuropathy in both of her feet/feeling neuropathy in both of her ankles/patient reports feeling neuropathy in both of her feet.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A, 017P21A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included CROMOGLICATE SODIUM (NASALCROM), LEVOTHYROXINE and ALPRAZOLAM for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (felt feverish right after her second shot.). On 29-Jan-2021, the patient experienced PAIN (felt achy) and INFLUENZA LIKE ILLNESS (flu like symptoms). On 11-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL (feeling neuropathy in both of her feet/feeling neuropathy in both of her ankles/patient reports feeling neuropathy in both of her feet.) (seriousness criterion medically significant). 11-Feb-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness), TENSION (overall tension), DECREASED APPETITE (lack of appetite), TACHYCARDIA (high tachycardia which occurred once), PAIN IN EXTREMITY (soreness in both arms), FATIGUE (fatigue) and MYALGIA (patient reports muscle pain in her arms and quad muscles). At the time of the report, NEUROPATHY PERIPHERAL (feeling neuropathy in both of her feet/feeling neuropathy in both of her ankles/patient reports feeling neuropathy in both of her feet.), PAIN (felt achy), INFLUENZA LIKE ILLNESS (flu like symptoms), MUSCULAR WEAKNESS (muscle weakness), TENSION (overall tension), DECREASED APPETITE (lack of appetite), TACHYCARDIA (high tachycardia which occurred once), PAIN IN EXTREMITY (soreness in both arms), PYREXIA (felt feverish right after her second shot.), FATIGUE (fatigue) and MYALGIA (patient reports muscle pain in her arms and quad muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: lost 13 pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received her second Moderna Covid-19 vaccine on in her left arm shoulder deltoid. The patient felt feverish right after her second shot. The day after she felt achy and flu like symptoms. Two weeks after the second shot the patient felt muscle weakness, overall tension, fatigue, lack of appetite, soreness in both arms, and high tachycardia which occurred once. It was found out about the Tachycardia through the Watch. The patient reported feeling neuropathy in both of her feet and ankles. The patient received her first Moderna Covid-19 booster dose in her left deltoid muscle. The patient had all of the same side effects as after her second shot but more severe (On 26-Oct-2021 Achy and flu like symptoms, On 9-Nov-2021 Muscle weakness, overall tension, fatigue, lack of appetite, feeling neuropathy in both of her feet, and feeling neuropathy in both of her ankles). The patient reported muscle pain in her arms and quad muscles. She had lack of appetite and lost 13 pounds. The patient was worked up for Multiple Scleorosis, Rheumatoid arthritis, lupus, brain tumor, Zika virus, lyme disease, inflammation in the blood, arthritis in the spine or other spine diseases. All were ruled out.  No treatment information was reported.  Company Comment : This spontaneous case concerns a 60-year-old female patient, with relevant concurrent hypothyroidism, who experienced unexpected, serious (medically significant) event neuropathy peripheral alongside other non-serious events, approximately 2 weeks after receiving a second dose of mRNA-1273.  She reported feeling neuropathy in both ankles and feet.  She had similar symptoms with increased severity after her booster shot of mRNA-1273 given around 8 months later, thus re-challenge is positive.  She was worked-up for several diseases including autoimmune conditions, brain tumor, arthritis, spinal conditions, and infections like Zika and Lyme disease, all of which were ruled out.  Treatment details were not reported.  Outcome was unknown.  The concurrent hypothyroidism could be a confounding factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-630583, MOD-2022-630614.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient, with relevant concurrent hypothyroidism, who experienced unexpected, serious (medically significant) event neuropathy peripheral alongside other non-serious events, approximately 2 weeks after receiving a second dose of mRNA-1273.  She reported feeling neuropathy in both ankles and feet.  She had similar symptoms with increased severity after her booster shot of mRNA-1273 given around 8 months later, thus re-challenge is positive.  She was worked-up for several diseases including autoimmune conditions, brain tumor, arthritis, spinal conditions, and infections like Zika and Lyme disease, all of which were ruled out.  Treatment details were not reported.  Outcome was unknown.  The concurrent hypothyroidism could be a confounding factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.