Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Discomfort, Electromyogram abnormal, Gait disturbance, Hyperhidrosis
Clinical narrative: sweaty feet; The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Bactrim).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PYREXIA (Fever). On 19-Apr-2021, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweaty feet). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) (intravenous) at a dose of 1 gram once a week. At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021) was resolving, HYPERHIDROSIS (sweaty feet) outcome was unknown and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) increased. On an unknown date, Electromyogram: abnormal (abnormal) abnormal. On an unknown date, Lipoprotein (a): increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller also mentioned that her son has numbness still after 8 weeks and also specified as numbness went away with steroid medication and reappeared after completing the dose. patient Height was given 5'11" inches Treatment medication provided Corticosteroids,Oral steroidal medication for 5 days Laboratory data  MRI, EMG, LP provided with unknown results, lipoprotein levels were increased. Reporter stated that pt.'s mobility greatly improved his legs still numb although he reports his quads appear to be somewhat better  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Company Comment: This case concerns a 23-year-old male patient with no relevant medical history reported, who experienced serious unexpected eventsof chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), with symptoms of paraesthesia, discomfort, pain, hypoesthesia and gait disturbance. The event started occurring approximately 3 days after the second dose of Spikevax. Rechallenge was not applicable since the event occurred after the second dose and no additional doses will be administered.  The benefit-risk relationship of drug is not affected by this report. Based on the information provided, causal or contributing role of Spikevax in triggering CIDP cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Significant Follow-up -new received Patient medical history, weight, ethnicity , lab data, treatment medication, vaccine facility type added, Event pyrexia outcome updated, New events were added, I narrative updated; Sender's Comments: This case concerns a 23-year-old male patient with no relevant medical history reported, who experienced serious unexpected eventsof chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), with symptoms of paraesthesia, discomfort, pain, hypoesthesia and gait disturbance. The event started occurring approximately 3 days after the second dose of Spikevax. Rechallenge was not applicable since the event occurred after the second dose and no additional doses will be administered.  The benefit-risk relationship of drug is not affected by this report. Based on the information provided, causal or contributing role of Spikevax in triggering CIDP cannot be excluded.