Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site paraesthesia, Viral infection
Clinical narrative: Positive COVID test about 5 months after first vaccine; Tested + for neuropathy antibody for neuropathy (TS-HDS) after first vaccine; Loud boom noise in head 3 months after first vaccine; Glands across the body swelled  3 months after first vaccine; Pain left elbow and shoulder 2 months after first vaccine/Joint pain 2 months after first vaccine; Virus infection but not Covid; Short Breath at rest 2 months after first vaccine; MD said she was having nervous brake down; Fungal infection on the chest 10 days after first vaccine; Sick with viral infection but negative for COVID after first vaccine; Rush to head like Headache after first vaccine; Tingling Left Arm Injection Site after first vaccine; Still Breastfeeding at time of first vaccine; insomnia; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Tested + for neuropathy antibody for neuropathy (TS-HDS) after first vaccine) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced INSOMNIA (insomnia). On 21-Jul-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling Left Arm Injection Site after first vaccine) and MATERNAL EXPOSURE DURING BREAST FEEDING (Still Breastfeeding at time of first vaccine). On 23-Jul-2021, the patient experienced VIRAL INFECTION (Sick with viral infection but negative for COVID after first vaccine) and HEAD DISCOMFORT (Rush to head like Headache after first vaccine). On 31-Jul-2021, the patient experienced FUNGAL INFECTION (Fungal infection on the chest 10 days after first vaccine). On 03-Aug-2021, the patient experienced MENTAL DISORDER (MD said she was having nervous brake down). In September 2021, the patient experienced DYSPNOEA (Short Breath at rest 2 months after first vaccine), VIRAL INFECTION (Virus infection but not Covid) and ARTHRALGIA (Pain left elbow and shoulder 2 months after first vaccine/Joint pain 2 months after first vaccine). In October 2021, the patient experienced TINNITUS (Loud boom noise in head 3 months after first vaccine) and LYMPHADENOPATHY (Glands across the body swelled  3 months after first vaccine). In December 2021, the patient experienced NEUROPATHY PERIPHERAL (Tested + for neuropathy antibody for neuropathy (TS-HDS) after first vaccine) (seriousness criterion medically significant). On 21-Jan-2022, the patient experienced COVID-19 (Positive COVID test about 5 months after first vaccine). The patient was treated with FLUCONAZOLE in 2021 for Fungal infection, at an unspecified dose and frequency; ZOLPIDEM TARTRATE (AMBIEN) from 2021 to 2021 for Insomnia, at a dose of 5 milligram and IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) (intravenous) ongoing from February 2022 at an unspecified dose and frequency. On 23-Jul-2021, VACCINATION SITE PARAESTHESIA (Tingling Left Arm Injection Site after first vaccine) and MATERNAL EXPOSURE DURING BREAST FEEDING (Still Breastfeeding at time of first vaccine) had resolved. On 14-Aug-2021, FUNGAL INFECTION (Fungal infection on the chest 10 days after first vaccine) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Tested + for neuropathy antibody for neuropathy (TS-HDS) after first vaccine) was resolving, COVID-19 (Positive COVID test about 5 months after first vaccine), VIRAL INFECTION (Sick with viral infection but negative for COVID after first vaccine), MENTAL DISORDER (MD said she was having nervous brake down), DYSPNOEA (Short Breath at rest 2 months after first vaccine), TINNITUS (Loud boom noise in head 3 months after first vaccine), VIRAL INFECTION (Virus infection but not Covid), HEAD DISCOMFORT (Rush to head like Headache after first vaccine), LYMPHADENOPATHY (Glands across the body swelled  3 months after first vaccine) and ARTHRALGIA (Pain left elbow and shoulder 2 months after first vaccine/Joint pain 2 months after first vaccine) outcome was unknown and INSOMNIA (insomnia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: normal (normal) Normal. In 2021, Magnetic resonance imaging: normal (normal) Normal. In July 2021, SARS-CoV-2 test: negative (Negative) Negative. In September 2021, SARS-CoV-2 test: negative (Negative) negative COVID-19 test during the 2nd episode of viral infection. In December 2021, Antibody test: positive (Positive) Tested + for neuropathy antibody for neuropathy (TS-HDS).. On 21-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive COVID test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 23-Jul-2021, patient felt like a rush to head like a Headache. She had 2 babies. After vaccination, she started catching everything from the kids. She had muscle spasm below collar bone, was not sure if it was the throat.  Visited the doctor and was told that patient was having a nervous breakdown. Day 10 after vaccination, had a fungal infection on the chest. Patient skin was burning and tingling, thought it was the hormones from breastfeeding. Tingling skin, felt like skin was sunburned and was having sensory issues mostly on the left arm. In Oct-2021 had explosive nerve system sequala, started on back and spread, sweating abnormally, and muscle pain. Felt like electricity running through body. Then pins and needles across all body, twitches and spasm in whole body and head,Tremors in sleep. Her body was jerking in sleep and the spasm was so bad that could not be slept. If slept on her back, she would crunch in sleep, and if on the stomach legs felt like scorpion. Finally the doctor gave sleeping medications and was able to sleep with sleeping medications.By late Dec-2021 muscles started getting better. Antifungal Fluconazole tablets in late Jul-2021 or Aug-2021. For sleep the Doctor gave Ambien 5 mg. 7 tablets and she did not take all of them. After a few nights using Ambien, was able to sleep normal, without medication. They prescribed to antipsychotic and anti-depressant.  No concomitant medications were reported.  Company comment: This spontaneous case concerns a 38-year-old, female patient with no medical history reported who experienced the unexpected, serious (medically significant) event of Peripheral neuropathy and unexpected, non-serious adverse event of special interest of COVID-19 after receiving the first dose of mRNA-1273 vaccine. Maternal exposure during breastfeeding was also reported as an additional event. Symptoms of peripheral neuropathy occurred 10 days after vaccination while COVID-19 happened six months after vaccination. Patient developed an unspecified viral infection two days after vaccination. The event was accompanied by muscle spasm in the infraclavicular area. She consulted a physician and was diagnosed to have nervous breakdown. Ten days after vaccination, she developed burning and tingling sensation mostly on the left arm. The neurologic complaints have worsened with involvement of the back area followed by pins and needles sensation all over the body. She also noted generalized twitching and spasm. Insomnia occurred as a result of the event for which she was treated with Zolpidem 5mg. MRI and EKG were normal but antibody for TS-HDS showed positive result. She was diagnosed to have post-vaccination sequala by her physician and was prescribed with unspecified antipsychotic and antidepressant. She also tested positive for COVID-19 approximately 6 months after the first dose. Intravenous immunoglobulin was given but the indication was not clearly specified. At the time of the report, peripheral neuropathy is resolving. The reported event of viral infection remains a confounder for the event peripheral neuropathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-580187 (Patient Link).; Sender's Comments: This spontaneous case concerns a 38-year-old, female patient with no medical history reported who experienced the unexpected, serious (medically significant) event of Peripheral neuropathy and unexpected, non-serious adverse event of special interest of COVID-19 after receiving the first dose of mRNA-1273 vaccine. Maternal exposure during breastfeeding was also reported as an additional event. Symptoms of peripheral neuropathy occurred 10 days after vaccination while COVID-19 happened six months after vaccination. Patient developed an unspecified viral infection two days after vaccination. The event was accompanied by muscle spasm in the infraclavicular area. She consulted a physician and was diagnosed to have nervous breakdown. Ten days after vaccination, she developed burning and tingling sensation mostly on the left arm. The neurologic complaints have worsened with involvement of the back area followed by pins and needles sensation all over the body. She also noted generalized twitching and spasm. Insomnia occurred as a result of the event for which she was treated with Zolpidem 5mg. MRI and EKG were normal but antibody for TS-HDS showed positive result. She was diagnosed to have post-vaccination sequala by her physician and was prescribed with unspecified antipsychotic and antidepressant. She also tested positive for COVID-19 approximately 6 months after the first dose. Intravenous immunoglobulin was given but the indication was not clearly specified. At the time of the report, peripheral neuropathy is resolving. The reported event of viral infection remains a confounder for the event peripheral neuropathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.