Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Hypoaesthesia, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Upper left buttocks pain; Fever; Extreme debilitating sciatica; Numbness on her left leg all the way up and down/numbness on three of her toes (big toe and two toes)/upper part of her foot is numb; tingling in the foot; At night it was difficult to sleep; My energy level is not what it used to be; strange backache occurred in the back of her waist; Was sick; First dose 10-May-2021, second dose 21-Jun-2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SCIATICA (Extreme debilitating sciatica) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Backache. Concurrent medical conditions included Asthma since 1979, Allergy to antibiotic (some antibiotics) and Sulfonamide allergy. Concomitant products included SALMETEROL XINAFOATE (SEREVENT) and CICLESONIDE (ALVESCO) for Asthma.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced VACCINATION COMPLICATION (Was sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 10-May-2021, second dose 21-Jun-2021). On 25-Jul-2021, the patient experienced BACK PAIN (strange backache occurred in the back of her waist). On 01-Aug-2021, the patient experienced SCIATICA (Extreme debilitating sciatica) (seriousness criterion disability), HYPOAESTHESIA (Numbness on her left leg all the way up and down/numbness on three of her toes (big toe and two toes)/upper part of her foot is numb), PARAESTHESIA (tingling in the foot), INSOMNIA (At night it was difficult to sleep) and ASTHENIA (My energy level is not what it used to be). On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (Upper left buttocks pain) and PYREXIA (Fever). The patient was treated with ERYTHROMYCIN at an unspecified dose and frequency. On 21-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 10-May-2021, second dose 21-Jun-2021) had resolved. On 23-Jun-2021, VACCINATION COMPLICATION (Was sick) had resolved. At the time of the report, SCIATICA (Extreme debilitating sciatica) and HYPOAESTHESIA (Numbness on her left leg all the way up and down/numbness on three of her toes (big toe and two toes)/upper part of her foot is numb) was resolving, MUSCULOSKELETAL PAIN (Upper left buttocks pain), PARAESTHESIA (tingling in the foot), INSOMNIA (At night it was difficult to sleep), ASTHENIA (My energy level is not what it used to be) and PYREXIA (Fever) outcome was unknown and BACK PAIN (strange backache occurred in the back of her waist) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   After second shot, patient had to lay down the next day and following day. Patient saw two doctors and a chiropractor. She had to get a walker, she was still not totally over it. The chiropractor gave her some minor exercises that she could not do. It was horrible. She could do them but there was still tingling in the foot. She had to rest, and she could not do her daily routine. When she does any type of work at home, she had to lay down and rest after. She was fearful of taking any booster shots.  The patient Could not walk and cannot go up and down stairs very much and Loss of personal independence  Company comment: This case concerns a 75-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Sciatica and other non serious adverse events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, inappropriate schedule of vaccine administered was captured. The event occurred approximately 41 days after the second dose of Spikevax. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report. As per RA, Sciatica evolved in significant disruption of the ability to conduct normal life function, thus it is was assessed as serious as per Disability.   This case was linked to MOD-2021-333617 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up received on 30-Sep-2021 included reporter details, patient demographics, medical history, concomitant medications, additional events, treatment medications and event outcome.; Sender's Comments: This case concerns a 75-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Sciatica and other non serious adverse events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, inappropriate schedule of vaccine administered was captured. The event occurred approximately 41 days after the second dose of Spikevax. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report. As per RA, Sciatica evolved in significant disruption of the ability to conduct normal life function, thus it is was assessed as serious as per Disability.