Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Back pain, Headache, Inappropriate schedule of product administration
Clinical narrative: She had an autoimmune reaction; she already had a bad back but this aggravated after she got the vaccine; Terrible headache; 1st dose Apr2021; 2nd dose Jun2021; This spontaneous case was reported by a patient and describes the occurrence of AUTOIMMUNE DISORDER (She had an autoimmune reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Drug resistance (Sulfa drug resistant). Concurrent medical conditions included Back discomfort (Before Moderna vaccine.).    In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced HEADACHE (Terrible headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Apr2021; 2nd dose Jun2021). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (She had an autoimmune reaction) (seriousness criterion medically significant) and BACK PAIN (she already had a bad back but this aggravated after she got the vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. In June 2021, HEADACHE (Terrible headache) had resolved. In November 2021, AUTOIMMUNE DISORDER (She had an autoimmune reaction) had resolved. At the time of the report, BACK PAIN (she already had a bad back but this aggravated after she got the vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Apr2021; 2nd dose Jun2021) outcome was unknown.            No concomitant medications were reported.   The patient never ever had COVID positive test or diagnosis. The patient never had a similar event in the past. The patient did not received other vaccines within 1 month prior to Moderna COVID-19 vaccine. She got the 2nd dose sometime in Jun 2021 and the next day when she woke up, she had a terrible headache which stopped on the 3rd day. The paitent's back problem was still continuous at the time of second dose vaccination. She consulted with a specialist and she was told that she had an autoimmune reaction to the vaccine. She consulted with a specialist and she was told that she had an autoimmune reaction to the vaccine. The patient went to the emergency room.  Company comment: This spontaneous case concerns a 60-year-old female patient, with relevant medical history of back discomfort, who experienced the unexpected serious (medically significant) event of Autoimmune disorder that occurred after receiving the mRNA-1273 vaccine as 2nd dose. Patient reported a terrible headache when she woke up the day after vaccination, which lasted for 3 days. Also reported continuous back pain which was present even before vaccination that was aggravated after vaccination. Consulted a specialist and was told to have autoimmune reaction to the vaccine. Took Paracetamol as treatment for back pain. The outcome of event was reported as resolved. The medical history of back discomfort could be considered as a contributory factor. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed serious based on medical judgement.   This case was linked to MOD-2022-601647 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60-year-old female patient, with relevant medical history of back discomfort, who experienced the unexpected serious (medically significant) event of Autoimmune disorder that occurred after receiving the mRNA-1273 vaccine as 2nd dose. Patient reported a terrible headache when she woke up the day after vaccination, which lasted for 3 days. Also reported continuous back pain which was present even before vaccination that was aggravated after vaccination. Consulted a specialist and was told to have autoimmune reaction to the vaccine. Took Paracetamol as treatment for back pain. The outcome of event was reported as resolved. The medical history of back discomfort could be considered as a contributory factor. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed serious based on medical judgement.