Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site exfoliation
Clinical narrative: arm peeled like a sunburn/peeling on the site of injection; Brain fog; This month I haven't had a period; Eyelids were swollen; Sciatica going down my right side; back pain centrally located above tailbone/lower back worse/lower back started to hurt/severe pain in lower back; nerve pain sensation/pain was nerve pain that had me screaming in pain when I moved; severe pain when moves or bends over or adjust body in any way; Felt sick; Shaking as I moved from the pain; Could not get out of the bathtub/Able to move but very, very slow; Swollen lymph nodes; First period I had after lasted for 2 wks; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (back pain centrally located above tailbone/lower back worse/lower back started to hurt/severe pain in lower back), NEURALGIA (nerve pain sensation/pain was nerve pain that had me screaming in pain when I moved), PAIN (severe pain when moves or bends over or adjust body in any way), SWELLING OF EYELID (Eyelids were swollen) and HEAVY MENSTRUAL BLEEDING (First period I had after lasted for 2 wks) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ESTRADIOL from 08-Mar-2021 to an unknown date for Menstrual migraine, 3,3'-DIINDOLYLMETHANE, ASCORBIC ACID, BRASSICA CRETICA, PIPER NIGRUM, TOCOPHEROL (DIM ACTIVE) for Mental disorder NOS, ESTRADIOL (ESTROGEN), PROGESTERONE and MINERALS NOS, VITAMINS NOS (STRESS B COMPLEX [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 11-Mar-2021 at 5:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (severe pain when moves or bends over or adjust body in any way), MALAISE (Felt sick), TREMOR (Shaking as I moved from the pain) and MOBILITY DECREASED (Could not get out of the bathtub/Able to move but very, very slow). On 12-Mar-2021 at 6:15 AM, the patient experienced BACK PAIN (back pain centrally located above tailbone/lower back worse/lower back started to hurt/severe pain in lower back) and NEURALGIA (nerve pain sensation/pain was nerve pain that had me screaming in pain when I moved). In March 2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 16-Mar-2021, the patient experienced SCIATICA (Sciatica going down my right side). On 18-Mar-2021, the patient experienced SWELLING OF EYELID (Eyelids were swollen). In May 2021, the patient experienced AMENORRHOEA (This month I haven't had a period). On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (First period I had after lasted for 2 wks), VACCINATION SITE EXFOLIATION (arm peeled like a sunburn/peeling on the site of injection) and FEELING ABNORMAL (Brain fog). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 12-Mar-2021 for Low back pain and Nerve pain, at a dose of 2 dosage form; PARACETAMOL (TYLENOL) in March 2021 for Low back pain and Nerve pain, at an unspecified dose and frequency; OXYCODONE on 13-Mar-2021 for Low back pain and Nerve pain, at an unspecified dose and frequency; HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) (oral) from 14-Mar-2021 to 16-Mar-2021 for Low back pain and Nerve pain, at a dose of 5-325 mg, UNK; HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Low back pain and Nerve pain, at an unspecified dose and frequency and Physical therapy (muscle relaxants,heating pad, cold packs, lotions for back pain relief, hot shower) for Back pain. On 25-Apr-2021, BACK PAIN (back pain centrally located above tailbone/lower back worse/lower back started to hurt/severe pain in lower back) and NEURALGIA (nerve pain sensation/pain was nerve pain that had me screaming in pain when I moved) had resolved. At the time of the report, PAIN (severe pain when moves or bends over or adjust body in any way), HEAVY MENSTRUAL BLEEDING (First period I had after lasted for 2 wks), MOBILITY DECREASED (Could not get out of the bathtub/Able to move but very, very slow), SCIATICA (Sciatica going down my right side) and LYMPHADENOPATHY (Swollen lymph nodes) had resolved, SWELLING OF EYELID (Eyelids were swollen), AMENORRHOEA (This month I haven't had a period), VACCINATION SITE EXFOLIATION (arm peeled like a sunburn/peeling on the site of injection), MALAISE (Felt sick) and TREMOR (Shaking as I moved from the pain) outcome was unknown and FEELING ABNORMAL (Brain fog) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Blood pressure measurement: 90/68 (Inconclusive) 90/68. On 14-Mar-2021, Body temperature: 98.1 f (Inconclusive) 98.1 F. On 14-Mar-2021, Heart rate: 82 (Inconclusive) 82. On 14-Mar-2021, Respiratory rate: 16 (Inconclusive) 16. In March 2021, Antibody test: which i have (Positive) which I have. In March 2021, Blood test: normal (normal) Normal. In March 2021, Bone scan: normal (normal) Normal. In March 2021, Spinal X-ray: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant included cannabidiol (CBD) Gummies 10mg (started in 2020 and ongoing) for sleep. On the morning after her first dose of the Moderna vaccine, she woke up and and 6:15 AM started to feel lower back pain. She took a hot bath and could not get out of the bathtub. The pain was described as in her lower back and it was nerve pain, not muscle pain. She took ibuprofen (ADVIL) and laid down. She could not move when she woke up. She reported screaming and crying with pain, felt sick and was shaking as she moved. Her doctor prescribed an unspecified muscle relaxer that did nothing. She continued taking ibuprofen (ADVIL) with acetaminophen (TYLENOL) and the muscle relaxer with no relief. On 14-Mar-2021, she went to the urgent care and received hydrocodone and was told to use a heating pad. On 16-Mar-2021, she was able to move but very, very slow. She was then left with sciatica going down her right side. She went to her chiropractor but she could not adjust her for fear of hurting her. On 18-Mar-2021, she woke up with swollen eyelids that she had to use eye tape to keep up. The patient went to an allergist to see if it was an allergy and was told "no." Her allergist and other doctor told her not to get the second shot. Blood work, X-rays of her lower back and a bone scan all came back normal. The patient was tested for antibodies "which I have." On 24-May-2021, she went to the chiropractor who said she finally felt normal in the back. The patient stated she wasn't having any problems before the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: New event added in event tab. On 25-May-2021: Patient demographics updated. Concomitant medications of progesterone, estradiol, DIM, stress B-complex added. Events of swelling of eyelid, heavy menstrual bleeding, amenorrhoea, vaccination site exfoliation, malaise, tremor, mobility decreased, sciatica, feeling abnormal, and lymphadenopathy added. Events outcome updated. Lab data added.