Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Influenza like illness, Lyme disease, Magnetic resonance imaging head normal
Clinical narrative: Lyme disease; had little muscle twitches; dizzy spells; extremely tired; headaches a month after receiving the booster shot; really bad joint pain; felt sick for 2 days; flu like symptoms; stiffness and soreness in his muscles, especially in the neck; stiffness and soreness in his muscles, especially in the neck; This spontaneous case was reported by a patient and describes the occurrence of LYME DISEASE (Lyme disease) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 012A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache (Prior to the vaccine, patient headaches were resolved with a couple of Tylenols.). Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 28-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NECK PAIN (stiffness and soreness in his muscles, especially in the neck), MUSCULOSKELETAL STIFFNESS (stiffness and soreness in his muscles, especially in the neck), ILLNESS (felt sick for 2 days) and ARTHRALGIA (really bad joint pain). In January 2022, the patient experienced HEADACHE (headaches a month after receiving the booster shot). On an unknown date, the patient experienced LYME DISEASE (Lyme disease) (seriousness criterion medically significant), MUSCLE TWITCHING (had little muscle twitches), DIZZINESS (dizzy spells) and FATIGUE (extremely tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of since receiving the booster; PARACETAMOL (TYLENOL) for Headache, at a dose of Prior to booster; PREDNISONE at an unspecified dose and frequency; DOXYCYCLINE for Lyme disease, at an unspecified dose and frequency; TOPIRAMATE (TOPAMAX) at an unspecified dose and frequency; ALPRAZOLAM (XANAX) at an unspecified dose and frequency and TRAMADOL for Prophylactic, at an unspecified dose and frequency. In December 2021, ILLNESS (felt sick for 2 days) had resolved. At the time of the report, LYME DISEASE (Lyme disease) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms), NECK PAIN (stiffness and soreness in his muscles, especially in the neck), MUSCULOSKELETAL STIFFNESS (stiffness and soreness in his muscles, especially in the neck), MUSCLE TWITCHING (had little muscle twitches), DIZZINESS (dizzy spells), ARTHRALGIA (really bad joint pain), HEADACHE (headaches a month after receiving the booster shot) and FATIGUE (extremely tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram head: No abnormality. On an unknown date, Computerised tomogram neck: No abnormality. On an unknown date, Magnetic resonance imaging head: No abnormality. On an unknown date, Magnetic resonance imaging neck: No abnormality.         Patient height was reported as 167.64cm and weight was 92.989 kgs. Since patient received the booster dose, he had nothing but problems. The patient had to be in and out of doctor's offices and specialists to figure out what was going on with him. The patient said that a couple of hours after receiving the booster dose, he started experiencing bad joint pain. Then a couple of hours after that patient started experiencing flu like symptoms due to which felt sick for 2 days. The joint pain kept occurring. The patient had it for at least a month and a half where it was not going away. The patient also started experiencing headaches a month after receiving the booster shot, which had not gone away since. The patient said that it occurs periodically where his neck gets really stiff and sometimes it was not that bad. The same thing happened with headaches too. In the last couple of days patient's symptoms flared up again. The patient said that he never experienced this kind of side effect from anything before. The patient had headaches almost every day since he received the booster shot. Prior to this, his headaches were resolved with a couple of Tylenols. However, ever since receiving the booster shot, his headaches did not subside even with Tylenol. The patient had seen his family doctor and two different neurosurgeons for his issues, but they had not able to diagnose him with anything specifically. The patient was currently waiting on results for Lupus which he was hoping to receive in the next couple of days. The patient had been feeling miserable since he received the booster shot of Moderna. The patient was not test positive for COVID-19. The patient had not experienced a similar event in the past.   This case was linked to MOD-2022-628898 (Patient Link).  Company comment: This is a spontaneous case reported by a patient concerning a 30-year-old male patient with relevant medical history of Headache (Prior to the vaccine, patient headaches were resolved with a couple of Tylenols), who experienced the unexpected, serious, medically significant event of Lyme disease, which occurred on an unknown date, thus, exact latency between vaccination and onset of the event could not be assessed. The patient received three doses of mRNA-1273. He reported that a couple of hours after receiving the booster dose, he started experiencing bad joint pain. A couple of hours later, he started with flu-like-symptoms and felt sick for two days. He had flu-like symptoms after his second dose as well, which recovered after two days. The joint pain had not recovered at least for a month and a half. He also experienced headaches a month after receiving the booster dose, everyday, that did not resolve with Tylenol as it did before. He felt extremely tired, had little muscle twitches, dizzy spells, stiffness and soreness in his muscles, especially in the neck. He was evaluated by the family doctor and two different neurosurgeons, that had not reached any specific diagnosis. Magnetic resonance imaging and computerized tomography scans of his brain and neck were performed with no abnormal findings. Lupus test was pending. The patient was treated with Doxycycline for Lyme disease. The medical history of headache could be a predisposing factor associated with the non-serious event of headache. The non-serious events of influenza like illness, neck pain, Musculoskeletal stiffness, muscle twitching, illness, dizziness, arthralgia, headache and fatigue could be symptoms of Lyme disease. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a patient concerning a 30-year-old male patient with relevant medical history of Headache (Prior to the vaccine, patient headaches were resolved with a couple of Tylenols), who experienced the unexpected, serious, medically significant event of Lyme disease, which occurred on an unknown date, thus, exact latency between vaccination and onset of the event could not be assessed. The patient received three doses of mRNA-1273. He reported that a couple of hours after receiving the booster dose, he started experiencing bad joint pain. A couple of hours later, he started with flu-like-symptoms and felt sick for two days. He had flu-like symptoms after his second dose as well, which recovered after two days. The joint pain had not recovered at least for a month and a half. He also experienced headaches a month after receiving the booster dose, everyday, that did not resolve with Tylenol as it did before. He felt extremely tired, had little muscle twitches, dizzy spells, stiffness and soreness in his muscles, especially in the neck. He was evaluated by the family doctor and two different neurosurgeons, that had not reached any specific diagnosis. Magnetic resonance imaging and computerized tomography scans of his brain and neck were performed with no abnormal findings. Lupus test was pending. The patient was treated with Doxycycline for Lyme disease. The medical history of headache could be a predisposing factor associated with the non-serious event of headache. The non-serious events of influenza like illness, neck pain, Musculoskeletal stiffness, muscle twitching, illness, dizziness, arthralgia, headache and fatigue could be symptoms of Lyme disease. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.