chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Hypersomnia
Clinical narrative: pregnant; slept all the next day; extremely tired; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant), HYPERSOMNIA (slept all the next day) and FATIGUE (extremely tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant), HYPERSOMNIA (slept all the next day) and FATIGUE (extremely tired). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant), HYPERSOMNIA (slept all the next day) and FATIGUE (extremely tired) had resolved.            Concomitant products were not reported. Treatment information was not provided.    This case was linked to MOD-2021-028139, MOD-2021-028139 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Seborrhoeic keratosis
Clinical narrative: irritated seborrheic keratosis; This spontaneous case was reported by a nurse and describes the occurrence of SEBORRHOEIC KERATOSIS (irritated seborrheic keratosis) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and M012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high, Rosacea and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), ATORVASTATIN for LDL increased, METRONIDAZOLE (METROGEL) for Rosacea, MULTIVITAMINS [VITAMINS NOS] and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEBORRHOEIC KERATOSIS (irritated seborrheic keratosis). On 29-Apr-2021, SEBORRHOEIC KERATOSIS (irritated seborrheic keratosis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-032767, MOD-2021-032767 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Head discomfort, Headache, Magnetic resonance imaging
Clinical narrative: Horizontal diplopia; Pressure headache; Lightheadedness; Headache; This spontaneous case was reported by a physician and describes the occurrence of DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache), DIZZINESS (Lightheadedness) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diplopia from October 2020 to December 2020. Previously administered products included for an unreported indication: INFLUENZA in October 2019. Concurrent medical conditions included Hypertension since 11-Jan-2011, Anxiety since 11-Jan-2011, Allergic rhinitis since 01-Jan-1980, HSV infection since 11-Jan-1998 and Drug allergy (Bactrim). Concomitant products included MOMETASONE FUROATE (NASONEX) from 12-May-2017 to an unknown date and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 12-May-2017 to an unknown date for Allergic rhinitis, SERTRALINE from 11-Jan-2011 to an unknown date for Anxiety, VALACICLOVIR HYDROCHLORIDE (VALTREX) from 11-Jan-1998 to an unknown date for HSV infection, ENALAPRIL from 11-Jan-2011 to an unknown date for Hypertension.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache) and DIZZINESS (Lightheadedness). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache) and HEADACHE (Headache) had not resolved and DIZZINESS (Lightheadedness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Done Three time.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEADACHE (Headache) to be possibly related. No further causality assessments were provided for DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache) and DIZZINESS (Lightheadedness).    Patient underwent complete workup and concluded on NOV-2020, and it was negative for multiple sclerosis, myasthenia gravis, any inflammatory disease and vasculitis. Patient also had sixth cranial nerve weakness. On 05-JAN-2021, patient had experienced recurrence of diplopia.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Horizontal diplopia; Pressure headache; Lightheadedness; Headache; This spontaneous case was reported by a physician and describes the occurrence of DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache), DIZZINESS (Lightheadedness) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diplopia from October 2020 to December 2020. Previously administered products included for an unreported indication: INFLUENZA in October 2019. Concurrent medical conditions included Hypertension since 11-Jan-2011, Anxiety since 11-Jan-2011, Allergic rhinitis since 01-Jan-1980, HSV infection since 11-Jan-1998 and Drug allergy (Bactrim). Concomitant products included MOMETASONE FUROATE (NASONEX) from 12-May-2017 to an unknown date and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 12-May-2017 to an unknown date for Allergic rhinitis, SERTRALINE from 11-Jan-2011 to an unknown date for Anxiety, VALACICLOVIR HYDROCHLORIDE (VALTREX) from 11-Jan-1998 to an unknown date for HSV infection, ENALAPRIL from 11-Jan-2011 to an unknown date for Hypertension.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache) and DIZZINESS (Lightheadedness). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache) and HEADACHE (Headache) had not resolved and DIZZINESS (Lightheadedness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Done Three time.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEADACHE (Headache) to be possibly related. No further causality assessments were provided for DIPLOPIA (Horizontal diplopia), HEAD DISCOMFORT (Pressure headache) and DIZZINESS (Lightheadedness).    Patient underwent complete workup and concluded on NOV-2020, and it was negative for multiple sclerosis, myasthenia gravis, any inflammatory disease and vasculitis. Patient also had sixth cranial nerve weakness. On 05-JAN-2021, patient had experienced recurrence of diplopia.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dermatitis allergic, Pruritus allergic
Clinical narrative: Allergy to vaccine; Pruritus allergic; Allergic rash; This spontaneous case was reported by a physician and describes the occurrence of ALLERGY TO VACCINE (Allergy to vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergy to vaccine). At the time of the report, ALLERGY TO VACCINE (Allergy to vaccine) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lymphadenopathy, Pain in jaw
Clinical narrative: Dizziness; jaw pain; swollen lymph nodes, both side of my neck; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 03-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN JAW (jaw pain), LYMPHADENOPATHY (swollen lymph nodes, both side of my neck) and HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN JAW (jaw pain), LYMPHADENOPATHY (swollen lymph nodes, both side of my neck) and HEADACHE (Headache). On 25-Apr-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, PAIN IN JAW (jaw pain), LYMPHADENOPATHY (swollen lymph nodes, both side of my neck) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Dyspnoea, Headache
Clinical narrative: Shaking; Weak; Cough; Shortness of breath; Itching at injection site; Fever 101.4; Pain and terrible aching; Headache; Injection site swelling; Swollen upper arm with redness for 10 days at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath) and VACCINATION SITE PRURITUS (Itching at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Influenza from 18-Jan-2021 to 25-Jan-2021. Concurrent medical conditions included Blood pressure. Concomitant products included ASA, ESTRADIOL (ESTRACE), DILTIAZEM (CARDIZEM [DILTIAZEM]), POTASSIUM CHLORATE and DIAZEPAM for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath), VACCINATION SITE PRURITUS (Itching at injection site), PYREXIA (Fever 101.4), MYALGIA (Pain and terrible aching), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Swollen upper arm with redness for 10 days at injection site). On 06-Mar-2021, MYALGIA (Pain and terrible aching) had resolved. On 07-Mar-2021, TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath), VACCINATION SITE PRURITUS (Itching at injection site), PYREXIA (Fever 101.4), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Swollen upper arm with redness for 10 days at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 101.4 (abnormal) 101.4F.         No Treatment medications were provided   This case was linked to MOD-2021-019687 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tremor, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Shaking; Weak; Cough; Shortness of breath; Itching at injection site; Fever 101.4; Pain and terrible aching; Headache; Injection site swelling; Swollen upper arm with redness for 10 days at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath) and VACCINATION SITE PRURITUS (Itching at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Influenza from 18-Jan-2021 to 25-Jan-2021. Concurrent medical conditions included Blood pressure. Concomitant products included ASA, ESTRADIOL (ESTRACE), DILTIAZEM (CARDIZEM [DILTIAZEM]), POTASSIUM CHLORATE and DIAZEPAM for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath), VACCINATION SITE PRURITUS (Itching at injection site), PYREXIA (Fever 101.4), MYALGIA (Pain and terrible aching), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Swollen upper arm with redness for 10 days at injection site). On 06-Mar-2021, MYALGIA (Pain and terrible aching) had resolved. On 07-Mar-2021, TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath), VACCINATION SITE PRURITUS (Itching at injection site), PYREXIA (Fever 101.4), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Swollen upper arm with redness for 10 days at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 101.4 (abnormal) 101.4F.         No Treatment medications were provided   This case was linked to MOD-2021-019687 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Shaking; Weak; Cough; Shortness of breath; Itching at injection site; Fever 101.4; Pain and terrible aching; Headache; Injection site swelling; Swollen upper arm with redness for 10 days at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath) and VACCINATION SITE PRURITUS (Itching at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Influenza from 18-Jan-2021 to 25-Jan-2021. Concurrent medical conditions included Blood pressure. Concomitant products included ASA, ESTRADIOL (ESTRACE), DILTIAZEM (CARDIZEM [DILTIAZEM]), POTASSIUM CHLORATE and DIAZEPAM for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath), VACCINATION SITE PRURITUS (Itching at injection site), PYREXIA (Fever 101.4), MYALGIA (Pain and terrible aching), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Swollen upper arm with redness for 10 days at injection site). On 06-Mar-2021, MYALGIA (Pain and terrible aching) had resolved. On 07-Mar-2021, TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath), VACCINATION SITE PRURITUS (Itching at injection site), PYREXIA (Fever 101.4), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Swollen upper arm with redness for 10 days at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 101.4 (abnormal) 101.4F.         No Treatment medications were provided   This case was linked to MOD-2021-019687 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and PAIN IN EXTREMITY (Sore arm/Arm pain) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI FE 1.5/30) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/Arm pain). On an unknown date, the patient experienced PRURITUS (Itchiness). On 28-Mar-2021, PAIN IN EXTREMITY (Sore arm/Arm pain) had resolved. At the time of the report, PRURITUS (Itchiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.   This case was linked to MOD-2021-102349 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Hypoacusis, Tinnitus
Clinical narrative: Difficulty hearing; Ringing in ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in ears) and HYPOACUSIS (Difficulty hearing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Ringing in ears (after taking chloroquine in 2013). Concurrent medical conditions included Depression. Concomitant products included SERTRALINE from 10-Jan-2019 to an unknown date for Depression, VALACICLOVIR HYDROCHLORIDE (VALTREX) from 01-Jan-1997 to an unknown date for Prevention.   On 30-Dec-2020 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 1:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced TINNITUS (Ringing in ears). On an unknown date, the patient experienced HYPOACUSIS (Difficulty hearing). At the time of the report, TINNITUS (Ringing in ears) and HYPOACUSIS (Difficulty hearing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: abnormal (abnormal) Loss of high frequency.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ENT offered vitamin b, hearing aide, cognitive behavioral, and white noise.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up Information was Received  on 04-JUN-2021: Event still ongoing On 04-Jun-2021: Follow-up Information was received on 04-JUN-2021 and does not contain new information
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Peripheral swelling
Clinical narrative: cyst under the left armpit; Small swelling in her left arm pit,swelling in both her arm pits; This spontaneous case was reported by a consumer and describes the occurrence of CYST (cyst under the left armpit) and PERIPHERAL SWELLING (Small swelling in her left arm pit,swelling in both her arm pits) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus (type one insulin dependent diabetic for fifty years this December).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced PERIPHERAL SWELLING (Small swelling in her left arm pit,swelling in both her arm pits). On an unknown date, the patient experienced CYST (cyst under the left armpit). On 22-Mar-2021, PERIPHERAL SWELLING (Small swelling in her left arm pit,swelling in both her arm pits) had resolved. At the time of the report, CYST (cyst under the left armpit) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-102335 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: significant-event added
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Lymphoma, Nodular lymphoma involving lymph nodes of axilla and upper limb and Chronic lymphocytic leukaemia.    No Medical History information was reported.   On 10-Jul-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (blood in vomit, mucus), CHEST PAIN (chest pains), DYSPNOEA (Difficulty during breathing), ASTHENIA (Extremely no energy, tired and weakness) and PAIN (Pain) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic migraine (Worse) since 08-Mar-2019 and Blood pressure high (worse) since 13-Dec-2018. Concomitant products included PARACETAMOL (TYLENOL) from 23-Mar-2021 to an unknown date for an unknown indication. On 23-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced HAEMATEMESIS (blood in vomit, mucus), CHEST PAIN (chest pains), DYSPNOEA (Difficulty during breathing), ASTHENIA (Extremely no energy, tired and weakness), PAIN (Pain), COUGH (Uncurable cough), FATIGUE (Extremely tired) and VOMITING (vomiting). 20-Apr-2021, the patient experienced FOAMING AT MOUTH (white glue like substance run out of my mouth) and SLEEP APNOEA SYNDROME (stop breeathing in sleep, disgusting sounds). At the time of the report, HAEMATEMESIS (blood in vomit, mucus), CHEST PAIN (chest pains), ASTHENIA (Extremely no energy, tired and weakness), PAIN (Pain), COUGH (Uncurable cough), FOAMING AT MOUTH (white glue like substance run out of my mouth), SLEEP APNOEA SYNDROME (stop breeathing in sleep, disgusting sounds), FATIGUE (Extremely tired) and VOMITING (vomiting) had not resolved and DYSPNOEA (Difficulty during breathing) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided. This case was linked to MOD-2021-187349. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Reporter details, patient's medical history and additional events were added. On 13-Jun-2021: The follow up included no new information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Foaming at mouth, Haematemesis, Pain, Sleep apnoea syndrome, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (blood in vomit, mucus), CHEST PAIN (chest pains), DYSPNOEA (Difficulty during breathing), ASTHENIA (Extremely no energy, tired and weakness) and PAIN (Pain) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic migraine (Worse) since 08-Mar-2019 and Blood pressure high (worse) since 13-Dec-2018. Concomitant products included PARACETAMOL (TYLENOL) from 23-Mar-2021 to an unknown date for an unknown indication. On 23-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced HAEMATEMESIS (blood in vomit, mucus), CHEST PAIN (chest pains), DYSPNOEA (Difficulty during breathing), ASTHENIA (Extremely no energy, tired and weakness), PAIN (Pain), COUGH (Uncurable cough), FATIGUE (Extremely tired) and VOMITING (vomiting). 20-Apr-2021, the patient experienced FOAMING AT MOUTH (white glue like substance run out of my mouth) and SLEEP APNOEA SYNDROME (stop breeathing in sleep, disgusting sounds). At the time of the report, HAEMATEMESIS (blood in vomit, mucus), CHEST PAIN (chest pains), ASTHENIA (Extremely no energy, tired and weakness), PAIN (Pain), COUGH (Uncurable cough), FOAMING AT MOUTH (white glue like substance run out of my mouth), SLEEP APNOEA SYNDROME (stop breeathing in sleep, disgusting sounds), FATIGUE (Extremely tired) and VOMITING (vomiting) had not resolved and DYSPNOEA (Difficulty during breathing) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided. This case was linked to MOD-2021-187349. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Reporter details, patient's medical history and additional events were added. On 13-Jun-2021: The follow up included no new information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash pruritic
Clinical narrative: red itchy rash; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (red itchy rash) and PERIPHERAL SWELLING (Swollen arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI FE 1.5/30) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced RASH PRURITIC (red itchy rash) and PERIPHERAL SWELLING (Swollen arm). On 02-May-2021, RASH PRURITIC (red itchy rash) and PERIPHERAL SWELLING (Swollen arm) had resolved.            No treatment details were provided. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-102290 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102290:First dose case
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster
Clinical narrative: Thought had Shingles; Back pain; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Thought had Shingles) and BACK PAIN (Back pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Ankylosing spondylitis.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced BACK PAIN (Back pain). On an unknown date, the patient experienced HERPES ZOSTER (Thought had Shingles). The patient was treated with SULFASALAZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Thought had Shingles) and BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BACK PAIN (Back pain) to be possibly related. No further causality assessment was provided for HERPES ZOSTER (Thought had Shingles).    No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: recovery of sense of smell; recovery of sense of taste; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAROSMIA (recovery of sense of smell) and TASTE DISORDER (recovery of sense of taste) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (recovery of sense of smell) and TASTE DISORDER (recovery of sense of taste). At the time of the report, PAROSMIA (recovery of sense of smell) and TASTE DISORDER (recovery of sense of taste) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications or treatment information was reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Headache, Pain
Clinical narrative: Body ache; Pain bones; Fever; Feeling tired; chills; Headache; Sore arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), BONE PAIN (Pain bones), PYREXIA (Fever), FATIGUE (Feeling tired) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Body ache), BONE PAIN (Pain bones), PYREXIA (Fever), FATIGUE (Feeling tired), CHILLS (chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm injection site). At the time of the report, PAIN (Body ache), BONE PAIN (Pain bones), PYREXIA (Fever), FATIGUE (Feeling tired), CHILLS (chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported   This case was linked to MOD-2021-037299 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: As per the TCR Report received on 12-May-2021 has denial for further follow up and to contact the patient.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Body ache; Pain bones; Fever; Feeling tired; chills; Headache; Sore arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), BONE PAIN (Pain bones), PYREXIA (Fever), FATIGUE (Feeling tired) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Body ache), BONE PAIN (Pain bones), PYREXIA (Fever), FATIGUE (Feeling tired), CHILLS (chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm injection site). At the time of the report, PAIN (Body ache), BONE PAIN (Pain bones), PYREXIA (Fever), FATIGUE (Feeling tired), CHILLS (chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported   This case was linked to MOD-2021-037299 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: As per the TCR Report received on 12-May-2021 has denial for further follow up and to contact the patient.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Generalized aching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Ankylosing spondylitis.    Concurrent medical conditions included Psoriatic arthritis and Ankylosing spondylitis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Generalized aching) and HEADACHE (Headache). At the time of the report, PAIN (Generalized aching) and HEADACHE (Headache) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Influenza like illness, Type IV hypersensitivity reaction
Clinical narrative: covid arm; Flu type reaction really bad; I ended up in bed; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (covid arm), INFLUENZA LIKE ILLNESS (Flu type reaction really bad) and BEDRIDDEN (I ended up in bed) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ESTRADIOL (ESTRING) for an unknown indication.    Concurrent medical conditions included Cerebral palsy (CP).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ESTRADIOL (ESTRING) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (covid arm), INFLUENZA LIKE ILLNESS (Flu type reaction really bad) and BEDRIDDEN (I ended up in bed). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (covid arm), INFLUENZA LIKE ILLNESS (Flu type reaction really bad) and BEDRIDDEN (I ended up in bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Events were added and the patient denies consent for follow-up
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: injection site erythema; injection site pruritus; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site erythema) and VACCINATION SITE PRURITUS (injection site pruritus) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site erythema) and VACCINATION SITE PRURITUS (injection site pruritus). At the time of the report, VACCINATION SITE ERYTHEMA (injection site erythema) and VACCINATION SITE PRURITUS (injection site pruritus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sore after first COVID Vaccination; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Arm sore after first COVID Vaccination) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore after first COVID Vaccination). At the time of the report, PAIN IN EXTREMITY (Arm sore after first COVID Vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Crying, Fatigue, Gait disturbance, Headache
Clinical narrative: shivering that my teeeth were chattering; 102 fever; Headache; Tired; could not walk on my feet; Crying; Vaccination site pain; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk on my feet), CRYING (Crying), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Myalgia) and CHILLS (shivering that my teeeth were chattering) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to arthropod sting.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced GAIT DISTURBANCE (could not walk on my feet), CRYING (Crying), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Myalgia), PYREXIA (102 fever), HEADACHE (Headache) and FATIGUE (Tired). On an unknown date, the patient experienced CHILLS (shivering that my teeeth were chattering). At the time of the report, GAIT DISTURBANCE (could not walk on my feet), CRYING (Crying), MYALGIA (Myalgia), CHILLS (shivering that my teeeth were chattering), PYREXIA (102 fever), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain) had not resolved.            No concomitant medications were provided.No treatment informations were provided. Action taken with mRNA-1273 in response to the events was not applicable.  Additional information:Patient described it to my husband as what patient think cancer of the bones would feel like. Eventually I fell asleep and then slept for over 24 hours. I was tired for the next few days (3ish). To this day my arm still does not feel right- I can feel where the shot was given inside my arm (not by touch).   This case was linked to MOD-2021-021375 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: shivering that my teeeth were chattering; 102 fever; Headache; Tired; could not walk on my feet; Crying; Vaccination site pain; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk on my feet), CRYING (Crying), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Myalgia) and CHILLS (shivering that my teeeth were chattering) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to arthropod sting.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced GAIT DISTURBANCE (could not walk on my feet), CRYING (Crying), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Myalgia), PYREXIA (102 fever), HEADACHE (Headache) and FATIGUE (Tired). On an unknown date, the patient experienced CHILLS (shivering that my teeeth were chattering). At the time of the report, GAIT DISTURBANCE (could not walk on my feet), CRYING (Crying), MYALGIA (Myalgia), CHILLS (shivering that my teeeth were chattering), PYREXIA (102 fever), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain) had not resolved.            No concomitant medications were provided.No treatment informations were provided. Action taken with mRNA-1273 in response to the events was not applicable.  Additional information:Patient described it to my husband as what patient think cancer of the bones would feel like. Eventually I fell asleep and then slept for over 24 hours. I was tired for the next few days (3ish). To this day my arm still does not feel right- I can feel where the shot was given inside my arm (not by touch).   This case was linked to MOD-2021-021375 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Ocular discomfort, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of aggravated condition (worsening of ocular symptoms/flare-ups), ocular discomfort (ocular symptoms) and pyrexia (fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included multiple sclerosis. Concomitant products included Ocrevus (ocrelizumab) for an unknown indication. On Feb 16, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced aggravated condition (worsening of ocular symptoms/flare-ups), ocular discomfort (ocular symptoms) and pyrexia (fever). At the time of the report, aggravated condition (worsening of ocular symptoms/flare-ups), ocular discomfort (ocular symptoms) and pyrexia (fever) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment information provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Headache, Nasal congestion
Clinical narrative: flares; Nasal congestion; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (flares), NASAL CONGESTION (Nasal congestion) and HEADACHE (headaches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TOFACITINIB CITRATE (XELJANZ) from 01-Feb-2021 to an unknown date for Rheumatoid arthritis, FLUTICASONE PROPIONATE, KETOTIFEN FUMARATE, MACROGOL 400, PROPYLENE GLYCOL (SYSTANE), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), ACICLOVIR SODIUM (ACYCLOVIR), CICLOSPORIN (RESTASIS MULTIDOSE), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), SALBUTAMOL SULFATE (VENTOLIN HFA), ALBUTEROL SULFATE, RANITIDINE HCL and METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE) for an unknown indication, VITAMIN D3.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (flares), NASAL CONGESTION (Nasal congestion) and HEADACHE (headaches). At the time of the report, ARTHRITIS (flares), NASAL CONGESTION (Nasal congestion) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was instructed by md to stop taking XELJANZ one week before and one week after each vaccine dose. Patient reports during the time not taking XELJANZ he had flares and nasal congestion   This case was linked to MOD-2021-104951 (Patient Link).