chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Itchy; Swelling arm; Fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Fever) in an elderly female 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.    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 On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Fever). At the time of the report, PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant drugs and Treatment information was reported.    This case was linked to MOD-2021-213585 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up Received on 01-JUN-2021 contains No New Information On 02-Jun-2021: Follow-up Received on 02-JUN-2021 contains No New Information On 08-Jun-2021: Follow-up Received on 08-JUN-2021 contains No New Information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Patient had a hot area where the vaccine was given; Patient had a area of redness where the vaccine was given; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Patient had a hot area where the vaccine was given) and VACCINATION SITE ERYTHEMA (Patient had a area of redness where the vaccine was given) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE WARMTH (Patient had a hot area where the vaccine was given) and VACCINATION SITE ERYTHEMA (Patient had a area of redness where the vaccine was given). At the time of the report, VACCINATION SITE WARMTH (Patient had a hot area where the vaccine was given) and VACCINATION SITE ERYTHEMA (Patient had a area of redness where the vaccine was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.Treatment medication was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pin at injection site for 2 days), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (fatigue lasting 7 days) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042l20a and 001b21a) for COVID-19 vaccination. Concurrent medical conditions included Kidney failure chronic since 01-Nov-2016 and Hypertension since 1991. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), AMLODIPINE, ATORVASTATIN, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and ACETAMINOPHEN for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pin at injection site for 2 days), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (fatigue lasting 7 days). On 19-Mar-2021, VACCINATION SITE PAIN (Pin at injection site for 2 days) had resolved. On 20-Mar-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. On 24-Mar-2021, FATIGUE (fatigue lasting 7 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-014165.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of SKIN IRRITATION (Skin irritation) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic lymphocytic leukemia since 16-Nov-2018. Concomitant products included IBRUTINIB (IMBRUVICA) from 16-Nov-2018 to an unknown date for Chronic lymphocytic leukemia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (Skin irritation). At the time of the report, SKIN IRRITATION (Skin irritation) 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 did not provide any causality assessments.   Treatment information was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Pain
Clinical narrative: Body aches with Humira; Not feeling well after receiving second dose of Covid-19 vaccine; Dizziness after receiving second dose of Covid-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Body aches with Humira), MALAISE (Not feeling well after receiving second dose of Covid-19 vaccine) and DIZZINESS (Dizziness after receiving second dose of Covid-19 vaccine) in a 62-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.    No Medical History information was reported.   In November 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN (Body aches with Humira), MALAISE (Not feeling well after receiving second dose of Covid-19 vaccine) and DIZZINESS (Dizziness after receiving second dose of Covid-19 vaccine). At the time of the report, PAIN (Body aches with Humira), MALAISE (Not feeling well after receiving second dose of Covid-19 vaccine) and DIZZINESS (Dizziness after receiving second dose of Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter. Events are recovered in month of february 2021.   This case was linked to MOD-2021-079906 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: sore arm; nausea; tired; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), FATIGUE (tired) and PYREXIA (fever) 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 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), FATIGUE (tired) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), FATIGUE (tired) and PYREXIA (fever) outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: feeling achy all over; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (feeling achy all over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).    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 MYALGIA (feeling achy all over). At the time of the report, MYALGIA (feeling achy all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       patient was exposed to two of positive covid people, after 12 days he had taken vaccination. no treatment given and no concomitant medication provided   This case was linked to US-MODERNATX, INC.-MOD-2021-133136 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-133136:wife
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received a dose of the Pfizer COVID-19 vaccine/ confirmation e-mail that she received says vaccinated with Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received a dose of the Pfizer COVID-19 vaccine/ confirmation e-mail that she received says vaccinated with Moderna) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ER8729) for COVID-19 vaccination.     Concomitant products included AMINOPHYLLINE, CAFFEINE, EPHEDRINE HYDROCHLORIDE, PHENOBARBITAL, POTASSIUM IODIDE (ASTHMA "18") for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received a dose of the Pfizer COVID-19 vaccine/ confirmation e-mail that she received says vaccinated with Moderna). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received a dose of the Pfizer COVID-19 vaccine/ confirmation e-mail that she received says vaccinated with Moderna) outcome was unknown. Not Provided      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 events was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash was itchy; Red and swollen patches on elbow; red and swollen patches on elbow; Rash has spread on her face - above cheek, below eye, right side of the chin, neck, rash is uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash was itchy), RASH ERYTHEMATOUS (Red and swollen patches on elbow), JOINT SWELLING (red and swollen patches on elbow) and RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck, rash is uncomfortable) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 012A21A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE for Gastric disorder, DICYCLOMINE [DICYCLOVERINE] for Stomach discomfort, ATORVASTATIN and LISINOPRIL for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced RASH PRURITIC (rash was itchy), RASH ERYTHEMATOUS (Red and swollen patches on elbow), JOINT SWELLING (red and swollen patches on elbow) and RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck, rash is uncomfortable). At the time of the report, RASH PRURITIC (rash was itchy) and RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck, rash is uncomfortable) outcome was unknown and RASH ERYTHEMATOUS (Red and swollen patches on elbow) and JOINT SWELLING (red and swollen patches on elbow) had not resolved.            Treatment Doctor from urgent care prescribed her with Triamcinolone 0.1 percent cream 30 gm. She applied this for 5 days. Again on 25-Mar-2021, she consulted with her primary HCP who discontinued the cream and prescribed her with Eucerin cream and Eczema release cream. Patient also took over-the-counter medications - Claritin non-drowsy, Clear eye drops, Benadryl spray. None of these seem to be working and patient tried a mixture of vaseline with baking soda for a relief from the itchiness.  Concomitant medication reported also included health pill over-the-counter.   This case was linked to MOD-2021-101991 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nightmare, Pain in extremity
Clinical narrative: Nightmares; Sore arm; Fatigue; Muscle aches; Chills; Pyrexia; This spontaneous case was reported by a physician and describes the occurrence of NIGHTMARE (Nightmares), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), MYALGIA (Muscle aches) and CHILLS (Chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Surgery (uspecified intestinal disorder and colon stenosis). Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NIGHTMARE (Nightmares), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), MYALGIA (Muscle aches), CHILLS (Chills) and PYREXIA (Pyrexia). At the time of the report, NIGHTMARE (Nightmares), FATIGUE (Fatigue), MYALGIA (Muscle aches), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-102023 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nightmares; Sore arm; Fatigue; Muscle aches; Chills; Pyrexia; This spontaneous case was reported by a physician and describes the occurrence of NIGHTMARE (Nightmares), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), MYALGIA (Muscle aches) and CHILLS (Chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Surgery (uspecified intestinal disorder and colon stenosis). Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NIGHTMARE (Nightmares), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), MYALGIA (Muscle aches), CHILLS (Chills) and PYREXIA (Pyrexia). At the time of the report, NIGHTMARE (Nightmares), FATIGUE (Fatigue), MYALGIA (Muscle aches), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-102023 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Ultrasound scan, Ventricular hypertrophy
Clinical narrative: headache has consistently increased recently to a 4/10 than previously 2/10; left ventricle hypertrophy; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VENTRICULAR HYPERTROPHY (left ventricle hypertrophy), FATIGUE (Fatigue) and HEADACHE (headache has consistently increased recently to a 4/10 than previously 2/10) in a patient of an unknown age and gender 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. On 16-Apr-2021, the patient experienced VENTRICULAR HYPERTROPHY (left ventricle hypertrophy). On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (headache has consistently increased recently to a 4/10 than previously 2/10). At the time of the report, VENTRICULAR HYPERTROPHY (left ventricle hypertrophy), FATIGUE (Fatigue) and HEADACHE (headache has consistently increased recently to a 4/10 than previously 2/10) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Ultrasound scan: left ventricle hypertrophy (abnormal) Heart ultrasound-left ventricle hypertrophy.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced fatigue x 3 days post 2nd dose of Moderna Covid 19 Vaccine 17 Apr 2021. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (left arm hurt) and myalgia (whole body hurt) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 21, 2021, patient experienced pain in extremity (left arm hurt) and myalgia (whole body hurt). The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid virus test postive) in a 48-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 Ulcerative colitis.No Medical History information was reported. On 09-Oct-2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid virus test postive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid virus test postive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 Moderna vaccine was Not applicable
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site haemorrhage, Pain, Pyrexia
Clinical narrative: Bleeding at the injection site; Soreness; fatigue; low grade fever; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE HAEMORRHAGE (Bleeding at the injection site), PAIN (Soreness), FATIGUE (fatigue) and PYREXIA (low grade fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 042 L20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease, Alcohol use (Wine, 2 drinks a week (started 2020)), Attention deficit hyperactivity disorder, Adhesive tape allergy (Rash) and Allergy to vaccine (Whooping cough manifested to Anaphylactic reaction). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit hyperactivity disorder, ETHINYLESTRADIOL, LEVONORGESTREL (SRONYX) for Birth control, SULFASALAZINE for Crohn's disease, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 26-Jan-2021, the patient experienced PAIN (Soreness), FATIGUE (fatigue) and PYREXIA (low grade fever). On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (Bleeding at the injection site). On 26-Jan-2021, PAIN (Soreness), FATIGUE (fatigue) and PYREXIA (low grade fever) had resolved. At the time of the report, INJECTION SITE HAEMORRHAGE (Bleeding at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN (Soreness), FATIGUE (fatigue) and PYREXIA (low grade fever) to be probably related. No further causality assessment was provided for INJECTION SITE HAEMORRHAGE (Bleeding at the injection site).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (red and swollen patches on elbow), INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck), FATIGUE (tiredness) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PANTOPRAZOLE, ATORVASTATIN, LISINOPRIL and DICYCLOMINE HYDROCHLORIDE for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (tiredness), HEADACHE (headache), CHILLS (Chills) and PYREXIA (fever (up to 100 degrees Fahrenheit)). On 07-Mar-2021, the patient experienced JOINT SWELLING (red and swollen patches on elbow) and RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck). The patient was treated with TRIAMCINOLONE (topical) on 20-Mar-2021 at a dose of 0.1%  30 g; AVENA SATIVA (EUCERIN ECZEMA RELIEF) on 25-Mar-2021 at a dose of 1 dosage form; SALICYLIC ACID (EUCERIN [SALICYLIC ACID]) on 25-Mar-2021 at a dose of 1 dosage form; LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form; GLYCEROL, NAPHAZOLINE HYDROCHLORIDE (CLEAR EYES REDNESS RELIEF) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 01-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (tiredness), HEADACHE (headache), CHILLS (Chills) and PYREXIA (fever (up to 100 degrees Fahrenheit)) had resolved. At the time of the report, JOINT SWELLING (red and swollen patches on elbow) and RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Body temperature: 100 degree f (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products included health pill over-the-counter. This case was linked to MOD-2021-101978.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pyrexia, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (red and swollen patches on elbow), INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck), FATIGUE (tiredness) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PANTOPRAZOLE, ATORVASTATIN, LISINOPRIL and DICYCLOMINE HYDROCHLORIDE for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (tiredness), HEADACHE (headache), CHILLS (Chills) and PYREXIA (fever (up to 100 degrees Fahrenheit)). On 07-Mar-2021, the patient experienced JOINT SWELLING (red and swollen patches on elbow) and RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck). The patient was treated with TRIAMCINOLONE (topical) on 20-Mar-2021 at a dose of 0.1%  30 g; AVENA SATIVA (EUCERIN ECZEMA RELIEF) on 25-Mar-2021 at a dose of 1 dosage form; SALICYLIC ACID (EUCERIN [SALICYLIC ACID]) on 25-Mar-2021 at a dose of 1 dosage form; LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form; GLYCEROL, NAPHAZOLINE HYDROCHLORIDE (CLEAR EYES REDNESS RELIEF) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 01-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (tiredness), HEADACHE (headache), CHILLS (Chills) and PYREXIA (fever (up to 100 degrees Fahrenheit)) had resolved. At the time of the report, JOINT SWELLING (red and swollen patches on elbow) and RASH (Rash has spread on her face - above cheek, below eye, right side of the chin, neck) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Body temperature: 100 degree f (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products included health pill over-the-counter. This case was linked to MOD-2021-101978.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Headache, Malaise, Pain
Clinical narrative: feeling cold; Feeling sick; Sore body feeling as hit by a truck" and a horrendous pain; bad headache; high fever 103.8F; This spontaneous case was reported by an other and describes the occurrence of FEELING COLD (feeling cold), MALAISE (Feeling sick), PAIN (Sore body feeling as hit by a truck" and a horrendous pain), HEADACHE (bad headache) and PYREXIA (high fever 103.8F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (feeling cold), MALAISE (Feeling sick), PAIN (Sore body feeling as hit by a truck" and a horrendous pain), HEADACHE (bad headache) and PYREXIA (high fever 103.8F). At the time of the report, FEELING COLD (feeling cold), MALAISE (Feeling sick), PAIN (Sore body feeling as hit by a Mack truck" and a horrendous pain), HEADACHE (bad headache) and PYREXIA (high fever 103.8F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.8 (High) High fever of 103.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling cold; Feeling sick; Sore body feeling as hit by a truck" and a horrendous pain; bad headache; high fever 103.8F; This spontaneous case was reported by an other and describes the occurrence of FEELING COLD (feeling cold), MALAISE (Feeling sick), PAIN (Sore body feeling as hit by a truck" and a horrendous pain), HEADACHE (bad headache) and PYREXIA (high fever 103.8F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (feeling cold), MALAISE (Feeling sick), PAIN (Sore body feeling as hit by a truck" and a horrendous pain), HEADACHE (bad headache) and PYREXIA (high fever 103.8F). At the time of the report, FEELING COLD (feeling cold), MALAISE (Feeling sick), PAIN (Sore body feeling as hit by a Mack truck" and a horrendous pain), HEADACHE (bad headache) and PYREXIA (high fever 103.8F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.8 (High) High fever of 103.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Myalgia, Nausea
Clinical narrative: Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and NAUSEA (Nausea) 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 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced MYALGIA (Muscle pain) and NAUSEA (Nausea). At the time of the report, MYALGIA (Muscle pain) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood glucose: increased (High) Spike in blood sugar.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia, Nausea, Palpitations, Pyrexia
Clinical narrative: Racing heart; Shortness of breath if over assert self; nausea; High fever; Body ache; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (Racing heart), DYSPNOEA (Shortness of breath if over assert self), NAUSEA (nausea), PYREXIA (High fever) and MYALGIA (Body ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PALPITATIONS (Racing heart), DYSPNOEA (Shortness of breath if over assert self), NAUSEA (nausea), PYREXIA (High fever) and MYALGIA (Body ache). At the time of the report, PALPITATIONS (Racing heart), DYSPNOEA (Shortness of breath if over assert self), NAUSEA (nausea), PYREXIA (High fever) and MYALGIA (Body ache) 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 did not provide any causality assessments.   No concomitant medications were provided.  The treatment reported as Tylenol.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal
Clinical narrative: feel terrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel terrible) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PREGABALIN (LYRICA) for an unknown indication.    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 PREGABALIN (LYRICA) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel terrible). At the time of the report, FEELING ABNORMAL (feel terrible) 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 did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had a little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a little bit of fever) in an 87-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had a little bit of fever). At the time of the report, PYREXIA (Had a little bit of fever) outcome was unknown.        Patient reported that she was waiting to take Ciprofloxacin after she got the 2nd vaccine.  No treatment related information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-037512 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-037512:First dose case
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I was in bed all day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was in bed all day) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (I was in bed all day). At the time of the report, FATIGUE (I was in bed all day) outcome was unknown.            No concomitant medications reported. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Profuse sweating; Vomiting; Very high fever 103F to 104F; Bad chills / Rigors at nights; Little headache; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Profuse sweating), PYREXIA (Very high fever 103F to 104F), CHILLS (Bad chills / Rigors at nights), VOMITING (Vomiting) and HEADACHE (Little headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA), TESTOSTERONE and CYANOCOBALAMIN (VIT B 12) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HYPERHIDROSIS (Profuse sweating), PYREXIA (Very high fever 103F to 104F), CHILLS (Bad chills / Rigors at nights), VOMITING (Vomiting) and HEADACHE (Little headache). On 07-Apr-2021, HYPERHIDROSIS (Profuse sweating), PYREXIA (Very high fever 103F to 104F), CHILLS (Bad chills / Rigors at nights), VOMITING (Vomiting) and HEADACHE (Little headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment- Received Tylenol medications for the adverse reactions developed   This case was linked to MOD-2021-102013 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy rash on right arm near injection site; itchy rash on right arm near injection site; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PRURITUS (itchy rash on right arm near injection site) and VACCINATION SITE RASH (itchy rash on right arm near injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drugs), Adhesive tape allergy, Ulcerative colitis since 1984, Hashimoto's disease since 1995, Blood pressure high since 2010, Osteoporosis since 2019 and Type 1 diabetes mellitus since 12-Feb-1978. Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, ALENDRONATE SODIUM, COLECALCIFEROL (FOSAMAX D) for Osteoporosis, INSULIN LISPRO (HUMALOG) for Type 1 diabetes mellitus, MESALAZINE (ASACOL HD) for Ulcerative colitis.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy rash on right arm near injection site) and VACCINATION SITE RASH (itchy rash on right arm near injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy rash on right arm near injection site) and VACCINATION SITE RASH (itchy rash on right arm near injection site) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No treatment information was reported.   This case was linked to MOD-2021-027704, MOD-2021-027704 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: general body ache; fever 100.5 degrees; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (general body ache) and PYREXIA (fever 100.5 degrees) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PAIN (general body ache) and PYREXIA (fever 100.5 degrees). At the time of the report, PAIN (general body ache) and PYREXIA (fever 100.5 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 100.5 (High) 100.5 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-100625 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hypoaesthesia, Lymphadenopathy, Paraesthesia
Clinical narrative: lymph nodes are not as badly swollen but she thinks this is due to taking prednisone; throat is closed a little but not completely; sensation spread to her hands; sensation spread to her hands; restrictive breathing; enlarged lymph nodes; tingling and numbness in her feet.; tingling and numbness in her feet; "usual symptoms" such as chills and fever which lasted that day; "usual symptoms" such as chills and fever which lasted that day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS ("usual symptoms" such as chills and fever which lasted that day), PYREXIA ("usual symptoms" such as chills and fever which lasted that day), PARAESTHESIA (tingling and numbness in her feet.), HYPOAESTHESIA (tingling and numbness in her feet) and PARAESTHESIA (sensation spread to her hands) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS ("usual symptoms" such as chills and fever which lasted that day) and PYREXIA ("usual symptoms" such as chills and fever which lasted that day). On 24-Mar-2021, the patient experienced PARAESTHESIA (tingling and numbness in her feet.) and HYPOAESTHESIA (tingling and numbness in her feet). On 07-Apr-2021, the patient experienced PARAESTHESIA (sensation spread to her hands), HYPOAESTHESIA (sensation spread to her hands), DYSPNOEA (restrictive breathing) and LYMPHADENOPATHY (enlarged lymph nodes). On 03-May-2021, the patient experienced LYMPHADENOPATHY (lymph nodes are not as badly swollen but she thinks this is due to taking prednisone) and THROAT TIGHTNESS (throat is closed a little but not completely). On 24-Feb-2021, CHILLS ("usual symptoms" such as chills and fever which lasted that day) and PYREXIA ("usual symptoms" such as chills and fever which lasted that day) had resolved. At the time of the report, PARAESTHESIA (tingling and numbness in her feet.), HYPOAESTHESIA (tingling and numbness in her feet), PARAESTHESIA (sensation spread to her hands), HYPOAESTHESIA (sensation spread to her hands), DYSPNOEA (restrictive breathing), LYMPHADENOPATHY (enlarged lymph nodes), LYMPHADENOPATHY (lymph nodes are not as badly swollen but she thinks this is due to taking prednisone) and THROAT TIGHTNESS (throat is closed a little but not completely) outcome was unknown. Not Provided          No concomitant details were provided.  Treatment details include Prednisone.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat tightness
Clinical narrative: lymph nodes are not as badly swollen but she thinks this is due to taking prednisone; throat is closed a little but not completely; sensation spread to her hands; sensation spread to her hands; restrictive breathing; enlarged lymph nodes; tingling and numbness in her feet.; tingling and numbness in her feet; "usual symptoms" such as chills and fever which lasted that day; "usual symptoms" such as chills and fever which lasted that day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS ("usual symptoms" such as chills and fever which lasted that day), PYREXIA ("usual symptoms" such as chills and fever which lasted that day), PARAESTHESIA (tingling and numbness in her feet.), HYPOAESTHESIA (tingling and numbness in her feet) and PARAESTHESIA (sensation spread to her hands) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS ("usual symptoms" such as chills and fever which lasted that day) and PYREXIA ("usual symptoms" such as chills and fever which lasted that day). On 24-Mar-2021, the patient experienced PARAESTHESIA (tingling and numbness in her feet.) and HYPOAESTHESIA (tingling and numbness in her feet). On 07-Apr-2021, the patient experienced PARAESTHESIA (sensation spread to her hands), HYPOAESTHESIA (sensation spread to her hands), DYSPNOEA (restrictive breathing) and LYMPHADENOPATHY (enlarged lymph nodes). On 03-May-2021, the patient experienced LYMPHADENOPATHY (lymph nodes are not as badly swollen but she thinks this is due to taking prednisone) and THROAT TIGHTNESS (throat is closed a little but not completely). On 24-Feb-2021, CHILLS ("usual symptoms" such as chills and fever which lasted that day) and PYREXIA ("usual symptoms" such as chills and fever which lasted that day) had resolved. At the time of the report, PARAESTHESIA (tingling and numbness in her feet.), HYPOAESTHESIA (tingling and numbness in her feet), PARAESTHESIA (sensation spread to her hands), HYPOAESTHESIA (sensation spread to her hands), DYSPNOEA (restrictive breathing), LYMPHADENOPATHY (enlarged lymph nodes), LYMPHADENOPATHY (lymph nodes are not as badly swollen but she thinks this is due to taking prednisone) and THROAT TIGHTNESS (throat is closed a little but not completely) outcome was unknown. Not Provided          No concomitant details were provided.  Treatment details include Prednisone.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous case was reported by an other and describes the occurrence of FEELING ABNORMAL (Really just not feeling good) in a male 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) (Intramuscular) 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. On an unknown date, the patient experienced FEELING ABNORMAL (Really just not feeling good). At the time of the report, FEELING ABNORMAL (Really just not feeling good) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.