chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Sensitive skin, Swelling
Clinical narrative: burning sensation; Sensitive skin; swelling; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation), SENSITIVE SKIN (Sensitive skin) and SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.   On 02-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 BURNING SENSATION (burning sensation), SENSITIVE SKIN (Sensitive skin) and SWELLING (swelling). At the time of the report, BURNING SENSATION (burning sensation), SENSITIVE SKIN (Sensitive skin) and SWELLING (swelling) outcome was unknown.            Treatment information was not provided.  Upon in internal review on 21 May 2021, the age was corrected to an unknown age
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Depression, Pain in extremity
Clinical narrative: arm was really sore; depression is really bad today; stomach was slightly messed up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore), ABDOMINAL DISCOMFORT (stomach was slightly messed up) and DEPRESSION (depression is really bad today) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL DISCOMFORT (stomach was slightly messed up). On 07-Apr-2021, the patient experienced DEPRESSION (depression is really bad today). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was really sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm was really sore), ABDOMINAL DISCOMFORT (stomach was slightly messed up) and DEPRESSION (depression is really bad today) outcome was unknown.            Concomitant medication included rixalti, deplan, celexa and a thyroid medication. Treatment medication included Advil.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulders) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulders). At the time of the report, ARTHRALGIA (Sore shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-069622, MOD-2021-069962, MOD-2021-069954 (Patient Link).   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Exposure during pregnancy, Fatigue, Poor quality sleep, Vaccination site pain
Clinical narrative: couldn't sleep; Tired; Pregnant; Sore arm; Stomach crumps; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), VACCINATION SITE PAIN (Sore arm), ABDOMINAL PAIN UPPER (Stomach crumps), POOR QUALITY SLEEP (couldn't sleep) and FATIGUE (Tired) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FISH OIL (OMEGA 3 FISH OILS), PROBIOTICS NOS, COLECALCIFEROL, MENAQUINONE-7 (VITAMIN D3 K2) and LECITHIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-Feb-2021 and the estimated date of delivery was 24-Nov-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant), VACCINATION SITE PAIN (Sore arm) and ABDOMINAL PAIN UPPER (Stomach crumps). On 01-Apr-2021, the patient experienced POOR QUALITY SLEEP (couldn't sleep) and FATIGUE (Tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 06-Mar-2021, VACCINATION SITE PAIN (Sore arm) had resolved. On 03-Apr-2021, POOR QUALITY SLEEP (couldn't sleep) and FATIGUE (Tired) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach crumps) had resolved. Unknown
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Outbreak of the hives; Itchy; Rash lasted for over 3 months and started on the day of her first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Outbreak of the hives), PRURITUS (Itchy) and RASH (Rash lasted for over 3 months and started on the day of her first vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced URTICARIA (Outbreak of the hives), PRURITUS (Itchy) and RASH (Rash lasted for over 3 months and started on the day of her first vaccine). The patient was treated with PREDNISONE ongoing since an unknown date for Hives, at a dose of UNK dosage form and CORTISONE for Rash, at a dose of UNK dosage form. On 15-May-2021, PRURITUS (Itchy) and RASH (Rash lasted for over 3 months and started on the day of her first vaccine) had resolved. At the time of the report, URTICARIA (Outbreak of the hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-069975 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Added rash as an event, treatment drug and narrative were updated. Event outcome updated.; Sender's Comments:  MOD-2021-069975:Second dose
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Nausea
Clinical narrative: Sore throat; Fatigue; Headache; Chills; Nausea; Lymph nodes swollen; Injection site pain, swelling, redness; Injection site pain, swelling, redness; Injection site pain, swelling, redness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE PAIN (Injection site pain, swelling, redness), VACCINATION SITE SWELLING (Injection site pain, swelling, redness) and VACCINATION SITE ERYTHEMA (Injection site pain, swelling, redness). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE PAIN (Injection site pain, swelling, redness), VACCINATION SITE SWELLING (Injection site pain, swelling, redness) and VACCINATION SITE ERYTHEMA (Injection site pain, swelling, redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Sore throat; Fatigue; Headache; Chills; Nausea; Lymph nodes swollen; Injection site pain, swelling, redness; Injection site pain, swelling, redness; Injection site pain, swelling, redness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE PAIN (Injection site pain, swelling, redness), VACCINATION SITE SWELLING (Injection site pain, swelling, redness) and VACCINATION SITE ERYTHEMA (Injection site pain, swelling, redness). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE PAIN (Injection site pain, swelling, redness), VACCINATION SITE SWELLING (Injection site pain, swelling, redness) and VACCINATION SITE ERYTHEMA (Injection site pain, swelling, redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Polyuria
Clinical narrative: Urinated lot of times; This spontaneous case was reported by a consumer and describes the occurrence of POLYURIA (Urinated lot of times) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POLYURIA (Urinated lot of times). At the time of the report, POLYURIA (Urinated lot of times) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-069954, MOD-2021-069622 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is real sore/Can not lift and hold arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY outcome was unknown. Not Provided.          Treatment details includes Biofreeze, Heating Pad, Trying exercise it. No concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Pruritus, Vaccination site mass
Clinical narrative: Pain from arm; Pain from wrist, body aches; Bumps on arm; Itching; Pain on injection site; Pain from elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain from arm), PAIN (Pain from wrist, body aches), VACCINATION SITE MASS (Bumps on arm), PRURITUS (Itching) and VACCINATION SITE PAIN (Pain on injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (Medical history reported as rheumatoid arthritis). Concomitant products included INFLIXIMAB (REMICADE) for Rheumatoid arthritis.   On 08-Mar-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 PAIN IN EXTREMITY (Pain from arm), PAIN (Pain from wrist, body aches), VACCINATION SITE MASS (Bumps on arm), PRURITUS (Itching), VACCINATION SITE PAIN (Pain on injection site) and ARTHRALGIA (Pain from elbow). At the time of the report, PAIN IN EXTREMITY (Pain from arm), PAIN (Pain from wrist, body aches), VACCINATION SITE MASS (Bumps on arm), PRURITUS (Itching), VACCINATION SITE PAIN (Pain on injection site) and ARTHRALGIA (Pain from elbow) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information included prednisone.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain from arm; Pain from wrist, body aches; Bumps on arm; Itching; Pain on injection site; Pain from elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain from arm), PAIN (Pain from wrist, body aches), VACCINATION SITE MASS (Bumps on arm), PRURITUS (Itching) and VACCINATION SITE PAIN (Pain on injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (Medical history reported as rheumatoid arthritis). Concomitant products included INFLIXIMAB (REMICADE) for Rheumatoid arthritis.   On 08-Mar-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 PAIN IN EXTREMITY (Pain from arm), PAIN (Pain from wrist, body aches), VACCINATION SITE MASS (Bumps on arm), PRURITUS (Itching), VACCINATION SITE PAIN (Pain on injection site) and ARTHRALGIA (Pain from elbow). At the time of the report, PAIN IN EXTREMITY (Pain from arm), PAIN (Pain from wrist, body aches), VACCINATION SITE MASS (Bumps on arm), PRURITUS (Itching), VACCINATION SITE PAIN (Pain on injection site) and ARTHRALGIA (Pain from elbow) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information included prednisone.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Supraventricular extrasystoles
Clinical narrative: Severe case of palpitations; Premature atrial contractions; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Severe case of palpitations) and SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contractions) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Severe case of palpitations) and SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contractions). At the time of the report, PALPITATIONS (Severe case of palpitations) and SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contractions) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. No concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Additional information received on 17-May-2021 has no new information. On 16-Jul-2021: ADR Form attached.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Pain
Clinical narrative: more side effect; She is been in a circle of pain and not getting better; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (more side effect) and PAIN (She is been in a circle of pain and not getting better) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Autoimmune disorder. Concomitant products included METHOTREXATE SODIUM (METHOTREXATE [METHOTREXATE SODIUM]) for RA.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-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 ADVERSE DRUG REACTION (more side effect) and PAIN (She is been in a circle of pain and not getting better). At the time of the report, ADVERSE DRUG REACTION (more side effect) and PAIN (She is been in a circle of pain and not getting better) was resolving. Not Provided          Concomitant medication include methotrexate for RA (stopped 5 days before the vaccination)and blood pressure medicine, No treatment medication reported. The patient reported that she restarted the rheumatoid arthritis medications again. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow- up information received on 17 May 2021. Events outcome were updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in arm of vaccine, still ongoing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm of vaccine, still ongoing) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm of vaccine, still ongoing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain in arm of vaccine, still ongoing) had not resolved.      Action taken with mRNA-1273 in response to the events was not applicable     No concomitant medications provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling of relaxation, Neck pain, Pain
Clinical narrative: pain in the waist; must lie down; back pain; neck pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (pain in the waist) and FEELING OF RELAXATION (must lie down) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced NECK PAIN (neck pain). On 06-Apr-2021, the patient experienced BACK PAIN (back pain). On 07-Apr-2021, the patient experienced PAIN (pain in the waist) and FEELING OF RELAXATION (must lie down). On 06-Apr-2021, NECK PAIN (neck pain) had resolved. On 07-Apr-2021, BACK PAIN (back pain) had resolved. At the time of the report, PAIN (pain in the waist) and FEELING OF RELAXATION (must lie down) outcome was unknown. Not Provided          Treatment include Tylenol. Concomitant product include cholesterol medication, high blood pressure medication.
Sex: M
Vaccine: COVID19
Symptoms: Hepatic lesion, Liver function test increased
Clinical narrative: liver lesions; This spontaneous case was reported by a physician and describes the occurrence of HEPATIC LESION (liver lesions) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC LESION (liver lesions). At the time of the report, HEPATIC LESION (liver lesions) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test increased: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin exfoliation
Clinical narrative: Scaly hands/Rough hands/ Dry hands; rash on inside of fingers of both hands, rash on both palm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Scaly hands/Rough hands/ Dry hands) and RASH (rash on inside of fingers of both hands, rash on both palm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced RASH (rash on inside of fingers of both hands, rash on both palm). On 10-Mar-2021, the patient experienced SKIN EXFOLIATION (Scaly hands/Rough hands/ Dry hands). The patient was treated with WHITE SOFT PARAFFIN (AQUAPHOR [WHITE SOFT PARAFFIN]) at a dose of 1 dosage form; PARAFFIN (MOISTURIZER) ongoing since an unknown date at a dose of 1 dosage form and CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) at a dose of 1 dosage form. On 10-Mar-2021, RASH (rash on inside of fingers of both hands, rash on both palm) had resolved. At the time of the report, SKIN EXFOLIATION (Scaly hands/Rough hands/ Dry hands) outcome was unknown.            No concomitant medications provided.  The patient received both scheduled doses of mRNA-1273 , therefore action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received and  reporter's contact information was updated.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 01-Feb-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 01-Feb-2021, the patient experienced HEADACHE (Headache). On 02-Feb-2021, HEADACHE (Headache) had resolved. Not Provided          No concomitant medications and treatment information were reported.   This case was linked to MODERNATX, INC.-MOD-2021-069947 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-069947:1st dose case
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA, PRURITUS, and RASH in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS and RASH. On 26-Feb-2021, the patient experienced URTICARIA. The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency; BENADRYL for Hives, at a dose of UNK dosage form and TYLENOL at an unspecified dose and frequency. On 15-May-2021, PRURITUS and RASH had resolved. At the time of the report, URTICARIA had resolved.            No relevant concomitant medications were provided. Patient stated that after her 2nd shot hives returned and got worse. Patient had removed different foods from her diet thinking it could be unrelated to the vaccine.  Treatment activities for event was also done Steroids. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-069957.   Most recent FOLLOW-UP information incorporated above included on 24-May-2021: Follow-up information was received and the outcome of all events were updated to resolved.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain, Symptom recurrence
Clinical narrative: Body aches; Feels like she had COVID-19 again; Feeling of sickness; Hurting head; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), SYMPTOM RECURRENCE (Feels like she had COVID-19 again), MALAISE (Feeling of sickness), HEADACHE (Hurting head) and CHILLS (Cold chills) 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 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 experienced PAIN (Body aches), SYMPTOM RECURRENCE (Feels like she had COVID-19 again), MALAISE (Feeling of sickness), HEADACHE (Hurting head) and CHILLS (Cold chills). At the time of the report, PAIN (Body aches), SYMPTOM RECURRENCE (Feels like she had COVID-19 again), MALAISE (Feeling of sickness), HEADACHE (Hurting head) and CHILLS (Cold chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: TCR received on 6-Aug-2021 contains updated outcome of events and patient details (gender and initials).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at the injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site). At the time of the report, VACCINATION SITE PAIN (tenderness at the injection site) outcome was unknown. Not Provided          Patient stated that she was taking medicines for Arthritis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Fatigue; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included LEUCOVORIN CALCIUM for an unknown indication.    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 PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body pain) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Vaccination site pain
Clinical narrative: Numbness on the entire right side of his body when he lies on it; Pain on the arm of the injection site; soreness at the injection site,; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on the entire right side of his body when he lies on it), PAIN IN EXTREMITY (Pain on the arm of the injection site) and VACCINATION SITE PAIN (soreness at the injection site,) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 IN EXTREMITY (Pain on the arm of the injection site) and VACCINATION SITE PAIN (soreness at the injection site,). On 10-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness on the entire right side of his body when he lies on it). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HYPOAESTHESIA (Numbness on the entire right side of his body when he lies on it), PAIN IN EXTREMITY (Pain on the arm of the injection site) and VACCINATION SITE PAIN (soreness at the injection site,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant product was reported
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Chest discomfort, Dyspepsia, Heart rate
Clinical narrative: Heart started to pound very rapidly; Heartburn; Felt sick; Tightness in chest; I didnt feel well for a good 3 days and then slowly started to come around; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart started to pound very rapidly), DYSPEPSIA (Heartburn), ILLNESS (Felt sick), CHEST DISCOMFORT (Tightness in chest) and ASTHENIA (I didnt feel well for a good 3 days and then slowly started to come around) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes since 2000, High cholesterol since 1990, Pernicious anaemia and Depression since 1980. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, OMEPRAZOLE for Esophageal reflux, CYANOCOBALAMIN (VIT B12) for Pernicious anaemia, ASPIRIN [ACETYLSALICYLIC ACID] for Pseudoaneurysm.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PALPITATIONS (Heart started to pound very rapidly), DYSPEPSIA (Heartburn), CHEST DISCOMFORT (Tightness in chest) and ASTHENIA (I didnt feel well for a good 3 days and then slowly started to come around). 01-Apr-2021, the patient experienced ILLNESS (Felt sick). On 02-Apr-2021, PALPITATIONS (Heart started to pound very rapidly), DYSPEPSIA (Heartburn) and CHEST DISCOMFORT (Tightness in chest) had resolved. At the time of the report, ILLNESS (Felt sick) outcome was unknown and ASTHENIA (I didnt feel well for a good 3 days and then slowly started to come around) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood pressure measurement: 140/84 (High) High systolic BP 140/84 mmHg at 8 pm, 160/90 (High) High systolic BP 160/90 mmHg at 10 pm and 160/94 (High) High systolic BP 160/94 mmHg at 12 mid. On 01-Apr-2021, Heart rate: 160 (High) His pulse was elevated for about 4 hours 160 beats per minute at 8 pm, 170 (High) His pulse was elevated for about 4 hours 170 beats per minute at 10 pm and 170 (High) His pulse was elevated for about 4 hours 170 beats per minute at 12mid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-069951 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Patient demographics updated. Medical History added. Lab data added. Concomitant medications added. Events (Chest discomfort, asthenia) added. Events outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069951:Wife case
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Palpitations
Clinical narrative: Heart started to pound very rapidly; Heartburn; Felt sick; Tightness in chest; I didnt feel well for a good 3 days and then slowly started to come around; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart started to pound very rapidly), DYSPEPSIA (Heartburn), ILLNESS (Felt sick), CHEST DISCOMFORT (Tightness in chest) and ASTHENIA (I didnt feel well for a good 3 days and then slowly started to come around) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes since 2000, High cholesterol since 1990, Pernicious anaemia and Depression since 1980. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, OMEPRAZOLE for Esophageal reflux, CYANOCOBALAMIN (VIT B12) for Pernicious anaemia, ASPIRIN [ACETYLSALICYLIC ACID] for Pseudoaneurysm.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PALPITATIONS (Heart started to pound very rapidly), DYSPEPSIA (Heartburn), CHEST DISCOMFORT (Tightness in chest) and ASTHENIA (I didnt feel well for a good 3 days and then slowly started to come around). 01-Apr-2021, the patient experienced ILLNESS (Felt sick). On 02-Apr-2021, PALPITATIONS (Heart started to pound very rapidly), DYSPEPSIA (Heartburn) and CHEST DISCOMFORT (Tightness in chest) had resolved. At the time of the report, ILLNESS (Felt sick) outcome was unknown and ASTHENIA (I didnt feel well for a good 3 days and then slowly started to come around) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood pressure measurement: 140/84 (High) High systolic BP 140/84 mmHg at 8 pm, 160/90 (High) High systolic BP 160/90 mmHg at 10 pm and 160/94 (High) High systolic BP 160/94 mmHg at 12 mid. On 01-Apr-2021, Heart rate: 160 (High) His pulse was elevated for about 4 hours 160 beats per minute at 8 pm, 170 (High) His pulse was elevated for about 4 hours 170 beats per minute at 10 pm and 170 (High) His pulse was elevated for about 4 hours 170 beats per minute at 12mid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-069951 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Patient demographics updated. Medical History added. Lab data added. Concomitant medications added. Events (Chest discomfort, asthenia) added. Events outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069951:Wife case
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: sore arm; headache; vomiting; Red arm; Itchy arm; Arm very swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PRURITUS (Itchy arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Historical  condition not reported.). Concomitant products included MULTIVITAMINS [VITAMINS NOS] and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Arm very swollen). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and VOMITING (vomiting). At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown and VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Arm very swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: sore arm; headache; vomiting; Red arm; Itchy arm; Arm very swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PRURITUS (Itchy arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Historical  condition not reported.). Concomitant products included MULTIVITAMINS [VITAMINS NOS] and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Arm very swollen). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and VOMITING (vomiting). At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown and VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Arm very swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Same complaint after the cortisone injection; got the COVID vaccine and pain was back again; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Same complaint after the cortisone injection; got the COVID vaccine and pain was back again) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Same complaint after the cortisone injection; got the COVID vaccine and pain was back again). At the time of the report, PAIN (Same complaint after the cortisone injection; got the COVID vaccine and pain was back again) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm was swollen for three days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen for three days after the first dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen for three days after the first dose). At the time of the report, PERIPHERAL SWELLING (Arm was swollen for three days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Description: The patient reported that her arm was swollen for three days after the first dose. Just touching it really hurt.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-075015 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: tiredness; achiness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) and MYALGIA (achiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001B21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included BENZOCAINE (TOPICALE [BENZOCAINE]) for Dental treatment.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (tiredness) and MYALGIA (achiness). On 15-Feb-2021, FATIGUE (tiredness) and MYALGIA (achiness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.     This case was linked to MOD-2021-070004 (E2B Linked Report).; Sender's Comments:  MOD-2021-070004:case for second dose
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Nausea, Paraesthesia
Clinical narrative: tingling in arms and legs; has been getting worse ever since 1st dose; Patient has been having extreme fatigue that started after receiving 1st dose; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in arms and legs), CONDITION AGGRAVATED (has been getting worse ever since 1st dose), FATIGUE (Patient has been having extreme fatigue that started after receiving 1st dose), NAUSEA (nausea) and HEADACHE (headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, 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 experienced PARAESTHESIA (tingling in arms and legs), CONDITION AGGRAVATED (has been getting worse ever since 1st dose), FATIGUE (Patient has been having extreme fatigue that started after receiving 1st dose), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with LORAZEPAM (ATIVAN) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling in arms and legs), CONDITION AGGRAVATED (has been getting worse ever since 1st dose), FATIGUE (Patient has been having extreme fatigue that started after receiving 1st dose), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Treatment also include steroids. Upon internal review on 4-Aug-21, the age was corrected to 35 years