chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Paraesthesia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: vaccination site swelling; Vaccination site erythema; Had flu like symptoms; Tingling in one arm for several days, then tingling in other arm and recently in legs above the knee, upper thigh; Very bothersome and annoying; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Had flu like symptoms), PARAESTHESIA (Tingling in one arm for several days, then tingling in other arm and recently in legs above the knee, upper thigh), FEELING ABNORMAL (Very bothersome and annoying), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant medication information not provided.  Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) and SIMVASTATIN for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Had flu like symptoms), PARAESTHESIA (Tingling in one arm for several days, then tingling in other arm and recently in legs above the knee, upper thigh) and FEELING ABNORMAL (Very bothersome and annoying). On an unknown date, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Had flu like symptoms), PARAESTHESIA (Tingling in one arm for several days, then tingling in other arm and recently in legs above the knee, upper thigh), FEELING ABNORMAL (Very bothersome and annoying), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-071105 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over her body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over her body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-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 08-Apr-2021, the patient experienced URTICARIA (hives all over her body). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at a dose of UNK dosage form. At the time of the report, URTICARIA (hives all over her body) outcome was unknown.            Please note, there is no evidence that the patient took Medrol, she was advised again using steroid by her physician friend.  The Concomitant medications were not provided.; 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Vaccination site pain
Clinical narrative: Dry cough that continues; Fatigue for a week; Has a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Has a sore arm), FATIGUE (Fatigue for a week) and COUGH (Dry cough that continues) in a 58-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 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Has a sore arm). On 03-Apr-2021, the patient experienced FATIGUE (Fatigue for a week). On 08-Apr-2021, the patient experienced COUGH (Dry cough that continues). At the time of the report, VACCINATION SITE PAIN (Has a sore arm), FATIGUE (Fatigue for a week) and COUGH (Dry cough that continues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications provided. No Treatment History was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Insomnia, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Keeps awake at night; Progressing down arm; Injection site hot; Injection site is itchy; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Keeps awake at night), CONDITION AGGRAVATED (Progressing down arm), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031321V) 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 02-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site swollen). On an unknown date, the patient experienced INSOMNIA (Keeps awake at night) and CONDITION AGGRAVATED (Progressing down arm). At the time of the report, INSOMNIA (Keeps awake at night), CONDITION AGGRAVATED (Progressing down arm), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache
Clinical narrative: Dizziness; Mild headache; Loss of energy; Felt drained; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Loss of energy), FEELING ABNORMAL (Felt drained), DIZZINESS (Dizziness) and HEADACHE (Mild headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ASTHENIA (Loss of energy), FEELING ABNORMAL (Felt drained) and HEADACHE (Mild headache). On 27-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, ASTHENIA (Loss of energy), FEELING ABNORMAL (Felt drained), DIZZINESS (Dizziness) and HEADACHE (Mild headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided. Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03AK26A) for COVID-19 vaccination. The patient's past medical history included Dry eyes (She previously has had dry eyes in past). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. Not Provided. Relevant concomitant medications were not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event/s was not applicable. This case was linked to MOD-2021-071131.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: When it was administered, its content was very little compared to those of her colleagues; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (When it was administered, its content was very little compared to those of her colleagues) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (When it was administered, its content was very little compared to those of her colleagues). On 01-Apr-2021, ACCIDENTAL UNDERDOSE (When it was administered, its content was very little compared to those of her colleagues) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient thought that it was not completely complete dose.  Treatment information was not provided.; Sender's Comments: This report refers to a case of Accidental Underdose for mRNA-1273 (Lot #: 007B21A)  with no associated AEs.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, 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 medications provided. Treatment information mentioned Tylenol.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Insomnia, Neck pain, Pain in extremity
Clinical narrative: Unable to sleep; Headache; Sore shoulder; Sore neck; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Sore neck), PAIN IN EXTREMITY (Sore arm), INSOMNIA (Unable to sleep), ARTHRALGIA (Sore shoulder) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 030L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure management, OMEPRAZOLE for Heartburn.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced NECK PAIN (Sore neck). 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 22-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder). On 24-Feb-2021, the patient experienced INSOMNIA (Unable to sleep) and HEADACHE (Headache). The patient was treated with Physical therapy for Neck pain; Physical therapy for Pain in extremity and Physical therapy for Arthralgia. At the time of the report, NECK PAIN (Sore neck), INSOMNIA (Unable to sleep), ARTHRALGIA (Sore shoulder) and HEADACHE (Headache) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            patient went to emergency room and left after few hours after receiving muscle relaxant.patient was also prescribed with medications for sleep and pain but do not work effectively. patient had lab work MRI and X-ray done. On 26 Feb 2021, patient went to doctor and the doctor gave another muscle relaxer.  .   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Received follow-up updated patient demographics, anatomical location, concomitant medications, new events have been updated
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Hypoaesthesia
Clinical narrative: Tingling sensation on the left arm; Numbness on the left arm; Pain from shoulder to the fingers on the left side; Dizziness; About to throw up; Chills; Fever; Headache; Weakness; Stiffness in the neck; Stiffness in the shoulder; Stiffness in the back; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MUSCULOSKELETAL STIFFNESS (Stiffness in the neck), MUSCULOSKELETAL STIFFNESS (Stiffness in the shoulder), MUSCULOSKELETAL STIFFNESS (Stiffness in the back) and PARAESTHESIA (Tingling sensation on the left arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A. and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ASTHENIA (Weakness), MUSCULOSKELETAL STIFFNESS (Stiffness in the neck), MUSCULOSKELETAL STIFFNESS (Stiffness in the shoulder), MUSCULOSKELETAL STIFFNESS (Stiffness in the back), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness). 08-Apr-2021, the patient experienced VOMITING (About to throw up). On 09-Apr-2021, the patient experienced PARAESTHESIA (Tingling sensation on the left arm). 09-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness on the left arm) and PAIN IN EXTREMITY (Pain from shoulder to the fingers on the left side). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, ASTHENIA (Weakness), MUSCULOSKELETAL STIFFNESS (Stiffness in the neck), MUSCULOSKELETAL STIFFNESS (Stiffness in the shoulder), MUSCULOSKELETAL STIFFNESS (Stiffness in the back), PARAESTHESIA (Tingling sensation on the left arm), HYPOAESTHESIA (Numbness on the left arm), PAIN IN EXTREMITY (Pain from shoulder to the fingers on the left side), DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (About to throw up) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 12-APR-2021 contains Treatment medications Tylenol and Advil were added. Events were updated. On 30-Jun-2021: Follow-up received on 30-JUN-2021 contains No New Information.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Tingling sensation on the left arm; Numbness on the left arm; Pain from shoulder to the fingers on the left side; Dizziness; About to throw up; Chills; Fever; Headache; Weakness; Stiffness in the neck; Stiffness in the shoulder; Stiffness in the back; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MUSCULOSKELETAL STIFFNESS (Stiffness in the neck), MUSCULOSKELETAL STIFFNESS (Stiffness in the shoulder), MUSCULOSKELETAL STIFFNESS (Stiffness in the back) and PARAESTHESIA (Tingling sensation on the left arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A. and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ASTHENIA (Weakness), MUSCULOSKELETAL STIFFNESS (Stiffness in the neck), MUSCULOSKELETAL STIFFNESS (Stiffness in the shoulder), MUSCULOSKELETAL STIFFNESS (Stiffness in the back), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness). 08-Apr-2021, the patient experienced VOMITING (About to throw up). On 09-Apr-2021, the patient experienced PARAESTHESIA (Tingling sensation on the left arm). 09-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness on the left arm) and PAIN IN EXTREMITY (Pain from shoulder to the fingers on the left side). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, ASTHENIA (Weakness), MUSCULOSKELETAL STIFFNESS (Stiffness in the neck), MUSCULOSKELETAL STIFFNESS (Stiffness in the shoulder), MUSCULOSKELETAL STIFFNESS (Stiffness in the back), PARAESTHESIA (Tingling sensation on the left arm), HYPOAESTHESIA (Numbness on the left arm), PAIN IN EXTREMITY (Pain from shoulder to the fingers on the left side), DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (About to throw up) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 12-APR-2021 contains Treatment medications Tylenol and Advil were added. Events were updated. On 30-Jun-2021: Follow-up received on 30-JUN-2021 contains No New Information.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nodule, Pain, Pruritus, Urticaria
Clinical narrative: bumps on his arms; itching; hives on both arms; bad headache; severe body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives on both arms), HEADACHE (bad headache), PAIN (severe body aches), PRURITUS (itching) and NODULE (bumps on his arms) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE (GENVOYA [COBICISTAT;ELVITEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE]) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (bad headache) and PAIN (severe body aches). On 31-Mar-2021, the patient experienced URTICARIA (hives on both arms) and PRURITUS (itching). On 08-Apr-2021, the patient experienced NODULE (bumps on his arms). On 03-Apr-2021, HEADACHE (bad headache) and PAIN (severe body aches) had resolved, PRURITUS (itching) outcome was unknown. At the time of the report, URTICARIA (hives on both arms) and NODULE (bumps on his arms) outcome was unknown. Not Provided          Treatment medication provided were Clobetasol propionate which helped with the itching caused by the hives  The patient is on immunosuppressive therapy.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 22-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 027B21A) for COVID-19 vaccination.     The patient's past medical history included Abortion (Induced abortion in 2015). Concomitant products included DIFENIDOL HYDROCHLORIDE (DIPHENIDOL [DIFENIDOL HYDROCHLORIDE]), DOXYLAMINE SUCCINATE;PYRIDOXINE and OMEPRAZOLE for Nausea, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 01-Feb-2021 to an unknown date for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-Aug-2021. On 10-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 08-Apr-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Fatigue, Laziness
Clinical narrative: feel like her energy load was down; exhausted; immediate boom on her chest/heart like nothing she has experienced before; felt lousy after the 1st dose and hasn't bounced back from that; Med Info Agent: Return call to Safety crosslink case MOD21-072378. Updated email for contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Migraine, Vaccination complication, Vomiting
Clinical narrative: Migraine; Vomiting; Shingles/7 to 8 days after her second shot, she had her first shingles episode.; Covid arm develop in lower arm; This case was initially received via Regulatory Agency (Reference number: US-irms-MOD21-127520 ) on 08-Apr-2021. The most recent information was received on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), HERPES ZOSTER (Shingles/7 to 8 days after her second shot, she had her first shingles episode.), VACCINATION COMPLICATION (Covid arm develop in lower arm) and VOMITING (Vomiting) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A71A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (took medication though she was not taking it at that time because she' was waiting to feel better.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION COMPLICATION (Covid arm develop in lower arm). On 30-Mar-2021, the patient experienced HERPES ZOSTER (Shingles/7 to 8 days after her second shot, she had her first shingles episode.). On an unknown date, the patient experienced MIGRAINE (Migraine) and VOMITING (Vomiting). In April 2021, VACCINATION COMPLICATION (Covid arm develop in lower arm) had resolved. At the time of the report, MIGRAINE (Migraine) and VOMITING (Vomiting) outcome was unknown and HERPES ZOSTER (Shingles/7 to 8 days after her last shot, she had her last shingles episode.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug details not provided.  Treatment details not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Added patient details, medical history and event details.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Lacrimation increased, Pyrexia, Visual impairment
Clinical narrative: Fever; Constant watery eyes; Eyes hurt; Watery eyes affects vision; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Constant watery eyes), EYE PAIN (Eyes hurt), VISUAL IMPAIRMENT (Watery eyes affects vision) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 03AK26A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced LACRIMATION INCREASED (Constant watery eyes), EYE PAIN (Eyes hurt) and VISUAL IMPAIRMENT (Watery eyes affects vision). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, LACRIMATION INCREASED (Constant watery eyes), EYE PAIN (Eyes hurt), VISUAL IMPAIRMENT (Watery eyes affects vision) and PYREXIA (Fever) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment medication includes Eye Steroid (Alrex), Eye Antihistamine, Oral Antihistamine (Zyrtec).   This case was linked to MOD-2021-071120 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: follow up was received on 12-APR-2021 , event was updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness little lower that injection site looks like sunburn; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness little lower that injection site looks like sunburn) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, AMLODIPINE, GLIMEPIRIDE, LOSARTAN and ROSUVASTATIN for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness little lower that injection site looks like sunburn). At the time of the report, VACCINATION SITE ERYTHEMA (redness little lower that injection site looks like sunburn) had not resolved. Unknown    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Dardinacy (for diabetes) used as a concomitant medication.  Patient was treated by ice pack.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Asthenia, Body temperature, Chills
Clinical narrative: Flu like symptoms; My stomach feels like it has a big knot in it; I'm bloated; Fever of 101.3°F; Fatigue; Chills; Nauseated; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like symptoms), ABDOMINAL DISCOMFORT (My stomach feels like it has a big knot in it), ABDOMINAL DISTENSION (I'm bloated) and PYREXIA (Fever of 101.3°F) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (My stomach feels like it has a big knot in it), ABDOMINAL DISTENSION (I'm bloated), PYREXIA (Fever of 101.3°F), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nauseated). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was treated with ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) ongoing from 24-Mar-2021 for GERD, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever of 101.3°F), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown and ABDOMINAL DISCOMFORT (My stomach feels like it has a big knot in it), ABDOMINAL DISTENSION (I'm bloated) and NAUSEA (Nauseated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 101.3 (High) 101.3°F.         The patient took simeticone for treatment of GERD.  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Email response received on 19 Jul 2021, AE reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Flu like symptoms; My stomach feels like it has a big knot in it; I'm bloated; Fever of 101.3°F; Fatigue; Chills; Nauseated; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like symptoms), ABDOMINAL DISCOMFORT (My stomach feels like it has a big knot in it), ABDOMINAL DISTENSION (I'm bloated) and PYREXIA (Fever of 101.3°F) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (My stomach feels like it has a big knot in it), ABDOMINAL DISTENSION (I'm bloated), PYREXIA (Fever of 101.3°F), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nauseated). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was treated with ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) ongoing from 24-Mar-2021 for GERD, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever of 101.3°F), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown and ABDOMINAL DISCOMFORT (My stomach feels like it has a big knot in it), ABDOMINAL DISTENSION (I'm bloated) and NAUSEA (Nauseated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 101.3 (High) 101.3°F.         The patient took simeticone for treatment of GERD.  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Email response received on 19 Jul 2021, AE reported
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Muscle spasms, Pharyngeal swelling
Clinical narrative: This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (swelling back of throat), MUSCLE SPASMS (muscle spasm) and HEART RATE INCREASED (rise in heart rate) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swelling back of throat), MUSCLE SPASMS (muscle spasm) and HEART RATE INCREASED (rise in heart rate). At the time of the report, PHARYNGEAL SWELLING (swelling back of throat), MUSCLE SPASMS (muscle spasm) and HEART RATE INCREASED (rise in heart rate) had resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Heart rate: High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication: diphenhydramine and Steroid. Patient went to urgent care then to ER and the issue lasted 3 weeks. Patient went to a Ears mouth and throat specialist. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: No significant information was received.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: neck lymph node swelling after the 1st dose; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (neck lymph node swelling after the 1st dose) and PAIN IN EXTREMITY (sore arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chickenpox (Patient had chickenpox as a child). Previously administered products included for an unreported indication: TUBERCULOSIS VACCINES (Patient received Tb injection as a child.). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced LYMPHADENOPATHY (neck lymph node swelling after the 1st dose) and PAIN IN EXTREMITY (sore arm). At the time of the report, LYMPHADENOPATHY (neck lymph node swelling after the 1st dose) had resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided    Treatment medication included Ibuprofen. Concomitant medications were not reported.   This case was linked to MOD-2021-071156 (Patient Link).
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years of age had de vaccine administered (pediatric - special population); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age had de vaccine administered (pediatric - special population)) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age had de vaccine administered (pediatric - special population)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age had de vaccine administered (pediatric - special population)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Nausea, Oral discomfort, Oral herpes, Oral pain
Clinical narrative: HSV-1; Painful and feels like burning in mouth; Feels like burning in mouth; Nausea; cold sore in mouth, several in lips; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES SIMPLEX (HSV-1), ORAL HERPES (cold sore in mouth, several in lips), ORAL PAIN (Painful and feels like burning in mouth), ORAL DISCOMFORT (Feels like burning in mouth) and NAUSEA (Nausea) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB (HUMIRA), METOPROLOL, MACROGOL 3350 (MIRALAX), PREGABALIN (LYRICA), RABEPRAZOLE, LINACLOTIDE (LINZESS), ATORVASTATIN, DULOXETINE, ACETYLSALICYLIC ACID (ASPIRIN 81), BUPRENORPHINE HYDROCHLORIDE (BELBUCA), AZELASTINE HCL and LISINOPRIL for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ORAL HERPES (cold sore in mouth, several in lips). On an unknown date, the patient experienced HERPES SIMPLEX (HSV-1), ORAL PAIN (Painful and feels like burning in mouth), ORAL DISCOMFORT (Feels like burning in mouth) and NAUSEA (Nausea). At the time of the report, HERPES SIMPLEX (HSV-1), ORAL HERPES (cold sore in mouth, several in lips), ORAL PAIN (Painful and feels like burning in mouth), ORAL DISCOMFORT (Feels like burning in mouth) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Valacyclovir 500 mg 2 tablets everyday for 10 days
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: sore arm after receiving the first dose; weak; She also had a half a day where she felt weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after receiving the first dose), ASTHENIA (weak) and FATIGUE (She also had a half a day where she felt weak and tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (Insulin dependent). Concomitant products included INSULIN for Diabetes.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm after receiving the first dose), ASTHENIA (weak) and FATIGUE (She also had a half a day where she felt weak and tired). On 08-Mar-2021, ASTHENIA (weak) and FATIGUE (She also had a half a day where she felt weak and tired) had resolved. On 10-Mar-2021, PAIN IN EXTREMITY (sore arm after receiving the first dose) had resolved.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Hot to the touch; Hardness, redness hot to the touch; Redness hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE INDURATION (Hardness, redness hot to the touch) and VACCINATION SITE ERYTHEMA (Redness hot to the touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE INDURATION (Hardness, redness hot to the touch) and VACCINATION SITE ERYTHEMA (Redness hot to the touch). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE INDURATION (Hardness, redness hot to the touch) and VACCINATION SITE ERYTHEMA (Redness hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for three days and couldn't see any patients) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for three days and couldn't see any patients). At the time of the report, ILLNESS (Sick for three days and couldn't see any patients) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment and concomitant medication information was provided by the reporter. Reporter did not allow further contact.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore) outcome was unknown.     Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment for the event was not reported.   This case was linked to MOD-2021-071149 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of paresthesia (tingling in fingers after 1st dose), hypoesthesia (numbness in fingers after 1st dose), rash (rash on face after 1st dose), hypoesthesia (numbness on face after 1st dose) and pain (body aches after 1st dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 019B21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypoesthesia (numbness in fingers after 1st dose), rash (rash on face after 1st dose), hypoesthesia (numbness on face after 1st dose), pain (body aches after 1st dose) and hypoesthesia (arm feels numb after 1st dose). At the time of the report, paresthesia (tingling in fingers after 1st dose), hypoesthesia (numbness in fingers after 1st dose), rash (rash on face after 1st dose), hypoesthesia (numbness on face after 1st dose), pain (body aches after 1st dose) and hypoesthesia (arm feels numb after 1st dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, treatment information or list of concomitant medications.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood pressure measurement, Pain in extremity, Pruritus
Clinical narrative: Pain down back; Itchiness down back and neck; Pain in right arm and elbow; Welts on body (neck, shoulder, arm and back); Painful right shoulder blade; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Pain down back), PRURITUS (Itchiness down back and neck), PAIN IN EXTREMITY (Pain in right arm and elbow), URTICARIA (Welts on body (neck, shoulder, arm and back)) and ARTHRALGIA (Painful right shoulder blade) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031BZ1A4) for COVID-19 vaccination.     The patient's past medical history included Lung operation NOS (Lung surgery about 1 Year ago) in 2020. Concurrent medical conditions included Immune system disorder (Immune compromised).   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced BACK PAIN (Pain down back), PRURITUS (Itchiness down back and neck), PAIN IN EXTREMITY (Pain in right arm and elbow), URTICARIA (Welts on body (neck, shoulder, arm and back)) and ARTHRALGIA (Painful right shoulder blade). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, BACK PAIN (Pain down back), PRURITUS (Itchiness down back and neck), PAIN IN EXTREMITY (Pain in right arm and elbow), URTICARIA (Welts on body (neck, shoulder, arm and back)) and ARTHRALGIA (Painful right shoulder blade) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: elevated (High) Elevated.         No relevant concomitant medications were reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pain down back; Itchiness down back and neck; Pain in right arm and elbow; Welts on body (neck, shoulder, arm and back); Painful right shoulder blade; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Pain down back), PRURITUS (Itchiness down back and neck), PAIN IN EXTREMITY (Pain in right arm and elbow), URTICARIA (Welts on body (neck, shoulder, arm and back)) and ARTHRALGIA (Painful right shoulder blade) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031BZ1A4) for COVID-19 vaccination.     The patient's past medical history included Lung operation NOS (Lung surgery about 1 Year ago) in 2020. Concurrent medical conditions included Immune system disorder (Immune compromised).   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced BACK PAIN (Pain down back), PRURITUS (Itchiness down back and neck), PAIN IN EXTREMITY (Pain in right arm and elbow), URTICARIA (Welts on body (neck, shoulder, arm and back)) and ARTHRALGIA (Painful right shoulder blade). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, BACK PAIN (Pain down back), PRURITUS (Itchiness down back and neck), PAIN IN EXTREMITY (Pain in right arm and elbow), URTICARIA (Welts on body (neck, shoulder, arm and back)) and ARTHRALGIA (Painful right shoulder blade) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: elevated (High) Elevated.         No relevant concomitant medications were reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.