chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ILLNESS (sick) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   In September 2020, the patient started TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) at an unspecified dose. 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). At the time of the report, ILLNESS (sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash erythematous
Clinical narrative: red rash; itchy; warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), PRURITUS (itchy) and FEELING HOT (warm to touch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included TOCILIZUMAB (ACTEMRA) for Immunodeficiency.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash), PRURITUS (itchy) and FEELING HOT (warm to touch). The patient was treated with PARACETAMOL (TYNELOL) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red rash), PRURITUS (itchy) and FEELING HOT (warm to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up information received and contains significant information. outcome of the events red rash, itchy, warm to touch was updated from unknown to Recovered/ resolved and declined further follow-up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: chest pressure; shortness of breath; Dizziness; Rapid heartbeat; headache; nausea; extreme dizziness; hives; rapid heartbeat; chest pressure; shortness of breath; sweating; throat tightness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness), URTICARIA (hives), PALPITATIONS (rapid heartbeat), the first episode of CHEST DISCOMFORT (chest pressure) and the first episode of DYSPNOEA (shortness of breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (extreme dizziness), URTICARIA (hives), PALPITATIONS (rapid heartbeat), the first episode of CHEST DISCOMFORT (chest pressure), the first episode of DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweating), THROAT TIGHTNESS (throat tightness), HEADACHE (headache) and NAUSEA (nausea). On 11-Mar-2021, the patient experienced the second episode of CHEST DISCOMFORT (chest pressure), the second episode of DYSPNOEA (shortness of breath), DIZZINESS (Dizziness) and PALPITATIONS (Rapid heartbeat). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. On 10-Mar-2021, DIZZINESS (extreme dizziness), PALPITATIONS (rapid heartbeat), HYPERHIDROSIS (sweating), THROAT TIGHTNESS (throat tightness), HEADACHE (headache) and NAUSEA (nausea) had resolved. On 11-Mar-2021, last episode of CHEST DISCOMFORT (chest pressure), the last episode of DYSPNOEA (shortness of breath), DIZZINESS (Dizziness) and PALPITATIONS (Rapid heartbeat) had resolved. At the time of the report, URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Throat tightness, Urticaria
Clinical narrative: chest pressure; shortness of breath; Dizziness; Rapid heartbeat; headache; nausea; extreme dizziness; hives; rapid heartbeat; chest pressure; shortness of breath; sweating; throat tightness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness), URTICARIA (hives), PALPITATIONS (rapid heartbeat), the first episode of CHEST DISCOMFORT (chest pressure) and the first episode of DYSPNOEA (shortness of breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (extreme dizziness), URTICARIA (hives), PALPITATIONS (rapid heartbeat), the first episode of CHEST DISCOMFORT (chest pressure), the first episode of DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweating), THROAT TIGHTNESS (throat tightness), HEADACHE (headache) and NAUSEA (nausea). On 11-Mar-2021, the patient experienced the second episode of CHEST DISCOMFORT (chest pressure), the second episode of DYSPNOEA (shortness of breath), DIZZINESS (Dizziness) and PALPITATIONS (Rapid heartbeat). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. On 10-Mar-2021, DIZZINESS (extreme dizziness), PALPITATIONS (rapid heartbeat), HYPERHIDROSIS (sweating), THROAT TIGHTNESS (throat tightness), HEADACHE (headache) and NAUSEA (nausea) had resolved. On 11-Mar-2021, last episode of CHEST DISCOMFORT (chest pressure), the last episode of DYSPNOEA (shortness of breath), DIZZINESS (Dizziness) and PALPITATIONS (Rapid heartbeat) had resolved. At the time of the report, URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore in injection site // first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore in injection site // first dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ROSUVASTATIN and ORPHENADRINE CITRATE, PARACETAMOL (ANAREX [ORPHENADRINE CITRATE;PARACETAMOL]) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore in injection site // first dose). At the time of the report, VACCINATION SITE PAIN (sore in injection site // first dose) had not resolved.             No treatment medications provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD21-027282 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Limb injury, Peripheral swelling, Pyrexia
Clinical narrative: very tired; no appetite yesterday; Fever; ARM WAS LITTLE SWOLLEN; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (very tired), DECREASED APPETITE (no appetite yesterday), LIMB INJURY (SORE ARM) and PERIPHERAL SWELLING (ARM WAS LITTLE SWOLLEN) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and LATANOPROST for an unknown indication.   On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 14-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 14-Feb-2021, the patient experienced LIMB INJURY (SORE ARM). On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (ARM WAS LITTLE SWOLLEN). On 15-Mar-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced FATIGUE (very tired) and DECREASED APPETITE (no appetite yesterday). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), FATIGUE (very tired), DECREASED APPETITE (no appetite yesterday), LIMB INJURY (SORE ARM) and PERIPHERAL SWELLING (ARM WAS LITTLE SWOLLEN) outcome was unknown. Not Provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Rash, Skin swelling, Vaccination complication
Clinical narrative: same side effects as the first dose came back; developed a skin rash that was swollen; developed a skin rash that was swollen; fever of 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (same side effects as the first dose came back), SKIN SWELLING (developed a skin rash that was swollen), RASH (developed a skin rash that was swollen) and PYREXIA (fever of 99 degrees) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.    On 04-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) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION COMPLICATION (same side effects as the first dose came back), SKIN SWELLING (developed a skin rash that was swollen), RASH (developed a skin rash that was swollen) and PYREXIA (fever of 99 degrees). At the time of the report, VACCINATION COMPLICATION (same side effects as the first dose came back), SKIN SWELLING (developed a skin rash that was swollen), RASH (developed a skin rash that was swollen) and PYREXIA (fever of 99 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 99 f (High) had a fever of 99 degrees.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bowel movement irregularity, Constipation
Clinical narrative: Some effects on her GI; Bowel movement was different; constipation; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Some effects on her GI), BOWEL MOVEMENT IRREGULARITY (Bowel movement was different) and CONSTIPATION (constipation) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE (LIBRAX [CHLORDIAZEPOXIDE HYDROCHLORIDE;CLIDINIUM BROMIDE]), OMEPRAZOLE, VORTIOXETINE HYDROBROMIDE (TRINTELLIX), DIAZEPAM (VALIUM), METOPROLOL TARTRATE, OLMESARTAN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PARACETAMOL (TYLENOL), MINERALS NOS, VITAMINS NOS (CENTRUM PLUS), ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), VITAMIN E NOS (VITAMIN E [VITAMIN E NOS]) and ESTRADIOL (ESTROGEN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Some effects on her GI), BOWEL MOVEMENT IRREGULARITY (Bowel movement was different) and CONSTIPATION (constipation). At the time of the report, ABDOMINAL DISCOMFORT (Some effects on her GI), BOWEL MOVEMENT IRREGULARITY (Bowel movement was different) and CONSTIPATION (constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-047088 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: Non significant follow up. Patient demographic details added
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Musculoskeletal stiffness
Clinical narrative: Balance issues; weakness; stiffness; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Balance issues), ASTHENIA (weakness), MUSCULOSKELETAL STIFFNESS (stiffness) and DIZZINESS (lightheadedness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 027L20A) for COVID-19 vaccination.     Concomitant products included CHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE (LIBRAX [CHLORDIAZEPOXIDE HYDROCHLORIDE;CLIDINIUM BROMIDE]), OMEPRAZOLE, VORTIOXETINE HYDROBROMIDE (TRINTELLIX), METOPROLOL TARTRATE, DIAZEPAM (VALIUM), OLMESARTAN, ESTROGENS CONJUGATED (ESTROGENON), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC), PARACETAMOL (TYLENOL), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-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 BALANCE DISORDER (Balance issues), ASTHENIA (weakness), MUSCULOSKELETAL STIFFNESS (stiffness) and DIZZINESS (lightheadedness). At the time of the report, BALANCE DISORDER (Balance issues), ASTHENIA (weakness), MUSCULOSKELETAL STIFFNESS (stiffness) and DIZZINESS (lightheadedness) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-047053 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received. Reporter address and email updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 patient received vaccine from the syringes after 6 hours of recommended time frame; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patient received vaccine from the syringes after 6 hours of recommended time frame) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown, unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patient received vaccine from the syringes after 6 hours of recommended time frame). On 13-Mar-2021, EXPIRED PRODUCT ADMINISTERED (6 patient received vaccine from the syringes after 6 hours of recommended time frame) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (DIARRHEA) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-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 DIARRHOEA (DIARRHEA). At the time of the report, DIARRHOEA (DIARRHEA) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.    This case was linked to MOD-2021-029989 (Patient Link).
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Back pain, Malaise, Vomiting
Clinical narrative: back pain; Stomach swell; out of sorts; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), ABDOMINAL DISTENSION (Stomach swell), MALAISE (out of sorts) and VOMITING (vomiting) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 BACK PAIN (back pain), ABDOMINAL DISTENSION (Stomach swell), MALAISE (out of sorts) and VOMITING (vomiting). At the time of the report, BACK PAIN (back pain), ABDOMINAL DISTENSION (Stomach swell), MALAISE (out of sorts) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Insomnia
Clinical narrative: light sensitivity; low grade headache; muscle pain; joint pain; felt very exhausted; Injection site very very red/Redness around injection site has spread to a much larger area; brain fog; did not sleep very well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), INSOMNIA (did not sleep very well), PHOTOPHOBIA (light sensitivity), HEADACHE (low grade headache) and MYALGIA (muscle pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog), INSOMNIA (did not sleep very well) and VACCINATION SITE ERYTHEMA (Injection site very very red/Redness around injection site has spread to a much larger area). On 13-Mar-2021, the patient experienced PHOTOPHOBIA (light sensitivity), HEADACHE (low grade headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (felt very exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 14-Mar-2021, FEELING ABNORMAL (brain fog), INSOMNIA (did not sleep very well), PHOTOPHOBIA (light sensitivity), HEADACHE (low grade headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (felt very exhausted) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Injection site very very red/Redness around injection site has spread to a much larger area) outcome was unknown.            No concomitant medication was reported.  Patient initially took Tylenol which did not help and later ibuprofen which made her feel better.  Action taken with mRNA-1273 with respect to events was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Photophobia, Vaccination site erythema
Clinical narrative: light sensitivity; low grade headache; muscle pain; joint pain; felt very exhausted; Injection site very very red/Redness around injection site has spread to a much larger area; brain fog; did not sleep very well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), INSOMNIA (did not sleep very well), PHOTOPHOBIA (light sensitivity), HEADACHE (low grade headache) and MYALGIA (muscle pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog), INSOMNIA (did not sleep very well) and VACCINATION SITE ERYTHEMA (Injection site very very red/Redness around injection site has spread to a much larger area). On 13-Mar-2021, the patient experienced PHOTOPHOBIA (light sensitivity), HEADACHE (low grade headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (felt very exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 14-Mar-2021, FEELING ABNORMAL (brain fog), INSOMNIA (did not sleep very well), PHOTOPHOBIA (light sensitivity), HEADACHE (low grade headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (felt very exhausted) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Injection site very very red/Redness around injection site has spread to a much larger area) outcome was unknown.            No concomitant medication was reported.  Patient initially took Tylenol which did not help and later ibuprofen which made her feel better.  Action taken with mRNA-1273 with respect to events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Erythema, Pyrexia
Clinical narrative: red marks like that on her arm, 2 by 1 streak across her arm; loss of appetite; fever of 101.3; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red marks like that on her arm, 2 by 1 streak across her arm), DECREASED APPETITE (loss of appetite) and PYREXIA (fever of 101.3) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (red marks like that on her arm, 2 by 1 streak across her arm), DECREASED APPETITE (loss of appetite) and PYREXIA (fever of 101.3). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (red marks like that on her arm, 2 by 1 streak across her arm), DECREASED APPETITE (loss of appetite) and PYREXIA (fever of 101.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 101.3 f High.         Concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-047087.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeding disorder, Illness, Nausea
Clinical narrative: Nauseous; Fatigue/ felt tired and draggy; Achy feeling like she was getting sick; Didn't want to eat; only wanted to sleep; pain in her left arm at the injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Achy feeling like she was getting sick), FEEDING DISORDER (Didn't want to eat), SOMNOLENCE (only wanted to sleep), VACCINATION SITE PAIN (pain in her left arm at the injection site) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 6 or G15M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Jan).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in her left arm at the injection site) and CHILLS (Chills). On 27-Feb-2021, the patient experienced ILLNESS (Achy feeling like she was getting sick), FEEDING DISORDER (Didn't want to eat), SOMNOLENCE (only wanted to sleep) and FATIGUE (Fatigue/ felt tired and draggy). On 28-Feb-2021, the patient experienced NAUSEA (Nauseous). On 27-Feb-2021, VACCINATION SITE PAIN (pain in her left arm at the injection site) had resolved. At the time of the report, ILLNESS (Achy feeling like she was getting sick), FEEDING DISORDER (Didn't want to eat), CHILLS (Chills) and NAUSEA (Nauseous) had resolved and SOMNOLENCE (only wanted to sleep) and FATIGUE (Fatigue/ felt tired and draggy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Nauseous; Fatigue/ felt tired and draggy; Achy feeling like she was getting sick; Didn't want to eat; only wanted to sleep; pain in her left arm at the injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Achy feeling like she was getting sick), FEEDING DISORDER (Didn't want to eat), SOMNOLENCE (only wanted to sleep), VACCINATION SITE PAIN (pain in her left arm at the injection site) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 6 or G15M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Jan).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in her left arm at the injection site) and CHILLS (Chills). On 27-Feb-2021, the patient experienced ILLNESS (Achy feeling like she was getting sick), FEEDING DISORDER (Didn't want to eat), SOMNOLENCE (only wanted to sleep) and FATIGUE (Fatigue/ felt tired and draggy). On 28-Feb-2021, the patient experienced NAUSEA (Nauseous). On 27-Feb-2021, VACCINATION SITE PAIN (pain in her left arm at the injection site) had resolved. At the time of the report, ILLNESS (Achy feeling like she was getting sick), FEEDING DISORDER (Didn't want to eat), CHILLS (Chills) and NAUSEA (Nauseous) had resolved and SOMNOLENCE (only wanted to sleep) and FATIGUE (Fatigue/ felt tired and draggy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 99.6 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were provided.   This case was linked to MOD-2021-131302 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received contains no new information regarding dose 1 of mRNA-1273.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Pyrexia
Clinical narrative: dizziness /felt lightheaded; Low grade fever; nonstop headache; typical soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (typical soreness in the arm), DIZZINESS (dizziness /felt lightheaded), PYREXIA (Low grade fever) and HEADACHE (nonstop headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (typical soreness in the arm) and HEADACHE (nonstop headache). On an unknown date, the patient experienced DIZZINESS (dizziness /felt lightheaded) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at a dose of 1 dosage form and NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (typical soreness in the arm), DIZZINESS (dizziness /felt lightheaded), PYREXIA (Low grade fever) and HEADACHE (nonstop headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up received does not contains non significant information (contact information updated)
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: flu shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WRONG PRODUCT ADMINISTERED (flu shot) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: influenza on 15-Mar-2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (flu shot). At the time of the report, WRONG PRODUCT ADMINISTERED (flu shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: TCR attached - NNI
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Inquired about administering the second dose to a patient who is 16 years old; 16 years old patient received the first dose of the Moderna vaccine/inquired about administering the second dose to a patient who was 16 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received the first dose of the Moderna vaccine/inquired about administering the second dose to a patient who was 16 years old) and OFF LABEL USE (Inquired about administering the second dose to a patient who is 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received the first dose of the Moderna vaccine/inquired about administering the second dose to a patient who was 16 years old). On 16-Mar-2021, the patient experienced OFF LABEL USE (Inquired about administering the second dose to a patient who is 16 years old). On 03-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received the first dose of the Moderna vaccine/inquired about administering the second dose to a patient who was 16 years old) had resolved. At the time of the report, OFF LABEL USE (Inquired about administering the second dose to a patient who is 16 years old) 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.   The reporter was a registered Nurse who was helping to administer vaccine in the clinic, and inquired about administering the second dose to a patient who was 16 years old and has received already the first dose of the Moderna vaccine 41 days ago, on 03-Feb-2021.  No Concomitant product use was reported. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Oxygen saturation, Vaccination site erythema, Vaccination site pain
Clinical narrative: chronic migraines few did not follow her typical migraine pattern; Itchy Injection Site; Sore Injection Site; Swollen Injection Site; Red Injection Site; Muscle Ache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (chronic migraines few did not follow her typical migraine pattern), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Chronic migraine.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and MYALGIA (Muscle Ache). On an unknown date, the patient experienced MIGRAINE (chronic migraines few did not follow her typical migraine pattern). On 15-Mar-2021, VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and MYALGIA (Muscle Ache) had resolved. At the time of the report, MIGRAINE (chronic migraines few did not follow her typical migraine pattern) outcome was unknown and VACCINATION SITE PRURITUS (Itchy Injection Site) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 90 (Low) 90 Percent.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Reporter details, Patient's medical history, lab data and event data  has been updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: chronic migraines few did not follow her typical migraine pattern; Itchy Injection Site; Sore Injection Site; Swollen Injection Site; Red Injection Site; Muscle Ache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (chronic migraines few did not follow her typical migraine pattern), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Chronic migraine.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and MYALGIA (Muscle Ache). On an unknown date, the patient experienced MIGRAINE (chronic migraines few did not follow her typical migraine pattern). On 15-Mar-2021, VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site) and MYALGIA (Muscle Ache) had resolved. At the time of the report, MIGRAINE (chronic migraines few did not follow her typical migraine pattern) outcome was unknown and VACCINATION SITE PRURITUS (Itchy Injection Site) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 90 (Low) 90 Percent.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Reporter details, Patient's medical history, lab data and event data  has been updated.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Localized inflammation; Elevated temperature of 102; Itchiness in the injection site; Swelling/ Injection site is slightly raised; Redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Localized inflammation), VACCINATION SITE PRURITUS (Itchiness in the injection site), VACCINATION SITE SWELLING (Swelling/ Injection site is slightly raised), VACCINATION SITE ERYTHEMA (Redness in the injection site) and PYREXIA (Elevated temperature of 102) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination.     The patient's past medical history included Bone marrow disorder and Chemotherapy (8 years ago). Concurrent medical conditions included Blood pressure abnormal. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness in the injection site), VACCINATION SITE SWELLING (Swelling/ Injection site is slightly raised) and VACCINATION SITE ERYTHEMA (Redness in the injection site). On an unknown date, the patient experienced INFLAMMATION (Localized inflammation) and PYREXIA (Elevated temperature of 102). The patient was treated with CORTISONE at a dose of UNK dosage form. On 23-Mar-2021, VACCINATION SITE PRURITUS (Itchiness in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) had resolved. At the time of the report, INFLAMMATION (Localized inflammation), VACCINATION SITE SWELLING (Swelling/ Injection site is slightly raised) and PYREXIA (Elevated temperature of 102) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication use included unspecified blood pressure medication. Patient stated that she has a complex history as she had chemotherapy eight years ago for a bone marrow disorder but that she sees a hematologist and oncologist and that everything was stable.   This case was linked to MOD-2021-069888 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up received included past medical history, suspect product details, concomitant medication details and outcome. On 06-Jul-2021: additional event and contact info added
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Patient was very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient was very sleepy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced SOMNOLENCE (Patient was very sleepy). At the time of the report, SOMNOLENCE (Patient was very sleepy) outcome was unknown.            No Concomitant and  treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable. .   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: TCR: nonsafety info
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hypokinesia, Insomnia, Nausea
Clinical narrative: could not move and she could not bend when she got up; she could not sleep or lay down as she normally does; Dizziness; head spinning/ vertigo; Nausea; pain in her arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo), HYPOKINESIA (could not move and she could not bend when she got up) and INSOMNIA (she could not sleep or lay down as she normally does) in a 52-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.  Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE ER) and OXCARBAMAZEPINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm) and CHILLS (Chills). On 14-Mar-2021, the patient experienced DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo) and NAUSEA (Nausea). On an unknown date, the patient experienced HYPOKINESIA (could not move and she could not bend when she got up) and INSOMNIA (she could not sleep or lay down as she normally does). At the time of the report, PAIN IN EXTREMITY (pain in her arm), DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo), HYPOKINESIA (could not move and she could not bend when she got up), INSOMNIA (she could not sleep or lay down as she normally does), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vertigo
Clinical narrative: could not move and she could not bend when she got up; she could not sleep or lay down as she normally does; Dizziness; head spinning/ vertigo; Nausea; pain in her arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo), HYPOKINESIA (could not move and she could not bend when she got up) and INSOMNIA (she could not sleep or lay down as she normally does) in a 52-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.  Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE ER) and OXCARBAMAZEPINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm) and CHILLS (Chills). On 14-Mar-2021, the patient experienced DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo) and NAUSEA (Nausea). On an unknown date, the patient experienced HYPOKINESIA (could not move and she could not bend when she got up) and INSOMNIA (she could not sleep or lay down as she normally does). At the time of the report, PAIN IN EXTREMITY (pain in her arm), DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo), HYPOKINESIA (could not move and she could not bend when she got up), INSOMNIA (she could not sleep or lay down as she normally does), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.