chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: its positive effect and it would be great if this vaccine works for IBS people; started feeling better; I thought I would be very sick after vaccine; my bloating went away for 2 to 3 days; my diarrhea went away for 2 to 3 days; my stomach pain went away for 2 to 3 days; My IBS problem completely gone for 2 and 3 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling better), ILLNESS (I thought I would be very sick after vaccine), ABDOMINAL DISTENSION (my bloating went away for 2 to 3 days), DIARRHEA (my diarrhea went away for 2 to 3 days) and ABDOMINAL PAIN UPPER (my stomach pain went away for 2 to 3 days) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome and Hysterectomy (I had hysterectomy couple of years ago). Concomitant products included MOMETASONE FUROATE (NASONEX), CETIRIZINE, OMEPRAZOLE, METOPROLOL, DICYCLOMINE [DICYCLOVERINE], FLUOXETINE and ALPRAZOLAM (XANAX) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 30-Apr-2021, the patient experienced FEELING ABNORMAL (started feeling better), ILLNESS (I thought I would be very sick after vaccine), ABDOMINAL DISTENSION (my bloating went away for 2 to 3 days), DIARRHEA (my diarrhea went away for 2 to 3 days), ABDOMINAL PAIN UPPER (my stomach pain went away for 2 to 3 days) and IRRITABLE BOWEL SYNDROME (My IBS problem completely gone for 2 and 3 days). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (its positive effect and it would be great if this vaccine works for IBS people). At the time of the report, FEELING ABNORMAL (started feeling better), ILLNESS (I thought I would be very sick after vaccine), ABDOMINAL DISTENSION (my bloating went away for 2 to 3 days), DIARRHEA (my diarrhea went away for 2 to 3 days), ABDOMINAL PAIN UPPER (my stomach pain went away for 2 to 3 days), IRRITABLE BOWEL SYNDROME (My IBS problem completely gone for 2 and 3 days) and IRRITABLE BOWEL SYNDROME (its positive effect and it would be great if this vaccine works for IBS people) outcome was unknown.            Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Disturbance in attention, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: terrible side effects/seems very unusual; tightness; spasm; felt the wave of the flu; heavy head; couldn't focus; not normal for me; joint pain; muscle ache; headache; exhaustion/super tired; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (terrible side effects/seems very unusual), MUSCLE TIGHTNESS (tightness), MUSCLE SPASMS (spasm), INFLUENZA (felt the wave of the flu) and HEAD DISCOMFORT (heavy head) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 0Z1CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible side effects/seems very unusual), MUSCLE TIGHTNESS (tightness), MUSCLE SPASMS (spasm), INFLUENZA (felt the wave of the flu), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't focus), FEELING ABNORMAL (not normal for me), ARTHRALGIA (joint pain), MYALGIA (muscle ache), HEADACHE (headache) and FATIGUE (exhaustion/super tired). At the time of the report, VACCINATION COMPLICATION (terrible side effects/seems very unusual), MUSCLE TIGHTNESS (tightness), MUSCLE SPASMS (spasm), INFLUENZA (felt the wave of the flu), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't focus), FEELING ABNORMAL (not normal for me), ARTHRALGIA (joint pain), MYALGIA (muscle ache), HEADACHE (headache) and FATIGUE (exhaustion/super tired) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.   This case was linked to MOD-2021-128240 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Muscle spasms, Muscle tightness, Myalgia
Clinical narrative: terrible side effects/seems very unusual; tightness; spasm; felt the wave of the flu; heavy head; couldn't focus; not normal for me; joint pain; muscle ache; headache; exhaustion/super tired; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (terrible side effects/seems very unusual), MUSCLE TIGHTNESS (tightness), MUSCLE SPASMS (spasm), INFLUENZA (felt the wave of the flu) and HEAD DISCOMFORT (heavy head) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 0Z1CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible side effects/seems very unusual), MUSCLE TIGHTNESS (tightness), MUSCLE SPASMS (spasm), INFLUENZA (felt the wave of the flu), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't focus), FEELING ABNORMAL (not normal for me), ARTHRALGIA (joint pain), MYALGIA (muscle ache), HEADACHE (headache) and FATIGUE (exhaustion/super tired). At the time of the report, VACCINATION COMPLICATION (terrible side effects/seems very unusual), MUSCLE TIGHTNESS (tightness), MUSCLE SPASMS (spasm), INFLUENZA (felt the wave of the flu), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't focus), FEELING ABNORMAL (not normal for me), ARTHRALGIA (joint pain), MYALGIA (muscle ache), HEADACHE (headache) and FATIGUE (exhaustion/super tired) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.   This case was linked to MOD-2021-128240 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: terrible side effects/seems very unusual; tightness; spasm; felt the wave of the flu; heavy head; couldn't focus; not normal for me; joint pain; muscle ache; headache; exhaustion/super tired; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (terrible side effects/seems very unusual), MUSCLE TIGHTNESS (tightness), MUSCLE SPASMS (spasm), INFLUENZA (felt the wave of the flu) and HEAD DISCOMFORT (heavy head) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 0Z1CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible side effects/seems very unusual), MUSCLE TIGHTNESS (tightness), MUSCLE SPASMS (spasm), INFLUENZA (felt the wave of the flu), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't focus), FEELING ABNORMAL (not normal for me), ARTHRALGIA (joint pain), MYALGIA (muscle ache), HEADACHE (headache) and FATIGUE (exhaustion/super tired). At the time of the report, VACCINATION COMPLICATION (terrible side effects/seems very unusual), MUSCLE TIGHTNESS (tightness), MUSCLE SPASMS (spasm), INFLUENZA (felt the wave of the flu), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't focus), FEELING ABNORMAL (not normal for me), ARTHRALGIA (joint pain), MYALGIA (muscle ache), HEADACHE (headache) and FATIGUE (exhaustion/super tired) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.   This case was linked to MOD-2021-128240 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hepatic pain, Hyperhidrosis
Clinical narrative: This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of RENAL PAIN (liver and kidney pain\the same thing happened to him), HEPATIC PAIN (liver and kidney pain\the same thing happened to him), VACCINATION COMPLICATION (disgust/feeling unwell/the same thing happened to him), HYPERHIDROSIS (sweat\the same thing happened to him) and ARTHRALGIA (joint pain/the same thing happened to him) in a male patient of an unknown age 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 Cirrhosis liver (non-alcoholic cirrhosis) and Cancer. Concurrent medical conditions included Diabetes, White blood cell disorder (elevated) and Thrombocytopenia, unspecified.On 11-May-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 RENAL PAIN (liver and kidney pain\the same thing happened to him), HEPATIC PAIN (liver and kidney pain\the same thing happened to him), VACCINATION COMPLICATION (disgust/feeling unwell/the same thing happened to him), HYPERHIDROSIS (sweat\the same thing happened to him), ARTHRALGIA (joint pain/the same thing happened to him), MYALGIA (had arm pain/body aches/muscle and joint pain), FATIGUE (fatigue/the same thing happened to him) and HEADACHE ( headache). At the time of the report, RENAL PAIN (liver and kidney pain\the same thing happened to him), HEPATIC PAIN (liver and kidney pain\the same thing happened to him), VACCINATION COMPLICATION (disgust/feeling unwell/the same thing happened to him), HYPERHIDROSIS (sweat\the same thing happened to him), ARTHRALGIA (joint pain/the same thing happened to him), MYALGIA (had arm pain/body aches/muscle and joint pain), FATIGUE (fatigue/the same thing happened to him) and HEADACHE ( headache) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications was reported.Treatment information was not provided. Patient had her white blood cells were elevated and platelets count were low.This case was linked to MOD21-090141, MOD21-090181, US-MODERNATX, INC.-MOD-2021-128357 (E2B Linked Report).; Sender's Comments:  MOD21-090141:Same reporter, different patient MOD21-090181:Same reporter, different patient US-MODERNATX, INC.-MOD-2021-128357:linked
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Renal pain, Vaccination complication
Clinical narrative: This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of RENAL PAIN (liver and kidney pain\the same thing happened to him), HEPATIC PAIN (liver and kidney pain\the same thing happened to him), VACCINATION COMPLICATION (disgust/feeling unwell/the same thing happened to him), HYPERHIDROSIS (sweat\the same thing happened to him) and ARTHRALGIA (joint pain/the same thing happened to him) in a male patient of an unknown age 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 Cirrhosis liver (non-alcoholic cirrhosis) and Cancer. Concurrent medical conditions included Diabetes, White blood cell disorder (elevated) and Thrombocytopenia, unspecified.On 11-May-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 RENAL PAIN (liver and kidney pain\the same thing happened to him), HEPATIC PAIN (liver and kidney pain\the same thing happened to him), VACCINATION COMPLICATION (disgust/feeling unwell/the same thing happened to him), HYPERHIDROSIS (sweat\the same thing happened to him), ARTHRALGIA (joint pain/the same thing happened to him), MYALGIA (had arm pain/body aches/muscle and joint pain), FATIGUE (fatigue/the same thing happened to him) and HEADACHE ( headache). At the time of the report, RENAL PAIN (liver and kidney pain\the same thing happened to him), HEPATIC PAIN (liver and kidney pain\the same thing happened to him), VACCINATION COMPLICATION (disgust/feeling unwell/the same thing happened to him), HYPERHIDROSIS (sweat\the same thing happened to him), ARTHRALGIA (joint pain/the same thing happened to him), MYALGIA (had arm pain/body aches/muscle and joint pain), FATIGUE (fatigue/the same thing happened to him) and HEADACHE ( headache) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications was reported.Treatment information was not provided. Patient had her white blood cells were elevated and platelets count were low.This case was linked to MOD21-090141, MOD21-090181, US-MODERNATX, INC.-MOD-2021-128357 (E2B Linked Report).; Sender's Comments:  MOD21-090141:Same reporter, different patient MOD21-090181:Same reporter, different patient US-MODERNATX, INC.-MOD-2021-128357:linked
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of the vaccine not being given on day 36 after the 1st dose 26Jan2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine not being given on day 36 after the 1st dose 26Jan2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history provided. No concomitant medication provided.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine not being given on day 36 after the 1st dose 26Jan2021). On 13-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine not being given on day 36 after the 1st dose 26Jan2021) had resolved.        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.   No concomitant product was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Joint swelling, Myalgia
Clinical narrative: I am having a nerve pain especially on my back; It is sciatica nerve related back pain; both my knees are really bad and swelling.; It is sciatica nerve related back pain; my knees they do not function well; there was no arm pain initially. Now my right arm get sore occasionally. it comes and goes away; both my knees are in pain.; Lots of muscle pain, the muscle pain is generalized and went up to neck; I've been tired.; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (I am having a nerve pain especially on my back), BACK PAIN (It is sciatica nerve related back pain), JOINT SWELLING (both my knees are really bad and swelling.), SCIATICA (It is sciatica nerve related back pain) and VACCINATION COMPLICATION (my knees they do not function well) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-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 NEURALGIA (I am having a nerve pain especially on my back), BACK PAIN (It is sciatica nerve related back pain), JOINT SWELLING (both my knees are really bad and swelling.), SCIATICA (It is sciatica nerve related back pain), VACCINATION COMPLICATION (my knees they do not function well), PAIN IN EXTREMITY (there was no arm pain initially. Now my right arm get sore occasionally. it comes and goes away), ARTHRALGIA (both my knees are in pain.), MYALGIA (Lots of muscle pain, the muscle pain is generalized and went up to neck) and FATIGUE (I've been tired.). At the time of the report, NEURALGIA (I am having a nerve pain especially on my back), BACK PAIN (It is sciatica nerve related back pain), JOINT SWELLING (both my knees are really bad and swelling.), SCIATICA (It is sciatica nerve related back pain), VACCINATION COMPLICATION (my knees they do not function well), PAIN IN EXTREMITY (there was no arm pain initially. Now my right arm get sore occasionally. it comes and goes away), ARTHRALGIA (both my knees are in pain.), MYALGIA (Lots of muscle pain, the muscle pain is generalized and went up to neck) and FATIGUE (I've been tired.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Sciatica, Vaccination complication
Clinical narrative: I am having a nerve pain especially on my back; It is sciatica nerve related back pain; both my knees are really bad and swelling.; It is sciatica nerve related back pain; my knees they do not function well; there was no arm pain initially. Now my right arm get sore occasionally. it comes and goes away; both my knees are in pain.; Lots of muscle pain, the muscle pain is generalized and went up to neck; I've been tired.; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (I am having a nerve pain especially on my back), BACK PAIN (It is sciatica nerve related back pain), JOINT SWELLING (both my knees are really bad and swelling.), SCIATICA (It is sciatica nerve related back pain) and VACCINATION COMPLICATION (my knees they do not function well) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-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 NEURALGIA (I am having a nerve pain especially on my back), BACK PAIN (It is sciatica nerve related back pain), JOINT SWELLING (both my knees are really bad and swelling.), SCIATICA (It is sciatica nerve related back pain), VACCINATION COMPLICATION (my knees they do not function well), PAIN IN EXTREMITY (there was no arm pain initially. Now my right arm get sore occasionally. it comes and goes away), ARTHRALGIA (both my knees are in pain.), MYALGIA (Lots of muscle pain, the muscle pain is generalized and went up to neck) and FATIGUE (I've been tired.). At the time of the report, NEURALGIA (I am having a nerve pain especially on my back), BACK PAIN (It is sciatica nerve related back pain), JOINT SWELLING (both my knees are really bad and swelling.), SCIATICA (It is sciatica nerve related back pain), VACCINATION COMPLICATION (my knees they do not function well), PAIN IN EXTREMITY (there was no arm pain initially. Now my right arm get sore occasionally. it comes and goes away), ARTHRALGIA (both my knees are in pain.), MYALGIA (Lots of muscle pain, the muscle pain is generalized and went up to neck) and FATIGUE (I've been tired.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Covid; Never received second dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid) and PRODUCT DOSE OMISSION ISSUE (Never received second dose of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 COVID-19 (Covid) and PRODUCT DOSE OMISSION ISSUE (Never received second dose of the vaccine). At the time of the report, COVID-19 (Covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Never received second dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     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.   Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information was not provided.  Pharmacist want to know if they need to restart the vaccination series.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hot flush, Mass, Peripheral swelling
Clinical narrative: Redness in arm; Swelling in arm; Hot arm; Hard lump; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), HOT FLUSH (Hot arm) and MASS (Hard lump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), HOT FLUSH (Hot arm) and MASS (Hard lump). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), HOT FLUSH (Hot arm) and MASS (Hard lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-128305, US-MODERNATX, INC.-MOD-2021-128576, US-MODERNATX, INC.-MOD-2021-128649, US-MODERNATX, INC.-MOD-2021-128643, US-MODERNATX, INC.-MOD-2021-128612, US-MODERNATX, INC.-MOD-2021-128689 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128305: US-MODERNATX, INC.-MOD-2021-128576: US-MODERNATX, INC.-MOD-2021-128649: US-MODERNATX, INC.-MOD-2021-128689: US-MODERNATX, INC.-MOD-2021-128612: US-MODERNATX, INC.-MOD-2021-128643:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Felt like flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Felt like flu) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 027B21) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA (Felt like flu). On 03-Apr-2021, INFLUENZA (Felt like flu) had resolved.            No relevant concomitant medications were reported. No treatment details were reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-127980 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non-significant follow-up appended. On 22-Jul-2021: Follow  up information contains Reporter's Address. On 28-Jul-2021: Follow-up information include no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127980:Case for husband
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the right arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RALOXIFENE, CLOMIPRAMINE, MAGNESIUM, LOSARTAN, ATORVASTATIN, METOPROLOL SUCCINATE, METRONIDAZOLE and KETOCONAZOLE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness of the right arm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of the right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. The patient called with a concern whether taking paracetamol couple of hours after the second dose reduce the effect of the vaccine and also reported soreness of the right arm. The first dose was received on the left arm and the second dose was received on the right arm.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia oral, Presyncope, Speech disorder
Clinical narrative: Numbness around her mouth; She feels like not able to talk properly; Light headache after few hours of vaccine; feel like pass out; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (feel like pass out), DIZZINESS (Dizziness), HYPOAESTHESIA ORAL (Numbness around her mouth), SPEECH DISORDER (She feels like not able to talk properly) and HEADACHE (Light headache after few hours of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PRESYNCOPE (feel like pass out), DIZZINESS (Dizziness) and HEADACHE (Light headache after few hours of vaccine). On 13-May-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness around her mouth) and SPEECH DISORDER (She feels like not able to talk properly). At the time of the report, PRESYNCOPE (feel like pass out), DIZZINESS (Dizziness), HYPOAESTHESIA ORAL (Numbness around her mouth), SPEECH DISORDER (She feels like not able to talk properly) and HEADACHE (Light headache after few hours of vaccine) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in both legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both legs) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 039A21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE MRNA (MRNA 1273) on 11-Mar-2021. Past adverse reactions to the above products included Pain in leg with COVID-19 VACCINE MRNA (MRNA 1273). Concomitant products included PRAVASTATIN and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in both legs). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and MELOXICAM at a dose of 15 mg. At the time of the report, PAIN IN EXTREMITY (Pain in both legs) outcome was unknown.            This case was linked to MOD-2021-060835 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever that is up and down and not past 103 degrees) and CHILLS (Chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 025B21A) for COVID-19 vaccination.No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (Fever that is up and down and not past 103 degrees) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PYREXIA (Fever that is up and down and not past 103 degrees) and CHILLS (Chills) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 103 (High) Up and down fever not past 103 degrees. Concomitant product use was not provided. Action taken with mRNA-1273 in response to the events was  not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-127262 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-127262:Wife
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Erythema, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in both feet), PERIPHERAL SWELLING (Swelling in both feet), BURNING SENSATION (Burning sensation in both legs) and CHILLS (Periodic chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 007M204) for COVID-19 vaccination. Concurrent medical conditions included Gout, High cholesterol and Arthritis. Concomitant products included PREDNISONE for Arthritis, PRAVASTATIN for Cholesterol high, ALLOPURINOL for Gout. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness in both feet), PERIPHERAL SWELLING (Swelling in both feet), BURNING SENSATION (Burning sensation in both legs) and CHILLS (Periodic chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Redness in both feet), PERIPHERAL SWELLING (Swelling in both feet), BURNING SENSATION (Burning sensation in both legs) and CHILLS (Periodic chills) outcome was unknown. Other concomitant medications included Tylenol to treat arthritis. Action taken with mRNA-1273 in response to the events were not applicable.This case was linked to MOD-2021-123813 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: psoriatic arthritis diminished, stiffness in joints diminished, redness and skin scales on elbows, hands, knees, and chin improving, symptom improvement following Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (psoriatic arthritis diminished, stiffness in joints diminished, redness and skin scales on elbows, hands, knees, and chin improving, symptom improvement following Moderna vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease (Diagnosed at age 30.) since 1994 and Spinal cord injury. Concurrent medical conditions included Psoriatic arthritis (Chronic psoriatic arthritis) and Fibromyalgia. Concomitant products included METHOTREXATE and ETANERCEPT (ENBREL) for Arthritis, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit disorder, BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for Opioid use disorder.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (psoriatic arthritis diminished, stiffness in joints diminished, redness and skin scales on elbows, hands, knees, and chin improving, symptom improvement following Moderna vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (psoriatic arthritis diminished, stiffness in joints diminished, redness and skin scales on elbows, hands, knees, and chin improving, symptom improvement following Moderna vaccine) outcome was unknown.            Patient received the first dose of Moderna covid-19 vaccine on 01-Apr-2021 and reported that he suffered from chronic psoriatic arthritis over his entire body and after receiving the vaccine he reported that " Not one joint hurts" and he is please with the result he experienced today. All other symptoms are improving or has been diminished. Patient received the second dose on 29-Apr-2021.  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.; 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Pyrexia
Clinical narrative: Fever; Chills lasted for 6 hours; Back spasms; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Back spasms), PYREXIA (Fever) and CHILLS (Chills lasted for 6 hours) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced MUSCLE SPASMS (Back spasms). On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills lasted for 6 hours). At the time of the report, MUSCLE SPASMS (Back spasms) had not resolved and PYREXIA (Fever) and CHILLS (Chills lasted for 6 hours) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication was not provided.  Treatment included muscle relaxer for the back spasm.  Patient reported he did not have any adverse events after 1st dose of the vaccine. Back spasms are still present but getting better.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14-JUN-2021.  Email address of reporter has been updated,  two new events pyrexia and chills provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Delirium, Diarrhoea
Clinical narrative: Shaking with chills; Diaphoresis; Stuffy nose; Temperature of 100.4 degrees F; Chills; Feeling delirious; Loss of appetite; Diarrhea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Feeling delirious) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: PNEUMOVAX, Spironolactone and TETANUS VACCIN. Past adverse reactions to the above products included Blood dyscrasia with Spironolactone. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (cephalosporin) and Reaction to previous exposure to any vaccine. Concomitant products included LEVOTHYROXINE, PANTOPRAZOLE, Vitamin D, OXYCODONE, CHLORZOXAZONE, VILAZODONE HYDROCHLORIDE (VIIBRYD), OXCARBAZEPINE, POTASSIUM, FUROSEMIDE, MONTELUKAST and MIRTAZAPINE for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced DELIRIUM (Feeling delirious) , TREMOR (Shaking with chills), HYPERHIDROSIS (Diaphoresis), NASAL CONGESTION (Stuffy nose), PYREXIA (Temperature of 100.4 degrees F) and CHILLS (Chills). In May 2021, the patient experienced DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). At the time of the report, DELIRIUM (Feeling delirious), DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), TREMOR (Shaking with chills), HYPERHIDROSIS (Diaphoresis), NASAL CONGESTION (Stuffy nose), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown and PYREXIA (Temperature of 100.4 degrees F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Body temperature: 102.4 (Inconclusive) Temperature of 100.4 degrees F.         Treatment for the events included acetaminophen and ibuprofen. Action taken with mRNA-1273 in response to the events were not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Nasal congestion, Pyrexia, Tremor
Clinical narrative: Shaking with chills; Diaphoresis; Stuffy nose; Temperature of 100.4 degrees F; Chills; Feeling delirious; Loss of appetite; Diarrhea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Feeling delirious) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: PNEUMOVAX, Spironolactone and TETANUS VACCIN. Past adverse reactions to the above products included Blood dyscrasia with Spironolactone. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (cephalosporin) and Reaction to previous exposure to any vaccine. Concomitant products included LEVOTHYROXINE, PANTOPRAZOLE, Vitamin D, OXYCODONE, CHLORZOXAZONE, VILAZODONE HYDROCHLORIDE (VIIBRYD), OXCARBAZEPINE, POTASSIUM, FUROSEMIDE, MONTELUKAST and MIRTAZAPINE for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced DELIRIUM (Feeling delirious) , TREMOR (Shaking with chills), HYPERHIDROSIS (Diaphoresis), NASAL CONGESTION (Stuffy nose), PYREXIA (Temperature of 100.4 degrees F) and CHILLS (Chills). In May 2021, the patient experienced DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). At the time of the report, DELIRIUM (Feeling delirious), DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), TREMOR (Shaking with chills), HYPERHIDROSIS (Diaphoresis), NASAL CONGESTION (Stuffy nose), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown and PYREXIA (Temperature of 100.4 degrees F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Body temperature: 102.4 (Inconclusive) Temperature of 100.4 degrees F.         Treatment for the events included acetaminophen and ibuprofen. Action taken with mRNA-1273 in response to the events were not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Bedridden, Disturbance in attention, Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (side effects got progressively worse), BEDRIDDEN (couldn't get out of bed), MUSCLE TIGHTNESS (muscle tightness), HEAD DISCOMFORT (heavy head) and DISTURBANCE IN ATTENTION (couldn't concentrate) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0Z1CZ1A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history were reported. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects got progressively worse), BEDRIDDEN (couldn't get out of bed), MUSCLE TIGHTNESS (muscle tightness), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't concentrate), ILLNESS (feeling of sickness and flu), INFLUENZA (feeling of sickness and flu), FEELING ABNORMAL (not feeling great but felt a little better/it is not normal for her/felt really bad), ANXIETY (it is concerning), HYPOKINESIA (Couldnt move), HEADACHE (headache) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION COMPLICATION (side effects got progressively worse), BEDRIDDEN (couldn't get out of bed), MUSCLE TIGHTNESS (muscle tightness), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't concentrate), ILLNESS (feeling of sickness and flu), INFLUENZA (feeling of sickness and flu), FEELING ABNORMAL (not feeling great but felt a little better/it is not normal for her/felt really bad), ANXIETY (it is concerning), HYPOKINESIA (Couldnt move), HEADACHE (headache) and ARTHRALGIA (Joint pain) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant products included Birth Control. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hypokinesia, Illness, Influenza
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (side effects got progressively worse), BEDRIDDEN (couldn't get out of bed), MUSCLE TIGHTNESS (muscle tightness), HEAD DISCOMFORT (heavy head) and DISTURBANCE IN ATTENTION (couldn't concentrate) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0Z1CZ1A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history were reported. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects got progressively worse), BEDRIDDEN (couldn't get out of bed), MUSCLE TIGHTNESS (muscle tightness), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't concentrate), ILLNESS (feeling of sickness and flu), INFLUENZA (feeling of sickness and flu), FEELING ABNORMAL (not feeling great but felt a little better/it is not normal for her/felt really bad), ANXIETY (it is concerning), HYPOKINESIA (Couldnt move), HEADACHE (headache) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION COMPLICATION (side effects got progressively worse), BEDRIDDEN (couldn't get out of bed), MUSCLE TIGHTNESS (muscle tightness), HEAD DISCOMFORT (heavy head), DISTURBANCE IN ATTENTION (couldn't concentrate), ILLNESS (feeling of sickness and flu), INFLUENZA (feeling of sickness and flu), FEELING ABNORMAL (not feeling great but felt a little better/it is not normal for her/felt really bad), ANXIETY (it is concerning), HYPOKINESIA (Couldnt move), HEADACHE (headache) and ARTHRALGIA (Joint pain) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant products included Birth Control. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.