chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Vaccination complication
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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling abnormal, Feeling cold, Head discomfort
Clinical narrative: Whole face felt numb like it was asleep; Her left arm felt like it had fallen asleep; Felt tired; Felt strange; Numbness in left arm (from injection site to hand); Pressure on left side of head; Cold sensation in left arm; Panic attack; Anxiety; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Numbness in left arm (from injection site to hand)), HEAD DISCOMFORT (Pressure on left side of head), FEELING COLD (Cold sensation in left arm), PANIC ATTACK (Panic attack) and ANXIETY (Anxiety) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 12-May-2021, the patient experienced HYPOAESTHESIA (Numbness in left arm (from injection site to hand)), HEAD DISCOMFORT (Pressure on left side of head), FEELING COLD (Cold sensation in left arm), PANIC ATTACK (Panic attack) and ANXIETY (Anxiety). On 13-May-2021, the patient experienced FEELING ABNORMAL (Felt strange) and FATIGUE (Felt tired). On an unknown date, the patient experienced HYPOAESTHESIA (Whole face felt numb like it was asleep) and LIMB DISCOMFORT (Her left arm felt like it had fallen asleep). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (Numbness in left arm (from injection site to hand)), HEAD DISCOMFORT (Pressure on left side of head), FEELING COLD (Cold sensation in left arm), PANIC ATTACK (Panic attack), ANXIETY (Anxiety), FEELING ABNORMAL (Felt strange), HYPOAESTHESIA (Whole face felt numb like it was asleep), LIMB DISCOMFORT (Her left arm felt like it had fallen asleep) and FATIGUE (Felt tired) 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Panic attack
Clinical narrative: Whole face felt numb like it was asleep; Her left arm felt like it had fallen asleep; Felt tired; Felt strange; Numbness in left arm (from injection site to hand); Pressure on left side of head; Cold sensation in left arm; Panic attack; Anxiety; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Numbness in left arm (from injection site to hand)), HEAD DISCOMFORT (Pressure on left side of head), FEELING COLD (Cold sensation in left arm), PANIC ATTACK (Panic attack) and ANXIETY (Anxiety) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 12-May-2021, the patient experienced HYPOAESTHESIA (Numbness in left arm (from injection site to hand)), HEAD DISCOMFORT (Pressure on left side of head), FEELING COLD (Cold sensation in left arm), PANIC ATTACK (Panic attack) and ANXIETY (Anxiety). On 13-May-2021, the patient experienced FEELING ABNORMAL (Felt strange) and FATIGUE (Felt tired). On an unknown date, the patient experienced HYPOAESTHESIA (Whole face felt numb like it was asleep) and LIMB DISCOMFORT (Her left arm felt like it had fallen asleep). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (Numbness in left arm (from injection site to hand)), HEAD DISCOMFORT (Pressure on left side of head), FEELING COLD (Cold sensation in left arm), PANIC ATTACK (Panic attack), ANXIETY (Anxiety), FEELING ABNORMAL (Felt strange), HYPOAESTHESIA (Whole face felt numb like it was asleep), LIMB DISCOMFORT (Her left arm felt like it had fallen asleep) and FATIGUE (Felt tired) 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Underdose
Clinical narrative: The pharmacist was not sure if she gave the dose or syringe was empty; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The pharmacist was not sure if she gave the dose or syringe was empty) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-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 UNDERDOSE (The pharmacist was not sure if she gave the dose or syringe was empty). On 15-Apr-2021, UNDERDOSE (The pharmacist was not sure if she gave the dose or syringe was empty) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant  medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: updated reporter's address and email details
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hepatic pain, Hyperhidrosis
Clinical narrative: Liver pain; Kidney pain; Feeling unwell; Headache; Hard arm / body aches/arm pain/hurt her arm; Fatigue; Joint pain; Feeling unwell/ disgust; Sweats; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling unwell/ disgust), HYPERHIDROSIS (Sweats), HEPATIC PAIN (Liver pain), RENAL PAIN (Kidney pain) and MALAISE (Feeling unwell) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cirrhosis of liver without mention of alcohol and Cancer. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, INSULIN, VITAMINA D3 and METOPROLOL for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION COMPLICATION (Feeling unwell/ disgust), HYPERHIDROSIS (Sweats), HEADACHE (Headache), MYALGIA (Hard arm / body aches/arm pain/hurt her arm), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-May-2021, the patient experienced HEPATIC PAIN (Liver pain), RENAL PAIN (Kidney pain) and MALAISE (Feeling unwell). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 200 mg. At the time of the report, VACCINATION COMPLICATION (Feeling unwell/ disgust), HYPERHIDROSIS (Sweats), HEPATIC PAIN (Liver pain), RENAL PAIN (Kidney pain), MALAISE (Feeling unwell), HEADACHE (Headache), MYALGIA (Hard arm / body aches/arm pain/hurt her arm), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-090181, MOD21-090182, US-MODERNATX, INC.-MOD-2021-128357 (E2B Linked Report).; Sender's Comments:  MOD21-090181:Rep same patient different MOD21-090182:Rep same patient different US-MODERNATX, INC.-MOD-2021-128357:Reporter's case
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Renal pain, Vaccination complication
Clinical narrative: Liver pain; Kidney pain; Feeling unwell; Headache; Hard arm / body aches/arm pain/hurt her arm; Fatigue; Joint pain; Feeling unwell/ disgust; Sweats; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling unwell/ disgust), HYPERHIDROSIS (Sweats), HEPATIC PAIN (Liver pain), RENAL PAIN (Kidney pain) and MALAISE (Feeling unwell) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cirrhosis of liver without mention of alcohol and Cancer. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, INSULIN, VITAMINA D3 and METOPROLOL for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION COMPLICATION (Feeling unwell/ disgust), HYPERHIDROSIS (Sweats), HEADACHE (Headache), MYALGIA (Hard arm / body aches/arm pain/hurt her arm), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-May-2021, the patient experienced HEPATIC PAIN (Liver pain), RENAL PAIN (Kidney pain) and MALAISE (Feeling unwell). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 200 mg. At the time of the report, VACCINATION COMPLICATION (Feeling unwell/ disgust), HYPERHIDROSIS (Sweats), HEPATIC PAIN (Liver pain), RENAL PAIN (Kidney pain), MALAISE (Feeling unwell), HEADACHE (Headache), MYALGIA (Hard arm / body aches/arm pain/hurt her arm), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-090181, MOD21-090182, US-MODERNATX, INC.-MOD-2021-128357 (E2B Linked Report).; Sender's Comments:  MOD21-090181:Rep same patient different MOD21-090182:Rep same patient different US-MODERNATX, INC.-MOD-2021-128357:Reporter's case
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dysarthria, Facial paralysis
Clinical narrative: nerve paralysis; bell's palsy; slurred speech; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (nerve paralysis), CONDITION AGGRAVATED (bell's palsy) and DYSARTHRIA (slurred speech) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy (11 years ago, asymptomatic).    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced FACIAL PARALYSIS (nerve paralysis), CONDITION AGGRAVATED (bell's palsy) and DYSARTHRIA (slurred speech). At the time of the report, FACIAL PARALYSIS (nerve paralysis), CONDITION AGGRAVATED (bell's palsy) and DYSARTHRIA (slurred speech) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment Prednisone 60mg daily for 1 week.  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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Feeling abnormal, Lymph node pain, Muscle tightness, Nodule
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She woke up felt very weird with her lympahtic nodes), LYMPH NODE PAIN (She woke up felt very weird with her lympahtic nodes ,being painful), SWELLING (Swelling on left side of neck), EAR PAIN (Ear ache, which was going to her left jaw) and NODULE (She states feeling a lot of pressure and could feel a little ball on left side of neck) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included vitamins for an unknown indication.On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced FEELING ABNORMAL (She woke up felt very weird with her lympahtic nodes), LYMPH NODE PAIN (She woke up felt very weird with her lympahtic nodes ,being painful), SWELLING (Swelling on left side of neck), EAR PAIN (Ear ache, which was going to her left jaw) and MUSCLE TIGHTNESS (could not turn neck in the beginning). On an unknown date, the patient experienced NODULE (She states feeling a lot of pressure and could feel a little ball on left side of neck). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. On 13-May-2021, MUSCLE TIGHTNESS (could not turn neck in the beginning) had resolved. At the time of the report, FEELING ABNORMAL (She woke up felt very weird with her lympahtic nodes), LYMPH NODE PAIN (She woke up felt very weird with her lympahtic nodes ,being painful), SWELLING (Swelling on left side of neck), EAR PAIN (Ear ache, which was going to her left jaw) and NODULE (She states feeling a lot of pressure and could feel a little ball on left side of neck) 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She woke up felt very weird with her lympahtic nodes), LYMPH NODE PAIN (She woke up felt very weird with her lympahtic nodes ,being painful), SWELLING (Swelling on left side of neck), EAR PAIN (Ear ache, which was going to her left jaw) and NODULE (She states feeling a lot of pressure and could feel a little ball on left side of neck) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included vitamins for an unknown indication.On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced FEELING ABNORMAL (She woke up felt very weird with her lympahtic nodes), LYMPH NODE PAIN (She woke up felt very weird with her lympahtic nodes ,being painful), SWELLING (Swelling on left side of neck), EAR PAIN (Ear ache, which was going to her left jaw) and MUSCLE TIGHTNESS (could not turn neck in the beginning). On an unknown date, the patient experienced NODULE (She states feeling a lot of pressure and could feel a little ball on left side of neck). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. On 13-May-2021, MUSCLE TIGHTNESS (could not turn neck in the beginning) had resolved. At the time of the report, FEELING ABNORMAL (She woke up felt very weird with her lympahtic nodes), LYMPH NODE PAIN (She woke up felt very weird with her lympahtic nodes ,being painful), SWELLING (Swelling on left side of neck), EAR PAIN (Ear ache, which was going to her left jaw) and NODULE (She states feeling a lot of pressure and could feel a little ball on left side of neck) 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Uncomfortable / Swollen lymph nodes on my left collar bone / remained the same size; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Uncomfortable / Swollen lymph nodes on my left collar bone / remained the same size) in a 41-year-old female patient who received mRNA-1273 (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced LYMPHADENOPATHY (Uncomfortable / Swollen lymph nodes on my left collar bone / remained the same size). At the time of the report, LYMPHADENOPATHY (Uncomfortable / Swollen lymph nodes on my left collar bone / remained the same size) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications included birth control pills.  Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash under arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (rash under arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced RASH (rash under arm). At the time of the report, RASH (rash under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-128314 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non significant follow up received on 14-JUN-2021, no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128314:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Mass excision, Swelling
Clinical narrative: Redness; Swelling; Hot; Hard lump; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hot) and MASS EXCISION (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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hot) and MASS EXCISION (Hard lump). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hot) and MASS EXCISION (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 medication information  were not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-128176, 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 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128176: US-MODERNATX, INC.-MOD-2021-128643: US-MODERNATX, INC.-MOD-2021-128576: US-MODERNATX, INC.-MOD-2021-128612: US-MODERNATX, INC.-MOD-2021-128649: US-MODERNATX, INC.-MOD-2021-128689:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Headache
Clinical narrative: in bed for 3 days; headache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (in bed for 3 days) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 006M20A) for COVID-19 vaccination.     No medical history was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced BEDRIDDEN (in bed for 3 days) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 17-Mar-2021, BEDRIDDEN (in bed for 3 days) and HEADACHE (headache) had resolved.            Concomitant medication information were not reported.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-128294 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128294:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chromaturia, Fatigue, Sunburn
Clinical narrative: Sunburn feeling on top of head; Dark urine; Fatigue; Joint aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SUNBURN (Sunburn feeling on top of head), CHROMATURIA (Dark urine), FATIGUE (Fatigue) and ARTHRALGIA (Joint aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUNBURN (Sunburn feeling on top of head), CHROMATURIA (Dark urine), FATIGUE (Fatigue) and ARTHRALGIA (Joint aches). At the time of the report, SUNBURN (Sunburn feeling on top of head), CHROMATURIA (Dark urine), FATIGUE (Fatigue) and ARTHRALGIA (Joint aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information were not reported Treatment medication information were not reported
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Sore hand; little bit of a mild fever of 99F for only a couple of hours with first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore hand) and PYREXIA (little bit of a mild fever of 99F for only a couple of hours with first shot) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore hand) and PYREXIA (little bit of a mild fever of 99F for only a couple of hours with first shot). On 10-Apr-2021, PYREXIA (little bit of a mild fever of 99F for only a couple of hours with first shot) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 99.0 (Borderline) Mild fever of 99.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment was reported for these events.  Reporter reports that after the first shot her husband had a sore hand and a little bit  of a mild fever  of 99F for only a couple of hours   This case was linked to MOD-2021-128369 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: the injection site, on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA ( the injection site, on her left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included METOPROLOL, CLOPIDOGREL, FLUNARIZINE, LOPERAMIDE and OMEPRAZOLE for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced INJECTION SITE ERYTHEMA (the injection site, on her left arm). The patient was treated with ACETAMINOPHEN on 11-May-2021 for Injection site erythema, at a dose of 300 mg. At the time of the report, INJECTION SITE ERYTHEMA (the injection site, on her left arm) 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.   Concomitant medication include Metoprolol, clopidogrel, flunarizine, loperamide 2 a day, omeprazole.  Patient wants to know if the redness is normal and what to do about it.   This case was linked to US-MODERNATX, INC.-MOD-2021-128145, US-MODERNATX, INC.-MOD-2021-128266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128145: US-MODERNATX, INC.-MOD-2021-128266:Reporter's case
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeding disorder, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Felt uneasy; Not able to eat anything; Fever of 103F; Vomiting; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt uneasy), FEEDING DISORDER (Not able to eat anything), PYREXIA (Fever of 103F), VOMITING (Vomiting) and HEADACHE (Bad headache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced FEELING ABNORMAL (Felt uneasy), FEEDING DISORDER (Not able to eat anything), PYREXIA (Fever of 103F), VOMITING (Vomiting) and HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) on 13-May-2021 at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt uneasy), FEEDING DISORDER (Not able to eat anything), VOMITING (Vomiting) and HEADACHE (Bad headache) outcome was unknown and PYREXIA (Fever of 103F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 103 (High) high.         As reported stated patient took Tylenol the morning of report (13-May-2021) with no relief. On 13-May-2021, his fever went up, then down, then up again.  Concomitant medications were not reported.   This case was linked to MOD-2021-128346 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Felt uneasy; Not able to eat anything; Fever of 103F; Vomiting; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt uneasy), FEEDING DISORDER (Not able to eat anything), PYREXIA (Fever of 103F), VOMITING (Vomiting) and HEADACHE (Bad headache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced FEELING ABNORMAL (Felt uneasy), FEEDING DISORDER (Not able to eat anything), PYREXIA (Fever of 103F), VOMITING (Vomiting) and HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) on 13-May-2021 at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt uneasy), FEEDING DISORDER (Not able to eat anything), VOMITING (Vomiting) and HEADACHE (Bad headache) outcome was unknown and PYREXIA (Fever of 103F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 103 (High) high.         As reported stated patient took Tylenol the morning of report (13-May-2021) with no relief. On 13-May-2021, his fever went up, then down, then up again.  Concomitant medications were not reported.   This case was linked to MOD-2021-128346 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose administered too early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early). On 13-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications unknown.  Nurse would like to know when the next dose can be given or if it should be given at all.  no treatment information was provided.   This case was linked to MOD21-090279, US-MODERNATX, INC.-MOD-2021-128426, US-MODERNATX, INC.-MOD-2021-138320 (E2B Linked Report).; Sender's Comments:  MOD21-090279:cross link US-MODERNATX, INC.-MOD-2021-128426:cross link US-MODERNATX, INC.-MOD-2021-138320:Crosslinked case of reporter- Different patient
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of rash on neck chest and sides in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 008C21A) for COVID-19 immunization. Previously administered products included for an unreported indication: COVID-19 Moderna vaccine (dose 1) on Apr 13, 2021. On May 11, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 12, 2021, patient experienced rash on neck chest and sides. At the time of the report, rash on neck chest and sides outcome: unknown. Symptoms are not painful or bothersome, patient was looking for treatment options.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose administered too early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-128379, US-MODERNATX, INC.-MOD-2021-128469, US-MODERNATX, INC.-MOD-2021-138320 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128379:cross link US-MODERNATX, INC.-MOD-2021-128469:cross link US-MODERNATX, INC.-MOD-2021-138320:Crosslinked case of reporter- Different patient
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received an expired dose of the vaccine) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 024C21A) for COVID-19 immunization. No medical history reported. On May 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 13, 2021, patient administered expired product (patient received an expired dose of the vaccine). On May 13, 2021, administered expired product (patient received an expired dose of the vaccine) resolved. The reporter did not provide any causality assessments.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: scheduled to receive dose 2 on 1Apr2021, but missed it due to COVID; tested/confirmed that patient contracted COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (scheduled to receive dose 2 on 1Apr2021, but missed it due to COVID) and COVID-19 (tested/confirmed that patient contracted COVID) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included PREGABALIN (LYRICA) for Fibromyalgia.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COVID-19 (tested/confirmed that patient contracted COVID). On 01-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (scheduled to receive dose 2 on 1Apr2021, but missed it due to COVID). The patient was treated with VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. On 01-Apr-2021, PRODUCT DOSE OMISSION ISSUE (scheduled to receive dose 2 on 1Apr2021, but missed it due to COVID) had resolved. At the time of the report, COVID-19 (tested/confirmed that patient contracted COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at the injection site after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-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) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No treatment information was provided
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early). On 13-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drugs and treatment medications were reported.This case was linked to US-MODERNATX, INC.-MOD-2021-128426, US-MODERNATX, INC.-MOD-2021-128544, US-MODERNATX, INC.-MOD-2021-138320 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128426:cross link US-MODERNATX, INC.-MOD-2021-128544:cross link US-MODERNATX, INC.-MOD-2021-138320:Crosslinked case of reporter- Different patient
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Dose of Moderna vaccine leaked at of syringe onto patients arm; Unable to determine amount leaked; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Dose of Moderna vaccine leaked at of syringe onto patients arm) and UNDERDOSE (Unable to determine amount leaked) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 040B21A) for COVID-19 vaccination.     The patient's past medical history included Vitamin D deficiency and Splenomegaly. Concurrent medical conditions included Hyperlipidemia. Concomitant products included ATORVASTATIN from 06-Jan-2021 to an unknown date for High cholesterol, OMEPRAZOLE from 06-Jan-2021 to an unknown date for Indigestion, VITAMIN D3 from 06-Jan-2021 to an unknown date for Vitamin D deficiency.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 13-May-2021, the patient experienced DEVICE CONNECTION ISSUE (Dose of Moderna vaccine leaked at of syringe onto patients arm) and UNDERDOSE (Unable to determine amount leaked). On 13-May-2021, DEVICE CONNECTION ISSUE (Dose of Moderna vaccine leaked at of syringe onto patients arm) and UNDERDOSE (Unable to determine amount leaked) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16 Apr 2021,patient received first dose and there were no side effects. On 13 May 2021,received second dose and during vaccination needle became detached from syringe and unknown amount of drug dripped on to patient's arm.  Action taken with mRNA-1273 in response to the events was not applicable. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: non significant follow up document added
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Diarrhoea, Dyspnoea, Nausea, Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of diarrhea, dyspnea (shortness of breath), ageusia (loss of taste for one week), product dose omission issue (has not received the second dose today, May 13, 2021; day 94 post first dose) and nausea in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 17, 2021, patient experienced diarrhea, dyspnea (shortness of breath), ageusia (loss of taste for one week) and nausea. On an unknown date, patient experienced product dose omission issue (has not received the second dose today, May 13, 2021; day 94 post first dose). On Feb 20, 2021, dyspnea  (shortness of breath) resolved. On Feb 24, 2021, ageusia (loss of taste for one week) resolved. On Mar 3, 2021, diarrhea and nausea resolved. At the time of the report, product dose omission issue (has not received the second dose today, May 13, 2021; day 94 post first dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medication information and treatment information not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore upper arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication and Medications for high cholesterol (didn't specify)    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore upper arm). On 16-Apr-2021, PAIN IN EXTREMITY (Sore upper arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Menstrual disorder, Myalgia
Clinical narrative: started menstruating today with blood clots in her period; soreness of muscle; a bit fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (started menstruating today with blood clots in her period), MYALGIA (soreness of muscle) and FATIGUE (a bit fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE, COLECALCIFEROL (D3) and Serotonin Inhibitor for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced MENSTRUAL DISORDER (started menstruating today with blood clots in her period), MYALGIA (soreness of muscle) and FATIGUE (a bit fatigue). At the time of the report, MENSTRUAL DISORDER (started menstruating today with blood clots in her period), MYALGIA (soreness of muscle) and FATIGUE (a bit fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD21-090276, US-MODERNATX, INC.-MOD-2021-128629 (E2B Linked Report).; Sender's Comments:  MOD21-090276:crosslink US-MODERNATX, INC.-MOD-2021-128629:
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. No Medical History information was reported.On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-128469, US-MODERNATX, INC.-MOD-2021-138320 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128469:cross link US-MODERNATX, INC.-MOD-2021-138320:Crosslinked case of reporter- Different patient