chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pricked cartilage in finger and drew blood with syringe before administering vaccine to patient; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Pricked cartilage in finger and drew blood with syringe before administering vaccine to patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced UNDERDOSE (Pricked cartilage in finger and drew blood with syringe before administering vaccine to patient). On 14-Apr-2021, UNDERDOSE (Pricked cartilage in finger and drew blood with syringe before administering vaccine to patient) 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.   On 07-May-2021, Dr. responded saying, patient received the complete dose and had no further issues.  No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: got a small pimple in the armpit and it hurts; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (got a small pimple in the armpit and it hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced ACNE (got a small pimple in the armpit and it hurts). At the time of the report, ACNE (got a small pimple in the armpit and it hurts) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extremely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely exhausted) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B76A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021 at 7:00 AM, 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 13-Apr-2021, the patient experienced FATIGUE (extremely exhausted). At the time of the report, FATIGUE (extremely exhausted) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medication was given to patient. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Patient refused to provide email and denied further follow up.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: About 25% to 50% of the vaccine was injected; 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 ACCIDENTAL UNDERDOSE (About 25% to 50% of the vaccine was injected) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (About 25% to 50% of the vaccine was injected). At the time of the report, ACCIDENTAL UNDERDOSE (About 25% to 50% of the vaccine was injected) outcome was unknown. Not Provided      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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Sore neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore neck) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced NECK PAIN (Sore neck) and HEADACHE (headache). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache and Neck pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Sore neck) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Surgery, Transfusion
Clinical narrative: surgery; blood transfusion; This spontaneous case was reported by a pharmacist and describes the occurrence of SURGERY (surgery) and TRANSFUSION (blood transfusion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SURGERY (surgery) and TRANSFUSION (blood transfusion). At the time of the report, SURGERY (surgery) and TRANSFUSION (blood transfusion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Could not get 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Could not get 2nd dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Could not get 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Could not get 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Headache, Pain in extremity
Clinical narrative: possible expired dose;Three doses were left out at ambient room temperature past there beyond use date; sore arm; headache; fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (possible expired dose;Three doses were left out at ambient room temperature past there beyond use date), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and FATIGUE (fatigue) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (possible expired dose;Three doses were left out at ambient room temperature past there beyond use date), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and FATIGUE (fatigue). On 12-Apr-2021, EXPIRED PRODUCT ADMINISTERED (possible expired dose;Three doses were left out at ambient room temperature past there beyond use date) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and FATIGUE (fatigue) outcome 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.   Treatment information was not provided.    This case was linked to MOD21-075517, MOD21-075500, MOD21-074055, MOD21-075351, MOD21-075527, MOD21-075540, MOD21-075544, MOD21-075549 (E2B Linked Report). This case was linked to MOD-2021-076892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up information included patient's initials.; Sender's Comments:  MOD21-075517:Cross linked case MOD21-075500:Cross linked case MOD21-074055:Cross linked case MOD21-075351:Cross linked case MOD21-075527:Cross linked case MOD21-075540:Cross linked case MOD21-075544:Cross linked case MOD21-075549:Cross linked case
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Side effects; Fever of 102 degree Fahrenheit; Massive body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects), PYREXIA (Fever of 102 degree Fahrenheit) and MYALGIA (Massive body aches) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects), PYREXIA (Fever of 102 degree Fahrenheit) and MYALGIA (Massive body aches). At the time of the report, VACCINATION COMPLICATION (Side effects), PYREXIA (Fever of 102 degree Fahrenheit) and MYALGIA (Massive body aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient refused to provide email and denied further follow up.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Event outcome was updated to resolved from unknown for all events.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: arm still has a little swelling and soreness; red before but not today; arm still has a little swelling and soreness; red before but not today; arm still has a little swelling and soreness; red before but not today; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (arm still has a little swelling and soreness; red before but not today), PAIN IN EXTREMITY (arm still has a little swelling and soreness; red before but not today) and ERYTHEMA (arm still has a little swelling and soreness; red before but not today) 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 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced SWELLING (arm still has a little swelling and soreness; red before but not today), PAIN IN EXTREMITY (arm still has a little swelling and soreness; red before but not today) and ERYTHEMA (arm still has a little swelling and soreness; red before but not today). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SWELLING (arm still has a little swelling and soreness; red before but not today), PAIN IN EXTREMITY (arm still has a little swelling and soreness; red before but not today) and ERYTHEMA (arm still has a little swelling and soreness; red before but not today) outcome was unknown. Not Provided          No concomitant medications were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-076541 (Linked Report).; Sender's Comments:  MOD-2021-076541:First dose case
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: lump near her collar bone on left side; This spontaneous case was reported by a consumer and describes the occurrence of MASS (lump near her collar bone on left side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) 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 13-Apr-2021, the patient experienced MASS (lump near her collar bone on left side). At the time of the report, MASS (lump near her collar bone on left side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Not treatment information was provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: small spots of hives on the back of his head, arm and legs; rash is all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (small spots of hives on the back of his head, arm and legs) and RASH (rash is all over the body) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (small spots of hives on the back of his head, arm and legs) and RASH (rash is all over the body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (small spots of hives on the back of his head, arm and legs) and RASH (rash is all over the body) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. Treatment included unspecified topical steroid cream. No concomitant medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This morning it was unsual to find that pain is different/ felt decrease pain; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (This morning it was unsual to find that pain is different/ felt decrease pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic arthritis (He was due for knee replacement in 2 weeks of time.He stated normally, he used to have locked knees, very painful knee when he wakes up in the morning.).   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (This morning it was unsual to find that pain is different/ felt decrease pain). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (This morning it was unsual to find that pain is different/ felt decrease pain) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Illness
Clinical narrative: symptoms were mild; fatigue; fever 103°F; weakness; chills; muscle ache; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (symptoms were mild), FATIGUE (fatigue), PYREXIA (fever 103°F), ASTHENIA (weakness) and CHILLS (chills) in a female 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 No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (symptoms were mild), FATIGUE (fatigue), PYREXIA (fever 103°F), ASTHENIA (weakness), CHILLS (chills), MYALGIA (muscle ache) and DIZZINESS (dizziness). At the time of the report, ILLNESS (symptoms were mild) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-075629 (E2B Linked Report).; Sender's Comments:  MOD21-075629:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: symptoms were mild; fatigue; fever 103°F; weakness; chills; muscle ache; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (symptoms were mild), FATIGUE (fatigue), PYREXIA (fever 103°F), ASTHENIA (weakness) and CHILLS (chills) in a female 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 No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (symptoms were mild), FATIGUE (fatigue), PYREXIA (fever 103°F), ASTHENIA (weakness), CHILLS (chills), MYALGIA (muscle ache) and DIZZINESS (dizziness). At the time of the report, ILLNESS (symptoms were mild) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-075629 (E2B Linked Report).; Sender's Comments:  MOD21-075629:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Concussion, Dyspnoea, Fatigue, Influenza like illness, Vaccination site pain
Clinical narrative: mild trouble breathing; sore arm; fatigue; flu like symptoms; Three concussions; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (mild trouble breathing), CONCUSSION (Three concussions), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Hypertension (Patient is on some blood pressure medication) and Crohn's disease. Concomitant products included WARFARIN for Atrial fibrillation, PROBIOTICS NOS for an unknown indication, TURMERIC [CURCUMA LONGA RHIZOME].   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue). In March 2021, the patient experienced CONCUSSION (Three concussions). On an unknown date, the patient experienced DYSPNOEA (mild trouble breathing). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (mild trouble breathing), CONCUSSION (Three concussions), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) outcome was unknown. Not Provided          The treatment included paracetamol, ibuprofen and menthol drops for the pain.  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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: today rash that is itchy; been itching off and on for the past week; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (been itching off and on for the past week) and RASH (today rash that is itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included EPINEPHRINE (EPIPEN), HYDROXYCHLOROQUINE, SPIRONOLACTONE, SALBUTAMOL (ALBUTEROL HFA) and VITAMIN D3 for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (been itching off and on for the past week). On 14-Apr-2021, the patient experienced RASH (today rash that is itchy). At the time of the report, PRURITUS (been itching off and on for the past week) and RASH (today rash that is itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Other concomitant was Breo inhaler. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Suspected COVID-19
Clinical narrative: Swab test came back detected but in the reference it came back not detected; Had a positive exposure at work; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE TO SARS-COV-2 (Had a positive exposure at work) and SUSPECTED COVID-19 (Swab test came back detected but in the reference it came back not detected) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Had a positive exposure at work). On 12-Apr-2021, the patient experienced SUSPECTED COVID-19 (Swab test came back detected but in the reference it came back not detected). At the time of the report, EXPOSURE TO SARS-COV-2 (Had a positive exposure at work) and SUSPECTED COVID-19 (Swab test came back detected but in the reference it came back not detected) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: raised area about 4 inches wide at injection site; itchy; red; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (raised area about 4 inches wide at injection site) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced VACCINATION SITE SWELLING (raised area about 4 inches wide at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (raised area about 4 inches wide at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  Treatment information not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: Achy bones; Difficult breathing; Right arm was numb (like when had the stroke 8 years ago); Dizziness; Tenderness; intense itchy in the hands; Lymph nodes in the neck are painful; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Achy bones), DYSPNOEA (Difficult breathing), HYPOAESTHESIA (Right arm was numb (like when had the stroke 8 years ago)), DIZZINESS (Dizziness) and TENDERNESS (Tenderness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (patient states that 8 years ago had a stroke , when the right arm was numb.) and Numbness of upper extremities. Concurrent medical conditions included Diabetes. Concomitant products included PREDNISONE, METFORMIN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 09-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 BONE PAIN (Achy bones), DYSPNOEA (Difficult breathing), HYPOAESTHESIA (Right arm was numb (like when had the stroke 8 years ago)), DIZZINESS (Dizziness), TENDERNESS (Tenderness), PRURITUS (intense itchy in the hands), LYMPH NODE PAIN (Lymph nodes in the neck are painful), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, BONE PAIN (Achy bones), DYSPNOEA (Difficult breathing), HYPOAESTHESIA (Right arm was numb (like when had the stroke 8 years ago)), DIZZINESS (Dizziness), TENDERNESS (Tenderness), PRURITUS (intense itchy in the hands), LYMPH NODE PAIN (Lymph nodes in the neck are painful), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included paracetamol to mitigate the symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Nausea, Pruritus, Pyrexia, Tenderness
Clinical narrative: Achy bones; Difficult breathing; Right arm was numb (like when had the stroke 8 years ago); Dizziness; Tenderness; intense itchy in the hands; Lymph nodes in the neck are painful; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Achy bones), DYSPNOEA (Difficult breathing), HYPOAESTHESIA (Right arm was numb (like when had the stroke 8 years ago)), DIZZINESS (Dizziness) and TENDERNESS (Tenderness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (patient states that 8 years ago had a stroke , when the right arm was numb.) and Numbness of upper extremities. Concurrent medical conditions included Diabetes. Concomitant products included PREDNISONE, METFORMIN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 09-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 BONE PAIN (Achy bones), DYSPNOEA (Difficult breathing), HYPOAESTHESIA (Right arm was numb (like when had the stroke 8 years ago)), DIZZINESS (Dizziness), TENDERNESS (Tenderness), PRURITUS (intense itchy in the hands), LYMPH NODE PAIN (Lymph nodes in the neck are painful), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, BONE PAIN (Achy bones), DYSPNOEA (Difficult breathing), HYPOAESTHESIA (Right arm was numb (like when had the stroke 8 years ago)), DIZZINESS (Dizziness), TENDERNESS (Tenderness), PRURITUS (intense itchy in the hands), LYMPH NODE PAIN (Lymph nodes in the neck are painful), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included paracetamol to mitigate the symptoms.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Experiencing itching, hive like, 1-2 weeks after getting the second shot; Experiencing itching, hive like, 1-2 weeks after getting the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Experiencing itching, hive like, 1-2 weeks after getting the second shot) and URTICARIA (Experiencing itching, hive like, 1-2 weeks after getting the second shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Experiencing itching, hive like, 1-2 weeks after getting the second shot) and URTICARIA (Experiencing itching, hive like, 1-2 weeks after getting the second shot). At the time of the report, PRURITUS (Experiencing itching, hive like, 1-2 weeks after getting the second shot) and URTICARIA (Experiencing itching, hive like, 1-2 weeks after getting the second shot) outcome was unknown. Not Provided          No relevant concomitant medications were reported. The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Mild cough; Weakness; Lack of efficacy; Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid), COUGH (Mild cough), ASTHENIA (Weakness) and DRUG INEFFECTIVE (Lack of efficacy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (Tested positive for covid) and DRUG INEFFECTIVE (Lack of efficacy). On an unknown date, the patient experienced COUGH (Mild cough) and ASTHENIA (Weakness). On 09-Apr-2021, DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown. At the time of the report, COVID-19 (Tested positive for covid), COUGH (Mild cough) and ASTHENIA (Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medicines were reported. Treatment information included hydration and vitamins.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is  assessed as unlikely related. The other events are in consistence with COVID-19. The event of lack of efficacy is assessed as possible.   This case was linked to MOD-2021-076318 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Upon internal review on 12-Jul-2021, the event of Lack of Effect was added.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is  assessed as unlikely related. The other events are in consistence with COVID-19. The event of lack of efficacy is assessed as possible.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Nausea, Pyrexia
Clinical narrative: Weakness; Nausea; Muscle pain; Fever (she is pretty hot); This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), NAUSEA (Nausea), MYALGIA (Muscle pain) and PYREXIA (Fever (she is pretty hot)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included OMEPRAZOLE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced ASTHENIA (Weakness), NAUSEA (Nausea), MYALGIA (Muscle pain) and PYREXIA (Fever (she is pretty hot)). On 15-Apr-2021, ASTHENIA (Weakness), NAUSEA (Nausea), MYALGIA (Muscle pain) and PYREXIA (Fever (she is pretty hot)) had resolved.            Concomitant medications included High blood pressure medications and Heart medication. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-076479, MODERNATX, INC.-MOD-2021-076514, MODERNATX, INC.-MOD-2021-076603 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-076479:1st dose vaccine - husband MODERNATX, INC.-MOD-2021-076514:2nd dose vaccine - husband MODERNATX, INC.-MOD-2021-076603:1st dose vaccine - Wife
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-076597 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076597:Second Dose Case
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen neck lymph node; This spontaneous case was reported by a non-health professional and describes the occurrence of LYMPHADENOPATHY (Swollen neck lymph node) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen neck lymph node). At the time of the report, LYMPHADENOPATHY (Swollen neck lymph node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: red spot on injection arm , spot is size of a fist; spot does itch a little; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spot on injection arm , spot is size of a fist) and PRURITUS (spot does itch a little) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced RASH MACULAR (red spot on injection arm , spot is size of a fist) and PRURITUS (spot does itch a little). At the time of the report, RASH MACULAR (red spot on injection arm , spot is size of a fist) and PRURITUS (spot does itch a little) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was not provided. No treatment information was not provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction on his tongue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction on his tongue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A07A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction on his tongue). At the time of the report, HYPERSENSITIVITY (allergic reaction on his tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076599 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076599:For second dose
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Oropharyngeal pain, Somnolence
Clinical narrative: Slept from 1pm to 6am; Sore throat; Warm head; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), FEELING HOT (Warm head) and SOMNOLENCE (Slept from 1pm to 6am) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and FEELING HOT (Warm head). On 16-Mar-2021, the patient experienced SOMNOLENCE (Slept from 1pm to 6am). On 17-Mar-2021, OROPHARYNGEAL PAIN (Sore throat), FEELING HOT (Warm head) and SOMNOLENCE (Slept from 1pm to 6am) had resolved.            Concomitant medications were not reported.  Patient had experienced events after second dose.  No treatment medications were used for events.   This case was linked to MOD-2021-076601 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on forehead/hives on right hand; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on forehead/hives on right hand) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Bipolar disorder and Type 2 diabetes mellitus.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced URTICARIA (Hives on forehead/hives on right hand). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on forehead/hives on right hand) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient developed hives on their right hand and forehead on 01-Apr-2021. On 14-Apr-2021, the hives on right hand and forehead have improved but were still present.  Reportedly, the patient took Benadryl as treatment medication.  Concomitant product use included unspecified medications for blood pressure, bipolar disorder and type-II diabetes mellitus.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 045A21A) 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) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN (abdominal pain). At the time of the report, ABDOMINAL PAIN (abdominal pain) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dizziness, Ear pain, Pain in extremity, Paraesthesia
Clinical narrative: sore arm; pins and needles in half side of right brain every time she would eat; jawline and right side of thyroid of neck had water blisters; dizziness; ear soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PARAESTHESIA (pins and needles in half side of right brain every time she would eat), BLISTER (jawline and right side of thyroid of neck had water blisters), DIZZINESS (dizziness) and EAR PAIN (ear soreness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PARAESTHESIA (pins and needles in half side of right brain every time she would eat), BLISTER (jawline and right side of thyroid of neck had water blisters), DIZZINESS (dizziness) and EAR PAIN (ear soreness). At the time of the report, PAIN IN EXTREMITY (sore arm), PARAESTHESIA (pins and needles in half side of right brain every time she would eat), BLISTER (jawline and right side of thyroid of neck had water blisters), DIZZINESS (dizziness) and EAR PAIN (ear soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: No specific follow-up information recorded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Dyspnoea, Headache
Clinical narrative: So dizzy that felt like passing out; Sick to her stomach; Diarrhea; Fast rapid heart beat; Couldn't move; Could breathe but not right; Lymph nodes on both sides of her neck swollen; Vomiting; Massive headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (So dizzy that felt like passing out), ABDOMINAL DISCOMFORT (Sick to her stomach), DIARRHOEA (Diarrhea), PALPITATIONS (Fast rapid heart beat) and HYPOKINESIA (Couldn't move) in a 60-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 Cancer (Patient is on remission from cancer for the third time.) and Heart attack (Patient reported having several heart attacks in the past.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE SODIUM (LEVOXYL), CARVEDILOL and LOVASTATIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DIZZINESS (So dizzy that felt like passing out), ABDOMINAL DISCOMFORT (Sick to her stomach), DIARRHOEA (Diarrhea), PALPITATIONS (Fast rapid heart beat), HYPOKINESIA (Couldn't move), DYSPNOEA (Could breathe but not right), LYMPHADENOPATHY (Lymph nodes on both sides of her neck swollen), VOMITING (Vomiting) and HEADACHE (Massive headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Apr-2021, DIZZINESS (So dizzy that felt like passing out) and HYPOKINESIA (Couldn't move) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Sick to her stomach), LYMPHADENOPATHY (Lymph nodes on both sides of her neck swollen), VOMITING (Vomiting) and HEADACHE (Massive headache) outcome was unknown, DIARRHOEA (Diarrhea) and PALPITATIONS (Fast rapid heart beat) had not resolved and DYSPNOEA (Could breathe but not right) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.