chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Swelling face
Clinical narrative: left side of his face and jaw swollen; does not feel really well; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (left side of his face and jaw swollen), MALAISE (does not feel really well) and PAIN IN EXTREMITY (arm sore) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE and BENAZEPRIL.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced SWELLING FACE (left side of his face and jaw swollen), MALAISE (does not feel really well) and PAIN IN EXTREMITY (arm sore). On 31-Jan-2021, PAIN IN EXTREMITY (arm sore) had resolved. At the time of the report, SWELLING FACE (left side of his face and jaw swollen) and MALAISE (does not feel really well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included diphenhydramine (Benadryl).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypokinesia, Impaired work ability, Muscle spasms, Muscular weakness
Clinical narrative: Left arm is numb; Muscle spasm; Can't use her left arm and she's left handed; Can barely take a shower/When she washes dishes, dish will fall off on her hand; Weakness in her left arm; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (Left arm is numb), MUSCLE SPASMS (Muscle spasm), HYPOKINESIA (Can't use her left arm and she's left handed), IMPAIRED WORK ABILITY (Can barely take a shower/When she washes dishes, dish will fall off on her hand) and MUSCULAR WEAKNESS (Weakness in her left arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HYPOAESTHESIA (Left arm is numb), MUSCLE SPASMS (Muscle spasm), HYPOKINESIA (Can't use her left arm and she's left handed), IMPAIRED WORK ABILITY (Can barely take a shower/When she washes dishes, dish will fall off on her hand) and MUSCULAR WEAKNESS (Weakness in her left arm). At the time of the report, HYPOAESTHESIA (Left arm is numb), MUSCLE SPASMS (Muscle spasm) and HYPOKINESIA (Can't use her left arm and she's left handed) was resolving and IMPAIRED WORK ABILITY (Can barely take a shower/When she washes dishes, dish will fall off on her hand) and MUSCULAR WEAKNESS (Weakness in her left arm) 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.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experiencing some side effects; A spontaneous report was received from a Consumer concerning a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events experiencing some side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was reported by the reporter.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experiencing some side effects.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, experiencing some side effects was not reported.; Reporter's Comments: Very limited information regarding this event  has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness when touching site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness when touching site of injection) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness when touching site of injection). The patient was treated with IBUPROFEN for Vaccination site pain, at an unspecified dose and frequency. On 25-Jan-2021, VACCINATION SITE PAIN (Soreness when touching site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: couldn't move her arm; tried to move and it´s hurt; really bad hurt inside the injection site, in lthe eft arm; little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little soreness), MOBILITY DECREASED (couldn't move her arm), PAIN IN EXTREMITY (tried to move and it´s hurt) and VACCINATION SITE PAIN (really bad hurt inside the injection site, in lthe eft arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal), Thyroid disorder, Cholesterol and Blood pressure abnormal. Concomitant products included POTASSIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (little soreness). On 01-Feb-2021, the patient experienced MOBILITY DECREASED (couldn't move her arm), PAIN IN EXTREMITY (tried to move and it´s hurt) and VACCINATION SITE PAIN (really bad hurt inside the injection site, in lthe eft arm). At the time of the report, PAIN (little soreness), MOBILITY DECREASED (couldn't move her arm), PAIN IN EXTREMITY (tried to move and it´s hurt) and VACCINATION SITE PAIN (really bad hurt inside the injection site, in lthe eft arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken were thyroids pills, cholesterol pills, blood pressure meds, medications for for acid reflux. Treatment medications taken was Ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: on and off low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (on and off low grade fever) 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 05-Jan-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 PYREXIA (on and off low grade fever). At the time of the report, PYREXIA (on and off low grade fever) had not 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 assessment.  Patient has been experiencing fever for a month now.  No concomitant medications were reported. Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site pain
Clinical narrative: Soreness at the injection site; Rash at the injection Site; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  soreness at the injection site, rash at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unkown) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the events soreness at the injection site. rash at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, soreness at the injection site, was considered unknown. The outcome of the event, rash at the injection site, was Recovering/resolving at the time of the report.; Reporter'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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache today; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache today) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (Headache today). At the time of the report, HEADACHE (Headache today) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Erythema, Feeling abnormal, Injection site pain, Lymphocyte count
Clinical narrative: Elevated WBC; Elevated Platelets; Elevated Absolute Lymphocytes; Felt sleepy all day; Felt bad; No hunger; hives the size of a dollar bill; felt lump on the left arm; Redness; Itchiness; Little soreness injection arm; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day) and FEELING ABNORMAL (Felt bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Acute myeloid leukemia (brother, sister and niece died due to Acute myeloid leukemia (AML) blast). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE PAIN (Little soreness injection arm). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day), FEELING ABNORMAL (Felt bad), APPETITE DISORDER (No hunger), URTICARIA (hives the size of a dollar bill), VACCINATION SITE MASS (felt lump on the left arm), ERYTHEMA (Redness) and PRURITUS (Itchiness). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day), FEELING ABNORMAL (Felt bad), APPETITE DISORDER (No hunger), URTICARIA (hives the size of a dollar bill), VACCINATION SITE MASS (felt lump on the left arm) and INJECTION SITE PAIN (Little soreness injection arm) outcome was unknown and ERYTHEMA (Redness) and PRURITUS (Itchiness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Lymphocyte count: high (High) High. In 2021, Platelet count: high (High) High. In 2021, White blood cell count: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication included Benadryl (diphenhydramine) and Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Followup information was received on 30-Mar-2021 reporter details, medical history, laboratory data concomitant medication and events were captured.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count increased, Platelet count, Platelet count increased, Pruritus, Somnolence
Clinical narrative: Elevated WBC; Elevated Platelets; Elevated Absolute Lymphocytes; Felt sleepy all day; Felt bad; No hunger; hives the size of a dollar bill; felt lump on the left arm; Redness; Itchiness; Little soreness injection arm; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day) and FEELING ABNORMAL (Felt bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Acute myeloid leukemia (brother, sister and niece died due to Acute myeloid leukemia (AML) blast). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE PAIN (Little soreness injection arm). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day), FEELING ABNORMAL (Felt bad), APPETITE DISORDER (No hunger), URTICARIA (hives the size of a dollar bill), VACCINATION SITE MASS (felt lump on the left arm), ERYTHEMA (Redness) and PRURITUS (Itchiness). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day), FEELING ABNORMAL (Felt bad), APPETITE DISORDER (No hunger), URTICARIA (hives the size of a dollar bill), VACCINATION SITE MASS (felt lump on the left arm) and INJECTION SITE PAIN (Little soreness injection arm) outcome was unknown and ERYTHEMA (Redness) and PRURITUS (Itchiness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Lymphocyte count: high (High) High. In 2021, Platelet count: high (High) High. In 2021, White blood cell count: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication included Benadryl (diphenhydramine) and Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Followup information was received on 30-Mar-2021 reporter details, medical history, laboratory data concomitant medication and events were captured.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site mass, White blood cell count, White blood cell count increased
Clinical narrative: Elevated WBC; Elevated Platelets; Elevated Absolute Lymphocytes; Felt sleepy all day; Felt bad; No hunger; hives the size of a dollar bill; felt lump on the left arm; Redness; Itchiness; Little soreness injection arm; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day) and FEELING ABNORMAL (Felt bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Acute myeloid leukemia (brother, sister and niece died due to Acute myeloid leukemia (AML) blast). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE PAIN (Little soreness injection arm). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day), FEELING ABNORMAL (Felt bad), APPETITE DISORDER (No hunger), URTICARIA (hives the size of a dollar bill), VACCINATION SITE MASS (felt lump on the left arm), ERYTHEMA (Redness) and PRURITUS (Itchiness). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day), FEELING ABNORMAL (Felt bad), APPETITE DISORDER (No hunger), URTICARIA (hives the size of a dollar bill), VACCINATION SITE MASS (felt lump on the left arm) and INJECTION SITE PAIN (Little soreness injection arm) outcome was unknown and ERYTHEMA (Redness) and PRURITUS (Itchiness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Lymphocyte count: high (High) High. In 2021, Platelet count: high (High) High. In 2021, White blood cell count: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication included Benadryl (diphenhydramine) and Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Followup information was received on 30-Mar-2021 reporter details, medical history, laboratory data concomitant medication and events were captured.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Muscle tightness at injection site; Warm injection site; Redness injection site; Itchy injection site; Swollen injection site; mild pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Muscle tightness at injection site), VACCINATION SITE WARMTH (Warm injection site), VACCINATION SITE PAIN (mild pain at the injection site), VACCINATION SITE ERYTHEMA (Redness injection site) and VACCINATION SITE PRURITUS (Itchy injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (mild pain at the injection site). On 30-Jan-2021, the patient experienced MUSCLE TIGHTNESS (Muscle tightness at injection site), VACCINATION SITE WARMTH (Warm injection site), VACCINATION SITE ERYTHEMA (Redness injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, MUSCLE TIGHTNESS (Muscle tightness at injection site), VACCINATION SITE WARMTH (Warm injection site), VACCINATION SITE PAIN (mild pain at the injection site), VACCINATION SITE ERYTHEMA (Redness injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Muscle tightness at injection site; Warm injection site; Redness injection site; Itchy injection site; Swollen injection site; mild pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Muscle tightness at injection site), VACCINATION SITE WARMTH (Warm injection site), VACCINATION SITE PAIN (mild pain at the injection site), VACCINATION SITE ERYTHEMA (Redness injection site) and VACCINATION SITE PRURITUS (Itchy injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (mild pain at the injection site). On 30-Jan-2021, the patient experienced MUSCLE TIGHTNESS (Muscle tightness at injection site), VACCINATION SITE WARMTH (Warm injection site), VACCINATION SITE ERYTHEMA (Redness injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, MUSCLE TIGHTNESS (Muscle tightness at injection site), VACCINATION SITE WARMTH (Warm injection site), VACCINATION SITE PAIN (mild pain at the injection site), VACCINATION SITE ERYTHEMA (Redness injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Tenderness
Clinical narrative: large red spot; itches a little bit; a little bit tender; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (large red spot), PRURITUS (itches a little bit) and TENDERNESS (a little bit tender) 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 RASH MACULAR (large red spot), PRURITUS (itches a little bit) and TENDERNESS (a little bit tender). At the time of the report, RASH MACULAR (large red spot), PRURITUS (itches a little bit) and TENDERNESS (a little bit tender) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.   This case was linked to MOD21-017590, MOD21-017606 (E2B Linked Report). This case was linked to MOD-2021-019286 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Non-significant follow-up received on 19-Apr-2021, appended in the case on 27-Apr-2021.; Sender's Comments:  MOD21-017590: MOD21-017606:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eyelid thickening, Fatigue, Headache, Rash
Clinical narrative: Drooping eyelids; swelling in neck on both sides; swelling of both eyelids; Skin on neck appears pink; Light headedness; SKIN ON NECK APPEARS PINK; Headache; Fatigue; face swollen on right side; This spontaneous case was reported by a consumer and describes the occurrence of EYELID THICKENING (Drooping eyelids), SWELLING (swelling in neck on both sides), SWELLING OF EYELID (swelling of both eyelids), SKIN DISCOLOURATION (Skin on neck appears pink) and DIZZINESS (Light headedness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced SWELLING FACE (face swollen on right side), HEADACHE (Headache) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced EYELID THICKENING (Drooping eyelids), SWELLING (swelling in neck on both sides), SWELLING OF EYELID (swelling of both eyelids), SKIN DISCOLOURATION (Skin on neck appears pink), DIZZINESS (Light headedness) and RASH (SKIN ON NECK APPEARS PINK). The patient was treated with PREDNISONE at a dose of 1 dosage form. On 31-Jan-2021, HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, EYELID THICKENING (Drooping eyelids), SWELLING (swelling in neck on both sides), SWELLING OF EYELID (swelling of both eyelids), SKIN DISCOLOURATION (Skin on neck appears pink), DIZZINESS (Light headedness), SWELLING FACE (face swollen on right side) and RASH (SKIN ON NECK APPEARS PINK) 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.   Patient had a teladoc appointment with their HCP. The HCP prescribed prednisone for three days. According to the patient, the HCP could not make a determination whether the reaction was related to the vaccine or something else   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up received
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Swelling, Swelling face, Swelling of eyelid
Clinical narrative: Drooping eyelids; swelling in neck on both sides; swelling of both eyelids; Skin on neck appears pink; Light headedness; SKIN ON NECK APPEARS PINK; Headache; Fatigue; face swollen on right side; This spontaneous case was reported by a consumer and describes the occurrence of EYELID THICKENING (Drooping eyelids), SWELLING (swelling in neck on both sides), SWELLING OF EYELID (swelling of both eyelids), SKIN DISCOLOURATION (Skin on neck appears pink) and DIZZINESS (Light headedness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced SWELLING FACE (face swollen on right side), HEADACHE (Headache) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced EYELID THICKENING (Drooping eyelids), SWELLING (swelling in neck on both sides), SWELLING OF EYELID (swelling of both eyelids), SKIN DISCOLOURATION (Skin on neck appears pink), DIZZINESS (Light headedness) and RASH (SKIN ON NECK APPEARS PINK). The patient was treated with PREDNISONE at a dose of 1 dosage form. On 31-Jan-2021, HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, EYELID THICKENING (Drooping eyelids), SWELLING (swelling in neck on both sides), SWELLING OF EYELID (swelling of both eyelids), SKIN DISCOLOURATION (Skin on neck appears pink), DIZZINESS (Light headedness), SWELLING FACE (face swollen on right side) and RASH (SKIN ON NECK APPEARS PINK) 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.   Patient had a teladoc appointment with their HCP. The HCP prescribed prednisone for three days. According to the patient, the HCP could not make a determination whether the reaction was related to the vaccine or something else   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up received
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Tremor (L) and (R) hand, arm; fever, chills; Pain at injection site; Headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremor (L) and (R) hand, arm), VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache), ARTHRALGIA (joint pain) and PYREXIA (fever, chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache) and ARTHRALGIA (joint pain). On 16-Jan-2021, the patient experienced PYREXIA (fever, chills). On 20-Jan-2021, the patient experienced TREMOR (Tremor (L) and (R) hand, arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Jan-2021, PYREXIA (fever, chills) had resolved. On 19-Jan-2021, VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache) and ARTHRALGIA (joint pain) had resolved. At the time of the report, TREMOR (Tremor (L) and (R) hand, arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.  The patient was under a doctor care for past 6 months for tremors.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information included outcome of the event tremor.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased, Ocular hyperaemia
Clinical narrative: Red eyes; Watery eyes; A spontaneous report was received from a consumer concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red eyes and watery eyes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, approximately seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced red eyes and watery eyes. The patient checked to ER (emergency room). Treatment for the event included olopatadine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events red eyes and watery eyes was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache, in a pain scale from 1 to 10 it's a 2, mostly in the front of his head, sometimes it goes to the sides; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache, in a pain scale from 1 to 10 it's a 2, mostly in the front of his head, sometimes it goes to the sides) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, PIOGLITAZONE, EMPAGLIFLOZIN, SIMVASTATIN and LISINOPRIL for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (headache, in a pain scale from 1 to 10 it's a 2, mostly in the front of his head, sometimes it goes to the sides). At the time of the report, HEADACHE (headache, in a pain scale from 1 to 10 it's a 2, mostly in the front of his head, sometimes it goes to the sides) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment medications include Acetaminophen and Ibuprofen.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Paraesthesia, Peripheral coldness
Clinical narrative: Her Skin was itchy; Her Skin was prickly; A little Fatigue; Tingling her left arm and fingers; Face was red and hot; Redness went down her neck; Her hands were cold; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling her left arm and fingers), FEELING HOT (Face was red and hot), ERYTHEMA (Redness went down her neck), PERIPHERAL COLDNESS (Her hands were cold) and PRURITUS (Her Skin was itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (oesophageal). Concurrent medical conditions included Hypertension and Cholesterol.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PARAESTHESIA (Tingling her left arm and fingers), FEELING HOT (Face was red and hot), ERYTHEMA (Redness went down her neck) and PERIPHERAL COLDNESS (Her hands were cold). On 30-Jan-2021, the patient experienced PRURITUS (Her Skin was itchy), PARAESTHESIA (Her Skin was prickly) and FATIGUE (A little Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 30-Jan-2021 at a dose of 1 dosage form. On 29-Jan-2021, FEELING HOT (Face was red and hot), ERYTHEMA (Redness went down her neck) and PERIPHERAL COLDNESS (Her hands were cold) had resolved. On 30-Jan-2021, PARAESTHESIA (Tingling her left arm and fingers), PRURITUS (Her Skin was itchy), PARAESTHESIA (Her Skin was prickly) and FATIGUE (A little Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified high blood pressure, cholesterol and gastric reflux medications.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received and contains Reporter contact details updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Her Skin was itchy; Her Skin was prickly; A little Fatigue; Tingling her left arm and fingers; Face was red and hot; Redness went down her neck; Her hands were cold; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling her left arm and fingers), FEELING HOT (Face was red and hot), ERYTHEMA (Redness went down her neck), PERIPHERAL COLDNESS (Her hands were cold) and PRURITUS (Her Skin was itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (oesophageal). Concurrent medical conditions included Hypertension and Cholesterol.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PARAESTHESIA (Tingling her left arm and fingers), FEELING HOT (Face was red and hot), ERYTHEMA (Redness went down her neck) and PERIPHERAL COLDNESS (Her hands were cold). On 30-Jan-2021, the patient experienced PRURITUS (Her Skin was itchy), PARAESTHESIA (Her Skin was prickly) and FATIGUE (A little Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 30-Jan-2021 at a dose of 1 dosage form. On 29-Jan-2021, FEELING HOT (Face was red and hot), ERYTHEMA (Redness went down her neck) and PERIPHERAL COLDNESS (Her hands were cold) had resolved. On 30-Jan-2021, PARAESTHESIA (Tingling her left arm and fingers), PRURITUS (Her Skin was itchy), PARAESTHESIA (Her Skin was prickly) and FATIGUE (A little Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified high blood pressure, cholesterol and gastric reflux medications.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received and contains Reporter contact details updated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination site reaction
Clinical narrative: Got shingles; Injection site reactions; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Got shingles) and VACCINATION SITE REACTION (Injection site reactions) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Got shingles) and VACCINATION SITE REACTION (Injection site reactions). The patient was treated with ANTIVIRALS ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Got shingles) and VACCINATION SITE REACTION (Injection site reactions) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. description of injection site reaction was not provided.  Patient's medical history including any past history of shingles is lacking . Further information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PYREXIA (Fever). On 01-Feb-2021, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details were not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Tired; sore arm; A spontaneous report was received from a consumer concerning a 74 years old, female patient who experienced Sore arm/vaccination site pain and tiredness/Fatigue.    The patient's medical history included Osteopenia. Products known to have been used by the patient, included Muscle relaxant, medicine for reflux and osteopenia.   On 05 JAN 2021 the patient received the first of two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscular in left arm for prophylaxis of COVID-19 infection.  On 03 FEB 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    After the first dose of vaccination on 05-JAN-21, patient experienced side effects from 06 Jan 2021 to 07 Jan 2021 like sore arm.   She stated that she did not feel the needle when administered. After the second dose on 03 Feb 2021, she experienced sore arm and tiredness. This time she felt the needle during administration.   Treatment information was not reported.   Action taken with the drug in response to the event(s) was not applicable.  The event(s), Sore arm and fatigue was unknown and product administration error was recovered.; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided by reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Initial additional: first dose date, event onset date and reporter (consumer) causality updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Injection site swelling
Clinical narrative: head pressure; dizziness/similar to vertigo; swelling at the injection site; leg fatigue; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021. The most recent information was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head pressure), DIZZINESS (dizziness/similar to vertigo), INJECTION SITE SWELLING (swelling at the injection site) and FATIGUE (leg fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEAD DISCOMFORT (head pressure), DIZZINESS (dizziness/similar to vertigo), INJECTION SITE SWELLING (swelling at the injection site) and FATIGUE (leg fatigue). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, HEAD DISCOMFORT (head pressure) had not resolved and DIZZINESS (dizziness/similar to vertigo), INJECTION SITE SWELLING (swelling at the injection site) and FATIGUE (leg fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient has had multiple reactions, some occurred 7 hours after initial dose and some developed later and are still ongoing. After 6 hours, she experienced head pressure and severe leg fatigue (described as similar to post workout) She also experienced dizziness similar to vertigo. Patient was scheduled to receive 2nd dose of vaccine on Feb 4th and still had swelling at the injection site and was asking for an opinion on if she should receive the next dose. Hence, it is not yet confirmed if second dose of vaccine was received.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non Significant FU: TCR : AE outcome, treatment medications update and follow up is declined
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Toothache
Clinical narrative: Severe teeth pain; Nerve inflammation; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Severe teeth pain), INFLAMMATION (Nerve inflammation) and HEADACHE (Severe headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced TOOTHACHE (Severe teeth pain), INFLAMMATION (Nerve inflammation) and HEADACHE (Severe headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, TOOTHACHE (Severe teeth pain), INFLAMMATION (Nerve inflammation) and HEADACHE (Severe headache) outcome was unknown.            Concomitant medications were not provided by the reporter.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.