chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested COVID positive after receiving vaccine; High fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID positive after receiving vaccine), PYREXIA (High fever), CHILLS (Chills) and FATIGUE (Fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL, PARICALCITOL (ZEMPLAR) and CHLORPHENAMINE MALEATE, PHENYLPROPANOLAMINE HYDROCHLORIDE (TRIACTIN [CHLORPHENAMINE MALEATE;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (High fever), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced COVID-19 (Tested COVID positive after receiving vaccine). At the time of the report, COVID-19 (Tested COVID positive after receiving vaccine), PYREXIA (High fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and negative (Negative) Patient tested negative for second COVID-19  test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-044606 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchiness at the site of injection; Rash above the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE RASH (Rash above the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE RASH (Rash above the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE RASH (Rash above the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site rash
Clinical narrative: Soreness of the arm; Real Itching; Two rashy spots around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm), PRURITUS (Real Itching) and VACCINATION SITE RASH (Two rashy spots around the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Diabetes and COPD.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of the arm), PRURITUS (Real Itching) and VACCINATION SITE RASH (Two rashy spots around the injection site). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm), PRURITUS (Real Itching) and VACCINATION SITE RASH (Two rashy spots around the injection site) 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.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: Neck pain; Arm pit pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) and PAIN (Arm pit pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced NECK PAIN (Neck pain) and PAIN (Arm pit pain). At the time of the report, NECK PAIN (Neck pain) and PAIN (Arm pit pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were provided. No Treatment information reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Feeling abnormal, Pain
Clinical narrative: Mental fogginess; Clammy feeling; Body Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Mental fogginess), COLD SWEAT (Clammy feeling), PAIN (Body Aches) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Nerve damage.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Mental fogginess), COLD SWEAT (Clammy feeling), PAIN (Body Aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Chills, General body pain and Clammy, at an unspecified dose and frequency. On 20-Feb-2021, COLD SWEAT (Clammy feeling), PAIN (Body Aches) and CHILLS (Chills) had resolved. At the time of the report, FEELING ABNORMAL (Mental fogginess) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood Pressure pill, nerve damage pill.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Headache, Pyrexia
Clinical narrative: loss of taste; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), HEADACHE (Headache) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 AGEUSIA (loss of taste), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, AGEUSIA (loss of taste), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: weak; Flu like symptoms; Sore arm; Really tired; fever after the second dose; Chills really bad; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), FATIGUE (Really tired) and PYREXIA (fever after the second dose) in a 78-year-old patient of an unknown gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), FATIGUE (Really tired), PYREXIA (fever after the second dose) and CHILLS (Chills really bad). At the time of the report, ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), FATIGUE (Really tired), PYREXIA (fever after the second dose) and CHILLS (Chills really bad) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: weak; Flu like symptoms; Sore arm; Really tired; fever after the second dose; Chills really bad; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), FATIGUE (Really tired) and PYREXIA (fever after the second dose) in a 78-year-old patient of an unknown gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), FATIGUE (Really tired), PYREXIA (fever after the second dose) and CHILLS (Chills really bad). At the time of the report, ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), FATIGUE (Really tired), PYREXIA (fever after the second dose) and CHILLS (Chills really bad) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Inflammation, Rash pruritic, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: New rash inflamed; New rash on front of whole arm which is inflammed and itchy; rash is hot to touch; Rash at injection site was inflammed and itchy; Rash at injection site was inflammed and itchy; Rash at injection site; Red circle at injection site about 5" across; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (New rash inflamed), RASH PRURITIC (New rash on front of whole arm which is inflammed and itchy), FEELING HOT (rash is hot to touch), VACCINATION SITE INFLAMMATION (Rash at injection site was inflammed and itchy) and VACCINATION SITE PRURITUS (Rash at injection site was inflammed and itchy) in a 42-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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (Rash at injection site was inflammed and itchy), VACCINATION SITE PRURITUS (Rash at injection site was inflammed and itchy), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE ERYTHEMA (Red circle at injection site about 5" across) and VACCINATION SITE SWELLING (Vaccination site swelling). On 09-Mar-2021, the patient experienced INFLAMMATION (New rash inflamed), RASH PRURITIC (New rash on front of whole arm which is inflammed and itchy) and FEELING HOT (rash is hot to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. In March 2021, VACCINATION SITE PRURITUS (Rash at injection site was inflammed and itchy), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. At the time of the report, INFLAMMATION (New rash inflamed), RASH PRURITIC (New rash on front of whole arm which is inflammed and itchy), FEELING HOT (rash is hot to touch) and VACCINATION SITE ERYTHEMA (Red circle at injection site about 5" across) had not resolved and VACCINATION SITE INFLAMMATION (Rash at injection site was inflammed and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: New rash inflamed; New rash on front of whole arm which is inflammed and itchy; rash is hot to touch; Rash at injection site was inflammed and itchy; Rash at injection site was inflammed and itchy; Rash at injection site; Red circle at injection site about 5" across; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (New rash inflamed), RASH PRURITIC (New rash on front of whole arm which is inflammed and itchy), FEELING HOT (rash is hot to touch), VACCINATION SITE INFLAMMATION (Rash at injection site was inflammed and itchy) and VACCINATION SITE PRURITUS (Rash at injection site was inflammed and itchy) in a 42-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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (Rash at injection site was inflammed and itchy), VACCINATION SITE PRURITUS (Rash at injection site was inflammed and itchy), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE ERYTHEMA (Red circle at injection site about 5" across) and VACCINATION SITE SWELLING (Vaccination site swelling). On 09-Mar-2021, the patient experienced INFLAMMATION (New rash inflamed), RASH PRURITIC (New rash on front of whole arm which is inflammed and itchy) and FEELING HOT (rash is hot to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. In March 2021, VACCINATION SITE PRURITUS (Rash at injection site was inflammed and itchy), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. At the time of the report, INFLAMMATION (New rash inflamed), RASH PRURITIC (New rash on front of whole arm which is inflammed and itchy), FEELING HOT (rash is hot to touch) and VACCINATION SITE ERYTHEMA (Red circle at injection site about 5" across) had not resolved and VACCINATION SITE INFLAMMATION (Rash at injection site was inflammed and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia
Clinical narrative: Difficulties moving her arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Difficulties moving her arm) 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 26-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 HYPOKINESIA (Difficulties moving her arm). At the time of the report, HYPOKINESIA (Difficulties moving her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue
Clinical narrative: Wiped out; She was Extremely tired and no energy; Father stated that she slept and stayed in bed for most of the day on Saturday and Sunday which; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ASTHENIA (Wiped out), FATIGUE (She was Extremely tired and no energy) and ARTHRALGIA (Father stated that she slept and stayed in bed for most of the day on Saturday and Sunday which) 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 13-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 13-Mar-2021, the patient experienced ASTHENIA (Wiped out), FATIGUE (She was Extremely tired and no energy) and ARTHRALGIA (Father stated that she slept and stayed in bed for most of the day on Saturday and Sunday which). On 15-Mar-2021, ASTHENIA (Wiped out) and FATIGUE (She was Extremely tired and no energy) had resolved. At the time of the report, ARTHRALGIA (Father stated that she slept and stayed in bed for most of the day on Saturday and Sunday which) had not resolved.            No treatment was given for events.  No concomitant medications were reported.   This case was linked to MOD21-053529 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore Arm (left); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore Arm (left)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE PAIN (Sore Arm (left)). At the time of the report, INJECTION SITE PAIN (Sore Arm (left)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Peripheral coldness
Clinical narrative: feels worse; Patient is freezing/hands and feet are ice; Fatigue/wants to lay down and take a nap under many blankets; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels worse), PERIPHERAL COLDNESS (Patient is freezing/hands and feet are ice), FATIGUE (Fatigue/wants to lay down and take a nap under many blankets) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feels worse), PERIPHERAL COLDNESS (Patient is freezing/hands and feet are ice), FATIGUE (Fatigue/wants to lay down and take a nap under many blankets) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feels worse), PERIPHERAL COLDNESS (Patient is freezing/hands and feet are ice), FATIGUE (Fatigue/wants to lay down and take a nap under many blankets) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Muscle cramps on the outer side of his right lower leg; A spontaneous report was received from a consumer concerning a 71-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle cramps on the outer side of his right lower leg/muscle spasms.  The patient's medical history mentions radiation therapy for prostate cancer and anterior fusion of the neck in 2003. Concomitant medications were not provided.  On 10 Feb 2021, approximately 22 days prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Mar 2021, post the first dose of the vaccine, the patient experienced muscle cramps on the outer side of his right lower leg between the knee and the ankle. This would occur when he puts pressure on his right butt cheek. The cramps had become worse to the point that he cannot walk.  On 10 Mar 2021, the patient received the second of the two planned doses of mRNA-1273 (Batch number: 001B21A) in the right arm for prophylaxis of COVID-19 infection.   The event, experienced muscle cramps on the outer side of his right lower leg, was deemed a disability due to mention of not being able to walk.  Treatment information mentioned baclofen and applied foam patches and a hot and cold compress. Lab tests were not provided.  Action taken with mRNA-1273 in response to the events was not applicable as patient took both doses of the vaccine.  The outcome of the events, muscle cramps on the outer side of his right lower leg, was considered unknown.; 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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose decreased, Dizziness, Fatigue, Headache
Clinical narrative: Antibody testing results which indicated a severe allergic reaction/ serious adverse event.; Injection arm went numb from her elbow to her fingers.; Felt like sugars were low for about 5 hours; Dizziness; Muscle pain; Joint pain; Couldn't do anything and she was very fatigue and exhausted; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Antibody testing results which indicated a severe allergic reaction/ serious adverse event.), INJECTION SITE HYPOAESTHESIA (Injection arm went numb from her elbow to her fingers.), BLOOD GLUCOSE DECREASED (Felt like sugars were low for about 5 hours), DIZZINESS (Dizziness) and MYALGIA (Muscle pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERSENSITIVITY (Antibody testing results which indicated a severe allergic reaction/ serious adverse event.), INJECTION SITE HYPOAESTHESIA (Injection arm went numb from her elbow to her fingers.), BLOOD GLUCOSE DECREASED (Felt like sugars were low for about 5 hours), DIZZINESS (Dizziness), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Couldn't do anything and she was very fatigue and exhausted) and HEADACHE (Headache). At the time of the report, HYPERSENSITIVITY (Antibody testing results which indicated a severe allergic reaction/ serious adverse event.), INJECTION SITE HYPOAESTHESIA (Injection arm went numb from her elbow to her fingers.), BLOOD GLUCOSE DECREASED (Felt like sugars were low for about 5 hours), DIZZINESS (Dizziness), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Couldn't do anything and she was very fatigue and exhausted) outcome was unknown and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site hypoaesthesia, Myalgia
Clinical narrative: Antibody testing results which indicated a severe allergic reaction/ serious adverse event.; Injection arm went numb from her elbow to her fingers.; Felt like sugars were low for about 5 hours; Dizziness; Muscle pain; Joint pain; Couldn't do anything and she was very fatigue and exhausted; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Antibody testing results which indicated a severe allergic reaction/ serious adverse event.), INJECTION SITE HYPOAESTHESIA (Injection arm went numb from her elbow to her fingers.), BLOOD GLUCOSE DECREASED (Felt like sugars were low for about 5 hours), DIZZINESS (Dizziness) and MYALGIA (Muscle pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERSENSITIVITY (Antibody testing results which indicated a severe allergic reaction/ serious adverse event.), INJECTION SITE HYPOAESTHESIA (Injection arm went numb from her elbow to her fingers.), BLOOD GLUCOSE DECREASED (Felt like sugars were low for about 5 hours), DIZZINESS (Dizziness), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Couldn't do anything and she was very fatigue and exhausted) and HEADACHE (Headache). At the time of the report, HYPERSENSITIVITY (Antibody testing results which indicated a severe allergic reaction/ serious adverse event.), INJECTION SITE HYPOAESTHESIA (Injection arm went numb from her elbow to her fingers.), BLOOD GLUCOSE DECREASED (Felt like sugars were low for about 5 hours), DIZZINESS (Dizziness), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Couldn't do anything and she was very fatigue and exhausted) outcome was unknown and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Balance disorder, Depressed mood, Illness
Clinical narrative: really sick for 48 hrs; still has no energy,feels spaced out with no energy; feels sick to her stomach; feels off balance; Feels like on the ocean rocking; arm was really sore; nauseas; Lymph nodes at base of neck was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick for 48 hrs), ASTHENIA (still has no energy,feels spaced out with no energy), ABDOMINAL DISCOMFORT (feels sick to her stomach), BALANCE DISORDER (feels off balance) and DEPRESSED MOOD (Feels like on the ocean rocking ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Past medical history not provided).   On 05-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 05-Mar-2021, the patient experienced ILLNESS (really sick for 48 hrs), ASTHENIA (still has no energy,feels spaced out with no energy), ABDOMINAL DISCOMFORT (feels sick to her stomach), BALANCE DISORDER (feels off balance), DEPRESSED MOOD (Feels like on the ocean rocking ), PAIN IN EXTREMITY (arm was really sore), NAUSEA (nauseas) and LYMPHADENOPATHY (Lymph nodes at base of neck was swollen). At the time of the report, ILLNESS (really sick for 48 hrs), ASTHENIA (still has no energy,feels spaced out with no energy), ABDOMINAL DISCOMFORT (feels sick to her stomach), BALANCE DISORDER (feels off balance), DEPRESSED MOOD (Feels like on the ocean rocking ), PAIN IN EXTREMITY (arm was really sore), NAUSEA (nauseas) and LYMPHADENOPATHY (Lymph nodes at base of neck was swollen) outcome was unknown.            Concomitant medications taken by the patient were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: really sick for 48 hrs; still has no energy,feels spaced out with no energy; feels sick to her stomach; feels off balance; Feels like on the ocean rocking; arm was really sore; nauseas; Lymph nodes at base of neck was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick for 48 hrs), ASTHENIA (still has no energy,feels spaced out with no energy), ABDOMINAL DISCOMFORT (feels sick to her stomach), BALANCE DISORDER (feels off balance) and DEPRESSED MOOD (Feels like on the ocean rocking ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Past medical history not provided).   On 05-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 05-Mar-2021, the patient experienced ILLNESS (really sick for 48 hrs), ASTHENIA (still has no energy,feels spaced out with no energy), ABDOMINAL DISCOMFORT (feels sick to her stomach), BALANCE DISORDER (feels off balance), DEPRESSED MOOD (Feels like on the ocean rocking ), PAIN IN EXTREMITY (arm was really sore), NAUSEA (nauseas) and LYMPHADENOPATHY (Lymph nodes at base of neck was swollen). At the time of the report, ILLNESS (really sick for 48 hrs), ASTHENIA (still has no energy,feels spaced out with no energy), ABDOMINAL DISCOMFORT (feels sick to her stomach), BALANCE DISORDER (feels off balance), DEPRESSED MOOD (Feels like on the ocean rocking ), PAIN IN EXTREMITY (arm was really sore), NAUSEA (nauseas) and LYMPHADENOPATHY (Lymph nodes at base of neck was swollen) outcome was unknown.            Concomitant medications taken by the patient were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Incorrect dose administered, Vaccination site discharge, Vaccination site pain
Clinical narrative: Vaccine leaked out of their arm so they're worrried that they did not get the full dose; Vaccine leaked out of their arm so they're worrried that they did not get the full dose; Felt some cold in their arm; Bit of pain in their arm; A spontaneous report was received from a 45 year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine leaked out of their arm so they're worried that they did not get the full dose/ Vaccination site discharge and  Inappropriate dose of vaccine administered, felt some cold in their arm/ feeling cold and bit of pain in their arm/vaccination site pain.  The patient's medical history and concomitant medications were not provided.    On 01 Mar 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 01ZAZ1A) in left arm for COVID-19 infection prophylaxis.  On 01 Mar 2021, the patient got the vaccine and picture of it showed that the vaccine leaked out of his arm so they're worried that they did not get the full dose. The photo also shows that the needle was still inside, and the vaccine was leaking out. Patient felt some cold in arm and thought that it was because the vaccine was going in, but was not sure how much of it got in or not, because the person that administered the vaccine cleaned the injection site after and also under their arm. Patient also had a bit of pain in his arm.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, felt some cold in their arm, vaccine leaked out of their arm so they're worried that they did not get the full dose/ Vaccination site discharge and  Inappropriate dose of vaccine administered was resolved; whereas, the outcome of, bit of pain in their arm, was unknown.; Reporter's Comments: This report refers to a case of (vaccination site discharge and incorrect dose administered) for mRNA-1273 (lot# 01ZAZ1A). Based on the current available information and temporal association between the use of the product and the start date of the events (feeling cold and vaccination site pain), a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fluid retention, Oedema peripheral, Peripheral swelling
Clinical narrative: Water retention and swelling in legs below knee; Water retention and swelling in legs below knee; Lower Limb Edema; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema). At the time of the report, FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema) outcome was unknown.            Patient concomitantly takes pills for hypertension.   No treatment information was provided.   This case was linked to MOD-2021-044513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No new information added in the FU as Lower Limb edema Event persists before also with the patient .
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 13-Mar-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 13-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Action taken with the mRNA-1273 in response to the event is not applicable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itching on the arm down the injection site; Bullet rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching on the arm down the injection site) and INJECTION SITE RASH (Bullet rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (lymph nodes removed on both her arms and one of the leg). Concomitant products included OLMESARTAN, METOPROLOL and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 26-Feb-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 INJECTION SITE PRURITUS (Itching on the arm down the injection site) and INJECTION SITE RASH (Bullet rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 15-Mar-2021 at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Itching on the arm down the injection site) and INJECTION SITE RASH (Bullet rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Thyroid Medication. The patient mentioned that she got lymph nodes removed on both her arms and one of the leg   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Dizziness, Fatigue
Clinical narrative: backache; feeling terrible; pain in left knee, excruciating and cannot bend the knee; Red hot lump at injection site; hard, red hot lump at injection site; Itching at injection site; Red hot lump at injection site; Swelling at injection site 2.5 inches; Throwing up; Feeling weak and tired; Low grade fever; head was hurting; Felt weak; Dizziness; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), BACK PAIN (backache) and MALAISE (feeling terrible) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PREGABALIN, BIOTIN and VITAMINS NOS for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 ASTHENIA (Felt weak), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), VOMITING (Throwing up), FATIGUE (Feeling weak and tired), PYREXIA (Low grade fever) and HEADACHE (head was hurting). On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Red hot lump at injection site), VACCINATION SITE MASS (hard, red hot lump at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red hot lump at injection site) and VACCINATION SITE SWELLING (Swelling at injection site 2.5 inches). On 12-Mar-2021, the patient experienced BACK PAIN (backache), MALAISE (feeling terrible) and ARTHRALGIA (pain in left knee, excruciating and cannot bend the knee). On 10-Mar-2021, PYREXIA (Low grade fever) had resolved. At the time of the report, ASTHENIA (Felt weak), SOMNOLENCE (Sleepy), BACK PAIN (backache), MALAISE (feeling terrible), VACCINATION SITE WARMTH (Red hot lump at injection site), VACCINATION SITE MASS (hard, red hot lump at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red hot lump at injection site), VACCINATION SITE SWELLING (Swelling at injection site 2.5 inches), VOMITING (Throwing up), FATIGUE (Feeling weak and tired) and ARTHRALGIA (pain in left knee, excruciating and cannot bend the knee) outcome was unknown and DIZZINESS (Dizziness) and HEADACHE (head was hurting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Ultrasound Doppler: normal (normal) To rule out blood clot.   Action taken with mRNA-1273 in response to the events was not applicable     no treatment medications provided   This case was linked to MOD-2021-044459 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pyrexia, Somnolence, Ultrasound Doppler
Clinical narrative: backache; feeling terrible; pain in left knee, excruciating and cannot bend the knee; Red hot lump at injection site; hard, red hot lump at injection site; Itching at injection site; Red hot lump at injection site; Swelling at injection site 2.5 inches; Throwing up; Feeling weak and tired; Low grade fever; head was hurting; Felt weak; Dizziness; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), BACK PAIN (backache) and MALAISE (feeling terrible) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PREGABALIN, BIOTIN and VITAMINS NOS for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 ASTHENIA (Felt weak), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), VOMITING (Throwing up), FATIGUE (Feeling weak and tired), PYREXIA (Low grade fever) and HEADACHE (head was hurting). On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Red hot lump at injection site), VACCINATION SITE MASS (hard, red hot lump at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red hot lump at injection site) and VACCINATION SITE SWELLING (Swelling at injection site 2.5 inches). On 12-Mar-2021, the patient experienced BACK PAIN (backache), MALAISE (feeling terrible) and ARTHRALGIA (pain in left knee, excruciating and cannot bend the knee). On 10-Mar-2021, PYREXIA (Low grade fever) had resolved. At the time of the report, ASTHENIA (Felt weak), SOMNOLENCE (Sleepy), BACK PAIN (backache), MALAISE (feeling terrible), VACCINATION SITE WARMTH (Red hot lump at injection site), VACCINATION SITE MASS (hard, red hot lump at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red hot lump at injection site), VACCINATION SITE SWELLING (Swelling at injection site 2.5 inches), VOMITING (Throwing up), FATIGUE (Feeling weak and tired) and ARTHRALGIA (pain in left knee, excruciating and cannot bend the knee) outcome was unknown and DIZZINESS (Dizziness) and HEADACHE (head was hurting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Ultrasound Doppler: normal (normal) To rule out blood clot.   Action taken with mRNA-1273 in response to the events was not applicable     no treatment medications provided   This case was linked to MOD-2021-044459 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: backache; feeling terrible; pain in left knee, excruciating and cannot bend the knee; Red hot lump at injection site; hard, red hot lump at injection site; Itching at injection site; Red hot lump at injection site; Swelling at injection site 2.5 inches; Throwing up; Feeling weak and tired; Low grade fever; head was hurting; Felt weak; Dizziness; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), BACK PAIN (backache) and MALAISE (feeling terrible) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PREGABALIN, BIOTIN and VITAMINS NOS for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 ASTHENIA (Felt weak), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), VOMITING (Throwing up), FATIGUE (Feeling weak and tired), PYREXIA (Low grade fever) and HEADACHE (head was hurting). On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Red hot lump at injection site), VACCINATION SITE MASS (hard, red hot lump at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red hot lump at injection site) and VACCINATION SITE SWELLING (Swelling at injection site 2.5 inches). On 12-Mar-2021, the patient experienced BACK PAIN (backache), MALAISE (feeling terrible) and ARTHRALGIA (pain in left knee, excruciating and cannot bend the knee). On 10-Mar-2021, PYREXIA (Low grade fever) had resolved. At the time of the report, ASTHENIA (Felt weak), SOMNOLENCE (Sleepy), BACK PAIN (backache), MALAISE (feeling terrible), VACCINATION SITE WARMTH (Red hot lump at injection site), VACCINATION SITE MASS (hard, red hot lump at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red hot lump at injection site), VACCINATION SITE SWELLING (Swelling at injection site 2.5 inches), VOMITING (Throwing up), FATIGUE (Feeling weak and tired) and ARTHRALGIA (pain in left knee, excruciating and cannot bend the knee) outcome was unknown and DIZZINESS (Dizziness) and HEADACHE (head was hurting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Ultrasound Doppler: normal (normal) To rule out blood clot.   Action taken with mRNA-1273 in response to the events was not applicable     no treatment medications provided   This case was linked to MOD-2021-044459 (Patient Link).