chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: Antibody test negative; This spontaneous case was reported by a physician and describes the occurrence of ANTIBODY TEST NEGATIVE (Antibody test negative) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Waldenstrom's macroglobulinemia.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Antibody test negative). At the time of the report, ANTIBODY TEST NEGATIVE (Antibody test negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: unknown (Negative) Antibody test negative.     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 concomitant medications were reported. Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: The follow up received on 27 MAY 2021 contain non significant information
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Slight headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. L-031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.   This case was linked to MOD-2021-037928 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Red rash at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Red rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 INJECTION SITE RASH (Red rash at injection site). At the time of the report, INJECTION SITE RASH (Red rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; bodyache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (bodyache) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 26-May-2021, the patient experienced PYREXIA (Fever), MYALGIA (bodyache) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), MYALGIA (bodyache) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Body temperature: inconclusive (Inconclusive) fever.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Malaise, Palpitations
Clinical narrative: not feeling well; heart palpitations; touble breathing; coughing all night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), PALPITATIONS (heart palpitations), COUGH (coughing all night) and DYSPNOEA (touble breathing) 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-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced COUGH (coughing all night). On an unknown date, the patient experienced MALAISE (not feeling well), PALPITATIONS (heart palpitations) and DYSPNOEA (touble breathing). At the time of the report, MALAISE (not feeling well), PALPITATIONS (heart palpitations), COUGH (coughing all night) and DYSPNOEA (touble breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter.  No treatment information reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first Moderna vaccine 3/24/21 but did not receive their second dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first Moderna vaccine 3/24/21 but did not receive their second dose.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first Moderna vaccine 3/24/21 but did not receive their second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first Moderna vaccine 3/24/21 but did not receive their second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided. treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: First shot gave me vertigo; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (First shot gave me vertigo) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (First shot gave me vertigo). At the time of the report, VERTIGO (First shot gave me vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-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 VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 470 (High) blood sugar level was 470  and was still up did  not went down.         Patient had received first dose on the first week of March, received the second dose on 10 Apr 2021. No relevant concomitant medications were provided. Patient was a diabetic but was on no medication for the past year. Patient experienced a sore arm and a 470 blood sugar level and was still up and not going down. No treatment information was provided. The action taken for mRNA-1273 was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness at the injection site; swelling at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: Have you heard of numbness on the arm after the shot; Have you heard of cold on the arm after the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Have you heard of numbness on the arm after the shot) and PERIPHERAL COLDNESS (Have you heard of cold on the arm after the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Have you heard of numbness on the arm after the shot) and PERIPHERAL COLDNESS (Have you heard of cold on the arm after the shot). At the time of the report, HYPOAESTHESIA (Have you heard of numbness on the arm after the shot) and PERIPHERAL COLDNESS (Have you heard of cold on the arm after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vials stored in refrigerator from 21 Apr until their administration on 25 May; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials stored in refrigerator from 21 Apr until their administration on 25 May) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-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 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials stored in refrigerator from 21 Apr until their administration on 25 May). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Vials stored in refrigerator from 21 Apr until their administration on 25 May) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; fever; chills; my body is aching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (my body is aching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (my body is aching). At the time of the report, HEADACHE (Headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (my body is aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information provided.    AE submitted  -Headache fever chills  -I just received my shot yesterday now my body is aching and i feel like i have a headache yet   Reporter did not allow further contact
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 25-May-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) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Memory impairment
Clinical narrative: Short-term memory is really bad; Hard time breathing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Short-term memory is really bad) and DYSPNOEA (Hard time breathing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 MEMORY IMPAIRMENT (Short-term memory is really bad) and DYSPNOEA (Hard time breathing). At the time of the report, MEMORY IMPAIRMENT (Short-term memory is really bad) and DYSPNOEA (Hard time breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Magnetic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Magnetic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Magnetic reaction). At the time of the report, HYPERSENSITIVITY (Magnetic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness around vaccination site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (soreness around vaccination site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness around vaccination site). On 27-Apr-2021, VACCINATION SITE PAIN (soreness around vaccination site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  Company comment: 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.   This case was linked to MOD-2021-181520 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-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) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Treatment information was not provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: painful; almost hard to move the arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (painful) and JOINT RANGE OF MOTION DECREASED (almost hard to move the arm) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ISOTRETINOIN (ACCUTANE) for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PAIN (painful) and JOINT RANGE OF MOTION DECREASED (almost hard to move the arm). At the time of the report, PAIN (painful) and JOINT RANGE OF MOTION DECREASED (almost hard to move the 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 treatment medication was reported .
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Mouth ulceration, Oral mucosal roughening, Pain in extremity, Rash erythematous
Clinical narrative: arm pain/sore arm; small red rash in the upper arm; small patches that feel rough inside the mouth; burst blister that do not hurt; spots in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain/sore arm), RASH ERYTHEMATOUS (small red rash in the upper arm), ORAL MUCOSAL ROUGHENING (small patches that feel rough inside the mouth), BLISTER (burst blister that do not hurt) and MOUTH ULCERATION (spots in the mouth) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Concomitant products included Ritalin for ADHD for ADHD, Eyedrop for glaucoma for Glaucoma, Medication for hypothyroidism for Hypothyroidism.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain/sore arm), RASH ERYTHEMATOUS (small red rash in the upper arm), ORAL MUCOSAL ROUGHENING (small patches that feel rough inside the mouth), BLISTER (burst blister that do not hurt) and MOUTH ULCERATION (spots in the mouth). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm pain/sore arm), RASH ERYTHEMATOUS (small red rash in the upper arm), ORAL MUCOSAL ROUGHENING (small patches that feel rough inside the mouth), BLISTER (burst blister that do not hurt) and MOUTH ULCERATION (spots in the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received first dose of Moderna Covid-19 vaccine on 16May2021. It was administered on the right dominant arm. Patient's arm was sore and developed a small red rash in the upper arm. But was concerned patient was a something never experienced before:  small patches that feel rough inside the mouth (inner part of cheeks). Patient described it as "burst blister that do not hurt" and "spots in the mouth". This last symptom has not subsided. Patient is nervous on getting second dose. Patient took Tylenol.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: soreness; Headache; Chills; mild fever; body aches; pain in major joints; fatigued; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (soreness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (mild fever) and MYALGIA (body aches) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE PAIN (soreness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (mild fever), MYALGIA (body aches), ARTHRALGIA (pain in major joints) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-May-2021, VACCINATION SITE PAIN (soreness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (mild fever), MYALGIA (body aches), ARTHRALGIA (pain in major joints) and FATIGUE (fatigued) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took 2 dosed of Tylenol.  Company comment: 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.   This case was linked to MOD-2021-181504 (Patient Link).; Sender'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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: soreness; Headache; Chills; mild fever; body aches; pain in major joints; fatigued; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (soreness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (mild fever) and MYALGIA (body aches) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE PAIN (soreness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (mild fever), MYALGIA (body aches), ARTHRALGIA (pain in major joints) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-May-2021, VACCINATION SITE PAIN (soreness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (mild fever), MYALGIA (body aches), ARTHRALGIA (pain in major joints) and FATIGUE (fatigued) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took 2 dosed of Tylenol.  Company comment: 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.   This case was linked to MOD-2021-181504 (Patient Link).; Sender'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.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspepsia, Throat irritation
Clinical narrative: heart burn; chestburn; chest discomfort; Burning in throat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heart burn), CHEST PAIN (chestburn), CHEST DISCOMFORT (chest discomfort) and THROAT IRRITATION (Burning in throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     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 DYSPEPSIA (heart burn), CHEST PAIN (chestburn), CHEST DISCOMFORT (chest discomfort) and THROAT IRRITATION (Burning in throat). At the time of the report, DYSPEPSIA (heart burn), CHEST PAIN (chestburn), CHEST DISCOMFORT (chest discomfort) and THROAT IRRITATION (Burning in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Platelet count increased
Clinical narrative: My platlet count is high; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT INCREASED (My platlet count is high) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT INCREASED (My platlet count is high). At the time of the report, PLATELET COUNT INCREASED (My platlet count is high) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided  Patient was due Saturday for last Moderna shot.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination complication
Clinical narrative: experiencing nearly all side effects; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experiencing nearly all side effects) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experiencing nearly all side effects) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (experiencing nearly all side effects) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported.  Treatment medication was not reported.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nauseous; a little vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and VOMITING (a little vomiting) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced NAUSEA (nauseous) and VOMITING (a little vomiting). At the time of the report, NAUSEA (nauseous) and VOMITING (a little vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Headache
Clinical narrative: Ear ache; Sharp pain in my head; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear ache) and HEADACHE (Sharp pain in my head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (Ear ache) and HEADACHE (Sharp pain in my head). At the time of the report, EAR PAIN (Ear ache) and HEADACHE (Sharp pain in my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Feeling abnormal, Pain of skin
Clinical narrative: Developed bruises on my lower legs and arms; Very stinging to the touch; Miserable with the stinging sensation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Developed bruises on my lower legs and arms), PAIN OF SKIN (Very stinging to the touch) and FEELING ABNORMAL (Miserable with the stinging sensation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-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 an unknown date, the patient experienced CONTUSION (Developed bruises on my lower legs and arms), PAIN OF SKIN (Very stinging to the touch) and FEELING ABNORMAL (Miserable with the stinging sensation). At the time of the report, CONTUSION (Developed bruises on my lower legs and arms) and PAIN OF SKIN (Very stinging to the touch) had not resolved and FEELING ABNORMAL (Miserable with the stinging sensation) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: I am feeling chills/I have chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (I am feeling chills/I have chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced CHILLS (I am feeling chills/I have chills). At the time of the report, CHILLS (I am feeling chills/I have chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Hypertension
Clinical narrative: chest pain; sudden very high blood pressure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and HYPERTENSION (sudden very high blood pressure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) and HYPERTENSION (sudden very high blood pressure). At the time of the report, CHEST PAIN (chest pain) and HYPERTENSION (sudden very high blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer
Clinical narrative: several canker sores in my mouth; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of APHTHOUS ULCER (several canker sores in my mouth) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced APHTHOUS ULCER (several canker sores in my mouth). At the time of the report, APHTHOUS ULCER (several canker sores in my mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Headache, Myalgia
Clinical narrative: Felt weak and achy; Could hardly walk from one room to the next; Really bad headache/Headache comes back every often and last for 3days; Felt weak and achy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak and achy), GAIT DISTURBANCE (Could hardly walk from one room to the next), HEADACHE (Really bad headache/Headache comes back every often and last for 3days) and MYALGIA (Felt weak and achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-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 ASTHENIA (Felt weak and achy), GAIT DISTURBANCE (Could hardly walk from one room to the next), HEADACHE (Really bad headache/Headache comes back every often and last for 3days) and MYALGIA (Felt weak and achy). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Felt weak and achy), GAIT DISTURBANCE (Could hardly walk from one room to the next), HEADACHE (Really bad headache/Headache comes back every often and last for 3days) and MYALGIA (Felt weak and achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: did not receive the second dose of the vaccine for 2 months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the vaccine for 2 months) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the vaccine for 2 months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the vaccine for 2 months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in my arm). At the time of the report, VACCINATION SITE PAIN (Pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Itchiness at injection site; hives at injection site; red at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE URTICARIA (hives at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE and CEFALEXIN (KEFLEX [CEFALEXIN]) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE URTICARIA (hives at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE URTICARIA (hives at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: very tired; and achy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired) and MYALGIA (and achy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History 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 FATIGUE (very tired) and MYALGIA (and achy). At the time of the report, FATIGUE (very tired) and MYALGIA (and achy) outcome was unknown.            No treatment and concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: a lot of swelling in my leg; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (a lot of swelling in my leg) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (a lot of swelling in my leg). At the time of the report, PERIPHERAL SWELLING (a lot of swelling in my leg) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: experiencing joint pain in hip and knees; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (experiencing joint pain in hip and knees) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (experiencing joint pain in hip and knees). At the time of the report, ARTHRALGIA (experiencing joint pain in hip and knees) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.