chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: Left arm swelled up to the "size of a soda can" / left arm is still swollen; Normal aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm swelled up to the "size of a soda can" / left arm is still swollen   ) and MYALGIA (Normal aches and pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced PERIPHERAL SWELLING (Left arm swelled up to the "size of a soda can" / left arm is still swollen   ) and MYALGIA (Normal aches and pain). At the time of the report, PERIPHERAL SWELLING (Left arm swelled up to the "size of a soda can" / left arm is still swollen   ) had not resolved and MYALGIA (Normal aches and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Diarrhoea, Flatulence, Stool analysis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea/got progressively worst) and FLATULENCE (Gassy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-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 DIARRHOEA (Diarrhea/got progressively worst) and FLATULENCE (Gassy). At the time of the report, DIARRHOEA (Diarrhea/got progressively worst) and FLATULENCE (Gassy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: negative (Negative) Negative. On an unknown date, Stool analysis: negative (Negative) Negative. No concomitant medication was provided. Treatment medication was not provided by the reporter. Patient started to have diarrhea, which got progressively worst, a bad diarrhea, gassy, on 24May2021 it was bad, he's had it ever since, went to multiple doctors, he only receives treatment. This case was linked to MOD-2021-279487 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving a dose from a vial that was opened more than 12hs before vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving a dose from a vial that was opened more than 12hs before vaccination) in a 59-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 06-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving a dose from a vial that was opened more than 12hs before vaccination). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (receiving a dose from a vial that was opened more than 12hs before vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took unknown medication as concomitant drug.  No treatment drug information was provided by reporter.  Medical Assistant called as 4 patients received doses from 1 vial between 1 to 2pm on the 06Aug2021, which was first opened on 05Aug2021 at 9:20 am.
Sex: U
Vaccine: COVID19
Symptoms: Cardiomegaly, Pain in extremity
Clinical narrative: Arm hurts; Possible heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) and CARDIOMEGALY (Possible heart inflammation) 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 PAIN IN EXTREMITY (Arm hurts) and CARDIOMEGALY (Possible heart inflammation). At the time of the report, PAIN IN EXTREMITY (Arm hurts) and CARDIOMEGALY (Possible heart inflammation) 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 provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood pressure measurement, Dizziness, Feeding disorder
Clinical narrative: Has not received the second dose > 4 months after the first dose; every time she tried to get-up, she almost passed out; Lightheaded; Low Blood Pressure (90/60 mmHg); Could not eat anything; Loss of sense of smell; Loss of sense of taste; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure (90/60 mmHg)), FEEDING DISORDER (Could not eat anything), ANOSMIA (Loss of sense of smell) and AGEUSIA (Loss of sense of taste) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure (90/60 mmHg)), FEEDING DISORDER (Could not eat anything), ANOSMIA (Loss of sense of smell), AGEUSIA (Loss of sense of taste) and PRESYNCOPE (every time she tried to get-up, she almost passed out). On 06-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose > 4 months after the first dose). On 04-May-2021, DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure (90/60 mmHg)), FEEDING DISORDER (Could not eat anything), ANOSMIA (Loss of sense of smell), AGEUSIA (Loss of sense of taste) and PRESYNCOPE (every time she tried to get-up, she almost passed out) had resolved. On 06-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose > 4 months after the first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Blood pressure measurement: 90/60 mmhg (Low) 90/60 mmHg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Presyncope, Product dose omission issue
Clinical narrative: Has not received the second dose > 4 months after the first dose; every time she tried to get-up, she almost passed out; Lightheaded; Low Blood Pressure (90/60 mmHg); Could not eat anything; Loss of sense of smell; Loss of sense of taste; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure (90/60 mmHg)), FEEDING DISORDER (Could not eat anything), ANOSMIA (Loss of sense of smell) and AGEUSIA (Loss of sense of taste) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure (90/60 mmHg)), FEEDING DISORDER (Could not eat anything), ANOSMIA (Loss of sense of smell), AGEUSIA (Loss of sense of taste) and PRESYNCOPE (every time she tried to get-up, she almost passed out). On 06-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose > 4 months after the first dose). On 04-May-2021, DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure (90/60 mmHg)), FEEDING DISORDER (Could not eat anything), ANOSMIA (Loss of sense of smell), AGEUSIA (Loss of sense of taste) and PRESYNCOPE (every time she tried to get-up, she almost passed out) had resolved. On 06-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose > 4 months after the first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Blood pressure measurement: 90/60 mmhg (Low) 90/60 mmHg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Localised infection, Paraesthesia, Peripheral swelling, Rash
Clinical narrative: my arm is swollen; tingling; COVID arm; arm is infected; redness is spreading; rash on front side of the arm, almost going to the under arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm is swollen), PARAESTHESIA (tingling), VACCINATION COMPLICATION (COVID arm), LOCALISED INFECTION (arm is infected) and ERYTHEMA (redness is spreading) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (my arm is swollen), PARAESTHESIA (tingling), VACCINATION COMPLICATION (COVID arm), LOCALISED INFECTION (arm is infected), ERYTHEMA (redness is spreading) and RASH (rash on front side of the arm, almost going to the under arm). At the time of the report, PERIPHERAL SWELLING (my arm is swollen), PARAESTHESIA (tingling), VACCINATION COMPLICATION (COVID arm), LOCALISED INFECTION (arm is infected), ERYTHEMA (redness is spreading) and RASH (rash on front side of the arm, almost going to the under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product reported by reporter.  No treatment medication reported by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: my arm is swollen; tingling; COVID arm; arm is infected; redness is spreading; rash on front side of the arm, almost going to the under arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm is swollen), PARAESTHESIA (tingling), VACCINATION COMPLICATION (COVID arm), LOCALISED INFECTION (arm is infected) and ERYTHEMA (redness is spreading) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (my arm is swollen), PARAESTHESIA (tingling), VACCINATION COMPLICATION (COVID arm), LOCALISED INFECTION (arm is infected), ERYTHEMA (redness is spreading) and RASH (rash on front side of the arm, almost going to the under arm). At the time of the report, PERIPHERAL SWELLING (my arm is swollen), PARAESTHESIA (tingling), VACCINATION COMPLICATION (COVID arm), LOCALISED INFECTION (arm is infected), ERYTHEMA (redness is spreading) and RASH (rash on front side of the arm, almost going to the under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product reported by reporter.  No treatment medication reported by reporter.   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: arm pain/same symptoms; a little bit of a fever; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain/same symptoms), PYREXIA (a little bit of a fever), FATIGUE (fatigue) and MYALGIA (body aches) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second 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/same symptoms), PYREXIA (a little bit of a fever), FATIGUE (fatigue) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain/same symptoms), PYREXIA (a little bit of a fever), FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No  concomitant medication provided by the reporter.   This case was linked to MOD-2021-279498 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up received, includes no new information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient was positive for covid even after receiving both doses of vaccine; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Patient was positive for covid even after receiving both doses of vaccine) 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.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 COVID-19 (Patient was positive for covid even after receiving both doses of vaccine). At the time of the report, COVID-19 (Patient was positive for covid even after receiving both doses of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In the end of January, Covid test was performed with positive results  No concomitant medication was reported.                   No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient received the first dose in either April or May, past recommended interval; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient received the first dose in either April or May, past recommended interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient received the first dose in either April or May, past recommended interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient received the first dose in either April or May, past recommended interval) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fear of death, Myalgia
Clinical narrative: thought that was going to die; tremendous body ache/awful body ache; This spontaneous case was reported by a consumer and describes the occurrence of FEAR OF DEATH (thought that was going to die) and MYALGIA (tremendous body ache/awful body ache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 041L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included OMEPRAZOLE and BACLOFEN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEAR OF DEATH (thought that was going to die) and MYALGIA (tremendous body ache/awful body ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEAR OF DEATH (thought that was going to die) and MYALGIA (tremendous body ache/awful body ache) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Product dose omission issue
Clinical narrative: blisters in her mouth; it has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine. This spontaneous case was reported by a pharmacist and describes the occurrence of ORAL MUCOSAL BLISTERING (blisters in her mouth) and PRODUCT DOSE OMISSION ISSUE (it has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL MUCOSAL BLISTERING (blisters in her mouth) and PRODUCT DOSE OMISSION ISSUE (it has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine.). At the time of the report, ORAL MUCOSAL BLISTERING (blisters in her mouth) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (it has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after more than 30 days in the refrigerator/Outside recommended dosing window; Vaccine administered after more than 30 days in the refrigerator/Outside recommended dosing window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator/Outside recommended dosing window) and PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator/Outside recommended dosing window) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator/Outside recommended dosing window) and PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator/Outside recommended dosing window). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator/Outside recommended dosing window) and PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator/Outside recommended dosing window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine) 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 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 PRODUCT DOSE OMISSION ISSUE (It has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient stated that he wanted to get Johnson & Johnson Covid-19 Vaccine, since they have not gotten their second dose of  Moderna Covid-19 Vaccine. Pharmacist also mentioned that it has been 5 months since they have got their first dose of Moderna Covid-19 Vaccine. Patient did not experience any side effects after first dose.  No treatment information was provided.   This case was linked to MOD-2021-279675 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction (after a mosquito bite he reacted with an allergic like response all over the body,last for a couple of days and this last weekend happened again).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (headache). On 25-Mar-2021, HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-279707 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic pain.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in arm). At the time of the report, VACCINATION SITE PAIN (pain in arm) had resolved.            Patient stated she suffers from chronic pain already and she is a sick person anyway.  No treatment and concomitant medications were provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pain in extremity, Pruritus
Clinical narrative: Allergy from mosquito all over body; felt tired for 2 days; arm soreness; Arm Itchy; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PRURITUS (Arm Itchy), HYPERSENSITIVITY (Allergy from mosquito all over body) and FATIGUE (felt tired for 2 days) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to arthropod bite (Patient experienced the same allergic reaction from vaccine that he experienced one month ago after a mosquito bite. He had an allergic reaction all over his body which lasted for a couple of days.).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), PRURITUS (Arm Itchy) and FATIGUE (felt tired for 2 days). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy from mosquito all over body). On 27-Apr-2021, FATIGUE (felt tired for 2 days) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness), PRURITUS (Arm Itchy) and HYPERSENSITIVITY (Allergy from mosquito all over body) outcome was unknown.            No concomitant medications were provided. No Treatment medications were provided.   This case was linked to MOD-2021-279689 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Somnolence, Vaccination site erythema, Vaccination site swelling
Clinical narrative: She also seem not to stay awake, was noted to sleep all day long; Two hours after getting the vaccine  she experienced headache; She also has a knot on the injection site which is swollen; She also has a knot on the injection site which is swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (She also seem not to stay awake, was noted to sleep all day long), HEADACHE (Two hours after getting the vaccine  she experienced headache), VACCINATION SITE SWELLING (She also has a knot on the injection site which is swollen) and VACCINATION SITE ERYTHEMA (She also has a knot on the injection site which is swollen and red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced SOMNOLENCE (She also seem not to stay awake, was noted to sleep all day long), HEADACHE (Two hours after getting the vaccine  she experienced headache), VACCINATION SITE SWELLING (She also has a knot on the injection site which is swollen) and VACCINATION SITE ERYTHEMA (She also has a knot on the injection site which is swollen and red). At the time of the report, SOMNOLENCE (She also seem not to stay awake, was noted to sleep all day long), HEADACHE (Two hours after getting the vaccine  she experienced headache), VACCINATION SITE SWELLING (She also has a knot on the injection site which is swollen) and VACCINATION SITE ERYTHEMA (She also has a knot on the injection site which is swollen and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not reported.  Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Nasal congestion, Pain
Clinical narrative: chest pain, comes and goes; nasal congestion; pain on the left side of her body; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (chest pain, comes and goes), CHEST DISCOMFORT (congested) and PAIN (pain on the left side of her body) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced CHEST PAIN (chest pain, comes and goes), CHEST DISCOMFORT (congested) and PAIN (pain on the left side of her body). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain, comes and goes), CHEST DISCOMFORT (congested) and PAIN (pain on the left side of her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information was provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Hiccups, Myalgia
Clinical narrative: Uncontrollable hiccups; Arm pain; Muscle pain; Chills; Fever; Tiredness; Skin redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Skin redness), HICCUPS (Uncontrollable hiccups), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle pain) and CHILLS (Chills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced ERYTHEMA (Skin redness), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness). On 04-Aug-2021, the patient experienced HICCUPS (Uncontrollable hiccups). At the time of the report, ERYTHEMA (Skin redness), HICCUPS (Uncontrollable hiccups), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow up received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Uncontrollable hiccups; Arm pain; Muscle pain; Chills; Fever; Tiredness; Skin redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Skin redness), HICCUPS (Uncontrollable hiccups), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle pain) and CHILLS (Chills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced ERYTHEMA (Skin redness), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness). On 04-Aug-2021, the patient experienced HICCUPS (Uncontrollable hiccups). At the time of the report, ERYTHEMA (Skin redness), HICCUPS (Uncontrollable hiccups), PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow up received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Contracted covid after both doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted covid after both doses) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced COVID-19 (Contracted covid after both doses). At the time of the report, COVID-19 (Contracted covid after both doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive..         No concomitant medications were reported. No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Motor dysfunction, Myalgia, Vaccination site movement impairment
Clinical narrative: it took it's toll on her left hand, which doesn't work as well anymore; The grasping & strength in her left hand are not as good; arm is difficulty to move; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (it took it's toll on her left hand, which doesn't work as well anymore), MOTOR DYSFUNCTION (The grasping & strength in her left hand are not as good), HYPOKINESIA (arm is difficulty to move) and MYALGIA (arm sore) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis. Concurrent medical conditions included Penicillin allergy. Concomitant products included PICOLAMINE SALICYLATE (REFLEX [PICOLAMINE SALICYLATE]) for Chronic UTI, LEVOTHYROXINE for Hypothyroidism, BOTULINUM TOXIN TYPE A (BOTOX) for Spastic bladder, NALTREXONE and GABAPENTIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (it took it's toll on her left hand, which doesn't work as well anymore), MOTOR DYSFUNCTION (The grasping & strength in her left hand are not as good), HYPOKINESIA (arm is difficulty to move) and MYALGIA (arm sore). On 17-Aug-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (it took it's toll on her left hand, which doesn't work as well anymore), MOTOR DYSFUNCTION (The grasping & strength in her left hand are not as good) and MYALGIA (arm sore) had resolved and HYPOKINESIA (arm is difficulty to move) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided by the reporter. The patient has severe MS and was in the wheelchair for years and was not sure whether the events caused by vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: follow up received on 10-sep-21 with New events, outcome concomitant medications was added.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving a dose from a vial that was opened more than 12hs before vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) in a 50-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 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial that was opened more than 12hs before vaccination) to be not applicable.    No treatment medications were provided. Concomitant medications were reported as unknown.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in neck, under jaw near adam's apple, midline; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in neck, under jaw near adam's apple, midline) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in neck, under jaw near adam's apple, midline). The patient was treated with PARACETAMOL (TYLENOL) for Swollen lymph nodes, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Swollen lymph nodes, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in neck, under jaw near adam's apple, midline) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypoaesthesia, Malaise, Myalgia
Clinical narrative: tingling in both arms and all the way down to their fingers; numbness in both arms and all the way down to their fingers; skin felt hypersensitive/ hurt to wash their hands; Fever; Chills; Body aches; Fatigue; Nausea; under the weather; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (under the weather), PARAESTHESIA (tingling in both arms and all the way down to their fingers), HYPOAESTHESIA (numbness in both arms and all the way down to their fingers), SENSITIVE SKIN (skin felt hypersensitive/ hurt to wash their hands) and PYREXIA (Fever) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient confirmed they had COVID last year) in 2020.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced MALAISE (under the weather). On 05-Aug-2021, the patient experienced PARAESTHESIA (tingling in both arms and all the way down to their fingers), HYPOAESTHESIA (numbness in both arms and all the way down to their fingers), SENSITIVE SKIN (skin felt hypersensitive/ hurt to wash their hands), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 05-Aug-2021, SENSITIVE SKIN (skin felt hypersensitive/ hurt to wash their hands), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, MALAISE (under the weather), PARAESTHESIA (tingling in both arms and all the way down to their fingers) and HYPOAESTHESIA (numbness in both arms and all the way down to their fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product information was not provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Pyrexia, Sensitive skin
Clinical narrative: tingling in both arms and all the way down to their fingers; numbness in both arms and all the way down to their fingers; skin felt hypersensitive/ hurt to wash their hands; Fever; Chills; Body aches; Fatigue; Nausea; under the weather; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (under the weather), PARAESTHESIA (tingling in both arms and all the way down to their fingers), HYPOAESTHESIA (numbness in both arms and all the way down to their fingers), SENSITIVE SKIN (skin felt hypersensitive/ hurt to wash their hands) and PYREXIA (Fever) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient confirmed they had COVID last year) in 2020.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced MALAISE (under the weather). On 05-Aug-2021, the patient experienced PARAESTHESIA (tingling in both arms and all the way down to their fingers), HYPOAESTHESIA (numbness in both arms and all the way down to their fingers), SENSITIVE SKIN (skin felt hypersensitive/ hurt to wash their hands), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 05-Aug-2021, SENSITIVE SKIN (skin felt hypersensitive/ hurt to wash their hands), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, MALAISE (under the weather), PARAESTHESIA (tingling in both arms and all the way down to their fingers) and HYPOAESTHESIA (numbness in both arms and all the way down to their fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: caller received the 1st dose of the Moderna vaccine on January 2021 and didn't receive the 2nd one; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (caller received the 1st dose of the Moderna vaccine on January 2021 and didn't receive the 2nd one) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (caller received the 1st dose of the Moderna vaccine on January 2021 and didn't receive the 2nd one). In January 2021, PRODUCT DOSE OMISSION ISSUE (caller received the 1st dose of the Moderna vaccine on January 2021 and didn't receive the 2nd one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Appetite lost; Lethargic; diarrhea; little bit of shortness of breath at times; coughing up phlegm when using their CPAP machine at night; muscle pain; headache\ pain in the right temple; feeling like they are going to vomit; Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite lost), LETHARGY (Lethargic), DIARRHOEA (diarrhea), DYSPNOEA (little bit of shortness of breath at times) and PRODUCTIVE COUGH (coughing up phlegm when using their CPAP machine at night) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.     On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced DECREASED APPETITE (Appetite lost), LETHARGY (Lethargic), DIARRHOEA (diarrhea), DYSPNOEA (little bit of shortness of breath at times), PRODUCTIVE COUGH (coughing up phlegm when using their CPAP machine at night), MYALGIA (muscle pain), HEADACHE (headache\ pain in the right temple), NAUSEA (feeling like they are going to vomit), FATIGUE (Fatigue) and CHILLS (chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Appetite lost), LETHARGY (Lethargic), DYSPNOEA (little bit of shortness of breath at times), PRODUCTIVE COUGH (coughing up phlegm when using their CPAP machine at night), MYALGIA (muscle pain), HEADACHE (headache\ pain in the right temple), NAUSEA (feeling like they are going to vomit), FATIGUE (Fatigue) and CHILLS (chills) had not resolved and DIARRHOEA (diarrhea) 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 included ice packs, and rest to help with the symptoms.