chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days since first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days since first shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days since first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days since first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Temperature intolerance
Clinical narrative: has sensitivity to heat when she goes outside; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TEMPERATURE INTOLERANCE (has sensitivity to heat when she goes outside) 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) at an unspecified dose. On an unknown date, the patient experienced TEMPERATURE INTOLERANCE (has sensitivity to heat when she goes outside). At the time of the report, TEMPERATURE INTOLERANCE (has sensitivity to heat when she goes outside) outcome was unknown.            Treatment and concomitant product information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient still had not gotten her 2nd dose - over 36 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient still had not gotten her 2nd dose - over 36 days after 1st dose) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient still had not gotten her 2nd dose - over 36 days after 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient still had not gotten her 2nd dose - over 36 days after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment were not reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Muscle spasms, Myalgia, Pain, Vaccination site erythema
Clinical narrative: body cramps/leg cramps; he is hurting; Body aches; leg cramps; sick from the stomach; soreness in the area of the shot; redness in the area of the shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (body cramps/leg cramps), PAIN (he is hurting), ABDOMINAL DISCOMFORT (sick from the stomach), VACCINATION SITE PAIN (soreness in the area of the shot) and VACCINATION SITE ERYTHEMA (redness in the area of the shot) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hernia (Patient had several hernia surgeries in the past.) and Surgery (Patient had several hernia surgeries in the past.). Concurrent medical conditions included Cramps (Patient suffers from cramps for several years now.). Concomitant products included CARISOPRODOL (SOMA [CARISOPRODOL]) for Cramp.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced VACCINATION SITE PAIN (soreness in the area of the shot) and VACCINATION SITE ERYTHEMA (redness in the area of the shot). On 28-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (sick from the stomach). On an unknown date, the patient experienced MUSCLE SPASMS (body cramps/leg cramps), PAIN (he is hurting), MYALGIA (Body aches) and MUSCLE SPASMS (leg cramps). At the time of the report, MUSCLE SPASMS (body cramps/leg cramps), PAIN (he is hurting), ABDOMINAL DISCOMFORT (sick from the stomach), VACCINATION SITE PAIN (soreness in the area of the shot), VACCINATION SITE ERYTHEMA (redness in the area of the shot), MYALGIA (Body aches) and MUSCLE SPASMS (leg cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: body cramps/leg cramps; he is hurting; Body aches; leg cramps; sick from the stomach; soreness in the area of the shot; redness in the area of the shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (body cramps/leg cramps), PAIN (he is hurting), ABDOMINAL DISCOMFORT (sick from the stomach), VACCINATION SITE PAIN (soreness in the area of the shot) and VACCINATION SITE ERYTHEMA (redness in the area of the shot) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hernia (Patient had several hernia surgeries in the past.) and Surgery (Patient had several hernia surgeries in the past.). Concurrent medical conditions included Cramps (Patient suffers from cramps for several years now.). Concomitant products included CARISOPRODOL (SOMA [CARISOPRODOL]) for Cramp.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced VACCINATION SITE PAIN (soreness in the area of the shot) and VACCINATION SITE ERYTHEMA (redness in the area of the shot). On 28-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (sick from the stomach). On an unknown date, the patient experienced MUSCLE SPASMS (body cramps/leg cramps), PAIN (he is hurting), MYALGIA (Body aches) and MUSCLE SPASMS (leg cramps). At the time of the report, MUSCLE SPASMS (body cramps/leg cramps), PAIN (he is hurting), ABDOMINAL DISCOMFORT (sick from the stomach), VACCINATION SITE PAIN (soreness in the area of the shot), VACCINATION SITE ERYTHEMA (redness in the area of the shot), MYALGIA (Body aches) and MUSCLE SPASMS (leg cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Gait disturbance, Heart rate decreased, Heart rate increased
Clinical narrative: very hot then very cold; pulse was 140 pulse was 110,heart rate as up to 120 going up steps,110 going room to room; walking very slowly; Went back to 50/pulse then decreased back to 50 or 60 intermittently; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (very hot then very cold), HEART RATE INCREASED (pulse was 140 pulse was 110,heart rate as up to 120 going up steps,110 going room to room), GAIT DISTURBANCE (walking very slowly) and HEART RATE DECREASED (Went back to 50/pulse then decreased back to 50 or 60 intermittently) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) unknown. On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (very hot then very cold), HEART RATE INCREASED (pulse was 140 pulse was 110,heart rate as up to 120 going up steps,110 going room to room), GAIT DISTURBANCE (walking very slowly) and HEART RATE DECREASED (Went back to 50/pulse then decreased back to 50 or 60 intermittently). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (very hot then very cold), HEART RATE INCREASED (pulse was 140 pulse was 110,heart rate as up to 120 going up steps,110 going room to room), GAIT DISTURBANCE (walking very slowly) and HEART RATE DECREASED (Went back to 50/pulse then decreased back to 50 or 60 intermittently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No Treatment information was reported   Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received a dose of the Moderna COVID-19 vaccine at the age of 16; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a dose of the Moderna COVID-19 vaccine at the age of 16) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concomitant products included LORATADINE from 04-Oct-2017 to an unknown date and MONTELUKAST from 04-Oct-2017 to an unknown date for Allergic rhinitis.    On 26-Jun-2021 at 4:16 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a dose of the Moderna COVID-19 vaccine at the age of 16). On 26-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a dose of the Moderna COVID-19 vaccine at the age of 16) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not seek any medical care. No treatment medication were reported. It require clarification and confirmation if adverse events occurred after the vaccine was administered.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: significant follow up received on 04-Aug-2021 in which new event updated.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had their 1st dose of the Moderna Covid-19 Vaccine on 27May2021 but has not had the 2nd dose/2nd dose not received; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had their 1st dose of the Moderna Covid-19 Vaccine on 27May2021 but has not had the 2nd dose/2nd dose not received) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic pain. Concomitant products included OXYCODONE and GABAPENTIN for Pain.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had their 1st dose of the Moderna Covid-19 Vaccine on 27May2021 but has not had the 2nd dose/2nd dose not received). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had their 1st dose of the Moderna Covid-19 Vaccine on 27May2021 but has not had the 2nd dose/2nd dose not received) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had their 1st dose of the Moderna Covid-19 Vaccine on 27May2021 but has not had the 2nd dose/2nd dose not received) to be possibly related.    Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received on 5-AUG-2021. Added patient demographics, medical history, suspect drug details, concomitant medication, event details and causality.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: fell onto wall; Dizzy; This spontaneous case was reported by a health care professional and describes the occurrence of FALL (fell onto wall) and DIZZINESS (Dizzy) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was reported.     On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced FALL (fell onto wall) and DIZZINESS (Dizzy). At the time of the report, FALL (fell onto wall) and DIZZINESS (Dizzy) 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.   No Concomitant medications were reported.  No treatmentmedications were reported. 127/83.Hr 85 R22,O2 99% 130/82 HR 77 99% 126/85 HR72 99% 124/82 HR 75 99% 130/84 HR 75 R18 99% EMS ARRIVED.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Feeling abnormal, Muscle twitching, Myalgia
Clinical narrative: tested positive for COVID-19 infection; starting to experience twitching in his legs; heartbroken; starting to experience muscle pains in his legs; coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), COVID-19 (tested positive for COVID-19 infection), MUSCLE TWITCHING (starting to experience twitching in his legs), FEELING ABNORMAL (heartbroken) and MYALGIA (starting to experience muscle pains in his legs) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 13-May-2020. Concomitant products included METFORMIN, IRBESARTAN, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PRAVASTATIN, INSULIN HUMAN (INSULIN [INSULIN HUMAN]), INSULIN LISPRO (ADMELOG), TRAZODONE, GABAPENTIN, ESCITALOPRAM and HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (coughing). On 03-Aug-2021, the patient experienced COVID-19 (tested positive for COVID-19 infection), MUSCLE TWITCHING (starting to experience twitching in his legs), FEELING ABNORMAL (heartbroken) and MYALGIA (starting to experience muscle pains in his legs). At the time of the report, COUGH (coughing), COVID-19 (tested positive for COVID-19 infection), MUSCLE TWITCHING (starting to experience twitching in his legs), FEELING ABNORMAL (heartbroken) and MYALGIA (starting to experience muscle pains in his legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2020, SARS-CoV-2 test: positive (Positive) Positive. On 03-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had no known drug of food allergies.  Patient had not taken or used any treatment medications.  The patient wears a mask and patient unsure how he became infected with COVID-19 again.  Patient was recently at a nursing home and a person there was coughing.   This case was linked to MOD-2021-275395 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 infection; starting to experience twitching in his legs; heartbroken; starting to experience muscle pains in his legs; coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), COVID-19 (tested positive for COVID-19 infection), MUSCLE TWITCHING (starting to experience twitching in his legs), FEELING ABNORMAL (heartbroken) and MYALGIA (starting to experience muscle pains in his legs) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 13-May-2020. Concomitant products included METFORMIN, IRBESARTAN, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PRAVASTATIN, INSULIN HUMAN (INSULIN [INSULIN HUMAN]), INSULIN LISPRO (ADMELOG), TRAZODONE, GABAPENTIN, ESCITALOPRAM and HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (coughing). On 03-Aug-2021, the patient experienced COVID-19 (tested positive for COVID-19 infection), MUSCLE TWITCHING (starting to experience twitching in his legs), FEELING ABNORMAL (heartbroken) and MYALGIA (starting to experience muscle pains in his legs). At the time of the report, COUGH (coughing), COVID-19 (tested positive for COVID-19 infection), MUSCLE TWITCHING (starting to experience twitching in his legs), FEELING ABNORMAL (heartbroken) and MYALGIA (starting to experience muscle pains in his legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2020, SARS-CoV-2 test: positive (Positive) Positive. On 03-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had no known drug of food allergies.  Patient had not taken or used any treatment medications.  The patient wears a mask and patient unsure how he became infected with COVID-19 again.  Patient was recently at a nursing home and a person there was coughing.   This case was linked to MOD-2021-275395 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients received doses from an expire vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received doses from an expire vial) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) 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 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received doses from an expire vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (10 patients received doses from an expire vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Cough, Dyspnoea, Pain
Clinical narrative: Pain in lungs, side of lungs to back of lungs; Hard to breathe, started after getting the vaccine; After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso; Recently been coughing; The pain moves around, I didnt have it before the vaccine; After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso; when breathe it hurts; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Pain in lungs, side of lungs to back of lungs), DYSPNOEA (Hard to breathe, started after getting the vaccine), ABDOMINAL PAIN (After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso), COUGH (Recently been coughing) and PAIN (The pain moves around, I didnt have it before the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21D and 022B1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history is provided by reporter.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-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 PULMONARY PAIN (Pain in lungs, side of lungs to back of lungs), DYSPNOEA (Hard to breathe, started after getting the vaccine), ABDOMINAL PAIN (After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso), COUGH (Recently been coughing), PAIN (The pain moves around, I didnt have it before the vaccine), BACK PAIN (After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso) and PAINFUL RESPIRATION (when breathe it hurts). At the time of the report, PULMONARY PAIN (Pain in lungs, side of lungs to back of lungs), DYSPNOEA (Hard to breathe, started after getting the vaccine), ABDOMINAL PAIN (After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso), COUGH (Recently been coughing), PAIN (The pain moves around, I didnt have it before the vaccine), BACK PAIN (After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso) and PAINFUL RESPIRATION (when breathe it hurts) had not resolved.            No concomitant medication were provided.  No treatment details were provided  The action taken with mRNA with the events was considered as not applicable.   This case was linked to MOD-2021-278304 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Painful respiration, Pulmonary pain
Clinical narrative: Pain in lungs, side of lungs to back of lungs; Hard to breathe, started after getting the vaccine; After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso; Recently been coughing; The pain moves around, I didnt have it before the vaccine; After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso; when breathe it hurts; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Pain in lungs, side of lungs to back of lungs), DYSPNOEA (Hard to breathe, started after getting the vaccine), ABDOMINAL PAIN (After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso), COUGH (Recently been coughing) and PAIN (The pain moves around, I didnt have it before the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21D and 022B1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history is provided by reporter.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-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 PULMONARY PAIN (Pain in lungs, side of lungs to back of lungs), DYSPNOEA (Hard to breathe, started after getting the vaccine), ABDOMINAL PAIN (After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso), COUGH (Recently been coughing), PAIN (The pain moves around, I didnt have it before the vaccine), BACK PAIN (After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso) and PAINFUL RESPIRATION (when breathe it hurts). At the time of the report, PULMONARY PAIN (Pain in lungs, side of lungs to back of lungs), DYSPNOEA (Hard to breathe, started after getting the vaccine), ABDOMINAL PAIN (After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso), COUGH (Recently been coughing), PAIN (The pain moves around, I didnt have it before the vaccine), BACK PAIN (After second dose, went from middle of back to entire left side of abdominal region, top to lower entire torso) and PAINFUL RESPIRATION (when breathe it hurts) had not resolved.            No concomitant medication were provided.  No treatment details were provided  The action taken with mRNA with the events was considered as not applicable.   This case was linked to MOD-2021-278304 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Periorbital swelling, Sensitive skin, Swelling of eyelid
Clinical narrative: swollen eye/eyelid; swelling is from corner of nose to eye lid and underneath; sensitive to touch; super puffy; left eye was itching; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-127474 ) 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 EYE PRURITUS (left eye was itching), EYE SWELLING (swollen eye/eyelid), SWELLING OF EYELID (swelling is from corner of nose to eye lid and underneath), SENSITIVE SKIN (sensitive to touch) and PERIORBITAL SWELLING (super puffy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     It was reported that the patient had no medical history.  Concurrent medical conditions included Gluten sensitivity, Allergy (Allergic to hops), Dairy intolerance (Allergic to dairy products) and Drug allergy (Allergic to Wellbutrin). Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced EYE PRURITUS (left eye was itching). On 06-Aug-2021, the patient experienced EYE SWELLING (swollen eye/eyelid), SWELLING OF EYELID (swelling is from corner of nose to eye lid and underneath), SENSITIVE SKIN (sensitive to touch) and PERIORBITAL SWELLING (super puffy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) (topical) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE PRURITUS (left eye was itching) was resolving and EYE SWELLING (swollen eye/eyelid), SWELLING OF EYELID (swelling is from corner of nose to eye lid and underneath), SENSITIVE SKIN (sensitive to touch) and PERIORBITAL SWELLING (super puffy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported also include Eye drops.  Patient reports that around 2:45 AM on 05-Aug-2021, she woke up and her left eye was itching, thinking it was a mosquito bite.  The itching was followed by supper puffy swollen left eye/eye lid. patient describes the reaction sensitive to touch. The location of the swelling is from corner of the nose to eye lid and underneath.  Patient used pain medications and Benadryl topical product to alleviate the symptoms and patient states that medication did help with the itching but not swelling.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Resident did not receive 2nd dose of Moderna COVID-19 vaccine; 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 (Resident did not receive 2nd dose of Moderna COVID-19 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.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Resident did not receive 2nd dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Resident did not receive 2nd dose of Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment details were provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I haven't taken the 2nd vaccine yet.; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I haven't taken the 2nd vaccine yet.) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I haven't taken the 2nd vaccine yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I haven't taken the 2nd vaccine yet.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose more than 35 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose more than 35 days ago) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A20A-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose more than 35 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose more than 35 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concurrent and treatment medication was reported by patient. Her second dose was scheduled for 08 Sep 2021.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (Vomited) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNONWN) 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 DIARRHOEA (Diarrhea) and VOMITING (Vomited). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomited) outcome was unknown.            No concomitant medications reported. No treatment medications reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Limb discomfort, Mobility decreased, Muscular weakness
Clinical narrative: pain in her  left arm; hardly can move her left arm; mobility decreased; weekness in arms; sleep difficult; pain in left arm at site of where shot was given; tingling; numbness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her  left arm), LIMB DISCOMFORT (hardly can move her left arm), PARAESTHESIA (tingling), HYPOAESTHESIA (numbness) and MOBILITY DECREASED (mobility decreased) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sleep apnea. Concomitant products included LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRINE), METFORMIN, LOSARTAN, AMLODIPINE, CALCIUM, ERGOCALCIFEROL (OSCAL 250+D), HYDROCHLOROTHIAZIDE, SALBUTAMOL (ALBUTEROL HFA) and MULTIVITAMIN & MINERAL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PARAESTHESIA (tingling), HYPOAESTHESIA (numbness) and VACCINATION SITE PAIN (pain in left arm at site of where shot was given). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her  left arm), LIMB DISCOMFORT (hardly can move her left arm), MOBILITY DECREASED (mobility decreased), MUSCULAR WEAKNESS (weekness in arms) and INSOMNIA (sleep difficult). At the time of the report, PAIN IN EXTREMITY (pain in her  left arm), LIMB DISCOMFORT (hardly can move her left arm), PARAESTHESIA (tingling), HYPOAESTHESIA (numbness), MOBILITY DECREASED (mobility decreased), MUSCULAR WEAKNESS (weekness in arms) and INSOMNIA (sleep difficult) outcome was unknown and VACCINATION SITE PAIN (pain in left arm at site of where shot was given) had not resolved.            Patient historical condition includes remove thyroid with an unknown date.  No treatment medication was provided.   This case was linked to MOD-2021-315380 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Significant Follow up
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: pain in her  left arm; hardly can move her left arm; mobility decreased; weekness in arms; sleep difficult; pain in left arm at site of where shot was given; tingling; numbness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her  left arm), LIMB DISCOMFORT (hardly can move her left arm), PARAESTHESIA (tingling), HYPOAESTHESIA (numbness) and MOBILITY DECREASED (mobility decreased) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sleep apnea. Concomitant products included LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRINE), METFORMIN, LOSARTAN, AMLODIPINE, CALCIUM, ERGOCALCIFEROL (OSCAL 250+D), HYDROCHLOROTHIAZIDE, SALBUTAMOL (ALBUTEROL HFA) and MULTIVITAMIN & MINERAL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PARAESTHESIA (tingling), HYPOAESTHESIA (numbness) and VACCINATION SITE PAIN (pain in left arm at site of where shot was given). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her  left arm), LIMB DISCOMFORT (hardly can move her left arm), MOBILITY DECREASED (mobility decreased), MUSCULAR WEAKNESS (weekness in arms) and INSOMNIA (sleep difficult). At the time of the report, PAIN IN EXTREMITY (pain in her  left arm), LIMB DISCOMFORT (hardly can move her left arm), PARAESTHESIA (tingling), HYPOAESTHESIA (numbness), MOBILITY DECREASED (mobility decreased), MUSCULAR WEAKNESS (weekness in arms) and INSOMNIA (sleep difficult) outcome was unknown and VACCINATION SITE PAIN (pain in left arm at site of where shot was given) had not resolved.            Patient historical condition includes remove thyroid with an unknown date.  No treatment medication was provided.   This case was linked to MOD-2021-315380 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Significant Follow up
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 3 patients on 10FEB2022 (1 Booster dose and 2 primary doses); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 3 patients on 10FEB2022 (1 Booster dose and 2 primary doses)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022 at 9:42 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2022 at 9:42 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 3 patients on 10FEB2022 (1 Booster dose and 2 primary doses)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 3 patients on 10FEB2022 (1 Booster dose and 2 primary doses)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. HCP stated that they received a box of vials on 7-Jan-2022. There was one vial which was used after 30 days being in the fridge (30 days were on 6-Feb-2022) and they administered Moderna COVID-19 vaccine to 5 patients. HCP stated that she does not have the personal information of those patients. The vaccines were administered in the pharmacy: 3 patients on 10-Feb-2022 (1 Booster dose and 2 primary doses) and 2 patients on 9-Feb-2022 (1 booster and 1 primary dose ).  On 10-Feb-2022 the patients received the vaccine one hours after first puncture and on 9-Feb-2022 the patients received the vaccine almost 3 hours since the first punctured. HCP stated that there is no temperature excursion during the administration of that vial (the vials were in the fridge). Patient had no allergy to medications, food and other products. Patient received vaccine 4 days after use by date, and stated that patient experienced no adverse side effects from vaccine.   This case was linked to MOD-2022-480648 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Follow up received on 11-FEB-2022 Contains non Significant information On 01-Mar-2022: Significant follow up appended- reporter added, patient details added, Product details added,Narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Vaccine breakthrough infection; COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) and COVID-19 (COVID-19) 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 considered VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) and COVID-19 (COVID-19) to be related.    Results shown that vaccine breakthrough infections are overrepresented by antibody-resistant SARS-CoV-2 variants, and that symptomatic breakthrough infections may be as efficient in spreading COVID-19 as unvaccinated infections, regardless of the infecting lineage.  Concomitant, treatment medication information were not reported.  This is a literature-non-study case  concerning  a  patient of unknown age and gender with no reported medical history, who experienced the unexpected serious events of Vaccine breakthrough infection and Covid-19 as an added event. The events occurred on an unknown date after the unspecified dose of mRNA-1273 COVID 19 Vaccine. It was noted that Differences in viral loads were non-significant.  Vaccine breakthrough infections are overrepresented by antibody-resistant SARS-CoV-2 variants. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-491379, MOD-2022-491472, MOD-2022-491473, MOD-2022-491474, MOD-2022-491475, MOD-2022-491476, MOD-2022-491477, MOD-2022-491478, MOD-2022-491479, MOD-2022-491480, MOD-2022-491481 (Patient Link).; Sender's Comments: This is a literature-non-study case  concerning  a  patient of unknown age and gender with no reported medical history, who experienced the unexpected serious events of Vaccine breakthrough infection and Covid-19 as an added event. The events occurred on an unknown date after the unspecified dose of mRNA-1273 COVID 19 Vaccine. It was noted that Differences in viral loads were non-significant.  Vaccine breakthrough infections are overrepresented by antibody-resistant SARS-CoV-2 variants. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date; Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry/Booster given past by use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry/Booster given past by use date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022 at 10:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry/Booster given past by use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry/Booster given past by use date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No Treatment medication was reported. The vial was initially stored in the refrigerator on 18-JAN-2022 No vials undergo any temperature excursions. It was reported that the expiration date was verified with the CDC website and confirmed that it was not expired. No unusual adverse effects were noted.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2022: Followup received: Added booster dose administration time and anatomical location, new event (product storage error). Updated inarrative supplement.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: injected expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (injected expired Moderna COVID-19 vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (injected expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (injected expired Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that storage condition at the time of the excursion was refrigerated storage (temp 38F to 40F). On 24-Jan-2022 vial was moved from freezer to refrigerator. No abnormality was reported in vaccine state change. Number of vials or doses impacted 1 vial 7.5 ml (14 dose each). Vial was unpunctured and no previous excursion was reported.  There was no adverse event reported. The patient had none allergies. It was unknown if the patient had been diagnosed with or tested positive for COVID-19.  No treatment medications were reported.   This case was linked to MOD-2022-497451, MOD-2022-497480, MOD-2022-497474 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Follow up received contains, added patient demographic, product (dose number, dose and units, anatomical location, route of administration) and narrative was updated.