chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; 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 DIZZINESS (Dizziness) 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 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). The patient was treated with VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at a dose of 1 dosage form; VITAMIN D [VITAMIN D NOS] ongoing since an unknown date at a dose of 1 dosage form; VITAMIN B NOS ongoing since an unknown date at a dose of 1 dosage form; UBIDECARENONE (COQ10 [UBIDECARENONE]) ongoing since an unknown date at a dose of 1 dosage form and MAGNESIUM GLYCINATE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient stopped drinking diet soda and used glasses that blocks blue light. Concomitant medications were not provided by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2021-232184 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-232184:Other patient who reported events after Moderna vaccine
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; body ache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and MYALGIA (body ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body ache). At the time of the report, PYREXIA (fever) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of allergy to vaccine (allergic) and fatigue (just a little tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031L20A) for COVID-19 immunization. No medical history reported. On Jan 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 18, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 21, 2021, patient experienced allergy to vaccine (allergic) and fatigue (just a little tired). On Jan 22, 2021, allergy to vaccine (allergic) and fatigue (just a little tired) resolved. mRNA-1273 (Moderna COVID-19 vaccine), unknown, and mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: dosing remained unchanged. No concomitant medication or treatment information provided. This case linked to MOD-2021-233289 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Vaccine that was expired on 20Jun2021 was administered to 4 patients on 22Jun2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was expired on 20Jun2021 was administered to 4 patients on 22Jun2021) and NO ADVERSE EVENT (no adverse event) 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 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was expired on 20Jun2021 was administered to 4 patients on 22Jun2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that was expired on 20Jun2021 was administered to 4 patients on 22Jun2021) had resolved and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. no treatment medication provided.  It was reported that there was no adverse events/adverse outcomes resulted from this expired Moderna during their second vaccinations.   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: follow up document received on 16-08-21 with new information.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (slight numbness in feet & sole of feet) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history reported. On Jun 23, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19vaccine), unknown route; 1 dosage form. On Jun 23, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced hypoesthesia (slight numbness in feet & sole of feet). At the time of the report, hypoesthesia (slight numbness in feet & sole of feet): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: can you get side effects next day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (can you get side effects next day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (can you get side effects next day). At the time of the report, VACCINATION COMPLICATION (can you get side effects next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Slight headache). On 09-Mar-2021, HEADACHE (Slight headache) had resolved.            No Concomitant medication was reported.  No Treatment medication was reported.   This case was linked to MOD-2021-232713 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: If i got the first dose but it's been six weeks, do i have to start over with the first dose again?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (If i got the first dose but it's been six weeks, do i have to start over with the first dose again?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (If i got the first dose but it's been six weeks, do i have to start over with the first dose again?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (If i got the first dose but it's been six weeks, do i have to start over with the first dose again?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: a rash on her both thighs / now is on her arm, chest, stomach, back, which she still has.; big red patches; it looks like hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash on her both thighs / now is on her arm, chest, stomach, back, which she still has.), ERYTHEMA (big red patches) and URTICARIA (it looks like hives) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced RASH (a rash on her both thighs / now is on her arm, chest, stomach, back, which she still has.), ERYTHEMA (big red patches) and URTICARIA (it looks like hives). At the time of the report, RASH (a rash on her both thighs / now is on her arm, chest, stomach, back, which she still has.), ERYTHEMA (big red patches) and URTICARIA (it looks like hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Still tested positive after getting Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Still tested positive after getting Moderna 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 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 COVID-19 (Still tested positive after getting Moderna vaccine). At the time of the report, COVID-19 (Still tested positive after getting Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dental discomfort, Lip swelling, Pruritus, Urticaria
Clinical narrative: Within an hour I had four hives in all my body, except face, pubic area, throat and rectum; Itchiness in all my body; Lips swelling; My teeth were dumb; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Within an hour I had four hives in all my body, except face, pubic area, throat and rectum), PRURITUS (Itchiness in all my body), LIP SWELLING (Lips swelling) and DENTAL DISCOMFORT (My teeth were dumb) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced URTICARIA (Within an hour I had four hives in all my body, except face, pubic area, throat and rectum), PRURITUS (Itchiness in all my body), LIP SWELLING (Lips swelling) and DENTAL DISCOMFORT (My teeth were dumb). The patient was treated with COLLOIDAL BATH ongoing since an unknown date at a dose of UNK dosage form; PREDNISONE ongoing since an unknown date for Itching, at a dose of UNK dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL TOTAL) ongoing since an unknown date at an unspecified dose and frequency. On 19-Feb-2021, LIP SWELLING (Lips swelling) and DENTAL DISCOMFORT (My teeth were dumb) had resolved. At the time of the report, URTICARIA (Within an hour I had four hives in all my body, except face, pubic area, throat and rectum) and PRURITUS (Itchiness in all my body) had resolved.            No concomitants were provided.   This case was linked to MOD-2021-233268 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: NNI follow-up. no new information received
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reporting an adverse event as the patient declined to provide any information; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reporting an adverse event as the patient declined to provide any information) 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 VACCINATION COMPLICATION (reporting an adverse event as the patient declined to provide any information). At the time of the report, VACCINATION COMPLICATION (reporting an adverse event as the patient declined to provide any information) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no relevant concomitant product was reported.  no treatment product was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: an expired vaccine (34 days in the refrigerator) was given to 57 patients; 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 EXPIRED PRODUCT ADMINISTERED (an expired vaccine (34 days in the refrigerator) was given to 57 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) 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 20-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (an expired vaccine (34 days in the refrigerator) was given to 57 patients). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (an expired vaccine (34 days in the refrigerator) was given to 57 patients) 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 reported. No treatment information provided. The reported states that the Moderna covid-19 vaccine was left in the refrigerator for more than 30 days. The 30th day mark was on 19JUN2021 and the vaccine was administered from 20JUN2021 till today 23JUN2021 to a total of 57 patients.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection after first dose; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergies for the last 20 years that are on and off) and Pollen allergy (Sinus infections from pollen.). Concomitant products included METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Allergy.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection after first dose). The patient was treated with PREDNISONE for Sinus infection, at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection after first dose) had not resolved.            Patient was advised to stop Medrol until he receive dose-2.       Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Vaccination site erythema
Clinical narrative: the red area is the size of a golf ball; non stop headaches; chills; nausea; injection site is red; injection site is swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (the red area is the size of a golf ball), HEADACHE (non stop headaches), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE ERYTHEMA (injection site is red) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced VACCINATION SITE MASS (the red area is the size of a golf ball), HEADACHE (non stop headaches), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen). At the time of the report, VACCINATION SITE MASS (the red area is the size of a golf ball), HEADACHE (non stop headaches), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Body temperature: 99 (High) 99 degree Farenheight temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: the red area is the size of a golf ball; non stop headaches; chills; nausea; injection site is red; injection site is swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (the red area is the size of a golf ball), HEADACHE (non stop headaches), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE ERYTHEMA (injection site is red) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced VACCINATION SITE MASS (the red area is the size of a golf ball), HEADACHE (non stop headaches), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen). At the time of the report, VACCINATION SITE MASS (the red area is the size of a golf ball), HEADACHE (non stop headaches), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Body temperature: 99 (High) 99 degree Farenheight temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood test, Vaccination failure
Clinical narrative: after receiving 2 doses of the Moderna COVID-19 Vaccine had 2 blood test and said that has No antibodies what so ever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (after receiving 2 doses of the Moderna COVID-19 Vaccine had 2 blood test and said that has No antibodies what so ever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, LEVOTHYROXINE, TRAMADOL and OMEPRAZOLE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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 VACCINATION FAILURE (after receiving 2 doses of the Moderna COVID-19 Vaccine had 2 blood test and said that has No antibodies what so ever). At the time of the report, VACCINATION FAILURE (after receiving 2 doses of the Moderna COVID-19 Vaccine had 2 blood test and said that has No antibodies what so ever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Blood test: no antibodies found (normal) After two bood test, the patient has no antibodies whatsoever. On an unknown date, Antibody test: negative (Negative) negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medication were not provided. The patient reported that she had underwent blood tests on 06 May 2021 and second date was unknown. The patient reported that she has no antibodies reported after the blood test.  This is a case of vaccination failure (no antibodies response detected) without adverse events. Causality is not applicable.; Sender's Comments: This is a case of vaccination failure (no antibodies response detected) without adverse events. Causality is not applicable.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient recieved a moderna vaccine and they were under the age of 18; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient recieved a moderna vaccine and they were under the age of 18) in a 17-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient recieved a moderna vaccine and they were under the age of 18). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient recieved a moderna vaccine and they were under the age of 18) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: they stored the vaccine improperly; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (they stored the vaccine improperly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046a21A and o31a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (they stored the vaccine improperly). On 15-Apr-2021, PRODUCT STORAGE ERROR (they stored the vaccine improperly) had resolved. Not Provided           No concomitant medication information was provided No treatment medication information was provided
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Now past the 42 day mark (around 60 days) and has not yet received the second dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Now past the 42 day mark (around 60 days) and has not yet received the second dose.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Now past the 42 day mark (around 60 days) and has not yet received the second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Now past the 42 day mark (around 60 days) and has not yet received the second dose.) 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 medication provided by reporter.  No treatment medication provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up received included non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchy at the injection site.; in the past few days my arm is red; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy at the injection site.), VACCINATION SITE ERYTHEMA (in the past few days my arm is red) and VACCINATION SITE SWELLING (swollen at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy at the injection site.), VACCINATION SITE ERYTHEMA (in the past few days my arm is red) and VACCINATION SITE SWELLING (swollen at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy at the injection site.), VACCINATION SITE ERYTHEMA (in the past few days my arm is red) and VACCINATION SITE SWELLING (swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Text: Is this correct? Yes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Text: Is this correct? Yes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Text: Is this correct? Yes). At the time of the report, VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Text: Is this correct? Yes) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: potentially not getting second dose before day 35; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (potentially not getting second dose before day 35) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (potentially not getting second dose before day 35). At the time of the report, PRODUCT DOSE OMISSION ISSUE (potentially not getting second dose before day 35) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: I have a 101.5 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I have a 101.5 fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (I have a 101.5 fever). At the time of the report, PYREXIA (I have a 101.5 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) High.         No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: After the second shot, have people complained about having a metal taste in their mouth; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (After the second shot, have people complained about having a metal taste in their mouth) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (After the second shot, have people complained about having a metal taste in their mouth). At the time of the report, DYSGEUSIA (After the second shot, have people complained about having a metal taste in their mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vaccination site hypoaesthesia
Clinical narrative: Sore arm; Numbing in arm vaccine was received; Nausea; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPOAESTHESIA (Numbing in arm vaccine was received), NAUSEA (Nausea) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPOAESTHESIA (Numbing in arm vaccine was received), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPOAESTHESIA (Numbing in arm vaccine was received), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: experienced pain all over; fever of 100.5 degrees Fahrenheit; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (experienced pain all over), PYREXIA (fever of 100.5 degrees Fahrenheit), CHILLS (chills) and HEADACHE (headaches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PHENYTOIN (DILANTIN [PHENYTOIN]) for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced MYALGIA (experienced pain all over), PYREXIA (fever of 100.5 degrees Fahrenheit), CHILLS (chills) and HEADACHE (headaches). At the time of the report, MYALGIA (experienced pain all over), PYREXIA (fever of 100.5 degrees Fahrenheit), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.     Treatment medication was not provided.    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.
Sex: U
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: changes in a menstrual cycle; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUAL DISORDER (changes in a menstrual cycle) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (changes in a menstrual cycle). At the time of the report, MENSTRUAL DISORDER (changes in a menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I got my my last moderna shot a month ago and my arm still hurting where the injection was given.Is this normal?; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (I got my my last moderna shot a month ago and my arm still hurting where the injection was given.Is this normal?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (I got my my last moderna shot a month ago and my arm still hurting where the injection was given.Is this normal?). At the time of the report, VACCINATION SITE PAIN (I got my my last moderna shot a month ago and my arm still hurting where the injection was given.Is this normal?) outcome was unknown.            Concomitant and treatment medications were not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jun-2021 and was forwarded to Moderna on 23-Jun-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of PARAESTHESIA (Tingling) 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 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 22-Jun-2021, the patient experienced PARAESTHESIA (Tingling). At the time of the report, PARAESTHESIA (Tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Hyperaesthesia teeth, Loose tooth
Clinical narrative: Gum pain; Terrible sensitivity to hot and cold/had to change from using electric brush and her toothpaste; Felt like her tooth will fall out; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Gum pain), HYPERAESTHESIA TEETH (Terrible sensitivity to hot and cold/had to change from using electric brush and her toothpaste) and LOOSE TOOTH (Felt like her tooth will fall out) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Root canal infection. Previously administered products included for Product used for unknown indication: Super shingles shot in 2018, Pneumonia shot in September 2018 and Flu shot in September 2020. Concomitant products included ATORVASTATIN and LEVOTHYROXINE 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-Mar-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 GINGIVAL PAIN (Gum pain), HYPERAESTHESIA TEETH (Terrible sensitivity to hot and cold/had to change from using electric brush and her toothpaste) and LOOSE TOOTH (Felt like her tooth will fall out). At the time of the report, GINGIVAL PAIN (Gum pain), HYPERAESTHESIA TEETH (Terrible sensitivity to hot and cold/had to change from using electric brush and her toothpaste) and LOOSE TOOTH (Felt like her tooth will fall out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was reported.   This case was linked to MOD-2021-233451 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: No New Information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swelling of lips with filler; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of lips with filler) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #036A21A and 015MZOA) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (Swelling of lips with filler). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling of lips with filler) had not resolved.            Other concomitant medication includes Ice,
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Headache, Nausea
Clinical narrative: Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, NAUSEA (Nausea) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood cholesterol: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021included no new information. On 08-Jul-2021: Follow-up received on 12-JUL-2021 contains secondary reporter contact details updated and suspect product dose months was updated.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose from a vial that was expired/e vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/e vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/e vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/e vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature) 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 information was reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up information received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Watery diarrhea for 3 days; 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 DIARRHOEA (Watery diarrhea for 3 days) 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 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Watery diarrhea for 3 days). At the time of the report, DIARRHOEA (Watery diarrhea for 3 days) had resolved.            No concomitant medications reported.  Treatment information not reported.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 3-4 months out from the first dose and have not yet received the second dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (3-4 months out from the first dose and have not yet received the second dose.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (3-4 months out from the first dose and have not yet received the second dose.). On 24-Feb-2021, PRODUCT DOSE OMISSION ISSUE (3-4 months out from the first dose and have not yet received the second dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medication information were not provided.   This case was linked to MOD-2021-233605 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Heart rate decreased
Clinical narrative: slow heart rate, since I have had vaccine; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE DECREASED (slow heart rate, since I have had 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 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 HEART RATE DECREASED (slow heart rate, since I have had vaccine). At the time of the report, HEART RATE DECREASED (slow heart rate, since I have had vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.