chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 antibody test
Clinical narrative: did not receive the second dose of Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence did not receive the second dose of Moderna Vaccine in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Suspected COVID-19, Patient was assuming that she had Covid in December and was asymptomatic in December 2020.    On 10-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 did not receive the second dose of Moderna Vaccine. At the time of the report, did not receive the second dose of Moderna Vaccine had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test normal test showed immunity.         No concomitant medications were reported.  Patient was assuming that she had Covid in December and was asymptomatic. Her son and her husband had it at that time with symptoms.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above included Follow up received on 7-SEP-2021. Reporter details, Patient gender, Date of birth, pregnancy status, and date of administration of 1st dose was updated. Medical history was updated which was missed from initial document.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: third Moderna vaccine on an unknown date/3 Moderna doses; second dose on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021); 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 EXTRA DOSE ADMINISTERED (third Moderna vaccine on an unknown date/3 Moderna doses) and EXPIRED PRODUCT ADMINISTERED (second dose on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (second dose on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021)). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (third Moderna vaccine on an unknown date/3 Moderna doses). On 09-Jul-2021, EXPIRED PRODUCT ADMINISTERED (second dose on 09/Jul/2021, lot 039K20A (expired vaccine 21/Jun/2021)) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (third Moderna vaccine on an unknown date/3 Moderna doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-278794 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant Follow-up received on 05-Aug-2021. Snapshot of the Initial doc was attached and the reporter details were added. On 09-Sep-2021: Follow-up doc received on 13-Sep-2021 and it contains no new information.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna Dose 1 under 18 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Dose 1 under 18 years old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021 at 3:34 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021 at 3:00 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Dose 1 under 18 years old). On 07-Sep-2021 at 3:34 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Dose 1 under 18 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 07-Sep-2021 at 3:34 PM, received second dose via intramuscular in left deltoid was noted. Patient's height is 5.7 inches.  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow Up received, updated Reporter's information,  patient demographic details (female) and details about the both doses of the suspected vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Lost my sense of smell 9 days after taken first shot; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost my sense of smell 9 days after taken first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 ANOSMIA (Lost my sense of smell 9 days after taken first shot). At the time of the report, ANOSMIA (Lost my sense of smell 9 days after taken first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.  The patient got the first shot of the vaccine after 7 month of Covid   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow-up information received contains no significant information
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 17 years was given the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (17 years was given the vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C51A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced OFF LABEL USE (17 years was given the vaccine). On 20-Jul-2021, OFF LABEL USE (17 years was given the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Expire Date: Product Was schedule to expire on 17AUG2021 after removal from freezer.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Hasn't received the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of Hasn't received the second dose 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 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 Hasn't received the second dose. At the time of the report, Hasn't received the second dose 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 treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: chest pain; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath) 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 CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath). At the time of the report, CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath) outcome was unknown.            No Concomitant drugs were reported.  No Treatment medications were reported.   Reporter did not allow further contact
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose administered on 27Jul2021; 2nd dose administered on 04Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 27Jul2021; 2nd dose administered on 04Aug2021) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 04C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 27Jul2021; 2nd dose administered on 04Aug2021). On 04-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 27Jul2021; 2nd dose administered on 04Aug2021) had resolved.            Concomitant product information was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Illness, Nausea, Pyrexia
Clinical narrative: states that he feels sometimes the nausea, but he doesn't get it every day, gets it once on a while; it made him feel sick, but it wasn't as bad as the first one; the first day was fine but that night he was super cold as ice; had 3 blankets on because he was shivering; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, FEELING COLD, CHILLS, PYREXIA, and NAUSEA in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (He had Covid19 in January). Concomitant products included ESCITALOPRAM for an unknown indication.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021, the patient experienced ILLNESS and PYREXIA. 26-Jul-2021, the patient experienced FEELING COLD and CHILLS. On an unknown date, the patient experienced NAUSEA. At the time of the report, ILLNESS, FEELING COLD, CHILLS, PYREXIA, and NAUSEA outcome was unknown.            No Treatment mediation were reported.   This case was linked to MOD-2021-281448 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She had a sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D2-1A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 17-Jul-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 PAIN (She had a sore arm). At the time of the report, VACCINATION SITE PAIN (She had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported stated she received vaccine in the left arm as her doctor stated not to do it on her right arm because of breast cancer. No Treatment medications provided.   This case was linked to MOD-2021-287461 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fear, Product dose omission issue
Clinical narrative: She got scared; Did not get her second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (She got scared) and PRODUCT DOSE OMISSION ISSUE (Did not get her second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEAR (She got scared) and PRODUCT DOSE OMISSION ISSUE (Did not get her second vaccine). At the time of the report, FEAR (She got scared) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not get her second vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: experienced the extreme fatigue after second dose vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (experienced the extreme fatigue after second dose vaccination) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (experienced the extreme fatigue after second dose vaccination). At the time of the report, FATIGUE (experienced the extreme fatigue after second dose vaccination) outcome was unknown.            Concomitant product information was not provided. The cardiologist does not know what it is and could only prove that it wasn't a heart problem.  Treatment information was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: my skin started itching: I have red dots in the area where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (my skin started itching) and VACCINATION SITE ERYTHEMA (I have red dots in the area where the shot was given) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (my skin started itching) and VACCINATION SITE ERYTHEMA (I have red dots in the area where the shot was given). At the time of the report, PRURITUS (my skin started itching) and VACCINATION SITE ERYTHEMA (I have red dots in the area where the shot was given) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cold; I'm only still feeling a little tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and FATIGUE (I'm only still feeling a little tired) 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 NASOPHARYNGITIS (Cold) and FATIGUE (I'm only still feeling a little tired). At the time of the report, NASOPHARYNGITIS (Cold) was resolving and FATIGUE (I'm only still feeling a little tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.  The patient did not experience fever, coughing or sneezing. Patient was supposed to get 2nd Moderna shot in the morning   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 expired doses administered as 1st dose; 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 (3 expired doses administered as 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 expired doses administered as 1st dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 expired doses administered as 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  No Treatment medication was reported
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Injection site exfoliation, Injection site pain, Injection site rash
Clinical narrative: It started itching; Now, she feels as if her bones hurt; She also has swelling in her ankles; It's black in color.; As of now it's peeling at injection site; When she extend her fingers, they hurt at joints/complaining of joint pain; She started with tendered injection site for 4 days after receiving 2nd dose; She noticed some rash on injection site 3 days after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It started itching), BONE PAIN (Now, she feels as if her bones hurt), JOINT SWELLING (She also has swelling in her ankles), VACCINATION SITE DISCOLOURATION (It's black in color.) and INJECTION SITE EXFOLIATION (As of now it's peeling at injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE RASH (She noticed some rash on injection site 3 days after receiving 2nd dose). On 15-Aug-2021, the patient experienced INJECTION SITE PAIN (She started with tendered injection site for 4 days after receiving 2nd dose). On an unknown date, the patient experienced PRURITUS (It started itching), BONE PAIN (Now, she feels as if her bones hurt), JOINT SWELLING (She also has swelling in her ankles), VACCINATION SITE DISCOLOURATION (It's black in color.), INJECTION SITE EXFOLIATION (As of now it's peeling at injection site) and ARTHRALGIA (When she extend her fingers, they hurt at joints/complaining of joint pain). The patient was treated with ALOE VERA for Adverse event, at a dose of Unknown and HAMAMELIS SPP. (WITCH HAZEL [HAMAMELIS SPP.]) for Adverse event, at a dose of Unknown. At the time of the report, PRURITUS (It started itching), BONE PAIN (Now, she feels as if her bones hurt), JOINT SWELLING (She also has swelling in her ankles), VACCINATION SITE DISCOLOURATION (It's black in color.), INJECTION SITE EXFOLIATION (As of now it's peeling at injection site), INJECTION SITE RASH (She noticed some rash on injection site 3 days after receiving 2nd dose), INJECTION SITE PAIN (She started with tendered injection site for 4 days after receiving 2nd dose) and ARTHRALGIA (When she extend her fingers, they hurt at joints/complaining of joint pain) outcome was unknown.            No concomitant medications were reported. Treatment medication includes Pain relievers.   This case was linked to MOD-2021-288025 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pruritus, Vaccination site discolouration
Clinical narrative: It started itching; Now, she feels as if her bones hurt; She also has swelling in her ankles; It's black in color.; As of now it's peeling at injection site; When she extend her fingers, they hurt at joints/complaining of joint pain; She started with tendered injection site for 4 days after receiving 2nd dose; She noticed some rash on injection site 3 days after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It started itching), BONE PAIN (Now, she feels as if her bones hurt), JOINT SWELLING (She also has swelling in her ankles), VACCINATION SITE DISCOLOURATION (It's black in color.) and INJECTION SITE EXFOLIATION (As of now it's peeling at injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE RASH (She noticed some rash on injection site 3 days after receiving 2nd dose). On 15-Aug-2021, the patient experienced INJECTION SITE PAIN (She started with tendered injection site for 4 days after receiving 2nd dose). On an unknown date, the patient experienced PRURITUS (It started itching), BONE PAIN (Now, she feels as if her bones hurt), JOINT SWELLING (She also has swelling in her ankles), VACCINATION SITE DISCOLOURATION (It's black in color.), INJECTION SITE EXFOLIATION (As of now it's peeling at injection site) and ARTHRALGIA (When she extend her fingers, they hurt at joints/complaining of joint pain). The patient was treated with ALOE VERA for Adverse event, at a dose of Unknown and HAMAMELIS SPP. (WITCH HAZEL [HAMAMELIS SPP.]) for Adverse event, at a dose of Unknown. At the time of the report, PRURITUS (It started itching), BONE PAIN (Now, she feels as if her bones hurt), JOINT SWELLING (She also has swelling in her ankles), VACCINATION SITE DISCOLOURATION (It's black in color.), INJECTION SITE EXFOLIATION (As of now it's peeling at injection site), INJECTION SITE RASH (She noticed some rash on injection site 3 days after receiving 2nd dose), INJECTION SITE PAIN (She started with tendered injection site for 4 days after receiving 2nd dose) and ARTHRALGIA (When she extend her fingers, they hurt at joints/complaining of joint pain) outcome was unknown.            No concomitant medications were reported. Treatment medication includes Pain relievers.   This case was linked to MOD-2021-288025 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Became ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Became ill) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 ILLNESS (Became ill). At the time of the report, ILLNESS (Became ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not get the second dose, "first dose early this year: he was unable to go get the second dose"; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get the second dose, "first dose early this year: he was unable to go get the second dose") in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get the second dose, "first dose early this year: he was unable to go get the second dose"). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get the second dose, "first dose early this year: he was unable to go get the second dose") outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination complication
Clinical narrative: had some mild symptoms after the shot that were constitutional in nature; It has now been 6 months since their first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (had some mild symptoms after the shot that were constitutional in nature) and PRODUCT DOSE OMISSION ISSUE (It has now been 6 months since their first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had some mild symptoms after the shot that were constitutional in nature) and PRODUCT DOSE OMISSION ISSUE (It has now been 6 months since their first dose). At the time of the report, VACCINATION COMPLICATION (had some mild symptoms after the shot that were constitutional in nature) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It has now been 6 months since their first 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 treatment was reported.  It was reported that, patient subsequently received steroids & was told to delay 2nd dose further. It had now been 6 months since their first dose.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed his second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed his second vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his second vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed his second vaccine) had resolved.            No concomitant medication information was provided. No treatment medication were provided.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness
Clinical narrative: Extremely Weak after the second dose; Extremely Sick after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extremely Weak after the second dose) and ILLNESS (Extremely Sick after the second dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No specified medical history has been reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced ASTHENIA (Extremely Weak after the second dose) and ILLNESS (Extremely Sick after the second dose). In February 2021, ASTHENIA (Extremely Weak after the second dose) and ILLNESS (Extremely Sick after the second dose) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided. She was researching as to what to expect from a third dose of the vaccine. She was immune compromised and she would like to know what to expect prior to getting a third shot.    This case was linked to MOD-2021-005642 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left injection site arm was sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (left injection site arm was sore). On 29-Dec-2020, VACCINATION SITE PAIN (left injection site arm was sore) had resolved.            No concomitant medications were provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-288149 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heavy menstrual bleeding, Myalgia
Clinical narrative: Got period two days ago but today a little heavier; Tiredness; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Got period two days ago but today a little heavier), FATIGUE (Tiredness) and MYALGIA (Soreness) 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 11-Aug-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 HEAVY MENSTRUAL BLEEDING (Got period two days ago but today a little heavier), FATIGUE (Tiredness) and MYALGIA (Soreness). At the time of the report, HEAVY MENSTRUAL BLEEDING (Got period two days ago but today a little heavier), FATIGUE (Tiredness) and MYALGIA (Soreness) 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.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Pain in extremity
Clinical narrative: very painful arm that lasted weeks; Stomach ache; Diarrhea; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very painful arm that lasted weeks), ABDOMINAL PAIN UPPER (Stomach ache), DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very painful arm that lasted weeks), ABDOMINAL PAIN UPPER (Stomach ache), DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (very painful arm that lasted weeks) had resolved and ABDOMINAL PAIN UPPER (Stomach ache), DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received 1st dose of Moderna COVID-19 vaccine and not received the 2nd dose; 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 Received 1st dose of Moderna COVID-19 vaccine and not received the 2nd dose in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-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 Received 1st dose of Moderna COVID-19 vaccine and not received the 2nd dose. At the time of the report, Received 1st dose of Moderna COVID-19 vaccine and not received the 2nd dose had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Administrator of a healthcare facility did not think that any of the patients got COVID after vaccination. The corporate office or someone in the protocol office made a decision to stop the vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than; administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than) and PRODUCT STORAGE ERROR (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than) and PRODUCT STORAGE ERROR (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than) and PRODUCT STORAGE ERROR (administered a dose to a male patient on 16Aug2021 from a vial that was first punctured on 13Aug2021 and was kept at room temperature since than) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Urticaria
Clinical narrative: hives; itching; patient never went back to get the second dose; This case was received via a Regulatory Authority (Reference number: MOD21-131443) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itching) and PRODUCT DOSE OMISSION ISSUE (patient never went back to get the second dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.  Treatment medication for hives include Steroids.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced URTICARIA (hives), PRURITUS (itching) and PRODUCT DOSE OMISSION ISSUE (patient never went back to get the second dose). At the time of the report, URTICARIA (hives) and PRURITUS (itching) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient never went back to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by reporter.  No concomitant medication reported.  Treatment medication for hives include Steroids.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I never got my second/got first dose in month of jan; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I never got my second/got first dose in month of jan) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19.) in August 2020.    On 20-Jan-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 (I never got my second/got first dose in month of jan). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I never got my second/got first dose in month of jan) 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 information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: follow up document received on 16-AUG-2021 contains Reporter information updated, patient demographics added and batch/lot number added.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: underarm swelling; pain in the arm; blue marks on the swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (underarm swelling), PAIN IN EXTREMITY (pain in the arm) and SKIN DISCOLOURATION (blue marks on the swelling) 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 14-Aug-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 PERIPHERAL SWELLING (underarm swelling), PAIN IN EXTREMITY (pain in the arm) and SKIN DISCOLOURATION (blue marks on the swelling). At the time of the report, PERIPHERAL SWELLING (underarm swelling), PAIN IN EXTREMITY (pain in the arm) and SKIN DISCOLOURATION (blue marks on the swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: felt like injection was given too high on her arm too close to shoulder joint; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like injection was given too high on her arm too close to shoulder joint) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like injection was given too high on her arm too close to shoulder joint). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (felt like injection was given too high on her arm too close to shoulder joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, Headache
Clinical narrative: He developed cough; Fatigue; Headache; body ache; Fever; Lack of drug ineffective; tested positive for COVID 19; Rhinitis; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for COVID 19), RHINITIS (Rhinitis), COUGH (He developed cough), FATIGUE (Fatigue) and HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced COVID-19 (tested positive for COVID 19), RHINITIS (Rhinitis), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (body ache), PYREXIA (Fever) and DRUG INEFFECTIVE (Lack of drug ineffective). On an unknown date, the patient experienced COUGH (He developed cough). In August 2021, COVID-19 (tested positive for COVID 19), RHINITIS (Rhinitis), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (body ache) and PYREXIA (Fever) had resolved. At the time of the report, COUGH (He developed cough) had not resolved and DRUG INEFFECTIVE (Lack of drug ineffective) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, COVID-19: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter. The patient was treated by his doctor
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Rhinitis
Clinical narrative: He developed cough; Fatigue; Headache; body ache; Fever; Lack of drug ineffective; tested positive for COVID 19; Rhinitis; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for COVID 19), RHINITIS (Rhinitis), COUGH (He developed cough), FATIGUE (Fatigue) and HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced COVID-19 (tested positive for COVID 19), RHINITIS (Rhinitis), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (body ache), PYREXIA (Fever) and DRUG INEFFECTIVE (Lack of drug ineffective). On an unknown date, the patient experienced COUGH (He developed cough). In August 2021, COVID-19 (tested positive for COVID 19), RHINITIS (Rhinitis), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (body ache) and PYREXIA (Fever) had resolved. At the time of the report, COUGH (He developed cough) had not resolved and DRUG INEFFECTIVE (Lack of drug ineffective) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, COVID-19: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter. The patient was treated by his doctor