chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site muscle weakness, Injection site pain, Tenderness
Clinical narrative: tenderness that was in the upper left arm deltoid muscle; soreness on injection site upper deltoid muscle; weakness on injection site upper deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MUSCLE WEAKNESS (weakness on injection site upper deltoid muscle), TENDERNESS (tenderness that was in the upper left arm deltoid muscle) and INJECTION SITE PAIN (soreness on injection site upper deltoid muscle) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. NDC# 80777027315) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced INJECTION SITE MUSCLE WEAKNESS (weakness on injection site upper deltoid muscle). On 11-Jul-2021, the patient experienced INJECTION SITE PAIN (soreness on injection site upper deltoid muscle). On 12-Jul-2021, the patient experienced TENDERNESS (tenderness that was in the upper left arm deltoid muscle). On 13-Jul-2021, INJECTION SITE MUSCLE WEAKNESS (weakness on injection site upper deltoid muscle), TENDERNESS (tenderness that was in the upper left arm deltoid muscle) and INJECTION SITE PAIN (soreness on injection site upper deltoid muscle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up contains no new information but added secondary contact details in general tab that were missed to capture initially and also updated Batch number that was not fully captured.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twitching) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MINOCYCLINE and CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]) for an unknown indication.   On 31-Mar-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 MUSCLE TWITCHING (Twitching). At the time of the report, MUSCLE TWITCHING (Twitching) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-059968 .   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received contains Initiative
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Feeling abnormal, Feeling hot, Headache
Clinical narrative: Im not feeling good / something running around at my back and tummy; not feeling well; felt heat inside my body; headache; heavy on my chest; pain in arms; Feelings of weakness; side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache) and CHEST DISCOMFORT (heavy on my chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 18-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 FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache), CHEST DISCOMFORT (heavy on my chest), PAIN IN EXTREMITY (pain in arms), ASTHENIA (Feelings of weakness) and VACCINATION COMPLICATION (side effects). At the time of the report, FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache), CHEST DISCOMFORT (heavy on my chest), PAIN IN EXTREMITY (pain in arms), ASTHENIA (Feelings of weakness) and VACCINATION COMPLICATION (side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: The follow-up information received contain significant information- New events added.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Vaccination complication
Clinical narrative: Im not feeling good / something running around at my back and tummy; not feeling well; felt heat inside my body; headache; heavy on my chest; pain in arms; Feelings of weakness; side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache) and CHEST DISCOMFORT (heavy on my chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 18-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 FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache), CHEST DISCOMFORT (heavy on my chest), PAIN IN EXTREMITY (pain in arms), ASTHENIA (Feelings of weakness) and VACCINATION COMPLICATION (side effects). At the time of the report, FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache), CHEST DISCOMFORT (heavy on my chest), PAIN IN EXTREMITY (pain in arms), ASTHENIA (Feelings of weakness) and VACCINATION COMPLICATION (side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: The follow-up information received contain significant information- New events added.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021) 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 was given by reporter.  No treatment medication was given by reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Added reporter information: first name, last name, occupation, reporter type, address, postal code.added patient detail: Date of birth, pregnancy status no. On 14-Sep-2021: Non-significant follow-up appended; Sender's Comments: This case concerns 30 -year-old female patient with no medical history, who experienced the unexpected event of Expired product administered. First dose of mRNA-1273, Moderna COVID-19 was administered after exposure to room temperature more than 24 hours. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was considered unknown. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Blood pressure measurement, Disorientation, Dyspnoea, Fatigue
Clinical narrative: horrible reaction/really bad reaction; felt she dislocated her brain; rash across the top of her forehead that looked like she was having shingles; red bumps in forehead; disoriented; lethargic; Rash over arms; heart started pumping/heart started racing really hard/heart was throbbing/heart was racing; could not breathe; did not feel good; really tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (horrible reaction/really bad reaction), HEADACHE (headache), FEELING ABNORMAL (felt she dislocated her brain), MALAISE (did not feel good) and PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (She had had heart surgery in 2012 to repair a hole in her heart, doctors put a patch there) in 2012. Concurrent medical conditions included Penicillin allergy.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache) and FATIGUE (really tired). On 10-Feb-2021, the patient experienced MALAISE (did not feel good). On 11-Feb-2021, the patient experienced PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing) and DYSPNOEA (could not breathe). On an unknown date, the patient experienced ADVERSE REACTION (horrible reaction/really bad reaction), FEELING ABNORMAL (felt she dislocated her brain), HERPES ZOSTER (rash across the top of her forehead that looked like she was having shingles), RASH ERYTHEMATOUS (red bumps in forehead), DISORIENTATION (disoriented), LETHARGY (lethargic) and RASH (Rash over arms). At the time of the report, ADVERSE REACTION (horrible reaction/really bad reaction), HEADACHE (headache), FEELING ABNORMAL (felt she dislocated her brain), MALAISE (did not feel good), PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing), DYSPNOEA (could not breathe), HERPES ZOSTER (rash across the top of her forehead that looked like she was having shingles), RASH ERYTHEMATOUS (red bumps in forehead), DISORIENTATION (disoriented), LETHARGY (lethargic), FATIGUE (really tired) and RASH (Rash over arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200 (High) blood pressure was 200. On an unknown date, Heart rate: 91 (High) pulse 91.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate, Herpes zoster, Lethargy
Clinical narrative: horrible reaction/really bad reaction; felt she dislocated her brain; rash across the top of her forehead that looked like she was having shingles; red bumps in forehead; disoriented; lethargic; Rash over arms; heart started pumping/heart started racing really hard/heart was throbbing/heart was racing; could not breathe; did not feel good; really tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (horrible reaction/really bad reaction), HEADACHE (headache), FEELING ABNORMAL (felt she dislocated her brain), MALAISE (did not feel good) and PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (She had had heart surgery in 2012 to repair a hole in her heart, doctors put a patch there) in 2012. Concurrent medical conditions included Penicillin allergy.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache) and FATIGUE (really tired). On 10-Feb-2021, the patient experienced MALAISE (did not feel good). On 11-Feb-2021, the patient experienced PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing) and DYSPNOEA (could not breathe). On an unknown date, the patient experienced ADVERSE REACTION (horrible reaction/really bad reaction), FEELING ABNORMAL (felt she dislocated her brain), HERPES ZOSTER (rash across the top of her forehead that looked like she was having shingles), RASH ERYTHEMATOUS (red bumps in forehead), DISORIENTATION (disoriented), LETHARGY (lethargic) and RASH (Rash over arms). At the time of the report, ADVERSE REACTION (horrible reaction/really bad reaction), HEADACHE (headache), FEELING ABNORMAL (felt she dislocated her brain), MALAISE (did not feel good), PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing), DYSPNOEA (could not breathe), HERPES ZOSTER (rash across the top of her forehead that looked like she was having shingles), RASH ERYTHEMATOUS (red bumps in forehead), DISORIENTATION (disoriented), LETHARGY (lethargic), FATIGUE (really tired) and RASH (Rash over arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200 (High) blood pressure was 200. On an unknown date, Heart rate: 91 (High) pulse 91.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Palpitations, Rash, Rash erythematous
Clinical narrative: horrible reaction/really bad reaction; felt she dislocated her brain; rash across the top of her forehead that looked like she was having shingles; red bumps in forehead; disoriented; lethargic; Rash over arms; heart started pumping/heart started racing really hard/heart was throbbing/heart was racing; could not breathe; did not feel good; really tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (horrible reaction/really bad reaction), HEADACHE (headache), FEELING ABNORMAL (felt she dislocated her brain), MALAISE (did not feel good) and PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (She had had heart surgery in 2012 to repair a hole in her heart, doctors put a patch there) in 2012. Concurrent medical conditions included Penicillin allergy.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache) and FATIGUE (really tired). On 10-Feb-2021, the patient experienced MALAISE (did not feel good). On 11-Feb-2021, the patient experienced PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing) and DYSPNOEA (could not breathe). On an unknown date, the patient experienced ADVERSE REACTION (horrible reaction/really bad reaction), FEELING ABNORMAL (felt she dislocated her brain), HERPES ZOSTER (rash across the top of her forehead that looked like she was having shingles), RASH ERYTHEMATOUS (red bumps in forehead), DISORIENTATION (disoriented), LETHARGY (lethargic) and RASH (Rash over arms). At the time of the report, ADVERSE REACTION (horrible reaction/really bad reaction), HEADACHE (headache), FEELING ABNORMAL (felt she dislocated her brain), MALAISE (did not feel good), PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing), DYSPNOEA (could not breathe), HERPES ZOSTER (rash across the top of her forehead that looked like she was having shingles), RASH ERYTHEMATOUS (red bumps in forehead), DISORIENTATION (disoriented), LETHARGY (lethargic), FATIGUE (really tired) and RASH (Rash over arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200 (High) blood pressure was 200. On an unknown date, Heart rate: 91 (High) pulse 91.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PRODUCT DOSE OMISSION ISSUE (Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Event verbatim updated.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: They gave a first dose of Moderna COVID19 Vaccine to a 15 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (They gave a first dose of Moderna COVID19 Vaccine to a 15 year old) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (They gave a first dose of Moderna COVID19 Vaccine to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (They gave a first dose of Moderna COVID19 Vaccine to a 15 year old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.; Sender's Comments: This case concerns a 15 year-old male patient with no reported medical history, who experienced the unexpected event of Product administered to patient of inappropriate age. The event occurred on the same day as the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Myocarditis, Troponin I
Clinical narrative: Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: COVID-19 Vaccine and Myocarditis. 2021;00:1-2     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 MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: 65% 65%. On an unknown date, Troponin I: 18.94 ng/ml 18.94 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    Concomitant medications were not reported. Therapy for the event was not reported. It was reported that all patients recovered within 6 days of their presentation with complications. This analysis shows that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications.  This literature report concerns a 24 year old male patient who experienced myocarditis unknown duration after vaccination with second dose of mRNA-1273. The occurrence of the event is consistent with the current understanding of the mechanism of action of the vaccine (known to cause the event).The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-317848, MOD-2021-317975, MOD-2021-317976, MOD-2021-317977 (Patient Link).; Sender's Comments: This literature report concerns a 24 year old male patient who experienced myocarditis unknown duration after vaccination with second dose of mRNA-1273. The occurrence of the event is consistent with the current understanding of the mechanism of action of the vaccine (known to cause the event).The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Feeling abnormal, Illness, Lymphadenopathy
Clinical narrative: migraine; injection site big red dot or rash; had a chill; swollen lymph nodes; pain in her left breast; pain in her neck on the left; she did not feel good; felt like she was getting sick; pain under her left arm/pain in her left leg; pain in her arm/pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm/pain in her left arm), BREAST PAIN (pain in her left breast), NECK PAIN (pain in her neck on the left), FEELING ABNORMAL (she did not feel good) and ILLNESS (felt like she was getting sick) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04AF21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm/pain in her left arm). On 13-Sep-2021, the patient experienced BREAST PAIN (pain in her left breast), NECK PAIN (pain in her neck on the left), FEELING ABNORMAL (she did not feel good), ILLNESS (felt like she was getting sick), PAIN (pain under her left arm/pain in her left leg  ), CHILLS (had a chill) and LYMPHADENOPATHY (swollen lymph nodes). On 16-Sep-2021, the patient experienced VACCINATION SITE RASH (injection site big red dot or rash). On an unknown date, the patient experienced MIGRAINE (migraine). At the time of the report, PAIN IN EXTREMITY (pain in her arm/pain in her left arm) had resolved and BREAST PAIN (pain in her left breast), NECK PAIN (pain in her neck on the left), FEELING ABNORMAL (she did not feel good), ILLNESS (felt like she was getting sick), PAIN (pain under her left arm/pain in her left leg  ), MIGRAINE (migraine), CHILLS (had a chill), LYMPHADENOPATHY (swollen lymph nodes) and VACCINATION SITE RASH (injection site big red dot or rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.  Patient had pain in her arm, which lasted for 3 days.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Newevent Injection site big red dot or rash was added.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Neck pain, Pain, Pain in extremity, Vaccination site rash
Clinical narrative: migraine; injection site big red dot or rash; had a chill; swollen lymph nodes; pain in her left breast; pain in her neck on the left; she did not feel good; felt like she was getting sick; pain under her left arm/pain in her left leg; pain in her arm/pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm/pain in her left arm), BREAST PAIN (pain in her left breast), NECK PAIN (pain in her neck on the left), FEELING ABNORMAL (she did not feel good) and ILLNESS (felt like she was getting sick) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04AF21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm/pain in her left arm). On 13-Sep-2021, the patient experienced BREAST PAIN (pain in her left breast), NECK PAIN (pain in her neck on the left), FEELING ABNORMAL (she did not feel good), ILLNESS (felt like she was getting sick), PAIN (pain under her left arm/pain in her left leg  ), CHILLS (had a chill) and LYMPHADENOPATHY (swollen lymph nodes). On 16-Sep-2021, the patient experienced VACCINATION SITE RASH (injection site big red dot or rash). On an unknown date, the patient experienced MIGRAINE (migraine). At the time of the report, PAIN IN EXTREMITY (pain in her arm/pain in her left arm) had resolved and BREAST PAIN (pain in her left breast), NECK PAIN (pain in her neck on the left), FEELING ABNORMAL (she did not feel good), ILLNESS (felt like she was getting sick), PAIN (pain under her left arm/pain in her left leg  ), MIGRAINE (migraine), CHILLS (had a chill), LYMPHADENOPATHY (swollen lymph nodes) and VACCINATION SITE RASH (injection site big red dot or rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.  Patient had pain in her arm, which lasted for 3 days.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Newevent Injection site big red dot or rash was added.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Alpha 1 foetoprotein, Platelet count
Clinical narrative: After the vaccine he felt bad from his stomach/ he always had stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (After the vaccine he felt bad from his stomach/ he always had stomach) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Tumorectomy (He had an ablation to kill a 5 centimeters tumor) in August 2021. Concurrent medical conditions included Immunocompromised, HIV disease (For many years), Cancer (For many years), Cirrhosis liver (For many years), Tumour (Cancerous and he has been given Chemotherapy treatment and an Embolization) and Heartburn. Concomitant products included OMEPRAZOL [OMEPRAZOLE] for Heartburn, ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE (TRIUMEQ) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (After the vaccine he felt bad from his stomach/ he always had stomach). At the time of the report, ABDOMINAL DISCOMFORT (After the vaccine he felt bad from his stomach/ he always had stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alpha 1 foetoprotein: high (High) High, Found in Blood test. On an unknown date, Platelet count: low (Low) Low, blood platelets are through the floor.         Treatment information was not provided. Patient stated that after second dose he received Flu shot on an unknown date.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old. he got1 injection of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old. he got1 injection of Moderna) in a 14-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 (14 year old. he got1 injection of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old. he got1 injection of Moderna) had resolved.            Concomitant medications were not provided.  Treatment medications were not provided.  Events included I will monitor the symptoms if and will respond later
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination.     The patient's past medical history included Multiple myeloma and Bone marrow transplant NOS (bone marrow cancer) in 2007.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (Sore arm). On 13-Feb-2021, MYALGIA (Sore arm) had resolved.            No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-320886, MOD-2021-320895 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021; product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021) and PRODUCT STORAGE ERROR (product storage error) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (product storage error). On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021) had resolved. At the time of the report, PRODUCT STORAGE ERROR (product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. No treatment medications were provided. 13 doses of Moderna vaccine were inadvertently given past the vaccine beyond use-date (i.e. past 30 days at fridge temperature) of 9/5/21.   This case was linked to MOD-2021-320876 (Patient Link).; Sender's Comments: This case concerns a 26-year-old, male subject with no relevant medical history who was administered with an expired Spikevax product for his second dose of the vaccine. No information on the first dose received by the patient. There were no reported AEs/SAEs associated with this expired product administration. The rechallenge was not applicable in this situation. Causality was not provided by the reporter or not applicable. The benefit-risk relationship of the vaccine is not affected by this report. This case was reviewed via RA
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dizziness, Erythema, Lymph node pain
Clinical narrative: pain in my shoulder; a little lightheaded; a little redness and swelling; it started itching; swelling at the injection site; excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas; a little swelling; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching) and VACCINATION SITE SWELLING (swelling at the injection site) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Asthma.    On 26-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 ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching), VACCINATION SITE SWELLING (swelling at the injection site), LYMPH NODE PAIN (excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas), SWELLING (a little swelling) and CHEST DISCOMFORT (chest congestion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching), VACCINATION SITE SWELLING (swelling at the injection site), LYMPH NODE PAIN (excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas), SWELLING (a little swelling) and CHEST DISCOMFORT (chest congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Vaccination site swelling
Clinical narrative: pain in my shoulder; a little lightheaded; a little redness and swelling; it started itching; swelling at the injection site; excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas; a little swelling; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching) and VACCINATION SITE SWELLING (swelling at the injection site) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Asthma.    On 26-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 ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching), VACCINATION SITE SWELLING (swelling at the injection site), LYMPH NODE PAIN (excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas), SWELLING (a little swelling) and CHEST DISCOMFORT (chest congestion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (pain in my shoulder), DIZZINESS (a little lightheaded), ERYTHEMA (a little redness and swelling), PRURITUS (it started itching), VACCINATION SITE SWELLING (swelling at the injection site), LYMPH NODE PAIN (excruciating pain in both lymph nodes/ pain occurs whenever he applies pressure to these areas), SWELLING (a little swelling) and CHEST DISCOMFORT (chest congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dehydration, Dysphagia, Feeding disorder
Clinical narrative: Perfused diaphoresis; really anorexic again; could not eat for 2 weeks; trouble drinking; really sick; got dehydrated; really nauseous; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking) and ILLNESS (really sick) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037821B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (sick for 2 weeks with a dry cough, anorexic, could not eat anything, nauseous) on 07-Feb-2021, COVID-19 pneumonia (admitted in hospital from 7-Feb-2021 to 11-Feb-2021) and Chest X-ray (showed a bit of scarring on the lower left quadrant ).  Concomitant products included METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Migraine, CALCIPOTRIOL (DOVONEX) for Psoriasis, CALCIUM, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], VALPROATE SEMISODIUM (DEPAKOTE ER), GABAPENTIN (GABAPENTIN "PCD"), CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (1120 GLUCOSAMINE & CHONDROITINE), LEVOTHYROXINE, MELATONINE, METFORMIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS), CARVEDILOL (COREG), CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN), DULOXETINE HYDROCHLORIDE (CYMBALTA), EZETIMIBE (ZETIA), MAGNESIUM OXIDE, GINKGO BILOBA, PANAX QUINQUEFOLIUS (GINSENG AMERICANO) and ORIGANUM VULGARE (OREGANO) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking), ILLNESS (really sick), DEHYDRATION (got dehydrated), NAUSEA (really nauseous) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking), ILLNESS (really sick), DEHYDRATION (got dehydrated), NAUSEA (really nauseous) and CHILLS (chills) had resolved.      Treatment information was not provided.  The patient also took concomitant medications such as garden of life (probiotic formulated by physician) once daily and vitamin 1000 mg (200mg total daily).   This case was linked to MOD-2021-321229 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Nausea
Clinical narrative: Perfused diaphoresis; really anorexic again; could not eat for 2 weeks; trouble drinking; really sick; got dehydrated; really nauseous; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking) and ILLNESS (really sick) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037821B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (sick for 2 weeks with a dry cough, anorexic, could not eat anything, nauseous) on 07-Feb-2021, COVID-19 pneumonia (admitted in hospital from 7-Feb-2021 to 11-Feb-2021) and Chest X-ray (showed a bit of scarring on the lower left quadrant ).  Concomitant products included METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Migraine, CALCIPOTRIOL (DOVONEX) for Psoriasis, CALCIUM, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], VALPROATE SEMISODIUM (DEPAKOTE ER), GABAPENTIN (GABAPENTIN "PCD"), CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (1120 GLUCOSAMINE & CHONDROITINE), LEVOTHYROXINE, MELATONINE, METFORMIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS), CARVEDILOL (COREG), CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN), DULOXETINE HYDROCHLORIDE (CYMBALTA), EZETIMIBE (ZETIA), MAGNESIUM OXIDE, GINKGO BILOBA, PANAX QUINQUEFOLIUS (GINSENG AMERICANO) and ORIGANUM VULGARE (OREGANO) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking), ILLNESS (really sick), DEHYDRATION (got dehydrated), NAUSEA (really nauseous) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking), ILLNESS (really sick), DEHYDRATION (got dehydrated), NAUSEA (really nauseous) and CHILLS (chills) had resolved.      Treatment information was not provided.  The patient also took concomitant medications such as garden of life (probiotic formulated by physician) once daily and vitamin 1000 mg (200mg total daily).   This case was linked to MOD-2021-321229 (Patient Link).