chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dysarthria, Fatigue, Rash
Clinical narrative: During the call patient seemed like she was having trouble speaking/Patient was having trouble keeping up with the conversation; Bad rash on chest/Rash on legs/Really bad rash on neck and chest area/Rash on stomach/Rash on arms; Bad allergic reaction to the Moderna vaccine; Patient feels tired/tired that she couldn't go to the car to get the card; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (During the call patient seemed like she was having trouble speaking/Patient was having trouble keeping up with the conversation), RASH (Bad rash on chest/Rash on legs/Really bad rash on neck and chest area/Rash on stomach/Rash on arms), ALLERGY TO VACCINE (Bad allergic reaction to the Moderna vaccine) and FATIGUE (Patient feels tired/tired that she couldn't go to the car to get the card) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (allergic to some medication).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSARTHRIA (During the call patient seemed like she was having trouble speaking/Patient was having trouble keeping up with the conversation), RASH (Bad rash on chest/Rash on legs/Really bad rash on neck and chest area/Rash on stomach/Rash on arms), ALLERGY TO VACCINE (Bad allergic reaction to the Moderna vaccine) and FATIGUE (Patient feels tired/tired that she couldn't go to the car to get the card). At the time of the report, DYSARTHRIA (During the call patient seemed like she was having trouble speaking/Patient was having trouble keeping up with the conversation), RASH (Bad rash on chest/Rash on legs/Really bad rash on neck and chest area/Rash on stomach/Rash on arms), ALLERGY TO VACCINE (Bad allergic reaction to the Moderna vaccine) and FATIGUE (Patient feels tired/tired that she couldn't go to the car to get the card) had not resolved.            No concomitant medications reported.  Patient received the first booster dose.  Patient was historically on steroids but not anymore because it was affecting the heart.  It was reported that patient sought medical care. The day after the booster patient started to experience the symptoms.  No Treatment medication was reported.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Urticaria, Vaccination site pain
Clinical narrative: she felt significantly more pain than the previous 3 doses.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she felt significantly more pain than the previous 3 doses.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-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 SITE PAIN (she felt significantly more pain than the previous 3 doses.). At the time of the report, VACCINATION SITE PAIN (she felt significantly more pain than the previous 3 doses.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant product use was reported.  No treatment information was provided.   This case was linked to MOD-2022-555537, MOD-2022-555540, MOD-2022-555523 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: she felt significantly more pain than the previous 3 doses.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she felt significantly more pain than the previous 3 doses.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-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 SITE PAIN (she felt significantly more pain than the previous 3 doses.). At the time of the report, VACCINATION SITE PAIN (she felt significantly more pain than the previous 3 doses.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant product use was reported.  No treatment information was provided.   This case was linked to MOD-2022-555537, MOD-2022-555540, MOD-2022-555523 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Urticaria, Vaccination site pain
Clinical narrative: she felt significantly more pain han the previous 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she felt significantly more pain han the previous 3 doses) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 613A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-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 VACCINATION SITE PAIN (she felt significantly more pain han the previous 3 doses). At the time of the report, VACCINATION SITE PAIN (she felt significantly more pain han the previous 3 doses) outcome was unknown.            Concomitant product use was not provided by the reporter. It was reported that the patient felt pain during every dose of the vaccine. Treatment information was not provided.   This case was linked to MOD-2022-555535, MOD-2022-555540, MOD-2022-555523 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: she felt significantly more pain han the previous 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she felt significantly more pain han the previous 3 doses) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 613A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-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 VACCINATION SITE PAIN (she felt significantly more pain han the previous 3 doses). At the time of the report, VACCINATION SITE PAIN (she felt significantly more pain han the previous 3 doses) outcome was unknown.            Concomitant product use was not provided by the reporter. It was reported that the patient felt pain during every dose of the vaccine. Treatment information was not provided.   This case was linked to MOD-2022-555535, MOD-2022-555540, MOD-2022-555523 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site rash, Vaccination site reaction
Clinical narrative: left arm which is her injection arm, she had COVID arm; hives which jumped all over her body; rash feeling; redness in 2 by 2 inch; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04AL21A, 032F21A, 030L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Fatty liver, Penicillin allergy and Iodine contrast media allergy (radioactive iodine contrast).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch). At the time of the report, VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-555542 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site urticaria, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: left arm which is her injection arm, she had COVID arm; hives which jumped all over her body; rash feeling; redness in 2 by 2 inch; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04AL21A, 032F21A, 030L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Fatty liver, Penicillin allergy and Iodine contrast media allergy (radioactive iodine contrast).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch). At the time of the report, VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-555542 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Lethargy
Clinical narrative: left arm which is her injection arm, she had COVID arm; hives which jumped all over her body; rash feeling; redness in 2 by 2 inch; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04AL21A, 032F21A, 030L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Fatty liver, Penicillin allergy and Iodine contrast media allergy (radioactive iodine contrast).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch). At the time of the report, VACCINATION SITE REACTION (left arm which is her injection arm, she had COVID arm), URTICARIA (hives which jumped all over her body), VACCINATION SITE RASH (rash feeling) and VACCINATION SITE ERYTHEMA (redness in 2 by 2 inch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-555542 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Losing my hair; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Losing my hair) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ALOPECIA (Losing my hair). At the time of the report, ALOPECIA (Losing my hair) had not resolved.            No concomitant medications were reported. No treatment medications were reported.  Patient was wondering if there was something can put him onto that would restore whatever he had lost. He was fairly sure it was from your vaccines.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Incorrect route of product administration, Nausea, Pyrexia
Clinical narrative: sick for a week; diarrhea; nauseous; 106 degree fever; second booster was administered inappropriately and was not giving in the deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for a week), DIARRHOEA (diarrhea), NAUSEA (nauseous), PYREXIA (106 degree fever) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second booster was administered inappropriately and was not giving in the deltoid muscle) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for a week), DIARRHOEA (diarrhea), NAUSEA (nauseous), PYREXIA (106 degree fever) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second booster was administered inappropriately and was not giving in the deltoid muscle). At the time of the report, ILLNESS (sick for a week) had resolved and DIARRHOEA (diarrhea), NAUSEA (nauseous), PYREXIA (106 degree fever) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second booster was administered inappropriately and was not giving in the deltoid muscle) outcome was unknown.            No concomitant and treatment medications were reported by the reporter. Patient has since read that it may have cause her vaccine to fail. Patient would like to know if that was true and if she needs to get another. Patient has spoken to the pharmacist that the technician gave it in the wrong location. Patient did not think the vaccination provider was going to call us about the error. Patient had the first three shots (including the booster) and never had one side effect but after getting this second booster dose she experiencing 106 degree fever, diarrhea, nauseous, sick for a week.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Source Document contains non-significant information.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Illness, Mobility decreased, Rash
Clinical narrative: got really sick; had to be in bed for a whole week; allergic to the Moderna shots; got a rash; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week), ALLERGY TO VACCINE (allergic to the Moderna shots) and RASH (got a rash) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy and Lactose intolerant.    On 23-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 ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week), ALLERGY TO VACCINE (allergic to the Moderna shots) and RASH (got a rash). At the time of the report, ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week), ALLERGY TO VACCINE (allergic to the Moderna shots) and RASH (got a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had no Acute and Chronic illnesses at the time of vaccination and patient had not taken other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Symptoms were improved.  No treatment medications were reported   This case was linked to MOD-2022-555541 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered a vaccine which has been punctured for more that 12 hours and left at the counter at room for 18 hours; Administered a vaccine which has been punctured for more that 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a vaccine which has been punctured for more that 12 hours) and PRODUCT STORAGE ERROR (Administered a vaccine which has been punctured for more that 12 hours and left at the counter at room for 18 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 012M20A, 013M20A and 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 30-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a vaccine which has been punctured for more that 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered a vaccine which has been punctured for more that 12 hours and left at the counter at room for 18 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a vaccine which has been punctured for more that 12 hours) and PRODUCT STORAGE ERROR (Administered a vaccine which has been punctured for more that 12 hours and left at the counter at room for 18 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  The vial was first punctured on  29-Apr-2022 at 5pm and administered on 3- Apr-2022 at 11am. Vaccine was inadvertently administered which has been punctured and left at the counter at room for 18 hours. Vial did not undergone any temperature excursion issue. The vial was initially stored in the refrigerator on 20-Apr-2022.  No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Report a side effect; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (Report a side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Report a side effect). At the time of the report, IMMUNISATION REACTION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The caller wanted to report a side effect.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Pain in the arm of injection; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm of injection) and MYALGIA (Achiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE and ACYCLOVIR [ACICLOVIR] for an unknown indication.    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 VACCINATION SITE PAIN (Pain in the arm of injection) and MYALGIA (Achiness). At the time of the report, VACCINATION SITE PAIN (Pain in the arm of injection) and MYALGIA (Achiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       History relating to mentioned AE and both acute and chronic illnesses at the time of vaccination were reported as no. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as unknown.  The patient experienced pain in the arm of injection and achiness after every vaccine for a couple of days.  No treatment information were reported.   This case was linked to MOD-2021-030157, MOD-2022-555702 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She felt significantly more pain than the previous 3 doses) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 613A21A, 024M20A and 057M21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (She felt significantly more pain than the previous 3 doses). At the time of the report, VACCINATION SITE PAIN (She felt significantly more pain than the previous 3 doses) outcome was unknown. No concomitant medication were provided. No treatment details were provided. This case was linked to MOD-2022-555537, MOD-2022-555535, MOD-2022-555523 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Illness, Mobility decreased, Rash
Clinical narrative: got really sick; had to be in bed for a whole week.; she is allergic to the Moderna shots; got a rash; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week.), ALLERGY TO VACCINE (she is allergic to the Moderna shots) and RASH (got a rash) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (amoxicillin) and Lactose intolerant.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-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 ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week.), ALLERGY TO VACCINE (she is allergic to the Moderna shots) and RASH (got a rash). At the time of the report, ILLNESS (got really sick), MOBILITY DECREASED (had to be in bed for a whole week.), ALLERGY TO VACCINE (she is allergic to the Moderna shots) and RASH (got a rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The patient went to office visit.   This case was linked to MOD-2022-555530 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Neck mass, Osteitis
Clinical narrative: Coughing after 2nd booster/He was coughing as he was speaking; He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting; He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting; He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing after 2nd booster/He was coughing as he was speaking), OSTEITIS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting), NECK MASS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting) and ARTHRALGIA (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2022, the patient received fourth 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 an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, the patient experienced COUGH (Coughing after 2nd booster/He was coughing as he was speaking), OSTEITIS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting), NECK MASS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting) and ARTHRALGIA (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting). At the time of the report, COUGH (Coughing after 2nd booster/He was coughing as he was speaking) had not resolved and OSTEITIS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting), NECK MASS (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting) and ARTHRALGIA (He states that his shoulder collar bone towards the neck has a knot, Inflamed, and it is hurting) outcome was unknown.            No concomitant medications were reported. The patient was reluctant to provide information and was irritated with the questions. No treatment medications were reported.   This case was linked to MOD-2022-556083 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain
Clinical narrative: Achiness on my left side of my neck; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Achiness on my left side of my neck) and FATIGUE (Extreme fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Patient had not been diagnosed with or tested positive for COVID-19.  The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Food allergy (Red dye 40 allergy and intolerance), Food allergy (Yellow dye 5/6 allergy and intolerance), Hypothyroidism since 05-Mar-2021 and Scoliosis (Lumber spine) on 06-Jan-1975. Concomitant products included LEVOTHYROXINE from 05-Mar-2001 to an unknown date for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS], VITAMIN D3 from 12-Sep-2019 to an unknown date and ASCORBIC ACID (VITAMIN C WITH ROSE HIPS [ASCORBIC ACID]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Achiness on my left side of my neck) and FATIGUE (Extreme fatigue). At the time of the report, NECK PAIN (Achiness on my left side of my neck) and FATIGUE (Extreme fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged.       Frequency of Vitamin C with rose hips was reported as as necessary.  Treatment medications were not provided.   This case was linked to MOD-2021-020909 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: he was wheezing prior to receiving the 2nd booster shot.; This spontaneous case was reported by a patient and describes the occurrence of WHEEZING (he was wheezing prior to receiving the 2nd booster shot.) in a 62-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WHEEZING (he was wheezing prior to receiving the 2nd booster shot.). At the time of the report, WHEEZING (he was wheezing prior to receiving the 2nd booster shot.) outcome was unknown.          Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-555946 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bone pain, Myalgia
Clinical narrative: he was wheezing prior to receiving the 2nd booster shot.; This spontaneous case was reported by a patient and describes the occurrence of WHEEZING (he was wheezing prior to receiving the 2nd booster shot.) in a 62-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WHEEZING (he was wheezing prior to receiving the 2nd booster shot.). At the time of the report, WHEEZING (he was wheezing prior to receiving the 2nd booster shot.) outcome was unknown.          Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-555946 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate irregular
Clinical narrative: he was wheezing prior to receiving the 2nd booster shot.; This spontaneous case was reported by a patient and describes the occurrence of WHEEZING (he was wheezing prior to receiving the 2nd booster shot.) in a 62-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WHEEZING (he was wheezing prior to receiving the 2nd booster shot.). At the time of the report, WHEEZING (he was wheezing prior to receiving the 2nd booster shot.) outcome was unknown.          Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-555946 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was administered vaccine which was opened sometime in April and administered on 01May2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 939902, 030L20A and 025J20-2A) for COVID-19 vaccination. Concurrent medical conditions included Pollen allergy. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was administered vaccine which was opened sometime in April and administered on 01May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient was administered vaccine which was opened sometime in April and administered on 01May2022) outcome was unknown. No concomitant medications were reported. From the COVID-19 vaccination on 01-May-2022, he had no reaction to it. During administration, he asked when the vaccine was opened. The person who was administering it said sometime in April. He saw online the vial should be discarded after 12 hours once punctured. No treatment medications were reported. This case was linked to MOD-2022-555870, MOD-2022-555960, MOD-2022-555961 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit of a sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (a little bit of a sore arm) outcome was unknown.      Patient did not seek medical care for the event. Treatment information was not provided.   This case was linked to MOD-2022-556239, MOD-2022-555509, MOD-2022-556238 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit of a sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 045A21A and 031M20A) for COVID-19 vaccination.     Patient has no allergies. Patient has never been diagnosed or tested positive for COVID-19. Patient has no acute or chronic illness at the time of vaccination.  Previously administered products included for Product used for unknown indication: Flu shot (patient  doesn´t remember the exact date.) in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced PAIN IN EXTREMITY (a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (a little bit of a sore arm) outcome was unknown.            Patient did not seek medical care for the event.   This case was linked to MOD-2022-556239, MOD-2022-555509, MOD-2022-556237 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Pain in extremity
Clinical narrative: After receiving the fourth dose, the patient is having a lot more of a sore arm than with the last shots; has a big painful and swelling lump under the armpit, lump is pretty large, it has the size of a baseball; lump is hard, sore, and very painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After receiving the fourth dose, the patient is having a lot more of a sore arm than with the last shots), AXILLARY MASS (has a big painful and swelling lump under the armpit, lump is pretty large, it has the size of a baseball) and AXILLARY PAIN (lump is hard, sore, and very painful to the touch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 039F21A, 045A21A and 031M20A) for COVID-19 vaccination.     The patient was never diagnosed or tested positive for COVID-19 disease. The patient did not have any allergies to medications, food and other products. The patient had no acute or chronic illnesses at the time of vaccination.  Previously administered products included for Flu: FLU VACCINE VII (patient does not remember the exact date of administration) in October 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (After receiving the fourth dose, the patient is having a lot more of a sore arm than with the last shots), AXILLARY MASS (has a big painful and swelling lump under the armpit, lump is pretty large, it has the size of a baseball) and AXILLARY PAIN (lump is hard, sore, and very painful to the touch). At the time of the report, PAIN IN EXTREMITY (After receiving the fourth dose, the patient is having a lot more of a sore arm than with the last shots), AXILLARY MASS (has a big painful and swelling lump under the armpit, lump is pretty large, it has the size of a baseball) and AXILLARY PAIN (lump is hard, sore, and very painful to the touch) had not resolved.            Concomitant medication included multivitamins (over the counter medications).  On 30-Apr-2022, the patient received the second booster dose of Moderna COVID-19 vaccine.  The adverse event did not cause the patient to seek medical care.  The patient experienced sore arm with the other received doses of Moderna COVID-19 vaccine.  No treatment information was provided.   This case was linked to MOD-2022-555509, MOD-2022-556237, MOD-2022-556238 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior; vial stored post puncture vial was stored under refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator). On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  On 31-Mar-2022, The vial was initially stored in the refrigerator.  On 21-Apr-2022 at 10:20 am, The vial was first punctured.  On 22-Apr-2022 at 9:30 am - 1:15 pm, The vaccine was administered.  The patient has not reported any adverse reactions to the expired dose administered.   Post puncture vial was stored in refrigerator and the vial did not undergo any temperature excursions.  The vial was not exposed to room temperature for more than 24 hours.  No treatment drug was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose was administered to the patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered to the patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered to the patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered to the patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial was initially stored in the refrigerator was on 31-Mar-2022. The vial was first punctured was on 21-Apr-2022 at 10:20 am and was stored in refrigerator post puncture. The exact administration time was not provided but it was reported that on 22-Apr-2022, the patients were received the vaccines from 9:30 am to 1:15 pm. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature (8 degree to 25 degree Celsius= 46 degree to 77 degree Fahrenheit) was unknown but it was reported that the vial did not expose to room temperature for greater than 24 hours.  The patient did not report any adverse reactions.  No treatment information was provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial stored post puncture vial was stored under refrigerator; Moderna doses administered past 12 hour BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour BUD) and PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour BUD) and PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  Vial was first punctured on 21APR2022 at 10:20 AM and stored in Refrigerator.  Patient did not experienced any adverse event to the expired dose administered.  No treatment medication was reported by the reporter.