chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, SARS-CoV-2 antibody test, Tenderness
Clinical narrative: minimal tenderness in his arm; He also experianced some fatigue; Patient received the "Moderna booster dose" (third dose) / patient received three doses of the Moderna covid-19 /did not realize he had received the vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received the "Moderna booster dose" (third dose) / patient received three doses of the Moderna covid-19 /did not realize he had received the vaccine), TENDERNESS (minimal tenderness in his arm) and FATIGUE (He also experianced some fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 028620A and 050C21A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Stent insertion NOS (2 heart stent). Concurrent medical conditions included Polymyalgia rheumatica and Hypertension. Concomitant products included PREDNISONE for Polymyalgia rheumatica, APIXABAN (ELIQUIS), ATENOLOL, LISINOPRIL and FEBUXOSTAT (ULORIC) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received the "Moderna booster dose" (third dose) / patient received three doses of the Moderna covid-19 /did not realize he had received the vaccine). On an unknown date, the patient experienced TENDERNESS (minimal tenderness in his arm) and FATIGUE (He also experianced some fatigue). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received the "Moderna booster dose" (third dose) / patient received three doses of the Moderna covid-19 /did not realize he had received the vaccine) had resolved and TENDERNESS (minimal tenderness in his arm) and FATIGUE (He also experianced some fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-209097 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received, updated events and concomitant medications; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in my arm). At the time of the report, PAIN IN EXTREMITY (soreness in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Today my arm is sore similar to the days after I received the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Today my arm is sore similar to the days after I received the vaccine) in an 82-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 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 PAIN IN EXTREMITY (Today my arm is sore similar to the days after I received the vaccine). At the time of the report, PAIN IN EXTREMITY (Today my arm is sore similar to the days after I received the vaccine) outcome was unknown.            Concomitant products were not provided. No treatment drugs were not provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine vial was first punctured over 24 hours ago (administered); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine vial was first punctured over 24 hours ago (administered)) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine vial was first punctured over 24 hours ago (administered)). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine vial was first punctured over 24 hours ago (administered)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that the vaccine was punctured 24 hours prior to administration and kept in the refrigerator. The patient did not report any adverse symptoms following administration.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Initial additional, demographic details updated. On 14-Jun-2021: Initial additional.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 68 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16C21A) for COVID-19 vaccination.     NO Medical History Information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16C21A) for COVID-19 vaccination.     NO Medical History Information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had a really bad reaction to my first shot; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (I had a really bad reaction to my first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a really bad reaction to my first shot). At the time of the report, VACCINATION COMPLICATION (I had a really bad reaction to my first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 vaccination. No Medical History Information was reported.  On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot). On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 05-Jun-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 vaccination.  No Medical History Information was reported. On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot). On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; severe body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (severe body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical History Information was reported.    On an unknown date, the patient received 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 03-Jun-2021, the patient experienced CHILLS (Chills) and MYALGIA (severe body aches). At the time of the report, CHILLS (Chills) and MYALGIA (severe body aches) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Reporter did not allow further contact This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (severe body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical History Information was reported.    On an unknown date, the patient received 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 03-Jun-2021, the patient experienced CHILLS (Chills) and MYALGIA (severe body aches). At the time of the report, CHILLS (Chills) and MYALGIA (severe body aches) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: been throw up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (been throw up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (been throw up). At the time of the report, VOMITING (been throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2.5 months since first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2.5 months since first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2.5 months since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2.5 months since first dose) 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.   No concomitant medications were reported.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2.5 months since first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2.5 months since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2.5 months since first dose) 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.   No concomitant medications were reported.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling of relaxation, Pain, Vaccination site pain
Clinical narrative: shoot pain through the arm; relaxed arm; it hurt right under where I got the shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (shoot pain through the arm), FEELING OF RELAXATION (relaxed arm) and VACCINATION SITE PAIN (it hurt right under where I got the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (shoot pain through the arm), FEELING OF RELAXATION (relaxed arm) and VACCINATION SITE PAIN (it hurt right under where I got the shot). At the time of the report, PAIN (shoot pain through the arm), FEELING OF RELAXATION (relaxed arm) and VACCINATION SITE PAIN (it hurt right under where I got the shot) 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.   No concomitant medications were reported.  No treatment information was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Malaise
Clinical narrative: Not feeling well right now; when moves gets really dizzy; head is really bothering / hit head in the bathtub; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well right now), DIZZINESS (when moves gets really dizzy) and HEAD DISCOMFORT (head is really bothering / hit head in the bathtub) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02669) for COVID-19 vaccination.     No Medical History Information was reported.     On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced MALAISE (Not feeling well right now), DIZZINESS (when moves gets really dizzy) and HEAD DISCOMFORT (head is really bothering / hit head in the bathtub). At the time of the report, MALAISE (Not feeling well right now), DIZZINESS (when moves gets really dizzy) and HEAD DISCOMFORT (head is really bothering / hit head in the bathtub) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was reported This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well right now), DIZZINESS (when moves gets really dizzy) and HEAD DISCOMFORT (head is really bothering / hit head in the bathtub) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02669) for COVID-19 vaccination.     No Medical History Information was reported.     On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced MALAISE (Not feeling well right now), DIZZINESS (when moves gets really dizzy) and HEAD DISCOMFORT (head is really bothering / hit head in the bathtub). At the time of the report, MALAISE (Not feeling well right now), DIZZINESS (when moves gets really dizzy) and HEAD DISCOMFORT (head is really bothering / hit head in the bathtub) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was reported
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the recommended interval inter doses; This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval inter doses) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified. Concomitant products included DIGOXIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval inter doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval inter doses) 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.   concomitant medications included heart pills. No treatment medication for the event were reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: i have a fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (i have a fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (i have a fever). At the time of the report, PYREXIA (i have a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling). At the time of the report, SWELLING (Swelling) 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Muscle discomfort, Musculoskeletal discomfort, Nausea
Clinical narrative: feel nauseated; I felt a heavy arm; Muscle discomfort; discomfort that went to neck in same left side, discomfort it's been coming and going; tired after the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired after the shot), LIMB DISCOMFORT (I felt a heavy arm), MUSCLE DISCOMFORT (Muscle discomfort), MUSCULOSKELETAL DISCOMFORT (discomfort that went to neck in same left side, discomfort it's been coming and going) and NAUSEA (feel nauseated) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced FATIGUE (tired after the shot). On 15-May-2021, the patient experienced LIMB DISCOMFORT (I felt a heavy arm), MUSCLE DISCOMFORT (Muscle discomfort) and MUSCULOSKELETAL DISCOMFORT (discomfort that went to neck in same left side, discomfort it's been coming and going). On 03-Jun-2021, the patient experienced NAUSEA (feel nauseated). The patient was treated with PARACETAMOL (PANADOL) (oral) at a dose of 500 milligram as required. On 17-May-2021, LIMB DISCOMFORT (I felt a heavy arm), MUSCLE DISCOMFORT (Muscle discomfort) and MUSCULOSKELETAL DISCOMFORT (discomfort that went to neck in same left side, discomfort it's been coming and going) had resolved. At the time of the report, FATIGUE (tired after the shot) and NAUSEA (feel nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: small itchy hives 3 days after the second shot; small itchy hives 3 days after the second shot; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (small itchy hives 3 days after the second shot) and URTICARIA (small itchy hives 3 days after the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (small itchy hives 3 days after the second shot) and URTICARIA (small itchy hives 3 days after the second shot). At the time of the report, PRURITUS (small itchy hives 3 days after the second shot) and URTICARIA (small itchy hives 3 days after the second shot) outcome was unknown.            No concomitant medications reported by investigator No treatment medications provided by the reporter
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Period 2 weeks early; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Period 2 weeks early) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced MENSTRUATION IRREGULAR (Period 2 weeks early). At the time of the report, MENSTRUATION IRREGULAR (Period 2 weeks early) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Reaction to preservatives, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site warmth; Allergic to preservatives; Vaccination site erythema; Vaccination site swelling; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (Injection site warmth), REACTION TO PRESERVATIVES (Allergic to preservatives), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and FATIGUE (fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Reaction to preservatives (Allergy to Preservatives). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced FATIGUE (fatigue). On 28-May-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warmth), REACTION TO PRESERVATIVES (Allergic to preservatives), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, VACCINATION SITE WARMTH (Injection site warmth), REACTION TO PRESERVATIVES (Allergic to preservatives), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and FATIGUE (fatigue) 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 information was provided.  On 28MAY2021, Patient experienced an allergic reaction at injection site which has turned to red, swollen, warm with a diameter of 2.5 inches. Patient also experienced fatigue.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Product administration error; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error). At the time of the report, PRODUCT ADMINISTRATION ERROR (Product administration error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Nurse called in to report that 18 dose of the Moderna COVID-19 vaccine were administered to patients after the vaccine's storage viability had been exceeded. All of these doses came from the same LOT of vaccine. The vaccine was received and placed in a refrigerated sate on 22Apr2021. The vaccines stayed in this condition until their usage dates. On 27May2021, 6 patients received their SECOND dose from this vaccine vial LOT. Then, on 03Jun2021, 11patients received their SECOND dose of the vaccine from the LOT in question.  No other side effects have been reported from these patients at this time.  No concomitant medications or treatment details were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: get pain when raising arm or squeezing hand; Fatigued; initial arm pain that went away/ arm pain that came on 4 or 5 days after injection and is persistent; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (initial arm pain that went away/ arm pain that came on 4 or 5 days after injection and is persistent), MYALGIA (get pain when raising arm or squeezing hand) and FATIGUE (Fatigued) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced PAIN IN EXTREMITY (initial arm pain that went away/ arm pain that came on 4 or 5 days after injection and is persistent). On 22-May-2021, the patient experienced MYALGIA (get pain when raising arm or squeezing hand) and FATIGUE (Fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 19-May-2021, PAIN IN EXTREMITY (initial arm pain that went away/ arm pain that came on 4 or 5 days after injection and is persistent) had resolved. At the time of the report, MYALGIA (get pain when raising arm or squeezing hand) and FATIGUE (Fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Motion sickness, Nausea, Vomiting
Clinical narrative: motion sickness; feeling uncomfortable; persistent nausea, varying degrees severity; 3x vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MOTION SICKNESS (motion sickness), DISCOMFORT (feeling uncomfortable), NAUSEA (persistent nausea, varying degrees severity) and VOMITING (3x vomiting) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced MOTION SICKNESS (motion sickness), DISCOMFORT (feeling uncomfortable), NAUSEA (persistent nausea, varying degrees severity) and VOMITING (3x vomiting). At the time of the report, MOTION SICKNESS (motion sickness), DISCOMFORT (feeling uncomfortable), NAUSEA (persistent nausea, varying degrees severity) and VOMITING (3x vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines includes Imodium (1 tab, twice a day)
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Product administration error; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-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) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error). At the time of the report, PRODUCT ADMINISTRATION ERROR (Product administration error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medication were not provided.   Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: Sick after the 2nd dose; Have been fighting a fever after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after the 2nd dose) and PYREXIA (Have been fighting a fever after the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced PYREXIA (Have been fighting a fever after the 2nd dose). On an unknown date, the patient experienced ILLNESS (Sick after the 2nd dose). At the time of the report, ILLNESS (Sick after the 2nd dose) and PYREXIA (Have been fighting a fever after the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment products were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache; body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and MYALGIA (body aches). At the time of the report, HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: soreness at the site of injection; overpowering headache in the afternoon and it went downhill from there, patient was in bed until night; also noted a very high level of body ache from head to toe; feels like having a flu but not stomach flu; feeling nauseous; they received a vaccine that is past the suggested used by date; patient was in bed until night,; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (soreness at the site of injection), HEADACHE (overpowering headache in the afternoon and it went downhill from there, patient was in bed until night), MYALGIA (also noted a very high level of body ache from head to toe), INFLUENZA LIKE ILLNESS (feels like having a flu but not stomach flu) and NAUSEA (feeling nauseous) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of injection), HEADACHE (overpowering headache in the afternoon and it went downhill from there, patient was in bed until night), MYALGIA (also noted a very high level of body ache from head to toe), INFLUENZA LIKE ILLNESS (feels like having a flu but not stomach flu), NAUSEA (feeling nauseous), PRODUCT ADMINISTRATION ERROR (they received a vaccine that is past the suggested used by date) and BEDRIDDEN (patient was in bed until night,). At the time of the report, VACCINATION SITE PAIN (soreness at the site of injection), HEADACHE (overpowering headache in the afternoon and it went downhill from there, patient was in bed until night), MYALGIA (also noted a very high level of body ache from head to toe), INFLUENZA LIKE ILLNESS (feels like having a flu but not stomach flu), NAUSEA (feeling nauseous), PRODUCT ADMINISTRATION ERROR (they received a vaccine that is past the suggested used by date) and BEDRIDDEN (patient was in bed until night,) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   2nd dose: right arm given on: 1June2021 lot no.: 049C21A (not sure if 099C21A due to bad penmanship)   This case was linked to MOD-2021-209017 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Vaccination site pain
Clinical narrative: soreness at the site of injection; overpowering headache in the afternoon and it went downhill from there, patient was in bed until night; also noted a very high level of body ache from head to toe; feels like having a flu but not stomach flu; feeling nauseous; they received a vaccine that is past the suggested used by date; patient was in bed until night,; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (soreness at the site of injection), HEADACHE (overpowering headache in the afternoon and it went downhill from there, patient was in bed until night), MYALGIA (also noted a very high level of body ache from head to toe), INFLUENZA LIKE ILLNESS (feels like having a flu but not stomach flu) and NAUSEA (feeling nauseous) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of injection), HEADACHE (overpowering headache in the afternoon and it went downhill from there, patient was in bed until night), MYALGIA (also noted a very high level of body ache from head to toe), INFLUENZA LIKE ILLNESS (feels like having a flu but not stomach flu), NAUSEA (feeling nauseous), PRODUCT ADMINISTRATION ERROR (they received a vaccine that is past the suggested used by date) and BEDRIDDEN (patient was in bed until night,). At the time of the report, VACCINATION SITE PAIN (soreness at the site of injection), HEADACHE (overpowering headache in the afternoon and it went downhill from there, patient was in bed until night), MYALGIA (also noted a very high level of body ache from head to toe), INFLUENZA LIKE ILLNESS (feels like having a flu but not stomach flu), NAUSEA (feeling nauseous), PRODUCT ADMINISTRATION ERROR (they received a vaccine that is past the suggested used by date) and BEDRIDDEN (patient was in bed until night,) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   2nd dose: right arm given on: 1June2021 lot no.: 049C21A (not sure if 099C21A due to bad penmanship)   This case was linked to MOD-2021-209017 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular
Clinical narrative: Ever since then I've been experiencing severe headaches; missed my monthly cycle; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Ever since then I've been experiencing severe headaches) and MENSTRUATION IRREGULAR (missed my monthly cycle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced HEADACHE (Ever since then I've been experiencing severe headaches) and MENSTRUATION IRREGULAR (missed my monthly cycle). At the time of the report, HEADACHE (Ever since then I've been experiencing severe headaches) and MENSTRUATION IRREGULAR (missed my monthly cycle) outcome was unknown.            Concomitant products were not provided. Treatment products were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error) and PRODUCT STORAGE ERROR (Product storage error). On 02-Jun-2021, PRODUCT ADMINISTRATION ERROR (Product administration error) and PRODUCT STORAGE ERROR (Product storage error) had resolved. Concomitant medications were not provided by the reporter. On  01-Jun-2021, six vials were moved out of the freezer in to a refrigerator. During transportation of the vials, the temperature in portable refrigerator which contained the vials dropped down to 35.5F and then to 15.1F. The vials were under the recommended temperature of 36 to 45 F for almost 1 hour. On 02-Jun-2021, the local vaccination center who received those six vials, administered 30 doses in to 30 patients from three of the vials. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 01-JUL-2021 included no new information.