chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site reaction
Clinical narrative: Bad reaction that went over their shoulder; developed a bad reaction in their arm on the site if the injection; 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 VACCINATION COMPLICATION (Bad reaction that went over their shoulder) and VACCINATION SITE REACTION (developed a bad reaction in their arm on the site if the injection) 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 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Bad reaction that went over their shoulder) and VACCINATION SITE REACTION (developed a bad reaction in their arm on the site if the injection). At the time of the report, VACCINATION COMPLICATION (Bad reaction that went over their shoulder) and VACCINATION SITE REACTION (developed a bad reaction in their arm on the site if the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment was not specified.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.). On 29-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.) had resolved.        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.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: havent gotten  2nd jab. Its been over a month.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (havent gotten  2nd jab. Its been over a month.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (havent gotten  2nd jab. Its been over a month.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (havent gotten  2nd jab. Its been over a month.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient have concerned that can he suffer from blood clots that form after 2nd shot   No concomitant medications were reported  No treatment information was provided   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Induration, Vaccination site pain
Clinical narrative: Arm was hard like a charley horse; he felt run down and tired; Arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Arm was hard like a charley horse), FATIGUE (he felt run down and tired) and VACCINATION SITE PAIN (Arm was really sore) 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.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INDURATION (Arm was hard like a charley horse), FATIGUE (he felt run down and tired) and VACCINATION SITE PAIN (Arm was really sore). At the time of the report, INDURATION (Arm was hard like a charley horse), FATIGUE (he felt run down and tired) and VACCINATION SITE PAIN (Arm was really sore) outcome was unknown.            Concomitant product use was not provided.  Treatment product information was not provided.   This case was linked to MOD-2021-269938, MOD-2021-270022 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Vitamin B12 deficiency
Clinical narrative: 1/3 of the dose of the normal Moderna COVID-19 Vaccine; Received third dose because of low levels of B12; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (1/3 of the dose of the normal Moderna COVID-19 Vaccine) and VITAMIN B12 DEFICIENCY (Received third dose because of low levels of B12) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088O21A) 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 ACCIDENTAL UNDERDOSE (1/3 of the dose of the normal Moderna COVID-19 Vaccine) and VITAMIN B12 DEFICIENCY (Received third dose because of low levels of B12). At the time of the report, ACCIDENTAL UNDERDOSE (1/3 of the dose of the normal Moderna COVID-19 Vaccine) had resolved and VITAMIN B12 DEFICIENCY (Received third dose because of low levels of B12) outcome was unknown.            Concomitant medication was not provided Treatment information was not reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Followup document added Lot no and event
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This case was received via an unknown source (no reference has been entered for a health authority or partner) on 04-Sep-2021 and was forwarded to Moderna on 04-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (nauseous). At the time of the report, NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that, patient chest feels right after 5 hours of vaccine administration. No relevant concomitant medications were reported. Treatment information was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that the  o~Number of doses/vials: "2 doses/ 1 vial"  o~Date the vial was initially stored in the refrigerator:  "He thinks on 31AUG2021 but not 100% sure."          o~"The vial was first punctured and left at room temperature on  01SEP2021 o~"Date(s) of administration of vaccine when applicable: "02SEP2021"  o~Did the vial undergo any previous temperature excursions?  "NO"    o~Total amount of time the vial was exposed to room temperature range (46° to 77° F):  "A little over 24 hours"  Concomitant medications were not reported. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I got my second shot of Moderna vaccine a week too early/Second dose received less than 25 days after the first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got my second shot of Moderna vaccine a week too early/Second dose received less than 25 days after the first dose of the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got my second shot of Moderna vaccine a week too early/Second dose received less than 25 days after the first dose of the Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got my second shot of Moderna vaccine a week too early/Second dose received less than 25 days after the first dose of the Moderna Covid-19 vaccine) had resolved.            No concomitant medications were provided. No treatment medications were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased activity, Fatigue, Headache, Hyperhidrosis
Clinical narrative: not feeling well/feel so sick after taking the Moderna booster; not able to do anything/still laying around unable to do anything; swelling underneath armpit/swollen lymph nodes; swelling underneath armpit/swollen lymph nodes; headache; muscle aches; fatigue/fatigued; have chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well/feel so sick after taking the Moderna booster), DECREASED ACTIVITY (not able to do anything/still laying around unable to do anything), HYPERHIDROSIS (swelling underneath armpit/swollen lymph nodes), LYMPHADENOPATHY (swelling underneath armpit/swollen lymph nodes) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 04-Sep-2021, the patient experienced MALAISE (not feeling well/feel so sick after taking the Moderna booster), DECREASED ACTIVITY (not able to do anything/still laying around unable to do anything), HYPERHIDROSIS (swelling underneath armpit/swollen lymph nodes), LYMPHADENOPATHY (swelling underneath armpit/swollen lymph nodes), HEADACHE (headache), MYALGIA (muscle aches), FATIGUE (fatigue/fatigued) and CHILLS (have chills). At the time of the report, MALAISE (not feeling well/feel so sick after taking the Moderna booster), DECREASED ACTIVITY (not able to do anything/still laying around unable to do anything), HYPERHIDROSIS (swelling underneath armpit/swollen lymph nodes), LYMPHADENOPATHY (swelling underneath armpit/swollen lymph nodes), HEADACHE (headache), MYALGIA (muscle aches), FATIGUE (fatigue/fatigued) and CHILLS (have chills) had not resolved.            No concomitant medication was provided by reporter. No treatment information was provided was provided by reporter.  The patient was completely fine after receiving the second dose of vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow up received included updated outcome of all events
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Myalgia
Clinical narrative: not feeling well/feel so sick after taking the Moderna booster; not able to do anything/still laying around unable to do anything; swelling underneath armpit/swollen lymph nodes; swelling underneath armpit/swollen lymph nodes; headache; muscle aches; fatigue/fatigued; have chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well/feel so sick after taking the Moderna booster), DECREASED ACTIVITY (not able to do anything/still laying around unable to do anything), HYPERHIDROSIS (swelling underneath armpit/swollen lymph nodes), LYMPHADENOPATHY (swelling underneath armpit/swollen lymph nodes) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 04-Sep-2021, the patient experienced MALAISE (not feeling well/feel so sick after taking the Moderna booster), DECREASED ACTIVITY (not able to do anything/still laying around unable to do anything), HYPERHIDROSIS (swelling underneath armpit/swollen lymph nodes), LYMPHADENOPATHY (swelling underneath armpit/swollen lymph nodes), HEADACHE (headache), MYALGIA (muscle aches), FATIGUE (fatigue/fatigued) and CHILLS (have chills). At the time of the report, MALAISE (not feeling well/feel so sick after taking the Moderna booster), DECREASED ACTIVITY (not able to do anything/still laying around unable to do anything), HYPERHIDROSIS (swelling underneath armpit/swollen lymph nodes), LYMPHADENOPATHY (swelling underneath armpit/swollen lymph nodes), HEADACHE (headache), MYALGIA (muscle aches), FATIGUE (fatigue/fatigued) and CHILLS (have chills) had not resolved.            No concomitant medication was provided by reporter. No treatment information was provided was provided by reporter.  The patient was completely fine after receiving the second dose of vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow up received included updated outcome of all events
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: son came in contact with 3 other people that got the shot and still got COVID-19; 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 COVID-19 (son came in contact with 3 other people that got the shot and still got COVID-19) 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 03-Sep-2021, the patient experienced COVID-19 (son came in contact with 3 other people that got the shot and still got COVID-19). At the time of the report, COVID-19 (son came in contact with 3 other people that got the shot and still got COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: skin was peeling off  their fingers; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN EXFOLIATION (skin was peeling off  their fingers) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced SKIN EXFOLIATION (skin was peeling off  their fingers). At the time of the report, SKIN EXFOLIATION (skin was peeling off  their fingers) 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 medication was reported No treatment drug was reported
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort
Clinical narrative: Many women have experienced breast issues; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOMFORT (Many women have experienced breast issues) 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 BREAST DISCOMFORT (Many women have experienced breast issues). At the time of the report, BREAST DISCOMFORT (Many women have experienced breast issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   It was reported that these women had to do mammograms.  Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the right arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL], CARVEDILOL, LISINOPRIL and FUROSEMIDE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain on the right arm). At the time of the report, PAIN IN EXTREMITY (Pain on the right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included Nebulizer (4 treatments per day) and Hydroziline. No treatment medications were reported.   This case was linked to MOD-2021-307454, MOD-2021-307468 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received contains no new information On 08-Sep-2021: Follow up received contains no new information On 08-Sep-2021: Non significant follow up received on 08-Sep-2021
Sex: U
Vaccine: COVID19
Symptoms: Mass, Myalgia
Clinical narrative: Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna; Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna) and MYALGIA (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MASS (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna) and MYALGIA (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna). At the time of the report, MASS (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna) and MYALGIA (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: just received my first vaccine shot yesterday today I'm starting to feel bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (just received my first vaccine shot yesterday today I'm starting to feel bad) 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 FEELING ABNORMAL (just received my first vaccine shot yesterday today I'm starting to feel bad). At the time of the report, FEELING ABNORMAL (just received my first vaccine shot yesterday today I'm starting to feel bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: got COVID positive; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (got COVID positive) 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 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (got COVID positive). At the time of the report, SARS-COV-2 TEST POSITIVE (got COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-2 test: positive Positive.     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 reported. No treatment reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; pain on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the left arm) and PYREXIA (fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included Symbicort inhaler, albuterol, nebulizer (4 treatments per day), cardiovil, lisonopril, FUROSEMIDE and Hydroziline for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on the left arm). On 18-Aug-2021, the patient experienced PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (pain on the left arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     This case was linked to MOD-2021-307413, MOD-2021-307468. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I don't feel well after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I don't feel well after the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (I don't feel well after the second dose). At the time of the report, MALAISE (I don't feel well after the second dose) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu-like symptoms (2nd dose); Bad headache (2nd dose); Body aches (2nd dose); Fever (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms (2nd dose)), HEADACHE (Bad headache (2nd dose)), MYALGIA (Body aches (2nd dose)) and PYREXIA (Fever (2nd dose)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthmatic.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms (2nd dose)), HEADACHE (Bad headache (2nd dose)), MYALGIA (Body aches (2nd dose)) and PYREXIA (Fever (2nd dose)). On 16-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms (2nd dose)), HEADACHE (Bad headache (2nd dose)), MYALGIA (Body aches (2nd dose)) and PYREXIA (Fever (2nd dose)) had resolved.            No Concomitant medication was reported.  No Treatment medications were reported   This case was linked to MOD-2021-307233 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Pyrexia; Chills; a little bit of a sore arm but better by the 2nd day, Achy, Lots of pain in the lower left hand in the back which went up to the thoracic area; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Pyrexia), CHILLS (Chills), MYALGIA (a little bit of a sore arm but better by the 2nd day, Achy, Lots of pain in the lower left hand in the back which went up to the thoracic area) and FATIGUE (fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A, 010M20A and 062E21A) for COVID-19 vaccination.     Concurrent medical conditions included Ovarian cancer and Brain tumor (Patient reported they were immunocompromised). Concomitant products included METFORMIN, PITAVASTATIN CALCIUM (LIVALO), EZETIMIBE (ZETIA), DENOSUMAB (PROLIA), ACETYLSALICYLIC ACID (ASPIRIN 81), CALCIUM LACTATE, DL- LACTIC ACID (VAGISAN COMBI), TRAMADOL and GABAPENTIN (NEURONTIN) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Pyrexia), CHILLS (Chills), MYALGIA (a little bit of a sore arm but better by the 2nd day, Achy, Lots of pain in the lower left hand in the back which went up to the thoracic area) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PYREXIA (Pyrexia), CHILLS (Chills), MYALGIA (a little bit of a sore arm but better by the 2nd day, Achy, Lots of pain in the lower left hand in the back which went up to the thoracic area) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Pyrexia: 101.1 (High) 101.1 fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The first night after receiving the second dose the patient started experiencing fever and chills, a little bit of a sore arm but better by the second day, and fatigue.   This case was linked to MOD-2021-307114, MOD-2021-307467 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant F/U Case.: Patient weight , concomitant medication , Event start date added
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity, Pyrexia
Clinical narrative: Weakness; Pain on the right arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain on the right arm) and PYREXIA (Fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 031L20A and 010M20A) for COVID-19 vaccination.     No Relevant Medical History was provided.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT FORTE), SALBUTAMOL (ALBUTEROL HFA), LISINOPRIL, FUROSEMIDE, CARVEDILOL and HYDRALAZINE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain on the right arm) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain on the right arm) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not  provided.  Nebulizer (4 treatments per day)   was used as Concomitant medication.   This case was linked to MOD-2021-307454, MOD-2021-307413 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Breast mass
Clinical narrative: patient did a mammogram because developed and irregular looking thing in the breast.; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (patient did a mammogram because developed and irregular looking thing in the breast.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041M20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BREAST MASS (patient did a mammogram because developed and irregular looking thing in the breast.). At the time of the report, BREAST MASS (patient did a mammogram because developed and irregular looking thing in the breast.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did a mammogram and will have the results on Thursday, when a biopsy will be made.Lymph nodes are looking okay Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Vaccination complication
Clinical narrative: Little bit of soreness; Moderate to severe diarrhea; Minimal side effects; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Little bit of soreness), DIARRHEA (Moderate to severe diarrhea) and VACCINATION COMPLICATION (Minimal side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 006M20A and 027120A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third 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 (Little bit of soreness), DIARRHEA (Moderate to severe diarrhea) and VACCINATION COMPLICATION (Minimal side effects). At the time of the report, PAIN (Little bit of soreness), DIARRHEA (Moderate to severe diarrhea) and VACCINATION COMPLICATION (Minimal side effects) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was treated for cancer in the past.  No concomitant medication information was provided.  No treatment information was provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills for 2hrs; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills for 2hrs) and PYREXIA (fever) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (chills for 2hrs) and PYREXIA (fever). On 20-Feb-2021, CHILLS (chills for 2hrs) had resolved. On 21-Feb-2021, PYREXIA (fever) had resolved.            Concomitant medication includes chemotherapy.  No Treatment informations were reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: only received one dose of the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C021A and 053E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Abdominal disorder and Pain. Concomitant products included PANTOPRAZOLE for Abdominal disorder, LISINOPRIL, AMLODIPINE and DILTIAZEM for Blood pressure abnormal, TRAMADOL for Pain, PRAVASTATIN for an unknown indication.   On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            This case was linked to MOD-2021-307173 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cardiac discomfort, Injury
Clinical narrative: lot of people are getting injured with the kids and heart stuff; heart stuff; 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 INJURY (lot of people are getting injured with the kids and heart stuff) and CARDIAC DISCOMFORT (heart stuff) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJURY (lot of people are getting injured with the kids and heart stuff) and CARDIAC DISCOMFORT (heart stuff). At the time of the report, INJURY (lot of people are getting injured with the kids and heart stuff) and CARDIAC DISCOMFORT (heart stuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-307789, MOD-2021-308041 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days since first dose, no second dose received at this time; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days since first dose, no second dose received at this time) 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 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days since first dose, no second dose received at this time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days since first dose, no second dose received at this time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter.  Treatment information was not provided by reporter.   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: She was told it is covid arm,a delayed reaction in the skin; A delayed reaction in the skin; Severe pain in her arm; Itches like crazy; a small nut since at the injection site, which on 02Sep2021 it got bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (She was told it is covid arm,a delayed reaction in the skin), SKIN REACTION (A delayed reaction in the skin), VACCINATION SITE SWELLING (a small nut since at the injection site, which on 02Sep2021 it got bigger), VACCINATION SITE PAIN (Severe pain in her arm) and VACCINATION SITE PRURITUS (Itches like crazy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced VACCINATION SITE SWELLING (a small nut since at the injection site, which on 02Sep2021 it got bigger). On 02-Sep-2021, the patient experienced VACCINATION SITE REACTION (She was told it is covid arm,a delayed reaction in the skin), SKIN REACTION (A delayed reaction in the skin), VACCINATION SITE PAIN (Severe pain in her arm) and VACCINATION SITE PRURITUS (Itches like crazy). At the time of the report, VACCINATION SITE REACTION (She was told it is covid arm,a delayed reaction in the skin), SKIN REACTION (A delayed reaction in the skin), VACCINATION SITE SWELLING (a small nut since at the injection site, which on 02Sep2021 it got bigger), VACCINATION SITE PAIN (Severe pain in her arm) and VACCINATION SITE PRURITUS (Itches like crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 10 Moderna COVID-19 vials were in the freezer and experienced a temperature excursion; The caller confirms 18 patients were involved but the caller does not have any of that information with them to provide at this time.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 Moderna COVID-19 vials were in the freezer and experienced a temperature excursion) and EXPIRED PRODUCT ADMINISTERED (The caller confirms 18 patients were involved but the caller does not have any of that information with them to provide at this time.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 Moderna COVID-19 vials were in the freezer and experienced a temperature excursion) and EXPIRED PRODUCT ADMINISTERED (The caller confirms 18 patients were involved but the caller does not have any of that information with them to provide at this time.). At the time of the report, PRODUCT STORAGE ERROR (10 Moderna COVID-19 vials were in the freezer and experienced a temperature excursion) and EXPIRED PRODUCT ADMINISTERED (The caller confirms 18 patients were involved but the caller does not have any of that information with them to provide at this time.) 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 medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: a homeless person who received 1st dose and missed 2nd, more than 42 days have passed; 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 PRODUCT DOSE OMISSION ISSUE (a homeless person who received 1st dose and missed 2nd, more than 42 days have passed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (a homeless person who received 1st dose and missed 2nd, more than 42 days have passed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a homeless person who received 1st dose and missed 2nd, more than 42 days have passed) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Product dose omission issue
Clinical narrative: chest pain; missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and PRODUCT DOSE OMISSION ISSUE (missed second 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced CHEST PAIN (chest pain) and PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, CHEST PAIN (chest pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lethargy, Nausea
Clinical narrative: lethargy; I feel blah; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), FEELING ABNORMAL (I feel blah), HEADACHE (headache) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced LETHARGY (lethargy), FEELING ABNORMAL (I feel blah), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, LETHARGY (lethargy), FEELING ABNORMAL (I feel blah), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Significant Follow up received and outcome of events updated to recovered