chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Weak; Not eating as much as before; on-and-off sleepiness/Slept all day; "not feeling like herself"/Currently experiencing the symptoms and feeling worse.; Could not hold anything; Chills; Tired; Feeling nauseous; Vomiting; Feeling "under the weather"; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVITY TO WEATHER CHANGE (Feeling "under the weather"), ASTHENIA (Weak), DECREASED APPETITE (Not eating as much as before), SOMNOLENCE (on-and-off sleepiness/Slept all day) and FEELING ABNORMAL ("not feeling like herself"/Currently experiencing the symptoms and feeling worse.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 SENSITIVITY TO WEATHER CHANGE (Feeling "under the weather"). On 11-Jun-2021, the patient experienced ASTHENIA (Weak), DECREASED APPETITE (Not eating as much as before), SOMNOLENCE (on-and-off sleepiness/Slept all day), FEELING ABNORMAL ("not feeling like herself"/Currently experiencing the symptoms and feeling worse.), MOBILITY DECREASED (Could not hold anything), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Feeling nauseous) and VOMITING (Vomiting). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SENSITIVITY TO WEATHER CHANGE (Feeling "under the weather"), ASTHENIA (Weak), DECREASED APPETITE (Not eating as much as before), SOMNOLENCE (on-and-off sleepiness/Slept all day), FEELING ABNORMAL ("not feeling like herself"/Currently experiencing the symptoms and feeling worse.), MOBILITY DECREASED (Could not hold anything), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Feeling nauseous) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient just recently did the COVID test and still waiting for the result to come back.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Sensitivity to weather change, Somnolence, Vomiting
Clinical narrative: Weak; Not eating as much as before; on-and-off sleepiness/Slept all day; "not feeling like herself"/Currently experiencing the symptoms and feeling worse.; Could not hold anything; Chills; Tired; Feeling nauseous; Vomiting; Feeling "under the weather"; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVITY TO WEATHER CHANGE (Feeling "under the weather"), ASTHENIA (Weak), DECREASED APPETITE (Not eating as much as before), SOMNOLENCE (on-and-off sleepiness/Slept all day) and FEELING ABNORMAL ("not feeling like herself"/Currently experiencing the symptoms and feeling worse.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 SENSITIVITY TO WEATHER CHANGE (Feeling "under the weather"). On 11-Jun-2021, the patient experienced ASTHENIA (Weak), DECREASED APPETITE (Not eating as much as before), SOMNOLENCE (on-and-off sleepiness/Slept all day), FEELING ABNORMAL ("not feeling like herself"/Currently experiencing the symptoms and feeling worse.), MOBILITY DECREASED (Could not hold anything), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Feeling nauseous) and VOMITING (Vomiting). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SENSITIVITY TO WEATHER CHANGE (Feeling "under the weather"), ASTHENIA (Weak), DECREASED APPETITE (Not eating as much as before), SOMNOLENCE (on-and-off sleepiness/Slept all day), FEELING ABNORMAL ("not feeling like herself"/Currently experiencing the symptoms and feeling worse.), MOBILITY DECREASED (Could not hold anything), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Feeling nauseous) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient just recently did the COVID test and still waiting for the result to come back.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the vaccine after expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after expiry) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after expiry). On 12-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  It was reported that vaccine was punctured on 11 May 2021 at 10:30 am and administered on 12 May 2021 at 09:00 am. No adverse event was reported by the patient.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Used that punctured vial to vaccinate a male consumer; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used that punctured vial to vaccinate a male consumer) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Used that punctured vial to vaccinate a male consumer). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Used that punctured vial to vaccinate a male consumer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided. .
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received 3 doses of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received 3 doses of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 and 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 EXTRA DOSE ADMINISTERED (received 3 doses of Moderna vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (received 3 doses of Moderna vaccine) had resolved.            The caller told the customer care agent that her neighbor had both vaccine doses and then was given a 3rd dose .Moderna Customer Care agent only knew the gender of the patient the caller was calling on behalf of and that this patient who received 3 doses of Moderna vaccine. No Treatment medications were provided No  Concomitant medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Swelling
Clinical narrative: Is mild to moderate swelling all over the body normal; three vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Is mild to moderate swelling all over the body normal) and EXTRA DOSE ADMINISTERED (three 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 and 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 SWELLING (Is mild to moderate swelling all over the body normal) and EXTRA DOSE ADMINISTERED (three vaccine). At the time of the report, SWELLING (Is mild to moderate swelling all over the body normal) outcome was unknown and EXTRA DOSE ADMINISTERED (three vaccine) had resolved.            No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joints have been hurting for several weeks; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joints have been hurting for several weeks) 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 Back pain (Chronic back pain) and Surgery (Back fusion surgery).   On 18-May-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 an unknown date, the patient experienced ARTHRALGIA (joints have been hurting for several weeks). At the time of the report, ARTHRALGIA (joints have been hurting for several weeks) outcome was unknown.            Concomitant medication and treatment drug were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 100; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 100). At the time of the report, PYREXIA (fever of 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported,  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: Yeast infection; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL INFECTION (Yeast infection) 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 FUNGAL INFECTION (Yeast infection). At the time of the report, FUNGAL INFECTION (Yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: Swollen sore throat; Morning have a fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Swollen sore throat), PYREXIA (Morning have a fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jun-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 19-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Swollen sore throat), PYREXIA (Morning have a fever) and CHILLS (Chills). At the time of the report, OROPHARYNGEAL PAIN (Swollen sore throat), PYREXIA (Morning have a fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Severe hair loss after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Severe hair loss after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Severe hair loss after vaccination). At the time of the report, ALOPECIA (Severe hair loss after vaccination) outcome was unknown.            No treatment information is provided. No concomitant information is provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: lightheaded/Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded/Dizziness) 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 DIZZINESS (lightheaded/Dizziness). At the time of the report, DIZZINESS (lightheaded/Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was included.  No treatment drug details was provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: got 2nd vaccine and still feeling crappy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (got 2nd vaccine and still feeling crappy) 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 FEELING ABNORMAL (got 2nd vaccine and still feeling crappy). At the time of the report, FEELING ABNORMAL (got 2nd vaccine and still feeling crappy) outcome was unknown.            Concomitant medication and treatment drug were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: having a reaction to my second dose and not sure if it is serious or not; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having a reaction to my second dose and not sure if it is serious or not) 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, 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 VACCINATION COMPLICATION (having a reaction to my second dose and not sure if it is serious or not). At the time of the report, VACCINATION COMPLICATION (having a reaction to my second dose and not sure if it is serious or not) outcome was unknown.            Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: arm pain in 9 weeks after last Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm pain in 9 weeks after last Moderna 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, 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 MYALGIA (arm pain in 9 weeks after last Moderna shot). At the time of the report, MYALGIA (arm pain in 9 weeks after last Moderna shot) outcome was unknown.            Concomitant medication and treatment drug were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Feeling hot, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Swollen arm; Hot arm; Fever; Body aches/ Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Hot arm), PYREXIA (Fever) and MYALGIA (Body aches/ Sore 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 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 PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Hot arm), PYREXIA (Fever) and MYALGIA (Body aches/ Sore arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Hot arm), PYREXIA (Fever) and MYALGIA (Body aches/ Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: vitamin-b deficiency (Inconclusive) Vitamin-B deficiency.         Patient has went to doctor and  instructed to take vitamin-B.  No concomitant medication was provided.  No treatment medication was provided.  Patient went to doctor after experiencing side effects and had blood work and found out that b-vitamins were deficient and was instructed to take b-vitamins. Patient got second dose and experienced mild fever, body aches and a swollen and hot arm that was sore, that lasted 3 days.  Patient thought that b-vitamins were a part of what patient was experiencing.   This case was linked to MOD-2021-141432 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Erythema, Erythrasma, Pruritus, Rash
Clinical narrative: Eczema; Erythrasma; Redness/erythema; Itching/pruritus generalized; Rash generalized; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jun-2021. The most recent information was received on 16-Jul-2021 and was forwarded to Moderna on 16-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Eczema), ERYTHRASMA (Erythrasma), ERYTHEMA (Redness/erythema), PRURITUS (Itching/pruritus generalized) and RASH (Rash generalized) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A1B and 006M0A) for COVID-19 vaccination.     Relevant medical history information was not provided.  The patient's past medical history included Drug allergy (codeine), Drug allergy (Simvastatin) and Drug allergy (Fluvastatin). Previously administered products included for an unreported indication: NIACIN. Concomitant products included OMEPRAZOLE, CETIRIZINE, LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], PAROXETINE, COLECALCIFEROL (VITAMIN D3), ATORVASTATIN, METOPROLOL TARTRATE, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema), ERYTHRASMA (Erythrasma), ERYTHEMA (Redness/erythema), PRURITUS (Itching/pruritus generalized) and RASH (Rash generalized). The patient was treated with COAL TAR (topical) for Eczema, at a dose of 1 dosage form; PREDNISONE on 07-Feb-2021 at a dose of 4 mg and DOXYCYCLINE HYCLATE on 07-Feb-2021 at a dose of 100 mg. At the time of the report, ECZEMA (Eczema), ERYTHEMA (Redness/erythema), PRURITUS (Itching/pruritus generalized) and RASH (Rash generalized) had not resolved and ERYTHRASMA (Erythrasma) outcome was unknown.            This case was linked to MOD-2021-228244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow-up received on 16-Jul-2021 Contain added events information on patient demographics, patient history, concomitant medications, added treatment and outcome of not recovered. kindly assess as reported in SD.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose of Moderna Covid vaccine to be administered to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna Covid vaccine to be administered to a 17 year old) in a 17-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna Covid vaccine to be administered to a 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna Covid vaccine to be administered to a 17 year old) 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 medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo occurrences are much more frequent after receiving Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo occurrences are much more frequent after receiving Moderna 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, the patient experienced VERTIGO (vertigo occurrences are much more frequent after receiving Moderna Vaccine). At the time of the report, VERTIGO (vertigo occurrences are much more frequent after receiving Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment drug were not reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M70A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, CETIRIZINE, LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], PAROXETINE, ATORVASTATIN and VITAMIN D3 for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema). At the time of the report, ECZEMA (Eczema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant included Vitamin D3 was noted. Treatment included Creams, including Coaltar were provided by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Sleepy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (Sore arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (Sore arm). At the time of the report, SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: TCR attached
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I never got the 2nd dose/Is it ok to receive the 2nd dose months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I never got the 2nd dose/Is it ok to receive the 2nd dose months after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I never got the 2nd dose/Is it ok to receive the 2nd dose months after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I never got the 2nd dose/Is it ok to receive the 2nd dose months after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: The Additional document was received on 19-06-2021 and had significant information. Added patient demographics.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort
Clinical narrative: Chest to feel tight; Asthmatic reaction; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest to feel tight) and ASTHMA (Asthmatic reaction) 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 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Chest to feel tight) and ASTHMA (Asthmatic reaction). At the time of the report, CHEST DISCOMFORT (Chest to feel tight) and ASTHMA (Asthmatic reaction) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: I'm having a lot of body pain and my legs and arms; weakness; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I'm having a lot of body pain and my legs and arms), ASTHENIA (weakness), MYALGIA (body aches) and PYREXIA (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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I'm having a lot of body pain and my legs and arms), ASTHENIA (weakness), MYALGIA (body aches) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (I'm having a lot of body pain and my legs and arms), ASTHENIA (weakness), MYALGIA (body aches) and PYREXIA (fever) had resolved.            The concomitant medications were not reported.  The treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up appended outcome of event was updated
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little pain in the arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little pain in the arm after first dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN and LEVOTHYROXINE for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little pain in the arm after first dose). At the time of the report, PAIN IN EXTREMITY (little pain in the arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter No treatment information reported by the reporter   This case was linked to MOD-2021-228288 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: normal symptoms; This spontaneous case was reported by a nurse and describes the occurrence of ADVERSE REACTION (normal symptoms) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20a) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (normal symptoms). At the time of the report, ADVERSE REACTION (normal symptoms) 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.   Concomitant medication was not provided.  Treatment medication was not provided.   This case was linked to MOD-2021-075532 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain in my right hand subsides through out the day; clenched up into a fist/joint pain in my fingers and knuckles where I can't apply pressure with a fork, turn on the light switch or brushing my teeth; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my right hand subsides through out the day) and ARTHRALGIA (clenched up into a fist/joint pain in my fingers and knuckles where I can't apply pressure with a fork, turn on the light switch or brushing my teeth) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Thyroid disorder, VITAMIN D NOS 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 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in my right hand subsides through out the day) and ARTHRALGIA (clenched up into a fist/joint pain in my fingers and knuckles where I can't apply pressure with a fork, turn on the light switch or brushing my teeth). The patient was treated with GABAPENTIN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in my right hand subsides through out the day) had not resolved and ARTHRALGIA (clenched up into a fist/joint pain in my fingers and knuckles where I can't apply pressure with a fork, turn on the light switch or brushing my teeth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was prescribed medication for pain but it did not help.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Skin warm, Vaccination site rash
Clinical narrative: Rash very itchy; Heat is felt when touching the area; On her back/all over her body/rash moving down her arm towards her hand/ the rash went from 2inches to 4inches in length; Noticed a rash at injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of RASH PRURITIC (Rash very itchy), SKIN WARM (Heat is felt when touching the area), RASH (On her back/all over her body/rash moving down her arm towards her hand/ the rash went from 2inches to 4inches in length) and VACCINATION SITE RASH (Noticed a rash at injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and PROGESTERONE for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced RASH (On her back/all over her body/rash moving down her arm towards her hand/ the rash went from 2inches to 4inches in length) and VACCINATION SITE RASH (Noticed a rash at injection site). On an unknown date, the patient experienced RASH PRURITIC (Rash very itchy) and SKIN WARM (Heat is felt when touching the area). At the time of the report, RASH PRURITIC (Rash very itchy), SKIN WARM (Heat is felt when touching the area), RASH (On her back/all over her body/rash moving down her arm towards her hand/ the rash went from 2inches to 4inches in length) and VACCINATION SITE RASH (Noticed a rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment information not provided.    This case was linked to MOD-2021-228293, MOD-2021-229879 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Product dose omission issue
Clinical narrative: not gotten his second shot of Moderna; My shoulder still hurts, I can feel where I received the shot when I extend my arm out and is still in pain; Sore arm 2-3 hours receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not gotten his second shot of Moderna), MYALGIA (Sore arm 2-3 hours receiving the vaccine) and ARTHRALGIA (My shoulder still hurts, I can feel where I received the shot when I extend my arm out and is still in pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (Sore arm 2-3 hours receiving the vaccine). On 18-Jun-2021, the patient experienced ARTHRALGIA (My shoulder still hurts, I can feel where I received the shot when I extend my arm out and is still in pain). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not gotten his second shot of Moderna). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not gotten his second shot of Moderna) had resolved and MYALGIA (Sore arm 2-3 hours receiving the vaccine) and ARTHRALGIA (My shoulder still hurts, I can feel where I received the shot when I extend my arm out and is still in pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up document was received on 21-Jun-2021 which contain added event : Product dose omission issue. On 22-Jun-2021: Follow up document was attached on 22-Jun-2021 which contains Non-Significant information.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure fluctuation, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Blood pressure is fluctuating; Has not been feeling herself; Dizziness; She has no energy and spends a lot of time in bed/weakness; Tiredness; Body ache; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure is fluctuating), FEELING ABNORMAL (Has not been feeling herself), DIZZINESS (Dizziness), ASTHENIA (She has no energy and spends a lot of time in bed/weakness) and FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS and Hypertension. Concomitant products included LOSARTAN and LEVOTHYROXINE for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure is fluctuating), FEELING ABNORMAL (Has not been feeling herself), DIZZINESS (Dizziness), ASTHENIA (She has no energy and spends a lot of time in bed/weakness), FATIGUE (Tiredness), MYALGIA (Body ache), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) at a dose of 81 mg. At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure is fluctuating), FEELING ABNORMAL (Has not been feeling herself), DIZZINESS (Dizziness), ASTHENIA (She has no energy and spends a lot of time in bed/weakness), FATIGUE (Tiredness), MYALGIA (Body ache), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.            This case was linked to MOD-2021-228265 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Blood pressure is fluctuating; Has not been feeling herself; Dizziness; She has no energy and spends a lot of time in bed/weakness; Tiredness; Body ache; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure is fluctuating), FEELING ABNORMAL (Has not been feeling herself), DIZZINESS (Dizziness), ASTHENIA (She has no energy and spends a lot of time in bed/weakness) and FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS and Hypertension. Concomitant products included LOSARTAN and LEVOTHYROXINE for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure is fluctuating), FEELING ABNORMAL (Has not been feeling herself), DIZZINESS (Dizziness), ASTHENIA (She has no energy and spends a lot of time in bed/weakness), FATIGUE (Tiredness), MYALGIA (Body ache), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) at a dose of 81 mg. At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure is fluctuating), FEELING ABNORMAL (Has not been feeling herself), DIZZINESS (Dizziness), ASTHENIA (She has no energy and spends a lot of time in bed/weakness), FATIGUE (Tiredness), MYALGIA (Body ache), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.            This case was linked to MOD-2021-228265 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Discomfort, Pain, Paraesthesia
Clinical narrative: Tingling under arm and breast; Discomfort under breast; It hurts; Discomfort under arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling under arm and breast), BREAST DISCOMFORT (Discomfort under breast), PAIN (It hurts) and DISCOMFORT (Discomfort under arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PARAESTHESIA (Tingling under arm and breast), BREAST DISCOMFORT (Discomfort under breast), PAIN (It hurts) and DISCOMFORT (Discomfort under arm). At the time of the report, PARAESTHESIA (Tingling under arm and breast), BREAST DISCOMFORT (Discomfort under breast), PAIN (It hurts) and DISCOMFORT (Discomfort under arm) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination site pain, Vaccination site swelling
Clinical narrative: felt like someone slugged him in that area; soreness at injection site/ soreness built up gradually throughout out the day; injection site was slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (felt like someone slugged him in that area), VACCINATION SITE PAIN (soreness at injection site/ soreness built up gradually throughout out the day) and VACCINATION SITE SWELLING (injection site was slightly swollen) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included TESTOSTERONE for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced SLUGGISHNESS (felt like someone slugged him in that area), VACCINATION SITE PAIN (soreness at injection site/ soreness built up gradually throughout out the day) and VACCINATION SITE SWELLING (injection site was slightly swollen). On 11-May-2021, SLUGGISHNESS (felt like someone slugged him in that area), VACCINATION SITE PAIN (soreness at injection site/ soreness built up gradually throughout out the day) and VACCINATION SITE SWELLING (injection site was slightly swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.   This case was linked to MOD-2021-229879 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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 VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.