chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed to receive the 2nd dose of Moderna vaccine D64; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine D64) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-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 (Missed to receive the 2nd dose of Moderna vaccine D64). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine D64) had resolved.            NO Concomitant products used by the patient included.  Treatment information was not provided.  Patient missed the due date in order to receive the 2nd dose on 13-May-2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Live followed up received on 17-Jun-2021: addition of patient details, addition of batch number, event updated to Missed to receive the 2nd dose of Moderna vaccine D64.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: Feeling bad; I get sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad) and ILLNESS (I get sick) 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 FEELING ABNORMAL (Feeling bad) and ILLNESS (I get sick). At the time of the report, FEELING ABNORMAL (Feeling bad) and ILLNESS (I get sick) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Body temperature, Chills, Confusional state, Hypersomnia
Clinical narrative: Slept around the clock after the First Vaccine; Confusion; Shivering; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept around the clock after the First Vaccine), CONFUSIONAL STATE (Confusion), CHILLS (Shivering) and PYREXIA (High Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Hypertension, Seizure and Dyslipidemia. Concomitant products included SIMVASTATIN for Dyslipidemia, METOPROLOL for Hypertension, VALPROATE SEMISODIUM (DEPAKOTE) for Seizures, IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HYPERSOMNIA (Slept around the clock after the First Vaccine), CONFUSIONAL STATE (Confusion), CHILLS (Shivering) and PYREXIA (High Fever). On 04-Mar-2021, HYPERSOMNIA (Slept around the clock after the First Vaccine), CONFUSIONAL STATE (Confusion), CHILLS (Shivering) and PYREXIA (High Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 104 (High) 103-104 F. On an unknown date, Blood glucose: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-228389 (E2B Linked Report). This case was linked to MOD-2021-226399 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-228389:Same reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Slept around the clock after the First Vaccine; Confusion; Shivering; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept around the clock after the First Vaccine), CONFUSIONAL STATE (Confusion), CHILLS (Shivering) and PYREXIA (High Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Hypertension, Seizure and Dyslipidemia. Concomitant products included SIMVASTATIN for Dyslipidemia, METOPROLOL for Hypertension, VALPROATE SEMISODIUM (DEPAKOTE) for Seizures, IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HYPERSOMNIA (Slept around the clock after the First Vaccine), CONFUSIONAL STATE (Confusion), CHILLS (Shivering) and PYREXIA (High Fever). On 04-Mar-2021, HYPERSOMNIA (Slept around the clock after the First Vaccine), CONFUSIONAL STATE (Confusion), CHILLS (Shivering) and PYREXIA (High Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 104 (High) 103-104 F. On an unknown date, Blood glucose: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-228389 (E2B Linked Report). This case was linked to MOD-2021-226399 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-228389:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received the first dose on 05Feb2021 Patient is present for second dose of the Moderna Vaccine today 17june2021, (132 days after 1st dose)/132 days since the first dose and no second dose taken yet; 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 DOSE OMISSION ISSUE (Patient received the first dose on 05Feb2021 Patient is present for second dose of the Moderna Vaccine today 17june2021, (132 days after 1st dose)/132 days since the first dose and no second dose taken yet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received the first dose on 05Feb2021 Patient is present for second dose of the Moderna Vaccine today 17june2021, (132 days after 1st dose)/132 days since the first dose and no second dose taken yet). On 17-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Patient received the first dose on 05Feb2021 Patient is present for second dose of the Moderna Vaccine today 17june2021, (132 days after 1st dose)/132 days since the first dose and no second dose taken yet) 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 reported. Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: NNI FU - No new information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: my wife got the moderna and is all the sudden getting low platelets, is this a side affect; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (my wife got the moderna and is all the sudden getting low platelets, is this a side affect) 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 PLATELET COUNT DECREASED (my wife got the moderna and is all the sudden getting low platelets, is this a side affect). At the time of the report, PLATELET COUNT DECREASED (my wife got the moderna and is all the sudden getting low platelets, is this a side affect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: low (Low) Platelet count was low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: I have red blotched over my hips,lower back and in between my breasts; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (I have red blotched over my hips,lower back and in between my breasts) 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 RASH MACULAR (I have red blotched over my hips,lower back and in between my breasts). At the time of the report, RASH MACULAR (I have red blotched over my hips,lower back and in between my breasts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Received last vaccination on April 14th, about a month later Patient has  red blotched over  hips, lower back and in between breasts.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Very itchy; Red ring at injection site; Red and swollen; Left arm is still a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE ERYTHEMA (Red ring at injection site), VACCINATION SITE SWELLING (Red and swollen) and MYALGIA (Left arm is still a little sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 21-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 VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE ERYTHEMA (Red ring at injection site), VACCINATION SITE SWELLING (Red and swollen) and MYALGIA (Left arm is still a little sore). At the time of the report, VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE ERYTHEMA (Red ring at injection site), VACCINATION SITE SWELLING (Red and swollen) and MYALGIA (Left arm is still a little sore) 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 for the event was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19-JUL-2021 contains no significant information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site rash
Clinical narrative: Fever; Red hard rash at the injection site; Red hard rash at the injection site; Red hard rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Red hard rash at the injection site), VACCINATION SITE RASH (Red hard rash at the injection site), VACCINATION SITE ERYTHEMA (Red hard rash at the injection site) and PYREXIA (Fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-Jun-2021, the patient experienced VACCINATION SITE INDURATION (Red hard rash at the injection site), VACCINATION SITE RASH (Red hard rash at the injection site) and VACCINATION SITE ERYTHEMA (Red hard rash at the injection site). On 17-Jun-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, VACCINATION SITE INDURATION (Red hard rash at the injection site), VACCINATION SITE RASH (Red hard rash at the injection site), VACCINATION SITE ERYTHEMA (Red hard rash at the injection site) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jun-2021, Body temperature: 99.8 (High) The fever was measured at 99.8F.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Toothache
Clinical narrative: the roots of her teeth hurt; top of her head hurts when she touches her hair it radiates to all the teeth at the same time; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (the roots of her teeth hurt), PAIN (top of her head hurts when she touches her hair it radiates to all the teeth at the same time) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 02-Mar-2021, the patient experienced TOOTHACHE (the roots of her teeth hurt) and PAIN (top of her head hurts when she touches her hair it radiates to all the teeth at the same time). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 03-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, TOOTHACHE (the roots of her teeth hurt) and PAIN (top of her head hurts when she touches her hair it radiates to all the teeth at the same time) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Patient had a question that the pain at the root of her teeth is a side effect from  the vaccine. no concomitant medications are provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Four patients were given the second dose on Tuesday morning between 15hour and 18hour period.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients were given the second dose on Tuesday morning between 15hour and 18hour period.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients were given the second dose on Tuesday morning between 15hour and 18hour period.). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Four patients were given the second dose on Tuesday morning between 15hour and 18hour period.) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort
Clinical narrative: like if someone punched it in the arm; like worked out; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (like if someone punched it in the arm) and FATIGUE (like worked out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (like if someone punched it in the arm) and FATIGUE (like worked out). At the time of the report, LIMB DISCOMFORT (like if someone punched it in the arm) and FATIGUE (like worked out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided. No treatment information given.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed to receive the 2nd dose of vaccine , passed 35 days after the 1st dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of vaccine , passed 35 days after the 1st dose.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included ACETAMINOPHEN, SALBUTAMOL (ALBUTEROL HFA), ALBUTEROL SULFATE, ATORVASTATIN, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), FLUTICASONE, FUROSEMIDE, GUAIFENESIN, METOPROLOL SUCCINATE, NICOTINE, OXYCODONE, SERTRALINE, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), TRAMADOL and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication.    On 10-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 PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of vaccine , passed 35 days after the 1st dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of vaccine , passed 35 days after the 1st dose.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.  Patient lost the follow up and now came back to receive the 2nd dose of vaccine. Its passed 42 days after receiving the 1st dose.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-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 FATIGUE (Little tired). At the time of the report, FATIGUE (Little tired) outcome was unknown.            No concomitant and treatment medications were provided.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-226455 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test normal, Hypertension
Clinical narrative: back to ER with blood pressure was high again (156/103); blood pressure went up to 200/123; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure went up to 200/123) and HYPERTENSION (back to ER with blood pressure was high again (156/103)) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. I26B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included X-ray on 15-Jun-2021. Concomitant products included AMLODIPINE and BENAZEPRIL for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced HYPERTENSION (blood pressure went up to 200/123). On 16-Jun-2021, the patient experienced HYPERTENSION (back to ER with blood pressure was high again (156/103)). The patient was treated with CLONIDINE at a dose of .2 mg twice a day. At the time of the report, HYPERTENSION (blood pressure went up to 200/123) and HYPERTENSION (back to ER with blood pressure was high again (156/103)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Blood pressure measurement: 200/123 mmHg High. On 15-Jun-2021, Blood test normal: normal. On 16-Jun-2021, Blood pressure measurement: 156/103 mmHg High.     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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 29 hours after vial had been punctured; 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 EXPIRED PRODUCT ADMINISTERED (vaccine given 29 hours after vial had been punctured) 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) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 29 hours after vial had been punctured). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 29 hours after vial had been punctured) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No treatment information was reported.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea
Clinical narrative: Extreme weakness; Breathless going from point A to B; No energy and it continues; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Extreme weakness), DYSPNOEA (Breathless going from point A to B) and ASTHENIA (No energy and it continues) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-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 ASTHENIA (Extreme weakness), DYSPNOEA (Breathless going from point A to B) and ASTHENIA (No energy and it continues). At the time of the report, ASTHENIA (Extreme weakness), DYSPNOEA (Breathless going from point A to B) and ASTHENIA (No energy and it continues) outcome was unknown.            No concomitant and treatment medications were reported.  Patient reported that on 13 May, she received second shot and experienced extreme weakness, she was with no energy and it continued. Patient confirmed that she just turned 76 and was always active, but recently she felt breathless went from point A to B. And questioned could this be side effects.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Was quesy & light headed those 2 days.; FATIGUE; That night I had chills all night; I had a really bad headache; Was quesy & light headed those 2 days.; Very tired & achey also those 2 days.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Was quesy & light headed those 2 days.), FATIGUE (FATIGUE), CHILLS (That night I had chills all night), HEADACHE (I had a really bad headache) and NAUSEA (Was quesy & light headed those 2 days.) in a patient of an unknown age and gender 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 07-May-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 DIZZINESS (Was quesy & light headed those 2 days.), FATIGUE (FATIGUE), CHILLS (That night I had chills all night), HEADACHE (I had a really bad headache), NAUSEA (Was quesy & light headed those 2 days.) and MYALGIA (Very tired & achey also those 2 days.). At the time of the report, DIZZINESS (Was quesy & light headed those 2 days.), FATIGUE (FATIGUE), CHILLS (That night I had chills all night), HEADACHE (I had a really bad headache), NAUSEA (Was quesy & light headed those 2 days.) and MYALGIA (Very tired & achey also those 2 days.) outcome was unknown.            No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Was quesy & light headed those 2 days.; FATIGUE; That night I had chills all night; I had a really bad headache; Was quesy & light headed those 2 days.; Very tired & achey also those 2 days.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Was quesy & light headed those 2 days.), FATIGUE (FATIGUE), CHILLS (That night I had chills all night), HEADACHE (I had a really bad headache) and NAUSEA (Was quesy & light headed those 2 days.) in a patient of an unknown age and gender 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 07-May-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 DIZZINESS (Was quesy & light headed those 2 days.), FATIGUE (FATIGUE), CHILLS (That night I had chills all night), HEADACHE (I had a really bad headache), NAUSEA (Was quesy & light headed those 2 days.) and MYALGIA (Very tired & achey also those 2 days.). At the time of the report, DIZZINESS (Was quesy & light headed those 2 days.), FATIGUE (FATIGUE), CHILLS (That night I had chills all night), HEADACHE (I had a really bad headache), NAUSEA (Was quesy & light headed those 2 days.) and MYALGIA (Very tired & achey also those 2 days.) outcome was unknown.            No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) 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 PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided. No concomitant medication was reported
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numb sensation in fingers; tingling sensation in fingers; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (numb sensation in fingers) and PARAESTHESIA (tingling sensation in 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced HYPOAESTHESIA (numb sensation in fingers) and PARAESTHESIA (tingling sensation in fingers). At the time of the report, HYPOAESTHESIA (numb sensation in fingers) and PARAESTHESIA (tingling sensation in fingers) 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.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: itchy; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and ERYTHEMA (Redness) 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) 2 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 PRURITUS (itchy) and ERYTHEMA (Redness). At the time of the report, PRURITUS (itchy) and ERYTHEMA (Redness) was resolving.            Medical history was not provided.  Concomitant and treatment medications were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up document received and outcome of the events updated unknown to recovered.; Sender's Comments: Very limited information provided at this time.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0108AZ1A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal) and Hypertension. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), AMLODIPINE and ENALAPRIL for Hypertension.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.   This case was linked to MOD-2021-226228 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever 100.4ºF; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever 100.4ºF) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced PYREXIA (fever 100.4ºF). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PYREXIA (fever 100.4ºF) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jun-2021, Body temperature: 100.4 (Inconclusive) 100.4 degree fahrenheit.         No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Head discomfort, Headache, Pain, Sinusitis
Clinical narrative: I have discomforts in my head/I have felt my ears dazed pressure on my head; weak in my legs; my body throbs; I also feel as if I had very strong sinusitis in the T area of my face felt pressure; I started to feel very bad in my head with antumescent pain; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (I have discomforts in my head/I have felt my ears dazed pressure on my head), ASTHENIA (weak in my legs), PAIN (my body throbs), SINUSITIS (I also feel as if I had very strong sinusitis in the T area of my face felt pressure) and HEADACHE (I started to feel very bad in my head with antumescent pain) 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 08-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 HEAD DISCOMFORT (I have discomforts in my head/I have felt my ears dazed pressure on my head), ASTHENIA (weak in my legs), PAIN (my body throbs), SINUSITIS (I also feel as if I had very strong sinusitis in the T area of my face felt pressure) and HEADACHE (I started to feel very bad in my head with antumescent pain). At the time of the report, HEAD DISCOMFORT (I have discomforts in my head/I have felt my ears dazed pressure on my head), ASTHENIA (weak in my legs), PAIN (my body throbs), SINUSITIS (I also feel as if I had very strong sinusitis in the T area of my face felt pressure) and HEADACHE (I started to feel very bad in my head with antumescent pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Translation Follow up received and does not contain any new information. On 15-Jun-2021: Follow up contain non significant information. On 30-Jul-2021: Translation received and does not contain any new information.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She had a lot of pain after her first dose it went down from her arm to her lefts and hip,The pain also went to her shoulders and shoulder blades; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a lot of pain after her first dose it went down from her arm to her lefts and hip,The pain also went to her shoulders and shoulder blades) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She had a lot of pain after her first dose it went down from her arm to her lefts and hip,The pain also went to her shoulders and shoulder blades). The patient was treated with IBUPROFEN for Pain in joint involving shoulder region, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (She had a lot of pain after her first dose it went down from her arm to her lefts and hip,The pain also went to her shoulders and shoulder blades) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient intakes  unknown thyroid medication for unspecified thyroid condition. Treatment with Ibuprofen taken to alleviate the symptoms experienced.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Limb discomfort, Peripheral swelling, Pyrexia
Clinical narrative: legs sometimes doesn't work right; Back hurts got lot worse after vaccine; Pain making nervous; Right leg was swelling; Had to lay on left side and cannot lay on right side; Having temperature; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (legs sometimes doesn't work right), BACK PAIN (Back hurts got lot worse after vaccine), TENSION (Pain making nervous), PERIPHERAL SWELLING (Right leg was swelling) and SLEEP DISORDER (Had to lay on left side and cannot lay on right side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back ache (Patient stated her back hurts which she had all her life and got lot worse after vaccine.).   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 LIMB DISCOMFORT (legs sometimes doesn't work right), BACK PAIN (Back hurts got lot worse after vaccine), TENSION (Pain making nervous), PERIPHERAL SWELLING (Right leg was swelling), SLEEP DISORDER (Had to lay on left side and cannot lay on right side) and PYREXIA (Having temperature). At the time of the report, LIMB DISCOMFORT (legs sometimes doesn't work right), BACK PAIN (Back hurts got lot worse after vaccine), TENSION (Pain making nervous), PERIPHERAL SWELLING (Right leg was swelling) and SLEEP DISORDER (Had to lay on left side and cannot lay on right side) outcome was unknown and PYREXIA (Having temperature) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: unknown lot of problem with blood pressure..         The action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.  No treatment medications were reported.  Patient reported that she received both the doses of moderna covid-19 vaccine and doesn't remember the dates on which she received the vaccine.  Patient stated that she was having dimple in her right butt, this occurred 4 or 5 days after receiving the shot and she never seen that before. Patient said that her back hurts which she had that all her life and got lot worse after vaccine. She had to lay on left side and cannot lay on right side, was still having temperature as of 17Jun2021, lot of problem with blood pressure. she also stated that pain she had was making her nervous.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tension
Clinical narrative: legs sometimes doesn't work right; Back hurts got lot worse after vaccine; Pain making nervous; Right leg was swelling; Had to lay on left side and cannot lay on right side; Having temperature; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (legs sometimes doesn't work right), BACK PAIN (Back hurts got lot worse after vaccine), TENSION (Pain making nervous), PERIPHERAL SWELLING (Right leg was swelling) and SLEEP DISORDER (Had to lay on left side and cannot lay on right side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back ache (Patient stated her back hurts which she had all her life and got lot worse after vaccine.).   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 LIMB DISCOMFORT (legs sometimes doesn't work right), BACK PAIN (Back hurts got lot worse after vaccine), TENSION (Pain making nervous), PERIPHERAL SWELLING (Right leg was swelling), SLEEP DISORDER (Had to lay on left side and cannot lay on right side) and PYREXIA (Having temperature). At the time of the report, LIMB DISCOMFORT (legs sometimes doesn't work right), BACK PAIN (Back hurts got lot worse after vaccine), TENSION (Pain making nervous), PERIPHERAL SWELLING (Right leg was swelling) and SLEEP DISORDER (Had to lay on left side and cannot lay on right side) outcome was unknown and PYREXIA (Having temperature) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: unknown lot of problem with blood pressure..         The action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.  No treatment medications were reported.  Patient reported that she received both the doses of moderna covid-19 vaccine and doesn't remember the dates on which she received the vaccine.  Patient stated that she was having dimple in her right butt, this occurred 4 or 5 days after receiving the shot and she never seen that before. Patient said that her back hurts which she had that all her life and got lot worse after vaccine. She had to lay on left side and cannot lay on right side, was still having temperature as of 17Jun2021, lot of problem with blood pressure. she also stated that pain she had was making her nervous.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity
Clinical narrative: I expected the sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I expected the sore 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 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 PAIN IN EXTREMITY (I expected the sore arm). At the time of the report, PAIN IN EXTREMITY (I expected the sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Antibody test Negative done after 3 months of completing both vaccines. and positive (Positive) antibody test was positive after five month of vaccination.         No concomitant medication provided by reporter.  No treatment medication provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: follow up received on 12-jul-2021. contain significant lab data information ,patient gender also updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was administered to 23 patients on 11June2021 after the expiration date of 10June2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was administered to 23 patients on 11June2021 after the expiration date of 10June2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was administered to 23 patients on 11June2021 after the expiration date of 10June2021). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine was administered to 23 patients on 11June2021 after the expiration date of 10June2021) 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 information was provided.  No treatment information was not given.
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: he cannot move his arm; shoulder pain where he received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (he cannot move his arm) and VACCINATION SITE PAIN (shoulder pain where he received the 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 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 MOBILITY DECREASED (he cannot move his arm) and VACCINATION SITE PAIN (shoulder pain where he received the vaccine). At the time of the report, MOBILITY DECREASED (he cannot move his arm) and VACCINATION SITE PAIN (shoulder pain where he received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was unknown by the reporter.  Treatment information was not provided.  Patient had reported that He cannot live like this.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia
Clinical narrative: Within 3 days of having it I have numbness in both hands and feet; Brain fog; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Within 3 days of having it I have numbness in both hands and feet), FEELING ABNORMAL (Brain fog) and FATIGUE (Fatigue) 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 HYPOAESTHESIA (Within 3 days of having it I have numbness in both hands and feet), FEELING ABNORMAL (Brain fog) and FATIGUE (Fatigue). At the time of the report, HYPOAESTHESIA (Within 3 days of having it I have numbness in both hands and feet), FEELING ABNORMAL (Brain fog) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breathe; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSPNOEA (shortness of breathe) 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 DYSPNOEA (shortness of breathe). At the time of the report, DYSPNOEA (shortness of breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs are not given. Treatment information not provided.