chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), SKIN WARM (skin is hot), PRURITUS (itchy really bad) and PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 002CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), RASH (couple of days later rash spread over his arm and to body), MYALGIA (body aches / muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache) and NAUSEA (nausea / still having nausea). On an unknown date, the patient experienced SKIN WARM (skin is hot), PRURITUS (itchy really bad), PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg), DYSPNOEA (short of breath), CHEST PAIN (chest pain), JOINT SWELLING (Swollen ankle), VACCINATION COMPLICATION (Not feeling well), PYREXIA (fever that lasted about a week and half) and VACCINATION SITE RASH (rash on left shoulder where they administer the vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), SKIN WARM (skin is hot), PRURITUS (itchy really bad), PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg), DYSPNOEA (short of breath) and NAUSEA (nausea / still having nausea) had not resolved and CHEST PAIN (chest pain), JOINT SWELLING (Swollen ankle), VACCINATION COMPLICATION (Not feeling well), RASH (couple of days later rash spread over his arm and to body), PYREXIA (fever that lasted about a week and half), MYALGIA (body aches / muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache) and VACCINATION SITE RASH (rash on left shoulder where they administer the vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Followup received contains  added new events chest pain. On 06-Aug-2021: Follow-up received on 06-Aug-2021 included no new information.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Sugar levels high 280 and above; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Sugar levels high 280 and above) 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 26-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 BLOOD GLUCOSE INCREASED (Sugar levels high 280 and above). At the time of the report, BLOOD GLUCOSE INCREASED (Sugar levels high 280 and above) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: She started with chills next day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (She started with chills next day after receiving 2nd dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Sinus disorder and Diabetes.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced CHILLS (She started with chills next day after receiving 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (She started with chills next day after receiving 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included BP medicine, Sinus medicine, Diabetes medicine.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable      Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information was received on 30 Jun 2021 wherein event outcome of the event Chills was updated from unknown to resolved
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 Year old patient received 1st Moderna dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Year old patient received 1st Moderna dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Year old patient received 1st Moderna dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Year old patient received 1st Moderna dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The treatment information was not given.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) 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) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRURITUS (itchy). At the time of the report, PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 HERPES ZOSTER (Shingles). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported.  Pharmacist reported AE on behalf of patient who got Shingles after 1st dose of Moderna Vaccine. Consent obtained for safety follow up. Phone is the preferred method. Reporter mentioned that Potential AE for 2nd dose, contracted shingles antiviral medicine, should we give him 2nd dose.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: This spontaneous case was reported by an other and describes the occurrence of MUSCULAR WEAKNESS (Muscle Weakness in legs) 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 MUSCULAR WEAKNESS (Muscle Weakness in legs). At the time of the report, MUSCULAR WEAKNESS (Muscle Weakness in legs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment medication was given.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication
Clinical narrative: I can't text. It is brutally painful./ It feels like all the vaccine is stuck in one place; My arm is sooo painful/ Hurts so bad; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I can't text. It is brutally painful./ It feels like all the vaccine is stuck in one place) and MYALGIA (My arm is sooo painful/ Hurts so bad) 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 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION COMPLICATION (I can't text. It is brutally painful./ It feels like all the vaccine is stuck in one place) and MYALGIA (My arm is sooo painful/ Hurts so bad). At the time of the report, VACCINATION COMPLICATION (I can't text. It is brutally painful./ It feels like all the vaccine is stuck in one place) and MYALGIA (My arm is sooo painful/ Hurts so bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: what are the side effects from the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (what are the side effects from the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 (what are the side effects from the second shot). At the time of the report, VACCINATION COMPLICATION (what are the side effects from the second shot) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) 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) dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication  was provided.  No treatment medication  was provided.  Patient stated that Fully vaccinated but have caught a cold.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I missed my second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I missed my second dose) 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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I missed my second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I missed my second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient took the first dose and travelled due to family emergency and missed second dose. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 yr old received both doses of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old received both doses of the vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old received both doses of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old received both doses of the vaccine) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-114566 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients received expired second dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received expired second dose of vaccine) 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 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received expired second dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received expired second dose of vaccine) 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and SPIRONOLACTONE for an unknown indication.    On 01-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) had not 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.   patient experienced sore throat on 02-JUN-2021 and patient never had a sore throat in over 27 years prior to this incident. patient has not taken any medicine for treatment
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles 2-3 days later, localized.; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (Developed shingles 2-3 days later, localized.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included MS.    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 HERPES ZOSTER (Developed shingles 2-3 days later, localized.). At the time of the report, HERPES ZOSTER (Developed shingles 2-3 days later, localized.) 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.   Concomitant medications include unspecified immunosuppressive therapy treatment for multiple sclerosis.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Folowup received on 30-June-2021 and contains significant information
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: going through the side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (going through the 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (going through the side effects). At the time of the report, VACCINATION COMPLICATION (going through the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had my first shot on April 22 and am scheduled for my second shot tomorrow June 4, 2021.  (six weeks later); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my first shot on April 22 and am scheduled for my second shot tomorrow June 4, 2021.  (six weeks later)) 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 22-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my first shot on April 22 and am scheduled for my second shot tomorrow June 4, 2021.  (six weeks later)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my first shot on April 22 and am scheduled for my second shot tomorrow June 4, 2021.  (six weeks later)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: accidentally administered double dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (accidentally administered double dose) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 03-Jun-2021, the patient experienced ACCIDENTAL OVERDOSE (accidentally administered double dose). On 03-Jun-2021, ACCIDENTAL OVERDOSE (accidentally administered double dose) 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 relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-207329 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ¨Pain arm that lasted for a while after the 1st dose¨; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (¨Pain arm that lasted for a while after the 1st dose¨) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (¨Pain arm that lasted for a while after the 1st dose¨). At the time of the report, PAIN IN EXTREMITY (¨Pain arm that lasted for a while after the 1st dose¨) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  Treatment medication was not provided for dose 1
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Product dose omission issue
Clinical narrative: contracted COVID-19 after first vaccination; got very sick; had not had second dose as of time of the call; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (contracted COVID-19 after first vaccination), ILLNESS (got very sick) and PRODUCT DOSE OMISSION ISSUE (had not had second dose as of time of the call) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID-19 after first vaccination), ILLNESS (got very sick) and PRODUCT DOSE OMISSION ISSUE (had not had second dose as of time of the call). At the time of the report, COVID-19 (contracted COVID-19 after first vaccination) and ILLNESS (got very sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (had not had second dose as of time of the call) 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 drugs were reported. No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, Oropharyngeal pain, Palpitations
Clinical narrative: do not want to get second dose yet!; Rash all over body; Headache; aches and pains all over the body; Allergic Side Effects; Cough; Swollen Face; Palpitation; Ringing in the ear; Feel like punched in the throat; Hives; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Allergic Side Effects), COUGH (Cough), SWELLING FACE (Swollen Face), PALPITATIONS (Palpitation) and TINNITUS (Ringing in the ear) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism (she was not prescribed  Levothyroxine.) and Nodule (around the thyroid gland).    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced VACCINATION COMPLICATION (Allergic Side Effects), COUGH (Cough), SWELLING FACE (Swollen Face), PALPITATIONS (Palpitation), TINNITUS (Ringing in the ear), OROPHARYNGEAL PAIN (Feel like punched in the throat), URTICARIA (Hives), RASH (Rash all over body), HEADACHE (Headache) and MYALGIA (aches and pains all over the body). On 28-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (do not want to get second dose yet!). At the time of the report, VACCINATION COMPLICATION (Allergic Side Effects), COUGH (Cough), SWELLING FACE (Swollen Face), PALPITATIONS (Palpitation), TINNITUS (Ringing in the ear), OROPHARYNGEAL PAIN (Feel like punched in the throat), PRODUCT DOSE OMISSION ISSUE (do not want to get second dose yet!), RASH (Rash all over body), HEADACHE (Headache) and MYALGIA (aches and pains all over the body) outcome was unknown and URTICARIA (Hives) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: negative (Negative) did two PCR tests and both were negative prior to vaccination..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she had issues from Nov-2020 to May-2021 and did two Polymerase chain reaction(PCR) tests and both were negative prior to vaccination. Patient was waiting for her blood tests. The patient stated that she would not be getting the second dose. She called her doctor and was waiting for doctor to call back. No relevant concomitant medications were reported.  No treatment medication reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant follow up appended. Adverse event hives and some other side effects still having. Do not want to get second dose.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Product dose omission issue, Rash, Swelling face, Tinnitus
Clinical narrative: do not want to get second dose yet!; Rash all over body; Headache; aches and pains all over the body; Allergic Side Effects; Cough; Swollen Face; Palpitation; Ringing in the ear; Feel like punched in the throat; Hives; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Allergic Side Effects), COUGH (Cough), SWELLING FACE (Swollen Face), PALPITATIONS (Palpitation) and TINNITUS (Ringing in the ear) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism (she was not prescribed  Levothyroxine.) and Nodule (around the thyroid gland).    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced VACCINATION COMPLICATION (Allergic Side Effects), COUGH (Cough), SWELLING FACE (Swollen Face), PALPITATIONS (Palpitation), TINNITUS (Ringing in the ear), OROPHARYNGEAL PAIN (Feel like punched in the throat), URTICARIA (Hives), RASH (Rash all over body), HEADACHE (Headache) and MYALGIA (aches and pains all over the body). On 28-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (do not want to get second dose yet!). At the time of the report, VACCINATION COMPLICATION (Allergic Side Effects), COUGH (Cough), SWELLING FACE (Swollen Face), PALPITATIONS (Palpitation), TINNITUS (Ringing in the ear), OROPHARYNGEAL PAIN (Feel like punched in the throat), PRODUCT DOSE OMISSION ISSUE (do not want to get second dose yet!), RASH (Rash all over body), HEADACHE (Headache) and MYALGIA (aches and pains all over the body) outcome was unknown and URTICARIA (Hives) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: negative (Negative) did two PCR tests and both were negative prior to vaccination..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she had issues from Nov-2020 to May-2021 and did two Polymerase chain reaction(PCR) tests and both were negative prior to vaccination. Patient was waiting for her blood tests. The patient stated that she would not be getting the second dose. She called her doctor and was waiting for doctor to call back. No relevant concomitant medications were reported.  No treatment medication reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant follow up appended. Adverse event hives and some other side effects still having. Do not want to get second dose.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication
Clinical narrative: do not want to get second dose yet!; Rash all over body; Headache; aches and pains all over the body; Allergic Side Effects; Cough; Swollen Face; Palpitation; Ringing in the ear; Feel like punched in the throat; Hives; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Allergic Side Effects), COUGH (Cough), SWELLING FACE (Swollen Face), PALPITATIONS (Palpitation) and TINNITUS (Ringing in the ear) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism (she was not prescribed  Levothyroxine.) and Nodule (around the thyroid gland).    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced VACCINATION COMPLICATION (Allergic Side Effects), COUGH (Cough), SWELLING FACE (Swollen Face), PALPITATIONS (Palpitation), TINNITUS (Ringing in the ear), OROPHARYNGEAL PAIN (Feel like punched in the throat), URTICARIA (Hives), RASH (Rash all over body), HEADACHE (Headache) and MYALGIA (aches and pains all over the body). On 28-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (do not want to get second dose yet!). At the time of the report, VACCINATION COMPLICATION (Allergic Side Effects), COUGH (Cough), SWELLING FACE (Swollen Face), PALPITATIONS (Palpitation), TINNITUS (Ringing in the ear), OROPHARYNGEAL PAIN (Feel like punched in the throat), PRODUCT DOSE OMISSION ISSUE (do not want to get second dose yet!), RASH (Rash all over body), HEADACHE (Headache) and MYALGIA (aches and pains all over the body) outcome was unknown and URTICARIA (Hives) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: negative (Negative) did two PCR tests and both were negative prior to vaccination..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she had issues from Nov-2020 to May-2021 and did two Polymerase chain reaction(PCR) tests and both were negative prior to vaccination. Patient was waiting for her blood tests. The patient stated that she would not be getting the second dose. She called her doctor and was waiting for doctor to call back. No relevant concomitant medications were reported.  No treatment medication reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant follow up appended. Adverse event hives and some other side effects still having. Do not want to get second dose.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            No details provided in the chatbots only asked fever normal after second shot
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Nasal congestion, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (huge swelling in my arm), ERYTHEMA (and glowing red), NASAL CONGESTION (congestion), DIARRHOEA (diarrhea) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced NASAL CONGESTION (congestion), DIARRHOEA (diarrhea) and PYREXIA (fever). On an unknown date, the patient experienced PERIPHERAL SWELLING (huge swelling in my arm) and ERYTHEMA (and glowing red). At the time of the report, PERIPHERAL SWELLING (huge swelling in my arm), ERYTHEMA (and glowing red), NASAL CONGESTION (congestion), DIARRHOEA (diarrhea) and PYREXIA (fever) outcome was unknown. No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular
Clinical narrative: menstruation came sooner/menstruation came later; people who menstruated after 5 years of not doing so; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUATION IRREGULAR (menstruation came sooner/menstruation came later) and MENSTRUATION DELAYED (people who menstruated after 5 years of not doing so) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) 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 MENSTRUATION IRREGULAR (menstruation came sooner/menstruation came later) and MENSTRUATION DELAYED (people who menstruated after 5 years of not doing so). At the time of the report, MENSTRUATION IRREGULAR (menstruation came sooner/menstruation came later) and MENSTRUATION DELAYED (people who menstruated after 5 years of not doing so) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: while administering the dose, the needle separated from the syringe; not all the dose was administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (while administering the dose, the needle separated from the syringe) and UNDERDOSE (not all the dose was administered to the patient) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced DEVICE CONNECTION ISSUE (while administering the dose, the needle separated from the syringe) and UNDERDOSE (not all the dose was administered to the patient). On 03-Jun-2021, DEVICE CONNECTION ISSUE (while administering the dose, the needle separated from the syringe) and UNDERDOSE (not all the dose was administered to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the pharmacist was not sure how much of the dose was administered. Patient did not experience any adverse reactions from the dose at the time of the report.  No concomitant drugs were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm has become red), VACCINATION SITE SWELLING (arm has become swollen) and VACCINATION SITE INDURATION (hard around where my shot was administered) 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 an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm has become red), VACCINATION SITE SWELLING (arm has become swollen) and VACCINATION SITE INDURATION (hard around where my shot was administered). At the time of the report, VACCINATION SITE ERYTHEMA (arm has become red), VACCINATION SITE SWELLING (arm has become swollen) and VACCINATION SITE INDURATION (hard around where my shot was administered) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. No treatment information reported.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 101.1 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101.1 fever) 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 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (101.1 fever). At the time of the report, PYREXIA (101.1 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.1 (High) 101.1 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medication has been reported.
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: accidentally administered double dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (accidentally administered double dose) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced ACCIDENTAL OVERDOSE (accidentally administered double dose). On 03-Jun-2021, ACCIDENTAL OVERDOSE (accidentally administered double dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment medications were reported.   This case was linked to MOD-2021-207283 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling of the feet and legs/sewelling of my feet and leg; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of the feet and legs/sewelling of my feet and leg) 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 an unknown date, the patient experienced PERIPHERAL SWELLING (swelling of the feet and legs/sewelling of my feet and leg). At the time of the report, PERIPHERAL SWELLING (swelling of the feet and legs/sewelling of my feet and leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 0.08
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Headache, Muscle tightness, Myalgia
Clinical narrative: "he felt hot, then felt cold"; "tight muscles in his neck"; "it hurt really bad"; chills; "super bad headache"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE ("he felt hot, then felt cold"), MUSCLE TIGHTNESS ("tight muscles in his neck"), MYALGIA ("it hurt really bad"), CHILLS (chills) and HEADACHE ("super bad headache") in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE ("he felt hot, then felt cold"), MUSCLE TIGHTNESS ("tight muscles in his neck"), MYALGIA ("it hurt really bad"), CHILLS (chills) and HEADACHE ("super bad headache"). The patient was treated with IBUPROFEN at a dose of 200mg. On 27-May-2021, FEELING OF BODY TEMPERATURE CHANGE ("he felt hot, then felt cold"), MUSCLE TIGHTNESS ("tight muscles in his neck"), MYALGIA ("it hurt really bad"), CHILLS (chills) and HEADACHE ("super bad headache") 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 medications were provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Leg pains; Severe exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pains) and FATIGUE (Severe exhaustion) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic fatigue syndrome and AFib.    On 07-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 (Leg pains) and FATIGUE (Severe exhaustion). At the time of the report, PAIN IN EXTREMITY (Leg pains) outcome was unknown and FATIGUE (Severe exhaustion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that her second dose was due on 03/Jun/2021 and also was not functioning normal. The patient had leg pains for almost the whole month a couple weeks after the vaccine, severe exhaustion started and it had not gone away. Concomitant and treatment medication were not provided.