chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Intentional product use issue, Vaccination complication
Clinical narrative: Shortness of breath; fatigue; had reaction to vaccine; decided not to get the second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), FATIGUE (fatigue), VACCINATION COMPLICATION (had reaction to vaccine) and INTENTIONAL PRODUCT USE ISSUE (decided not to get the second vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Heart murmur.    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 DYSPNOEA (Shortness of breath), FATIGUE (fatigue), VACCINATION COMPLICATION (had reaction to vaccine) and INTENTIONAL PRODUCT USE ISSUE (decided not to get the second vaccination). At the time of the report, DYSPNOEA (Shortness of breath), FATIGUE (fatigue), VACCINATION COMPLICATION (had reaction to vaccine) and INTENTIONAL PRODUCT USE ISSUE (decided not to get the second vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Myalgia, Off label use
Clinical narrative: having chills; feeling warm; sore in her arms; Moderna as the 2nd vaccine after having Pfizer as the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (having chills), FEELING HOT (feeling warm), MYALGIA (sore in her arms) and OFF LABEL USE (Moderna as the 2nd vaccine after having Pfizer as the first vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (having chills), FEELING HOT (feeling warm), MYALGIA (sore in her arms) and OFF LABEL USE (Moderna as the 2nd vaccine after having Pfizer as the first vaccine). At the time of the report, CHILLS (having chills), FEELING HOT (feeling warm), MYALGIA (sore in her arms) and OFF LABEL USE (Moderna as the 2nd vaccine after having Pfizer as the first vaccine) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: stomach issues/diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (stomach issues/diarrhea) 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 DIARRHOEA (stomach issues/diarrhea). At the time of the report, DIARRHOEA (stomach issues/diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect). At the time of the report, VACCINATION COMPLICATION (Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.) outcome was unknown.            Description of Event or Problem: AE submitted via Chatbot: "What are common side effects the after you get the" "Second shot. day after"
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe itching all over; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itching all over) 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 (Severe itching all over). At the time of the report, PRURITUS (Severe itching all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: severe vertigo; arm hurts so badly; fever of 102.8 - 103.6 for 10 days; Fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (severe vertigo), MYALGIA (arm hurts so badly), PYREXIA (fever of 102.8 - 103.6 for 10 days), FATIGUE (Fatigue) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (severe vertigo), MYALGIA (arm hurts so badly), PYREXIA (fever of 102.8 - 103.6 for 10 days), FATIGUE (Fatigue) and NAUSEA (nausea). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at a dose of 25 milligram three times a day. At the time of the report, VERTIGO (severe vertigo), MYALGIA (arm hurts so badly), PYREXIA (fever of 102.8 - 103.6 for 10 days), FATIGUE (Fatigue) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.8-103.6 (High) 102.8-103.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient declined to take second dose. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and added lab data, treatment medication and new events. Updated event outcome of myalgia to Recovered/Resolved.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: severe vertigo; arm hurts so badly; fever of 102.8 - 103.6 for 10 days; Fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (severe vertigo), MYALGIA (arm hurts so badly), PYREXIA (fever of 102.8 - 103.6 for 10 days), FATIGUE (Fatigue) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (severe vertigo), MYALGIA (arm hurts so badly), PYREXIA (fever of 102.8 - 103.6 for 10 days), FATIGUE (Fatigue) and NAUSEA (nausea). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at a dose of 25 milligram three times a day. At the time of the report, VERTIGO (severe vertigo), MYALGIA (arm hurts so badly), PYREXIA (fever of 102.8 - 103.6 for 10 days), FATIGUE (Fatigue) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.8-103.6 (High) 102.8-103.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient declined to take second dose. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and added lab data, treatment medication and new events. Updated event outcome of myalgia to Recovered/Resolved.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (her second injection was in March and she experienced some pain in right arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 012M20A) for COVID-19 immunization. No medical history reported. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. In March 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced myalgia (her second injection was in March and she experienced some pain in right arm). At the time of the report, myalgia (her second injection was in March and she experienced some pain in right arm) resolved. No concomitant medication or treatment information provided. This case linked to MOD-2021-015032 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I did not go back for my second shot.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I did not go back for my 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 12-Mar-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 (I did not go back for my second shot.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I did not go back for my second shot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: "I feel sick"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("I feel 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS ("I feel sick"). At the time of the report, ILLNESS ("I feel sick") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: vaccine site be hot to touch; redness big like a baseball size; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (vaccine site be hot to touch) and VACCINATION SITE ERYTHEMA (redness big like a baseball size) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (vaccine site be hot to touch) and VACCINATION SITE ERYTHEMA (redness big like a baseball size). At the time of the report, VACCINATION SITE WARMTH (vaccine site be hot to touch) and VACCINATION SITE ERYTHEMA (redness big like a baseball size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose of Covid Vicine on March 8 can I still take the second dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (fist dose of Covid Vicine on March 8 can I still take the 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (fist dose of Covid Vicine on March 8 can I still take the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (fist dose of Covid Vicine on March 8 can I still take the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: long term side effect vomiting mucus; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (long term side effect vomiting mucus) 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 VOMITING (long term side effect vomiting mucus). At the time of the report, VOMITING (long term side effect vomiting mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (long term side effect vomiting mucus) 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 VOMITING (long term side effect vomiting mucus). At the time of the report, VOMITING (long term side effect vomiting mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of inappropriate schedule of product administration (received the second dose of vaccine when it is outside of recommended timeframe) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced inappropriate schedule of product administration (received the second dose of vaccine when it is outside of recommended timeframe). At the time of the report, inappropriate schedule of product administration (received the second dose of vaccine when it is outside of recommended timeframe) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Product dose omission issue
Clinical narrative: 2nd dose not given at day 36; shingles on her face; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (shingles on her face) and PRODUCT DOSE OMISSION ISSUE (2nd dose not given at day 36) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced HERPES ZOSTER (shingles on her face). On 28-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not given at day 36). On 28-Jun-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose not given at day 36) had resolved. At the time of the report, HERPES ZOSTER (shingles on her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient missed her second dose because she still had shingles on her face.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the 2nd dose of Moderna vaccine was given beyond the scheduled appointment; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose of Moderna vaccine was given beyond the scheduled appointment) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose of Moderna vaccine was given beyond the scheduled appointment). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose of Moderna vaccine was given beyond the scheduled appointment) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.  No adverse reactions were noted at the time of reporting.
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: slightly elevated wbc; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (slightly elevated wbc) 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 WHITE BLOOD CELL COUNT INCREASED (slightly elevated wbc). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (slightly elevated wbc) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: elevated (abnormal) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 35 days since got the first dose/ not gotten the second one (was scheduled to get it on 11Jun2021).; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 35 days since got the first dose/ not gotten the second one (was scheduled to get it on 11Jun2021).) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 35 days since got the first dose/ not gotten the second one (was scheduled to get it on 11Jun2021).). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 35 days since got the first dose/ not gotten the second one (was scheduled to get it on 11Jun2021).) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dermatitis, Erythema, Influenza like illness, Limb discomfort
Clinical narrative: flu like symptoms; her hand was heavy; hands and feet are tingling; burning; kind of red underneath/face is kind of red; whole back broke out last night; rash; kind of like dermatitis; been having issues with hands and feet; itching on her back; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), LIMB DISCOMFORT (her hand was heavy), PARAESTHESIA (hands and feet are tingling), BURNING SENSATION (burning) and ERYTHEMA (kind of red underneath/face is kind of red) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), LIMB DISCOMFORT (her hand was heavy), PARAESTHESIA (hands and feet are tingling), BURNING SENSATION (burning), ERYTHEMA (kind of red underneath/face is kind of red), SKIN EXFOLIATION (whole back broke out last night), RASH (rash), DERMATITIS (kind of like dermatitis), SKIN EXFOLIATION (been having issues with hands and feet) and PRURITUS (itching on her back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), LIMB DISCOMFORT (her hand was heavy), PARAESTHESIA (hands and feet are tingling), BURNING SENSATION (burning), ERYTHEMA (kind of red underneath/face is kind of red), SKIN EXFOLIATION (whole back broke out last night), RASH (rash), DERMATITIS (kind of like dermatitis), SKIN EXFOLIATION (been having issues with hands and feet) and PRURITUS (itching on her back) outcome was unknown. Not Provided          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 Caller wants to know if Benadryl is fine to continue taking No concomitant medication were reported    This case was linked to MOD-2021-238461 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash, Skin exfoliation
Clinical narrative: flu like symptoms; her hand was heavy; hands and feet are tingling; burning; kind of red underneath/face is kind of red; whole back broke out last night; rash; kind of like dermatitis; been having issues with hands and feet; itching on her back; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), LIMB DISCOMFORT (her hand was heavy), PARAESTHESIA (hands and feet are tingling), BURNING SENSATION (burning) and ERYTHEMA (kind of red underneath/face is kind of red) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), LIMB DISCOMFORT (her hand was heavy), PARAESTHESIA (hands and feet are tingling), BURNING SENSATION (burning), ERYTHEMA (kind of red underneath/face is kind of red), SKIN EXFOLIATION (whole back broke out last night), RASH (rash), DERMATITIS (kind of like dermatitis), SKIN EXFOLIATION (been having issues with hands and feet) and PRURITUS (itching on her back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), LIMB DISCOMFORT (her hand was heavy), PARAESTHESIA (hands and feet are tingling), BURNING SENSATION (burning), ERYTHEMA (kind of red underneath/face is kind of red), SKIN EXFOLIATION (whole back broke out last night), RASH (rash), DERMATITIS (kind of like dermatitis), SKIN EXFOLIATION (been having issues with hands and feet) and PRURITUS (itching on her back) outcome was unknown. Not Provided          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 Caller wants to know if Benadryl is fine to continue taking No concomitant medication were reported    This case was linked to MOD-2021-238461 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had my second shot 3 days ago and my headache is just getting worse; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had my second shot 3 days ago and my headache is just getting worse) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced HEADACHE (had my second shot 3 days ago and my headache is just getting worse). At the time of the report, HEADACHE (had my second shot 3 days ago and my headache is just getting worse) outcome was unknown.            No concomitant medications were provided.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: very tired; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (very tired) and HEADACHE (headache) 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 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (very tired) and HEADACHE (headache). At the time of the report, FATIGUE (very tired) and HEADACHE (headache) 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 medications were reported. Treatment information was unknown. This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (very tired) and HEADACHE (headache) 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 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (very tired) and HEADACHE (headache). At the time of the report, FATIGUE (very tired) and HEADACHE (headache) 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 medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Nasopharyngitis, Wheezing
Clinical narrative: can't get rid of this deep cough; wheezing; can't taste; can't taste or smell anything; sinus cold; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (can't get rid of this deep cough), WHEEZING (wheezing), AGEUSIA (can't taste), ANOSMIA (can't taste or smell anything) and NASOPHARYNGITIS (sinus cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 COUGH (can't get rid of this deep cough), WHEEZING (wheezing), AGEUSIA (can't taste), ANOSMIA (can't taste or smell anything) and NASOPHARYNGITIS (sinus cold). At the time of the report, COUGH (can't get rid of this deep cough), WHEEZING (wheezing), AGEUSIA (can't taste), ANOSMIA (can't taste or smell anything) and NASOPHARYNGITIS (sinus cold) outcome was unknown.            No concomitant medication information was reported.  Treatment medication was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Groin pain, Lymphadenopathy
Clinical narrative: lower left groin pain on the side of shot (left side)/ a little bit of soreness in her lower left groin; swollen lymph nodes in her neck; swollen lymph nodes in the armpit (underarm); This spontaneous case was reported by a patient and describes the occurrence of GROIN PAIN (lower left groin pain on the side of shot (left side)/ a little bit of soreness in her lower left groin), LYMPHADENOPATHY (swollen lymph nodes in her neck) and LYMPHADENOPATHY (swollen lymph nodes in the armpit (underarm)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (lower left groin pain on the side of shot (left side)/ a little bit of soreness in her lower left groin) and LYMPHADENOPATHY (swollen lymph nodes in the armpit (underarm)). an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in her neck). At the time of the report, GROIN PAIN (lower left groin pain on the side of shot (left side)/ a little bit of soreness in her lower left groin) outcome was unknown and LYMPHADENOPATHY (swollen lymph nodes in her neck) and LYMPHADENOPATHY (swollen lymph nodes in the armpit (underarm)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not provided. No treatment details were provided. Patient experienced the lower left groin pain on the side of the shot after around 8 weeks of shot. Doctor thought that it was hernia, She had to go again to check it's not ovarian related as she still experiencing soreness.   This case was linked to MOD-2021-065389 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Device malfunction, Facial pain, Swelling face
Clinical narrative: Face started swelling at the place she had fillers and hurting; Face started swelling at the place she had fillers and hurting; Dissolved all the fillers in her face; Thought all her teeth were abscessed; Every joint in her body is aching; Persistent cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Persistent cough), SWELLING FACE (Face started swelling at the place she had fillers and hurting), FACIAL PAIN (Face started swelling at the place she had fillers and hurting), DEVICE MALFUNCTION (Dissolved all the fillers in her face) and TOOTH ABSCESS (Thought all her teeth were abscessed) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin cosmetic procedure (fillers) in January 2020 and Skin cosmetic procedure (fillers) in November 2019.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Persistent cough). On an unknown date, the patient experienced SWELLING FACE (Face started swelling at the place she had fillers and hurting), FACIAL PAIN (Face started swelling at the place she had fillers and hurting), DEVICE MALFUNCTION (Dissolved all the fillers in her face), TOOTH ABSCESS (Thought all her teeth were abscessed) and ARTHRALGIA (Every joint in her body is aching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Persistent cough), SWELLING FACE (Face started swelling at the place she had fillers and hurting), FACIAL PAIN (Face started swelling at the place she had fillers and hurting), DEVICE MALFUNCTION (Dissolved all the fillers in her face), TOOTH ABSCESS (Thought all her teeth were abscessed) and ARTHRALGIA (Every joint in her body is aching) outcome was unknown.            No relevant concomitant medications were reported. Patient also took steroid medications (unspecified) for treatment.   This case was linked to MOD-2021-100618 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: Face started swelling at the place she had fillers and hurting; Face started swelling at the place she had fillers and hurting; Dissolved all the fillers in her face; Thought all her teeth were abscessed; Every joint in her body is aching; Persistent cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Persistent cough), SWELLING FACE (Face started swelling at the place she had fillers and hurting), FACIAL PAIN (Face started swelling at the place she had fillers and hurting), DEVICE MALFUNCTION (Dissolved all the fillers in her face) and TOOTH ABSCESS (Thought all her teeth were abscessed) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin cosmetic procedure (fillers) in January 2020 and Skin cosmetic procedure (fillers) in November 2019.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Persistent cough). On an unknown date, the patient experienced SWELLING FACE (Face started swelling at the place she had fillers and hurting), FACIAL PAIN (Face started swelling at the place she had fillers and hurting), DEVICE MALFUNCTION (Dissolved all the fillers in her face), TOOTH ABSCESS (Thought all her teeth were abscessed) and ARTHRALGIA (Every joint in her body is aching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Persistent cough), SWELLING FACE (Face started swelling at the place she had fillers and hurting), FACIAL PAIN (Face started swelling at the place she had fillers and hurting), DEVICE MALFUNCTION (Dissolved all the fillers in her face), TOOTH ABSCESS (Thought all her teeth were abscessed) and ARTHRALGIA (Every joint in her body is aching) outcome was unknown.            No relevant concomitant medications were reported. Patient also took steroid medications (unspecified) for treatment.   This case was linked to MOD-2021-100618 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Woman realized shortly after receiving the vaccine that she was pregnant.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Woman realized shortly after receiving the vaccine that she was pregnant.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Woman realized shortly after receiving the vaccine that she was pregnant.). At the time of the report, EXPOSURE DURING PREGNANCY (Woman realized shortly after receiving the vaccine that she was pregnant.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  The patient realized shortly after receiving the vaccine that she was 3weeks pregnant. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Body is Shivering; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Body is Shivering) 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 28-Jun-2021, the patient experienced CHILLS (Body is Shivering). At the time of the report, CHILLS (Body is Shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown. As per client, MI error in DOB capture as --1-JAN-1900
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Still feel horrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Still feel horrible) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Still feel horrible). At the time of the report, FEELING ABNORMAL (Still feel horrible) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Hepatic enzyme increased, Migraine, Nausea, Vomiting
Clinical narrative: extreme abdominal pain; nausea; vomiting; migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), ABDOMINAL PAIN (extreme abdominal pain), NAUSEA (nausea) and VOMITING (vomiting) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced MIGRAINE (migraine), NAUSEA (nausea) and VOMITING (vomiting). On 25-Jun-2021, the patient experienced ABDOMINAL PAIN (extreme abdominal pain). The patient was treated with ACETAMINOPHEN ongoing from 23-Jun-2021 at an unspecified dose and frequency and INVERT SUGAR, PHOSPHORIC ACID (EMETROL FISONS) ongoing from 23-Jun-2021 at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), ABDOMINAL PAIN (extreme abdominal pain), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme increased: extremely high (High) Her liver enzymes are extremely high on the results of her blood tests..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable. No concomitant medication was mentioned.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Red spots on the entire both legs for almost 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spots on the entire both legs for almost 3 weeks) in a 26-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, 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 RASH MACULAR (Red spots on the entire both legs for almost 3 weeks). At the time of the report, RASH MACULAR (Red spots on the entire both legs for almost 3 weeks) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported. No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-238755 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature decreased
Clinical narrative: Is it normal for my body temperature to drop; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Is it normal for my body temperature to drop) 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 BODY TEMPERATURE DECREASED (Is it normal for my body temperature to drop). At the time of the report, BODY TEMPERATURE DECREASED (Is it normal for my body temperature to drop) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) blood pressure is normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Feeling abnormal, Peripheral swelling, Pruritus
Clinical narrative: Red color; Very itchy; Rash in arm; Bump on arm; Heart was beating very fast like Tachycardia; Felt so bad; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart was beating very fast like Tachycardia), FEELING ABNORMAL (Felt so bad), PERIPHERAL SWELLING (Bump on arm), ERYTHEMA (Red color) and PRURITUS (Very itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to antibiotics.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, the patient experienced TACHYCARDIA (Heart was beating very fast like Tachycardia) and FEELING ABNORMAL (Felt so bad). On 14-Jun-2021, the patient experienced PERIPHERAL SWELLING (Bump on arm). On an unknown date, the patient experienced ERYTHEMA (Red color), PRURITUS (Very itchy) and RASH (Rash in arm). At the time of the report, TACHYCARDIA (Heart was beating very fast like Tachycardia), FEELING ABNORMAL (Felt so bad), PERIPHERAL SWELLING (Bump on arm), ERYTHEMA (Red color), PRURITUS (Very itchy) and RASH (Rash in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jun-2021, Blood pressure measurement: 173/103 (High) BP was 173/103..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  On 13-Jun-2021, at 5AM the patient got up to go to bathroom and her heart was beating very fast like Tachycardia and called 911. Her BP was 173/103 and she felt so bad but was not transported to hospital. The following day she had rash in arm with big bump, the red color lasted a week and it was very itchy.