chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Flu-like symtoms; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symtoms) and FATIGUE (Tiredness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symtoms) and FATIGUE (Tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symtoms) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Peripheral swelling
Clinical narrative: how do I handle the swollen are; will I have an allergic reaction; 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 HYPERSENSITIVITY (will I have an allergic reaction) and PERIPHERAL SWELLING (how do I handle the swollen are) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (will I have an allergic reaction) and PERIPHERAL SWELLING (how do I handle the swollen are). At the time of the report, HYPERSENSITIVITY (will I have an allergic reaction) and PERIPHERAL SWELLING (how do I handle the swollen are) 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: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: dry cough on and off; 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 COUGH (dry cough on and off) 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 COUGH (dry cough on and off). At the time of the report, COUGH (dry cough on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported.  No treatment was reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Left ankle swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Left ankle swollen) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced JOINT SWELLING (Left ankle swollen). At the time of the report, JOINT SWELLING (Left ankle swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: 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 PAIN IN EXTREMITY (arm is very sore), HEADACHE (Headache is bad and MYALGIA (achy all over/achy and sore today) 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-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 PAIN IN EXTREMITY (arm is very sore), HEADACHE (Headache is bad) and MYALGIA (achy all over/achy and sore today). At the time of the report, PAIN IN EXTREMITY (arm is very sore), HEADACHE (Headache is bad) and MYALGIA (achy all over/achy and sore today) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Ocular discomfort, Peripheral swelling
Clinical narrative: Body aches; swollen arm; nausea; vomiting; fatigue; couldn't keep eyes open; This spontaneous case was reported by a patient and describes the occurrence of OCULAR DISCOMFORT (couldn't keep eyes open), PERIPHERAL SWELLING (swollen arm), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (Body aches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced OCULAR DISCOMFORT (couldn't keep eyes open), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue). On 21-May-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. On 25-Apr-2021, NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) had resolved. On 23-May-2021, OCULAR DISCOMFORT (couldn't keep eyes open) and PERIPHERAL SWELLING (swollen arm) had resolved. At the time of the report, MYALGIA (Body aches) 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 information was provided.   This case was linked to MOD21-100216, MOD-2021-182849 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Body aches; swollen arm; nausea; vomiting; fatigue; couldn't keep eyes open; This spontaneous case was reported by a patient and describes the occurrence of OCULAR DISCOMFORT (couldn't keep eyes open), PERIPHERAL SWELLING (swollen arm), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (Body aches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced OCULAR DISCOMFORT (couldn't keep eyes open), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue). On 21-May-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. On 25-Apr-2021, NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) had resolved. On 23-May-2021, OCULAR DISCOMFORT (couldn't keep eyes open) and PERIPHERAL SWELLING (swollen arm) had resolved. At the time of the report, MYALGIA (Body aches) 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 information was provided.   This case was linked to MOD21-100216, MOD-2021-182849 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: body aches; 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 MYALGIA (body aches) 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 MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, SARS-CoV-2 antibody test
Clinical narrative: Energy level down to 60%; Exhaustion; Feeling chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Energy level down to 60%), FATIGUE (Exhaustion) and CHILLS (Feeling chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Post Covid Exhaustion) on 23-Dec-2020. Concurrent medical conditions included Chills since 26-Dec-2020 and Brain contusion (Brain fog) since 26-Dec-2020. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Enlarged prostate, ROSUVASTATIN CALCIUM (CRESTOR) from 20-Mar-2021 to 15-Jun-2021 for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Energy level down to 60%), FATIGUE (Exhaustion) and CHILLS (Feeling chills). At the time of the report, ASTHENIA (Energy level down to 60%), FATIGUE (Exhaustion) and CHILLS (Feeling chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, SARS-CoV-2 antibody test: positive (Positive) Positive.         Patient reported taking Statin for his cholesterol.  Concomitant product Crestor statin was used for an indication stated as heart prevention. No treatment information was provided.  Patient stated that he was recovering from COVID from January through March with exhaustion, chills and brain fog. He was at 90percent energy prior to vaccine. Then dropped to 70 percent post vaccine which had continued through June/ July. The patient stopped statin to see if that had caused the drop in energy, but after 1 month off, it had not appear to have been the causing for the events. The patient reported that the combination of prior antibodies from COVID and the antibodies from the shot had overloaded his neural system..   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up added on 13 JUL 2021 & it contains the upgraded information of reporter like name,email,city & contains patient weight,height,Medical history details & a new event also added. On 25-Jul-2021: Follow-up received contains significant information. The lab data was added.  The outcome of the events were updated from unknown to not recovered/ not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling cold, Myalgia, Vaccination site pain
Clinical narrative: Stomach pain a little bit; Feel very cold; Muscle pain; Have pain where  the injection was put in; 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 ABDOMINAL PAIN UPPER (Stomach pain a little bit), FEELING COLD (Feel very cold), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Have pain where  the injection was put in) 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-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 ABDOMINAL PAIN UPPER (Stomach pain a little bit), FEELING COLD (Feel very cold), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Have pain where  the injection was put in). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain a little bit), FEELING COLD (Feel very cold), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Have pain where  the injection was put in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching on arms and legs; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on arms and legs) 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 PRURITUS (Itching on arms and legs). At the time of the report, PRURITUS (Itching on arms and legs) outcome was unknown.        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.   The itching was driving her nuts.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Influenza like illness, Pain in extremity
Clinical narrative: Leg pain; Diarrhea; Fluish type symptoms; Couldn't get out of bed for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Fluish type symptoms) and BEDRIDDEN (Couldn't get out of bed for 3 days) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack and Cancer. Concomitant products included ALPRAZOLAM (XANAX) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Leg pain), DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Fluish type symptoms) and BEDRIDDEN (Couldn't get out of bed for 3 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and BACILLUS COAGULANS, PLANTAGO OVATA HUSK (FIBERMUCIL) at an unspecified dose and frequency. On 02-Apr-2021, BEDRIDDEN (Couldn't get out of bed for 3 days) had resolved. At the time of the report, PAIN IN EXTREMITY (Leg pain), DIARRHOEA (Diarrhea) and INFLUENZA LIKE ILLNESS (Fluish type symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he had very bad reactions after receiving the 1st dose. Patient reports that the reactions never went away 100 percent.   This case was linked to MOD-2021-182855 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Temp 100; puking; 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 (Temp 100) and VOMITING (puking) 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 (Temp 100) and VOMITING (puking). At the time of the report, PYREXIA (Temp 100) and VOMITING (puking) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Illness, Pruritus, Pyrexia
Clinical narrative: I got sick; Red; Upper arm is still warm; Itches like crazy; High 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 ILLNESS (I got sick), ERYTHEMA (Red), FEELING HOT (Upper arm is still warm), PRURITUS (Itches like crazy) and PYREXIA (High 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 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got sick), ERYTHEMA (Red), FEELING HOT (Upper arm is still warm), PRURITUS (Itches like crazy) and PYREXIA (High fever). At the time of the report, ILLNESS (I got sick) and PYREXIA (High fever) had resolved and ERYTHEMA (Red), FEELING HOT (Upper arm is still warm) and PRURITUS (Itches like crazy) had not resolved.            Concomitant product use was not provided. Treatment information was not provided.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 people received a dose from an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 people received a dose from an expired vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 people received a dose from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 people received a dose from an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.   Treatment and concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Updated patient informations
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Nausea, Peripheral swelling, Vomiting
Clinical narrative: Swollen arm; Swollen vagina with lesion that appear like herpes; Got pretty sick; Nausea; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VULVOVAGINAL SWELLING (Swollen vagina with lesion that appear like herpes), ILLNESS (Got pretty sick), NAUSEA (Nausea) and VOMITING (Vomiting) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). 21-May-2021, the patient experienced VULVOVAGINAL SWELLING (Swollen vagina with lesion that appear like herpes), ILLNESS (Got pretty sick), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. On 23-May-2021, PERIPHERAL SWELLING (Swollen arm), ILLNESS (Got pretty sick), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) had resolved. At the time of the report, VULVOVAGINAL SWELLING (Swollen vagina with lesion that appear like herpes) outcome was unknown.            No concomitant product use was provided by the reporter.     This case was linked to MOD-2021-182771 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-jun-2021 contains No new information
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal swelling
Clinical narrative: Swollen arm; Swollen vagina with lesion that appear like herpes; Got pretty sick; Nausea; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VULVOVAGINAL SWELLING (Swollen vagina with lesion that appear like herpes), ILLNESS (Got pretty sick), NAUSEA (Nausea) and VOMITING (Vomiting) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). 21-May-2021, the patient experienced VULVOVAGINAL SWELLING (Swollen vagina with lesion that appear like herpes), ILLNESS (Got pretty sick), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. On 23-May-2021, PERIPHERAL SWELLING (Swollen arm), ILLNESS (Got pretty sick), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) had resolved. At the time of the report, VULVOVAGINAL SWELLING (Swollen vagina with lesion that appear like herpes) outcome was unknown.            No concomitant product use was provided by the reporter.     This case was linked to MOD-2021-182771 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-jun-2021 contains No new information
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Diarrhoea, Headache
Clinical narrative: Diarrhea; Loss of taste; Loss of smell; Feel like crap; Body chills; Aches / body pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Feel like crap) and CHILLS (Body chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Heart attack. Concurrent medical conditions included Cancer. Concomitant products included ALPRAZOLAM (XANAX) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Feel like crap), CHILLS (Body chills), MYALGIA (Aches / body pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and BACILLUS COAGULANS, PLANTAGO OVATA HUSK (FIBERMUCIL) at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Feel like crap), CHILLS (Body chills), MYALGIA (Aches / body pain) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 test: negative (Negative) COVID test came back Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken mRNA 1273 with the events was considered as not applicable.   This case was linked to MOD-2021-182815 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: The follow-up was received on 9-JUN-2021 and has no new information.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Myalgia, SARS-CoV-2 test
Clinical narrative: Diarrhea; Loss of taste; Loss of smell; Feel like crap; Body chills; Aches / body pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Feel like crap) and CHILLS (Body chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Heart attack. Concurrent medical conditions included Cancer. Concomitant products included ALPRAZOLAM (XANAX) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Feel like crap), CHILLS (Body chills), MYALGIA (Aches / body pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and BACILLUS COAGULANS, PLANTAGO OVATA HUSK (FIBERMUCIL) at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ILLNESS (Feel like crap), CHILLS (Body chills), MYALGIA (Aches / body pain) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 test: negative (Negative) COVID test came back Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken mRNA 1273 with the events was considered as not applicable.   This case was linked to MOD-2021-182815 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: The follow-up was received on 9-JUN-2021 and has no new information.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Getting your period a day after even though already got it; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Getting your period a day after even though already got it) 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 MENSTRUAL DISORDER (Getting your period a day after even though already got it). At the time of the report, MENSTRUAL DISORDER (Getting your period a day after even though already got it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: 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 (Side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Patient has side effects after the 2nd dose like when he had COVID in March; 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 ADVERSE REACTION (Patient has side effects after the 2nd dose like when he had COVID in March) 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 ADVERSE REACTION (Patient has side effects after the 2nd dose like when he had COVID in March). At the time of the report, ADVERSE REACTION (Patient has side effects after the 2nd dose like when he had COVID in March) outcome was unknown.            no concomitant medications are provided. Treatment information were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Influenza
Clinical narrative: if i have secundary effects like cough and flu, it's normal?; if i have secundary effects like cough and flu, it's normal?; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (if i have secundary effects like cough and flu, it's normal?) and INFLUENZA (if i have secundary effects like cough and flu, it's normal?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (if i have secundary effects like cough and flu, it's normal?) and INFLUENZA (if i have secundary effects like cough and flu, it's normal?). At the time of the report, COUGH (if i have secundary effects like cough and flu, it's normal?) and INFLUENZA (if i have secundary effects like cough and flu, it's normal?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment information was provided no concomitant medication were reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to second Moderna vaccine; 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 (Reaction to second Moderna vaccine) 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) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to second Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Reaction to second Moderna vaccine) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: increasing hives and itching/Small itchy red raised dots hands feet and torso; itching; site swollen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (increasing hives and itching/Small itchy red raised dots hands feet and torso), PRURITUS (itching) and SWELLING (site swollen) 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) .5 milliliter. On an unknown date, the patient experienced URTICARIA (increasing hives and itching/Small itchy red raised dots hands feet and torso), PRURITUS (itching) and SWELLING (site swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (increasing hives and itching/Small itchy red raised dots hands feet and torso), PRURITUS (itching) and SWELLING (site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Intercepted product prescribing error, Product dose omission issue, Rash
Clinical narrative: patient had come in to receive a J&J vaccine already received a Moderna vaccine; did not receive second injection of moderna covid 19 vaccine within 42 days; rash from neck down; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCEPTED PRODUCT PRESCRIBING ERROR (patient had come in to receive a J&J vaccine already received a Moderna vaccine), PRODUCT DOSE OMISSION ISSUE (did not receive second injection of moderna covid 19 vaccine within 42 days) and RASH (rash from neck down) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCEPTED PRODUCT PRESCRIBING ERROR (patient had come in to receive a J&J vaccine already received a Moderna vaccine), PRODUCT DOSE OMISSION ISSUE (did not receive second injection of moderna covid 19 vaccine within 42 days) and RASH (rash from neck down). At the time of the report, INTERCEPTED PRODUCT PRESCRIBING ERROR (patient had come in to receive a J&J vaccine already received a Moderna vaccine), PRODUCT DOSE OMISSION ISSUE (did not receive second injection of moderna covid 19 vaccine within 42 days) and RASH (rash from neck down) 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.   Patient visited HCP and was suggested to get Johnson and Johnson vaccine as second dose. No Concomitant medications was reported. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: patient had come in to receive a J&J vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: bad side effects from 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 (bad side effects from 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 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 VACCINATION COMPLICATION (bad side effects from second shot). At the time of the report, VACCINATION COMPLICATION (bad side effects from second shot) outcome was unknown.            Concomitant medication history not provided. Treatment information was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Myalgia
Clinical narrative: Lymph nodes Swelled; Arm Hurt; Couldn't swallow; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Lymph nodes Swelled), MYALGIA (Arm Hurt) and DYSPHAGIA (Couldn't swallow) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic, Drug allergy, Latex allergy, Gluten intolerance, Food allergy, Milk allergy, Allergy to antibiotic and Wheelchair user. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced LYMPHADENOPATHY (Lymph nodes Swelled), MYALGIA (Arm Hurt) and DYSPHAGIA (Couldn't swallow). At the time of the report, LYMPHADENOPATHY (Lymph nodes Swelled) had resolved and MYALGIA (Arm Hurt) and DYSPHAGIA (Couldn't swallow) had not resolved.        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 treatment information was provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm after the 1st dose; Headache after the 1st dose; General tiredness after the 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm after the 1st dose), HEADACHE (Headache after the 1st dose) and FATIGUE (General tiredness after the 1st dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after the 1st dose), HEADACHE (Headache after the 1st dose) and FATIGUE (General tiredness after the 1st dose). On 10-Apr-2021, HEADACHE (Headache after the 1st dose) and FATIGUE (General tiredness after the 1st dose) had resolved. On 12-Apr-2021, PAIN IN EXTREMITY (Sore arm after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness around injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (soreness around injection site) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness around injection site). On 27-Apr-2021, VACCINATION SITE PAIN (soreness around injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-183009 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bile acid malabsorption, Body temperature, Chills, Diarrhoea, Fatigue
Clinical narrative: aches and pains,felt like hit by a ton of bricks; had diarrhea and has gone 30 times a dayit's uncontrolling.; yellow bile going through; extremely tired; chills; fever 101; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches and pains,felt like hit by a ton of bricks), DIARRHOEA (had diarrhea and has gone 30 times a dayit's uncontrolling.), BILE ACID MALABSORPTION (yellow bile going through), FATIGUE (extremely tired) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (aches and pains,felt like hit by a ton of bricks), DIARRHOEA (had diarrhea and has gone 30 times a dayit's uncontrolling.), BILE ACID MALABSORPTION (yellow bile going through), FATIGUE (extremely tired), CHILLS (chills) and PYREXIA (fever 101). The patient was treated with GLUCOSE, POTASSIUM CITRATE, SODIUM CHLORIDE, SODIUM CITRATE (PEDIALYTE [GLUCOSE;POTASSIUM CITRATE;SODIUM CHLORIDE;SODIUM CITRATE]) for Supplementation therapy, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (aches and pains,felt like hit by a ton of bricks), DIARRHOEA (had diarrhea and has gone 30 times a dayit's uncontrolling.), BILE ACID MALABSORPTION (yellow bile going through), FATIGUE (extremely tired), CHILLS (chills) and PYREXIA (fever 101) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 101 (High) high.         This case was linked to MOD-2021-208084 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: significant follow up received on 07 Jun 2021, outcome of the evets updated, treatment medication updated
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: aches and pains,felt like hit by a ton of bricks; had diarrhea and has gone 30 times a dayit's uncontrolling.; yellow bile going through; extremely tired; chills; fever 101; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches and pains,felt like hit by a ton of bricks), DIARRHOEA (had diarrhea and has gone 30 times a dayit's uncontrolling.), BILE ACID MALABSORPTION (yellow bile going through), FATIGUE (extremely tired) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (aches and pains,felt like hit by a ton of bricks), DIARRHOEA (had diarrhea and has gone 30 times a dayit's uncontrolling.), BILE ACID MALABSORPTION (yellow bile going through), FATIGUE (extremely tired), CHILLS (chills) and PYREXIA (fever 101). The patient was treated with GLUCOSE, POTASSIUM CITRATE, SODIUM CHLORIDE, SODIUM CITRATE (PEDIALYTE [GLUCOSE;POTASSIUM CITRATE;SODIUM CHLORIDE;SODIUM CITRATE]) for Supplementation therapy, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (aches and pains,felt like hit by a ton of bricks), DIARRHOEA (had diarrhea and has gone 30 times a dayit's uncontrolling.), BILE ACID MALABSORPTION (yellow bile going through), FATIGUE (extremely tired), CHILLS (chills) and PYREXIA (fever 101) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 101 (High) high.         This case was linked to MOD-2021-208084 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: significant follow up received on 07 Jun 2021, outcome of the evets updated, treatment medication updated
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Really having trouble breathing had second shot yesterday; 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 DYSPNOEA (Really having trouble breathing had second shot yesterday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Really having trouble breathing had second shot yesterday). At the time of the report, DYSPNOEA (Really having trouble breathing had second shot yesterday) outcome was unknown.            No concomitant information was provided. Treatment information was not provided.