chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Hyperaesthesia, Pain in extremity, Rash, Rash erythematous
Clinical narrative: rash is slightly itchy; the rash quite red and big; Rashes in cheeks, ears, chest, stomach, abdomen, upper thighs, all over neck and back; a sore arm; bruise; sensitive to touch; dry sinus cavity; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise), HYPERAESTHESIA (sensitive to touch), SINUSITIS (dry sinus cavity), RASH ERYTHEMATOUS (the rash quite red and big) and RASH PRURITIC (rash is slightly itchy) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D3 and DIPHENHYDRAMINE CITRATE, IBUPROFEN (MOTRIN PM) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CONTUSION (bruise), HYPERAESTHESIA (sensitive to touch), SINUSITIS (dry sinus cavity) and PAIN IN EXTREMITY (a sore arm). On 21-Mar-2021, the patient experienced RASH ERYTHEMATOUS (the rash quite red and big) and RASH (Rashes in cheeks, ears, chest, stomach, abdomen, upper thighs, all over neck and back). On 22-Mar-2021, the patient experienced RASH PRURITIC (rash is slightly itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONTUSION (bruise), HYPERAESTHESIA (sensitive to touch), SINUSITIS (dry sinus cavity), RASH ERYTHEMATOUS (the rash quite red and big), RASH PRURITIC (rash is slightly itchy) and PAIN IN EXTREMITY (a sore arm) outcome was unknown and RASH (Rashes in cheeks, ears, chest, stomach, abdomen, upper thighs, all over neck and back) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator   Patient states that the rash quite red and big, all over from her neck, thighs, back, chest, abdomen, looks better now, slightly itchy, not bothersome at all.   This case was linked to MOD-2021-116648 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10MAY2021, updated reporter details, concomitant medications and 2nd dose details and reported the adverse events after 2nd dose was similar to 1st dose.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Sinusitis
Clinical narrative: rash is slightly itchy; the rash quite red and big; Rashes in cheeks, ears, chest, stomach, abdomen, upper thighs, all over neck and back; a sore arm; bruise; sensitive to touch; dry sinus cavity; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise), HYPERAESTHESIA (sensitive to touch), SINUSITIS (dry sinus cavity), RASH ERYTHEMATOUS (the rash quite red and big) and RASH PRURITIC (rash is slightly itchy) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D3 and DIPHENHYDRAMINE CITRATE, IBUPROFEN (MOTRIN PM) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CONTUSION (bruise), HYPERAESTHESIA (sensitive to touch), SINUSITIS (dry sinus cavity) and PAIN IN EXTREMITY (a sore arm). On 21-Mar-2021, the patient experienced RASH ERYTHEMATOUS (the rash quite red and big) and RASH (Rashes in cheeks, ears, chest, stomach, abdomen, upper thighs, all over neck and back). On 22-Mar-2021, the patient experienced RASH PRURITIC (rash is slightly itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONTUSION (bruise), HYPERAESTHESIA (sensitive to touch), SINUSITIS (dry sinus cavity), RASH ERYTHEMATOUS (the rash quite red and big), RASH PRURITIC (rash is slightly itchy) and PAIN IN EXTREMITY (a sore arm) outcome was unknown and RASH (Rashes in cheeks, ears, chest, stomach, abdomen, upper thighs, all over neck and back) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator   Patient states that the rash quite red and big, all over from her neck, thighs, back, chest, abdomen, looks better now, slightly itchy, not bothersome at all.   This case was linked to MOD-2021-116648 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10MAY2021, updated reporter details, concomitant medications and 2nd dose details and reported the adverse events after 2nd dose was similar to 1st dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: redness injection site; soreness at the injection site; little itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE ERYTHEMA (redness injection site) and VACCINATION SITE PAIN (soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (little itchy) and VACCINATION SITE PAIN (soreness at the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness injection site). At the time of the report, VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE ERYTHEMA (redness injection site) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Balance disorder, Diabetes mellitus, Feeling hot, Hyperhidrosis
Clinical narrative: Stick to stomach; Diaphoresis; Felt hot; Disoriented; nauseated; Wanted to throw up; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Stick to stomach), HYPERHIDROSIS (Diaphoresis), FEELING HOT (Felt hot), BALANCE DISORDER (Disoriented) and NAUSEA (nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   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 ABDOMINAL DISCOMFORT (Stick to stomach), HYPERHIDROSIS (Diaphoresis), FEELING HOT (Felt hot), BALANCE DISORDER (Disoriented), NAUSEA (nauseated) and VOMITING (Wanted to throw up). At the time of the report, ABDOMINAL DISCOMFORT (Stick to stomach), HYPERHIDROSIS (Diaphoresis), FEELING HOT (Felt hot), BALANCE DISORDER (Disoriented), NAUSEA (nauseated) and VOMITING (Wanted to throw up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Diabetes mellitus, bsl= 173.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Stick to stomach; Diaphoresis; Felt hot; Disoriented; nauseated; Wanted to throw up; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Stick to stomach), HYPERHIDROSIS (Diaphoresis), FEELING HOT (Felt hot), BALANCE DISORDER (Disoriented) and NAUSEA (nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   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 ABDOMINAL DISCOMFORT (Stick to stomach), HYPERHIDROSIS (Diaphoresis), FEELING HOT (Felt hot), BALANCE DISORDER (Disoriented), NAUSEA (nauseated) and VOMITING (Wanted to throw up). At the time of the report, ABDOMINAL DISCOMFORT (Stick to stomach), HYPERHIDROSIS (Diaphoresis), FEELING HOT (Felt hot), BALANCE DISORDER (Disoriented), NAUSEA (nauseated) and VOMITING (Wanted to throw up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Diabetes mellitus, bsl= 173.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Hyperhidrosis, Muscle spasms, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (profuse sweating), MUSCLE SPASMS (Muscle cramping across the chest), DYSPNOEA (Difficulty breathing), BACK PAIN (spread across the upper chest and her back) and MYALGIA (severe muscle pain in shoulder area of the left upper arm and left side of the neck) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided.). Concomitant products included METOPROLOL TARTRATE and ESCITALOPRAM for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPERHIDROSIS (profuse sweating), MUSCLE SPASMS (Muscle cramping across the chest), DYSPNEA (Difficulty breathing), BACK PAIN (spread across the upper chest and her back) and MYALGIA (severe muscle pain in shoulder area of the left upper arm and left side of the neck). On 22-Mar-2021, HYPERHIDROSIS (profuse sweating) had resolved. At the time of the report, MUSCLE SPASMS (Muscle cramping across the chest), DYSPNOEA (Difficulty breathing), BACK PAIN (spread across the upper chest and her back) and MYALGIA (severe muscle pain in shoulder area of the left upper arm and left side of the neck) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included over-the-counter Aleve and Tylenol. Patient asks if she can get a second dose or not, after having potential adverse reactions to the first dose.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Decreased appetite, Headache, Pain
Clinical narrative: Cough; Appetite lost; Fever; covid-19; Headache; Ache; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough), DECREASED APPETITE (Appetite lost), PAIN (Ache), COVID-19 (covid-19) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (Ache) and HEADACHE (Headache). On 21-Mar-2021, the patient experienced COVID-19 (covid-19). On an unknown date, the patient experienced COUGH (Cough), DECREASED APPETITE (Appetite lost) and PYREXIA (Fever). In March 2021, PAIN (Ache) had resolved. On 23-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, COUGH (Cough), DECREASED APPETITE (Appetite lost), COVID-19 (covid-19) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided. Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cough; Appetite lost; Fever; covid-19; Headache; Ache; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough), DECREASED APPETITE (Appetite lost), PAIN (Ache), COVID-19 (covid-19) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (Ache) and HEADACHE (Headache). On 21-Mar-2021, the patient experienced COVID-19 (covid-19). On an unknown date, the patient experienced COUGH (Cough), DECREASED APPETITE (Appetite lost) and PYREXIA (Fever). In March 2021, PAIN (Ache) had resolved. On 23-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, COUGH (Cough), DECREASED APPETITE (Appetite lost), COVID-19 (covid-19) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided. Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pruritus, Rash, Vaccination site erythema
Clinical narrative: achiness; left arm at the injection site very hot; fatigue; red; kind of swollen; Pruritis; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), VACCINATION SITE WARMTH (left arm at the injection site very hot), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (kind of swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 2007, Hypertension since 2013, Asthma, Allergy to chemicals (Allergy to Monosodium glutamate and reaction hives.), Hay fever and Hives. Concomitant products included CHLORTHALIDONE and LOSARTAN for Blood pressure high, GLIMEPIRIDE for Diabetes, METFORMIN for Diabetes mellitus, ATORVASTATIN for Triglycerides high, CLOMIPRAMINE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), VACCINATION SITE WARMTH (left arm at the injection site very hot), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (kind of swollen), PRURITUS (Pruritis) and RASH (Rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN (achiness), VACCINATION SITE WARMTH (left arm at the injection site very hot), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (kind of swollen), PRURITUS (Pruritis) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details also included anti itch cream. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information included patient demographics, concomitant medication information and medical history.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: achiness; left arm at the injection site very hot; fatigue; red; kind of swollen; Pruritis; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), VACCINATION SITE WARMTH (left arm at the injection site very hot), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (kind of swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 2007, Hypertension since 2013, Asthma, Allergy to chemicals (Allergy to Monosodium glutamate and reaction hives.), Hay fever and Hives. Concomitant products included CHLORTHALIDONE and LOSARTAN for Blood pressure high, GLIMEPIRIDE for Diabetes, METFORMIN for Diabetes mellitus, ATORVASTATIN for Triglycerides high, CLOMIPRAMINE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), VACCINATION SITE WARMTH (left arm at the injection site very hot), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (kind of swollen), PRURITUS (Pruritis) and RASH (Rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN (achiness), VACCINATION SITE WARMTH (left arm at the injection site very hot), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (kind of swollen), PRURITUS (Pruritis) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details also included anti itch cream. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information included patient demographics, concomitant medication information and medical history.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: He stayed in bed all day; Felt weak after the vaccine; Arm was beet red; Sunburnt to the middle of the forearm; felt funny; Patient did not receive second dose and it has been 36 days; unapproved age group received Moderna vaccine <18 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of FATIGUE (He stayed in bed all day), ASTHENIA (Felt weak after the vaccine), ERYTHEMA (Arm was beet red), SKIN BURNING SENSATION (Sunburnt to the middle of the forearm) and THERAPEUTIC RESPONSE UNEXPECTED (felt funny) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unapproved age group received Moderna vaccine <18 years old). On an unknown date, the patient experienced FATIGUE (He stayed in bed all day), ASTHENIA (Felt weak after the vaccine), ERYTHEMA (Arm was beet red), SKIN BURNING SENSATION (Sunburnt to the middle of the forearm), THERAPEUTIC RESPONSE UNEXPECTED (felt funny) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose and it has been 36 days). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unapproved age group received Moderna vaccine <18 years old) had resolved. At the time of the report, FATIGUE (He stayed in bed all day) and ASTHENIA (Felt weak after the vaccine) outcome was unknown and ERYTHEMA (Arm was beet red), SKIN BURNING SENSATION (Sunburnt to the middle of the forearm), THERAPEUTIC RESPONSE UNEXPECTED (felt funny) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose and it has been 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Initials were updated, new events were added.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation, Therapeutic response unexpected
Clinical narrative: He stayed in bed all day; Felt weak after the vaccine; Arm was beet red; Sunburnt to the middle of the forearm; felt funny; Patient did not receive second dose and it has been 36 days; unapproved age group received Moderna vaccine <18 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of FATIGUE (He stayed in bed all day), ASTHENIA (Felt weak after the vaccine), ERYTHEMA (Arm was beet red), SKIN BURNING SENSATION (Sunburnt to the middle of the forearm) and THERAPEUTIC RESPONSE UNEXPECTED (felt funny) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unapproved age group received Moderna vaccine <18 years old). On an unknown date, the patient experienced FATIGUE (He stayed in bed all day), ASTHENIA (Felt weak after the vaccine), ERYTHEMA (Arm was beet red), SKIN BURNING SENSATION (Sunburnt to the middle of the forearm), THERAPEUTIC RESPONSE UNEXPECTED (felt funny) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose and it has been 36 days). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unapproved age group received Moderna vaccine <18 years old) had resolved. At the time of the report, FATIGUE (He stayed in bed all day) and ASTHENIA (Felt weak after the vaccine) outcome was unknown and ERYTHEMA (Arm was beet red), SKIN BURNING SENSATION (Sunburnt to the middle of the forearm), THERAPEUTIC RESPONSE UNEXPECTED (felt funny) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose and it has been 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Initials were updated, new events were added.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Hypersensitivity, Pruritus, Rash, Vaccination site discolouration
Clinical narrative: discoloration; it when to my neck and shoulders/it went to my head; Itchy; Hypersensitivity reaction; rash developed at the injection site; itchy bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (discoloration), RASH (it went to my neck and shoulders/it went to my head), PRURITUS (Itchy), HYPERSENSITIVITY (Hypersensitivity reaction) and VACCINATION SITE RASH (rash developed at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Hay fever, Hives (MSG), Diabetes since 2007 and Hypertension since 2013. Concomitant products included CHLORTHALIDONE and LOSARTAN for Blood pressure high, METFORMIN and GLIMEPIRIDE for Diabetes, ATORVASTATIN for Triglycerides high, CLOMIPRAMINE for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). In February 2021, the patient experienced VACCINATION SITE RASH (rash developed at the injection site) and VACCINATION SITE PRURITUS (itchy bumps). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (discoloration), RASH (it when to my neck and shoulders/it went to my head) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and CORTISONE (topical) from 28-Apr-2021 to 07-May-2021 at a dose of 1 dosage form. On 25-Apr-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. On 07-May-2021, RASH (it went to my neck and shoulders/it went to my head) and PRURITUS (Itchy) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (discoloration), VACCINATION SITE RASH (rash developed at the injection site) and VACCINATION SITE PRURITUS (itchy bumps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) 180s -190s.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication also included anti itch cream. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-055624, MOD-2021-055624 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021 and contains information's of patient demographic details,medical history,concomitant medication, dosing information, onset date and event outcome updated and new event(Hypersensitivity) were added.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: discoloration; it when to my neck and shoulders/it went to my head; Itchy; Hypersensitivity reaction; rash developed at the injection site; itchy bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (discoloration), RASH (it went to my neck and shoulders/it went to my head), PRURITUS (Itchy), HYPERSENSITIVITY (Hypersensitivity reaction) and VACCINATION SITE RASH (rash developed at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Hay fever, Hives (MSG), Diabetes since 2007 and Hypertension since 2013. Concomitant products included CHLORTHALIDONE and LOSARTAN for Blood pressure high, METFORMIN and GLIMEPIRIDE for Diabetes, ATORVASTATIN for Triglycerides high, CLOMIPRAMINE for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). In February 2021, the patient experienced VACCINATION SITE RASH (rash developed at the injection site) and VACCINATION SITE PRURITUS (itchy bumps). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (discoloration), RASH (it when to my neck and shoulders/it went to my head) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and CORTISONE (topical) from 28-Apr-2021 to 07-May-2021 at a dose of 1 dosage form. On 25-Apr-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. On 07-May-2021, RASH (it went to my neck and shoulders/it went to my head) and PRURITUS (Itchy) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (discoloration), VACCINATION SITE RASH (rash developed at the injection site) and VACCINATION SITE PRURITUS (itchy bumps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) 180s -190s.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication also included anti itch cream. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-055624, MOD-2021-055624 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021 and contains information's of patient demographic details,medical history,concomitant medication, dosing information, onset date and event outcome updated and new event(Hypersensitivity) were added.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Intestinal pain), DIARRHOEA (I have had diarrhea), VACCINATION SITE PAIN (shot hurt alot, pain when the needle went in also while the serum was going in it burned), MYALGIA (aches and pains all over my body) and PYREXIA (fever lasted 2 to 3 days) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Mar-2021, the patient experienced ABDOMINAL PAIN (Intestinal pain), DIARRHOEA (I have had diarrhea), VACCINATION SITE PAIN (shot hurt alot, pain when the needle went in also while the serum was going in it burned), MYALGIA (aches and pains all over my body) and PYREXIA (fever lasted 2 to 3 days). On 11-Mar-2021, VACCINATION SITE PAIN (shot hurt alot, pain when the needle went in also while the serum was going in it burned) had resolved. On 14-Mar-2021, PYREXIA (fever lasted 2 to 3 days) had resolved. On 16-Mar-2021, ABDOMINAL PAIN (Intestinal pain), DIARRHOEA (I have had diarrhea) and MYALGIA (aches and pains all over my body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-258749 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: NNI Case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Sore arm  again; Chills; Fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm  again), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-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 VACCINATION SITE PAIN (Sore arm  again), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (Sore arm  again), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 220/140 (High) 220/140.         No Concomitant Medication was provided. Treatment medications were not provided. Action taken with mRNA-1273 in response to the event was not applicable  Follow up : Patient doesn't wish to provide an email. Says everything is water under the bridge and would prefer that we don't bother patient anymore.   This case was linked to MOD21-040210, MOD-2021-027958, MOD-2021-027692 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Events sore arm again, chills, fever and headache were added. Outcome of events was resolved..2nd dose details were updated. Previous events soreness in the arm of the injection and difficulty breathing were deleted as it was confirmed the case is of second dose.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Benign lymph node neoplasm, Biopsy lymph gland, Extra dose administered, Lymphadenopathy
Clinical narrative: second shot of vaccine on 10Feb and on 12Feb; benign; Super clavicular lymph node swelling; This spontaneous case was reported by a health care professional and describes the occurrence of BENIGN LYMPH NODE NEOPLASM (benign), EXTRA DOSE ADMINISTERED (second shot of vaccine on 10Feb and on 12Feb) and LYMPHADENOPATHY (Super clavicular lymph node swelling) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (she got two lymph nodes removed).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 12-Feb-2021, the patient experienced LYMPHADENOPATHY (Super clavicular lymph node swelling). In March 2021, the patient experienced BENIGN LYMPH NODE NEOPLASM (benign). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (second shot of vaccine on 10Feb and on 12Feb). At the time of the report, BENIGN LYMPH NODE NEOPLASM (benign) and LYMPHADENOPATHY (Super clavicular lymph node swelling) outcome was unknown and EXTRA DOSE ADMINISTERED (second shot of vaccine on 10Feb and on 12Feb) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Biopsy lymph gland: came to know it was Benign.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Insomnia, Pruritus, Restless legs syndrome
Clinical narrative: itching in left arm; Pain around the injection site-left arm; Joint pain; Restless leg syndrome has intensified; Restless leg syndrome has intensified; hard for him to sleep; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESS LEGS SYNDROME (Restless leg syndrome has intensified), CONDITION AGGRAVATED (Restless leg syndrome has intensified), INSOMNIA (hard for him to sleep), PRURITUS (itching in left arm) and VACCINATION SITE PAIN (Pain around the injection site-left arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Restless leg syndrome (restless leg syndrome has intensified), Acid reflux (esophageal), Sleep disorder and Anxiety. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ALPRAZOLAM (ALPROZOLAM) for Anxiety, TRAZODONE from March 2021 to an unknown date for Sleep problem.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RESTLESS LEGS SYNDROME (Restless leg syndrome has intensified), CONDITION AGGRAVATED (Restless leg syndrome has intensified), INSOMNIA (hard for him to sleep), VACCINATION SITE PAIN (Pain around the injection site-left arm) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced PRURITUS (itching in left arm). At the time of the report, RESTLESS LEGS SYNDROME (Restless leg syndrome has intensified), CONDITION AGGRAVATED (Restless leg syndrome has intensified) and INSOMNIA (hard for him to sleep) outcome was unknown, PRURITUS (itching in left arm) and VACCINATION SITE PAIN (Pain around the injection site-left arm) had not resolved and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added medical history, concomitant medication, facility details and event. Updated patient demographics, re-challenge field and event outcome.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: itching in left arm; Pain around the injection site-left arm; Joint pain; Restless leg syndrome has intensified; Restless leg syndrome has intensified; hard for him to sleep; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESS LEGS SYNDROME (Restless leg syndrome has intensified), CONDITION AGGRAVATED (Restless leg syndrome has intensified), INSOMNIA (hard for him to sleep), PRURITUS (itching in left arm) and VACCINATION SITE PAIN (Pain around the injection site-left arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Restless leg syndrome (restless leg syndrome has intensified), Acid reflux (esophageal), Sleep disorder and Anxiety. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ALPRAZOLAM (ALPROZOLAM) for Anxiety, TRAZODONE from March 2021 to an unknown date for Sleep problem.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RESTLESS LEGS SYNDROME (Restless leg syndrome has intensified), CONDITION AGGRAVATED (Restless leg syndrome has intensified), INSOMNIA (hard for him to sleep), VACCINATION SITE PAIN (Pain around the injection site-left arm) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced PRURITUS (itching in left arm). At the time of the report, RESTLESS LEGS SYNDROME (Restless leg syndrome has intensified), CONDITION AGGRAVATED (Restless leg syndrome has intensified) and INSOMNIA (hard for him to sleep) outcome was unknown, PRURITUS (itching in left arm) and VACCINATION SITE PAIN (Pain around the injection site-left arm) had not resolved and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added medical history, concomitant medication, facility details and event. Updated patient demographics, re-challenge field and event outcome.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Inappropriate schedule of product administration
Clinical narrative: bronchitis; Potentially receiving the second dose of the vaccine more than 36 days after the the first dose; This spontaneous case was reported by a nurse and describes the occurrence of BRONCHITIS (bronchitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Potentially receiving the second dose of the vaccine more than 36 days after the the first dose) 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 10-Feb-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BRONCHITIS (bronchitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Potentially receiving the second dose of the vaccine more than 36 days after the the first dose). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BRONCHITIS (bronchitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Potentially receiving the second dose of the vaccine more than 36 days after the the first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included as antibiotic. No concomitant medication reported.   The patient was still on the antibiotics and will be on the prednisone for 16 days, which puts her way above the 42 days mark because she is supposed to wait 2 weeks after the prednisone before getting the second dose of the vaccine.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Nausea, Pain
Clinical narrative: pain; blood pressure went up; pulse went up; nausea; headaches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain), HYPERTENSION (blood pressure went up), HEART RATE INCREASED (pulse went up), NAUSEA (nausea) and HEADACHE (headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (pain), HYPERTENSION (blood pressure went up), HEART RATE INCREASED (pulse went up), NAUSEA (nausea) and HEADACHE (headaches). At the time of the report, PAIN (pain), HYPERTENSION (blood pressure went up), HEART RATE INCREASED (pulse went up), NAUSEA (nausea) and HEADACHE (headaches) outcome was unknown.            Concomitant drug was not administered.  Treatment for the event was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Bad reactions from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reactions from 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reactions from the first vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, VACCINATION COMPLICATION (Bad reactions from the first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-059502 (Patient Link).
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Vital signs measurement
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNEA (developed shortness of breath) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Type 2 diabetes mellitus, Congestive heart failure, Hypertension, Rheumatoid arthritis, Atrial fibrillation and Pacemaker insertion (cardiac). Concurrent medical conditions included Drug allergy (Cortisone). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DYSPNEA (developed shortness of breath). The patient was treated with OXYGEN for Shortness of breath, at a dose of UNK dosage form and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Shortness of breath, at a dose of UNK dosage form. At the time of the report, DYSPNOEA (developed shortness of breath) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: stable (normal) stable. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Concomitant medication was not reported. The patient continued with shortness of breath even with home oxygen and albuterol inhaler.  It was reported that no epinephrine or Benadryl was administered. Emergency Medical Services was called and evaluated the patient's condition; vitals were stable, so did not transport to ER. This case was linked to MOD-2021-028961, MOD-2021-032365.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Presyncope
Clinical narrative: Practically fainted; short of breath; Feels weak; 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 PRESYNCOPE (Practically fainted), DYSPNOEA (short of breath) and ASTHENIA (Feels weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TRETINOIN (RETIN-A) for an unknown indication.    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 PRESYNCOPE (Practically fainted), DYSPNOEA (short of breath) and ASTHENIA (Feels weak). At the time of the report, PRESYNCOPE (Practically fainted) outcome was unknown and DYSPNOEA (short of breath) and ASTHENIA (Feels weak) had not resolved.            Concomitant medications also include d unspecified thyroid medication and lots of vitamins.   Treatment to the events not reported.   This case was linked to MOD-2021-034392 (Patient Link).