chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feel feverish four days ago/feeling feverish after a week of getting the 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 PYREXIA (feel feverish four days ago/feeling feverish after a week of getting the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (feel feverish four days ago/feeling feverish after a week of getting the vaccine). At the time of the report, PYREXIA (feel feverish four days ago/feeling feverish after a week of getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist pave 7 doses on 01Jun2021 out of a vial,but does not know if vial was from 30May2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist pave 7 doses on 01Jun2021 out of a vial,but does not know if vial was from 30May2021) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist pave 7 doses on 01Jun2021 out of a vial,but does not know if vial was from 30May2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist pave 7 doses on 01Jun2021 out of a vial,but does not know if vial was from 30May2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Additional information was received from initial reporter and does not contain new information On 30-Jun-2021: Telephonic follow up response was received from initial reporter: Event verbatim was updated
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received the 1st dose > 35 Days and is determined not to get the 2nd one.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the 1st dose > 35 Days and is determined not to get the 2nd one.) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the 1st dose > 35 Days and is determined not to get the 2nd one.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the 1st dose > 35 Days and is determined not to get the 2nd one.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: site allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (site allergic reaction) 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 SITE REACTION (site allergic reaction). At the time of the report, VACCINATION SITE REACTION (site allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: arm was sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was sore) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (arm was sore). At the time of the report, MYALGIA (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Stuffy nose; Cough; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose) and COUGH (Cough) 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 NASAL CONGESTION (Stuffy nose) and COUGH (Cough). At the time of the report, NASAL CONGESTION (Stuffy nose) and COUGH (Cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) 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 SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Vomiting; Nausea; Stomach Pain; Dizziness; A lot of headache that still continues; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (A lot of headache that still continues), DIZZINESS (Dizziness), VOMITING (Vomiting), NAUSEA (Nausea) and ABDOMINAL PAIN UPPER (Stomach Pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 25-May-2021, the patient experienced HEADACHE (A lot of headache that still continues). On 29-May-2021, the patient experienced DIZZINESS (Dizziness). On 30-May-2021, the patient experienced VOMITING (Vomiting), NAUSEA (Nausea) and ABDOMINAL PAIN UPPER (Stomach Pain). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (CORICIDIN D [CHLORPHENAMINE MALEATE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ACETAMINOPHEN for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (A lot of headache that still continues), DIZZINESS (Dizziness), VOMITING (Vomiting), NAUSEA (Nausea) and ABDOMINAL PAIN UPPER (Stomach Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Med Info Agent:  Patient stated she had first dose of Moderna vaccine on Tuesday 25 May 2021 and since Tuesday night started to have a lot of headache that continues. On Saturday she started to feel dizzy and this continues, and on Sunday started to vomit and have nausea and stomach pain which continues. Says that her headache doesn't stop with anything. She already had Coricidin and Acetaminophen and pills for migraine each five or six hours but doesn't take out her headache.  Stated she doesn't have concomitant medications. Expiration date of vaccine is unknown.  Consent for Safety to follow up with patient, preferred method of contact by phone. Patient stated she doesn't have a doctor to provide contact for Safety to follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 diagnosis after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 diagnosis after vaccination) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced COVID-19 (COVID-19 diagnosis after vaccination). At the time of the report, COVID-19 (COVID-19 diagnosis after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Palpitations, Supraventricular extrasystoles
Clinical narrative: Premature atrial contraction; Occasional palpitations which became severe waking her up at night; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Occasional palpitations which became severe waking her up at night) and SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Stevens Johnson syndrome (Allegedly precipitated by Mycoplasma Infection) in 1991 and Mycoplasma infection.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PALPITATIONS (Occasional palpitations which became severe waking her up at night). On 09-Apr-2021, the patient experienced SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction). The patient was treated with DIAZEPAM (VALIUM) for Palpitations, at a dose of 3-4 doses. On 16-Apr-2021, PALPITATIONS (Occasional palpitations which became severe waking her up at night) and SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Echocardiogram: abnormal (abnormal) Diagnosed with premature Atrial Contraction.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their first dose of the Moderna Covid-19 vaccine and on 02-Apr-2021, the patient developed palpitations initially, occasionally but got worse until it woke them up at night. The patient's symptom persisted until it became severe. On 09-Apr-2021, the patient was advised by their healthcare provider to go to the emergency room and had an electrocardiogram done. The patient was diagnosed with premature atrial contraction.  Reportedly, the patient was told that it was not serious and was sent home. The patient was on beta blocker and was advised to take an extra half dose of the beta blocker together with valium if the palpitations occur. All in all, the patient was able to take 2 doses of the half dose beta blocker and 3-4 doses of valium which the patient claimed not to have helped with the palpitations. The palpitations tapered off in two weeks 16-Apr-2021 although the patient stated that they still would have occasional flip-flop skip beats.   On 06-May-2021, the patient had an echocardiogram as a workup for their palpitations but was still waiting for their appointment with a cardiologist to know the final result.  Concomitant medication included Beta blocker.  Treatment medications included Beta blocker and Valium.   This case was linked to MOD-2021-193514 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up was received on 30-Jun-2021 and updated the outcome of the event Premature atrial contraction and Palpitations from unknown to Recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Therapeutic response unexpected
Clinical narrative: improved state of mind from vaccine; Chills; fever; Body ache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (improved state of mind from vaccine), CHILLS (Chills), PYREXIA (fever) and MYALGIA (Body ache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050c21A and 016c21A) for COVID-19 vaccination.     No medical history was provided by reporter.    On 28-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) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (improved state of mind from vaccine), CHILLS (Chills), PYREXIA (fever) and MYALGIA (Body ache). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (improved state of mind from vaccine) outcome was unknown and CHILLS (Chills), PYREXIA (fever) and MYALGIA (Body ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included oswelia and olive leaves extract with MSM.  Treatment medication included Benadryl.  Patient reported improvement of quality of life after second dose.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: palpitations; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Premature ventricular contractions.    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 PALPITATIONS (palpitations). At the time of the report, PALPITATIONS (palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and Concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Eye swelling, Periorbital swelling, Swelling face
Clinical narrative: face swollen (described as skin hanging over eye, big pocket of skin under both eyes); skin hanging over eye,big pocket of skin under both eyes; both eyes were puffy and itchy; both eyes were puffy and itchy; left eye was irritated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE IRRITATION (left eye was irritated), PERIORBITAL SWELLING (both eyes were puffy and itchy), SWELLING FACE (face swollen (described as skin hanging over eye, big pocket of skin under both eyes)), EYE SWELLING (skin hanging over eye,big pocket of skin under both eyes) and EYE PRURITUS (both eyes were puffy and itchy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) 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) .5 milliliter. On 04-May-2021, the patient experienced EYE IRRITATION (left eye was irritated). On 05-May-2021, the patient experienced PERIORBITAL SWELLING (both eyes were puffy and itchy). 05-May-2021, the patient experienced EYE PRURITUS (both eyes were puffy and itchy). On 07-May-2021, the patient experienced SWELLING FACE (face swollen (described as skin hanging over eye, big pocket of skin under both eyes)) and EYE SWELLING (skin hanging over eye,big pocket of skin under both eyes). The patient was treated with TOBRAMYCIN on 05-May-2021 at an unspecified dose and frequency; OFLOXACIN on 06-May-2021 at a dose of 0.3 % and FLUOROMETHOLONE on 07-May-2021 at a dose of 0.1 %. At the time of the report, EYE IRRITATION (left eye was irritated), PERIORBITAL SWELLING (both eyes were puffy and itchy), SWELLING FACE (face swollen (described as skin hanging over eye, big pocket of skin under both eyes)), EYE SWELLING (skin hanging over eye,big pocket of skin under both eyes) and EYE PRURITUS (both eyes were puffy and itchy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-193722 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Aptyalism, Chapped lips, Cheilitis, Dry mouth, Dysgeusia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (sunburn in mouth), GINGIVAL DISCOMFORT (sunburn in gums), CHAPPED LIPS (lips began to chap), CHEILITIS (around lip has a rash) and DRY MOUTH (mouth is dry) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ORAL MUCOSAL ERYTHEMA (redness around the lips like someone punched him in the mout). On 01-Apr-2021, the patient experienced ORAL DISCOMFORT (sunburn in mouth), GINGIVAL DISCOMFORT (sunburn in gums) and CHAPPED LIPS (lips began to chap). On an unknown date, the patient experienced CHEILITIS (around lip has a rash), DRY MOUTH (mouth is dry), DYSGEUSIA (metal taste in mouth) and APTYALISM (saliva is not producing). At the time of the report, ORAL DISCOMFORT (sunburn in mouth), GINGIVAL DISCOMFORT (sunburn in gums), CHAPPED LIPS (lips began to chap), CHEILITIS (around lip has a rash), DRY MOUTH (mouth is dry), DYSGEUSIA (metal taste in mouth), APTYALISM (saliva is not producing) and ORAL MUCOSAL ERYTHEMA (redness around the lips like someone punched him in the mout) had not resolved. Treatment medications included Antibiotics and Prednisone. Patients had appointment with dermatology in September. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added reporter details and added event. On 27-Jul-2021: Follow-up received and contain non-significant information.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival discomfort, Oral discomfort, Oral mucosal erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (sunburn in mouth), GINGIVAL DISCOMFORT (sunburn in gums), CHAPPED LIPS (lips began to chap), CHEILITIS (around lip has a rash) and DRY MOUTH (mouth is dry) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ORAL MUCOSAL ERYTHEMA (redness around the lips like someone punched him in the mout). On 01-Apr-2021, the patient experienced ORAL DISCOMFORT (sunburn in mouth), GINGIVAL DISCOMFORT (sunburn in gums) and CHAPPED LIPS (lips began to chap). On an unknown date, the patient experienced CHEILITIS (around lip has a rash), DRY MOUTH (mouth is dry), DYSGEUSIA (metal taste in mouth) and APTYALISM (saliva is not producing). At the time of the report, ORAL DISCOMFORT (sunburn in mouth), GINGIVAL DISCOMFORT (sunburn in gums), CHAPPED LIPS (lips began to chap), CHEILITIS (around lip has a rash), DRY MOUTH (mouth is dry), DYSGEUSIA (metal taste in mouth), APTYALISM (saliva is not producing) and ORAL MUCOSAL ERYTHEMA (redness around the lips like someone punched him in the mout) had not resolved. Treatment medications included Antibiotics and Prednisone. Patients had appointment with dermatology in September. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added reporter details and added event. On 27-Jul-2021: Follow-up received and contain non-significant information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Rash erythematous, Swelling face, Urticaria
Clinical narrative: face swelling; bright red with little red dots; skin was red and systemic rash; full body urticarial rash all over the body; arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm; inj site became paper like rough; Moderna Arm; redness; pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DRYNESS (inj site became paper like rough), VACCINATION SITE REACTION (Moderna Arm), RASH ERYTHEMATOUS (skin was red and systemic rash), URTICARIA (full body urticarial rash all over the body) and PERIPHERAL SWELLING (arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE DRYNESS (inj site became paper like rough), VACCINATION SITE REACTION (Moderna Arm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain). On 17-Mar-2021, the patient experienced RASH ERYTHEMATOUS (skin was red and systemic rash), URTICARIA (full body urticarial rash all over the body) and PERIPHERAL SWELLING (arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm). On 20-Mar-2021, the patient experienced SWELLING FACE (face swelling) and ERYTHEMA (bright red with little red dots). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and PREDNISONE at a dose of UNK dosage form. On 19-Mar-2021, RASH ERYTHEMATOUS (skin was red and systemic rash) and URTICARIA (full body urticarial rash all over the body) had resolved. At the time of the report, VACCINATION SITE DRYNESS (inj site became paper like rough), VACCINATION SITE REACTION (Moderna Arm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain) outcome was unknown and PERIPHERAL SWELLING (arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm), SWELLING FACE (face swelling) and ERYTHEMA (bright red with little red dots) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided. The patient was treated with steroid in the emergency room on 21-Apr-2021.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Additional information received captured no new information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site dryness, Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: face swelling; bright red with little red dots; skin was red and systemic rash; full body urticarial rash all over the body; arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm; inj site became paper like rough; Moderna Arm; redness; pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DRYNESS (inj site became paper like rough), VACCINATION SITE REACTION (Moderna Arm), RASH ERYTHEMATOUS (skin was red and systemic rash), URTICARIA (full body urticarial rash all over the body) and PERIPHERAL SWELLING (arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE DRYNESS (inj site became paper like rough), VACCINATION SITE REACTION (Moderna Arm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain). On 17-Mar-2021, the patient experienced RASH ERYTHEMATOUS (skin was red and systemic rash), URTICARIA (full body urticarial rash all over the body) and PERIPHERAL SWELLING (arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm). On 20-Mar-2021, the patient experienced SWELLING FACE (face swelling) and ERYTHEMA (bright red with little red dots). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and PREDNISONE at a dose of UNK dosage form. On 19-Mar-2021, RASH ERYTHEMATOUS (skin was red and systemic rash) and URTICARIA (full body urticarial rash all over the body) had resolved. At the time of the report, VACCINATION SITE DRYNESS (inj site became paper like rough), VACCINATION SITE REACTION (Moderna Arm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain) outcome was unknown and PERIPHERAL SWELLING (arm swelling, on 20th march 2021 bilateral swelling on palms of arm and forearm), SWELLING FACE (face swelling) and ERYTHEMA (bright red with little red dots) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided. The patient was treated with steroid in the emergency room on 21-Apr-2021.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Additional information received captured no new information.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got first dose on 10Mar2021 and has not received the second yet/receive my second dose of the Moderna Covid-19 vaccine outside the recommended duration; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 10Mar2021 and has not received the second yet/receive my second dose of the Moderna Covid-19 vaccine outside the recommended duration) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 001B21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LISINOPRIL and OMEPRAZOLE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 10Mar2021 and has not received the second yet/receive my second dose of the Moderna Covid-19 vaccine outside the recommended duration). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 10Mar2021 and has not received the second yet/receive my second dose of the Moderna Covid-19 vaccine outside the recommended duration) outcome was unknown.            No treatment information was provided.  Patient received his second dose of the Moderna Covid-19 vaccine outside the recommended duration i.e. after 83 days of the first dose. Patient mentioned he did not had any adverse effects after taking second dose   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on29-JUN-2021 contains significant information. Details on second dose were added.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Hypersensitivity, Nasal congestion, Respiratory tract congestion
Clinical narrative: chest congestion; stuck up sinus; Allergic reaction; coughing; mucus in nose and throat; headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest congestion), SINUS CONGESTION (stuck up sinus), HYPERSENSITIVITY (Allergic reaction), COUGH (coughing) and NASAL CONGESTION (mucus in nose and throat) in a 68-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.     The patient's past medical history included Prostatic disorder (Prostate Problem).    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion), SINUS CONGESTION (stuck up sinus), HYPERSENSITIVITY (Allergic reaction), COUGH (coughing), NASAL CONGESTION (mucus in nose and throat) and HEADACHE (headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, RESPIRATORY TRACT CONGESTION (chest congestion), SINUS CONGESTION (stuck up sinus), HYPERSENSITIVITY (Allergic reaction), COUGH (coughing), NASAL CONGESTION (mucus in nose and throat) and HEADACHE (headaches) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication reported by reporter. His HCP  stated that for patient receiving the vaccine brought up allergies. Patient is starting to get better.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-192952 (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 events, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: chest congestion; stuck up sinus; Allergic reaction; coughing; mucus in nose and throat; headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest congestion), SINUS CONGESTION (stuck up sinus), HYPERSENSITIVITY (Allergic reaction), COUGH (coughing) and NASAL CONGESTION (mucus in nose and throat) in a 68-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.     The patient's past medical history included Prostatic disorder (Prostate Problem).    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion), SINUS CONGESTION (stuck up sinus), HYPERSENSITIVITY (Allergic reaction), COUGH (coughing), NASAL CONGESTION (mucus in nose and throat) and HEADACHE (headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, RESPIRATORY TRACT CONGESTION (chest congestion), SINUS CONGESTION (stuck up sinus), HYPERSENSITIVITY (Allergic reaction), COUGH (coughing), NASAL CONGESTION (mucus in nose and throat) and HEADACHE (headaches) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication reported by reporter. His HCP  stated that for patient receiving the vaccine brought up allergies. Patient is starting to get better.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-192952 (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 events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: covid arm which is severe after effect; 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 (covid arm which is severe after effect) 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 PAIN IN EXTREMITY (covid arm which is severe after effect). At the time of the report, PAIN IN EXTREMITY (covid arm which is severe after effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Not feeling great; Fatigue; Nausea; 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 MALAISE (Not feeling great), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 MALAISE (Not feeling great), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, MALAISE (Not feeling great), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.            No concomitant and treatment medications were reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 8 doses given today after vial was punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (8 doses given today after vial was punctured) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced INCORRECT DOSE ADMINISTERED (8 doses given today after vial was punctured). At the time of the report, INCORRECT DOSE ADMINISTERED (8 doses given today after vial was punctured) had 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.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: soar thoart; 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 OROPHARYNGEAL PAIN (soar thoart) 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 was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (soar thoart). At the time of the report, OROPHARYNGEAL PAIN (soar thoart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported , No treatment medication was reported .   Reporter did not allow further contact
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Slight fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Slight fever) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Slight fever). On 03-Feb-2021, PYREXIA (Slight fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose given to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Additional information include no new information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the vaccine site; 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 SITE PAIN (pain at the vaccine site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the vaccine site). At the time of the report, VACCINATION SITE PAIN (pain at the vaccine site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No other concomitant medicines  provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymphadenopathy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol high and Thyroid disorder.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced LYMPHADENOPATHY (lymphadenopathy). At the time of the report, LYMPHADENOPATHY (lymphadenopathy) had not resolved.            Concomitant product information included unspecified medications for high blood pressure, cholesterol, and thyroid.  No treatment had been used.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Vomiting
Clinical narrative: Abdominal discomfort; Nausea; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL DISCOMFORT (Abdominal discomfort), NAUSEA (Nausea) and VOMITING (Vomiting) 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 15-Apr-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 15-Apr-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Abdominal discomfort). At the time of the report, ABDOMINAL DISCOMFORT (Abdominal discomfort) and NAUSEA (Nausea) outcome was unknown and VOMITING (Vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: follow up received on 30 jun 2021 contain no new information.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MY SON OF 17 RECEIVED THE  FIRST DOSE; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (MY SON OF 17 RECEIVED THE  FIRST DOSE) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (MY SON OF 17 RECEIVED THE  FIRST DOSE). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (MY SON OF 17 RECEIVED THE  FIRST DOSE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatments were provided