chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Concomitant medication was not provided. Treatment information was not provided. Action taken with respect to mRNA-1273 was not applicable. It was reported that the patient was given both the doses of Moderna vaccine two weeks apart.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to PEG in moderna 1st vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to PEG in moderna 1st 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 VACCINATION COMPLICATION (Reaction to PEG in moderna 1st vaccine). At the time of the report, VACCINATION COMPLICATION (Reaction to PEG in moderna 1st vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Rash below injection site; A red rash below injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE ERYTHEMA (A red rash below 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 28-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE ERYTHEMA (A red rash below injection site). On 06-May-2021, VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE ERYTHEMA (A red rash below injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were taken by the patient.    Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 02-JUN-2021 contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm pain). At the time of the report, MYALGIA (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medicine were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; 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 HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. It was reported that the patient took second dose of mRNA-1273 on the 15th of an unknown month.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Extra dose administered
Clinical narrative: Arm is red and steaking to lower arm; My husband and i had our 3nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm is red and steaking to lower arm) and EXTRA DOSE ADMINISTERED (My husband and i had our 3nd vaccine) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ERYTHEMA (Arm is red and steaking to lower arm) and EXTRA DOSE ADMINISTERED (My husband and i had our 3nd vaccine). At the time of the report, ERYTHEMA (Arm is red and steaking to lower arm) outcome was unknown and EXTRA DOSE ADMINISTERED (My husband and i had our 3nd vaccine) had resolved.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vaccination complication
Clinical narrative: stomach pain; issues after th vaccines; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) and VACCINATION COMPLICATION (issues after th vaccines) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 ABDOMINAL PAIN UPPER (stomach pain) and VACCINATION COMPLICATION (issues after th vaccines). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and VACCINATION COMPLICATION (issues after th vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dizziness, Myalgia, Somnolence
Clinical narrative: extremely sleepy; Dizzy; tightness in chest; bad arm pain; bad shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (extremely sleepy), DIZZINESS (Dizzy), CHEST DISCOMFORT (tightness in chest), MYALGIA (bad arm pain) and ARTHRALGIA (bad shoulder pain) 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 No adverse event.    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 SOMNOLENCE (extremely sleepy), DIZZINESS (Dizzy), CHEST DISCOMFORT (tightness in chest), MYALGIA (bad arm pain) and ARTHRALGIA (bad shoulder pain). At the time of the report, SOMNOLENCE (extremely sleepy), DIZZINESS (Dizzy), CHEST DISCOMFORT (tightness in chest), MYALGIA (bad arm pain) and ARTHRALGIA (bad shoulder pain) outcome was unknown.            Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Just before retracting the needle some of the vaccine dripped on the patients arm; Vaccine leaked where the needle connects to the syringe/Just before she was retracting the needle some of the vaccine dripped on the patients arm; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Just before retracting the needle some of the vaccine dripped on the patients arm) and UNDERDOSE (Vaccine leaked where the needle connects to the syringe/Just before she was retracting the needle some of the vaccine dripped on the patients arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced DEVICE CONNECTION ISSUE (Just before retracting the needle some of the vaccine dripped on the patients arm) and UNDERDOSE (Vaccine leaked where the needle connects to the syringe/Just before she was retracting the needle some of the vaccine dripped on the patients arm). On 28-May-2021, DEVICE CONNECTION ISSUE (Just before retracting the needle some of the vaccine dripped on the patients arm) and UNDERDOSE (Vaccine leaked where the needle connects to the syringe/Just before she was retracting the needle some of the vaccine dripped on the patients arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment was reported
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Rash
Clinical narrative: Dry mouth; Rash along arm; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth) and RASH (Rash along arm) 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 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced RASH (Rash along arm). On 21-May-2021, the patient experienced DRY MOUTH (Dry mouth). At the time of the report, DRY MOUTH (Dry mouth) and RASH (Rash along arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: develop floaters in the vitreous of my right eye; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (develop floaters in the vitreous of my right eye) 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VITREOUS FLOATERS (develop floaters in the vitreous of my right eye). At the time of the report, VITREOUS FLOATERS (develop floaters in the vitreous of my right eye) outcome was unknown.            No concomitant medication provided. No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: chest is feeling Tighter and sore  then the first shot which was very minor; my chest is feeling Tighter and sore; 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 CHEST DISCOMFORT (chest is feeling Tighter and sore  then the first shot which was very minor) and CHEST PAIN (my chest is feeling Tighter and sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced CHEST DISCOMFORT (chest is feeling Tighter and sore  then the first shot which was very minor) and CHEST PAIN (my chest is feeling Tighter and sore). At the time of the report, CHEST DISCOMFORT (chest is feeling Tighter and sore  then the first shot which was very minor) and CHEST PAIN (my chest is feeling Tighter and sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       THERE IS NO CONCOMITENT MEDICATIONS USED IN THE TREATEMENT
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: I'm  in bbn pain today/hurting all over/Im in oain/body aches Pain/I'm hurting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (I'm  in bbn pain today/hurting all over/Im in oain/body aches Pain/I'm hurting) 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 MYALGIA (I'm  in bbn pain today/hurting all over/Im in oain/body aches Pain/I'm hurting). At the time of the report, MYALGIA (I'm  in bbn pain today/hurting all over/Im in oain/body aches Pain/I'm hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   Reporter did not allow further contact
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Dyspepsia, Insomnia, Myalgia
Clinical narrative: heart racing so fast; dizzy; digestion not good; unable to sleep; nerve pain (pain scale 7-8); short pain in injection site leg and stomach; short pain in injection site leg and stomach; unable to sleep because pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing so fast), DIZZINESS (dizzy), DYSPEPSIA (digestion not good), INSOMNIA (unable to sleep) and NEURALGIA (nerve pain (pain scale 7-8)) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced PALPITATIONS (heart racing so fast), DIZZINESS (dizzy), DYSPEPSIA (digestion not good), INSOMNIA (unable to sleep), NEURALGIA (nerve pain (pain scale 7-8)), PAIN IN EXTREMITY (short pain in injection site leg and stomach), ABDOMINAL PAIN UPPER (short pain in injection site leg and stomach) and MYALGIA (unable to sleep because pain). At the time of the report, PALPITATIONS (heart racing so fast), DIZZINESS (dizzy), DYSPEPSIA (digestion not good), INSOMNIA (unable to sleep), NEURALGIA (nerve pain (pain scale 7-8)), PAIN IN EXTREMITY (short pain in injection site leg and stomach), ABDOMINAL PAIN UPPER (short pain in injection site leg and stomach) and MYALGIA (unable to sleep because pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient consulted couple of doctors and had blood test, endoscopy and colonoscopy and awaiting for the results. Concomitant medications not provided. No treatment was reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Palpitations
Clinical narrative: heart racing so fast; dizzy; digestion not good; unable to sleep; nerve pain (pain scale 7-8); short pain in injection site leg and stomach; short pain in injection site leg and stomach; unable to sleep because pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing so fast), DIZZINESS (dizzy), DYSPEPSIA (digestion not good), INSOMNIA (unable to sleep) and NEURALGIA (nerve pain (pain scale 7-8)) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced PALPITATIONS (heart racing so fast), DIZZINESS (dizzy), DYSPEPSIA (digestion not good), INSOMNIA (unable to sleep), NEURALGIA (nerve pain (pain scale 7-8)), PAIN IN EXTREMITY (short pain in injection site leg and stomach), ABDOMINAL PAIN UPPER (short pain in injection site leg and stomach) and MYALGIA (unable to sleep because pain). At the time of the report, PALPITATIONS (heart racing so fast), DIZZINESS (dizzy), DYSPEPSIA (digestion not good), INSOMNIA (unable to sleep), NEURALGIA (nerve pain (pain scale 7-8)), PAIN IN EXTREMITY (short pain in injection site leg and stomach), ABDOMINAL PAIN UPPER (short pain in injection site leg and stomach) and MYALGIA (unable to sleep because pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient consulted couple of doctors and had blood test, endoscopy and colonoscopy and awaiting for the results. Concomitant medications not provided. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Terrible hair loss / Almost bald; 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 ALOPECIA (Terrible hair loss / Almost bald) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Terrible hair loss / Almost bald). At the time of the report, ALOPECIA (Terrible hair loss / Almost bald) outcome was unknown.            No concomitant medication was reported . no treatment medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Continuous coughing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Continuous coughing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 COUGH (Continuous coughing). At the time of the report, COUGH (Continuous coughing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday; I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday) and AGEUSIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday) and AGEUSIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday). At the time of the report, ANOSMIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday) and AGEUSIA (I lost taste and smell when I had covid - lasted about 6 weeks.  Happened again after first vaccine and was still the case when I got the second one yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rashes that itch; 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 RASH PRURITIC (rashes that itch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rashes that itch). At the time of the report, RASH PRURITIC (rashes that itch) outcome was unknown.            No concomitant and treatment medications were not provided.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy, Prothrombin time
Clinical narrative: really affects my coagulation; This spontaneous case was reported by a patient and describes the occurrence of COAGULATION FACTOR DECREASED (Coagulation factor decreased) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination.     Concomitant products included PRAMIPEXOLE for Restless leg syndrome, WARFARIN SODIUM, METOPROLOL, PRAVASTATIN, TAMSULOSIN, DIGOXIN, MULTIVITAMIN [VITAMINS NOS] and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced COAGULATION FACTOR DECREASED (Coagulation factor decreased). At the time of the report, COAGULATION FACTOR DECREASED (Coagulation factor decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prothrombin time (2.0-3.0): 1.4 (Low) decreased.         The patient's concomitant medicines also include  Dorzolamide eye drops in both eyes thrice daily.  The patient enquired if the Moderna vaccine have had any effect on the prothrombin time. But there was no information available in US FAQs to answer the query. When agent placed a call back to the patient, the call had ended. Agent attempted to callback several times, without success.  There is no product complaint associated with this case. Treatment medication information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: now I have a lump in my arm; redness on the outside; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (now I have a lump in my arm) and VACCINATION SITE ERYTHEMA (redness on the outside) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (now I have a lump in my arm) and VACCINATION SITE ERYTHEMA (redness on the outside). At the time of the report, VACCINATION SITE MASS (now I have a lump in my arm) and VACCINATION SITE ERYTHEMA (redness on the outside) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chemical burn, Feeling hot, Pain, Vaccination site erythema, Vaccination site mass
Clinical narrative: bump around the injection site / bump is oval in shape; Physical appearance of injection site resembles the skin of an oragne; feels like a chemical burn; Warm to touch; Slightly painful; Red and raised area around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump around the injection site / bump is oval in shape), VACCINATION SITE REACTION (Physical appearance of injection site resembles the skin of an oragne), CHEMICAL BURN (feels like a chemical burn), FEELING HOT (Warm to touch) and PAIN (Slightly painful) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0221321a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder, Allergy NOS and Mucous discharge. Concomitant products included CHLORPHENIRAMINE MALEATE for Allergy NOS, GUAIFENESIN (MUCINEX) for Mucous discharge, LEVOTHYROXINE for Thyroid disorder.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE MASS (bump around the injection site / bump is oval in shape), VACCINATION SITE REACTION (Physical appearance of injection site resembles the skin of an oragne), CHEMICAL BURN (feels like a chemical burn), FEELING HOT (Warm to touch), PAIN (Slightly painful) and VACCINATION SITE ERYTHEMA (Red and raised area around injection site). At the time of the report, VACCINATION SITE MASS (bump around the injection site / bump is oval in shape), VACCINATION SITE REACTION (Physical appearance of injection site resembles the skin of an oragne), CHEMICAL BURN (feels like a chemical burn), FEELING HOT (Warm to touch), PAIN (Slightly painful) and VACCINATION SITE ERYTHEMA (Red and raised area around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: bump around the injection site / bump is oval in shape; Physical appearance of injection site resembles the skin of an oragne; feels like a chemical burn; Warm to touch; Slightly painful; Red and raised area around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump around the injection site / bump is oval in shape), VACCINATION SITE REACTION (Physical appearance of injection site resembles the skin of an oragne), CHEMICAL BURN (feels like a chemical burn), FEELING HOT (Warm to touch) and PAIN (Slightly painful) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0221321a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder, Allergy NOS and Mucous discharge. Concomitant products included CHLORPHENIRAMINE MALEATE for Allergy NOS, GUAIFENESIN (MUCINEX) for Mucous discharge, LEVOTHYROXINE for Thyroid disorder.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE MASS (bump around the injection site / bump is oval in shape), VACCINATION SITE REACTION (Physical appearance of injection site resembles the skin of an oragne), CHEMICAL BURN (feels like a chemical burn), FEELING HOT (Warm to touch), PAIN (Slightly painful) and VACCINATION SITE ERYTHEMA (Red and raised area around injection site). At the time of the report, VACCINATION SITE MASS (bump around the injection site / bump is oval in shape), VACCINATION SITE REACTION (Physical appearance of injection site resembles the skin of an oragne), CHEMICAL BURN (feels like a chemical burn), FEELING HOT (Warm to touch), PAIN (Slightly painful) and VACCINATION SITE ERYTHEMA (Red and raised area around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick since second dose yesterday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick since second dose yesterday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced ILLNESS (sick since second dose yesterday). At the time of the report, ILLNESS (sick since second dose yesterday) outcome was unknown.            Concomitant product use was not provided. No treatment was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Pain, Pain in extremity
Clinical narrative: right leg was sore/calf was sore; being normally able to walk 6-8 miles a day but couldn't after receiving the Moderna COVID-19 vaccine; slight soreness in the left arm; only sore if touched; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (slight soreness in the left arm), PAIN IN EXTREMITY (right leg was sore/calf was sore), PAIN (only sore if touched) and ASTHENIA (being normally able to walk 6-8 miles a day but couldn't after receiving the Moderna COVID-19 vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN and CYANOCOBALAMIN (B 12) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2021, the patient experienced MYALGIA (slight soreness in the left arm) and PAIN (only sore if touched). On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (right leg was sore/calf was sore) and ASTHENIA (being normally able to walk 6-8 miles a day but couldn't after receiving the Moderna COVID-19 vaccine). On 25-Jan-2021, MYALGIA (slight soreness in the left arm), PAIN IN EXTREMITY (right leg was sore/calf was sore), PAIN (only sore if touched) and ASTHENIA (being normally able to walk 6-8 miles a day but couldn't after receiving the Moderna COVID-19 vaccine) had resolved.            No treatment information was provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Chills, Pain in extremity, Pruritus
Clinical narrative: Itching; chills; Protruding chest pain; Left breast is hurting and has noticeable lymph nodes that actually feels like it wraps around to the back; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Protruding chest pain), BREAST PAIN (Left breast is hurting and has noticeable lymph nodes that actually feels like it wraps around to the back), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itching) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CHEST PAIN (Protruding chest pain), BREAST PAIN (Left breast is hurting and has noticeable lymph nodes that actually feels like it wraps around to the back) and PAIN IN EXTREMITY (Sore arm). On 24-Apr-2021, the patient experienced PRURITUS (Itching) and CHILLS (chills). The patient was treated with HYDROCORTISONE at a dose of UNK dosage form; VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of UNK dosage form; MOMETASONE at a dose of UNK dosage form and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Protruding chest pain), BREAST PAIN (Left breast is hurting and has noticeable lymph nodes that actually feels like it wraps around to the back), PRURITUS (Itching) and CHILLS (chills) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant product reported.  Action taken with m-RNA1273(moderna COVID-19 Vaccine) in response to events was not applicable. After receiving the first dose of moderna vaccine patient had protruding chest pain and 3 bumps on her back on 13-Apr-2021 were still present but was  lighter in color on 30-May-2021, the bumps were still itchy. After receiving  second dose of vaccine patient got chills, heat bump and itchy and it was ongoing.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Erythema, Fatigue, Hyperhidrosis
Clinical narrative: elevated temperature intermittently of 99.5 F but did not exceed; intermittently chills; intermittently body sweatiness; damp skin; day or 2 of fatigue; lower slight body ache / sore; redness where she had shot; tender; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BODY TEMPERATURE INCREASED (elevated temperature intermittently of 99.5 F but did not exceed), CHILLS (intermittently chills), HYPERHIDROSIS (intermittently body sweatiness), SKIN MACERATION (damp skin) and FATIGUE (day or 2 of fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (elevated temperature intermittently of 99.5 F but did not exceed), CHILLS (intermittently chills), HYPERHIDROSIS (intermittently body sweatiness), SKIN MACERATION (damp skin), FATIGUE (day or 2 of fatigue), MYALGIA (lower slight body ache / sore), ERYTHEMA (redness where she had shot) and TENDERNESS (tender). At the time of the report, BODY TEMPERATURE INCREASED (elevated temperature intermittently of 99.5 F but did not exceed), CHILLS (intermittently chills), HYPERHIDROSIS (intermittently body sweatiness), SKIN MACERATION (damp skin), FATIGUE (day or 2 of fatigue), MYALGIA (lower slight body ache / sore) and TENDERNESS (tender) had resolved and ERYTHEMA (redness where she had shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Skin maceration, Tenderness
Clinical narrative: elevated temperature intermittently of 99.5 F but did not exceed; intermittently chills; intermittently body sweatiness; damp skin; day or 2 of fatigue; lower slight body ache / sore; redness where she had shot; tender; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BODY TEMPERATURE INCREASED (elevated temperature intermittently of 99.5 F but did not exceed), CHILLS (intermittently chills), HYPERHIDROSIS (intermittently body sweatiness), SKIN MACERATION (damp skin) and FATIGUE (day or 2 of fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (elevated temperature intermittently of 99.5 F but did not exceed), CHILLS (intermittently chills), HYPERHIDROSIS (intermittently body sweatiness), SKIN MACERATION (damp skin), FATIGUE (day or 2 of fatigue), MYALGIA (lower slight body ache / sore), ERYTHEMA (redness where she had shot) and TENDERNESS (tender). At the time of the report, BODY TEMPERATURE INCREASED (elevated temperature intermittently of 99.5 F but did not exceed), CHILLS (intermittently chills), HYPERHIDROSIS (intermittently body sweatiness), SKIN MACERATION (damp skin), FATIGUE (day or 2 of fatigue), MYALGIA (lower slight body ache / sore) and TENDERNESS (tender) had resolved and ERYTHEMA (redness where she had shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I'm so tired; 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 FATIGUE (I'm so tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 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 FATIGUE (I'm so tired). At the time of the report, FATIGUE (I'm so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose not given in allowed time window; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not given in allowed time window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not given in allowed time window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not given in allowed time window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; VARlVAX administered after temperature excursion; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. Information regarding to the patient's medical history, concurrent condition and concomitant medication were not provided.     On 20-JUL-2021, the varicella virus vaccine live (oka/merck)(VARIVAX) (0.5ml, lot # T017685, expiration date 21-MAY-2022; strength and route were unknown) was administered for prophylaxis after temperature excursion (product storage error).      Temperature excursion of this vaccine was 5.9 Fahrenheit degrees for 8 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: part of the liquid came out / didn't know the exact lost volume; part of the liquid came out / dripped onto the patient's arm; part of the liquid came out / didn't know the exact lost volume; This case was reported by a other health professional via call center representative and described the occurrence of inadvertent exposure to vaccine in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2021, the patient received the 2nd dose of Shingrix. On 18th August 2021, unknown after receiving Shingrix, the patient experienced inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered. On an unknown date, the outcome of the inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered were unknown.  Additional details provided were as follows: Health care professional reported that during the administration of the 2nd dose of Shingrix, part of the liquid came out through the needle and dripped onto the patient's arm which led to Inadvertent exposure to vaccine,exposure via skin contact and Incomplete dose administered. Health care professional did not know the exact lost volume and wanted to know if the 2nd dose should be repeated or not. Batch number and expiry date of Shingrix requested but health care professional did not have it. Consented to follow-up was denied.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Dizziness, Feeling abnormal, Headache
Clinical narrative: TINGLING OF FACE (CHEEKS AND MOUTH) AND BOTH HANDS AND ARMS; BAD POUNDING HEADACHE (FELT LIKE BRAIN WANTED TO COME OUT OF MY HEAD); FEVER; NAUSEA (FELT LIKE PREGNANT AND SMELLS WERE BOTHERING); CONFUSED; FEELING SPACED OUT/ FEELING WEIRD; SLEPT FOR 2 DAYS STRAIGHT; DIZZY BUT NOT UNBALANCE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 14-AUG-2021 for prophylactic vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate for drug used for unknown indication, estrogens conjugated for drug used for unknown indication, levothyroxine for drug used for unknown indication, liothyronine sodium for drug used for unknown indication, and progesterone for drug used for unknown indication.  On 14-AUG-2021, the patient experienced confused. On 14-AUG-2021, the patient experienced feeling spaced out/ feeling weird. On 14-AUG-2021, the patient experienced slept for 2 days straight. On 14-AUG-2021, the patient experienced dizzy but not unbalance. On 14-AUG-2021, the patient experienced nausea (felt like pregnant and smells were bothering). On 14-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 16-AUG-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. On 18-AUG-2021, the patient experienced bad pounding headache (felt like brain wanted to come out of my head). On 18-AUG-2021 21:10, treatment medications included: paracetamol. On 19-AUG-2021, the patient experienced tingling of face (cheeks and mouth) and both hands and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 16-AUG-2021, was recovering from bad pounding headache (felt like brain wanted to come out of my head), had not recovered from confused, tingling of face (cheeks and mouth) and both hands and arms, nausea (felt like pregnant and smells were bothering), and feeling spaced out/ feeling weird, and the outcome of slept for 2 days straight and dizzy but not unbalance was not reported. This report was non-serious.