chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Ageusia, Anosmia, Chills, Cough
Clinical narrative: abdominal cramps; cough; congestion; she lost her sense of smell and taste; she lost her sense of smell and taste; body ache; chilis; ongoing fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal cramps), COUGH (cough), NASAL CONGESTION (congestion), AGEUSIA (she lost her sense of smell and taste) and ANOSMIA (she lost her sense of smell and taste) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-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 ABDOMINAL PAIN (abdominal cramps), COUGH (cough), NASAL CONGESTION (congestion), AGEUSIA (she lost her sense of smell and taste), ANOSMIA (she lost her sense of smell and taste), MYALGIA (body ache), CHILLS (chilis) and PYREXIA (ongoing fever). At the time of the report, ABDOMINAL PAIN (abdominal cramps), COUGH (cough), NASAL CONGESTION (congestion), AGEUSIA (she lost her sense of smell and taste), ANOSMIA (she lost her sense of smell and taste), MYALGIA (body ache), CHILLS (chilis) and PYREXIA (ongoing fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia
Clinical narrative: abdominal cramps; cough; congestion; she lost her sense of smell and taste; she lost her sense of smell and taste; body ache; chilis; ongoing fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal cramps), COUGH (cough), NASAL CONGESTION (congestion), AGEUSIA (she lost her sense of smell and taste) and ANOSMIA (she lost her sense of smell and taste) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-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 ABDOMINAL PAIN (abdominal cramps), COUGH (cough), NASAL CONGESTION (congestion), AGEUSIA (she lost her sense of smell and taste), ANOSMIA (she lost her sense of smell and taste), MYALGIA (body ache), CHILLS (chilis) and PYREXIA (ongoing fever). At the time of the report, ABDOMINAL PAIN (abdominal cramps), COUGH (cough), NASAL CONGESTION (congestion), AGEUSIA (she lost her sense of smell and taste), ANOSMIA (she lost her sense of smell and taste), MYALGIA (body ache), CHILLS (chilis) and PYREXIA (ongoing fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (room temperature for more than 12 hours) and product temperature excursion issue in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 002C21A) for COVID-19 immunization. No medical history reported. On Jun 2, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 2, 2021, patient administered expired product (room temperature for more than 12 hours). On an unknown date, patient experienced product temperature excursion issue. On Jun 3, 2021, administered expired product (room temperature for more than 12 hours) resolved. At the time of the report, product temperature excursion issue outcome: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; 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 TINNITUS (Ringing in ears) 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 TINNITUS (Ringing in ears). At the time of the report, TINNITUS (Ringing in ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 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 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 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna COVID-19 vaccine administered to 14 year old female; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to 14 year old female) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to 14 year old female). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to 14 year old female) 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: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site), FATIGUE (Tiredness) and MYALGIA (Muscle on the back and shoulder was achy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included LOSARTAN, FLUOXETINE, GABAPENTIN and METOPROLOL for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site), FATIGUE (Tiredness) and MYALGIA (Muscle on the back and shoulder was achy). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site), FATIGUE (Tiredness) and MYALGIA (Muscle on the back and shoulder was achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. This case was linked to MOD-2021-20769.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Erythema
Clinical narrative: a red itchy area for about 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (a red itchy area for about 3-4 days) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced ERYTHEMA (a red itchy area for about 3-4 days). On 06-Apr-2021, ERYTHEMA (a red itchy area for about 3-4 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: unknown (Inconclusive) Unknown.         No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-059919 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue all the time; 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 (Fatigue all the time) 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 FATIGUE (Fatigue all the time). At the time of the report, FATIGUE (Fatigue all the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: Yeast infection after getting my second 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 FUNGAL INFECTION (Yeast infection after getting my second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FUNGAL INFECTION (Yeast infection after getting my second dose). At the time of the report, FUNGAL INFECTION (Yeast infection after getting my second dose) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Feeling abnormal, Headache
Clinical narrative: Sensation similar to not feeling clever; Small headache; Vaccine administered to pregnant patient; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), FEELING ABNORMAL (Sensation similar to not feeling clever) and HEADACHE (Small headache) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 031B21A) for COVID-19 vaccination.     Previously administered products included for Pertussis: Tdap vaccine from 02-Apr-2021 to 03-Apr-2021. Past adverse reactions to the above products included Injection site pain with Tdap vaccine. Concomitant products included IRON from 17-Feb-2021 to an unknown date for Supplementation therapy, PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] from 19-Jul-2019 to an unknown date for an unknown indication.   On 02-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On 01-May-2021, the patient experienced FEELING ABNORMAL (Sensation similar to not feeling clever) and HEADACHE (Small headache). On 30-Apr-2021, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. On 01-May-2021, FEELING ABNORMAL (Sensation similar to not feeling clever) and HEADACHE (Small headache) had resolved.            Concomitant medication also included prenatal vitamins with DHA, one daily  with breakfast, orally from 19-Jul-2021. No treatment information provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-069858 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity, Paraesthesia oral
Clinical narrative: Heavy and weird tongue feeling; sore arm; not feeling good; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Heavy and weird tongue feeling), PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (Heavy and weird tongue feeling), PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good) and FATIGUE (fatigue). At the time of the report, PARAESTHESIA ORAL (Heavy and weird tongue feeling), PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided by reporter Treatment medicines were not reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Pain around injection site; Swelling around injection site; Rash around injection site and an inch down; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain around injection site), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE RASH (Rash around injection site and an inch down) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain around injection site), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE RASH (Rash around injection site and an inch down). On 10-Mar-2021, VACCINATION SITE PAIN (Pain around injection site) and VACCINATION SITE SWELLING (Swelling around injection site) had resolved. At the time of the report, VACCINATION SITE RASH (Rash around injection site and an inch down) outcome was unknown.            No concomitant medication was provided  Treatment medication was not provided  Action taken with mRNA-1273 Moderna vaccine was Not Applicable
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: "the chill"; body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS ("the chill") and MYALGIA (body ache) 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 31-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced CHILLS ("the chill") and MYALGIA (body ache). At the time of the report, CHILLS ("the chill") and MYALGIA (body ache) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: losing her taste a little bit/loss of taste was slight/loss of taste was subtle; losing her smell a little bit; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (losing her taste a little bit/loss of taste was slight/loss of taste was subtle) and ANOSMIA (losing her smell a little bit) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 041B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 20-Nov-2020, Gastric disorder (Unknown stomach issues) and Scalp disorder (unknown scalp issues). Concurrent medical conditions included Hypothyroidism (diagnosed 30 years ago), Allergic reaction to analgesics (Allergy to Ibuprofen (causes rash on chest)) and Drug allergy (Allergy to Claritin (increases heart rate and causes anxiety).). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced AGEUSIA (losing her taste a little bit/loss of taste was slight/loss of taste was subtle) and ANOSMIA (losing her smell a little bit). At the time of the report, AGEUSIA (losing her taste a little bit/loss of taste was slight/loss of taste was subtle) and ANOSMIA (losing her smell a little bit) 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 treatment information was reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: arm soreness; pressure headache; tired; itchiness; rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness), HEADACHE (pressure headache), FATIGUE (tired), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE RASH (rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PAIN (arm soreness), HEADACHE (pressure headache), FATIGUE (tired), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE RASH (rash). At the time of the report, VACCINATION SITE PAIN (arm soreness), HEADACHE (pressure headache), FATIGUE (tired), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE RASH (rash) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old received the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received the 1st dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received the 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Additional information included that the patient was about 16 years old at the time of 2nd dose.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Pharmacist on duty gave that dose to a patient; left the already drawn-up vaccine dose outside in room temperature 75 degrees F for about 18 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (left the already drawn-up vaccine dose outside in room temperature 75 degrees F for about 18 hours) and EXPIRED PRODUCT ADMINISTERED (Pharmacist on duty gave that dose to a patient) 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 02-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (left the already drawn-up vaccine dose outside in room temperature 75 degrees F for about 18 hours). On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist on duty gave that dose to a patient). On 02-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (left the already drawn-up vaccine dose outside in room temperature 75 degrees F for about 18 hours) had resolved. On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist on duty gave that dose to a patient) 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.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Pain in extremity, Peripheral swelling, SARS-CoV-2 antibody test
Clinical narrative: Large swelling extending from elbow to shoulder; Pain in fingers; Pain under the shoulder blade; Red spot at the injection site; Red spot at the injection site developed into large swelling; First dose on 11-Apr-2021 and second dose on 25-Apr-2021; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Large swelling extending from elbow to shoulder), PAIN IN EXTREMITY (Pain in fingers), ARTHRALGIA (Pain under the shoulder blade), VACCINATION SITE ERYTHEMA (Red spot at the injection site) and VACCINATION SITE SWELLING (Red spot at the injection site developed into large swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Allergy (Allergic to Bandages.).   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11-Apr-2021 and second dose on 25-Apr-2021). On an unknown date, the patient experienced PERIPHERAL SWELLING (Large swelling extending from elbow to shoulder), PAIN IN EXTREMITY (Pain in fingers), ARTHRALGIA (Pain under the shoulder blade), VACCINATION SITE ERYTHEMA (Red spot at the injection site) and VACCINATION SITE SWELLING (Red spot at the injection site developed into large swelling). The patient was treated with CORTISONE at a dose of Cortisone regimen. On 25-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11-Apr-2021 and second dose on 25-Apr-2021) had resolved. At the time of the report, PERIPHERAL SWELLING (Large swelling extending from elbow to shoulder), PAIN IN EXTREMITY (Pain in fingers), ARTHRALGIA (Pain under the shoulder blade), VACCINATION SITE ERYTHEMA (Red spot at the injection site) and VACCINATION SITE SWELLING (Red spot at the injection site developed into large swelling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Antibody test for COVID was performed within the 14 days of vaccination shows negative result.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant Follow up received: Patient allergies, event outcome, Anatomical location of vaccine given &  treatment information were updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Large swelling extending from elbow to shoulder; Pain in fingers; Pain under the shoulder blade; Red spot at the injection site; Red spot at the injection site developed into large swelling; First dose on 11-Apr-2021 and second dose on 25-Apr-2021; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Large swelling extending from elbow to shoulder), PAIN IN EXTREMITY (Pain in fingers), ARTHRALGIA (Pain under the shoulder blade), VACCINATION SITE ERYTHEMA (Red spot at the injection site) and VACCINATION SITE SWELLING (Red spot at the injection site developed into large swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Allergy (Allergic to Bandages.).   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11-Apr-2021 and second dose on 25-Apr-2021). On an unknown date, the patient experienced PERIPHERAL SWELLING (Large swelling extending from elbow to shoulder), PAIN IN EXTREMITY (Pain in fingers), ARTHRALGIA (Pain under the shoulder blade), VACCINATION SITE ERYTHEMA (Red spot at the injection site) and VACCINATION SITE SWELLING (Red spot at the injection site developed into large swelling). The patient was treated with CORTISONE at a dose of Cortisone regimen. On 25-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11-Apr-2021 and second dose on 25-Apr-2021) had resolved. At the time of the report, PERIPHERAL SWELLING (Large swelling extending from elbow to shoulder), PAIN IN EXTREMITY (Pain in fingers), ARTHRALGIA (Pain under the shoulder blade), VACCINATION SITE ERYTHEMA (Red spot at the injection site) and VACCINATION SITE SWELLING (Red spot at the injection site developed into large swelling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Antibody test for COVID was performed within the 14 days of vaccination shows negative result.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant Follow up received: Patient allergies, event outcome, Anatomical location of vaccine given &  treatment information were updated.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 17 year old patient was given the vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was given the vaccine.) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was given the vaccine.). On 01-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was given the vaccine.) 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.   No concomitants and treatment medicines were reported
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Feeling abnormal, Illness
Clinical narrative: got sick" for two days; some days she can't taste/taste "comes and goes"; "got sick" for two days; didn't feel right" for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("got sick" for two days), FEELING ABNORMAL (didn't feel right" for a week), FEELING ABNORMAL (got sick" for two days) and AGEUSIA (some days she can't taste/taste "comes and goes") in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 20-Nov-2020, Hashimoto's disease, Upset stomach and Scalp disorder. Concurrent medical conditions included Drug allergy (ibuprofen, causes rash on chest) and Drug allergy (Claritin (increases heart rate and causes anxiety).). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN 15 for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ILLNESS ("got sick" for two days) and FEELING ABNORMAL (didn't feel right" for a week). On an unknown date, the patient experienced FEELING ABNORMAL (got sick" for two days) and AGEUSIA (some days she can't taste/taste "comes and goes"). At the time of the report, ILLNESS ("got sick" for two days), FEELING ABNORMAL (didn't feel right" for a week), FEELING ABNORMAL (got sick" for two days) and AGEUSIA (some days she can't taste/taste "comes and goes") 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.   Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm is starting to swal, Swell; 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 PERIPHERAL SWELLING (arm is starting to swal, Swell) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was 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 PERIPHERAL SWELLING (arm is starting to swal, Swell). At the time of the report, PERIPHERAL SWELLING (arm is starting to swal, Swell) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Tenderness
Clinical narrative: tenderness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness) and MYALGIA (soreness ) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2003. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS] for Supplementation therapy, ASCORBIC ACID (VIT C) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced TENDERNESS (tenderness) and MYALGIA (soreness ). On 15-Apr-2021, TENDERNESS (tenderness) had resolved. At the time of the report, MYALGIA (soreness ) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-077660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow- up received on 30 JUNE 2021, contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: I have the standard sore arm/some muscle aches; Bad headache; My temp is holding steady at 100; sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (I have the standard sore arm/some muscle aches), HEADACHE (Bad headache) and PYREXIA (My temp is holding steady at 100) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney failure.   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 PAIN IN EXTREMITY (sore arm), MYALGIA (I have the standard sore arm/some muscle aches), HEADACHE (Bad headache) and PYREXIA (My temp is holding steady at 100). At the time of the report, PAIN IN EXTREMITY (sore arm), MYALGIA (I have the standard sore arm/some muscle aches), HEADACHE (Bad headache) and PYREXIA (My temp is holding steady at 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (Inconclusive) holding steady at 100.         No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: first dose of the moderna covid-19 vaccine and Today they received a dose of the Pfizer covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (first dose of the moderna covid-19 vaccine and Today they received a dose of the Pfizer covid-19 vaccine) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (first dose of the moderna covid-19 vaccine and Today they received a dose of the Pfizer covid-19 vaccine). On 03-Jun-2021, PRODUCT ADMINISTRATION ERROR (first dose of the moderna covid-19 vaccine and Today they received a dose of the Pfizer covid-19 vaccine) 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 Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Legs been hurting and achy; Muscles felt much weaker in the legs and was getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs been hurting and achy) and MUSCULAR WEAKNESS (Muscles felt much weaker in the legs and was getting worse) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, FLUOXETINE, GABAPENTIN and METOPROLOL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Legs been hurting and achy) and MUSCULAR WEAKNESS (Muscles felt much weaker in the legs and was getting worse). At the time of the report, PAIN IN EXTREMITY (Legs been hurting and achy) and MUSCULAR WEAKNESS (Muscles felt much weaker in the legs and was getting worse) outcome was unknown. Unknown          No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-207654 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy for 3 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (itchy for 3 days). On 27-Feb-2021, PRURITUS (itchy for 3 days) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant and treatment medications were reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Erythema, Feeling abnormal, Haemorrhage
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LEPROSY (Patient said it looks like he has leprosy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Psoriasis. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced BURNING SENSATION (burning), PSORIASIS (psoriasis/patient had flare up of psoriasis and rashes all over his scalp), HAEMORRHAGE (Bleeding), SCAB (extreme crust tightening on the scalp.), BLISTER (blister), RASH VESICULAR (blistering rash), PRURITUS (itching), RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE PAIN (little sore arm). On an unknown date, the patient experienced LEPROSY (Patient said it looks like he has leprosy) (seriousness criterion medically significant), FEELING ABNORMAL (like someone was pulling on his head) and ERYTHEMA (red marks in the opposite side of the elbow where the hand bends). The patient was treated with HYDROCORTISONE at a dose of 2.5 mg; FLUOCINOLONE ACETONIDE (topical) at a dose of 0.01 %; TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency and SELENIUM SULFIDE (SELSUN BLUE) at a dose of 1 dosage form. At the time of the report, LEPROSY (Patient said it looks like he has leprosy) and PSORIASIS (psoriasis/patient had flare up of psoriasis and rashes all over his scalp) outcome was unknown and BURNING SENSATION (burning), HAEMORRHAGE (Bleeding), SCAB (extreme crust tightening on the scalp.), BLISTER (blister), FEELING ABNORMAL (like someone was pulling on his head), RASH VESICULAR (blistering rash), ERYTHEMA (red marks in the opposite side of the elbow where the hand bends), PRURITUS (itching), RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE PAIN (little sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. On 30-Jun-2021, the patient reported that the reaction had subsided with the use of steroidal creams and oils. On 09-Jul-2021, the patient reported that he had had flare up of psoriasis and rashes all over his scalp and mentioned that it looked like he had leprosy. This case was linked to MOD-2021-207737. Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information received included treatment information and outcome of the event. On 09-Jul-2021: Additional information received included additional event.; 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Psoriasis, Rash erythematous, Rash vesicular, Scab
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LEPROSY (Patient said it looks like he has leprosy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Psoriasis. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced BURNING SENSATION (burning), PSORIASIS (psoriasis/patient had flare up of psoriasis and rashes all over his scalp), HAEMORRHAGE (Bleeding), SCAB (extreme crust tightening on the scalp.), BLISTER (blister), RASH VESICULAR (blistering rash), PRURITUS (itching), RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE PAIN (little sore arm). On an unknown date, the patient experienced LEPROSY (Patient said it looks like he has leprosy) (seriousness criterion medically significant), FEELING ABNORMAL (like someone was pulling on his head) and ERYTHEMA (red marks in the opposite side of the elbow where the hand bends). The patient was treated with HYDROCORTISONE at a dose of 2.5 mg; FLUOCINOLONE ACETONIDE (topical) at a dose of 0.01 %; TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency and SELENIUM SULFIDE (SELSUN BLUE) at a dose of 1 dosage form. At the time of the report, LEPROSY (Patient said it looks like he has leprosy) and PSORIASIS (psoriasis/patient had flare up of psoriasis and rashes all over his scalp) outcome was unknown and BURNING SENSATION (burning), HAEMORRHAGE (Bleeding), SCAB (extreme crust tightening on the scalp.), BLISTER (blister), FEELING ABNORMAL (like someone was pulling on his head), RASH VESICULAR (blistering rash), ERYTHEMA (red marks in the opposite side of the elbow where the hand bends), PRURITUS (itching), RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE PAIN (little sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. On 30-Jun-2021, the patient reported that the reaction had subsided with the use of steroidal creams and oils. On 09-Jul-2021, the patient reported that he had had flare up of psoriasis and rashes all over his scalp and mentioned that it looked like he had leprosy. This case was linked to MOD-2021-207737. Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information received included treatment information and outcome of the event. On 09-Jul-2021: Additional information received included additional event.; 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.