chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash pruritic
Clinical narrative: itchy rash on her lower abdomen and back which has gotten progressively worse; rash is now itching and burning, 12 inches wide by 10 inches hight from side of stomach to lower back with some spots down wtowards bikini line and other parts of torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (itchy rash on her lower abdomen and back which has gotten progressively worse) and BURNING SENSATION (rash is now itching and burning, 12 inches wide by 10 inches hight from side of stomach to lower back with some spots down wtowards bikini line and other parts of torso) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced RASH PRURITIC (itchy rash on her lower abdomen and back which has gotten progressively worse). 23-Apr-2021, the patient experienced BURNING SENSATION (rash is now itching and burning, 12 inches wide by 10 inches hight from side of stomach to lower back with some spots down wtowards bikini line and other parts of torso). At the time of the report, RASH PRURITIC (itchy rash on her lower abdomen and back which has gotten progressively worse) and BURNING SENSATION (rash is now itching and burning, 12 inches wide by 10 inches hight from side of stomach to lower back with some spots down wtowards bikini line and other parts of torso) had not resolved.            Her HCP prescribed prednisone and an unspecified ointment for the rash. She has also been self-treating by applying ice.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Myalgia
Clinical narrative: sore arm; Headache; possible spoiled vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), HEADACHE (Headache) and EXPIRED PRODUCT ADMINISTERED (possible spoiled vaccine administered) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm), HEADACHE (Headache) and EXPIRED PRODUCT ADMINISTERED (possible spoiled vaccine administered). At the time of the report, MYALGIA (sore arm), HEADACHE (Headache) and EXPIRED PRODUCT ADMINISTERED (possible spoiled vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-097962 (E2B Linked Report). This case was linked to MOD-2021-098020 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-097962:Case for patient
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient trying to get 2nd dose at 52 days; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient trying to get 2nd dose at 52 days) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient trying to get 2nd dose at 52 days).        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: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: out of date vaccine given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (out of date vaccine given) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042b21a) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (out of date vaccine given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (out of date vaccine given) outcome was unknown. Not Provided    Treatment medication was not provided.   Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD21-084169 (E2B Linked Report).; Sender's Comments:  MOD21-084169:Cross linked case
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received first shot of Moderna vaccine at age 16 years; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-097800, US-MODERNATX, INC.-MOD-2021-098304 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-097800: US-MODERNATX, INC.-MOD-2021-098304:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: really bad sore arm; headache; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really bad sore arm), CHILLS (chills) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) 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 28-Apr-2021, the patient experienced CHILLS (chills). On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (really bad sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (really bad sore arm), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Pruritus, Urticaria
Clinical narrative: weepy; pruritus; urticaria; covered with hives on the arms, torso, stomach and legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (covered with hives on the arms, torso, stomach and legs), CRYING (weepy), PRURITUS (pruritus) and URTICARIA (urticaria) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (covered with hives on the arms, torso, stomach and legs). On an unknown date, the patient experienced CRYING (weepy), PRURITUS (pruritus) and URTICARIA (urticaria). The patient was treated with Zyrtech at an unspecified dose and frequency. At the time of the report, URTICARIA (covered with hives on the arms, torso, stomach and legs) had resolved and CRYING (weepy), PRURITUS (pruritus) and URTICARIA (urticaria) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was prescribed steroid cream by HCP. patient used Zyrtech as a treatment daily   This case was linked to MOD-2021-098164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: ADR receivedmobole no. updated ,
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain, Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site hot after 2nd dose; Looks like he got punched in the arm after 2nd dose; Pain; Soreness; Huge red spot under where he had shot after 2nd dose; Injection site swollen after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot after 2nd dose), LIMB DISCOMFORT (Looks like he got punched in the arm after 2nd dose), PAIN (Pain), PAIN IN EXTREMITY (Soreness) and VACCINATION SITE ERYTHEMA (Huge red spot under where he had shot after 2nd dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001c21a and 003b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-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 VACCINATION SITE WARMTH (Injection site hot after 2nd dose), LIMB DISCOMFORT (Looks like he got punched in the arm after 2nd dose), PAIN (Pain), PAIN IN EXTREMITY (Soreness), VACCINATION SITE ERYTHEMA (Huge red spot under where he had shot after 2nd dose) and VACCINATION SITE SWELLING (Injection site swollen after 2nd dose). At the time of the report, VACCINATION SITE WARMTH (Injection site hot after 2nd dose), LIMB DISCOMFORT (Looks like he got punched in the arm after 2nd dose), PAIN (Pain), PAIN IN EXTREMITY (Soreness), VACCINATION SITE ERYTHEMA (Huge red spot under where he had shot after 2nd dose) and VACCINATION SITE SWELLING (Injection site swollen after 2nd dose) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   Patient took Anthax vaccine and experienced soreness and redspot.  Action taken in response to mRNA-1273 was considered to be not applicable.   This case was linked to MOD-2021-097969 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up was received on 01-June-2021 and patient demographics and two events ( pain and pain in extremity ) were updated.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site hot after 2nd dose; Looks like he got punched in the arm after 2nd dose; Pain; Soreness; Huge red spot under where he had shot after 2nd dose; Injection site swollen after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot after 2nd dose), LIMB DISCOMFORT (Looks like he got punched in the arm after 2nd dose), PAIN (Pain), PAIN IN EXTREMITY (Soreness) and VACCINATION SITE ERYTHEMA (Huge red spot under where he had shot after 2nd dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001c21a and 003b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-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 VACCINATION SITE WARMTH (Injection site hot after 2nd dose), LIMB DISCOMFORT (Looks like he got punched in the arm after 2nd dose), PAIN (Pain), PAIN IN EXTREMITY (Soreness), VACCINATION SITE ERYTHEMA (Huge red spot under where he had shot after 2nd dose) and VACCINATION SITE SWELLING (Injection site swollen after 2nd dose). At the time of the report, VACCINATION SITE WARMTH (Injection site hot after 2nd dose), LIMB DISCOMFORT (Looks like he got punched in the arm after 2nd dose), PAIN (Pain), PAIN IN EXTREMITY (Soreness), VACCINATION SITE ERYTHEMA (Huge red spot under where he had shot after 2nd dose) and VACCINATION SITE SWELLING (Injection site swollen after 2nd dose) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   Patient took Anthax vaccine and experienced soreness and redspot.  Action taken in response to mRNA-1273 was considered to be not applicable.   This case was linked to MOD-2021-097969 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up was received on 01-June-2021 and patient demographics and two events ( pain and pain in extremity ) were updated.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin reaction
Clinical narrative: Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021; Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) and SKIN REACTION (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) and SKIN REACTION (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021). At the time of the report, RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) and SKIN REACTION (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098528 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098528:2nd dose
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: full body hives; 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 URTICARIA (full body hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced URTICARIA (full body hives). At the time of the report, URTICARIA (full body hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Moderna Covid-19 vaccine at the age of 17 years old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna Covid-19 vaccine at the age of 17 years old) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna Covid-19 vaccine at the age of 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna Covid-19 vaccine at the age of 17 years old) had resolved. Not Provided      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 details were provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Diarrhea; No energy; Nausea; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), ASTHENIA (No energy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 56-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea), ASTHENIA (No energy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, DIARRHA (Diarrhea), ASTHENIA (No energy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 52 days past her first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (52 days past her first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (52 days past her first dose). On 29-Apr-2021, PRODUCT DOSE OMISSION ISSUE (52 days past her first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: was tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (was tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MESALAMINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CALCIUM, Multicomplete                                                  PO OD and AlgaeCal Plus                                                  PO BID for an unknown indication.    On 31-Mar-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 FATIGUE (was tired). Not Provided      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.   This case was linked to MOD-2021-098173 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Vertigo; hot rash near the injection site; itchy rash near the injection site; rash near the injection site; red rash near the injection site; swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), INJECTION SITE WARMTH (hot rash near the injection site), VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (rash near the injection site) and VACCINATION SITE ERYTHEMA (red rash near the injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Vertigo (approximately once every two years). Concomitant products included TELMISARTAN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INJECTION SITE WARMTH (hot rash near the injection site), VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (rash near the injection site), VACCINATION SITE ERYTHEMA (red rash near the injection site) and VACCINATION SITE SWELLING (swollen injection site). On 29-Apr-2021, the patient experienced VERTIGO (Vertigo). On 11-Apr-2021, INJECTION SITE WARMTH (hot rash near the injection site), VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (rash near the injection site), VACCINATION SITE ERYTHEMA (red rash near the injection site) and VACCINATION SITE SWELLING (swollen injection site) had resolved. At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient applied ice to the rash but did not take any medication for vertigo.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; hot rash near the injection site; itchy rash near the injection site; rash near the injection site; red rash near the injection site; swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), INJECTION SITE WARMTH (hot rash near the injection site), VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (rash near the injection site) and VACCINATION SITE ERYTHEMA (red rash near the injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Vertigo (approximately once every two years). Concomitant products included TELMISARTAN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INJECTION SITE WARMTH (hot rash near the injection site), VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (rash near the injection site), VACCINATION SITE ERYTHEMA (red rash near the injection site) and VACCINATION SITE SWELLING (swollen injection site). On 29-Apr-2021, the patient experienced VERTIGO (Vertigo). On 11-Apr-2021, INJECTION SITE WARMTH (hot rash near the injection site), VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (rash near the injection site), VACCINATION SITE ERYTHEMA (red rash near the injection site) and VACCINATION SITE SWELLING (swollen injection site) had resolved. At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient applied ice to the rash but did not take any medication for vertigo.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Constipation
Clinical narrative: Severe Constipation; Stomach issues; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Severe Constipation) and ABDOMINAL DISCOMFORT (Stomach issues) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CONSTIPATION (Severe Constipation) and ABDOMINAL DISCOMFORT (Stomach issues). At the time of the report, CONSTIPATION (Severe Constipation) and ABDOMINAL DISCOMFORT (Stomach issues) outcome was unknown. Not Provided          No concomitant product use was provided by the reporter.  No treatment medication was provided.  After both doses, she experienced severe constipation and stomach issues that went on for weeks. It didn't linger after the first dose but lasted over two weeks after the second dose. It is now back to Normal.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: New AE Added, Both dose details are updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain to hip and knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain to hip and knee) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced ARTHRALGIA (joint pain to hip and knee). At the time of the report, ARTHRALGIA (joint pain to hip and knee) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-098256 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Vomiting
Clinical narrative: vomiting; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (brain fog) and VOMITING (vomiting) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DISTURBANCE IN ATTENTION (brain fog). On an unknown date, the patient experienced VOMITING (vomiting). At the time of the report, DISTURBANCE IN ATTENTION (brain fog) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: mild fatigue 18 hours after injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild fatigue 18 hours after injection) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISOLONE ACETATE, TIMOLOL (BETIMOL [TIMOLOL]) and OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Mar-2021, the patient experienced FATIGUE (mild fatigue 18 hours after injection). On 17-Mar-2021, FATIGUE (mild fatigue 18 hours after injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported/unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Itchiness in right arm at injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Itchiness in right arm at injection site) and FATIGUE in a 56-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Itchiness in right arm at injection site) and FATIGUE. At the time of the report, VACCINATION SITE PAIN (Itchiness in right arm at injection site) and FATIGUE outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported, Treatment medication were not reported   This case was linked to MOD-2021-098206.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: significant F/U received On 12-Aug-2021: Follow up received contains, no new information. On 12-Aug-2021: Non-significant Information. Patient is enquiring about Modern boosters.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Nausea, Vomiting
Clinical narrative: She had nausea as well; Her stomach has been completely messed up; She had been vomiting for 24 hours; She also started with headache with sharp pains in her head; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Her stomach has been completely messed up), VOMITING (She had been vomiting for 24 hours), HEADACHE (She also started with headache with sharp pains in her head) and NAUSEA (She had nausea as well) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RITUXIMAB (RITUXAN) for Rheumatoid arthritis, ELETRIPTAN HYDROBROMIDE (RELPAX) for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Her stomach has been completely messed up), VOMITING (She had been vomiting for 24 hours) and HEADACHE (She also started with headache with sharp pains in her head). On an unknown date, the patient experienced NAUSEA (She had nausea as well). At the time of the report, ABDOMINAL PAIN UPPER (Her stomach has been completely messed up), VOMITING (She had been vomiting for 24 hours), HEADACHE (She also started with headache with sharp pains in her head) and NAUSEA (She had nausea as well) 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 details included  Nausea medicine
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccine area swollen; Vaccine area painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccine area swollen) and VACCINATION SITE PAIN (Vaccine area painful) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccine area swollen) and VACCINATION SITE PAIN (Vaccine area painful). At the time of the report, VACCINATION SITE SWELLING (Vaccine area swollen) and VACCINATION SITE PAIN (Vaccine area painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave expired vaccine to patient; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave expired vaccine to patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 02B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave expired vaccine to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave expired vaccine to patient) outcome was unknown. Not Provided      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 Concomitant medication details provided. No treatment information provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Expired product administered, Illness, Malaise
Clinical narrative: administered vaccine that was "not stored properly"/"room temperature since Monday"; got very ill for a few days; loss of energy; general malaise; nausea; chills; it was "not stored properly", "room temperature since Monday"; administered vaccine that was "not stored properly"/"room temperature since Monday"; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (it was "not stored properly", "room temperature since Monday"), POOR QUALITY PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"), EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"), ILLNESS (got very ill for a few days) and ASTHENIA (loss of energy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (it was "not stored properly", "room temperature since Monday") and POOR QUALITY PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"), ILLNESS (got very ill for a few days), ASTHENIA (loss of energy), MALAISE (general malaise), NAUSEA (nausea) and CHILLS (chills). At the time of the report, PRODUCT STORAGE ERROR (it was "not stored properly", "room temperature since Monday"), POOR QUALITY PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday") and EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday") had resolved and ILLNESS (got very ill for a few days), ASTHENIA (loss of energy), MALAISE (general malaise), NAUSEA (nausea) and CHILLS (chills) outcome was unknown. Not Provided      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 concomitant medication was reported.  No treatment medication was reported .    Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow Up document was received on 01-Jun-2021 which contains Updated outcome of the event as recovered and concomitant medication.; Sender's Comments:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Poor quality product administered, Product storage error
Clinical narrative: administered vaccine that was "not stored properly"/"room temperature since Monday"; got very ill for a few days; loss of energy; general malaise; nausea; chills; it was "not stored properly", "room temperature since Monday"; administered vaccine that was "not stored properly"/"room temperature since Monday"; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (it was "not stored properly", "room temperature since Monday"), POOR QUALITY PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"), EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"), ILLNESS (got very ill for a few days) and ASTHENIA (loss of energy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (it was "not stored properly", "room temperature since Monday") and POOR QUALITY PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"), ILLNESS (got very ill for a few days), ASTHENIA (loss of energy), MALAISE (general malaise), NAUSEA (nausea) and CHILLS (chills). At the time of the report, PRODUCT STORAGE ERROR (it was "not stored properly", "room temperature since Monday"), POOR QUALITY PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday") and EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday") had resolved and ILLNESS (got very ill for a few days), ASTHENIA (loss of energy), MALAISE (general malaise), NAUSEA (nausea) and CHILLS (chills) outcome was unknown. Not Provided      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 concomitant medication was reported.  No treatment medication was reported .    Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow Up document was received on 01-Jun-2021 which contains Updated outcome of the event as recovered and concomitant medication.; Sender's Comments:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: muscle pain; Late night, around 3am, her fever is coming, 100.2F/fever a little bit down after 30 minutes but it come back now; 100.2 F; Around 7pm, a little bit of started the pain around the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Around 7pm, a little bit of started the pain around the shot), MYALGIA (muscle pain) and PYREXIA (Late night, around 3am, her fever is coming, 100.2F/fever a little bit down after 30 minutes but it come back now; 100.2 F) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Product used for unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Around 7pm, a little bit of started the pain around the shot). On 29-Apr-2021, the patient experienced MYALGIA (muscle pain) and PYREXIA (Late night, around 3am, her fever is coming, 100.2F/fever a little bit down after 30 minutes but it come back now; 100.2 F). At the time of the report, VACCINATION SITE PAIN (Around 7pm, a little bit of started the pain around the shot), MYALGIA (muscle pain) and PYREXIA (Late night, around 3am, her fever is coming, 100.2F/fever a little bit down after 30 minutes but it come back now; 100.2 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medications were  ibuprofen and Aleve.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site discomfort
Clinical narrative: discomfort in the arm of the injection; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort in the arm of the injection) and HEADACHE (mild headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Palpitations, Swollen ankles (Left ankle got swollen) and Vein pain (Veins hurt).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (discomfort in the arm of the injection) and HEADACHE (mild headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOMFORT (discomfort in the arm of the injection) and HEADACHE (mild headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.   This case was linked to MOD-2021-098190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up information was received and the reporter information, event outcome were updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, Urticaria
Clinical narrative: covered with hives; rash; ugly, itchy and a purple bump on the right arm which the Health care Provider mentioned as swollen Lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (covered with hives), RASH (rash) and LYMPHADENOPATHY (ugly, itchy and a purple bump on the right arm which the Health care Provider mentioned as swollen Lymph nodes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-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 URTICARIA (covered with hives), RASH (rash) and LYMPHADENOPATHY (ugly, itchy and a purple bump on the right arm which the Health care Provider mentioned as swollen Lymph nodes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK, daily and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (covered with hives), RASH (rash) and LYMPHADENOPATHY (ugly, itchy and a purple bump on the right arm which the Health care Provider mentioned as swollen Lymph nodes) outcome was unknown. Not Provided          Patient had  hives that  were stated as ugly, itchy and a purple bump on the right arm  after the second dose .  Treatment medication included Steroid cream. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-098112 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up information was received and patient demographics was updated.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: weird adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (weird adverse reactions) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (weird adverse reactions). At the time of the report, VACCINATION COMPLICATION (weird adverse reactions) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.