chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Feeling abnormal, Heart rate
Clinical narrative: Nervousness; Altered; Blood pressure was a little low; Had a dizziness while sitting down; Feeling bad; Sudden rise in blood pressure that disrupted her. It went up to 193/14 mmHg and 147 heartbeats; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure was a little low), BLOOD PRESSURE INCREASED (Sudden rise in blood pressure that disrupted her. It went up to 193/14 mmHg and 147 heartbeats), TACHYCARDIA (Tachycardia), DIZZINESS (Had a dizziness while sitting down) and FEELING ABNORMAL (Feeling bad) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03C/KZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Deep vein thrombosis. Concomitant products included APIXABAN (ELIQUIS), ATENOLOL and ATORVASTATIN for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Sudden rise in blood pressure that disrupted her. It went up to 193/14 mmHg and 147 heartbeats), TACHYCARDIA (Tachycardia) and FEELING ABNORMAL (Feeling bad). On 14-Jan-2021, the patient experienced HYPOTENSION (Blood pressure was a little low) and DIZZINESS (Had a dizziness while sitting down). On an unknown date, the patient experienced NERVOUSNESS (Nervousness) and MOOD ALTERED (Altered). On 13-Jan-2021, BLOOD PRESSURE INCREASED (Sudden rise in blood pressure that disrupted her. It went up to 193/14 mmHg and 147 heartbeats) and TACHYCARDIA (Tachycardia) had resolved. On 14-Jan-2021, HYPOTENSION (Blood pressure was a little low) had resolved. At the time of the report, DIZZINESS (Had a dizziness while sitting down) had not resolved and FEELING ABNORMAL (Feeling bad), NERVOUSNESS (Nervousness) and MOOD ALTERED (Altered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 193/14 mmHg. On 13-Jan-2021, Heart rate: 147. On 14-Jan-2021, Blood pressure measurement: 134/78 mmHg. On 14-Jan-2021, Heart rate: 69.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Mood altered, Nervousness, Tachycardia
Clinical narrative: Nervousness; Altered; Blood pressure was a little low; Had a dizziness while sitting down; Feeling bad; Sudden rise in blood pressure that disrupted her. It went up to 193/14 mmHg and 147 heartbeats; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure was a little low), BLOOD PRESSURE INCREASED (Sudden rise in blood pressure that disrupted her. It went up to 193/14 mmHg and 147 heartbeats), TACHYCARDIA (Tachycardia), DIZZINESS (Had a dizziness while sitting down) and FEELING ABNORMAL (Feeling bad) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03C/KZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Deep vein thrombosis. Concomitant products included APIXABAN (ELIQUIS), ATENOLOL and ATORVASTATIN for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Sudden rise in blood pressure that disrupted her. It went up to 193/14 mmHg and 147 heartbeats), TACHYCARDIA (Tachycardia) and FEELING ABNORMAL (Feeling bad). On 14-Jan-2021, the patient experienced HYPOTENSION (Blood pressure was a little low) and DIZZINESS (Had a dizziness while sitting down). On an unknown date, the patient experienced NERVOUSNESS (Nervousness) and MOOD ALTERED (Altered). On 13-Jan-2021, BLOOD PRESSURE INCREASED (Sudden rise in blood pressure that disrupted her. It went up to 193/14 mmHg and 147 heartbeats) and TACHYCARDIA (Tachycardia) had resolved. On 14-Jan-2021, HYPOTENSION (Blood pressure was a little low) had resolved. At the time of the report, DIZZINESS (Had a dizziness while sitting down) had not resolved and FEELING ABNORMAL (Feeling bad), NERVOUSNESS (Nervousness) and MOOD ALTERED (Altered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 193/14 mmHg. On 13-Jan-2021, Heart rate: 147. On 14-Jan-2021, Blood pressure measurement: 134/78 mmHg. On 14-Jan-2021, Heart rate: 69.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Disturbance in attention, Dizziness, Headache
Clinical narrative: shaky; feels weak; could not focus; dizzy; has a headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (shaky), ASTHENIA (feels weak), DISTURBANCE IN ATTENTION (could not focus), DIZZINESS (dizzy) and HEADACHE (has a headache) in a 73-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 information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced NERVOUSNESS (shaky), ASTHENIA (feels weak), DISTURBANCE IN ATTENTION (could not focus), DIZZINESS (dizzy), HEADACHE (has a headache) and CHILLS (chills). At the time of the report, NERVOUSNESS (shaky), ASTHENIA (feels weak), DISTURBANCE IN ATTENTION (could not focus), DIZZINESS (dizzy), HEADACHE (has a headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-008161 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: shaky; feels weak; could not focus; dizzy; has a headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (shaky), ASTHENIA (feels weak), DISTURBANCE IN ATTENTION (could not focus), DIZZINESS (dizzy) and HEADACHE (has a headache) in a 73-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 information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced NERVOUSNESS (shaky), ASTHENIA (feels weak), DISTURBANCE IN ATTENTION (could not focus), DIZZINESS (dizzy), HEADACHE (has a headache) and CHILLS (chills). At the time of the report, NERVOUSNESS (shaky), ASTHENIA (feels weak), DISTURBANCE IN ATTENTION (could not focus), DIZZINESS (dizzy), HEADACHE (has a headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-008161 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot to touch around injection site; arm was sore; arm became red  around injection site; arm became swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (hot to touch around injection site), VACCINATION SITE SWELLING (arm became swollen), VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (arm became red  around injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) and Anxiety. Concurrent medical conditions included Hypersensitivity. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (oesophageal), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, CELECOXIB (CELEXA [CELECOXIB]) for Anxiety, IBUPROFEN.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm became swollen). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch around injection site), VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (arm became red  around injection site). On 07-Jan-2021, VACCINATION SITE SWELLING (arm became swollen) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (hot to touch around injection site), VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (arm became red  around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  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.; 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dyspnoea
Clinical narrative: Loss of taste; Loss of smell; Difficulty Breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DYSPNOEA (Difficulty Breathing). On 10-Jan-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, DYSPNOEA (Difficulty Breathing), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (injection site formed a bump), INJECTION SITE WARMTH (injection site was hot), INJECTION SITE PRURITUS (injection site itches) and INJECTION SITE ERYTHEMA (injection site was red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE MASS (injection site formed a bump), INJECTION SITE WARMTH (injection site was hot), INJECTION SITE PRURITUS (injection site itches) and INJECTION SITE ERYTHEMA (injection site was red). At the time of the report, INJECTION SITE MASS (injection site formed a bump), INJECTION SITE WARMTH (injection site was hot), INJECTION SITE PRURITUS (injection site itches) and INJECTION SITE ERYTHEMA (injection site was red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site hot; Injection site redness; Injection site swelling; Injection site painful; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site painful). At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site painful) 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 product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: welts on hands, wrists, injection site and elbows; itchy; welts were painful; swollen; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welts on hands, wrists, injection site and elbows), PRURITUS (itchy), RASH (welts were painful) and SWELLING (swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (welts on hands, wrists, injection site and elbows), PRURITUS (itchy), RASH (welts were painful) and SWELLING (swollen). At the time of the report, URTICARIA (welts on hands, wrists, injection site and elbows), PRURITUS (itchy), RASH (welts were painful) and SWELLING (swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: No specific follow-up information recorded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Back Ache; Cough; Sore throat; Headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Ache), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and NAUSEA (Nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced BACK PAIN (Back Ache), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, BACK PAIN (Back Ache), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication was reported.   Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Back Ache; Cough; Sore throat; Headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Ache), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and NAUSEA (Nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced BACK PAIN (Back Ache), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, BACK PAIN (Back Ache), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication was reported.   Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Injection site hot; Injection site hard in some places; Injection site size of an orange, red; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE INDURATION (Injection site hard in some places), VACCINATION SITE ERYTHEMA (Injection site size of an orange, red) and VACCINATION SITE PAIN (Arm was sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE INDURATION (Injection site hard in some places), VACCINATION SITE ERYTHEMA (Injection site size of an orange, red) and VACCINATION SITE PAIN (Arm was sore). At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE INDURATION (Injection site hard in some places), VACCINATION SITE ERYTHEMA (Injection site size of an orange, red) and VACCINATION SITE PAIN (Arm was sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Facial pain, Gingival discolouration, Gingival pain, Gingival pruritus
Clinical narrative: upper front tooth (has a crown and post in it) feels traumatized now, extremely painful; headache; gums are itchy; throbbing up to my left nostril; Can't chew food; Face is tender; Gums are red; Gums are painful; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL DISCOLOURATION (Gums are red), GINGIVAL PAIN (Gums are painful), DENTAL DISCOMFORT (upper front tooth (has a crown and post in it) feels traumatized now, extremely painful), MASTICATION DISORDER (Can't chew food) and FACIAL PAIN (Face is tender) in a 68-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.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced GINGIVAL DISCOLOURATION (Gums are red), GINGIVAL PAIN (Gums are painful), MASTICATION DISORDER (Can't chew food) and FACIAL PAIN (Face is tender). On 15-Jan-2021, the patient experienced DENTAL DISCOMFORT (upper front tooth (has a crown and post in it) feels traumatized now, extremely painful), HEADACHE (headache) and GINGIVAL PRURITUS (gums are itchy). At the time of the report, GINGIVAL DISCOLOURATION (Gums are red), GINGIVAL PAIN (Gums are painful), DENTAL DISCOMFORT (upper front tooth (has a crown and post in it) feels traumatized now, extremely painful), MASTICATION DISORDER (Can't chew food) and FACIAL PAIN (Face is tender) had not resolved and HEADACHE (headache) and GINGIVAL PRURITUS (gums are itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mastication disorder, Nasal discomfort
Clinical narrative: upper front tooth (has a crown and post in it) feels traumatized now, extremely painful; headache; gums are itchy; throbbing up to my left nostril; Can't chew food; Face is tender; Gums are red; Gums are painful; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL DISCOLOURATION (Gums are red), GINGIVAL PAIN (Gums are painful), DENTAL DISCOMFORT (upper front tooth (has a crown and post in it) feels traumatized now, extremely painful), MASTICATION DISORDER (Can't chew food) and FACIAL PAIN (Face is tender) in a 68-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.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced GINGIVAL DISCOLOURATION (Gums are red), GINGIVAL PAIN (Gums are painful), MASTICATION DISORDER (Can't chew food) and FACIAL PAIN (Face is tender). On 15-Jan-2021, the patient experienced DENTAL DISCOMFORT (upper front tooth (has a crown and post in it) feels traumatized now, extremely painful), HEADACHE (headache) and GINGIVAL PRURITUS (gums are itchy). At the time of the report, GINGIVAL DISCOLOURATION (Gums are red), GINGIVAL PAIN (Gums are painful), DENTAL DISCOMFORT (upper front tooth (has a crown and post in it) feels traumatized now, extremely painful), MASTICATION DISORDER (Can't chew food) and FACIAL PAIN (Face is tender) had not resolved and HEADACHE (headache) and GINGIVAL PRURITUS (gums are itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Clammy; Temperature of 100 degrees F; Arm was terribly sore; Arm was red; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clammy), VACCINATION SITE PAIN (Arm was terribly sore), VACCINATION SITE ERYTHEMA (Arm was red) and PYREXIA (Temperature of 100 degrees F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OLMESARTAN, ZINC, VITAMIN D NOS, GLUCOSAMINE and ASCORBIC ACID (VITAMIN C FLAVOUR) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was terribly sore) and VACCINATION SITE ERYTHEMA (Arm was red). On 14-Jan-2021, the patient experienced PYREXIA (Temperature of 100 degrees F). On 15-Jan-2021, the patient experienced COLD SWEAT (Clammy). At the time of the report, COLD SWEAT (Clammy), VACCINATION SITE PAIN (Arm was terribly sore), VACCINATION SITE ERYTHEMA (Arm was red) and PYREXIA (Temperature of 100 degrees F) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment reported was Tylenol for fever and some muscle cream for sore arm which both helped.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to touch; Injection site was itching; Redness; Swelling; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site was itching), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Tenderness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SL20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Adrenal insufficiency, Hypothyroidism, Hypertension, Depression, Degenerative bone disease, Sjogren's syndrome and Seasonal allergy. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), HYDROCORTISONE, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and TRAMADOL for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Tenderness). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itching). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site was itching), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Factor V Leiden carrier, Glucose tolerance test, Scan, Ultrasound abdomen
Clinical narrative: 31 weeks pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (31 weeks pregnant) in a 28-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Thrombosis (Superficial blood clot), Spontaneous abortion on 27-Nov-2019 and Depression (Resolved). Concurrent medical conditions included Alcohol use (Alcohol use: 4-5 Drinks per week). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Jun-2020 and the estimated date of delivery was 14-Mar-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (31 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 15-Jan-2021, EXPOSURE DURING PREGNANCY (31 weeks pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Factor V Leiden carrier: normal (normal) not a carrier. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Scan: normal (normal) Anatomy at 20 weeks. On an unknown date, Ultrasound abdomen: normal (normal) normal.     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.   06 Jul 2020, the pregnancy test was positive.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Insomnia, Pain in extremity
Clinical narrative: Tinnitus; Raised bump of the upper back; Trouble sleeping; Sore arm; Fatigue; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus), CONTUSION (Raised bump of the upper back), INSOMNIA (Trouble sleeping), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced INSOMNIA (Trouble sleeping), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache). On 07-Jan-2021, the patient experienced TINNITUS (Tinnitus) and CONTUSION (Raised bump of the upper back). On 08-Jan-2021, INSOMNIA (Trouble sleeping), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. On 11-Jan-2021, CONTUSION (Raised bump of the upper back) had resolved. At the time of the report, TINNITUS (Tinnitus) 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.   Treatment information was not provided. Lab tests were not provided.  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.; 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; Raised bump of the upper back; Trouble sleeping; Sore arm; Fatigue; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus), CONTUSION (Raised bump of the upper back), INSOMNIA (Trouble sleeping), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced INSOMNIA (Trouble sleeping), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache). On 07-Jan-2021, the patient experienced TINNITUS (Tinnitus) and CONTUSION (Raised bump of the upper back). On 08-Jan-2021, INSOMNIA (Trouble sleeping), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. On 11-Jan-2021, CONTUSION (Raised bump of the upper back) had resolved. At the time of the report, TINNITUS (Tinnitus) 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.   Treatment information was not provided. Lab tests were not provided.  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.; 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: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Feeling pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Feeling pain) and PYREXIA (Fever) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Feeling pain) and PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Feeling pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Acetaminophen.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Kind of dizziness that lasted two hours; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Kind of dizziness that lasted two hours) in a 70-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Kind of dizziness that lasted two hours). At the time of the report, DIZZINESS (Kind of dizziness that lasted two hours) had resolved. 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.   Laboratory details not provided. Treatment details were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No New Information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Arm was really really sore; Arm swelling further and further to the point the caller struggled to put on a sweater; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was really really sore), PERIPHERAL SWELLING (Arm swelling further and further to the point the caller struggled to put on a sweater) and HEADACHE (Headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was really really sore), PERIPHERAL SWELLING (Arm swelling further and further to the point the caller struggled to put on a sweater) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm was really really sore), PERIPHERAL SWELLING (Arm swelling further and further to the point the caller struggled to put on a sweater) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm all swollen up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm all swollen up) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm all swollen up). At the time of the report, PERIPHERAL SWELLING (Arm all swollen up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event,  a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,  a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site was itchy; Injection site was swollen; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events included none. No consultation with Healthcare professional done.  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.; 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Confusional state, Palpitations
Clinical narrative: Heart racing; Stomach ache; Weakness; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Stomach ache), ASTHENIA (Weakness) and CONFUSIONAL STATE (Confusion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Stomach ache), ASTHENIA (Weakness) and CONFUSIONAL STATE (Confusion). At the time of the report, PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Stomach ache) and CONFUSIONAL STATE (Confusion) outcome was unknown and ASTHENIA (Weakness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not used. Treatment medication was not used. The patient did not remember all the symptoms.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (if touches the arm it might kind of hurt) 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 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (if touches the arm it might kind of hurt). At the time of the report, PAIN IN EXTREMITY (if touches the arm it might kind of hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No laboratory data was provided. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: vaccination site erythema; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (arm got red again) 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 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced ERYTHEMA (arm got red again). At the time of the report, ERYTHEMA (arm got red again) 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.   No treatment information and concomitant medications provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.