chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vomiting
Clinical narrative: After second dose had muscle pain nausea vomiting; After second dose had muscle pain nausea vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (After second dose had muscle pain nausea vomiting) and VOMITING (After second dose had muscle pain nausea vomiting) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Dehydration. Concomitant products included DOXYCYCLINE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-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 MYALGIA (After second dose had muscle pain nausea vomiting) and VOMITING (After second dose had muscle pain nausea vomiting). At the time of the report, MYALGIA (After second dose had muscle pain nausea vomiting) and VOMITING (After second dose had muscle pain nausea vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-387032 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Serious pain on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Serious pain on the right arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C2A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Prostate cancer, Bladder cancer and Hypertension.    On 09-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Serious pain on the right arm). At the time of the report, PAIN IN EXTREMITY (Serious pain on the right arm) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: vertigo/started spinning last night; a little dizzy / super dizzy; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/started spinning last night) and DIZZINESS (a little dizzy / super dizzy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 22-Apr-2021, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced DIZZINESS (a little dizzy / super dizzy). On 14-Nov-2021, the patient experienced VERTIGO (vertigo/started spinning last night). At the time of the report, VERTIGO (vertigo/started spinning last night) and DIZZINESS (a little dizzy / super dizzy) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Malaise, Myalgia
Clinical narrative: Not feeling well; Fever of 100.7; Headache; Chills; Body aches; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), MALAISE (Not feeling well), PYREXIA (Fever of 100.7), HEADACHE (Headache) and CHILLS (Chills) in a 37-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 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm). On 15-Nov-2021, the patient experienced MALAISE (Not feeling well), PYREXIA (Fever of 100.7), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE REACTION (COVID Arm), MALAISE (Not feeling well), PYREXIA (Fever of 100.7), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Nov-2021, Body temperature: 100.7 (High) Fever of 100.7.         No concomitant medications were reported. No treatment medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site reaction
Clinical narrative: Not feeling well; Fever of 100.7; Headache; Chills; Body aches; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), MALAISE (Not feeling well), PYREXIA (Fever of 100.7), HEADACHE (Headache) and CHILLS (Chills) in a 37-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 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm). On 15-Nov-2021, the patient experienced MALAISE (Not feeling well), PYREXIA (Fever of 100.7), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE REACTION (COVID Arm), MALAISE (Not feeling well), PYREXIA (Fever of 100.7), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Nov-2021, Body temperature: 100.7 (High) Fever of 100.7.         No concomitant medications were reported. No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site rash
Clinical narrative: 1 week after my first vaccination I had a rash which covered my injection site arm.; fatigued, tired after her first vaccination; My injection site arm was sore for 3 days after the vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued, tired after her first vaccination), VACCINATION SITE PAIN (My injection site arm was sore for 3 days after the vaccination.) and VACCINATION SITE RASH (1 week after my first vaccination I had a rash which covered my injection site arm.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced FATIGUE (fatigued, tired after her first vaccination) and VACCINATION SITE PAIN (My injection site arm was sore for 3 days after the vaccination.). On 26-Oct-2021, the patient experienced VACCINATION SITE RASH (1 week after my first vaccination I had a rash which covered my injection site arm.). At the time of the report, FATIGUE (fatigued, tired after her first vaccination), VACCINATION SITE PAIN (My injection site arm was sore for 3 days after the vaccination.) and VACCINATION SITE RASH (1 week after my first vaccination I had a rash which covered my injection site arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received contains
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: catching a cold; diarrhea; experienced chills; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (catching a cold), DIARRHOEA (diarrhea), CHILLS (experienced chills), PYREXIA (fever) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034s21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced NASOPHARYNGITIS (catching a cold), DIARRHOEA (diarrhea), CHILLS (experienced chills), PYREXIA (fever) and NAUSEA (nausea). On 13-Nov-2021, NASOPHARYNGITIS (catching a cold), DIARRHOEA (diarrhea), CHILLS (experienced chills), PYREXIA (fever) and NAUSEA (nausea) had resolved.            No Concomitant medications were provided No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-384941 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-384941:Case link to same patient containg dose 1,2 information
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: largest fever blister on their upper lips; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (largest fever blister on their upper lips) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Fever blister. Previously administered products included for Product used for unknown indication: flu vaccine. Past adverse reactions to the above products included Swollen lymph nodes with flu vaccine. Concurrent medical conditions included Overweight (Patient states that they weight about 240 lbs.). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (largest fever blister on their upper lips). The patient was treated with DOCOSANOL (ABREVA) for Fever blister, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (largest fever blister on their upper lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Vitamin (Melaleuca peak performance total health 50+) as concomitant drug product.  Patient took the 2nd dose on 08-Apr-2021and lot no. 028A21A.   This case was linked to MOD-2021-387069 (Patient Link).
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Migraine, Pruritus
Clinical narrative: Migraines severely worsened during the past week/ he's not having 100% relief; Lot of itching; red spots, everywhere in body, forearm, upper arm, thigh, legs, back/ If I scratch it, the area becomes further red/ It keeps coming at different places all the time; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (Migraines severely worsened during the past week/ he's not having 100% relief), PRURITUS (Lot of itching) and ERYTHEMA (red spots, everywhere in body, forearm, upper arm, thigh, legs, back/ If I scratch it, the area becomes further red/ It keeps coming at different places all the time) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (chronic migraines) and Drug allergy (Advil (Ibuprofen)). Concomitant products included METOPROLOL for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced MIGRAINE (Migraines severely worsened during the past week/ he's not having 100% relief), PRURITUS (Lot of itching) and ERYTHEMA (red spots, everywhere in body, forearm, upper arm, thigh, legs, back/ If I scratch it, the area becomes further red/ It keeps coming at different places all the time). The patient was treated with SUMATRIPTAN ongoing since an unknown date for Migraine, at a dose of high dose. At the time of the report, MIGRAINE (Migraines severely worsened during the past week/ he's not having 100% relief), PRURITUS (Lot of itching) and ERYTHEMA (red spots, everywhere in body, forearm, upper arm, thigh, legs, back/ If I scratch it, the area becomes further red/ It keeps coming at different places all the time) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-387043, MOD-2021-387044 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia, Pain in extremity
Clinical narrative: had a lot of pain in his arm/his legs; soreness in his back; chronic soreness throughout his body; he's very very fatigued / very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a lot of pain in his arm/his legs), BACK PAIN (soreness in his back), MYALGIA (chronic soreness throughout his body) and FATIGUE (he's very very fatigued / very tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had a lot of pain in his arm/his legs), BACK PAIN (soreness in his back), MYALGIA (chronic soreness throughout his body) and FATIGUE (he's very very fatigued / very tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (had a lot of pain in his arm/his legs), BACK PAIN (soreness in his back), MYALGIA (chronic soreness throughout his body) and FATIGUE (he's very very fatigued / very tired) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided by the reporter. Other treatment medications include counter pain killers.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dyspnoea, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Extremely sick; Constant diarrhea; Severe stomach pain; Sweating; Shortness of breath; Hands went numb; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Extremely sick), DIARRHOEA (Constant diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), HYPERHIDROSIS (Sweating) and DYSPNOEA (Shortness of breath) in a  patient of an unknown age and gender 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely sick), DIARRHOEA (Constant diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), HYPERHIDROSIS (Sweating), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA (Hands went numb). At the time of the report, ILLNESS (Extremely sick), DIARRHOEA (Constant diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), HYPERHIDROSIS (Sweating), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA (Hands went numb) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Extremely sick; Constant diarrhea; Severe stomach pain; Sweating; Shortness of breath; Hands went numb; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Extremely sick), DIARRHOEA (Constant diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), HYPERHIDROSIS (Sweating) and DYSPNOEA (Shortness of breath) in a  patient of an unknown age and gender 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely sick), DIARRHOEA (Constant diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), HYPERHIDROSIS (Sweating), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA (Hands went numb). At the time of the report, ILLNESS (Extremely sick), DIARRHOEA (Constant diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), HYPERHIDROSIS (Sweating), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA (Hands went numb) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: intermittent fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (intermittent fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 dosage form. On an unknown date, the patient experienced PYREXIA (intermittent fever). At the time of the report, PYREXIA (intermittent fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.  Patient had the Moderna booster (1/2 dose) 20 days ago
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms; Felt feverish; Chills; Felt fatigued; All over body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Felt feverish), CHILLS (Chills), FATIGUE (Felt fatigued) and MYALGIA (All over body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 13-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Felt feverish), CHILLS (Chills), FATIGUE (Felt fatigued) and MYALGIA (All over body aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Felt feverish), CHILLS (Chills), FATIGUE (Felt fatigued) and MYALGIA (All over body aches) was resolving.            No concomitant medications were provided. No treatment medications were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Erythema, Pain, Peripheral swelling
Clinical narrative: Stinging my face; Cheeks were swollen; Like skin was very sensitive to the product; Arm is swollen; Arm is red/cheeks were red; Fever; Chills; Arm was itching; Patient is upset and uncomfortable with the situation; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Arm is red/cheeks were red), PRURITUS (Arm was itching), PAIN (Stinging my face) and SWELLING FACE (Cheeks were swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 032B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS 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 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Arm is red/cheeks were red), PYREXIA (Fever) and CHILLS (Chills). On 15-Nov-2021, the patient experienced PAIN (Stinging my face), SWELLING FACE (Cheeks were swollen) and SENSITIVE SKIN (Like skin was very sensitive to the product). In November 2021, the patient experienced PRURITUS (Arm was itching) and DISCOMFORT (Patient is upset and uncomfortable with the situation). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 10-Nov-2021 for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 13-Nov-2021 for Adverse event, at an unspecified dose and frequency. On 11-Nov-2021, CHILLS (Chills) had resolved. In November 2021, PYREXIA (Fever) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Arm is red/cheeks were red), PRURITUS (Arm was itching), PAIN (Stinging my face), SWELLING FACE (Cheeks were swollen), SENSITIVE SKIN (Like skin was very sensitive to the product) and DISCOMFORT (Patient is upset and uncomfortable with the situation) outcome was unknown.            Relevant concomitant included high blood pressure medicine once a day.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Sensitive skin, Swelling face
Clinical narrative: Stinging my face; Cheeks were swollen; Like skin was very sensitive to the product; Arm is swollen; Arm is red/cheeks were red; Fever; Chills; Arm was itching; Patient is upset and uncomfortable with the situation; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Arm is red/cheeks were red), PRURITUS (Arm was itching), PAIN (Stinging my face) and SWELLING FACE (Cheeks were swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 032B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS 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 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Arm is red/cheeks were red), PYREXIA (Fever) and CHILLS (Chills). On 15-Nov-2021, the patient experienced PAIN (Stinging my face), SWELLING FACE (Cheeks were swollen) and SENSITIVE SKIN (Like skin was very sensitive to the product). In November 2021, the patient experienced PRURITUS (Arm was itching) and DISCOMFORT (Patient is upset and uncomfortable with the situation). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 10-Nov-2021 for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 13-Nov-2021 for Adverse event, at an unspecified dose and frequency. On 11-Nov-2021, CHILLS (Chills) had resolved. In November 2021, PYREXIA (Fever) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Arm is red/cheeks were red), PRURITUS (Arm was itching), PAIN (Stinging my face), SWELLING FACE (Cheeks were swollen), SENSITIVE SKIN (Like skin was very sensitive to the product) and DISCOMFORT (Patient is upset and uncomfortable with the situation) outcome was unknown.            Relevant concomitant included high blood pressure medicine once a day.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site discharge, Vaccination site erythema, Vaccination site vesicles
Clinical narrative: His body became full of rash 2 days; At injection site on left arm, it became very red after 2 to 3 days.; 2 days later, it became like a boil with yellow liquid inside.; The liquid started to come out.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE VESICLES (2 days later, it became like a boil with yellow liquid inside.), VACCINATION SITE DISCHARGE (The liquid started to come out.), RASH (His body became full of rash 2 days) and VACCINATION SITE ERYTHEMA (At injection site on left arm, it became very red after 2 to 3 days.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In October 2021, the patient experienced VACCINATION SITE VESICLES (2 days later, it became like a boil with yellow liquid inside.), VACCINATION SITE DISCHARGE (The liquid started to come out.) and VACCINATION SITE ERYTHEMA (At injection site on left arm, it became very red after 2 to 3 days.). On an unknown date, the patient experienced RASH (His body became full of rash 2 days). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE VESICLES (2 days later, it became like a boil with yellow liquid inside.), VACCINATION SITE DISCHARGE (The liquid started to come out.), RASH (His body became full of rash 2 days) and VACCINATION SITE ERYTHEMA (At injection site on left arm, it became very red after 2 to 3 days.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment indication include topical cream No concomitant medicine were reported by the reporter
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Paraesthesia, Tachycardia
Clinical narrative: Woke up with fast heart rate; Tingling sensation; Fatigue; Chills; Sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Woke up with fast heart rate), PARAESTHESIA (Tingling sensation), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Sore muscles) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 023M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Dehydration. Concomitant products included DOXYCYCLINE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced TACHYCARDIA (Woke up with fast heart rate) and PARAESTHESIA (Tingling sensation). In November 2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Sore muscles). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Woke up with fast heart rate), PARAESTHESIA (Tingling sensation), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Sore muscles) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had receiver her vaccine on left non dominant arm.   This case was linked to MOD-2021-386967 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: The first two shots I got sick, like the flu; I was pretty sick.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (The first two shots I got sick, like the flu) and ILLNESS (I was pretty sick) 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 an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (The first two shots I got sick, like the flu) and ILLNESS (I was pretty sick). At the time of the report, INFLUENZA LIKE ILLNESS (The first two shots I got sick, like the flu) and ILLNESS (I was pretty sick) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported. The patient reported to refer to her own side effects after doses 1 and 2.  The patient was afraid to go get the booster, but she went anyway. The patient reported that she received the booster the day before yesterday of reporting, they gave her half the dose. She did not get sick and did not felt anything.   This case was linked to MOD-2021-027948 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient was given a booster dose instead of a 3rd full dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient was given a booster dose instead of a 3rd full dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 029A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Drug allergy, Drug allergy, Drug allergy, Renal cancer (Currently receiving immune therapy treatment.), Coronary artery disease, Hyperlipidemia and Hypertension.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 15-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient was given a booster dose instead of a 3rd full dose). On 15-Nov-2021, ACCIDENTAL UNDERDOSE (Immunocompromised patient was given a booster dose instead of a 3rd full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  No side effects noted after administration.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Significant follow-up appended - Medical history is added
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lymph node pain, Pain in extremity, Vaccination site pain
Clinical narrative: it's not painful, just annoying; can feel the tenderness on the lymph node area/It's sore, tender; Yesterday the whole right arm was sore ,a little sore; felt a little fatigued; under his right armpit where he got the injection it's a little tender; a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Yesterday the whole right arm was sore ,a little sore), FEELING ABNORMAL (it's not painful, just annoying), FATIGUE (felt a little fatigued), VACCINATION SITE PAIN (under his right armpit where he got the injection it's a little tender) and VACCINATION SITE SWELLING (a little swollen) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 031A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced PAIN IN EXTREMITY (Yesterday the whole right arm was sore ,a little sore), FATIGUE (felt a little fatigued), VACCINATION SITE PAIN (under his right armpit where he got the injection it's a little tender) and VACCINATION SITE SWELLING (a little swollen). On 15-Nov-2021, the patient experienced FEELING ABNORMAL (it's not painful, just annoying) and LYMPH NODE PAIN (can feel the tenderness on the lymph node area/It's sore, tender). On 15-Nov-2021, FATIGUE (felt a little fatigued) had resolved. At the time of the report, PAIN IN EXTREMITY (Yesterday the whole right arm was sore ,a little sore), FEELING ABNORMAL (it's not painful, just annoying), VACCINATION SITE PAIN (under his right armpit where he got the injection it's a little tender), VACCINATION SITE SWELLING (a little swollen) and LYMPH NODE PAIN (can feel the tenderness on the lymph node area/It's sore, tender) outcome was unknown.            No concomitant medication reported.  No treatment information was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: it's not painful, just annoying; can feel the tenderness on the lymph node area/It's sore, tender; Yesterday the whole right arm was sore ,a little sore; felt a little fatigued; under his right armpit where he got the injection it's a little tender; a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Yesterday the whole right arm was sore ,a little sore), FEELING ABNORMAL (it's not painful, just annoying), FATIGUE (felt a little fatigued), VACCINATION SITE PAIN (under his right armpit where he got the injection it's a little tender) and VACCINATION SITE SWELLING (a little swollen) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 031A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced PAIN IN EXTREMITY (Yesterday the whole right arm was sore ,a little sore), FATIGUE (felt a little fatigued), VACCINATION SITE PAIN (under his right armpit where he got the injection it's a little tender) and VACCINATION SITE SWELLING (a little swollen). On 15-Nov-2021, the patient experienced FEELING ABNORMAL (it's not painful, just annoying) and LYMPH NODE PAIN (can feel the tenderness on the lymph node area/It's sore, tender). On 15-Nov-2021, FATIGUE (felt a little fatigued) had resolved. At the time of the report, PAIN IN EXTREMITY (Yesterday the whole right arm was sore ,a little sore), FEELING ABNORMAL (it's not painful, just annoying), VACCINATION SITE PAIN (under his right armpit where he got the injection it's a little tender), VACCINATION SITE SWELLING (a little swollen) and LYMPH NODE PAIN (can feel the tenderness on the lymph node area/It's sore, tender) outcome was unknown.            No concomitant medication reported.  No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever after 2nd shot) and headache (mild headache after 2nd shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 016M20A and 026L20A) for COVID-19  immunization. No medical history reported. On Jan 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 11, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 11, 2021, patient experienced pyrexia (fever after 2nd shot) and headache (mild headache after 2nd shot). Patient treated with Plavix (clopidogrel bisulfate) for adverse event, at an unspecified dose and frequency and Crestor (rosuvastatin calcium) for adverse event, at an unspecified dose and frequency. On Feb 13, 2021, pyrexia (fever after 2nd shot) and headache (mild headache after 2nd shot): resolved. The reporter did not provide any causality assessments or concomitant medication. This case linked to MOD-2021-386996 (patient link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Vaccination complication, Vaccination site pain
Clinical narrative: Just minor problems with the first and second dose; Pain where we had received the shot; Mentioned having chronic migraines; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Just minor problems with the first and second dose), MIGRAINE (Mentioned having chronic migraines) and VACCINATION SITE PAIN (Pain where we had received the shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic migraine and Drug allergy (allergic to Advil (Ibuprofen).). Concomitant products included METOPROLOL TARTRATE (METOPROLOL [METOPROLOL TARTRATE]) for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (Just minor problems with the first and second dose) and VACCINATION SITE PAIN (Pain where we had received the shot). In February 2021, the patient experienced MIGRAINE (Mentioned having chronic migraines). The patient was treated with SUMATRIPTAN for Migraine, at an unspecified dose and frequency. On 06-Feb-2021, VACCINATION COMPLICATION (Just minor problems with the first and second dose) and VACCINATION SITE PAIN (Pain where we had received the shot) had resolved. At the time of the report, MIGRAINE (Mentioned having chronic migraines) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-387017, MOD-2021-387044 (Patient Link).
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Vaccination complication, Vaccination site pain
Clinical narrative: Just minor problems with the first and second dose; Mentioned having chronic migraines; Pain where we had received the shot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Just minor problems with the first and second dose), MIGRAINE (Mentioned having chronic migraines) and VACCINATION SITE PAIN (Pain where we had received the shot) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (HCP is allergic to Advil (Ibuprofen)). Concomitant products included METOPROLOL for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-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 COMPLICATION (Just minor problems with the first and second dose), MIGRAINE (Mentioned having chronic migraines) and VACCINATION SITE PAIN (Pain where we had received the shot). The patient was treated with SUMATRIPTAN for Migraine, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Just minor problems with the first and second dose), MIGRAINE (Mentioned having chronic migraines) and VACCINATION SITE PAIN (Pain where we had received the shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-387043, MOD-2021-387017 (Patient Link).
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Vaccination complication
Clinical narrative: 2  days after receiving 2nd Moderna along with flu shot patient have developed intermittent E; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (2  days after receiving 2nd Moderna along with flu shot patient have developed intermittent E) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    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 and INFLUENZA VACCINE (FLU) (unknown route) at an unspecified dose. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (2  days after receiving 2nd Moderna along with flu shot patient have developed intermittent E). At the time of the report, VACCINATION COMPLICATION (2  days after receiving 2nd Moderna along with flu shot patient have developed intermittent E) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got flu shot along with second dose of Moderna vaccine. No treatment was reported by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: not receiving 2nd dose; didn't feel well; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose) and MALAISE (didn't feel well) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose) and MALAISE (didn't feel well). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose) and MALAISE (didn't feel well) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Non-significant follow-up-received on 16-Nov-2021 and contains NNI
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dysstasia, Insomnia, Mobility decreased, Myalgia
Clinical narrative: bruising behind the left knee; unable to move; "cannot stand up sleep and sit"; "cannot stand up sleep and sit"; "cannot stand up sleep and sit"; muscle pain; This spontaneous case was reported by a physician and describes the occurrence of CONTUSION (bruising behind the left knee), MOBILITY DECREASED (unable to move), DYSSTASIA ("cannot stand up sleep and sit"), SITTING DISABILITY ("cannot stand up sleep and sit") and INSOMNIA ("cannot stand up sleep and sit") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruising behind the left knee), MOBILITY DECREASED (unable to move), DYSSTASIA ("cannot stand up sleep and sit"), SITTING DISABILITY ("cannot stand up sleep and sit"), INSOMNIA ("cannot stand up sleep and sit") and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, CONTUSION (bruising behind the left knee), MOBILITY DECREASED (unable to move), DYSSTASIA ("cannot stand up sleep and sit"), SITTING DISABILITY ("cannot stand up sleep and sit"), INSOMNIA ("cannot stand up sleep and sit") and MYALGIA (muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.