chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting very badly; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting very badly) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included INSULIN for Diabetes mellitus.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VOMITING (Vomiting very badly). At the time of the report, VOMITING (Vomiting very badly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 65 days ago; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 65 days ago) in an 87-year-old male patient who received mRNA-1273 (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL HCL for Blood pressure, LOVASTATIN for Cholesterol, OMEPRAZOLE for GERD, PREDNISONE and MIRTAZAPINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 65 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 65 days ago) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment details provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Headache, Hyperhidrosis, Lymphadenopathy
Clinical narrative: felt like she was burning up; was soaking wet; dry heaving; aches and pains like a really bad flu; horrible, pounding headache; vomiting a little; fever with temperature readings of 99, 101, 103, and 103.5; arm is a little swollen around the injection site; lymph nodes swollen in both arms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt like she was burning up), HYPERHIDROSIS (was soaking wet), RETCHING (dry heaving), PAIN (aches and pains like a really bad flu) and HEADACHE (horrible, pounding headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE and LOSARTAN for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced FEELING HOT (felt like she was burning up), HYPERHIDROSIS (was soaking wet), RETCHING (dry heaving), PAIN (aches and pains like a really bad flu), HEADACHE (horrible, pounding headache), VOMITING (vomiting a little), PYREXIA (fever with temperature readings of 99, 101, 103, and 103.5), VACCINATION SITE SWELLING (arm is a little swollen around the injection site) and LYMPHADENOPATHY (lymph nodes swollen in both arms). On 29-Apr-2021, FEELING HOT (felt like she was burning up), HYPERHIDROSIS (was soaking wet), RETCHING (dry heaving), PAIN (aches and pains like a really bad flu), HEADACHE (horrible, pounding headache), VOMITING (vomiting a little) and PYREXIA (fever with temperature readings of 99, 101, 103, and 103.5) had resolved. At the time of the report, VACCINATION SITE SWELLING (arm is a little swollen around the injection site) and LYMPHADENOPATHY (lymph nodes swollen in both arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 99 (High) 99, 101 (High) 101, 103 (High) 103 and 103.5 (High) 103.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04-JUN-2021, Patient demography updated, reporter details updated, 1st dose date corrected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Retching, Vaccination site swelling, Vomiting
Clinical narrative: felt like she was burning up; was soaking wet; dry heaving; aches and pains like a really bad flu; horrible, pounding headache; vomiting a little; fever with temperature readings of 99, 101, 103, and 103.5; arm is a little swollen around the injection site; lymph nodes swollen in both arms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt like she was burning up), HYPERHIDROSIS (was soaking wet), RETCHING (dry heaving), PAIN (aches and pains like a really bad flu) and HEADACHE (horrible, pounding headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE and LOSARTAN for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced FEELING HOT (felt like she was burning up), HYPERHIDROSIS (was soaking wet), RETCHING (dry heaving), PAIN (aches and pains like a really bad flu), HEADACHE (horrible, pounding headache), VOMITING (vomiting a little), PYREXIA (fever with temperature readings of 99, 101, 103, and 103.5), VACCINATION SITE SWELLING (arm is a little swollen around the injection site) and LYMPHADENOPATHY (lymph nodes swollen in both arms). On 29-Apr-2021, FEELING HOT (felt like she was burning up), HYPERHIDROSIS (was soaking wet), RETCHING (dry heaving), PAIN (aches and pains like a really bad flu), HEADACHE (horrible, pounding headache), VOMITING (vomiting a little) and PYREXIA (fever with temperature readings of 99, 101, 103, and 103.5) had resolved. At the time of the report, VACCINATION SITE SWELLING (arm is a little swollen around the injection site) and LYMPHADENOPATHY (lymph nodes swollen in both arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 99 (High) 99, 101 (High) 101, 103 (High) 103 and 103.5 (High) 103.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04-JUN-2021, Patient demography updated, reporter details updated, 1st dose date corrected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy menstrual bleeding with heavy clotting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding with heavy clotting) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE from 03-Mar-2021 to an unknown date for Allergy, DESOGESTREL, ETHINYLESTRADIOL (ISIBLOOM) from 12-Jan-1996 to an unknown date for Birth control, ACYCLOVIR [ACICLOVIR] from 12-Jan-1996 to an unknown date for Herpes NOS, MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) from 06-Jan-2018 to an unknown date for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021 at 5:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding with heavy clotting). On 06-May-2021, HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding with heavy clotting) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received, reporter information, height, weight, pregnant information, ethnic group, race, allergy, concomitant medications, patient had a prior history and event stop date added and event outcome updated.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported. Treatment medication was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain in extremity
Clinical narrative: sore arm down to elbow; Sick feeling after first dose; Delayed Muscle soreness in leg down to knee; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm down to elbow), MALAISE (Sick feeling after first dose) and MYALGIA (Delayed Muscle soreness in leg down to knee) in a 79-year-old male patient who received mRNA-1273 (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (unknown route) at an unspecified dose. On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm down to elbow), MALAISE (Sick feeling after first dose) and MYALGIA (Delayed Muscle soreness in leg down to knee). At the time of the report, PAIN IN EXTREMITY (sore arm down to elbow), MALAISE (Sick feeling after first dose) and MYALGIA (Delayed Muscle soreness in leg down to knee) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) and mRNA-1273 (Unknown Route) was unknown.       concomitant medications were not reported
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Fast heartbeat; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heartbeat) and PYREXIA (Fever). At the time of the report, HEART RATE INCREASED (Fast heartbeat) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dark circles under eyes, Diplopia, Headache, Inappropriate affect
Clinical narrative: shadows around her eyes; giggling for 1 hour; double vision; Hedd rash; fever; chills; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of DARK CIRCLES UNDER EYES (shadows around her eyes), INAPPROPRIATE AFFECT (giggling for 1 hour), DIPLOPIA (double vision), RASH (Hedd rash) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced DARK CIRCLES UNDER EYES (shadows around her eyes), INAPPROPRIATE AFFECT (giggling for 1 hour), DIPLOPIA (double vision), RASH (Hedd rash), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (headache). At the time of the report, DARK CIRCLES UNDER EYES (shadows around her eyes), INAPPROPRIATE AFFECT (giggling for 1 hour), DIPLOPIA (double vision), RASH (Hedd rash), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication listed.  No treatment reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: shadows around her eyes; giggling for 1 hour; double vision; Hedd rash; fever; chills; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of DARK CIRCLES UNDER EYES (shadows around her eyes), INAPPROPRIATE AFFECT (giggling for 1 hour), DIPLOPIA (double vision), RASH (Hedd rash) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced DARK CIRCLES UNDER EYES (shadows around her eyes), INAPPROPRIATE AFFECT (giggling for 1 hour), DIPLOPIA (double vision), RASH (Hedd rash), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (headache). At the time of the report, DARK CIRCLES UNDER EYES (shadows around her eyes), INAPPROPRIATE AFFECT (giggling for 1 hour), DIPLOPIA (double vision), RASH (Hedd rash), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication listed.  No treatment reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Cough, Feeling abnormal, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (Issue with lungs exacerbated after second shot), CONDITION AGGRAVATED (Issue with lungs exacerbated after second shot), COUGH (Coughing a lot/ There is nothing that comes up when she coughs), PAIN IN EXTREMITY (Pain in her arm) and PAIN (Pain that lasted the whole day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was sick with flu like symptoms, flu, high temperature) in December 2019 and Voicelessness (Voice was gone all of a sudden for a week.). Concurrent medical conditions included Lyme disease, Asthma and Pulmonary function impairment (Lost lung capacity and not been able to sing.) since 2019. Concomitant products included LEVOTHYROXINE and LORATADINE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced LUNG DISORDER (Issue with lungs exacerbated after second shot), CONDITION AGGRAVATED (Issue with lungs exacerbated after second shot), COUGH (Coughing a lot/ There is nothing that comes up when she coughs), PAIN IN EXTREMITY (Pain in her arm), PAIN (Pain that lasted the whole day), FEELING ABNORMAL (Did not feel good at all/Felt like a mini case of COVID.), PYREXIA (The second shot gave her a temperature/ highest her temperature got was 100.8), MYALGIA (Pain in muscles was for 24 hours) and HEADACHE (Headache that lasted for three days). On 29-Apr-2021, MYALGIA (Pain in muscles was for 24 hours) had resolved. On 30-Apr-2021, HEADACHE (Headache that lasted for three days) had resolved. At the time of the report, LUNG DISORDER (Issue with lungs exacerbated after second shot), CONDITION AGGRAVATED (Issue with lungs exacerbated after second shot), COUGH (Coughing a lot/ There is nothing that comes up when she coughs), PAIN IN EXTREMITY (Pain in her arm), FEELING ABNORMAL (Did not feel good at all/Felt like a mini case of COVID.) and PYREXIA (The second shot gave her a temperature/ highest her temperature got was 100.8) outcome was unknown and PAIN (Pain that lasted the whole day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 100.8 (High) 100.8.         Other concomitant products included inhaler and A-L Complex.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (Issue with lungs exacerbated after second shot), CONDITION AGGRAVATED (Issue with lungs exacerbated after second shot), COUGH (Coughing a lot/ There is nothing that comes up when she coughs), PAIN IN EXTREMITY (Pain in her arm) and PAIN (Pain that lasted the whole day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was sick with flu like symptoms, flu, high temperature) in December 2019 and Voicelessness (Voice was gone all of a sudden for a week.). Concurrent medical conditions included Lyme disease, Asthma and Pulmonary function impairment (Lost lung capacity and not been able to sing.) since 2019. Concomitant products included LEVOTHYROXINE and LORATADINE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced LUNG DISORDER (Issue with lungs exacerbated after second shot), CONDITION AGGRAVATED (Issue with lungs exacerbated after second shot), COUGH (Coughing a lot/ There is nothing that comes up when she coughs), PAIN IN EXTREMITY (Pain in her arm), PAIN (Pain that lasted the whole day), FEELING ABNORMAL (Did not feel good at all/Felt like a mini case of COVID.), PYREXIA (The second shot gave her a temperature/ highest her temperature got was 100.8), MYALGIA (Pain in muscles was for 24 hours) and HEADACHE (Headache that lasted for three days). On 29-Apr-2021, MYALGIA (Pain in muscles was for 24 hours) had resolved. On 30-Apr-2021, HEADACHE (Headache that lasted for three days) had resolved. At the time of the report, LUNG DISORDER (Issue with lungs exacerbated after second shot), CONDITION AGGRAVATED (Issue with lungs exacerbated after second shot), COUGH (Coughing a lot/ There is nothing that comes up when she coughs), PAIN IN EXTREMITY (Pain in her arm), FEELING ABNORMAL (Did not feel good at all/Felt like a mini case of COVID.) and PYREXIA (The second shot gave her a temperature/ highest her temperature got was 100.8) outcome was unknown and PAIN (Pain that lasted the whole day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 100.8 (High) 100.8.         Other concomitant products included inhaler and A-L Complex.  No treatment information was provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose over 65 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose over 65 days) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose over 65 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose over 65 days) had resolved.            No treatment related information has been reported.  Patient had no symptoms and patient did not take any medications on daily basis.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Injection site pain
Clinical narrative: vaccine administered from a punctured vial that stayed in the refrigerator for 14hs; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered from a punctured vial that stayed in the refrigerator for 14hs) and INJECTION SITE PAIN (injection site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered from a punctured vial that stayed in the refrigerator for 14hs) and INJECTION SITE PAIN (injection site pain). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered from a punctured vial that stayed in the refrigerator for 14hs) and INJECTION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product was reported   No treatment information was reported   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site mass
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (large bump under the vaccinated arm) and HEADACHE (headache) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.   On 29-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (large bump under the vaccinated arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (large bump under the vaccinated arm) and HEADACHE (headache) outcome was unknown.      Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Heat and redness at  the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (Heat and redness at  the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001653) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Heat and redness at  the injection site). On 26-Apr-2021, VACCINATION SITE ERYTHEMA (Heat and redness at  the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported. Treatment medication was not provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: sore arm like normal; Received dose and is 17 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose and is 17 years old) and PAIN IN EXTREMITY (sore arm like normal) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00157606) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose and is 17 years old). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm like normal). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose and is 17 years old) had resolved and PAIN IN EXTREMITY (sore arm like normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided  No treatment product information was provided  Patient confirmed that she has been trying to schedule second dose, but no one will administer it. She wonders if she should switch over to Pfizer to get the remaining dose because the second dose might go past the 42 days.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Influenza, Pain in extremity
Clinical narrative: very sick; flu; arm is still in pain for more than 2 weeks now; chills; so tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), INFLUENZA (flu), PAIN IN EXTREMITY (arm is still in pain for more than 2 weeks now), CHILLS (chills) and FATIGUE (so tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016BNA) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced ILLNESS (very sick), INFLUENZA (flu), PAIN IN EXTREMITY (arm is still in pain for more than 2 weeks now), CHILLS (chills) and FATIGUE (so tired). At the time of the report, ILLNESS (very sick), INFLUENZA (flu), PAIN IN EXTREMITY (arm is still in pain for more than 2 weeks now), CHILLS (chills) and FATIGUE (so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was taken for the events. Concomitant medications included unspecified vitamins.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted
Clinical narrative: Unable to receive 2nd dose- is in another country; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Unable to receive 2nd dose- is in another country) in a 57-year-old female patient who received mRNA-1273 (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Unable to receive 2nd dose- is in another country). On 30-Apr-2021, PRODUCT ADMINISTRATION INTERRUPTED (Unable to receive 2nd dose- is in another country) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment medication was provided  No concomitant medication was provided
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Delayed 2.5 inch circular red rash around the injection site; rash was red; red area was a little warm to the touch; red area was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Delayed 2.5 inch circular red rash around the injection site), VACCINATION SITE ERYTHEMA (rash was red), VACCINATION SITE WARMTH (red area was a little warm to the touch) and VACCINATION SITE PRURITUS (red area was itchy) in a 38-year-old female patient who received mRNA-1273 (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE RASH (Delayed 2.5 inch circular red rash around the injection site), VACCINATION SITE ERYTHEMA (rash was red), VACCINATION SITE WARMTH (red area was a little warm to the touch) and VACCINATION SITE PRURITUS (red area was itchy). At the time of the report, VACCINATION SITE RASH (Delayed 2.5 inch circular red rash around the injection site), VACCINATION SITE ERYTHEMA (rash was red), VACCINATION SITE WARMTH (red area was a little warm to the touch) and VACCINATION SITE PRURITUS (red area was itchy) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Med Info Agent: Moderna transfer case.  Caller said she received a vaccine 8 days ago, 22apr21, and she had a red spot on her arm.  Caller said she had a 2.5 inch circle around the injection site.  Callers first dose was on 22apr21, LOT#044B21A.  Caller said she had the Covid virus in late december, early january.  Caller said her rash was red, a little warm to the touch and a little itchy.  Caller was  concerned because the rash was delayed by a few days after the injection.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Palpitations, Pruritus, Rash, Vaccination site pruritus
Clinical narrative: Itching Injection Site; Itching on lower legs and scalp; Palpitations; Hypersensitivity reaction; Rash over inside of both arms, and chest, and mid-back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching Injection Site), PRURITUS (Itching on lower legs and scalp), PALPITATIONS (Palpitations), HYPERSENSITIVITY (Hypersensitivity reaction) and RASH (Rash over inside of both arms, and chest, and mid-back) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever. Concurrent medical conditions included Pollen allergy (sneezing, runny nose) since May 1966. Concomitant products included ACETAMINOPHEN, SILDENAFIL, METRONIDAZOLE and PROBIOTIC 10 for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (Itching on lower legs and scalp), PALPITATIONS (Palpitations), HYPERSENSITIVITY (Hypersensitivity reaction) and RASH (Rash over inside of both arms, and chest, and mid-back). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching Injection Site). The patient was treated with HYDROCORTISONE for Rash and Itching, at an unspecified dose and frequency. On 25-Apr-2021, VACCINATION SITE PRURITUS (Itching Injection Site) had resolved. In May 2021, PRURITUS (Itching on lower legs and scalp), PALPITATIONS (Palpitations), HYPERSENSITIVITY (Hypersensitivity reaction) and RASH (Rash over inside of both arms, and chest, and mid-back) had resolved.            Additional treatment medication included lotions (unspecified).   This case was linked to MOD-2021-033612 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Updated event details, outcome, suspect product details and concomitant medications.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Hypersensitivity, Injection site pain, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swollen arm), hypersensitivity (allergic reaction), pruritus (itchy burn), erythema (red arm) and myalgia (muscle pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016T21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Apr 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 24, 2021, patient experienced myalgia (muscle pain), chills, pyrexia (fever) and injection site pain. On May 1, 2021, patient experienced peripheral swelling (swollen arm), hypersensitivity (allergic reaction) and erythema (red arm). On May 2, 2021, patient experienced pruritus (itchy burn). The patient treated with Tylenol (paracetamol) at an unspecified dose and frequency. On Apr 27, 2021, myalgia (muscle pain), chills and pyrexia (fever) outcome: unknown. At the time of the report, peripheral swelling (swollen arm), hypersensitivity (allergic reaction), pruritus (itchy burn), erythema (red arm) and injection site pain outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication details reported. Reporter did not allow further contact.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swollen arm), hypersensitivity (allergic reaction), pruritus (itchy burn), erythema (red arm) and myalgia (muscle pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016T21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Apr 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 24, 2021, patient experienced myalgia (muscle pain), chills, pyrexia (fever) and injection site pain. On May 1, 2021, patient experienced peripheral swelling (swollen arm), hypersensitivity (allergic reaction) and erythema (red arm). On May 2, 2021, patient experienced pruritus (itchy burn). The patient treated with Tylenol (paracetamol) at an unspecified dose and frequency. On Apr 27, 2021, myalgia (muscle pain), chills and pyrexia (fever) outcome: unknown. At the time of the report, peripheral swelling (swollen arm), hypersensitivity (allergic reaction), pruritus (itchy burn), erythema (red arm) and injection site pain outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication details reported. Reporter did not allow further contact.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pain
Clinical narrative: itchiness; rash on hands and forearm; arm soreness; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (arm soreness), PRURITUS (itchiness) and RASH (rash on hands and forearm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hair dye sensitivity and Hay fever. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for Enlarged prostate.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 03-Mar-2021, the patient experienced PRURITUS (itchiness) and RASH (rash on hands and forearm). On 04-Mar-2021, VACCINATION SITE PAIN (arm soreness) had resolved. At the time of the report, PRURITUS (itchiness) and RASH (rash on hands and forearm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included an unspecified steroid pack which made the patient feel better, but the symptoms did not go away.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Insomnia, Pain, Pain in extremity
Clinical narrative: Very itchy/itch all over body; Very painful on the left arm; Hard to sleep at night; Burning sensation; Redness on the left arm; swollen; Painful poking from the inside; little bumby; Rash appeared on same arm (left arm)/rash all over the body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very itchy/itch all over body), PAIN IN EXTREMITY (Very painful on the left arm), INSOMNIA (Hard to sleep at night), BURNING SENSATION (Burning sensation) and ERYTHEMA (Redness on the left arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Flu shot. Concurrent medical conditions included Allergy to edible fungus (Allergy to mushroom.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PRURITUS (Very itchy/itch all over body), PAIN IN EXTREMITY (Very painful on the left arm), INSOMNIA (Hard to sleep at night), BURNING SENSATION (Burning sensation), ERYTHEMA (Redness on the left arm), SWELLING (swollen), PAIN (Painful poking from the inside), URTICARIA (little bumby) and RASH (Rash appeared on same arm (left arm)/rash all over the body). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, PRURITUS (Very itchy/itch all over body), PAIN IN EXTREMITY (Very painful on the left arm), INSOMNIA (Hard to sleep at night), BURNING SENSATION (Burning sensation), ERYTHEMA (Redness on the left arm), SWELLING (swollen), PAIN (Painful poking from the inside), URTICARIA (little bumby) and RASH (Rash appeared on same arm (left arm)/rash all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also included Hydrolyzed HCL. No concomitant Products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09 Jun 2021, contained completed vaccine hypersensitivity/anaphylaxis follow-up form. Updates to vaccine history, events and treatment information.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Very itchy/itch all over body; Very painful on the left arm; Hard to sleep at night; Burning sensation; Redness on the left arm; swollen; Painful poking from the inside; little bumby; Rash appeared on same arm (left arm)/rash all over the body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very itchy/itch all over body), PAIN IN EXTREMITY (Very painful on the left arm), INSOMNIA (Hard to sleep at night), BURNING SENSATION (Burning sensation) and ERYTHEMA (Redness on the left arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Flu shot. Concurrent medical conditions included Allergy to edible fungus (Allergy to mushroom.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PRURITUS (Very itchy/itch all over body), PAIN IN EXTREMITY (Very painful on the left arm), INSOMNIA (Hard to sleep at night), BURNING SENSATION (Burning sensation), ERYTHEMA (Redness on the left arm), SWELLING (swollen), PAIN (Painful poking from the inside), URTICARIA (little bumby) and RASH (Rash appeared on same arm (left arm)/rash all over the body). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, PRURITUS (Very itchy/itch all over body), PAIN IN EXTREMITY (Very painful on the left arm), INSOMNIA (Hard to sleep at night), BURNING SENSATION (Burning sensation), ERYTHEMA (Redness on the left arm), SWELLING (swollen), PAIN (Painful poking from the inside), URTICARIA (little bumby) and RASH (Rash appeared on same arm (left arm)/rash all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also included Hydrolyzed HCL. No concomitant Products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09 Jun 2021, contained completed vaccine hypersensitivity/anaphylaxis follow-up form. Updates to vaccine history, events and treatment information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm at the site of injection; Itching around the same area; Small rash around that same area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itching around the same area) and VACCINATION SITE RASH (Small rash around that same area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and METFORMIN for an unknown indication.   On 27-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itching around the same area) and VACCINATION SITE RASH (Small rash around that same area). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (Warm at the site of injection), VACCINATION SITE PRURITUS (Itching around the same area) and VACCINATION SITE RASH (Small rash around that same area) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Upon internal review on 16 Jun 2021, the patient age was captured as unknown.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Fatigue, Feeling cold, Hyperhidrosis, Insomnia
Clinical narrative: Huge rash on left arm a little below injection site; felt fatigued; up all night; could not control her body temperature; freezing cold, yet sweating at the same time; freezing cold, yet sweating at the same time; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE ABNORMAL (could not control her body temperature), FEELING COLD (freezing cold, yet sweating at the same time), HYPERHIDROSIS (freezing cold, yet sweating at the same time), INSOMNIA (up all night) and RASH (Huge rash on left arm a little below injection site) in a female patient of an unknown age 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 COVID-19 in February 2020 and COVID-19 from 11-Apr-2021 to 25-Apr-2021.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced BODY TEMPERATURE ABNORMAL (could not control her body temperature), FEELING COLD (freezing cold, yet sweating at the same time) and HYPERHIDROSIS (freezing cold, yet sweating at the same time). On 29-Apr-2021, the patient experienced INSOMNIA (up all night). On 30-Apr-2021, the patient experienced RASH (Huge rash on left arm a little below injection site) and FATIGUE (felt fatigued). On 28-Apr-2021, BODY TEMPERATURE ABNORMAL (could not control her body temperature), FEELING COLD (freezing cold, yet sweating at the same time) and HYPERHIDROSIS (freezing cold, yet sweating at the same time) had resolved. At the time of the report, INSOMNIA (up all night), RASH (Huge rash on left arm a little below injection site) and FATIGUE (felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator .No treatment medications provided by the reporter.  Caller stated she would  ask HCP about putting some cortisone cream.  Action taken with mRNA-1273 in response to events was not applicable.