chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: swelling of throat; bad headache; swelling of lymph nodes; general fatigue; feeling of chills; being under the weather; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (being under the weather), PHARYNGEAL SWELLING (swelling of throat), FATIGUE (general fatigue), CHILLS (feeling of chills) and HEADACHE (bad headache) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MALAISE (being under the weather), FATIGUE (general fatigue) and CHILLS (feeling of chills). On 23-Dec-2021, the patient experienced PHARYNGEAL SWELLING (swelling of throat), HEADACHE (bad headache) and LYMPHADENOPATHY (swelling of lymph nodes). At the time of the report, MALAISE (being under the weather), PHARYNGEAL SWELLING (swelling of throat), FATIGUE (general fatigue), CHILLS (feeling of chills), HEADACHE (bad headache) and LYMPHADENOPATHY (swelling of lymph nodes) was resolving.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient was on day 5 and patient still recovering.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: and in that facility they gave him another shot of the Moderna Covid19 Vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (and in that facility they gave him another shot of the Moderna Covid19 Vaccine.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 025J20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia (He had dementia since before the Moderna Covid19 Vaccine.).   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (and in that facility they gave him another shot of the Moderna Covid19 Vaccine.). On 25-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (and in that facility they gave him another shot of the Moderna Covid19 Vaccine.) had resolved.            Concomitant medications were not provided by reporter. It was reported that, after 2 doses, patient went to primary facility for a foot exam, when asked for the reason of the foot exam was because he needed a pedicure. Treatment information were not provided by reporter.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Vaccination site pain
Clinical narrative: Problem with his arm / The pain is 9 out of 10- almost 10; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Problem with his arm / The pain is 9 out of 10- almost 10) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041421A, 45B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced VACCINATION SITE PAIN (Problem with his arm / The pain is 9 out of 10- almost 10). At the time of the report, VACCINATION SITE PAIN (Problem with his arm / The pain is 9 out of 10- almost 10) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, Pain assessment (Unknown-10): 9 (High) 9 out of 10- almost 10.         No concomitant medication and treatment medication reported. Paitent did not blame the booster, but paitent could not  move his arm of injection (left). Three weeks later, he was still having problem with the arm; paitent could not  comb hair, paitent could not  sleep, Paitent was having a bad pain. Paitent doctor gave him a referral to get an Xray, but he has not gone back to see the doctor due to the holidays.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to a 16 year old age; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04IB2IA and 04IB2IA) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age). On 19-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old age) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-288020 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient of 16 years old received 2 doses of the Moderna COVID19  vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient of 16 years old received 2 doses of the Moderna COVID19  vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient of 16 years old received 2 doses of the Moderna COVID19  vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient of 16 years old received 2 doses of the Moderna COVID19  vaccine) had resolved.            No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-428400 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Injection site bruising, Injection site discolouration, Injection site erythema
Clinical narrative: First day after injection soreness, light swelling and redness of injection site. By the second day swelling and redness had spread. Tenderness of site was more pronounced followed with itchy skin. By the third day the injection site redness and swelling had started to spread around the top part of the arm starting to go under armpit area still having tenderness and itching of skin. By the fourth day the swelling and redness had increased to the point the arm was extremely tender and felt hard.  I saw  fit to go to urgent care at this point to be on the precautionary side due to the extreme discomfort and limited mobility due to swelling. Doctor informed me I was having a reaction to the vaccination I received and suggested that I do not get the second dose because the reaction could be more severe.  I was prescribed a steroid to take. After roughly a week the swelling had went down significantly and the itching was not as prominent  however there is now a bruise like discoloration of the skin at the injection site.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Limb discomfort, Mobility decreased, Oedema peripheral
Clinical narrative: First day after injection soreness, light swelling and redness of injection site. By the second day swelling and redness had spread. Tenderness of site was more pronounced followed with itchy skin. By the third day the injection site redness and swelling had started to spread around the top part of the arm starting to go under armpit area still having tenderness and itching of skin. By the fourth day the swelling and redness had increased to the point the arm was extremely tender and felt hard.  I saw  fit to go to urgent care at this point to be on the precautionary side due to the extreme discomfort and limited mobility due to swelling. Doctor informed me I was having a reaction to the vaccination I received and suggested that I do not get the second dose because the reaction could be more severe.  I was prescribed a steroid to take. After roughly a week the swelling had went down significantly and the itching was not as prominent  however there is now a bruise like discoloration of the skin at the injection site.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Vaccination complication
Clinical narrative: First day after injection soreness, light swelling and redness of injection site. By the second day swelling and redness had spread. Tenderness of site was more pronounced followed with itchy skin. By the third day the injection site redness and swelling had started to spread around the top part of the arm starting to go under armpit area still having tenderness and itching of skin. By the fourth day the swelling and redness had increased to the point the arm was extremely tender and felt hard.  I saw  fit to go to urgent care at this point to be on the precautionary side due to the extreme discomfort and limited mobility due to swelling. Doctor informed me I was having a reaction to the vaccination I received and suggested that I do not get the second dose because the reaction could be more severe.  I was prescribed a steroid to take. After roughly a week the swelling had went down significantly and the itching was not as prominent  however there is now a bruise like discoloration of the skin at the injection site.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Cellulitis, Cough, SARS-CoV-2 test positive
Clinical narrative: Pt received 2 doses of COVID19 vaccine in summer 2021 (but pt can't recall which vaccine and when exactly he received the two doses). Admitted for RLE cellulitis, incidentally covid positive with mild cough symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Axillary pain, Pain, Pain in extremity
Clinical narrative: arm pain; felling achy; had a little bit of pain under their armpit; received a third full dose instead of a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PAIN (felling achy), AXILLARY PAIN (had a little bit of pain under their armpit) and ACCIDENTAL OVERDOSE (received a third full dose instead of a booster dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 001B21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to epinephrine), Thyroid disorder (Thyroid condition) and Mitral valve prolapse (Heart condition).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (received a third full dose instead of a booster dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), PAIN (felling achy) and AXILLARY PAIN (had a little bit of pain under their armpit). On 23-Dec-2021, ACCIDENTAL OVERDOSE (received a third full dose instead of a booster dose) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain), PAIN (felling achy) and AXILLARY PAIN (had a little bit of pain under their armpit) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.  It was reported that the patient had not been working because they were hurt but clarified that was regarding something that had been going on for years. The patient took a spike protein test that showed a level of 1.78 or 1.76 after 8.5 months from  the second dose.   This case was linked to MOD-2021-428522 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore throat; Cough; Sore arm; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) had not resolved and PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided  Patient had a third shot on Monday and had sore arm, headache about 30 hrs and was fine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Malaise, Pain in extremity, Protein total
Clinical narrative: arm pain; Felt sick; felt like the getting the flu; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), MALAISE (Felt sick), INFLUENZA LIKE ILLNESS (felt like the getting the flu), PYREXIA (fever) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to epinephrine), Thyroid disorder (thyroid condition) and Mitral valve prolapse (heart condition).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), MALAISE (Felt sick), INFLUENZA LIKE ILLNESS (felt like the getting the flu), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm pain), MALAISE (Felt sick), INFLUENZA LIKE ILLNESS (felt like the getting the flu), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Protein total: 1.78 or 1.76 level of 1.78 or 1.76 after 8.5 months from the second dose.         No concomitant medications were reported. No treatment medications were reported. Patient stated that they have not been working because they were hurt but clarified that was regarding something that has been going on for years. Patient had arm pain, felt sick, had fever and chills and felt like the getting the flu for a couple of days.   This case was linked to MOD-2021-428505 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm pain; Felt sick; felt like the getting the flu; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), MALAISE (Felt sick), INFLUENZA LIKE ILLNESS (felt like the getting the flu), PYREXIA (fever) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to epinephrine), Thyroid disorder (thyroid condition) and Mitral valve prolapse (heart condition).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), MALAISE (Felt sick), INFLUENZA LIKE ILLNESS (felt like the getting the flu), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm pain), MALAISE (Felt sick), INFLUENZA LIKE ILLNESS (felt like the getting the flu), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Protein total: 1.78 or 1.76 level of 1.78 or 1.76 after 8.5 months from the second dose.         No concomitant medications were reported. No treatment medications were reported. Patient stated that they have not been working because they were hurt but clarified that was regarding something that has been going on for years. Patient had arm pain, felt sick, had fever and chills and felt like the getting the flu for a couple of days.   This case was linked to MOD-2021-428505 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills on body on and off after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills on body on and off after vaccination) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills on body on and off after vaccination). At the time of the report, CHILLS (Chills on body on and off after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment drugs were reported   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This spontaneous case was reported by a nurse and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre Syndrome) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre Syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre Syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was mentioned.  Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced unexpected event of Guillain-Barre Syndrome. It is not possible to establish a temporal relationship as vaccination date and start date of the event were not provided. Clinical course and treatment details were not disclosed. Very limited information regarding this event has been provided at this time. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced unexpected event of Guillain-Barre Syndrome. It is not possible to establish a temporal relationship as vaccination date and start date of the event were not provided. Clinical course and treatment details were not disclosed. Very limited information regarding this event has been provided at this time. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Urticaria
Clinical narrative: Sweats; Hives; Diarrhea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERHIDROSIS (Sweats), URTICARIA (Hives) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), URTICARIA (Hives) and DIARRHOEA (Diarrhea). At the time of the report, HYPERHIDROSIS (Sweats), URTICARIA (Hives) and DIARRHOEA (Diarrhea) had not resolved.            No concomitant medication information was provided. No treatment medication were provided. The symptoms recur up to every 1/7 days.
Sex: U
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: I am taking an antibiotic for an infection.; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (I am taking an antibiotic for an infection.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (I am taking an antibiotic for an infection.). At the time of the report, INFECTION (I am taking an antibiotic for an infection.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that reporter was scheduled for their second dose of Moderna Covid-19 Vaccine tomorrow. Patient was taking an antibiotic for an infection and be concerned about an interaction with vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: he received a full third shoot as an error; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (he received a full third shoot as an error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (he received a full third shoot as an error). At the time of the report, ACCIDENTAL OVERDOSE (he received a full third shoot as an error) had resolved.            Concomitant medication not reported. Treatment medication not reported.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: slight arm discomfort that latest about a day and a half after the first dose.; arm pain less than the first two doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (slight arm discomfort that latest about a day and a half after the first dose.) and VACCINATION SITE PAIN (arm pain less than the first two doses) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (slight arm discomfort that latest about a day and a half after the first dose.). In 2021, the patient experienced VACCINATION SITE PAIN (arm pain less than the first two doses). At the time of the report, VACCINATION SITE DISCOMFORT (slight arm discomfort that latest about a day and a half after the first dose.) had resolved and VACCINATION SITE PAIN (arm pain less than the first two doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-428659, MOD-2021-428660 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dysphemia, Pyrexia
Clinical narrative: stuttering; dizziness; joint pain; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPHEMIA (stuttering), DIZZINESS (dizziness), ARTHRALGIA (joint pain) and PYREXIA (fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced DYSPHEMIA (stuttering), DIZZINESS (dizziness), ARTHRALGIA (joint pain) and PYREXIA (fever). At the time of the report, DYSPHEMIA (stuttering), DIZZINESS (dizziness), ARTHRALGIA (joint pain) and PYREXIA (fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Moderna 1dose and 2nd dose previously and on 27dec2021 he received the booster shot. The patient had some side effects now that include stuttering, joint pain, dizziness, fever. The patient did not have the lot number of the vaccine. He had not contacted his doctor. No concomitant medications were reported. No treatment details were reported.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: arm pain; experienced slight arm discomfort that latest about a day and a half after the second; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (experienced slight arm discomfort that latest about a day and a half after the second) and VACCINATION SITE PAIN (arm pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOMFORT (experienced slight arm discomfort that latest about a day and a half after the second). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, VACCINATION SITE DISCOMFORT (experienced slight arm discomfort that latest about a day and a half after the second) had resolved and VACCINATION SITE PAIN (arm pain) outcome was unknown.            The patient had no known drug or food allergies. The patient experienced slight arm discomfort that last about a day and a half after the second dose. No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2021-428648, MOD-2021-428660 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Vaccination site pain
Clinical narrative: arm pain; experienced slight arm discomfort that latest about a day and a half after the second; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (experienced slight arm discomfort that latest about a day and a half after the second) and VACCINATION SITE PAIN (arm pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOMFORT (experienced slight arm discomfort that latest about a day and a half after the second). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, VACCINATION SITE DISCOMFORT (experienced slight arm discomfort that latest about a day and a half after the second) had resolved and VACCINATION SITE PAIN (arm pain) outcome was unknown.            The patient had no known drug or food allergies. The patient experienced slight arm discomfort that last about a day and a half after the second dose. No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2021-428648, MOD-2021-428660 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: slight arm pain (3rd booster dose)/arm pain less than the first two doses; given 3rd full dose (0.5 ml)  for "booster dose"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight arm pain (3rd booster dose)/arm pain less than the first two doses) and ACCIDENTAL OVERDOSE (given 3rd full dose (0.5 ml)  for "booster dose") in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 002A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced VACCINATION SITE PAIN (slight arm pain (3rd booster dose)/arm pain less than the first two doses) and ACCIDENTAL OVERDOSE (given 3rd full dose (0.5 ml)  for "booster dose"). On 21-Oct-2021, ACCIDENTAL OVERDOSE (given 3rd full dose (0.5 ml)  for "booster dose") had resolved. At the time of the report, VACCINATION SITE PAIN (slight arm pain (3rd booster dose)/arm pain less than the first two doses) outcome was unknown.            It was reported that patient is not immunocompromised and mentioned that the half (0.25 ml) booster dose wasn't yet approved at the time of the vaccination, which is why he received a full dose(0.5 ml). Patient had no known drug or food allergies.    No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-428648, MOD-2021-428659 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Vaccination site pain
Clinical narrative: slight arm pain (3rd booster dose)/arm pain less than the first two doses; given 3rd full dose (0.5 ml)  for "booster dose"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight arm pain (3rd booster dose)/arm pain less than the first two doses) and ACCIDENTAL OVERDOSE (given 3rd full dose (0.5 ml)  for "booster dose") in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 002A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced VACCINATION SITE PAIN (slight arm pain (3rd booster dose)/arm pain less than the first two doses) and ACCIDENTAL OVERDOSE (given 3rd full dose (0.5 ml)  for "booster dose"). On 21-Oct-2021, ACCIDENTAL OVERDOSE (given 3rd full dose (0.5 ml)  for "booster dose") had resolved. At the time of the report, VACCINATION SITE PAIN (slight arm pain (3rd booster dose)/arm pain less than the first two doses) outcome was unknown.            It was reported that patient is not immunocompromised and mentioned that the half (0.25 ml) booster dose wasn't yet approved at the time of the vaccination, which is why he received a full dose(0.5 ml). Patient had no known drug or food allergies.    No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-428648, MOD-2021-428659 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (same side effects like one she had with 1st shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (same side effects like one she had with 1st shot). At the time of the report, VACCINATION COMPLICATION (same side effects like one she had with 1st shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Patient would like to know if there will be the same side effects like one had with 1st shot. Patient is Scheduled for the second dose and was also scheduled for the surgery a week following vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Rectal fissure
Clinical narrative: rectal fissure; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL FISSURE (rectal fissure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-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 RECTAL FISSURE (rectal fissure). The patient was treated with HYDROCORTISONE ACETATE (ANUCORT-HC) ongoing since an unknown date for Rectal fissure, at a dose of 25 mg. At the time of the report, RECTAL FISSURE (rectal fissure) outcome was unknown.            No Concomitant Drug details were reported. Patient had rectal fissure they developed a few weeks ago.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: It's taking him a while to recover from it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (It's taking him a while to recover from it) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (He received his first dose (lot EW0162) of Pfizer COVID-19 Vaccine) on 19-Apr-2021 and Pfizer COVID-19 vaccine (He received his first dose (lot EW0173) of Pfizer COVID-19 Vaccine) on 10-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (It's taking him a while to recover from it). At the time of the report, VACCINATION COMPLICATION (It's taking him a while to recover from it) had not resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-428441 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Sore throat; Sinuses are draining; Coughing; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Sinuses are draining), COUGH (Coughing) and PYREXIA (Slight fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Sinuses are draining), COUGH (Coughing) and PYREXIA (Slight fever). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Sinuses are draining), COUGH (Coughing) and PYREXIA (Slight fever) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenectomy, Mastectomy
Clinical narrative: Double mastectomy with reconstruction; sentinel node was taken out; This spontaneous case was reported by a consumer and describes the occurrence of MASTECTOMY (Double mastectomy with reconstruction) and LYMPHADENECTOMY (sentinel node was taken out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MASTECTOMY (Double mastectomy with reconstruction) and LYMPHADENECTOMY (sentinel node was taken out). At the time of the report, MASTECTOMY (Double mastectomy with reconstruction) and LYMPHADENECTOMY (sentinel node was taken out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient was due to receive second dose on 15 Feb 2021.  No concomitant medications were reported. No treatment information were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Insomnia, Nasal congestion, Nasopharyngitis, Oropharyngeal discomfort
Clinical narrative: little bit of raspiness in his throat; bad cold; severe congestion/some mild congestion; sore throat; could only sleep for about an hour/only able to sleep for 1 hour at a time; cough up phlegm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (little bit of raspiness in his throat), NASOPHARYNGITIS (bad cold), NASAL CONGESTION (severe congestion/some mild congestion), OROPHARYNGEAL PAIN (sore throat) and INSOMNIA (could only sleep for about an hour/only able to sleep for 1 hour at a time) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 004C21A and 020A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced OROPHARYNGEAL DISCOMFORT (little bit of raspiness in his throat), NASOPHARYNGITIS (bad cold), NASAL CONGESTION (severe congestion/some mild congestion), OROPHARYNGEAL PAIN (sore throat), INSOMNIA (could only sleep for about an hour/only able to sleep for 1 hour at a time) and COUGH (cough up phlegm). The patient was treated with TRAZODONE for Difficulty sleeping, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Difficulty sleeping, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (little bit of raspiness in his throat) had not resolved and NASOPHARYNGITIS (bad cold), NASAL CONGESTION (severe congestion/some mild congestion), OROPHARYNGEAL PAIN (sore throat), INSOMNIA (could only sleep for about an hour/only able to sleep for 1 hour at a time) and COUGH (cough up phlegm) was resolving.            Concomitant medication taken by the patient included two different blood pressure medications and cholesterol medication. Current medical condition included blood pressure and cholesterol. Patient started taking Nyquil for his sleep, which allowed him to sleep longer.  Patient had events 24-36 hours after receiving the booster dose of the vaccine. Patient was only able to sleep for 1 hour at a time at first as he would have to wake up, cough up phlegm, then fall back asleep. Patient had an upcoming appointment on 3 Jan 2022.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: little bit of raspiness in his throat; bad cold; severe congestion/some mild congestion; sore throat; could only sleep for about an hour/only able to sleep for 1 hour at a time; cough up phlegm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (little bit of raspiness in his throat), NASOPHARYNGITIS (bad cold), NASAL CONGESTION (severe congestion/some mild congestion), OROPHARYNGEAL PAIN (sore throat) and INSOMNIA (could only sleep for about an hour/only able to sleep for 1 hour at a time) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 004C21A and 020A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced OROPHARYNGEAL DISCOMFORT (little bit of raspiness in his throat), NASOPHARYNGITIS (bad cold), NASAL CONGESTION (severe congestion/some mild congestion), OROPHARYNGEAL PAIN (sore throat), INSOMNIA (could only sleep for about an hour/only able to sleep for 1 hour at a time) and COUGH (cough up phlegm). The patient was treated with TRAZODONE for Difficulty sleeping, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Difficulty sleeping, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (little bit of raspiness in his throat) had not resolved and NASOPHARYNGITIS (bad cold), NASAL CONGESTION (severe congestion/some mild congestion), OROPHARYNGEAL PAIN (sore throat), INSOMNIA (could only sleep for about an hour/only able to sleep for 1 hour at a time) and COUGH (cough up phlegm) was resolving.            Concomitant medication taken by the patient included two different blood pressure medications and cholesterol medication. Current medical condition included blood pressure and cholesterol. Patient started taking Nyquil for his sleep, which allowed him to sleep longer.  Patient had events 24-36 hours after receiving the booster dose of the vaccine. Patient was only able to sleep for 1 hour at a time at first as he would have to wake up, cough up phlegm, then fall back asleep. Patient had an upcoming appointment on 3 Jan 2022.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: She had several symptoms/ 2nd shot she had side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had several symptoms/ 2nd shot she had side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She had several symptoms/ 2nd shot she had side effects). At the time of the report, VACCINATION COMPLICATION (She had several symptoms/ 2nd shot she had side effects) outcome was unknown.            No concomitant medication reported.  No treatment medication reported.  It was reported that after second vaccination patient had side effects.