chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first vaccine on April 10 can I still get my second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine on April 10 can I still get my second dose) 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 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine on April 10 can I still get my second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine on April 10 can I still get my second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling abnormal, Headache, Vaccination site pain
Clinical narrative: She is terrified of the side effects/Terrified of the Second Shot; Injection Site Hurt a little if touched; Extremely Tired; Dull Headache; Not feeling like her usual self; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site Hurt a little if touched), FATIGUE (Extremely Tired), HEADACHE (Dull Headache), FEELING ABNORMAL (Not feeling like her usual self) and ANXIETY (She is terrified of the side effects/Terrified of the Second Shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Radiation therapy in March 2021.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE PAIN (Injection Site Hurt a little if touched), FATIGUE (Extremely Tired), HEADACHE (Dull Headache) and FEELING ABNORMAL (Not feeling like her usual self). On 08-Jun-2021, the patient experienced ANXIETY (She is terrified of the side effects/Terrified of the Second Shot). On 15-May-2021, VACCINATION SITE PAIN (Injection Site Hurt a little if touched) had resolved. On 18-May-2021, FATIGUE (Extremely Tired), HEADACHE (Dull Headache) and FEELING ABNORMAL (Not feeling like her usual self) had resolved. At the time of the report, ANXIETY (She is terrified of the side effects/Terrified of the Second Shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm in the injection site; Swelling in the injection site; Redness in the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Warm in the injection site), VACCINATION SITE SWELLING (Swelling in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN for Diabetes, ESZOPICLONE (LUNESTA) for Sleeping sickness.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm in the injection site), VACCINATION SITE SWELLING (Swelling in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm in the injection site), VACCINATION SITE SWELLING (Swelling in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: chills a thousand times worse than normal; Chills with shakes that are  uncontrollable; I got my shot the following day I had fevers; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills a thousand times worse than normal) and TREMOR (Chills with shakes that are  uncontrollable) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO MEDICAL HISTORY WAS REPORTED BY REPORTER.     On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills a thousand times worse than normal) and TREMOR (Chills with shakes that are  uncontrollable). At the time of the report, CHILLS (chills a thousand times worse than normal) and TREMOR (Chills with shakes that are  uncontrollable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced with chills a thousand times worse than normal, and chills with shakes that are uncontrollable. no medical history was reported. no concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effect) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products and treatment medication were provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: Received 2nd dose less than 25 days after receiving 1st dose; Received 1st dose of Pfizer and 2nd dose of moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) and PRODUCT ADMINISTRATION ERROR (Received 1st dose of Pfizer and 2nd dose of moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) and PRODUCT ADMINISTRATION ERROR (Received 1st dose of Pfizer and 2nd dose of moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose less than 25 days after receiving 1st dose) and PRODUCT ADMINISTRATION ERROR (Received 1st dose of Pfizer and 2nd dose of moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse reported that a patient received 1st dose of Pfizer vaccine on 23May2021 and 2nd dose of moderna vaccine on 6Jun2021 on his left arm and the patient had no any adverse effects. The lot number of the 2nd dose of moderna vaccine is "022C21A". She gave the consent for follow up by safety.   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Received 1st dose of J&J and 2nd dose of moderna vaccine; Received 2nd dose more than 35 days after receiving 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose of J&J and 2nd dose of moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after receiving 1st dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose of J&J and 2nd dose of moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after receiving 1st dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose of J&J and 2nd dose of moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after receiving 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Shakes; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22); This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22)) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22)). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose less than 28 days after the 1st dose,( i.e. D22)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the events were not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09-JUN-2021 included non-significant information
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient received her first Moderna Covid-19 vaccine from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received her first Moderna Covid-19 vaccine from expired vial) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received her first Moderna Covid-19 vaccine from expired vial). On 07-Jun-2021, EXPIRED PRODUCT ADMINISTERED (A patient received her first Moderna Covid-19 vaccine from expired vial) 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 medications were mentioned.  No treatment details were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing started; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing started) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Bronchiectasis (Patient has a history of bronchiectasis without Cystic Fibrosis.) since 07-Jan-2017, Fibrillation atrial since 01-Jan-2020, Penicillin allergy (Hives as a reaction.), Sulfonamide allergy (Hives as a reaction.) and Drug allergy (Allergic to Ceclor . Hives as a reaction.). Concomitant products included ALBUTEROL [SALBUTAMOL] from 07-Jan-2017 to an unknown date for Bronchiectasis, ALLOPURINOL, APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication.   On 10-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing started). At the time of the report, COUGH (Coughing started) had not resolved.            No treatment medications were provide by reporter.  Patient started coughing about 2-3 months after receiving the Moderna covid-19 vaccine. She reportedly had a persistent cough secondary to non-cystic fibrosis bronchiectasis. Per report, the patient had a period of relief from coughing between the first and second doses of the vaccine. However, her cough progressively worsened to its pre-vaccination intensity within 3 months of receiving her second dose vaccination. The patient is concomitantly taking other unspecified medications.  Patient has a history of hives as a reaction to drug allergies including penicillin, sulfonamides, and cefaclor.       Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up included updated information regarding patient demographics, facility type, medical history, suspect product details like batch number, route of administration, anatomical location, added concomitant medications,  outcome of the event cough updated to recovered. On 09-Jul-2021: Follow-up information received to include updates on reaction for allergies, outcome of the event cough was update from recovered  to not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: A hemorrhage in the right eye; This spontaneous case was reported by a physician and describes the occurrence of EYE HAEMORRHAGE (A hemorrhage in the right eye) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE HAEMORRHAGE (A hemorrhage in the right eye). The patient was treated with CARBOMER (TEAR DROPS) at an unspecified dose and frequency. At the time of the report, EYE HAEMORRHAGE (A hemorrhage in the right eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include hydration.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Physician states patient experienced  localized reaction following 1st dose of Moderna COVID 19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Physician states patient experienced  localized reaction following 1st dose of Moderna COVID 19 vaccine) 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 VACCINATION COMPLICATION (Physician states patient experienced  localized reaction following 1st dose of Moderna COVID 19 vaccine). At the time of the report, VACCINATION COMPLICATION (Physician states patient experienced  localized reaction following 1st dose of Moderna COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Physician advised patient not to have 2nd dose of Moderna COVID19 vaccine. Treatment details were not provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore after the 1st dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) 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 PAIN IN EXTREMITY (arm was sore after the 1st dose). At the time of the report, PAIN IN EXTREMITY (arm was sore after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided. No concomitant medication provided.   This case was linked to MOD-2021-214787 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle soreness) 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 MYALGIA (muscle soreness). At the time of the report, MYALGIA (muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; Soreness at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever and took about 2weeks to recover.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (High fever and took about 2weeks to recover.) 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 PYREXIA (High fever and took about 2weeks to recover.). At the time of the report, PYREXIA (High fever and took about 2weeks to recover.) had resolved.        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.   patient was immunocompromised and  received the Moderna COVID-19 vaccine developed high fever and took about 2weeks to recover. No concomitant medications and treatment medications was provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: splitting headache; chills; nausea; muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (splitting headache), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced HEADACHE (splitting headache), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle pain). At the time of the report, HEADACHE (splitting headache), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported , No treatment medication was reported .   This case was linked to MOD-2021-214773 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: arthritis is improving,no pain,theumbs no longer recovered,she is happy; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (arthritis is improving,no pain,theumbs no longer recovered,she is happy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (arthritis is improving,no pain,theumbs no longer recovered,she is happy). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (arthritis is improving,no pain,theumbs no longer recovered,she is happy) outcome was unknown.            Caller reports that prior to getting the vaccine she had arthritis in both her thumbs. Patient reports that arthritis is improving since receiving the vaccines.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Facial pain, Malaise
Clinical narrative: both breast are severely soar,; pain on the right side of the face over the forehead spot; patient did not felt better/ still not ok."; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (both breast are severely soar,), FACIAL PAIN (pain on the right side of the face over the forehead spot) and MALAISE (patient did not felt better/ still not ok.") in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 024C21A.) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Gabapentin 100mg bid, Lexapro 10 mg OD and Zen ax TID for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 29-May-2021, the patient experienced BREAST PAIN (both breast are severely soar,), FACIAL PAIN (pain on the right side of the face over the forehead spot) and MALAISE (patient did not felt better/ still not ok."). At the time of the report, BREAST PAIN (both breast are severely soar,), FACIAL PAIN (pain on the right side of the face over the forehead spot) and MALAISE (patient did not felt better/ still not ok.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) 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 03-Jun-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 ASTHENIA (Weakness). At the time of the report, ASTHENIA (Weakness) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA is not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (missed the second dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (missed the second dose). At the time of the report, product dose omission issue (missed the second dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medication and treatment information not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Large red rash around injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Large red rash around injection site) 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Large red rash around injection site). At the time of the report, VACCINATION SITE RASH (Large red rash around injection site) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.  Action taken with the drug in response to events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pyrexia
Clinical narrative: Small redness on the arm; Little Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Small redness on the arm) and PYREXIA (Little Feverish) 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 02-Jun-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 08-Jun-2021, the patient experienced ERYTHEMA (Small redness on the arm) and PYREXIA (Little Feverish). At the time of the report, ERYTHEMA (Small redness on the arm) and PYREXIA (Little Feverish) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medication history information was reported.  Concomitant products included AMOXICILLIN for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided   This case was linked to MOD-2021-214827 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information was received and reporter information was updated. On 04-Aug-2021: Follow Up received- No new information for dose-1 related event.
Sex: U
Vaccine: COVID19
Symptoms: Fibromyalgia
Clinical narrative: Fibromyalgia flare; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia flare) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia flare). At the time of the report, FIBROMYALGIA (Fibromyalgia flare) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Fatigue, Flatulence
Clinical narrative: felt like they had tonsillitis; still weak; stomach is sort of out of sorts; I'm constantly having floaters, referring to bowel movements; Arm pain; ongoing fatigue the past two or three weeks/ tired all of the time; fever; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLITIS (felt like they had tonsillitis), ASTHENIA (still weak), ABDOMINAL DISCOMFORT (stomach is sort of out of sorts), FLATULENCE (I'm constantly having floaters, referring to bowel movements) and PAIN IN EXTREMITY (Arm pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth repair. Concomitant products included AMOXICILLIN for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TONSILLITIS (felt like they had tonsillitis), ASTHENIA (still weak), ABDOMINAL DISCOMFORT (stomach is sort of out of sorts), FLATULENCE (I'm constantly having floaters, referring to bowel movements), PAIN IN EXTREMITY (Arm pain), FATIGUE (ongoing fatigue the past two or three weeks/ tired all of the time) and PYREXIA (fever). At the time of the report, TONSILLITIS (felt like they had tonsillitis), PAIN IN EXTREMITY (Arm pain) and PYREXIA (fever) outcome was unknown and ASTHENIA (still weak), ABDOMINAL DISCOMFORT (stomach is sort of out of sorts), FLATULENCE (I'm constantly having floaters, referring to bowel movements) and FATIGUE (ongoing fatigue the past two or three weeks/ tired all of the time) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99.6 (High) Abnormal.         Treatment medications were not provided   This case was linked to MOD-2021-214821 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow up received on 30-JUN-2021. Reporter phone number, salutation, email address were updated and Events like stomach discomfort, floaters/Gas, Tired and weakness were updated
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tonsillitis
Clinical narrative: felt like they had tonsillitis; still weak; stomach is sort of out of sorts; I'm constantly having floaters, referring to bowel movements; Arm pain; ongoing fatigue the past two or three weeks/ tired all of the time; fever; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLITIS (felt like they had tonsillitis), ASTHENIA (still weak), ABDOMINAL DISCOMFORT (stomach is sort of out of sorts), FLATULENCE (I'm constantly having floaters, referring to bowel movements) and PAIN IN EXTREMITY (Arm pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth repair. Concomitant products included AMOXICILLIN for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TONSILLITIS (felt like they had tonsillitis), ASTHENIA (still weak), ABDOMINAL DISCOMFORT (stomach is sort of out of sorts), FLATULENCE (I'm constantly having floaters, referring to bowel movements), PAIN IN EXTREMITY (Arm pain), FATIGUE (ongoing fatigue the past two or three weeks/ tired all of the time) and PYREXIA (fever). At the time of the report, TONSILLITIS (felt like they had tonsillitis), PAIN IN EXTREMITY (Arm pain) and PYREXIA (fever) outcome was unknown and ASTHENIA (still weak), ABDOMINAL DISCOMFORT (stomach is sort of out of sorts), FLATULENCE (I'm constantly having floaters, referring to bowel movements) and FATIGUE (ongoing fatigue the past two or three weeks/ tired all of the time) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99.6 (High) Abnormal.         Treatment medications were not provided   This case was linked to MOD-2021-214821 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow up received on 30-JUN-2021. Reporter phone number, salutation, email address were updated and Events like stomach discomfort, floaters/Gas, Tired and weakness were updated
Sex: U
Vaccine: COVID19
Symptoms: Injection site rash, Limb discomfort
Clinical narrative: After my 2nd dose I was able to lift my arm unlike after my first dose; large red rash around injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE RASH (large red rash around injection site) and LIMB DISCOMFORT (After my 2nd dose I was able to lift my arm unlike after my first dose) 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (large red rash around injection site) and LIMB DISCOMFORT (After my 2nd dose I was able to lift my arm unlike after my first dose). At the time of the report, INJECTION SITE RASH (large red rash around injection site) had resolved and LIMB DISCOMFORT (After my 2nd dose I was able to lift my arm unlike after my first dose) outcome was unknown.            Concomitant drugs are not provided Treatment information not provided.   This case was linked to MOD-2021-214817 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm at the injection arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 024C21A) for COVID-19 vaccination.     The patient's past medical history included Shingles (Shingles attack few years back). Concomitant products included GABAPENTIN for Rheumatoid arthritis, ESCITALOPRAM OXALATE (LEXAPRO) and ALPRAZOLAM (ZENAX) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm at the injection arm). At the time of the report, PAIN IN EXTREMITY (Sore arm at the injection arm) outcome was unknown. Not Provided          Patient received no treatment for events that occurred due to first dose.  Action taken with the drug in response to events was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Allergic to the vaccine; injection site is red; Painful; Itching; Swollen; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE PAIN (Painful), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), VALSARTAN, AMLODIPINE, MAGNESIUM and OLOPATADINE HYDROCHLORIDE (PAZEO) for an unknown indication.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE PAIN (Painful), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen), PYREXIA (Fever) and ALLERGY TO VACCINE (Allergic to the vaccine). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form and DOXYCYCLINE at a dose of 100 mg. At the time of the report, VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE PAIN (Painful), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen), PYREXIA (Fever) and ALLERGY TO VACCINE (Allergic to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient went to her doctor on 09JUN2021. Treatment also included ice- pack.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Allergic to the vaccine; injection site is red; Painful; Itching; Swollen; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE PAIN (Painful), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), VALSARTAN, AMLODIPINE, MAGNESIUM and OLOPATADINE HYDROCHLORIDE (PAZEO) for an unknown indication.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE PAIN (Painful), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen), PYREXIA (Fever) and ALLERGY TO VACCINE (Allergic to the vaccine). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form and DOXYCYCLINE at a dose of 100 mg. At the time of the report, VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE PAIN (Painful), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen), PYREXIA (Fever) and ALLERGY TO VACCINE (Allergic to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient went to her doctor on 09JUN2021. Treatment also included ice- pack.