chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old patient received first dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old patient received first dose of Moderna vaccine) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) 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 19-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old patient received first dose of Moderna vaccine). On 19-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old patient received first dose of Moderna vaccine) 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 information provided.  Patient did not report any side effects after the vaccination.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pain, Paraesthesia, Pyrexia
Clinical narrative: achiness; tingling; Loss of appetite; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), PARAESTHESIA (tingling), DECREASED APPETITE (Loss of appetite), FATIGUE (fatigue) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-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 (achiness), PARAESTHESIA (tingling), DECREASED APPETITE (Loss of appetite), FATIGUE (fatigue) and PYREXIA (fever). The patient was treated with CALAMINE at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, PAIN (achiness), PARAESTHESIA (tingling), DECREASED APPETITE (Loss of appetite), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medication was reported.   This case was linked to MOD-2021-015832.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I ready got my vaccine on June 16) 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 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I ready got my vaccine on June 16). On 16-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I ready got my vaccine on June 16) had resolved. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Moderna vaccine dose 2 details added and event 'Missed dose' was changed to 'Inappropriate schedule of drug administration.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Pharmacist states patient received 1st dose 6Apr2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Pharmacist states patient received 1st dose 6Apr2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Pharmacist states patient received 1st dose 6Apr2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Pharmacist states patient received 1st dose 6Apr2021) 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.   No concomitant medications were provided.  No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Fallow up received and contains no new information
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose not received,Missed the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not received,Missed the 2nd dose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not received,Missed the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not received,Missed the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.  Patient was scheduled to 2nd dose on 1-APR-2021 however somehow missed it and wanted to know if patient could get 2nd shot or does need to start over again.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-06-2021 and additional non-significant information added as reporter address
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 13-Jun-2021, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.            No relevant concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-223907 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up received contains no new information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain in extremity, Somnolence
Clinical narrative: Sick; Slept on and off all day; Nauseous; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), ILLNESS (Sick), SOMNOLENCE (Slept on and off all day) and NAUSEA (Nauseous) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 11-Mar-2021, the patient experienced ILLNESS (Sick), SOMNOLENCE (Slept on and off all day) and NAUSEA (Nauseous). In March 2021, SOMNOLENCE (Slept on and off all day) and NAUSEA (Nauseous) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore) and ILLNESS (Sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-223978.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracting COVID-19 after receiving the Moderna Covid-19 vaccine; 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 COVID-19 (Contracting COVID-19 after receiving the 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracting COVID-19 after receiving the Moderna Covid-19 vaccine). At the time of the report, COVID-19 (Contracting COVID-19 after receiving the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site rash, Vaccination site warmth
Clinical narrative: Arm is hot to touch; Arm is hard; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is hot to touch), VACCINATION SITE INDURATION (Arm is hard) and VACCINATION SITE RASH (Rash) 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 SITE WARMTH (Arm is hot to touch), VACCINATION SITE INDURATION (Arm is hard) and VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE WARMTH (Arm is hot to touch), VACCINATION SITE INDURATION (Arm is hard) and VACCINATION SITE RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: The spot where I got the vaccine is now yellow and blueish; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCOLOURATION (The spot where I got the vaccine is now yellow and blueish) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (The spot where I got the vaccine is now yellow and blueish). At the time of the report, VACCINATION SITE DISCOLOURATION (The spot where I got the vaccine is now yellow and blueish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information was not provided.   Reporter did not allow further contact
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-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 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 16-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) 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.   No concomitant medication reported.  No treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: been 10 weeks since my first vaccine; 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 PRODUCT DOSE OMISSION ISSUE (been 10 weeks since my first 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (been 10 weeks since my first vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (been 10 weeks since my first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, COVID-19
Clinical narrative: I have all possible side effects; I believe I have got covid-19; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (I have all possible side effects) and COVID-19 (I believe I have got covid-19) 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 ADVERSE REACTION (I have all possible side effects) and COVID-19 (I believe I have got covid-19). At the time of the report, ADVERSE REACTION (I have all possible side effects) and COVID-19 (I believe I have got covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.   This case was linked to MOD-2021-223973 (Patient Link).   Reporter did not allow further contact
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pain in extremity, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: at the vaccination site it got itchy,it's like a bug bite or something; sore arm; red bump; inflammation; like a bug bite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (at the vaccination site it got itchy,it's like a bug bite or something), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red bump), INFLAMMATION (inflammation) and VACCINATION SITE REACTION (like a bug bite   ) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CANNABIS SATIVA (CANNABIS) for an unknown indication.    On 30-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 VACCINATION SITE PRURITUS (at the vaccination site it got itchy,it's like a bug bite or something), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red bump), INFLAMMATION (inflammation) and VACCINATION SITE REACTION (like a bug bite   ). At the time of the report, VACCINATION SITE PRURITUS (at the vaccination site it got itchy,it's like a bug bite or something), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red bump), INFLAMMATION (inflammation) and VACCINATION SITE REACTION (like a bug bite   ) 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.   No relevant concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-224027 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was still really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was still really sore) 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 28-May-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 was still really sore). At the time of the report, PAIN IN EXTREMITY (arm was still really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  No treatment information provided by Reporter.  Second dose scheduled on 29-JUN-2021.   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Musculoskeletal pain, Oropharyngeal pain, Throat tightness
Clinical narrative: Throat pain/ sore throat; Felt like throat was closing up; Pain in the left butt cheek; Got period with in 24 hours of getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Got period with in 24 hours of getting the vaccine), OROPHARYNGEAL PAIN (Throat pain/ sore throat), THROAT TIGHTNESS (Felt like throat was closing up) and MUSCULOSKELETAL PAIN (Pain in the left butt cheek) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02B21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergy to cinnamon) and Latex allergy. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced MENSTRUATION IRREGULAR (Got period with in 24 hours of getting the vaccine) and MUSCULOSKELETAL PAIN (Pain in the left butt cheek). On 15-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Throat pain/ sore throat) and THROAT TIGHTNESS (Felt like throat was closing up). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE (WALGREENS NON-DROWSY DAYTIME) for Throat pain, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, MENSTRUATION IRREGULAR (Got period with in 24 hours of getting the vaccine), OROPHARYNGEAL PAIN (Throat pain/ sore throat), THROAT TIGHTNESS (Felt like throat was closing up) and MUSCULOSKELETAL PAIN (Pain in the left butt cheek) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: Fever : 100.6 F; Joint pain that ¨it is the worst thing she ever had¨; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever : 100.6 F), ARTHRALGIA (Joint pain that ¨it is the worst thing she ever had¨) and HEADACHE (Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (patient takes Blood pressure pills¨.) and Heart disease, unspecified (patient takes¨Heart Medicine¨.).   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced PYREXIA (Fever : 100.6 F), ARTHRALGIA (Joint pain that ¨it is the worst thing she ever had¨) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 16-Jun-2021 at a dose of 2 tablets. At the time of the report, PYREXIA (Fever : 100.6 F), ARTHRALGIA (Joint pain that ¨it is the worst thing she ever had¨) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs include pills for stomach, blood pressure, allergy and heart ache.   No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: home address provided.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Peripheral swelling, Pruritus
Clinical narrative: allergic reaction; arm is still swollen; itched like a thousand mosquito bites; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (allergic reaction), PERIPHERAL SWELLING (arm is still swollen) and PRURITUS (itched like a thousand mosquito bites) 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, 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 ALLERGY TO VACCINE (allergic reaction), PERIPHERAL SWELLING (arm is still swollen) and PRURITUS (itched like a thousand mosquito bites). At the time of the report, ALLERGY TO VACCINE (allergic reaction), PERIPHERAL SWELLING (arm is still swollen) and PRURITUS (itched like a thousand mosquito bites) outcome was unknown.            Concomitant information were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: I had severe stomach cramping; 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 ABDOMINAL PAIN UPPER (I had severe stomach cramping) 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 ABDOMINAL PAIN UPPER (I had severe stomach cramping). At the time of the report, ABDOMINAL PAIN UPPER (I had severe stomach cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Grandson got sick after the vaccine; 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 ILLNESS (Grandson got sick after the 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Grandson got sick after the vaccine). At the time of the report, ILLNESS (Grandson got sick after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.   This case was linked to MOD-2021-223903, MOD-2021-223952 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence, Vaccination site rash
Clinical narrative: all she wanted to do was sleep; arm was sore; tired; her arm turned bright pink all around the wound which lasted about a week; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (all she wanted to do was sleep), PAIN IN EXTREMITY (arm was sore), FATIGUE (tired) and VACCINATION SITE RASH (her arm turned bright pink all around the wound which lasted about a week) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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. In April 2021, the patient experienced SOMNOLENCE (all she wanted to do was sleep), PAIN IN EXTREMITY (arm was sore), FATIGUE (tired) and VACCINATION SITE RASH (her arm turned bright pink all around the wound which lasted about a week). At the time of the report, SOMNOLENCE (all she wanted to do was sleep), PAIN IN EXTREMITY (arm was sore), FATIGUE (tired) and VACCINATION SITE RASH (her arm turned bright pink all around the wound which lasted about a week) had resolved.            No relevant concomitant medication was reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a headache after the shot; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had a headache after the shot   ) 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 HEADACHE (had a headache after the shot   ). At the time of the report, HEADACHE (had a headache after the shot   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot Injection Site after Second vaccine) and VACCINATION SITE ERYTHEMA (Red Injection Site after Second 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.   In June 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 16-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Hot Injection Site after Second vaccine) and VACCINATION SITE ERYTHEMA (Red Injection Site after Second vaccine). At the time of the report, VACCINATION SITE WARMTH (Hot Injection Site after Second vaccine) and VACCINATION SITE ERYTHEMA (Red Injection Site after Second vaccine) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Influenza
Clinical narrative: nose bleed; flu; 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 EPISTAXIS (nose bleed) and INFLUENZA (flu) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (nose bleed) and INFLUENZA (flu). At the time of the report, EPISTAXIS (nose bleed) and INFLUENZA (flu) 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
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Increased heart rate; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate) and DIZZINESS (Dizziness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Increased heart rate) and DIZZINESS (Dizziness). At the time of the report, HEART RATE INCREASED (Increased heart rate) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) in a 46-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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non significant follow up information. No new information
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy still after 23 hours from second dose.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy still after 23 hours from 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy still after 23 hours from second dose.). At the time of the report, DIZZINESS (dizzy still after 23 hours from second dose.) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a sore left arm after receiving 1st dose on 3rd day/left arm has been hurting) and MOBILITY DECREASED (could barely lift his arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (had a sore left arm after receiving 1st dose on 3rd day/left arm has ben hurting) and MOBILITY DECREASED (could barely lift his arm). At the time of the report, PAIN IN EXTREMITY (had a sore left arm after receiving 1st dose on 3rd day/left arm has ben hurting) and MOBILITY DECREASED (could barely lift his arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products included Blood pressure medication, Anti-depressants and ANTIBIOTICS for an unknown indication. Treatment included Ice, heating pad and Muscle rub. This case was linked to MOD-2021-224267. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR was received patient address was updated.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaccination site pain
Clinical narrative: Vaccine exposure during pregnancy; Soreness at injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (Soreness at injection site) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Sep-2021. On 23-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (Soreness at injection site). On 23-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication use was not provided.  Patient reported date of last menstrual period was unknown but also reported it was in November 2020.  No Treatment information was provided.  This is a case of product exposure during pregnancy with an associated adverse event of vaccination site pain in the mother. Based on temporal association a causal relationship cannot be excluded. For the event transposition of the great vessels a case for the unborn fetus has been requested to be opened.; Sender's Comments: This is a case of product exposure during pregnancy with an associated adverse event of vaccination site pain in the mother. Based on temporal association a causal relationship cannot be excluded. For the event transposition of the great vessels a case for the unborn fetus has been requested to be opened.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pruritus
Clinical narrative: itching; felt not his best/terrible and sick described as having no energy and could hardly move; headache suspected as migraine; sore arm muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm muscle), PRURITUS (itching), FATIGUE (felt not his best/terrible and sick described as having no energy and could hardly move) and HEADACHE (headache suspected as migraine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (benadryl). Concomitant products included FINASTERIDE and TAMSULOSIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm muscle). On 27-Feb-2021, the patient experienced FATIGUE (felt not his best/terrible and sick described as having no energy and could hardly move) and HEADACHE (headache suspected as migraine). On 28-Feb-2021, the patient experienced PRURITUS (itching). The patient was treated with ISOPROPANOL (RUBBING ALCOHOL) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, HEADACHE (headache suspected as migraine) had resolved. On 04-Mar-2021, FATIGUE (felt not his best/terrible and sick described as having no energy and could hardly move) had resolved. On 05-Mar-2021, PAIN IN EXTREMITY (sore arm muscle) and PRURITUS (itching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes blood pressure medication.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Rash, Tension, Vaccination complication
Clinical narrative: had a delayed response; erythema/rectangular shape about 3.5 inches by 2 inches on the deltoid; tenseness underneath the skin; felt dense; looked like a bad rash after you take a band aid off; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (had a delayed response), ERYTHEMA (erythema/rectangular shape about 3.5 inches by 2 inches on the deltoid), TENSION (tenseness underneath the skin), FEELING ABNORMAL (felt dense) and RASH (looked like a bad rash after you take a band aid off) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (sulfonamides).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION COMPLICATION (had a delayed response), ERYTHEMA (erythema/rectangular shape about 3.5 inches by 2 inches on the deltoid), TENSION (tenseness underneath the skin), FEELING ABNORMAL (felt dense) and RASH (looked like a bad rash after you take a band aid off). At the time of the report, VACCINATION COMPLICATION (had a delayed response), ERYTHEMA (erythema/rectangular shape about 3.5 inches by 2 inches on the deltoid), TENSION (tenseness underneath the skin), FEELING ABNORMAL (felt dense) and RASH (looked like a bad rash after you take a band aid off) 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 reported. No treatment medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vccaine given before 21 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vccaine given before 21 days after first dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vccaine given before 21 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vccaine given before 21 days after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment information were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling at the inection sight; redness at the inection sight; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (swelling at the inection sight) and VACCINATION SITE ERYTHEMA (redness at the inection sight) 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 VACCINATION SITE SWELLING (swelling at the inection sight) and VACCINATION SITE ERYTHEMA (redness at the inection sight). At the time of the report, VACCINATION SITE SWELLING (swelling at the inection sight) and VACCINATION SITE ERYTHEMA (redness at the inection sight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; 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 DIARRHOEA (Diarrhea) 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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose given outside vaccine window; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given outside vaccine window) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-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) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given outside vaccine window). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given outside vaccine window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnancy registry; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy registry) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy registry). At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy registry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second appointment; 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 PRODUCT DOSE OMISSION ISSUE (Missed the second appointment) 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 PRODUCT DOSE OMISSION ISSUE (Missed the second appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second appointment) 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 products were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Followup received on 14-JUL-2021  contains no new significant information. updated primary reporter details On 14-Jul-2021: Follow up received included on 14-JUL-2021 contains no new significant information