chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; 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 HEADACHE (Headaches) 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, 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 HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had not resolved.            No concomitant medications was reported. No treatment drug details was reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with COVID; He started presenting symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID) and COVID-19 (He started presenting symptoms) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced COVID-19 (He started presenting symptoms). On 13-Aug-2021, the patient experienced COVID-19 (Diagnosed with COVID). On 23-Aug-2021, COVID-19 (Diagnosed with COVID) and COVID-19 (He started presenting symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment included antibiotics for respiratory infection  Patient had appointment for the second dose on 02Sep2021
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: the second shot really really afected her stomach; still having a loose stool; if she eats something more than a cereal or a sandwich she feels terrible; fever; nausea has continued from last wednesday all the way til now; violently throwing up for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (the second shot really really afected her stomach), DIARRHOEA (still having a loose stool), FEELING ABNORMAL (if she eats something more than a cereal or a sandwich she feels terrible), PYREXIA (fever) and NAUSEA (nausea has continued from last wednesday all the way til now) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21 and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (the second shot really really afected her stomach), DIARRHOEA (still having a loose stool), FEELING ABNORMAL (if she eats something more than a cereal or a sandwich she feels terrible), PYREXIA (fever), NAUSEA (nausea has continued from last wednesday all the way til now) and VOMITING (violently throwing up for 2 days). The patient was treated with BISMUTH SUBSALICYLATE (PEPTOBISMOL) for Adverse event, at an unspecified dose and frequency. On 20-Aug-2021, VOMITING (violently throwing up for 2 days) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (the second shot really really afected her stomach), DIARRHOEA (still having a loose stool), FEELING ABNORMAL (if she eats something more than a cereal or a sandwich she feels terrible), PYREXIA (fever) and NAUSEA (nausea has continued from last wednesday all the way til now) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took over the counter peptobismol and an antinauseous, and it didn't work.   This case was linked to MOD-2021-299705.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: the second shot really really afected her stomach; still having a loose stool; if she eats something more than a cereal or a sandwich she feels terrible; fever; nausea has continued from last wednesday all the way til now; violently throwing up for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (the second shot really really afected her stomach), DIARRHOEA (still having a loose stool), FEELING ABNORMAL (if she eats something more than a cereal or a sandwich she feels terrible), PYREXIA (fever) and NAUSEA (nausea has continued from last wednesday all the way til now) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21 and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (the second shot really really afected her stomach), DIARRHOEA (still having a loose stool), FEELING ABNORMAL (if she eats something more than a cereal or a sandwich she feels terrible), PYREXIA (fever), NAUSEA (nausea has continued from last wednesday all the way til now) and VOMITING (violently throwing up for 2 days). The patient was treated with BISMUTH SUBSALICYLATE (PEPTOBISMOL) for Adverse event, at an unspecified dose and frequency. On 20-Aug-2021, VOMITING (violently throwing up for 2 days) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (the second shot really really afected her stomach), DIARRHOEA (still having a loose stool), FEELING ABNORMAL (if she eats something more than a cereal or a sandwich she feels terrible), PYREXIA (fever) and NAUSEA (nausea has continued from last wednesday all the way til now) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took over the counter peptobismol and an antinauseous, and it didn't work.   This case was linked to MOD-2021-299705.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Chills; Fatigue; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) in a 74-year-old patient of an unknown 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 CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            No concomitant medication was reported. No treatment history was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: tremors in my hands; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors in my hands) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No medical history was reported.    In March 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 TREMOR (tremors in my hands). At the time of the report, TREMOR (tremors in my hands) outcome was unknown.            Concomitant medications include Water pills, Thyroid medication,Cholesterol medication   Depression medication and Heart medication .  Treatment medications were not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: Patient received third dose from an expired vial; patient received a third dose from this vial that was left unpunctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received third dose from an expired vial) and OFF LABEL USE (patient received a third dose from this vial that was left unpunctured) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 031L20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary embolism, Neuropathy and Epilepsy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received third dose from an expired vial) and OFF LABEL USE (patient received a third dose from this vial that was left unpunctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received third dose from an expired vial) and OFF LABEL USE (patient received a third dose from this vial that was left unpunctured) 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.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received both doses when age 16; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Medical history was not provided.    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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16) had resolved.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  It was reported that her twin granddaughters received both doses of the Moderna Covid-19 Vaccine earlier this year when they were just 16 years old. She is now looking to get the 3rd dose for both but cannot find anyone to give them. This granddaughter received her 1st dose in late January/early February (unsure of exact dates because she does not have the vaccination card)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Influenza, Skin mass, Somnolence
Clinical narrative: have a ball between under their armpit and their chest on the left side; felt hot; spent most of the time asleep; like having the flu; headache; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (have a ball between under their armpit and their chest on the left side), FEELING HOT (felt hot), SOMNOLENCE (spent most of the time asleep), INFLUENZA (like having the flu) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-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 SKIN MASS (have a ball between under their armpit and their chest on the left side), FEELING HOT (felt hot), SOMNOLENCE (spent most of the time asleep), INFLUENZA (like having the flu) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN MASS (have a ball between under their armpit and their chest on the left side), FEELING HOT (felt hot), SOMNOLENCE (spent most of the time asleep), INFLUENZA (like having the flu) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Malaise, Nasal congestion
Clinical narrative: Felt so sick; Couldn't breath with one hole of his nose; "Reactions he never felt before"; Felt "bad bad"; Fever; Headaches; Chills; Did not received second dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt so sick), NASAL CONGESTION (Couldn't breath with one hole of his nose), VACCINATION COMPLICATION ("Reactions he never felt before"), FEELING ABNORMAL (Felt "bad bad") and PYREXIA (Fever) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-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 MALAISE (Felt so sick), NASAL CONGESTION (Couldn't breath with one hole of his nose), VACCINATION COMPLICATION ("Reactions he never felt before"), FEELING ABNORMAL (Felt "bad bad"), PYREXIA (Fever), HEADACHE (Headaches), CHILLS (Chills) and PRODUCT DOSE OMISSION ISSUE (Did not received second dose). At the time of the report, MALAISE (Felt so sick), NASAL CONGESTION (Couldn't breath with one hole of his nose), VACCINATION COMPLICATION ("Reactions he never felt before"), FEELING ABNORMAL (Felt "bad bad"), PYREXIA (Fever), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not received second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No relevant concomitant medications were reported.  Treatment information included warm vitamins and Home meds.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia, Vaccination complication
Clinical narrative: Felt so sick; Couldn't breath with one hole of his nose; "Reactions he never felt before"; Felt "bad bad"; Fever; Headaches; Chills; Did not received second dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt so sick), NASAL CONGESTION (Couldn't breath with one hole of his nose), VACCINATION COMPLICATION ("Reactions he never felt before"), FEELING ABNORMAL (Felt "bad bad") and PYREXIA (Fever) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-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 MALAISE (Felt so sick), NASAL CONGESTION (Couldn't breath with one hole of his nose), VACCINATION COMPLICATION ("Reactions he never felt before"), FEELING ABNORMAL (Felt "bad bad"), PYREXIA (Fever), HEADACHE (Headaches), CHILLS (Chills) and PRODUCT DOSE OMISSION ISSUE (Did not received second dose). At the time of the report, MALAISE (Felt so sick), NASAL CONGESTION (Couldn't breath with one hole of his nose), VACCINATION COMPLICATION ("Reactions he never felt before"), FEELING ABNORMAL (Felt "bad bad"), PYREXIA (Fever), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not received second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No relevant concomitant medications were reported.  Treatment information included warm vitamins and Home meds.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Asthenia, COVID-19, Chills
Clinical narrative: sickness; chills; Headache; very tired; hip hurts; Depression; has no energy; Vaccine received on top of shoulder on outside ball; taste loss; Covid-19; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), AGEUSIA (taste loss), RHINORRHOEA (Runny nose) and ILLNESS (sickness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concomitant products included WARFARIN for DVT, TOPIRAMATE (TOPAMAX) for Headache, VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR) and CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for an unknown indication.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced RHINORRHOEA (Runny nose). On 15-Aug-2021, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced AGEUSIA (taste loss) and ILLNESS (sickness). At the time of the report, COVID-19 (Covid-19), AGEUSIA (taste loss), RHINORRHOEA (Runny nose) and ILLNESS (sickness) 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.   She was tested positive for COVID-19 on 15-Aug-2021. Treatment was not specified.   This case was linked to MOD-2021-299980 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Headache, Illness, Product administered at inappropriate site
Clinical narrative: sickness; chills; Headache; very tired; hip hurts; Depression; has no energy; Vaccine received on top of shoulder on outside ball; taste loss; Covid-19; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), AGEUSIA (taste loss), RHINORRHOEA (Runny nose) and ILLNESS (sickness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concomitant products included WARFARIN for DVT, TOPIRAMATE (TOPAMAX) for Headache, VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR) and CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for an unknown indication.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced RHINORRHOEA (Runny nose). On 15-Aug-2021, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced AGEUSIA (taste loss) and ILLNESS (sickness). At the time of the report, COVID-19 (Covid-19), AGEUSIA (taste loss), RHINORRHOEA (Runny nose) and ILLNESS (sickness) 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.   She was tested positive for COVID-19 on 15-Aug-2021. Treatment was not specified.   This case was linked to MOD-2021-299980 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: sickness; chills; Headache; very tired; hip hurts; Depression; has no energy; Vaccine received on top of shoulder on outside ball; taste loss; Covid-19; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), AGEUSIA (taste loss), RHINORRHOEA (Runny nose) and ILLNESS (sickness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concomitant products included WARFARIN for DVT, TOPIRAMATE (TOPAMAX) for Headache, VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR) and CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for an unknown indication.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced RHINORRHOEA (Runny nose). On 15-Aug-2021, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced AGEUSIA (taste loss) and ILLNESS (sickness). At the time of the report, COVID-19 (Covid-19), AGEUSIA (taste loss), RHINORRHOEA (Runny nose) and ILLNESS (sickness) 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.   She was tested positive for COVID-19 on 15-Aug-2021. Treatment was not specified.   This case was linked to MOD-2021-299980 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Application site pain, Arthralgia, Chest pain, Chills, Headache
Clinical narrative: All the neck and arm and chest area hurts; Arm is more swollen, hard and hurts; Headache; Shivering went awat 10 mins later and felt asleep/chills and was Shivering; Swollen Nodule on the Clavicle; On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4; Arm and Shoulder was hurting; Arm is still swollen over there at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4), LYMPHADENOPATHY (Swollen Nodule on the Clavicle) and ARTHRALGIA (Arm and Shoulder was hurting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (Arm and Shoulder was hurting) and VACCINATION SITE SWELLING (Arm is still swollen over there at the injection site). On 18-Aug-2021, the patient experienced APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4). On 26-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen Nodule on the Clavicle). On an unknown date, the patient experienced CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), HEADACHE (Headache) and CHILLS (Shivering went awat 10 mins later and felt asleep/chills and was Shivering). At the time of the report, CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4), LYMPHADENOPATHY (Swollen Nodule on the Clavicle), ARTHRALGIA (Arm and Shoulder was hurting), HEADACHE (Headache) and CHILLS (Shivering went awat 10 mins later and felt asleep/chills and was Shivering) outcome was unknown and VACCINATION SITE SWELLING (Arm is still swollen over there at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not  provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy, Vaccination site swelling
Clinical narrative: All the neck and arm and chest area hurts; Arm is more swollen, hard and hurts; Headache; Shivering went awat 10 mins later and felt asleep/chills and was Shivering; Swollen Nodule on the Clavicle; On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4; Arm and Shoulder was hurting; Arm is still swollen over there at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4), LYMPHADENOPATHY (Swollen Nodule on the Clavicle) and ARTHRALGIA (Arm and Shoulder was hurting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (Arm and Shoulder was hurting) and VACCINATION SITE SWELLING (Arm is still swollen over there at the injection site). On 18-Aug-2021, the patient experienced APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4). On 26-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen Nodule on the Clavicle). On an unknown date, the patient experienced CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), HEADACHE (Headache) and CHILLS (Shivering went awat 10 mins later and felt asleep/chills and was Shivering). At the time of the report, CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4), LYMPHADENOPATHY (Swollen Nodule on the Clavicle), ARTHRALGIA (Arm and Shoulder was hurting), HEADACHE (Headache) and CHILLS (Shivering went awat 10 mins later and felt asleep/chills and was Shivering) outcome was unknown and VACCINATION SITE SWELLING (Arm is still swollen over there at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not  provided.
Sex: U
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Vaccination complication
Clinical narrative: Side effects; Stomach flu; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) and GASTROENTERITIS VIRAL (Stomach flu) 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 (Side effects) and GASTROENTERITIS VIRAL (Stomach flu). At the time of the report, VACCINATION COMPLICATION (Side effects) and GASTROENTERITIS VIRAL (Stomach flu) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications reported.  No treatment information was reported by reporter.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: she has a rash of bumps on her left arm around where the shot was given.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (she has a rash of bumps on her left arm around where the shot was given.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced VACCINATION SITE RASH (she has a rash of bumps on her left arm around where the shot was given.). At the time of the report, VACCINATION SITE RASH (she has a rash of bumps on her left arm around where the shot was given.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: Back pain; Pain between the shoulder blades three days later; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and ARTHRALGIA (Pain between the shoulder blades three days later) 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 BACK PAIN (Back pain) and ARTHRALGIA (Pain between the shoulder blades three days later). At the time of the report, BACK PAIN (Back pain) and ARTHRALGIA (Pain between the shoulder blades three days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported.   The treatment information was not provided.   Reporter did not allow further contact
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received both doses at 16 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses at 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Autoimmune disorder NOS.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses at 16 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses at 16 years old) had resolved.            No concomitant medication details were provided. No treatment information was mentioned.   This case was linked to MOD-2021-299844, MOD-2021-308656, MOD-2021-308669, MOD-2021-308669 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lacrimation increased, Pain in extremity, SARS-CoV-2 test
Clinical narrative: More than 35 days between doses; Watery eyes; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between doses), LACRIMATION INCREASED (Watery eyes) and PAIN IN EXTREMITY (Pain in the arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Blood pressure abnormal. Concomitant products included OXYGEN for an unknown indication.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between doses), LACRIMATION INCREASED (Watery eyes) and PAIN IN EXTREMITY (Pain in the arm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between doses), LACRIMATION INCREASED (Watery eyes) and PAIN IN EXTREMITY (Pain in the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID-19..         Concomitant medications included sugar pill, blood pressure and COPD medication.  Treatment information was not provided.   This case was linked to MOD-2021-299964 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: pins and needles sensation on both her feet, toes and legs/She went to her chiropractor she improved a bit but the pins and needles; legs felt like jello; had a hard time going up the stairs; weird sensation on her legs; numbness on her lower back; numbness when she lies on the side where she got the injection; feeling tired; congested; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested), PARAESTHESIA (pins and needles sensation on both her feet, toes and legs/She went to her chiropractor she improved a bit but the pins and needles), LIMB DISCOMFORT (legs felt like jello), GAIT DISTURBANCE (had a hard time going up the stairs) and FEELING ABNORMAL (weird sensation on her legs) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). On 24-Aug-2021, the patient experienced NASAL CONGESTION (congested) and FATIGUE (feeling tired). On 25-Aug-2021, the patient experienced PARAESTHESIA (pins and needles sensation on both her feet, toes and legs/She went to her chiropractor she improved a bit but the pins and needles), LIMB DISCOMFORT (legs felt like jello), GAIT DISTURBANCE (had a hard time going up the stairs), FEELING ABNORMAL (weird sensation on her legs), HYPOAESTHESIA (numbness on her lower back) and VACCINATION SITE ANAESTHESIA (numbness when she lies on the side where she got the injection). At the time of the report, NASAL CONGESTION (congested), PARAESTHESIA (pins and needles sensation on both her feet, toes and legs/She went to her chiropractor she improved a bit but the pins and needles), LIMB DISCOMFORT (legs felt like jello), GAIT DISTURBANCE (had a hard time going up the stairs), FEELING ABNORMAL (weird sensation on her legs), HYPOAESTHESIA (numbness on her lower back), VACCINATION SITE ANAESTHESIA (numbness when she lies on the side where she got the injection), FATIGUE (feeling tired), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-299954 (Parent-Child Link).   See case MOD-2021-299954 for details regarding the child case.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Nasal congestion, Paraesthesia, Vaccination site anaesthesia
Clinical narrative: pins and needles sensation on both her feet, toes and legs/She went to her chiropractor she improved a bit but the pins and needles; legs felt like jello; had a hard time going up the stairs; weird sensation on her legs; numbness on her lower back; numbness when she lies on the side where she got the injection; feeling tired; congested; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested), PARAESTHESIA (pins and needles sensation on both her feet, toes and legs/She went to her chiropractor she improved a bit but the pins and needles), LIMB DISCOMFORT (legs felt like jello), GAIT DISTURBANCE (had a hard time going up the stairs) and FEELING ABNORMAL (weird sensation on her legs) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). On 24-Aug-2021, the patient experienced NASAL CONGESTION (congested) and FATIGUE (feeling tired). On 25-Aug-2021, the patient experienced PARAESTHESIA (pins and needles sensation on both her feet, toes and legs/She went to her chiropractor she improved a bit but the pins and needles), LIMB DISCOMFORT (legs felt like jello), GAIT DISTURBANCE (had a hard time going up the stairs), FEELING ABNORMAL (weird sensation on her legs), HYPOAESTHESIA (numbness on her lower back) and VACCINATION SITE ANAESTHESIA (numbness when she lies on the side where she got the injection). At the time of the report, NASAL CONGESTION (congested), PARAESTHESIA (pins and needles sensation on both her feet, toes and legs/She went to her chiropractor she improved a bit but the pins and needles), LIMB DISCOMFORT (legs felt like jello), GAIT DISTURBANCE (had a hard time going up the stairs), FEELING ABNORMAL (weird sensation on her legs), HYPOAESTHESIA (numbness on her lower back), VACCINATION SITE ANAESTHESIA (numbness when she lies on the side where she got the injection), FATIGUE (feeling tired), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-299954 (Parent-Child Link).   See case MOD-2021-299954 for details regarding the child case.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Chills; Fatigue; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            Concomitant medication was not provided.  Treatment information was not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Reporter stated that the longest duration of symptoms was about 3 days.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Bumps at injection site; Injection site is itching really bad; Rash at injection site; Affected area like the size of medium bandage; Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site; Red injected site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site), VACCINATION SITE MASS (Bumps at injection site), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Red injected site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site) and VACCINATION SITE ERYTHEMA (Red injected site). On an unknown date, the patient experienced VACCINATION SITE MASS (Bumps at injection site), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Affected area like the size of medium bandage). On 18-Aug-2021, VACCINATION SITE ERYTHEMA (Red injected site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site), VACCINATION SITE MASS (Bumps at injection site), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Affected area like the size of medium bandage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Patient stated that injection side has been red since the day, got the shot, the affected area looks like the size of a medium bandage, it is red and noticeable hot. Patient took the temperature of forehead and temperature of affected area, affected area was almost a degree above the temperature of forehead.  The affected area felt hot when put hand over it, even without touching it, patient can feel that it was hot. Inside the red line was a red rash, bumps that itches really bad. Patient has not been itching it and uses 90% rubbing alcohol for the affected area.  Patient had an appointment on 24-Sep-2021 not related to vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Bumps at injection site; Injection site is itching really bad; Rash at injection site; Affected area like the size of medium bandage; Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site; Red injected site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site), VACCINATION SITE MASS (Bumps at injection site), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Red injected site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site) and VACCINATION SITE ERYTHEMA (Red injected site). On an unknown date, the patient experienced VACCINATION SITE MASS (Bumps at injection site), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Affected area like the size of medium bandage). On 18-Aug-2021, VACCINATION SITE ERYTHEMA (Red injected site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Temperature of affected area is almost one degree higher than her forehead/Noticeable hot injected site), VACCINATION SITE MASS (Bumps at injection site), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Affected area like the size of medium bandage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Patient stated that injection side has been red since the day, got the shot, the affected area looks like the size of a medium bandage, it is red and noticeable hot. Patient took the temperature of forehead and temperature of affected area, affected area was almost a degree above the temperature of forehead.  The affected area felt hot when put hand over it, even without touching it, patient can feel that it was hot. Inside the red line was a red rash, bumps that itches really bad. Patient has not been itching it and uses 90% rubbing alcohol for the affected area.  Patient had an appointment on 24-Sep-2021 not related to vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Rash
Clinical narrative: breastfeed; has broken out in a rash all over his body; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeed) and RASH (has broken out in a rash all over his body) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In August 2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (breastfeed) and RASH (has broken out in a rash all over his body). At the time of the report, EXPOSURE VIA BREAST MILK (breastfeed) and RASH (has broken out in a rash all over his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Parent received the first dose of the Moderna vaccine two mornings ago and on yesterday morning child has rash to who m she breastfeed and also mentioned that Nothing else has changed in my diet to cause an allergy reaction. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.