chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Nausea
Clinical narrative: Dizziness; Nausea; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (Dizziness) and NAUSEA (Nausea) 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 DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: low (Low) Low heart rate (within 10 minutes).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned.  No treatment medication was mentioned.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Disorientation, Dizziness, Feeling abnormal, Headache
Clinical narrative: she feels light headed; foggy\ also feels a cloud in her head/overall she doesn't feel right; disoriented; she feels dehydrated; she feels nauseated; massive headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (she feels light headed), FEELING ABNORMAL (foggy\ also feels a cloud in her head/overall she doesn't feel right), DISORIENTATION (disoriented), DEHYDRATION (she feels dehydrated) and NAUSEA (she feels nauseated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced DIZZINESS (she feels light headed), FEELING ABNORMAL (foggy\ also feels a cloud in her head/overall she doesn't feel right), DISORIENTATION (disoriented), DEHYDRATION (she feels dehydrated), NAUSEA (she feels nauseated) and HEADACHE (massive headache). At the time of the report, DIZZINESS (she feels light headed), FEELING ABNORMAL (foggy\ also feels a cloud in her head/overall she doesn't feel right), DISORIENTATION (disoriented), DEHYDRATION (she feels dehydrated), NAUSEA (she feels nauseated) and HEADACHE (massive headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient took medicines for it, She is concerned about dosage since she weighs 102 pounds, she wants to know if this or hot weather influences the speed side effects appear.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: she feels light headed; foggy\ also feels a cloud in her head/overall she doesn't feel right; disoriented; she feels dehydrated; she feels nauseated; massive headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (she feels light headed), FEELING ABNORMAL (foggy\ also feels a cloud in her head/overall she doesn't feel right), DISORIENTATION (disoriented), DEHYDRATION (she feels dehydrated) and NAUSEA (she feels nauseated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced DIZZINESS (she feels light headed), FEELING ABNORMAL (foggy\ also feels a cloud in her head/overall she doesn't feel right), DISORIENTATION (disoriented), DEHYDRATION (she feels dehydrated), NAUSEA (she feels nauseated) and HEADACHE (massive headache). At the time of the report, DIZZINESS (she feels light headed), FEELING ABNORMAL (foggy\ also feels a cloud in her head/overall she doesn't feel right), DISORIENTATION (disoriented), DEHYDRATION (she feels dehydrated), NAUSEA (she feels nauseated) and HEADACHE (massive headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient took medicines for it, She is concerned about dosage since she weighs 102 pounds, she wants to know if this or hot weather influences the speed side effects appear.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Couldn't receive the second one; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Couldn't receive the second one) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery.    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 (Couldn't receive the second one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Couldn't receive the second one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information were reported. No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-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 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient administered first dose of Moderna COVID-19 vaccine at the age of 17; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of Moderna COVID-19 vaccine at the age of 17) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of Moderna COVID-19 vaccine at the age of 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of Moderna COVID-19 vaccine at the age of 17) 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 Concomitant medications were reported. No Treatment medications were reported. The dentists want to knowhow they should proceed with these patients, are they able to complete the vaccination series. The second question was whether these patients could be enrolled in a clinical trial for the Moderna COVID-19 vaccine in pediatric patients.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose 50 days ago, second dose has not been given yet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 50 days ago, second dose has not been given yet) in a 47-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 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 50 days ago, second dose has not been given yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose 50 days ago, second dose has not been given yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment medication was reported.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine more than 12 hours from required time injected to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine more than 12 hours from required time injected to patient) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine more than 12 hours from required time injected to patient). On 31-Jul-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine more than 12 hours from required time injected to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications information was not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received and contain Non significant information.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Patient had a 8month baby she had prior vaccination that she was planning to breastfeed; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Patient had a 8month baby she had prior vaccination that she was planning to breastfeed) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026p21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Patient had a 8month baby she had prior vaccination that she was planning to breastfeed). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Patient had a 8month baby she had prior vaccination that she was planning to breastfeed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a 8month baby she had prior vaccination that she was planning to breastfeed . Therefore, she was not yet breastfeeding when she received the vaccine. No Concomitant product details were provided by the reporter. No Treatment information was provided.   This case was linked to MOD-2021-271978.   See case MOD-2021-271978 for details regarding the child case.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Lightheadedness; weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) and ASTHENIA (weakness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031120A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis (worsening, now on Prolia (every 6 mos. injections)) in 2014, Acute pancreatitis in 2009, High cholesterol in 2014 and Asthma (Lifelong). Concurrent medical conditions included Seasonal allergy (Lifelong) and Iodine allergy (Lifelong). Concomitant products included ATORVASTATIN for High cholesterol.   On 04-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Lightheadedness) and ASTHENIA (weakness). The patient was treated with Manual therapy (ECGs, OJ and fruit cup) for Dizziness and Manual therapy (ECGs, OJ and fruit cup) for Asthenia. At the time of the report, DIZZINESS (Lightheadedness) and ASTHENIA (weakness) was resolving. Not Provided          This case was linked to MOD-2021-020930.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) 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 reported. Treatment information was not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Headache, Rhinorrhoea
Clinical narrative: Cough; Runny nose; Dizziness; Itchy throat; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (Runny nose), DIZZINESS (Dizziness), THROAT IRRITATION (Itchy throat) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery. Concomitant products included AMOXICILLIN for an unknown indication.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced COUGH (Cough), RHINORRHOEA (Runny nose), DIZZINESS (Dizziness), THROAT IRRITATION (Itchy throat), HEADACHE (Headache) and FATIGUE (Tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), RHINORRHOEA (Runny nose), DIZZINESS (Dizziness), THROAT IRRITATION (Itchy throat), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products used included vitamins.  The patient explained they still having these symptoms but feeling a little better. The patient has taken ibuprofen and robitussin to help with the symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Cough; Runny nose; Dizziness; Itchy throat; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (Runny nose), DIZZINESS (Dizziness), THROAT IRRITATION (Itchy throat) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery. Concomitant products included AMOXICILLIN for an unknown indication.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced COUGH (Cough), RHINORRHOEA (Runny nose), DIZZINESS (Dizziness), THROAT IRRITATION (Itchy throat), HEADACHE (Headache) and FATIGUE (Tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), RHINORRHOEA (Runny nose), DIZZINESS (Dizziness), THROAT IRRITATION (Itchy throat), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products used included vitamins.  The patient explained they still having these symptoms but feeling a little better. The patient has taken ibuprofen and robitussin to help with the symptoms.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose yet / More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet / More than 36 days after the first dose without receiving the second dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, 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 (Patient hasn't received 2nd dose yet / More than 36 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet / More than 36 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Reporter details, Patient demographics was added , Start date of drug was updated , patient route of administration was updated ,Batch no added. Corresponding fields and narrative was updated.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Large red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Large red 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 RASH ERYTHEMATOUS (Large red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Large red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Arthritis Flare ups after second vaccine; Bumps on both hands come and go after second vaccine; Painful Hard Bumps on both hands after second vaccine; Can not work with hands after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Bumps on both hands come and go after second vaccine), PAIN IN EXTREMITY (Painful Hard Bumps on both hands after second vaccine), MOBILITY DECREASED (Can not work with hands after second vaccine) and ARTHRITIS (Arthritis Flare ups after second vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A) and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Bumps on both hands come and go after second vaccine), PAIN IN EXTREMITY (Painful Hard Bumps on both hands after second vaccine) and MOBILITY DECREASED (Can not work with hands after second vaccine). On 15-May-2021, the patient experienced ARTHRITIS (Arthritis Flare ups after second vaccine). The patient was treated with DICLOFENAC (VOLTAREN [DICLOFENAC]) (topical) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Bumps on both hands come and go after second vaccine), PAIN IN EXTREMITY (Painful Hard Bumps on both hands after second vaccine), MOBILITY DECREASED (Can not work with hands after second vaccine) and ARTHRITIS (Arthritis Flare ups after second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was received by the patient.  Treatment information included putting Copper Infused Gloves on hands reported by the patient.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Suspected COVID-19
Clinical narrative: First dose was over 4 months ago; Symptoms similar to COVID; This spontaneous case was reported by a non-health professional and describes the occurrence of SUSPECTED COVID-19 (Symptoms similar to COVID) and PRODUCT DOSE OMISSION ISSUE (First dose was over 4 months ago) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced SUSPECTED COVID-19 (Symptoms similar to COVID). On 30-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose was over 4 months ago). On 01-Apr-2021, SUSPECTED COVID-19 (Symptoms similar to COVID) had resolved. On 30-Jul-2021, PRODUCT DOSE OMISSION ISSUE (First dose was over 4 months ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administed 1 day after expiration date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administed 1 day after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administed 1 day after expiration date). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (dose administed 1 day after expiration date) 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 reported  No Treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Pain on armpit; Swollen lymph nodes/swollen armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Pain on armpit) and LYMPHADENOPATHY (Swollen lymph nodes/swollen armpit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced AXILLARY PAIN (Pain on armpit) and LYMPHADENOPATHY (Swollen lymph nodes/swollen armpit). At the time of the report, AXILLARY PAIN (Pain on armpit) and LYMPHADENOPATHY (Swollen lymph nodes/swollen armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Peripheral swelling, Vaccination site pain
Clinical narrative: Sudden swollen left arm/arm is now as big as 'Popeyes'; Warm to touch; Pain concentrating at the back of the elbow; Sudden painful left arm; pain scale of 10; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Sudden swollen left arm/arm is now as big as 'Popeyes'), FEELING HOT (Warm to touch), ARTHRALGIA (Pain concentrating at the back of the elbow) and VACCINATION SITE PAIN (Sudden painful left arm; pain scale of 10) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to moulds and Penicillin allergy.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced PERIPHERAL SWELLING (Sudden swollen left arm/arm is now as big as 'Popeyes'), FEELING HOT (Warm to touch), ARTHRALGIA (Pain concentrating at the back of the elbow) and VACCINATION SITE PAIN (Sudden painful left arm; pain scale of 10). At the time of the report, PERIPHERAL SWELLING (Sudden swollen left arm/arm is now as big as 'Popeyes'), FEELING HOT (Warm to touch), ARTHRALGIA (Pain concentrating at the back of the elbow) and VACCINATION SITE PAIN (Sudden painful left arm; pain scale of 10) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was not taking any prescribed medication or supplements.  Patient took CVS patch for pain, applied on the affected part.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Dysstasia, Feeling cold, Hypersensitivity
Clinical narrative: Severe allergy; my body felt cold; tightness in my chest/chest tightness got worse; not easy to take my breath; left and right foot started swollen/both left and right foot got more swollen(mostly the left one); Pulsing pain/pulsing pain on mainly the left foot. Right foot also have pulsing pain but not as much as left foot; I can't even step on my foot at all; can't sleep/hard time to sleep with; This case was received via  Medicines Agency (Reference number: US-irms-MOD21-125290   ) on 01-Aug-2021 and was forwarded to Moderna on 01-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergy), FEELING COLD (my body felt cold), CHEST DISCOMFORT (tightness in my chest/chest tightness got worse), DYSPNOEA (not easy to take my breath) and PERIPHERAL SWELLING (left and right foot started swollen/both left and right foot got more swollen(mostly the left one)) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Severe allergy), FEELING COLD (my body felt cold), CHEST DISCOMFORT (tightness in my chest/chest tightness got worse), DYSPNOEA (not easy to take my breath), PERIPHERAL SWELLING (left and right foot started swollen/both left and right foot got more swollen(mostly the left one)), PAIN IN EXTREMITY (Pulsing pain/pulsing pain on mainly the left foot. Right foot also have pulsing pain but not as much as left foot), DYSSTASIA (I can't even step on my foot at all) and INSOMNIA (can't sleep/hard time to sleep with). At the time of the report, HYPERSENSITIVITY (Severe allergy) outcome was unknown and FEELING COLD (my body felt cold), CHEST DISCOMFORT (tightness in my chest/chest tightness got worse), DYSPNOEA (not easy to take my breath), PERIPHERAL SWELLING (left and right foot started swollen/both left and right foot got more swollen(mostly the left one)), PAIN IN EXTREMITY (Pulsing pain/pulsing pain on mainly the left foot. Right foot also have pulsing pain but not as much as left foot), DYSSTASIA (I can't even step on my foot at all) and INSOMNIA (can't sleep/hard time to sleep with) had not resolved.            No concomitant medications reported. No treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information received contains  Reporter details, patient demographics, Events update - Feeling cold, Chest discomfort, Dyspnoea, Peripheral Swelling, Pain in extremity, Dysstasia, Insomnia, dose-1 and dose-2 details and same events after second vaccine
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Severe allergy; my body felt cold; tightness in my chest/chest tightness got worse; not easy to take my breath; left and right foot started swollen/both left and right foot got more swollen(mostly the left one); Pulsing pain/pulsing pain on mainly the left foot. Right foot also have pulsing pain but not as much as left foot; I can't even step on my foot at all; can't sleep/hard time to sleep with; This case was received via  Medicines Agency (Reference number: US-irms-MOD21-125290   ) on 01-Aug-2021 and was forwarded to Moderna on 01-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergy), FEELING COLD (my body felt cold), CHEST DISCOMFORT (tightness in my chest/chest tightness got worse), DYSPNOEA (not easy to take my breath) and PERIPHERAL SWELLING (left and right foot started swollen/both left and right foot got more swollen(mostly the left one)) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Severe allergy), FEELING COLD (my body felt cold), CHEST DISCOMFORT (tightness in my chest/chest tightness got worse), DYSPNOEA (not easy to take my breath), PERIPHERAL SWELLING (left and right foot started swollen/both left and right foot got more swollen(mostly the left one)), PAIN IN EXTREMITY (Pulsing pain/pulsing pain on mainly the left foot. Right foot also have pulsing pain but not as much as left foot), DYSSTASIA (I can't even step on my foot at all) and INSOMNIA (can't sleep/hard time to sleep with). At the time of the report, HYPERSENSITIVITY (Severe allergy) outcome was unknown and FEELING COLD (my body felt cold), CHEST DISCOMFORT (tightness in my chest/chest tightness got worse), DYSPNOEA (not easy to take my breath), PERIPHERAL SWELLING (left and right foot started swollen/both left and right foot got more swollen(mostly the left one)), PAIN IN EXTREMITY (Pulsing pain/pulsing pain on mainly the left foot. Right foot also have pulsing pain but not as much as left foot), DYSSTASIA (I can't even step on my foot at all) and INSOMNIA (can't sleep/hard time to sleep with) had not resolved.            No concomitant medications reported. No treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information received contains  Reporter details, patient demographics, Events update - Feeling cold, Chest discomfort, Dyspnoea, Peripheral Swelling, Pain in extremity, Dysstasia, Insomnia, dose-1 and dose-2 details and same events after second vaccine
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got very sick with the second covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very sick with the second covid vaccine) in a 56-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, 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 ILLNESS (Got very sick with the second covid vaccine). At the time of the report, ILLNESS (Got very sick with the second covid vaccine) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: I am having allergic reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (I am having allergic reaction to 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 ALLERGY TO VACCINE (I am having allergic reaction to the vaccine). At the time of the report, ALLERGY TO VACCINE (I am having allergic reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. No Treatment medications were provided by reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site mass
Clinical narrative: it was a bit itchy; small bump that did not grow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it was a bit itchy) and VACCINATION SITE MASS (small bump that did not grow) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PRURITUS (it was a bit itchy) and VACCINATION SITE MASS (small bump that did not grow). On 13-Jul-2021, PRURITUS (it was a bit itchy) and VACCINATION SITE MASS (small bump that did not grow) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.   This case was linked to MOD-2021-272121 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: huge red spot (3in by 4in) where it was injected and it's itchy; huge red spot (3in by 4in) where it was injected and it's itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (huge red spot (3in by 4in) where it was injected and it's itchy) and VACCINATION SITE ERYTHEMA (huge red spot (3in by 4in) where it was injected and it's itchy) 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 PRURITUS (huge red spot (3in by 4in) where it was injected and it's itchy) and VACCINATION SITE ERYTHEMA (huge red spot (3in by 4in) where it was injected and it's itchy). At the time of the report, VACCINATION SITE PRURITUS (huge red spot (3in by 4in) where it was injected and it's itchy) and VACCINATION SITE ERYTHEMA (huge red spot (3in by 4in) where it was injected and it's itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. Treatment information was not provided. Patient got the vaccination shot on the 22nd (exact date unspecified).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule, Pain in extremity
Clinical narrative: deep pain in her hands; hands appear bright red and don't function as usual; Large nodules have appeared on her hands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (deep pain in her hands), ERYTHEMA (hands appear bright red and don't function as usual) and NODULE (Large nodules have appeared on her hands) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Squamous cell carcinoma.    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 PAIN IN EXTREMITY (deep pain in her hands), ERYTHEMA (hands appear bright red and don't function as usual) and NODULE (Large nodules have appeared on her hands). At the time of the report, PAIN IN EXTREMITY (deep pain in her hands), ERYTHEMA (hands appear bright red and don't function as usual) and NODULE (Large nodules have appeared on her hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Sweating; Rash all over the upper torso and his back; Whole body is sore and achy; Chills; Fever of 102.6F; Pain in his arm to his hand on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), RASH (Rash all over the upper torso and his back), VACCINATION SITE PAIN (Pain in his arm to his hand on the injection site), MYALGIA (Whole body is sore and achy) and CHILLS (Chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (The patient is allergic to Haldol) and Drug allergy (The patient is allergic to Stemzine).    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced VACCINATION SITE PAIN (Pain in his arm to his hand on the injection site). On 29-Jul-2021, the patient experienced HYPERHIDROSIS (Sweating), RASH (Rash all over the upper torso and his back), MYALGIA (Whole body is sore and achy), CHILLS (Chills) and PYREXIA (Fever of 102.6F). At the time of the report, HYPERHIDROSIS (Sweating), RASH (Rash all over the upper torso and his back), VACCINATION SITE PAIN (Pain in his arm to his hand on the injection site), MYALGIA (Whole body is sore and achy), CHILLS (Chills) and PYREXIA (Fever of 102.6F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, Body temperature: 102.6 (High) 102.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  It was reported that the patient drank a lot of water as part of treatment.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: Sweating; Rash all over the upper torso and his back; Whole body is sore and achy; Chills; Fever of 102.6F; Pain in his arm to his hand on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), RASH (Rash all over the upper torso and his back), VACCINATION SITE PAIN (Pain in his arm to his hand on the injection site), MYALGIA (Whole body is sore and achy) and CHILLS (Chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (The patient is allergic to Haldol) and Drug allergy (The patient is allergic to Stemzine).    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced VACCINATION SITE PAIN (Pain in his arm to his hand on the injection site). On 29-Jul-2021, the patient experienced HYPERHIDROSIS (Sweating), RASH (Rash all over the upper torso and his back), MYALGIA (Whole body is sore and achy), CHILLS (Chills) and PYREXIA (Fever of 102.6F). At the time of the report, HYPERHIDROSIS (Sweating), RASH (Rash all over the upper torso and his back), VACCINATION SITE PAIN (Pain in his arm to his hand on the injection site), MYALGIA (Whole body is sore and achy), CHILLS (Chills) and PYREXIA (Fever of 102.6F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, Body temperature: 102.6 (High) 102.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  It was reported that the patient drank a lot of water as part of treatment.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Myalgia, Pain, Pyrexia
Clinical narrative: Upset stomach; Diarrhea; Pains; Fever; vomiting; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), PAIN (Pains), PYREXIA (Fever) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 28-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), PAIN (Pains), PYREXIA (Fever), VOMITING (vomiting) and MYALGIA (Aches). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), PAIN (Pains), PYREXIA (Fever), VOMITING (vomiting) and MYALGIA (Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Upset stomach; Diarrhea; Pains; Fever; vomiting; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), PAIN (Pains), PYREXIA (Fever) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 28-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), PAIN (Pains), PYREXIA (Fever), VOMITING (vomiting) and MYALGIA (Aches). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), PAIN (Pains), PYREXIA (Fever), VOMITING (vomiting) and MYALGIA (Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: I experience muscle pain and fever; I experience muscle pain and fever; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (I experience muscle pain and fever) and PYREXIA (I experience muscle pain and fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information was provided.    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) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced MYALGIA (I experience muscle pain and fever) and PYREXIA (I experience muscle pain and fever). At the time of the report, MYALGIA (I experience muscle pain and fever) and PYREXIA (I experience muscle pain and fever) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient enquired Will taking acetaminophen (Tylenol) affect the effectiveness of the vaccine