chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis
Clinical narrative: sweating around her neck; felt really hot instantly; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating around her neck) and FEELING HOT (felt really hot instantly) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced HYPERHIDROSIS (sweating around her neck) and FEELING HOT (felt really hot instantly). At the time of the report, HYPERHIDROSIS (sweating around her neck) and FEELING HOT (felt really hot instantly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations, Pyrexia
Clinical narrative: Had little fever; Had hard time breathing; Heart was racing; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had little fever), DYSPNOEA (Had hard time breathing) and PALPITATIONS (Heart was racing) in a 57-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had little fever), DYSPNOEA (Had hard time breathing) and PALPITATIONS (Heart was racing). At the time of the report, PYREXIA (Had little fever), DYSPNOEA (Had hard time breathing) and PALPITATIONS (Heart was racing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was given first dose from a vial that was punctured on 3MAY2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given first dose from a vial that was punctured on 3MAY2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was given first dose from a vial that was punctured on 3MAY2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given first dose from a vial that was punctured on 3MAY2021) outcome was unknown. Not Provided      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 provided. No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-109639 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109639:
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: 2 patients received vaccine from vial that was not swirled before administering; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-109442 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109442:Patient 1
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Achy; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Achy) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced CHILLS (Chills) and MYALGIA (Achy). On 01-May-2021, CHILLS (Chills) and MYALGIA (Achy) had resolved. Not Provided          No concomitant medication were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-066832 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066832:wife 1st dose case
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: aches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches) and ARTHRALGIA (Joint pain) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (aches) and ARTHRALGIA (Joint pain). At the time of the report, MYALGIA (aches) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No specific follow-up information recorded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Blister, Dyspnoea, Herpes zoster, Neuralgia
Clinical narrative: shingles onset after vaccine second dose; highly unusual and painful; difficulty breathing; nerve pain; nerve eruptions bilateral sacral dorsal area; bilateral sores in sacral dorsal area; weeping painful sores; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles onset after vaccine second dose), PAIN (highly unusual and painful), DYSPNOEA (difficulty breathing), NEURALGIA (nerve pain) and RASH (nerve eruptions bilateral sacral dorsal area) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced HERPES ZOSTER (shingles onset after vaccine second dose), PAIN (highly unusual and painful), DYSPNOEA (difficulty breathing), NEURALGIA (nerve pain), RASH (nerve eruptions bilateral sacral dorsal area), BLISTER (bilateral sores in sacral dorsal area) and ABSCESS (weeping painful sores). At the time of the report, HERPES ZOSTER (shingles onset after vaccine second dose), PAIN (highly unusual and painful), DYSPNOEA (difficulty breathing), NEURALGIA (nerve pain), RASH (nerve eruptions bilateral sacral dorsal area), BLISTER (bilateral sores in sacral dorsal area) and ABSCESS (weeping painful sores) outcome was unknown.            No concomitant medications were provided. Treatment medication reported includes Medical Cannabis to help sleep through pain and Naproxen 220 mg.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: shingles onset after vaccine second dose; highly unusual and painful; difficulty breathing; nerve pain; nerve eruptions bilateral sacral dorsal area; bilateral sores in sacral dorsal area; weeping painful sores; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles onset after vaccine second dose), PAIN (highly unusual and painful), DYSPNOEA (difficulty breathing), NEURALGIA (nerve pain) and RASH (nerve eruptions bilateral sacral dorsal area) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced HERPES ZOSTER (shingles onset after vaccine second dose), PAIN (highly unusual and painful), DYSPNOEA (difficulty breathing), NEURALGIA (nerve pain), RASH (nerve eruptions bilateral sacral dorsal area), BLISTER (bilateral sores in sacral dorsal area) and ABSCESS (weeping painful sores). At the time of the report, HERPES ZOSTER (shingles onset after vaccine second dose), PAIN (highly unusual and painful), DYSPNOEA (difficulty breathing), NEURALGIA (nerve pain), RASH (nerve eruptions bilateral sacral dorsal area), BLISTER (bilateral sores in sacral dorsal area) and ABSCESS (weeping painful sores) outcome was unknown.            No concomitant medications were provided. Treatment medication reported includes Medical Cannabis to help sleep through pain and Naproxen 220 mg.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (still has fever in it), VACCINATION SITE MASS (knot at injection site), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE ERYTHEMA (bright red area to injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE WARMTH (still has fever in it), VACCINATION SITE MASS (knot at injection site), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE ERYTHEMA (bright red area to injection site). At the time of the report, VACCINATION SITE WARMTH (still has fever in it), VACCINATION SITE MASS (knot at injection site), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE ERYTHEMA (bright red area to injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: patient received three doses of vaccine; dose two was beyond 36 days from first dose; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received three doses of vaccine) and INCORRECT DOSE ADMINISTERED (dose two was beyond 36 days from first dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A., 037K20A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-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 EXTRA DOSE ADMINISTERED (patient received three doses of vaccine) and INCORRECT DOSE ADMINISTERED (dose two was beyond 36 days from first dose). At the time of the report, EXTRA DOSE ADMINISTERED (patient received three doses of vaccine) and INCORRECT DOSE ADMINISTERED (dose two was beyond 36 days from first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial that had been punctured 1-2 days before; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial that had been punctured 1-2 days before) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 04-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial that had been punctured 1-2 days before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial that had been punctured 1-2 days before) outcome was unknown. Not Provided      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 treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Non-significant follow up: Source Document attached
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: I'm not feeling well"; "Last night I felt with chills"; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS ("Last night I felt with chills") and MALAISE (I'm not feeling well") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced CHILLS ("Last night I felt with chills"). On an unknown date, the patient experienced MALAISE (I'm not feeling well"). At the time of the report, CHILLS ("Last night I felt with chills") and MALAISE (I'm not feeling well") outcome was unknown. Not Provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Headache; loose bowel movement; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIARRHOEA (loose bowel movement) and FATIGUE (tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HEADACHE (Headache), DIARRHOEA (loose bowel movement) and FATIGUE (tiredness). On 01-May-2021, HEADACHE (Headache) had resolved. On 03-May-2021, FATIGUE (tiredness) had resolved. At the time of the report, DIARRHOEA (loose bowel movement) outcome was unknown. Not Provided      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 and treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-109637 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109637:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Peripheral coldness, Pyrexia
Clinical narrative: little/ mild fever; myalgia; weakness; hands and feet are cold; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little/ mild fever), MYALGIA (myalgia), ASTHENIA (weakness) and PERIPHERAL COLDNESS (hands and feet are cold) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (little/ mild fever), MYALGIA (myalgia), ASTHENIA (weakness) and PERIPHERAL COLDNESS (hands and feet are cold). At the time of the report, PYREXIA (little/ mild fever), MYALGIA (myalgia), ASTHENIA (weakness) and PERIPHERAL COLDNESS (hands and feet are cold) outcome was unknown. Not Provided      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.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia, Night sweats
Clinical narrative: Feels like  been hit by a bus; Fever; Chills; fatigued; myalgia; Night sweats; Rash; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), MYALGIA (myalgia), NIGHT SWEATS (Night sweats), FEELING ABNORMAL (Feels like  been hit by a bus) and RASH (Rash) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported.  Concomitant products included MAGNESIUM, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 23-Apr-2021, the patient experienced RASH (Rash). On 24-Apr-2021, the patient experienced MYALGIA (myalgia), NIGHT SWEATS (Night sweats), CHILLS (Chills) and FATIGUE (fatigued). On 10-May-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced FEELING ABNORMAL (Feels like  been hit by a bus). On 20-Apr-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. On 27-Apr-2021, RASH (Rash) had resolved. At the time of the report, MYALGIA (myalgia), NIGHT SWEATS (Night sweats), CHILLS (Chills), FATIGUE (fatigued) and PYREXIA (Fever) had not resolved and FEELING ABNORMAL (Feels like  been hit by a bus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Blood test: (normal) Bloodwork was clean. On 03-May-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that 5 weeks prior to getting vaccinated, patient reported quitting drinking also patient does not want to get 2nd dose of vaccine Treatment using  Tylenol was reported   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Significant follow up appended to AER MOD21-089100
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site pain
Clinical narrative: Feels like  been hit by a bus; Fever; Chills; fatigued; myalgia; Night sweats; Rash; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), MYALGIA (myalgia), NIGHT SWEATS (Night sweats), FEELING ABNORMAL (Feels like  been hit by a bus) and RASH (Rash) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported.  Concomitant products included MAGNESIUM, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 23-Apr-2021, the patient experienced RASH (Rash). On 24-Apr-2021, the patient experienced MYALGIA (myalgia), NIGHT SWEATS (Night sweats), CHILLS (Chills) and FATIGUE (fatigued). On 10-May-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced FEELING ABNORMAL (Feels like  been hit by a bus). On 20-Apr-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. On 27-Apr-2021, RASH (Rash) had resolved. At the time of the report, MYALGIA (myalgia), NIGHT SWEATS (Night sweats), CHILLS (Chills), FATIGUE (fatigued) and PYREXIA (Fever) had not resolved and FEELING ABNORMAL (Feels like  been hit by a bus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Blood test: (normal) Bloodwork was clean. On 03-May-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that 5 weeks prior to getting vaccinated, patient reported quitting drinking also patient does not want to get 2nd dose of vaccine Treatment using  Tylenol was reported   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Significant follow up appended to AER MOD21-089100
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urticaria, Vaccination site pruritus
Clinical narrative: Bumps; Itching at injection site; Breaking out in hives; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Bumps), URTICARIA (Breaking out in hives) and VACCINATION SITE PRURITUS (Itching at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BP medication for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-1900, the patient experienced URTICARIA (Breaking out in hives). On 03-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site). On 05-May-2021, the patient experienced SWELLING (Bumps). At the time of the report, SWELLING (Bumps), URTICARIA (Breaking out in hives) and VACCINATION SITE PRURITUS (Itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Pyrexia
Clinical narrative: Chills; Fever; Blood pressure went up to 160; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and BLOOD PRESSURE INCREASED (Blood pressure went up to 160) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and BLOOD PRESSURE INCREASED (Blood pressure went up to 160). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. On 18-Apr-2021, CHILLS (Chills), PYREXIA (Fever) and BLOOD PRESSURE INCREASED (Blood pressure went up to 160) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-043592 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dyspnoea, Feeling abnormal, Headache, Neck pain
Clinical narrative: Headache; breathing is different; not feeling really bad; bloating in stomach; neck pain; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), DYSPNOEA (breathing is different), FEELING ABNORMAL (not feeling really bad), ABDOMINAL DISTENSION (bloating in stomach) and NECK PAIN (neck pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported.).    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced HEADACHE (Headache), DYSPNOEA (breathing is different), FEELING ABNORMAL (not feeling really bad), ABDOMINAL DISTENSION (bloating in stomach) and NECK PAIN (neck pain). At the time of the report, HEADACHE (Headache), DYSPNOEA (breathing is different), FEELING ABNORMAL (not feeling really bad), ABDOMINAL DISTENSION (bloating in stomach) and NECK PAIN (neck pain) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Significant Followup Appended
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Taste disorder
Clinical narrative: less taste; could not taste anything; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (less taste) and TASTE DISORDER (could not taste anything) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Cholesterol, ATENOLOL and OLMESARTAN MEDOXOMIL for Hypertension, HYDROCHLOROTHIAZIDE for Hypertensive, SOLIFENACIN SUCCINATE for Overactive bladder, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced AGEUSIA (less taste) and TASTE DISORDER (could not taste anything). On 06-May-2021, AGEUSIA (less taste) and TASTE DISORDER (could not taste anything) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Influenza like illness, Vaccination site pain
Clinical narrative: Anxiety, feelings of impending doom (similar to someone having a heart attack); flu like symptoms; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety, feelings of impending doom (similar to someone having a heart attack)), INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (vaccination site pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-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 23-Apr-2021, the patient experienced ANXIETY (Anxiety, feelings of impending doom (similar to someone having a heart attack)), INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (vaccination site pain). At the time of the report, ANXIETY (Anxiety, feelings of impending doom (similar to someone having a heart attack)), INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-109482 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109482:Husbands case
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Myalgia
Clinical narrative: whole chest was achy; chills; achiness in both arms, then calves; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (whole chest was achy), CHILLS (chills) and MYALGIA (achiness in both arms, then calves) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 631B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST for Allergy, ASA and CLOPIDOGREL for Anticoagulant therapy, MIRTAZAPINE for Anxiety, GABAPENTIN for Foot pain, PANTOPRAZOLE for GERD, ATORVASTATIN and FENOFIBRATE for Hypercholesterolaemia, AMLODIPINE, LISINOPRIL and METOPROLOL TARTRATE for Hypertension, MELATONIN and TRAZODONE for Sleep disorder, FINASTERIDE, LEVOTHYROXINE and TAMSULOSIN for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced CHEST PAIN (whole chest was achy), CHILLS (chills) and MYALGIA (achiness in both arms, then calves). At the time of the report, CHEST PAIN (whole chest was achy), CHILLS (chills) and MYALGIA (achiness in both arms, then calves) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Sinus congestion
Clinical narrative: Cough; Sinus congestion; Sore throat; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), SINUS CONGESTION (Sinus congestion), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Low grade fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced COUGH (Cough), SINUS CONGESTION (Sinus congestion), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Low grade fever). At the time of the report, COUGH (Cough), SINUS CONGESTION (Sinus congestion), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Low grade fever) had resolved. Not Provided          No Concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up-event outcome updated and declined consent for further FU
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscle pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Muscle pain at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Muscle pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Muscle pain at the injection site) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported.  No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Flu-like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications include Ibuprofen and Paracetamol.   This case was linked to US-MODERNATX, INC.-MOD-2021-109499 (E2B Linked Report). This case was linked to MOD-2021-109560 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109499:Crosslink(MOD21-086966)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Had ringing in both ears that was intermittent/ The ringing became constant; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Had ringing in both ears that was intermittent/ The ringing became constant) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fatigue and Ringing in ears.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced TINNITUS (Had ringing in both ears that was intermittent/ The ringing became constant). At the time of the report, TINNITUS (Had ringing in both ears that was intermittent/ The ringing became constant) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-109561 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109561:Second Dose Case
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Moderna vaccine given within 14 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine given within 14 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine given within 14 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine given within 14 days) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Could hardly turn his neck for a fewdays.; pain in his arm; felt tired the next day; A sore neck at the base/he had pain in his arm that went into his neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (A sore neck at the base/he had pain in his arm that went into his neck), MUSCULOSKELETAL STIFFNESS (Could hardly turn his neck for a fewdays.), PAIN IN EXTREMITY (pain in his arm) and FATIGUE (felt tired the next day) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 011A21A) for COVID-19 vaccination.     No medical history was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced NECK PAIN (A sore neck at the base/he had pain in his arm that went into his neck). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Could hardly turn his neck for a fewdays.), PAIN IN EXTREMITY (pain in his arm) and FATIGUE (felt tired the next day). At the time of the report, NECK PAIN (A sore neck at the base/he had pain in his arm that went into his neck), MUSCULOSKELETAL STIFFNESS (Could hardly turn his neck for a fewdays.), PAIN IN EXTREMITY (pain in his arm) and FATIGUE (felt tired the next day) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 7-JUN-2021, updated first shot product details and added event (Musculoskeletal stiffness).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Developed a rash; Raised rash on multiple areas of the body that is pea-sized to half dollar-sized; Red (rash); Itchy (rash); This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Raised rash on multiple areas of the body that is pea-sized to half dollar-sized), RASH ERYTHEMATOUS (Red (rash)), RASH PRURITIC (Itchy (rash)) and RASH (Developed a rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE, CARVEDILOL, ATORVASTATIN, AMLODIPINE and ZOLPIDEM for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced RASH PAPULAR (Raised rash on multiple areas of the body that is pea-sized to half dollar-sized), RASH ERYTHEMATOUS (Red (rash)) and RASH PRURITIC (Itchy (rash)). On 11-Apr-2021, the patient experienced RASH (Developed a rash). At the time of the report, RASH PAPULAR (Raised rash on multiple areas of the body that is pea-sized to half dollar-sized), RASH ERYTHEMATOUS (Red (rash)), RASH PRURITIC (Itchy (rash)) and RASH (Developed a rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up received on 19-MAY-2021: Updated product information, events and concomitant medication and reporter information.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Redness is itchy; Redness is itchy , red and painful; Redness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness near injection site), VACCINATION SITE PRURITUS (Redness is itchy) and VACCINATION SITE PAIN (Redness is itchy , red and painful) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Consumer was exposed to Covid) in December 2020. Concurrent medical conditions included Drug allergy (Consumer is allergic to Lamisil.).   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness near injection site) and VACCINATION SITE PAIN (Redness is itchy , red and painful). On 05-May-2021, the patient experienced VACCINATION SITE PRURITUS (Redness is itchy). At the time of the report, VACCINATION SITE ERYTHEMA (Redness near injection site), VACCINATION SITE PRURITUS (Redness is itchy) and VACCINATION SITE PAIN (Redness is itchy , red and painful) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Extreme fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), PROBIOTIC 10, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and PARACETAMOL (TYLENOL) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, 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 FATIGUE (Extreme fatigue). On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reporte   This case was linked to MOD-2021-109542 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up received and Patient stated that she was experiencing Dizziness since February; Sender's Comments:  MOD-2021-109542:First Dose Case
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Food intolerance, Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Sore arm; Nausea; Throwing up; Slight fever; Not able to keep "regular food"; This spontaneous case was reported by a consumer and describes the occurrence of FOOD INTOLERANCE (Not able to keep "regular food"), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea), VOMITING (Throwing up) and PYREXIA (Slight fever) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FOOD INTOLERANCE (Not able to keep "regular food"), NAUSEA (Nausea), VOMITING (Throwing up) and PYREXIA (Slight fever). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with GUAIFENESIN (MUCINEX) for Nausea, at an unspecified dose and frequency. At the time of the report, FOOD INTOLERANCE (Not able to keep "regular food"), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea), VOMITING (Throwing up) and PYREXIA (Slight fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  On 07-Jul-2021, the patient reported that he was doing a lot better at the time of the report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up report received included information about outcome of the events and was updated to recovering/ resolving.