chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Mild shivers; Mild Body Aches; Tired; Chills; Foggy; Thirst; Mild Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), THIRST (Thirst), PYREXIA (Mild Fever), CHILLS (Mild shivers) and PAIN (Mild Body Aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Mild Fever). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy), THIRST (Thirst), CHILLS (Mild shivers), PAIN (Mild Body Aches), FATIGUE (Tired) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Apr-2021, PYREXIA (Mild Fever) had resolved. On 18-Apr-2021, FEELING ABNORMAL (Foggy), THIRST (Thirst), CHILLS (Mild shivers), PAIN (Mild Body Aches), FATIGUE (Tired) and CHILLS (Chills) had resolved.            Concomitant medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Mild shivers; Mild Body Aches; Tired; Chills; Foggy; Thirst; Mild Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), THIRST (Thirst), PYREXIA (Mild Fever), CHILLS (Mild shivers) and PAIN (Mild Body Aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Mild Fever). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy), THIRST (Thirst), CHILLS (Mild shivers), PAIN (Mild Body Aches), FATIGUE (Tired) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Apr-2021, PYREXIA (Mild Fever) had resolved. On 18-Apr-2021, FEELING ABNORMAL (Foggy), THIRST (Thirst), CHILLS (Mild shivers), PAIN (Mild Body Aches), FATIGUE (Tired) and CHILLS (Chills) had resolved.            Concomitant medications were not provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Sleeping a lot; Feeling tired/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping a lot) and FATIGUE (Feeling tired/fatigued) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced HYPERSOMNIA (Sleeping a lot) and FATIGUE (Feeling tired/fatigued). At the time of the report, HYPERSOMNIA (Sleeping a lot) and FATIGUE (Feeling tired/fatigued) 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 by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin mass, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Heat at injection site; Knot on arm above elbowand it has heat to touch; Redness on arm and shoulder and hot to touch; Redness at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat at injection site), SKIN MASS (Knot on arm above elbowand it has heat to touch), ERYTHEMA (Redness on arm and shoulder and hot to touch), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Heat at injection site), SKIN MASS (Knot on arm above elbowand it has heat to touch), ERYTHEMA (Redness on arm and shoulder and hot to touch), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE WARMTH (Heat at injection site), SKIN MASS (Knot on arm above elbowand it has heat to touch), ERYTHEMA (Redness on arm and shoulder and hot to touch), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Visual impairment
Clinical narrative: Can't see out of the right eye; Shingles\right side of their face, right eye and scalp have shingles and are damaged; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles\right side of their face, right eye and scalp have shingles and are damaged) and VISUAL IMPAIRMENT (Can't see out of the right eye) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HERPES ZOSTER (Shingles\right side of their face, right eye and scalp have shingles and are damaged). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Can't see out of the right eye). At the time of the report, HERPES ZOSTER (Shingles\right side of their face, right eye and scalp have shingles and are damaged) and VISUAL IMPAIRMENT (Can't see out of the right eye) outcome was unknown. Not Provided          No concomitant medication was reported  No treatment medication was reported Case is crosslinked to MOD21-079093   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Event detail updated
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Felt warmth flowing down arm right after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Felt warmth flowing down arm right after vaccination) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A1A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Felt warmth flowing down arm right after vaccination). At the time of the report, VACCINATION SITE WARMTH (Felt warmth flowing down arm right after vaccination) outcome was unknown. Not Provided          Concomitant medications included Pain medications. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Cough, Inappropriate schedule of product administration, Nasal congestion
Clinical narrative: diagnosed with positive covid test; More than 36 days have past since first shot, delayed second shot; cough; Nasal congestion; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (diagnosed with positive covid test), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have past since first shot, delayed second shot), COUGH (cough), NASAL CONGESTION (Nasal congestion) and ANOSMIA (Loss of smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (diagnosed with positive covid test), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have past since first shot, delayed second shot), COUGH (cough), NASAL CONGESTION (Nasal congestion) and ANOSMIA (Loss of smell). At the time of the report, SARS-COV-2 TEST POSITIVE (diagnosed with positive covid test), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have past since first shot, delayed second shot), COUGH (cough), NASAL CONGESTION (Nasal congestion) and ANOSMIA (Loss of smell) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, COVID-19 (other-Unknown positive/non-neutralizing): posiive positive/non-neutralizing (High) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received on 23-JUL-2021 , lab data updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: diagnosed with positive covid test; More than 36 days have past since first shot, delayed second shot; cough; Nasal congestion; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (diagnosed with positive covid test), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have past since first shot, delayed second shot), COUGH (cough), NASAL CONGESTION (Nasal congestion) and ANOSMIA (Loss of smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (diagnosed with positive covid test), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have past since first shot, delayed second shot), COUGH (cough), NASAL CONGESTION (Nasal congestion) and ANOSMIA (Loss of smell). At the time of the report, SARS-COV-2 TEST POSITIVE (diagnosed with positive covid test), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have past since first shot, delayed second shot), COUGH (cough), NASAL CONGESTION (Nasal congestion) and ANOSMIA (Loss of smell) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, COVID-19 (other-Unknown positive/non-neutralizing): posiive positive/non-neutralizing (High) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received on 23-JUL-2021 , lab data updated.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Bedridden, Chills, Fatigue
Clinical narrative: Asthma; fFtigue; Bedridden; Could not lift her arm; Arm was so sore at the injection site; Chills; Aches/ Pain; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bedridden), ASTHMA (Asthma), LIMB DISCOMFORT (Could not lift her arm), VACCINATION SITE PAIN (Arm was so sore at the injection site) and CHILLS (Chills) in a 43-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 COVID-19.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced LIMB DISCOMFORT (Could not lift her arm), VACCINATION SITE PAIN (Arm was so sore at the injection site), CHILLS (Chills), MYALGIA (Aches/ Pain) and ARTHRALGIA (Sore arm). On 20-Apr-2021, the patient experienced BEDRIDDEN (Bedridden). On 23-Apr-2021, the patient experienced FATIGUE (fFtigue). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHMA (Asthma). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (Bedridden), ASTHMA (Asthma), LIMB DISCOMFORT (Could not lift her arm), VACCINATION SITE PAIN (Arm was so sore at the injection site), CHILLS (Chills), MYALGIA (Aches/ Pain), ARTHRALGIA (Sore arm) and FATIGUE (fFtigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  It was reported that patient was on several medications after diagnosed with asthma. Patient stated that she cancelled her second shot.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-May-2021 contains significant information: added  medical history and new events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Vaccination site pain
Clinical narrative: Asthma; fFtigue; Bedridden; Could not lift her arm; Arm was so sore at the injection site; Chills; Aches/ Pain; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bedridden), ASTHMA (Asthma), LIMB DISCOMFORT (Could not lift her arm), VACCINATION SITE PAIN (Arm was so sore at the injection site) and CHILLS (Chills) in a 43-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 COVID-19.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced LIMB DISCOMFORT (Could not lift her arm), VACCINATION SITE PAIN (Arm was so sore at the injection site), CHILLS (Chills), MYALGIA (Aches/ Pain) and ARTHRALGIA (Sore arm). On 20-Apr-2021, the patient experienced BEDRIDDEN (Bedridden). On 23-Apr-2021, the patient experienced FATIGUE (fFtigue). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHMA (Asthma). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (Bedridden), ASTHMA (Asthma), LIMB DISCOMFORT (Could not lift her arm), VACCINATION SITE PAIN (Arm was so sore at the injection site), CHILLS (Chills), MYALGIA (Aches/ Pain), ARTHRALGIA (Sore arm) and FATIGUE (fFtigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  It was reported that patient was on several medications after diagnosed with asthma. Patient stated that she cancelled her second shot.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-May-2021 contains significant information: added  medical history and new events.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate, Myalgia
Clinical narrative: Achy body; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy body) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 032M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced MYALGIA (Achy body) and CHILLS (Chills). At the time of the report, MYALGIA (Achy body) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Heart rate: 114 (High) Abnormally high heart rate (up to 114 beats per minute).         No treatment information was provided. No concomitant product was reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis, Product dose omission issue
Clinical narrative: got a cold unrelated to COVID; Sick; failed get vaccinated with the second dose it has now been 72 days; This spontaneous case was reported by a health care professional and describes the occurrence of NASOPHARYNGITIS (got a cold unrelated to COVID), ILLNESS (Sick) and PRODUCT DOSE OMISSION ISSUE (failed get vaccinated with the second dose it has now been 72 days) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced NASOPHARYNGITIS (got a cold unrelated to COVID), ILLNESS (Sick) and PRODUCT DOSE OMISSION ISSUE (failed get vaccinated with the second dose it has now been 72 days). At the time of the report, NASOPHARYNGITIS (got a cold unrelated to COVID), ILLNESS (Sick) and PRODUCT DOSE OMISSION ISSUE (failed get vaccinated with the second dose it has now been 72 days) 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 medication were reported. Treatment medication was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Dysphonia, Fatigue
Clinical narrative: Feel very bad; Pain; Vvoice is agitated; Eats half of the usual; Tremors; Dizzy; Feels very heavy; As if she had all the AE of covid; Vomits; Headache; Chills; Tired; Nausea; Shivering of cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual) and TREMOR (Tremors) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A or H and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual), TREMOR (Tremors), DIZZINESS (Dizzy), LIMB DISCOMFORT (Feels very heavy), VACCINATION COMPLICATION (As if she had all the AE of covid), VOMITING (Vomits), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Nausea) and CHILLS (Shivering of cold). At the time of the report, FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual), TREMOR (Tremors), DIZZINESS (Dizzy), LIMB DISCOMFORT (Feels very heavy), VACCINATION COMPLICATION (As if she had all the AE of covid), VOMITING (Vomits), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Nausea) and CHILLS (Shivering of cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medication list was not provided. Treatment provided include injection for pain and sublingual pill for nausea. The patient reported that she had an X-ray of her lungs.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Limb discomfort, Nausea, Pain
Clinical narrative: Feel very bad; Pain; Vvoice is agitated; Eats half of the usual; Tremors; Dizzy; Feels very heavy; As if she had all the AE of covid; Vomits; Headache; Chills; Tired; Nausea; Shivering of cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual) and TREMOR (Tremors) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A or H and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual), TREMOR (Tremors), DIZZINESS (Dizzy), LIMB DISCOMFORT (Feels very heavy), VACCINATION COMPLICATION (As if she had all the AE of covid), VOMITING (Vomits), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Nausea) and CHILLS (Shivering of cold). At the time of the report, FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual), TREMOR (Tremors), DIZZINESS (Dizzy), LIMB DISCOMFORT (Feels very heavy), VACCINATION COMPLICATION (As if she had all the AE of covid), VOMITING (Vomits), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Nausea) and CHILLS (Shivering of cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medication list was not provided. Treatment provided include injection for pain and sublingual pill for nausea. The patient reported that she had an X-ray of her lungs.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor, Vaccination complication, Vomiting
Clinical narrative: Feel very bad; Pain; Vvoice is agitated; Eats half of the usual; Tremors; Dizzy; Feels very heavy; As if she had all the AE of covid; Vomits; Headache; Chills; Tired; Nausea; Shivering of cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual) and TREMOR (Tremors) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A or H and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual), TREMOR (Tremors), DIZZINESS (Dizzy), LIMB DISCOMFORT (Feels very heavy), VACCINATION COMPLICATION (As if she had all the AE of covid), VOMITING (Vomits), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Nausea) and CHILLS (Shivering of cold). At the time of the report, FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual), TREMOR (Tremors), DIZZINESS (Dizzy), LIMB DISCOMFORT (Feels very heavy), VACCINATION COMPLICATION (As if she had all the AE of covid), VOMITING (Vomits), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Nausea) and CHILLS (Shivering of cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medication list was not provided. Treatment provided include injection for pain and sublingual pill for nausea. The patient reported that she had an X-ray of her lungs.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Discomfort, Head discomfort, Limb discomfort, Pyrexia
Clinical narrative: Felt bloated; Body felt very heavy; Head felt very heavy; Heaviness in her legs; Very high fever during the day and at night for two consecutive days; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Felt bloated), DISCOMFORT (Body felt heavy), HEAD DISCOMFORT (felt heavy), LIMB DISCOMFORT (Heaviness in her legs) and PYREXIA (Very high fever for two consecutive days) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included BISOPROLOL FUMARATE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced ABDOMINAL DISTENSION (Felt bloated), DISCOMFORT (Body felt heavy), HEAD DISCOMFORT (Head felt heavy), LIMB DISCOMFORT (Heaviness in her legs) and PYREXIA (Very high fever during the day for two consecutive days). The patient was treated with ACETAMINOPHEN for Fever, at a dose of 650 mg. On 18-Apr-2021, PYREXIA (Very high fever for two consecutive days) had resolved. At the time of the report, ABDOMINAL DISTENSION (Felt bloated), DISCOMFORT (Body felt heavy), HEAD DISCOMFORT (Head felt heavy) and LIMB DISCOMFORT (Heaviness in her legs) 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.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Headache, Night sweats
Clinical narrative: Night Sweats (During the night); Stomach Cramps; Zero Energy; headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night Sweats (During the night)), ABDOMINAL PAIN UPPER (Stomach Cramps), ASTHENIA (Zero Energy) and HEADACHE (headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced NIGHT SWEATS (Night Sweats (During the night)), ABDOMINAL PAIN UPPER (Stomach Cramps), ASTHENIA (Zero Energy) and HEADACHE (headache). At the time of the report, NIGHT SWEATS (Night Sweats (During the night)), ABDOMINAL PAIN UPPER (Stomach Cramps), ASTHENIA (Zero Energy) and HEADACHE (headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: received a vaccination from a temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received a vaccination from a temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received a vaccination from a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (received a vaccination from a temperature excursion) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported. No treatment reported.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: 2nd dose given subcutaneous.; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose given subcutaneous.) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose given subcutaneous.). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose given subcutaneous.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: underage; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047a21a and 039b31A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage). On 23-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received captured reporter details.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: eyesight got fuzzy in the distance; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (eyesight got fuzzy in the distance) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, METOPROLOL, CHLORTHALIDONE and Hormone replacement for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (eyesight got fuzzy in the distance). At the time of the report, VISION BLURRED (eyesight got fuzzy in the distance) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment reported.   This case was linked to MOD-2021-081586 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced CHILLS (chills) and HEADACHE (headache). In April 2021, CHILLS (chills) and HEADACHE (headache) had resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medication were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081819 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081819:
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Unable to get the 2nd dose in recommended time frame; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose in recommended time frame) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose in recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose in recommended time frame) had resolved. 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.   Concomitant medication not provided. Treatment information not provided.  This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Fatigue, Pain in extremity, Rhinorrhoea
Clinical narrative: very itchy; very red (about 3inches x 1.5 inch); fatigue; uncontrollable runny nose; chest tightness; wheezing; burning; swollen size of a quarter and hard; swollen size of a quarter and hard; painful to the touch; soreness in the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning), VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE INDURATION (swollen size of a quarter and hard), VACCINATION SITE PAIN (painful to the touch) and PAIN IN EXTREMITY (soreness in the whole arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced BURNING SENSATION (burning), VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE INDURATION (swollen size of a quarter and hard), VACCINATION SITE PAIN (painful to the touch), PAIN IN EXTREMITY (soreness in the whole arm), RHINORRHOEA (uncontrollable runny nose), CHEST DISCOMFORT (chest tightness) and WHEEZING (wheezing). On 14-Apr-2021, the patient experienced FATIGUE (fatigue). On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (very red (about 3inches x 1.5 inch)). On 14-Apr-2021, VACCINATION SITE PAIN (painful to the touch) and PAIN IN EXTREMITY (soreness in the whole arm) had resolved. On 16-Apr-2021, FATIGUE (fatigue) had resolved. On 18-Apr-2021, BURNING SENSATION (burning), RHINORRHOEA (uncontrollable runny nose), CHEST DISCOMFORT (chest tightness) and WHEEZING (wheezing) had resolved. At the time of the report, VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (very red (about 3inches x 1.5 inch)) outcome was unknown and VACCINATION SITE INDURATION (swollen size of a quarter and hard) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: very itchy; very red (about 3inches x 1.5 inch); fatigue; uncontrollable runny nose; chest tightness; wheezing; burning; swollen size of a quarter and hard; swollen size of a quarter and hard; painful to the touch; soreness in the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning), VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE INDURATION (swollen size of a quarter and hard), VACCINATION SITE PAIN (painful to the touch) and PAIN IN EXTREMITY (soreness in the whole arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced BURNING SENSATION (burning), VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE INDURATION (swollen size of a quarter and hard), VACCINATION SITE PAIN (painful to the touch), PAIN IN EXTREMITY (soreness in the whole arm), RHINORRHOEA (uncontrollable runny nose), CHEST DISCOMFORT (chest tightness) and WHEEZING (wheezing). On 14-Apr-2021, the patient experienced FATIGUE (fatigue). On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (very red (about 3inches x 1.5 inch)). On 14-Apr-2021, VACCINATION SITE PAIN (painful to the touch) and PAIN IN EXTREMITY (soreness in the whole arm) had resolved. On 16-Apr-2021, FATIGUE (fatigue) had resolved. On 18-Apr-2021, BURNING SENSATION (burning), RHINORRHOEA (uncontrollable runny nose), CHEST DISCOMFORT (chest tightness) and WHEEZING (wheezing) had resolved. At the time of the report, VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (very red (about 3inches x 1.5 inch)) outcome was unknown and VACCINATION SITE INDURATION (swollen size of a quarter and hard) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: very itchy; very red (about 3inches x 1.5 inch); fatigue; uncontrollable runny nose; chest tightness; wheezing; burning; swollen size of a quarter and hard; swollen size of a quarter and hard; painful to the touch; soreness in the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning), VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE INDURATION (swollen size of a quarter and hard), VACCINATION SITE PAIN (painful to the touch) and PAIN IN EXTREMITY (soreness in the whole arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced BURNING SENSATION (burning), VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE INDURATION (swollen size of a quarter and hard), VACCINATION SITE PAIN (painful to the touch), PAIN IN EXTREMITY (soreness in the whole arm), RHINORRHOEA (uncontrollable runny nose), CHEST DISCOMFORT (chest tightness) and WHEEZING (wheezing). On 14-Apr-2021, the patient experienced FATIGUE (fatigue). On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (very red (about 3inches x 1.5 inch)). On 14-Apr-2021, VACCINATION SITE PAIN (painful to the touch) and PAIN IN EXTREMITY (soreness in the whole arm) had resolved. On 16-Apr-2021, FATIGUE (fatigue) had resolved. On 18-Apr-2021, BURNING SENSATION (burning), RHINORRHOEA (uncontrollable runny nose), CHEST DISCOMFORT (chest tightness) and WHEEZING (wheezing) had resolved. At the time of the report, VACCINATION SITE SWELLING (swollen size of a quarter and hard), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (very red (about 3inches x 1.5 inch)) outcome was unknown and VACCINATION SITE INDURATION (swollen size of a quarter and hard) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: eyesight got fuzzy in the distance; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (eyesight got fuzzy in the distance) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN, METOPROLOL and CHLORTHALIDONE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (eyesight got fuzzy in the distance). At the time of the report, VISION BLURRED (eyesight got fuzzy in the distance) outcome was unknown. Not Provided          Patient was hormone replacement.   This case was linked to MOD-2021-081563 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: soreness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-Apr-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (swelling) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Really bad headaches/headaches continuously all day long; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Really bad headaches/headaches continuously all day long) and NAUSEA (Nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), QUETIAPINE FUMARATE (SEROQUEL), BACLOFEN, PLECANATIDE (TRULANCE), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), HYDROCODONE BITARTRATE, PARACETAMOL (LORCET PLUS) and CELECOXIB (CELEBREX) for an unknown indication.   On 30-Mar-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) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced HEADACHE (Really bad headaches/headaches continuously all day long). On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, HEADACHE (Really bad headaches/headaches continuously all day long) and NAUSEA (Nausea) outcome was unknown.        Treatment included paracetamol.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pruritus
Clinical narrative: itching all over his body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over his body) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 026B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Dialysis.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching all over his body) and HEADACHE (Headache). At the time of the report, PRURITUS (itching all over his body) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-081603 (Patient Link).