chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness lasts more than one month; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness lasts more than one month) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness lasts more than one month). At the time of the report, DIZZINESS (dizziness lasts more than one month) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.  Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Pain, Visual impairment
Clinical narrative: Felt stinging sensations in foot, felt like bee stings on the foot; Having eyesight/vision problems lost sight for a period of time and relying more on eye glasses; Feeling confused; Lightheadedness and dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt stinging sensations in foot, felt like bee stings on the foot), VISUAL IMPAIRMENT (Having eyesight/vision problems lost sight for a period of time and relying more on eye glasses), CONFUSIONAL STATE (Feeling confused) and DIZZINESS (Lightheadedness and dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVETIRACETAM (KEPPRA XR) and OXCARBAZEPINE for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PAIN (Felt stinging sensations in foot, felt like bee stings on the foot), VISUAL IMPAIRMENT (Having eyesight/vision problems lost sight for a period of time and relying more on eye glasses), CONFUSIONAL STATE (Feeling confused) and DIZZINESS (Lightheadedness and dizziness). On 26-May-2021, PAIN (Felt stinging sensations in foot, felt like bee stings on the foot), VISUAL IMPAIRMENT (Having eyesight/vision problems lost sight for a period of time and relying more on eye glasses), CONFUSIONAL STATE (Feeling confused) and DIZZINESS (Lightheadedness and dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: very severe flu-like reaction; hot flash; sweat moments; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (very severe flu-like reaction), HOT FLUSH (hot flash), HYPERHIDROSIS (sweat moments) and PYREXIA (Feverish) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (very severe flu-like reaction), HOT FLUSH (hot flash), HYPERHIDROSIS (sweat moments) and PYREXIA (Feverish). At the time of the report, INFLUENZA LIKE ILLNESS (very severe flu-like reaction), HOT FLUSH (hot flash), HYPERHIDROSIS (sweat moments) and PYREXIA (Feverish) outcome was unknown. Not Provided          Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Chills; Tiredness; Headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache). On 18-Jun-2021, PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved.            No concomitant medications were reported. No treatment information was provided by the reporter.    This case was linked to MOD-2021-231341 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: Sick to his stomach; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to his stomach) and NAUSEA (Nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Sick to his stomach) and NAUSEA (Nauseated). At the time of the report, ABDOMINAL DISCOMFORT (Sick to his stomach) and NAUSEA (Nauseated) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-231478 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: my anxiety is pretty high; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (my anxiety is pretty high) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced ANXIETY (my anxiety is pretty high). At the time of the report, ANXIETY (my anxiety is pretty high) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Back pain, Bowel movement irregularity, Chemical burn
Clinical narrative: looks like burn; sleepy; stomach is larger; cannot eat much; not been "pooping like she normally does"; feet swollen; back pain; no energy; gained weight; missed period; pain in injection arm; This spontaneous case was reported by a patient and describes the occurrence of CHEMICAL BURN (looks like burn), SOMNOLENCE (sleepy), ABDOMINAL DISCOMFORT (stomach is larger), DECREASED APPETITE (cannot eat much) and BOWEL MOVEMENT IRREGULARITY (not been "pooping like she normally does") in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEMICAL BURN (looks like burn), SOMNOLENCE (sleepy), ABDOMINAL DISCOMFORT (stomach is larger), DECREASED APPETITE (cannot eat much), BOWEL MOVEMENT IRREGULARITY (not been "pooping like she normally does"), PERIPHERAL SWELLING (feet swollen), BACK PAIN (back pain), ASTHENIA (no energy), WEIGHT INCREASED (gained weight), MENSTRUATION IRREGULAR (missed period) and MYALGIA (pain in injection arm). At the time of the report, CHEMICAL BURN (looks like burn), SOMNOLENCE (sleepy), ABDOMINAL DISCOMFORT (stomach is larger), DECREASED APPETITE (cannot eat much), BOWEL MOVEMENT IRREGULARITY (not been "pooping like she normally does"), PERIPHERAL SWELLING (feet swollen), BACK PAIN (back pain), ASTHENIA (no energy), WEIGHT INCREASED (gained weight), MENSTRUATION IRREGULAR (missed period) and MYALGIA (pain in injection arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Menstruation irregular, Myalgia, Peripheral swelling, Somnolence
Clinical narrative: looks like burn; sleepy; stomach is larger; cannot eat much; not been "pooping like she normally does"; feet swollen; back pain; no energy; gained weight; missed period; pain in injection arm; This spontaneous case was reported by a patient and describes the occurrence of CHEMICAL BURN (looks like burn), SOMNOLENCE (sleepy), ABDOMINAL DISCOMFORT (stomach is larger), DECREASED APPETITE (cannot eat much) and BOWEL MOVEMENT IRREGULARITY (not been "pooping like she normally does") in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEMICAL BURN (looks like burn), SOMNOLENCE (sleepy), ABDOMINAL DISCOMFORT (stomach is larger), DECREASED APPETITE (cannot eat much), BOWEL MOVEMENT IRREGULARITY (not been "pooping like she normally does"), PERIPHERAL SWELLING (feet swollen), BACK PAIN (back pain), ASTHENIA (no energy), WEIGHT INCREASED (gained weight), MENSTRUATION IRREGULAR (missed period) and MYALGIA (pain in injection arm). At the time of the report, CHEMICAL BURN (looks like burn), SOMNOLENCE (sleepy), ABDOMINAL DISCOMFORT (stomach is larger), DECREASED APPETITE (cannot eat much), BOWEL MOVEMENT IRREGULARITY (not been "pooping like she normally does"), PERIPHERAL SWELLING (feet swollen), BACK PAIN (back pain), ASTHENIA (no energy), WEIGHT INCREASED (gained weight), MENSTRUATION IRREGULAR (missed period) and MYALGIA (pain in injection arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: looks like burn; sleepy; stomach is larger; cannot eat much; not been "pooping like she normally does"; feet swollen; back pain; no energy; gained weight; missed period; pain in injection arm; This spontaneous case was reported by a patient and describes the occurrence of CHEMICAL BURN (looks like burn), SOMNOLENCE (sleepy), ABDOMINAL DISCOMFORT (stomach is larger), DECREASED APPETITE (cannot eat much) and BOWEL MOVEMENT IRREGULARITY (not been "pooping like she normally does") in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEMICAL BURN (looks like burn), SOMNOLENCE (sleepy), ABDOMINAL DISCOMFORT (stomach is larger), DECREASED APPETITE (cannot eat much), BOWEL MOVEMENT IRREGULARITY (not been "pooping like she normally does"), PERIPHERAL SWELLING (feet swollen), BACK PAIN (back pain), ASTHENIA (no energy), WEIGHT INCREASED (gained weight), MENSTRUATION IRREGULAR (missed period) and MYALGIA (pain in injection arm). At the time of the report, CHEMICAL BURN (looks like burn), SOMNOLENCE (sleepy), ABDOMINAL DISCOMFORT (stomach is larger), DECREASED APPETITE (cannot eat much), BOWEL MOVEMENT IRREGULARITY (not been "pooping like she normally does"), PERIPHERAL SWELLING (feet swollen), BACK PAIN (back pain), ASTHENIA (no energy), WEIGHT INCREASED (gained weight), MENSTRUATION IRREGULAR (missed period) and MYALGIA (pain in injection arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed window for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed window for second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed window for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed window for second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Pyrexia, Somnolence
Clinical narrative: didn't feel good for a day, stayed in bed all day; weak; slept a lot; fever; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel good for a day, stayed in bed all day), ASTHENIA (weak), SOMNOLENCE (slept a lot), PYREXIA (fever) and FATIGUE (exhausted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (didn't feel good for a day, stayed in bed all day), ASTHENIA (weak), SOMNOLENCE (slept a lot), PYREXIA (fever) and FATIGUE (exhausted). At the time of the report, MALAISE (didn't feel good for a day, stayed in bed all day), ASTHENIA (weak), SOMNOLENCE (slept a lot), PYREXIA (fever) and FATIGUE (exhausted) outcome was unknown.            No concomitant and treatment medications were reported.   This case was linked to MOD-2021-008857 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: contracted COVID; has not received her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID) and PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was reported. .  Concomitant products included CITALOPRAM and LEVOTHYROXINE for an unknown indication.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID) and PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose). At the time of the report, COVID-19 (contracted COVID) and PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Fatigue, Muscular weakness
Clinical narrative: Weakness in muscles and legs; Fell twice after losing balance; a fall; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in muscles and legs), BALANCE DISORDER (Fell twice after losing balance), FALL (a fall) and FATIGUE (Fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. CA5A21A and 016821A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced MUSCULAR WEAKNESS (Weakness in muscles and legs), BALANCE DISORDER (Fell twice after losing balance), FALL (a fall) and FATIGUE (Fatigue). On 26-May-2021, MUSCULAR WEAKNESS (Weakness in muscles and legs), BALANCE DISORDER (Fell twice after losing balance), FALL (a fall) and FATIGUE (Fatigue) had resolved.            Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus infection, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS INFECTION (I tested positive for Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CORONAVIRUS INFECTION (I tested positive for Covid). At the time of the report, CORONAVIRUS INFECTION (I tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Get sick after getting the second shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Get sick after getting the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Get sick after getting the second shot). At the time of the report, ILLNESS (Get sick after getting the second shot) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Felt like I had the flu.; aches; fever/had a temperature of 100 degrees Farenheight.; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like I had the flu.), PAIN (aches), PYREXIA (fever/had a temperature of 100 degrees Farenheight.) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 404B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like I had the flu.), PAIN (aches) and FATIGUE (fatigue). 15-Apr-2021, the patient experienced PYREXIA (fever/had a temperature of 100 degrees Farenheight.). On 16-Apr-2021, INFLUENZA LIKE ILLNESS (Felt like I had the flu.), PAIN (aches), PYREXIA (fever/had a temperature of 100 degrees Farenheight.) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 100 (High) had a temperature of 100 degrees Fahrenheit..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided by reporter. No treatment information provided by reporter.  Patient received both of her Moderna Covid-19 vaccinations at a mass vaccination site
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: hives, little bump on the upper breast and arm; hives, little bump on the upper breast and arm; hives, little bump on the upper breast and arm; little itchiness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives, little bump on the upper breast and arm), BREAST MASS (hives, little bump on the upper breast and arm), PERIPHERAL SWELLING (hives, little bump on the upper breast and arm) and PRURITUS (little itchiness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Pollen allergy and Dust allergy. Concomitant products included ATENOLOL for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced URTICARIA (hives, little bump on the upper breast and arm), BREAST MASS (hives, little bump on the upper breast and arm), PERIPHERAL SWELLING (hives, little bump on the upper breast and arm) and PRURITUS (little itchiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 09-Mar-2021 at a dose of 1 dosage form. At the time of the report, URTICARIA (hives, little bump on the upper breast and arm), BREAST MASS (hives, little bump on the upper breast and arm), PERIPHERAL SWELLING (hives, little bump on the upper breast and arm) and PRURITUS (little itchiness) outcome was unknown.            Other concomitant drug include Allergy meds.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Nausea
Clinical narrative: sick to his stomach; Weak; Nauseated and sick to his stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to his stomach), ASTHENIA (Weak) and NAUSEA (Nauseated and sick to his stomach) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to his stomach), ASTHENIA (Weak) and NAUSEA (Nauseated and sick to his stomach). At the time of the report, ABDOMINAL DISCOMFORT (sick to his stomach), ASTHENIA (Weak) and NAUSEA (Nauseated and sick to his stomach) had not resolved.            No concomitant medications were reported. No treatment information was provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Fibromyalgia, Joint swelling, Myalgia
Clinical narrative: enlarged knuckles; burning legs,feet; fibromyalgia; football sized black and blue right arm; black and blue right arm; Neck pain; throbbing; Pain shot up arm to neck; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs,feet), FIBROMYALGIA (fibromyalgia), PERIPHERAL SWELLING (football sized black and blue right arm) and CONTUSION (black and blue right arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs,feet), FIBROMYALGIA (fibromyalgia), PERIPHERAL SWELLING (football sized black and blue right arm), CONTUSION (black and blue right arm), NECK PAIN (Neck pain), PAIN (throbbing) and MYALGIA (Pain shot up arm to neck). At the time of the report, JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs,feet), FIBROMYALGIA (fibromyalgia), PERIPHERAL SWELLING (football sized black and blue right arm), CONTUSION (black and blue right arm), NECK PAIN (Neck pain), PAIN (throbbing) and MYALGIA (Pain shot up arm to neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non significant FU- Contact information updated, Vaccine batch number added
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Peripheral swelling
Clinical narrative: enlarged knuckles; burning legs,feet; fibromyalgia; football sized black and blue right arm; black and blue right arm; Neck pain; throbbing; Pain shot up arm to neck; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs,feet), FIBROMYALGIA (fibromyalgia), PERIPHERAL SWELLING (football sized black and blue right arm) and CONTUSION (black and blue right arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs,feet), FIBROMYALGIA (fibromyalgia), PERIPHERAL SWELLING (football sized black and blue right arm), CONTUSION (black and blue right arm), NECK PAIN (Neck pain), PAIN (throbbing) and MYALGIA (Pain shot up arm to neck). At the time of the report, JOINT SWELLING (enlarged knuckles), BURNING SENSATION (burning legs,feet), FIBROMYALGIA (fibromyalgia), PERIPHERAL SWELLING (football sized black and blue right arm), CONTUSION (black and blue right arm), NECK PAIN (Neck pain), PAIN (throbbing) and MYALGIA (Pain shot up arm to neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non significant FU- Contact information updated, Vaccine batch number added
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Yellow discoloration at area of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOLOURATION (Yellow discoloration at area of injection) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 021B21A-1) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Yellow discoloration at area of injection). At the time of the report, VACCINATION SITE DISCOLOURATION (Yellow discoloration at area of injection) had resolved.            No concomitant medications were reported.  The patient stated that he has not used anything to alleviate the symptom neither has he called his healthcare provider.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Patient date of birth, height, ethnic group, dose details, event onset and outcome was updated.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1 st dose of the Moderna COVID-19 Vaccine on  07Mar2021; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1 st dose of the Moderna COVID-19 Vaccine on  07Mar2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1 st dose of the Moderna COVID-19 Vaccine on  07Mar2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1 st dose of the Moderna COVID-19 Vaccine on  07Mar2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: severe migraine; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (severe migraine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced MIGRAINE (severe migraine). The patient was treated with KETOROLAC for Migraine, at a dose of 1 dosage form. At the time of the report, MIGRAINE (severe migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Pain medication and Pseudaphed.  No concomitant medication has been reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant medication was not provided.  Treatment medication was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired second dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired second dose of Moderna Covid-19 vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired second dose of Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired second dose of Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash erythematous
Clinical narrative: warm to the touch, lasted 4-5 days; redness; big red patch in the right arm, lasted 4-5 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH ERYTHEMATOUS (big red patch in the right arm, lasted 4-5 days), FEELING HOT (warm to the touch, lasted 4-5 days) and ERYTHEMA (redness) in a 21-year-old male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (big red patch in the right arm, lasted 4-5 days), FEELING HOT (warm to the touch, lasted 4-5 days) and ERYTHEMA (redness). At the time of the report, RASH ERYTHEMATOUS (big red patch in the right arm, lasted 4-5 days), FEELING HOT (warm to the touch, lasted 4-5 days) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: More than 35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (More than 35 days after 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (More than 35 days after 1st dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (More than 35 days after 1st dose) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  It was reported that due to surgery the patient missed the second dosage. No concomitant or treatment medication has been reported.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus
Clinical narrative: Ive been itching for several weeks after the Moderna vaccine; Itching slowly getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Ive been itching for several weeks after the Moderna vaccine) and CONDITION AGGRAVATED (Itching slowly getting worse) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Ive been itching for several weeks after the Moderna vaccine) and CONDITION AGGRAVATED (Itching slowly getting worse). At the time of the report, PRURITUS (Ive been itching for several weeks after the Moderna vaccine) and CONDITION AGGRAVATED (Itching slowly getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Significant Follow-up Appended : Added NewEvent
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm was swollen; arm was sore for 7 to 8 days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen) and PAIN IN EXTREMITY (arm was sore for 7 to 8 days) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Allergy to poison ivy and oak). Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HYDROCHLOROTHIAZIDE) for Hypertension.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen) and PAIN IN EXTREMITY (arm was sore for 7 to 8 days). At the time of the report, PERIPHERAL SWELLING (arm was swollen) and PAIN IN EXTREMITY (arm was sore for 7 to 8 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-231544 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: ankle swelling; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (ankle swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (ankle swelling). At the time of the report, JOINT SWELLING (ankle swelling) outcome was unknown.            No concomitant medications were reported. No treatment information was provided by the reporter.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: patient has to push second dose out 10 days; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (patient has to push second dose out 10 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (patient has to push second dose out 10 days). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (patient has to push second dose out 10 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaesthesia, Burning sensation, Dermatitis contact, Feeling cold, Paraesthesia
Clinical narrative: right cheek and fingers like a freezing sensation; Right cheek and fingers like a freezing sensation; Burning sensation; She forgot to remove the band-aid on her arm and she had a reaction and now she has like a wheel mark; left cheek like an anesthetic sensation that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (right cheek and fingers like a freezing sensation), PARAESTHESIA (Right cheek and fingers like a freezing sensation), BURNING SENSATION (Burning sensation), DERMATITIS CONTACT (She forgot to remove the band-aid on her arm and she had a reaction and now she has like a wheel mark) and ANAESTHESIA (left cheek like an anesthetic sensation that comes and goes) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fractured mandible (Mandible disorder). Concurrent medical conditions included Seasonal allergy, Pollen allergy and Dust allergy.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced ANAESTHESIA (left cheek like an anesthetic sensation that comes and goes). On an unknown date, the patient experienced FEELING COLD (right cheek and fingers like a freezing sensation), PARAESTHESIA (Right cheek and fingers like a freezing sensation), BURNING SENSATION (Burning sensation) and DERMATITIS CONTACT (She forgot to remove the band-aid on her arm and she had a reaction and now she has like a wheel mark). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, FEELING COLD (right cheek and fingers like a freezing sensation), PARAESTHESIA (Right cheek and fingers like a freezing sensation), BURNING SENSATION (Burning sensation), DERMATITIS CONTACT (She forgot to remove the band-aid on her arm and she had a reaction and now she has like a wheel mark) and ANAESTHESIA (left cheek like an anesthetic sensation that comes and goes) outcome was unknown.            Patient has forgot to remove band-aid due to that reaction had occurred, like a wheel mark has been formed on her arm . Patient has stated that she has been using Allergy medications as a concomitants.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.    This case was linked to MOD-2021-231475 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Headache, Nausea
Clinical narrative: arm was swollen and red, like an allergic reaction; vertigo/the room was spinning; big red square 3x3; big red square 3x3; freezing with chills and fever; fever of 101.2; burning at the injection site; nauseated; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm was swollen and red, like an allergic reaction), ERYTHEMA (big red square 3x3), VERTIGO (vertigo/the room was spinning), RASH (big red square 3x3) and VACCINATION SITE PAIN (burning at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002121A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) and ESTRADIOL for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (burning at the injection site), NAUSEA (nauseated) and HEADACHE (Headache). On 22-Apr-2021, the patient experienced CHILLS (freezing with chills and fever) and PYREXIA (fever of 101.2). On 26-Apr-2021, the patient experienced ERYTHEMA (big red square 3x3) and RASH (big red square 3x3). On 05-May-2021, the patient experienced VERTIGO (vertigo/the room was spinning). On an unknown date, the patient experienced PERIPHERAL SWELLING (arm was swollen and red, like an allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness, at a dose of UNK dosage form. On 22-Apr-2021, CHILLS (freezing with chills and fever) and PYREXIA (fever of 101.2) had resolved. At the time of the report, PERIPHERAL SWELLING (arm was swollen and red, like an allergic reaction), ERYTHEMA (big red square 3x3), RASH (big red square 3x3), VACCINATION SITE PAIN (burning at the injection site), NAUSEA (nauseated) and HEADACHE (Headache) outcome was unknown and VERTIGO (vertigo/the room was spinning) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 101.2 (High) 101.2.         The reporter has stated that the patient was taking an unknown medication for vertigo and that it was reported that the medication was not helpful. The patient was still experiencing vertigo from the vaccine. After getting first shot on 21 Apr 2021, exactly 14 days later, the patient had major vertigo.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up information received on 13-AUG-2021- Non significant follow up received