chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: started feeling dizzy/lightheaded ever since/have continued to feel dizzy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (started feeling dizzy/lightheaded ever since/have continued to feel dizzy) 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 18-May-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 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (started feeling dizzy/lightheaded ever since/have continued to feel dizzy). At the time of the report, DIZZINESS (started feeling dizzy/lightheaded ever since/have continued to feel dizzy) had not resolved.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported  No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Myalgia, Nausea
Clinical narrative: Inconstant headache,; Arm ache; Nausea; flushed; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (flushed), HEADACHE (Inconstant headache,), MYALGIA (Arm ache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced FLUSHING (flushed). On an unknown date, the patient experienced HEADACHE (Inconstant headache,), MYALGIA (Arm ache) and NAUSEA (Nausea). At the time of the report, FLUSHING (flushed), HEADACHE (Inconstant headache,), MYALGIA (Arm ache) and NAUSEA (Nausea) 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 treatment and concomitant medication were provided   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Significant Follow up appended to MOD-2021-163875 On 06-Jul-2021: Follow up received on 06-JUL-2021. No new information
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: right arm felt so heavy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to the company on 25-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (right arm felt so heavy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 30-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced LIMB DISCOMFORT (right arm felt so heavy). At the time of the report, LIMB DISCOMFORT (right arm felt so heavy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: Diarrhea; Stomach upset; Nauseous; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach upset) and NAUSEA (Nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 23-May-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 DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach upset) and NAUSEA (Nauseous). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach upset) and NAUSEA (Nauseous) outcome was unknown.            Concomitant product was not provided by the reporter. No laboratory provided by reporter Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site tenderness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site tenderness). At the time of the report, INJECTION SITE PAIN (Injection site tenderness) had resolved.  The patient reported concomitant medication included cholesterol pill and thyroid pill. The patient reported no other symptoms or issues. The patient reported she was happy with the vaccine, as she felt fine both times. No information regarding corrective treatment was reported by the patient. No other information was obtained. This case was linked to MOD-2021-016013 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Muscular weakness, Tremor
Clinical narrative: Weak knees; Dizzy; Shakes; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weak knees), DIZZINESS (Dizzy), TREMOR (Shakes) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weak knees), DIZZINESS (Dizzy), TREMOR (Shakes) and CHILLS (Chills). At the time of the report, MUSCULAR WEAKNESS (Weak knees), DIZZINESS (Dizzy), TREMOR (Shakes) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided  No treatment medications provided
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness
Clinical narrative: Diarrhea; Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concomitant products included OMEGA-3 [OMEGA-3 NOS] for Product used for unknown indication, METFORMIN, ATORVASTATIN, LISINOPRIL, TAMSULOSIN, OMEPRAZOLE, ZINC, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Loss of smell since after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell since after first dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST for Allergy and Asthma, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, ROSUVASTATIN for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Heart disorder.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ANOSMIA (Loss of smell since after first dose). At the time of the report, ANOSMIA (Loss of smell since after first 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.   Patient reported that he was recommended to take anti bacteria cream but it doesn't helped.
Sex: U
Vaccine: COVID19
Symptoms: Induration, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: swollen rash that itches/ swollen; swollen rash that itches; swollen rash that itches; Hard under the skin; 4x4 cm and warm snfbit itches.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen rash that itches/ swollen), RASH (swollen rash that itches), PRURITUS (swollen rash that itches), INDURATION (Hard under the skin) and SKIN WARM (4x4 cm and warm snfbit itches.) 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 16-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 SWELLING (swollen rash that itches/ swollen), RASH (swollen rash that itches), PRURITUS (swollen rash that itches), INDURATION (Hard under the skin) and SKIN WARM (4x4 cm and warm snfbit itches.). At the time of the report, SWELLING (swollen rash that itches/ swollen), RASH (swollen rash that itches), PRURITUS (swollen rash that itches), INDURATION (Hard under the skin) and SKIN WARM (4x4 cm and warm snfbit itches.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) 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 23-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 an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: general discomfort; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (general discomfort) 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 DISCOMFORT (general discomfort). At the time of the report, DISCOMFORT (general discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication/lab results were reported. Treatment information not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Sleep disorder, Vaccination site pain
Clinical narrative: now she cannot lift her arm; she cannot sleep; experienced soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (now she cannot lift her arm), SLEEP DISORDER (she cannot sleep) and VACCINATION SITE PAIN (experienced soreness at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21F) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Acid reflux (esophageal). Concomitant products included TRAZODONE for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced LIMB DISCOMFORT (now she cannot lift her arm), SLEEP DISORDER (she cannot sleep) and VACCINATION SITE PAIN (experienced soreness at the injection site). At the time of the report, LIMB DISCOMFORT (now she cannot lift her arm), SLEEP DISORDER (she cannot sleep) and VACCINATION SITE PAIN (experienced soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Additional treatment information included antihypertensive medication, acid reflux medication and SSRI medication.  Patient stated that she has an appointment with her nurse practitioner tomorrow (25May2021).
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: pain moved to the front and rear of the upper arm/pain several places above my elbow; pain in my left arm near the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain moved to the front and rear of the upper arm/pain several places above my elbow) and VACCINATION SITE PAIN (pain in my left arm near the injection site) 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 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain moved to the front and rear of the upper arm/pain several places above my elbow) and VACCINATION SITE PAIN (pain in my left arm near the injection site). At the time of the report, PAIN (pain moved to the front and rear of the upper arm/pain several places above my elbow) and VACCINATION SITE PAIN (pain in my left arm near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient was administered 2nd dose of moderna vaccine on the 16th day after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient was administered 2nd dose of moderna vaccine on the 16th day after the 1st dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 022B21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included GABAPENTIN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOROTHIAZIDE), AMLODIPINE, CLOPIDOGREL BISULFATE (PLAVIX) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient was administered 2nd dose of moderna vaccine on the 16th day after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient was administered 2nd dose of moderna vaccine on the 16th day after the 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The caller stated that their computer system did not block from giving the 2nd dose to the patient and she wants to know what she needs to do now and requesting the information to be sent via email.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin swelling, Vaccination site mass, Vaccination site pain
Clinical narrative: Pain at the injection site; Arm is black and blue; Puffy and a lump has been formed; lump formed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), SKIN DISCOLOURATION (Arm is black and blue), SKIN SWELLING (Puffy and a lump has been formed) and VACCINATION SITE MASS (lump formed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A.) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included LEVOTHYROXINE, LOVASTATIN, AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CLOPIDOGREL BISULFATE (PLAVIX) and HCTZ for an unknown indication.   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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), SKIN DISCOLOURATION (Arm is black and blue), SKIN SWELLING (Puffy and a lump has been formed) and VACCINATION SITE MASS (lump formed). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), SKIN DISCOLOURATION (Arm is black and blue), SKIN SWELLING (Puffy and a lump has been formed) and VACCINATION SITE MASS (lump formed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details were provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick from it the next full day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick from it the next full day) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick from it the next full day). At the time of the report, ILLNESS (got sick from it the next full day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided.  No treatment information provided.  The patient stated that he was scheduled to have the 2nd shot tomorrow.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Lethargy, Rash macular, Vision blurred
Clinical narrative: Red blotches on left arm; Blurry left eye; Stomach pain; Lethargic; Feels very tired; This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (Red blotches on left arm), VISION BLURRED (Blurry left eye), ABDOMINAL PAIN UPPER (Stomach pain), LETHARGY (Lethargic) and FATIGUE (Feels very tired) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 017E21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, ATORVASTATIN, CLOPIDOGREL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and POTASSIUM for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced RASH MACULAR (Red blotches on left arm), VISION BLURRED (Blurry left eye), ABDOMINAL PAIN UPPER (Stomach pain), LETHARGY (Lethargic) and FATIGUE (Feels very tired). At the time of the report, RASH MACULAR (Red blotches on left arm), VISION BLURRED (Blurry left eye), ABDOMINAL PAIN UPPER (Stomach pain), LETHARGY (Lethargic) and FATIGUE (Feels very tired) outcome was unknown.            Treatment information not provided. Action taken with mRNA-1273 in response to the events was  not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of 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, 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 DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant and treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis has flared up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis has flared up) 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 ARTHRITIS (arthritis has flared up). At the time of the report, ARTHRITIS (arthritis has flared up) outcome was unknown.            Action taken with mRNA-1273 in response to the event was reported as not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Treatment information was not  reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Multiple allergies, Vulvovaginal discomfort, Vulvovaginal swelling
Clinical narrative: Have many allergies; Felt some irritation (vaginal area); Swelling in my vaginal area; Continued to get much worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have many allergies), VULVOVAGINAL DISCOMFORT (felt some irritation (vaginal area)), VULVOVAGINAL SWELLING (swelling in my vaginal area) and ADVERSE REACTION (continued to get much worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO MEDICAL HISTORY 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 VACCINATION COMPLICATION (have many allergies), VULVOVAGINAL DISCOMFORT (felt some irritation (vaginal area)), VULVOVAGINAL SWELLING (swelling in my vaginal area) and ADVERSE REACTION (continued to get much worse). At the time of the report, VACCINATION COMPLICATION (have many allergies), VULVOVAGINAL DISCOMFORT (felt some irritation (vaginal area)), VULVOVAGINAL SWELLING (swelling in my vaginal area) and ADVERSE REACTION (continued to get much worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were available.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: covid arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). At the time of the report, VACCINATION SITE REACTION (covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17years old patient received the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17years old patient received the Moderna COVID-19 vaccine) 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 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17years old patient received the Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17years old patient received the Moderna COVID-19 vaccine) 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.   Action taken :not applicable No concomitant and treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) 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 PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine was mistakenly administered to a 15 years old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was mistakenly administered to a 15 years old patient) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was mistakenly administered to a 15 years old patient). On 21-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was mistakenly administered to a 15 years old patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown. The patient had not reported any adverse reaction to the vaccine so far.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: Loss of taste; Loss of smell; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033G21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Jan-2021.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Side effects pretty strong; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side effects pretty strong) 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 ADVERSE REACTION (Side effects pretty strong). At the time of the report, ADVERSE REACTION (Side effects pretty strong) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment were provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: is redness around shot normal 2nd shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (is redness around shot normal 2nd 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (is redness around shot normal 2nd shot). At the time of the report, VACCINATION SITE ERYTHEMA (is redness around shot normal 2nd shot) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Had a strong reaction to the 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Had a strong reaction to the 1st vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE EVENT (Had a strong reaction to the 1st vaccine). At the time of the report, ADVERSE EVENT (Had a strong reaction to the 1st vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: May be pregnant but im not sure; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (May be pregnant but im not sure) 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 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced EXPOSURE DURING PREGNANCY (May be pregnant but im not sure). On 24-May-2021, EXPOSURE DURING PREGNANCY (May be pregnant but im not sure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient post receiving their first dose of vaccine reported that they realized that the patient might be pregnant, but the patient was not sure.  No Concomitant product use was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Illness, Influenza
Clinical narrative: extremely ill; Worse than a flew; stomach and back pain seems unusual; stomach and back pain seems unusual; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely ill), INFLUENZA (Worse than a flew), ABDOMINAL PAIN UPPER (stomach and back pain seems unusual) and BACK PAIN (stomach and back pain seems unusual) 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 (extremely ill), INFLUENZA (Worse than a flew), ABDOMINAL PAIN UPPER (stomach and back pain seems unusual) and BACK PAIN (stomach and back pain seems unusual). At the time of the report, ILLNESS (extremely ill), INFLUENZA (Worse than a flew), ABDOMINAL PAIN UPPER (stomach and back pain seems unusual) and BACK PAIN (stomach and back pain seems unusual) outcome was unknown.            Concomitant product used was not provided by the reporter.  Treatment information was not provided.  Event outcome was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain/ Soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/ Soreness) 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 PAIN (Pain/ Soreness). At the time of the report, PAIN (Pain/ Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction) and PRURITUS (face, neck, arm is itching) 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 21-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 ALLERGY TO VACCINE (Allergic reaction) and PRURITUS (face, neck, arm is itching). At the time of the report, ALLERGY TO VACCINE (Allergic reaction) and PRURITUS (face, neck, arm is itching) had not resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medication reported. No treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) 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 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 CHEST PAIN (chest pain). At the time of the report, CHEST PAIN (chest pain) outcome was unknown.            No concomitant medications was reported by the reporter  No treatment medications was  provided by the reporter
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Weakness; Fever; nausea; vomiting; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (body aches), PYREXIA (Fever), NAUSEA (nausea) and VOMITING (vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (body aches). On an unknown date, the patient experienced ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, ASTHENIA (Weakness), MYALGIA (body aches), PYREXIA (Fever), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.            Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to MOD-2021-080593 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Burning sensation
Clinical narrative: experienced the predicted side effects; additionally experienced a painful burning sensation in my internal organs that lasted for days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (experienced the predicted side effects) and BURNING SENSATION (additionally experienced a painful burning sensation in my internal organs that lasted for days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE EVENT (experienced the predicted side effects) and BURNING SENSATION (additionally experienced a painful burning sensation in my internal organs that lasted for days). At the time of the report, ADVERSE EVENT (experienced the predicted side effects) and BURNING SENSATION (additionally experienced a painful burning sensation in my internal organs that lasted for days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nodule
Clinical narrative: Nodule on extremity; This spontaneous case was reported by a physician and describes the occurrence of   in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis aggravated.    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 and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose.        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.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (Injection site is irritated) and INJECTION SITE ERYTHEMA (Injection site is red) 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 INJECTION SITE IRRITATION (Injection site is irritated) and INJECTION SITE ERYTHEMA (Injection site is red). At the time of the report, INJECTION SITE IRRITATION (Injection site is irritated) and INJECTION SITE ERYTHEMA (Injection site is red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: minor pain at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (minor pain at the injection site) 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 is reported by reporter.     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 DYSPNOEA (minor pain at the injection site). At the time of the report, DYSPNOEA (minor pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles on her face; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles on her face) 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 reporter.     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 HERPES ZOSTER (shingles on her face). At the time of the report, HERPES ZOSTER (shingles on her face) outcome was unknown.            No concomitant and treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow up received and does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Very red, hives like rash on her face and upper torso; Very red, hives like rash on her face and upper torso; Very red, hives like rash on her face and upper torso; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Very red, hives like rash on her face and upper torso), URTICARIA (Very red, hives like rash on her face and upper torso) and RASH (Very red, hives like rash on her face and upper torso) 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 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Very red, hives like rash on her face and upper torso), URTICARIA (Very red, hives like rash on her face and upper torso) and RASH (Very red, hives like rash on her face and upper torso). At the time of the report, RASH ERYTHEMATOUS (Very red, hives like rash on her face and upper torso), URTICARIA (Very red, hives like rash on her face and upper torso) and RASH (Very red, hives like rash on her face and upper torso) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment and Concomitant medicines were reported