chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Stomach pain; Fever; Nausea; Body ache; Headache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Body ache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Body ache) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Floaters and flashing on the eye) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VITREOUS FLOATERS (Floaters and flashing on the eye). At the time of the report, VITREOUS FLOATERS (Floaters and flashing on the eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by reporter.  Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: NNI. TCR document/ No consent to further follow up
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Fatigue, Pain in extremity, Rash, Seborrhoeic keratosis
Clinical narrative: They are seborrheic keratosis but turned blue under the light; Sore arm; Black spots under both arms; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of SEBORRHOEIC KERATOSIS (They are seborrheic keratosis but turned blue under the light), PAIN IN EXTREMITY (Sore arm), RASH (Black spots under both arms) and FATIGUE (fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M012M20A) for COVID-19 vaccination.     Concurrent medical conditions included LDL increased, Rosacea and Hyperchlorhydria. Concomitant products included OMEPRAZOLE for Hyperchlorhydria, ATORVASTATIN for LDL increased, METRONIDAZOLE (METROGEL) for Rosacea, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 12-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SEBORRHOEIC KERATOSIS (They are seborrheic keratosis but turned blue under the light), PAIN IN EXTREMITY (Sore arm), RASH (Black spots under both arms) and FATIGUE (fatigue). On 15-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved, FATIGUE (fatigue) was resolving. At the time of the report, SEBORRHOEIC KERATOSIS (They are seborrheic keratosis but turned blue under the light) and RASH (Black spots under both arms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: seborrheic keratosis (abnormal) Seborrheic keratosis.     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.   This case was linked to MOD-2021-102244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2021: New events were added. On 29-Apr-2021: Patient details, medical history, concomitant drugs, drug details and event outcomes were updated.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Weird side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Weird side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Weird side effects). At the time of the report, ADVERSE EVENT (Weird side effects) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.  Treatment: Not reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: elevated heart rate; lightheadedness and dizziness which felt like the room was spinning; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (elevated heart rate) and DIZZINESS (lightheadedness and dizziness which felt like the room was spinning) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (elevated heart rate) and DIZZINESS (lightheadedness and dizziness which felt like the room was spinning). At the time of the report, HEART RATE INCREASED (elevated heart rate) and DIZZINESS (lightheadedness and dizziness which felt like the room was spinning) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Headache, Illness, Vomiting
Clinical narrative: Severe headache; sick she felt after the vaccine; feeling very very dizzy; She's vomiting like crazy; she can't drink; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache), ILLNESS (sick she felt after the vaccine), DIZZINESS (feeling very very dizzy), VOMITING (She's vomiting like crazy) and DYSPHAGIA (she can't drink) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 301L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headache), ILLNESS (sick she felt after the vaccine), DIZZINESS (feeling very very dizzy), VOMITING (She's vomiting like crazy) and DYSPHAGIA (she can't drink). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, HEADACHE (Severe headache), ILLNESS (sick she felt after the vaccine), DIZZINESS (feeling very very dizzy), VOMITING (She's vomiting like crazy) and DYSPHAGIA (she can't drink) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included Pepto-Bismol but she vomited it out.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling slightly beat 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 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION COMPLICATION (Feeling slightly beat up). At the time of the report, VACCINATION COMPLICATION (Feeling slightly beat up) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Induration, Injection site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (localized induration, itchy on the injection site), INDURATION (localized induration, itchy on the injection site) and EYE PRURITUS (red, itchy eyes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis and Cataract operation.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE PRURITUS (localized induration, itchy on the injection site) and INDURATION (localized induration, itchy on the injection site). In February 2021, the patient experienced EYE PRURITUS (red, itchy eyes). In February 2021, EYE PRURITUS (red, itchy eyes) had resolved. At the time of the report, INJECTION SITE PRURITUS (localized induration, itchy on the injection site) and INDURATION (localized induration, itchy on 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) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included steroid eye drops. No concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness; vertigo; 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) and VERTIGO (vertigo) 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 provided by the reporter.  Concomitant products included PALBOCICLIB (IBRANCE) from 21-Oct-2019 to an unknown date for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced DIZZINESS (dizziness) and VERTIGO (vertigo). At the time of the report, DIZZINESS (dizziness) and VERTIGO (vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided   Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Nausea
Clinical narrative: Rash at the injection site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash at the injection site) and NAUSEA (Nausea) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE RASH (Rash at the injection site) and NAUSEA (Nausea). At the time of the report, INJECTION SITE RASH (Rash at the injection site) and NAUSEA (Nausea) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications were not provided.  No treatment information provided.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Vaccination site warmth
Clinical narrative: Left arm is blushed and hot on injection site; Left arm is blushed and hot on injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Left arm is blushed and hot on injection site) and VACCINATION SITE WARMTH (Left arm is blushed and hot on injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.  The patient's past medical history included No adverse event (No medical history reported.).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (Left arm is blushed and hot on injection site) and VACCINATION SITE WARMTH (Left arm is blushed and hot on injection site). At the time of the report, INJECTION SITE DISCOLOURATION (Left arm is blushed and hot on injection site) and VACCINATION SITE WARMTH (Left arm is blushed and hot on 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) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products use was not provided by the reporter.   Treatment for the event was not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Feb-2021 and was forwarded to Moderna on 16-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Left arm is blushed and hot on injection site) and VACCINATION SITE WARMTH (Left arm is blushed and hot on injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.  The patient's past medical history included No adverse event (No medical history reported.).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (Left arm is blushed and hot on injection site) and VACCINATION SITE WARMTH (Left arm is blushed and hot on injection site). At the time of the report, INJECTION SITE DISCOLOURATION (Left arm is blushed and hot on injection site) and VACCINATION SITE WARMTH (Left arm is blushed and hot on 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) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products use was not provided by the reporter.   Treatment for the event was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: High Fever 102 F.; couldn't get up; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High Fever 102 F.) and FATIGUE (couldn't get up) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date. Concomitant products included METFORMIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (High Fever 102 F.) and FATIGUE (couldn't get up). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (High Fever 102 F.) and FATIGUE (couldn't get up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Pyrexia: (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reported concomitant medication including "other diabetes medication.   Reported treatment details including ice. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High Fever 102 F.) and FATIGUE (couldn't get up) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date. Concomitant products included METFORMIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (High Fever 102 F.) and FATIGUE (couldn't get up). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (High Fever 102 F.) and FATIGUE (couldn't get up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Pyrexia: (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reported concomitant medication including "other diabetes medication.   Reported treatment details including ice.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: sore arm; a slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and PYREXIA (a slight fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and PYREXIA (a slight fever). At the time of the report, VACCINATION SITE PAIN (sore arm) and PYREXIA (a slight fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided   This case was linked to MOD-2021-027597 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Event outcome updated from unknown to recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea for 6 weeks now; Fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diplopia, Headache, Lymphadenopathy, Nausea
Clinical narrative: Lymph nodes in neck swollen on left side; Brightness in vision; soreness in arm; Headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Brightness in vision), PAIN IN EXTREMITY (soreness in arm), HEADACHE (Headache), LYMPHADENOPATHY (Lymph nodes in neck swollen on left side) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol high.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). On 15-Feb-2021, the patient experienced DIPLOPIA (Brightness in vision). On 16-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes in neck swollen on left side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE (COUGH SYRUP DEXTROMETHORPHAN) at an unspecified dose and frequency. At the time of the report, DIPLOPIA (Brightness in vision), PAIN IN EXTREMITY (soreness in arm), HEADACHE (Headache), LYMPHADENOPATHY (Lymph nodes in neck swollen on left side), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were cholesterol meds were used for
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Lymph nodes in neck swollen on left side; Brightness in vision; soreness in arm; Headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Brightness in vision), PAIN IN EXTREMITY (soreness in arm), HEADACHE (Headache), LYMPHADENOPATHY (Lymph nodes in neck swollen on left side) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol high.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). On 15-Feb-2021, the patient experienced DIPLOPIA (Brightness in vision). On 16-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes in neck swollen on left side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE (COUGH SYRUP DEXTROMETHORPHAN) at an unspecified dose and frequency. At the time of the report, DIPLOPIA (Brightness in vision), PAIN IN EXTREMITY (soreness in arm), HEADACHE (Headache), LYMPHADENOPATHY (Lymph nodes in neck swollen on left side), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were cholesterol meds were used for
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very tired, very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired, very sleepy) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (very tired, very sleepy). At the time of the report, FATIGUE (very tired, very sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Fear, Oedema
Clinical narrative: concerned about receiving 2nd dose; still has a red outline; raised edge; spreading to most of her upper arm; swollen; chills; lumpy on the injection site; red circle; itching; sore; red spot on her arm; red outline; huge area that is bumpy; diarrhea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore) and RASH MACULAR (red spot on her arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic kidney disease stage 3 (3rd stage kidney disease) since an unknown date and Rheumatoid arthritis since an unknown date. Concurrent medical conditions included Artificial sweetener intolerance, Drug allergy (antihistamines) and Food allergy (some additives in a "carrot cake mix".).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore), RASH MACULAR (red spot on her arm), ERYTHEMA (red outline), VACCINATION SITE MASS (huge area that is bumpy), DIARRHOEA (diarrhea), OEDEMA (raised edge), VACCINATION SITE ERYTHEMA (spreading to most of her upper arm), SWELLING (swollen) and CHILLS (chills). On 11-Feb-2021, the patient experienced ERYTHEMA (still has a red outline) and FEAR (concerned about receiving 2nd dose). At the time of the report, VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore), RASH MACULAR (red spot on her arm), ERYTHEMA (red outline), VACCINATION SITE MASS (huge area that is bumpy), DIARRHOEA (diarrhea), ERYTHEMA (still has a red outline), OEDEMA (raised edge), FEAR (concerned about receiving 2nd dose), VACCINATION SITE ERYTHEMA (spreading to most of her upper arm), SWELLING (swollen) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash macular, Swelling, Vaccination site erythema
Clinical narrative: concerned about receiving 2nd dose; still has a red outline; raised edge; spreading to most of her upper arm; swollen; chills; lumpy on the injection site; red circle; itching; sore; red spot on her arm; red outline; huge area that is bumpy; diarrhea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore) and RASH MACULAR (red spot on her arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic kidney disease stage 3 (3rd stage kidney disease) since an unknown date and Rheumatoid arthritis since an unknown date. Concurrent medical conditions included Artificial sweetener intolerance, Drug allergy (antihistamines) and Food allergy (some additives in a "carrot cake mix".).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore), RASH MACULAR (red spot on her arm), ERYTHEMA (red outline), VACCINATION SITE MASS (huge area that is bumpy), DIARRHOEA (diarrhea), OEDEMA (raised edge), VACCINATION SITE ERYTHEMA (spreading to most of her upper arm), SWELLING (swollen) and CHILLS (chills). On 11-Feb-2021, the patient experienced ERYTHEMA (still has a red outline) and FEAR (concerned about receiving 2nd dose). At the time of the report, VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore), RASH MACULAR (red spot on her arm), ERYTHEMA (red outline), VACCINATION SITE MASS (huge area that is bumpy), DIARRHOEA (diarrhea), ERYTHEMA (still has a red outline), OEDEMA (raised edge), FEAR (concerned about receiving 2nd dose), VACCINATION SITE ERYTHEMA (spreading to most of her upper arm), SWELLING (swollen) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: concerned about receiving 2nd dose; still has a red outline; raised edge; spreading to most of her upper arm; swollen; chills; lumpy on the injection site; red circle; itching; sore; red spot on her arm; red outline; huge area that is bumpy; diarrhea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore) and RASH MACULAR (red spot on her arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic kidney disease stage 3 (3rd stage kidney disease) since an unknown date and Rheumatoid arthritis since an unknown date. Concurrent medical conditions included Artificial sweetener intolerance, Drug allergy (antihistamines) and Food allergy (some additives in a "carrot cake mix".).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore), RASH MACULAR (red spot on her arm), ERYTHEMA (red outline), VACCINATION SITE MASS (huge area that is bumpy), DIARRHOEA (diarrhea), OEDEMA (raised edge), VACCINATION SITE ERYTHEMA (spreading to most of her upper arm), SWELLING (swollen) and CHILLS (chills). On 11-Feb-2021, the patient experienced ERYTHEMA (still has a red outline) and FEAR (concerned about receiving 2nd dose). At the time of the report, VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore), RASH MACULAR (red spot on her arm), ERYTHEMA (red outline), VACCINATION SITE MASS (huge area that is bumpy), DIARRHOEA (diarrhea), ERYTHEMA (still has a red outline), OEDEMA (raised edge), FEAR (concerned about receiving 2nd dose), VACCINATION SITE ERYTHEMA (spreading to most of her upper arm), SWELLING (swollen) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Peripheral coldness
Clinical narrative: Arm cold; Blood pressure of 208; 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 PERIPHERAL COLDNESS (Arm cold) and HYPERTENSION (Blood pressure of 208) 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 PERIPHERAL COLDNESS (Arm cold) and HYPERTENSION (Blood pressure of 208). At the time of the report, PERIPHERAL COLDNESS (Arm cold) and HYPERTENSION (Blood pressure of 208) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 208 (High) blood pressure of 208.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD21-023413, MOD21-024486 (E2B Linked Report).; Sender's Comments:  MOD21-023413: MOD21-024486:
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; A spontaneous report was received on 16 Feb 2021, from a consumer concerning a patient  (age and gender unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, rash, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue
Clinical narrative: felt fatigued, didn't want to do anything; some signals that she thought were sign of infection (redness); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt fatigued, didn't want to do anything) and ERYTHEMA (some signals that she thought were sign of infection (redness)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (felt fatigued, didn't want to do anything) and ERYTHEMA (some signals that she thought were sign of infection (redness)). On 19-Jan-2021, ERYTHEMA (some signals that she thought were sign of infection (redness)) had resolved. At the time of the report, FATIGUE (felt fatigued, didn't want to do anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extremely tired; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extremely tired/Fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) extremely tired.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), extremely tired was unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-032814:case for 2nd sister MOD21-029201: US-MODERNATX, INC.-MOD-2021-032814:case for 2nd sister
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash at injection site; tenderness; itchiness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (rash at injection site), TENDERNESS (tenderness) and VACCINATION SITE PRURITUS (itchiness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash at injection site), TENDERNESS (tenderness) and VACCINATION SITE PRURITUS (itchiness). At the time of the report, VACCINATION SITE RASH (rash at injection site), TENDERNESS (tenderness) and VACCINATION SITE PRURITUS (itchiness) 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.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: headache; chills; body aches; 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 HEADACHE (headache), CHILLS (chills) and PAIN (body aches) 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 HEADACHE (headache), CHILLS (chills) and PAIN (body aches). At the time of the report, HEADACHE (headache), CHILLS (chills) and PAIN (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CYST (Existing Cyst on leg became infected) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced CYST (Existing Cyst on leg became infected). The patient was treated with CEFALEXIN (CEPHALEX [CEFALEXIN]) for Symptomatic treatment, at a dose of 500 mg. At the time of the report, CYST (Existing Cyst on leg became infected) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion
Clinical narrative: nose congestion; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nose congestion) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot # 007M208) for COVID-19 vaccination.     No medication history was provided.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced NASAL CONGESTION (nose congestion) and HEADACHE (headache). At the time of the report, NASAL CONGESTION (nose congestion) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling abnormal, Feeling of relaxation, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking so bad), MOVEMENT DISORDER (he couldn't sit up any longer), FEELING ABNORMAL (felt bad), THINKING ABNORMAL (wasn't thinking right) and NIGHT SWEATS (woke up soaking wet) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Allergy, Blood cholesterol abnormal and Blood pressure abnormal. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (slight headache). On 10-Feb-2021, the patient experienced TREMOR (shaking so bad), FEELING ABNORMAL (felt bad), FEELING OF RELAXATION (felt better), CHILLS (chills) and MYALGIA (arm was hurting). On 11-Feb-2021, the patient experienced MOVEMENT DISORDER (he couldn't sit up any longer), THINKING ABNORMAL (wasn't thinking right), NIGHT SWEATS (woke up soaking wet), DYSPNOEA (shortness of breath) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, TREMOR (shaking so bad), MOVEMENT DISORDER (he couldn't sit up any longer), FEELING ABNORMAL (felt bad), THINKING ABNORMAL (wasn't thinking right), NIGHT SWEATS (woke up soaking wet), DYSPNOEA (shortness of breath), FEELING OF RELAXATION (felt better), PYREXIA (fever), HEADACHE (slight headache), CHILLS (chills) and MYALGIA (arm was hurting) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication includes cholesterol med, blood pressure med, allergy medication. This case was linked to MOD-2021-255312. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow-up - Lot no of suspect drug was updated.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Myalgia, Night sweats, Pyrexia, Thinking abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking so bad), MOVEMENT DISORDER (he couldn't sit up any longer), FEELING ABNORMAL (felt bad), THINKING ABNORMAL (wasn't thinking right) and NIGHT SWEATS (woke up soaking wet) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Allergy, Blood cholesterol abnormal and Blood pressure abnormal. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (slight headache). On 10-Feb-2021, the patient experienced TREMOR (shaking so bad), FEELING ABNORMAL (felt bad), FEELING OF RELAXATION (felt better), CHILLS (chills) and MYALGIA (arm was hurting). On 11-Feb-2021, the patient experienced MOVEMENT DISORDER (he couldn't sit up any longer), THINKING ABNORMAL (wasn't thinking right), NIGHT SWEATS (woke up soaking wet), DYSPNOEA (shortness of breath) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, TREMOR (shaking so bad), MOVEMENT DISORDER (he couldn't sit up any longer), FEELING ABNORMAL (felt bad), THINKING ABNORMAL (wasn't thinking right), NIGHT SWEATS (woke up soaking wet), DYSPNOEA (shortness of breath), FEELING OF RELAXATION (felt better), PYREXIA (fever), HEADACHE (slight headache), CHILLS (chills) and MYALGIA (arm was hurting) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication includes cholesterol med, blood pressure med, allergy medication. This case was linked to MOD-2021-255312. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow-up - Lot no of suspect drug was updated.