chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia
Clinical narrative: Pulse rate increasing eventually 122-136-145-156; Blood pressure was 176 over 110; Had fever on second day 102 Temp; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Pulse rate increasing eventually 122-136-145-156), HYPERTENSION (Blood pressure was 176 over 110) and PYREXIA (Had fever on second day 102 Temp) 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 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Pulse rate increasing eventually 122-136-145-156), HYPERTENSION (Blood pressure was 176 over 110) and PYREXIA (Had fever on second day 102 Temp). At the time of the report, HEART RATE INCREASED (Pulse rate increasing eventually 122-136-145-156), HYPERTENSION (Blood pressure was 176 over 110) and PYREXIA (Had fever on second day 102 Temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 176/110 (High) High. In 2021, Body temperature: 102 (High) High. In 2021, Fibrin D dimer: high (High) elevated. In 2021, Heart rate: 122 (High) Increasing 122-136-145-156..         Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-006816 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles pox many blisters the size of a quarter; Breakouts occur on abdomen or buttocks; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles pox many blisters the size of a quarter) and RASH (Breakouts occur on abdomen or buttocks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced RASH (Breakouts occur on abdomen or buttocks). On 30-Jan-2021, the patient experienced HERPES ZOSTER (Shingles pox many blisters the size of a quarter). The patient was treated with ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles pox many blisters the size of a quarter) and RASH (Breakouts occur on abdomen or buttocks) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. Patient said since the first dose and post second dose that they have had 3 outbreaks of shingles outbreaks.   This case was linked to MOD-2021-037485, MOD-2021-037485 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough Aggravated; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough Aggravated) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cough and Acute sinusitis (since 40 years).    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced COUGH (Cough Aggravated). At the time of the report, COUGH (Cough Aggravated) outcome was unknown.            Concomitant medication information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: follow-up received on 30-Jun-2021 contains NNI
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Headaches; Fever; A red , big and hot circle of 2 inches of diameter at the injection site; swelling at injection; A red , big and hot circle of 2 inches of diameter at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), HEADACHE (Headaches), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site) and VACCINATION SITE SWELLING (swelling at injection) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), HEADACHE (Headaches), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site) and VACCINATION SITE SWELLING (swelling at injection). At the time of the report, VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), HEADACHE (Headaches), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site) and VACCINATION SITE SWELLING (swelling at injection) outcome was unknown.            No concomitant and treatment medication provided   This case was linked to MOD-2021-020277 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received on 19-Jun-2021. No new information On 30-Jun-2021: Follow up received on 30-jun-2021. No new information
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Myalgia, Pyrexia
Clinical narrative: Cough; Fever; Chills; Headache; Muscle pain; This spontaneous case was reported by a pharmacist and describes the occurrence of COUGH (Cough), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle pain) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, COUGH (Cough), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-208885, MOD-2021-208885 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Heavy and Painful periods; Heavy and Painful periods; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy and Painful periods) and DYSMENORRHOEA (Heavy and Painful periods) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy and Painful periods) and DYSMENORRHOEA (Heavy and Painful periods). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy and Painful periods) and DYSMENORRHOEA (Heavy and Painful periods) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-209189 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurts under left arm pit), LYMPHADENOPATHY (swollen lymph nodes under left arm pit) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included INFLIXIMAB (REMICADE), PRAVASTATIN, PREDNISONE, COLECALCIFEROL (VIT D [COLECALCIFEROL]), AMLODIPINE, LEFLUNOMIDE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), LISINOPRIL, FOLIC ACID and MONTELUKAST. On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 09-Mar-2021, the patient experienced PAIN (hurts under left arm pit), LYMPHADENOPATHY (swollen lymph nodes under left arm pit) and HEADACHE (headache). At the time of the report, PAIN (hurts under left arm pit), LYMPHADENOPATHY (swollen lymph nodes under left arm pit) and HEADACHE (headache) outcome was unknown. CONCOMITANT MEICATION INCLUDES :allergy pills, latanopril. No treatment medication was reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: A patient was administered three doses of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (A patient was administered three doses of the Moderna COVID-19 vaccine.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced EXTRA DOSE ADMINISTERED (A patient was administered three doses of the Moderna COVID-19 vaccine.). In June 2021, EXTRA DOSE ADMINISTERED (A patient was administered three doses of the Moderna COVID-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Patient demographics and vaccine information updated
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Loss of personal independence in daily activities, Pain, Pyrexia, Rash
Clinical narrative: Still in pain; Unable to perform daily task; Fever of 103 degrees Fahrenheit; Severe rash that was isolated to the back, abdomen, stomach/rash progressed to all over the body even her toes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Severe rash that was isolated to the back, abdomen, stomach/rash progressed to all over the body even her toes), PAIN (Still in pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform daily task) and PYREXIA (Fever of 103 degrees Fahrenheit) 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 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced RASH (Severe rash that was isolated to the back, abdomen, stomach/rash progressed to all over the body even her toes) and PYREXIA (Fever of 103 degrees Fahrenheit). On an unknown date, the patient experienced PAIN (Still in pain) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform daily task). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form and PREDNISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Severe rash that was isolated to the back, abdomen, stomach/rash progressed to all over the body even her toes) was resolving, PAIN (Still in pain) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform daily task) had not resolved and PYREXIA (Fever of 103 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103 (High) 103 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  It was reported that the patient had a severe rash that was initially isolated to her stomach, back, and abdomen but later spread all over her body, even her toes.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I have had extremely painful reaction to my second dose yesterday; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have had extremely painful reaction to my second dose yesterday) 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 VACCINATION COMPLICATION (I have had extremely painful reaction to my second dose yesterday). At the time of the report, VACCINATION COMPLICATION (I have had extremely painful reaction to my second dose yesterday) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: My body hurt; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (My body hurt) in a 32-year-old patient of an unknown 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 MYALGIA (My body hurt). At the time of the report, MYALGIA (My body hurt) outcome was unknown.            No information regarding concomitant medications provided. No information regarding treatment medications provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) 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) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Concomitant medications were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: kidney pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of RENAL PAIN (kidney pain) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the 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 RENAL PAIN (kidney pain). At the time of the report, RENAL PAIN (kidney pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia
Clinical narrative: dizziness; soreness in Left arm,muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and MYALGIA (soreness in Left arm,muscle pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced DIZZINESS (dizziness) and MYALGIA (soreness in Left arm,muscle pain). At the time of the report, DIZZINESS (dizziness) and MYALGIA (soreness in Left arm,muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by reporter. No treatment medication provided by reporter.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injury, Pain in extremity, Somnolence
Clinical narrative: Sore arm; It's like I'm being wound down; I go into a deep sleep; I felt super tired that day,It's like a wall of fatigue hits me,real tired, like sick kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of INJURY (It's like I'm being wound down), SOMNOLENCE (I go into a deep sleep), PAIN IN EXTREMITY (Sore arm) and FATIGUE (I felt super tired that day,It's like a wall of fatigue hits me,real tired, like sick kind of tired) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 27-May-2021, the patient experienced FATIGUE (I felt super tired that day,It's like a wall of fatigue hits me,real tired, like sick kind of tired). On 31-May-2021, the patient experienced INJURY (It's like I'm being wound down) and SOMNOLENCE (I go into a deep sleep). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, INJURY (It's like I'm being wound down), SOMNOLENCE (I go into a deep sleep), PAIN IN EXTREMITY (Sore arm) and FATIGUE (I felt super tired that day,It's like a wall of fatigue hits me,real tired, like sick kind of tired) outcome was unknown.            The concomitant medications were not reported.  The treatment information was not provided.         Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up document was added on 1-JUL-2021. Event outcome was changed to unknown from recovered. New event added Sore arm.
Sex: U
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: Skin irritation; 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 SKIN IRRITATION (Skin irritation) 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 was provided by the reporter.     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 SKIN IRRITATION (Skin irritation). At the time of the report, SKIN IRRITATION (Skin irritation) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Very tired; 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 FATIGUE (Very tired) 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) (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 FATIGUE (Very tired). At the time of the report, FATIGUE (Very tired) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No concomitant medicines were reported. No treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Some side effects of the second 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 COMPLICATION (Some side effects of the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some side effects of the second shot). At the time of the report, VACCINATION COMPLICATION (Some side effects of the second shot) outcome was unknown.            No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain with 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain with 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   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 BACK PAIN (back pain with 2nd dose). At the time of the report, BACK PAIN (back pain with 2nd dose) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received and contains non-significant information- updated race information; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Muscle rigidity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of muscle rigidity (tightness) in a 32-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .5 mL. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .5 mL. On an unknown date, patient experienced muscle rigidity (tightness). At the time of the report, muscle rigidity (tightness) outcome: unknown. The patient did not received any treatment. Concomitant medications details and treatment information not reported. Action taken with mRNA-1273 (Moderna COVID-19 vaccine) in response to the event: not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: still feel weak/have no energy; how long can I expect the extreme fatigue to last; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (still feel weak/have no energy) and FATIGUE (how long can I expect the extreme fatigue to last) 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 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 ASTHENIA (still feel weak/have no energy) and FATIGUE (how long can I expect the extreme fatigue to last). At the time of the report, ASTHENIA (still feel weak/have no energy) and FATIGUE (how long can I expect the extreme fatigue to last) outcome was unknown.            No concomitant medications reported by reporter. No treatment medications provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mass, Myalgia, Neuralgia, Pain
Clinical narrative: hard lump; radiating down my arm; feels like a big bruise; radiating down my nerves; muscle in my arm where I got the shot has been getting more and more sore; This spontaneous case was reported by a non-health professional and describes the occurrence of MASS (hard lump), PAIN (radiating down my arm), CONTUSION (feels like a big bruise), NEURALGIA (radiating down my nerves) and MYALGIA (muscle in my arm where I got the shot has been getting more and more sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072C21A or 002C21A, writing unclear) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced MASS (hard lump), PAIN (radiating down my arm), CONTUSION (feels like a big bruise), NEURALGIA (radiating down my nerves) and MYALGIA (muscle in my arm where I got the shot has been getting more and more sore). The patient was treated with NAPROXEN SODIUM (ALEVE MAX) (oral) ongoing since an unknown date for Pain, at an unspecified dose and frequency and LIDOCAINE HYDROCHLORIDE (LIDOCAINE [LIDOCAINE HYDROCHLORIDE]) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, MASS (hard lump), PAIN (radiating down my arm), CONTUSION (feels like a big bruise), NEURALGIA (radiating down my nerves) and MYALGIA (muscle in my arm where I got the shot has been getting more and more sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medicine include Aleve and 4% Lidocaine roll-on pain reliever
Sex: F
Vaccine: COVID19
Symptoms: Tongue discolouration
Clinical narrative: my tongue was black; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOLOURATION (my tongue was black) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced TONGUE DISCOLOURATION (my tongue was black). At the time of the report, TONGUE DISCOLOURATION (my tongue was black) outcome was unknown.            The concomitant medications information was not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Intentional product use issue, Vaccination site pain
Clinical narrative: pain in the arm of the injection; tendon ball on the left side of the neck, near de collar bone, two little balls on the left side of the neck, near de collar bone; Second dose administered over 35 days after the first one.; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (tendon ball on the left side of the neck, near de collar bone, two little balls on the left side of the neck, near de collar bone), INTENTIONAL PRODUCT USE ISSUE (Second dose administered over 35 days after the first one.) and VACCINATION SITE PAIN (pain in the arm of the injection) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Second dose administered over 35 days after the first one.). On 04-Jun-2021, the patient experienced AXILLARY MASS (tendon ball on the left side of the neck, near de collar bone, two little balls on the left side of the neck, near de collar bone). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm of the injection). On 03-Jun-2021, INTENTIONAL PRODUCT USE ISSUE (Second dose administered over 35 days after the first one.) had resolved. At the time of the report, AXILLARY MASS (tendon ball on the left side of the neck, near de collar bone, two little balls on the left side of the neck, near de collar bone) and VACCINATION SITE PAIN (pain in the arm of the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medication for allergy occasionally. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Serum ferritin increased
Clinical narrative: increased ferritin levels; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SERUM FERRITIN INCREASED (increased ferritin levels) 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 was provided by the 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, 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 SERUM FERRITIN INCREASED (increased ferritin levels). At the time of the report, SERUM FERRITIN INCREASED (increased ferritin levels) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Consent for follow up declined. can the covid 19 vaccine from moderna cause increased ferritin levels. No concomitant product has been reported.   No treatment information has provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vomiting
Clinical narrative: Extremely tired; That whole night kind of starting 8 hours after the dose and ending 15 hours after she was vomiting and it wasn't as pregnancy; After her second dose she had fever that started 8 hours after the vaccine, and it lasted for about 18 hours; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PYREXIA (After her second dose she had fever that started 8 hours after the vaccine, and it lasted for about 18 hours), FATIGUE (Extremely tired) and VOMITING (That whole night kind of starting 8 hours after the dose and ending 15 hours after she was vomiting and it wasn't as pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A.) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMOXICILLIN and LEVOTHYROXINE for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Mar-2021 and the estimated date of delivery was 05-Dec-2021. On 05-May-2021, the patient experienced PYREXIA (After her second dose she had fever that started 8 hours after the vaccine, and it lasted for about 18 hours) and VOMITING (That whole night kind of starting 8 hours after the dose and ending 15 hours after she was vomiting and it wasn't as pregnancy). On an unknown date, the patient experienced FATIGUE (Extremely tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 06-May-2021, PYREXIA (After her second dose she had fever that started 8 hours after the vaccine, and it lasted for about 18 hours) and VOMITING (That whole night kind of starting 8 hours after the dose and ending 15 hours after she was vomiting and it wasn't as pregnancy) had resolved. At the time of the report, FATIGUE (Extremely tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site vesicles
Clinical narrative: Bubble up under the skin; Hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE VESICLES (Bubble up under the skin) and VACCINATION SITE PAIN (Hurts) 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 VACCINATION SITE VESICLES (Bubble up under the skin) and VACCINATION SITE PAIN (Hurts). At the time of the report, VACCINATION SITE VESICLES (Bubble up under the skin) and VACCINATION SITE PAIN (Hurts) 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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus, Vaccination complication
Clinical narrative: a reaction after my second dose; Tinnitus; clogged ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus), EAR DISCOMFORT (clogged ears) and VACCINATION COMPLICATION (a reaction after my second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L24A and 029L26A) for COVID-19 vaccination.     The patient's past medical history included Acupuncture since 22-Jun-2021. Concurrent medical conditions included Osteoporosis (post-menopause) and Sulfonamide allergy. Concomitant products included DENOSUMAB (PROLIA) from 02-Feb-2019 to an unknown date for Osteoporosis, COLECALCIFEROL, FISH OIL (OMEGA 3D), COLECALCIFEROL (VIT D [COLECALCIFEROL]), PROBIOTIC 4 and CYANOCOBALAMIN (VIT B12) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced TINNITUS (Tinnitus) and EAR DISCOMFORT (clogged ears). On an unknown date, the patient experienced VACCINATION COMPLICATION (a reaction after my second dose). The patient was treated with PREDNISONE for Ear feels clogged, at a dose of UNK dosage form; GINKGO BILOBA (GINGO BILOBA) for Ear feels clogged, at a dose of UNK dosage form and Manual therapy (Accupuncture started on 22-JUN-2021) for Tinnitus. At the time of the report, TINNITUS (Tinnitus) and EAR DISCOMFORT (clogged ears) had not resolved and VACCINATION COMPLICATION (a reaction after my second dose) outcome was unknown.            The doctor prescribed flavonoids to the patient for 1 month for ringing in ears .   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Patient demographics,Dose 1 details, past medical history, concomitant medications, treatment medications were reported On 28-Jul-2021: Non-significant follow-up
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Had COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Had COVID-19) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Had COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Had COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: I had the vaccine shot 2 days ago and this morning I woke up with it being red; I woke up with it being red and swollen/Why is my arm swollen after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (I had the vaccine shot 2 days ago and this morning I woke up with it being red) and VACCINATION SITE SWELLING (I woke up with it being red and swollen/Why is my arm swollen after the vaccination) 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. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (I had the vaccine shot 2 days ago and this morning I woke up with it being red) and VACCINATION SITE SWELLING (I woke up with it being red and swollen/Why is my arm swollen after the vaccination). At the time of the report, VACCINATION SITE ERYTHEMA (I had the vaccine shot 2 days ago and this morning I woke up with it being red) and VACCINATION SITE SWELLING (I woke up with it being red and swollen/Why is my arm swollen after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment products were reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Nausea; Headaches; Received the second dose of the Moderna covid19 vaccine while being 17 years of age; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the second dose of the Moderna covid19 vaccine while being 17 years of age), PAIN IN EXTREMITY (Pain in the arm), NAUSEA (Nausea) and HEADACHE (Headaches) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 014c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the second dose of the Moderna covid19 vaccine while being 17 years of age) and PAIN IN EXTREMITY (Pain in the arm). On 23-May-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headaches). On 22-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the second dose of the Moderna covid19 vaccine while being 17 years of age) had resolved. On 25-May-2021, PAIN IN EXTREMITY (Pain in the arm), NAUSEA (Nausea) and HEADACHE (Headaches) had resolved.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-090747 (Patient Link).
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccine side effects; 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 COMPLICATION (Vaccine side effects) in a 31-year-old patient of an unknown 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 VACCINATION COMPLICATION (Vaccine side effects). At the time of the report, VACCINATION COMPLICATION (Vaccine side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swelling lips; 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 LIP SWELLING (Swelling lips) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (Swelling lips). At the time of the report, LIP SWELLING (Swelling lips) 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.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: covid arm that is itchy; covid arm that is red; covid arm that is hot; covid arm that is swollen; covid arm that is painful and sore; covid arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (covid arm that is itchy), VACCINATION SITE ERYTHEMA (covid arm that is red), VACCINATION SITE WARMTH (covid arm that is hot), VACCINATION SITE SWELLING (covid arm that is swollen) and VACCINATION SITE PAIN (covid arm that is painful and sore) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included irms for an unknown indication.    On 26-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 VACCINATION SITE PRURITUS (covid arm that is itchy), VACCINATION SITE ERYTHEMA (covid arm that is red), VACCINATION SITE WARMTH (covid arm that is hot), VACCINATION SITE SWELLING (covid arm that is swollen), VACCINATION SITE PAIN (covid arm that is painful and sore) and VACCINATION SITE REACTION (covid arm). The patient was treated with irms at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.