chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants and treatments were not reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site swelling
Clinical narrative: swelling below the injection site; fatigue; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling below the injection site), FATIGUE (fatigue) and MYALGIA (muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling below the injection site), FATIGUE (fatigue) and MYALGIA (muscle aches). At the time of the report, VACCINATION SITE SWELLING (swelling below the injection site), FATIGUE (fatigue) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: had to leave work/unable to return to work; upset stomach; joint pain; fever up to 103 degrees F; chills; headache; nausea; muscle ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (had to leave work/unable to return to work), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (joint pain), PYREXIA (fever up to 103 degrees F) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (had to leave work/unable to return to work), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (joint pain), PYREXIA (fever up to 103 degrees F), CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), MYALGIA (muscle ache) and FATIGUE (fatigue). The patient was treated with NAPROXEN at a dose of 500 milligram,moved up to 1000 mg every 8 hours. At the time of the report, FEELING ABNORMAL (had to leave work/unable to return to work), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (joint pain), PYREXIA (fever up to 103 degrees F), CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), MYALGIA (muscle ache) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 103 (High) fever up to 103 degrees F. In April 2021, Body temperature: 101 (Low) fever had gone done to 101 degrees F and 97 (normal) Today her temp is 97 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was used.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: had to leave work/unable to return to work; upset stomach; joint pain; fever up to 103 degrees F; chills; headache; nausea; muscle ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (had to leave work/unable to return to work), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (joint pain), PYREXIA (fever up to 103 degrees F) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (had to leave work/unable to return to work), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (joint pain), PYREXIA (fever up to 103 degrees F), CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), MYALGIA (muscle ache) and FATIGUE (fatigue). The patient was treated with NAPROXEN at a dose of 500 milligram,moved up to 1000 mg every 8 hours. At the time of the report, FEELING ABNORMAL (had to leave work/unable to return to work), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (joint pain), PYREXIA (fever up to 103 degrees F), CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), MYALGIA (muscle ache) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 103 (High) fever up to 103 degrees F. In April 2021, Body temperature: 101 (Low) fever had gone done to 101 degrees F and 97 (normal) Today her temp is 97 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was used.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Right hand hurt after first dose; Aches after 1st dose; Slight headache after 1st dose; Fever after 1st dose; Joints hurt after 1st dose; Chills after first dose; Nausea after first dose; Diarrhea after first dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea after first dose), PAIN IN EXTREMITY (Right hand hurt after first dose), PAIN (Aches after 1st dose), HEADACHE (Slight headache after 1st dose) and PYREXIA (Fever after 1st dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007m21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Diabetes mellitus non-insulin-dependent. Concomitant products included IBUPROFEN for Arthritis, METFORMIN and LISINOPRIL for an unknown indication.    On 17-Feb-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 DIARRHOEA (Diarrhea after first dose), PAIN IN EXTREMITY (Right hand hurt after first dose), PAIN (Aches after 1st dose), HEADACHE (Slight headache after 1st dose), PYREXIA (Fever after 1st dose), ARTHRALGIA (Joints hurt after 1st dose), CHILLS (Chills after first dose) and NAUSEA (Nausea after first dose). At the time of the report, DIARRHOEA (Diarrhea after first dose), PAIN IN EXTREMITY (Right hand hurt after first dose), PAIN (Aches after 1st dose), HEADACHE (Slight headache after 1st dose), PYREXIA (Fever after 1st dose), ARTHRALGIA (Joints hurt after 1st dose) and CHILLS (Chills after first dose) had resolved and NAUSEA (Nausea after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included pain killers and fever reducers.   This case was linked to US-MODERNATX, INC.-MOD-2021-073210 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Added past medical history, event outcome and about vaccine second dose details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073210:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Right hand hurt after first dose; Aches after 1st dose; Slight headache after 1st dose; Fever after 1st dose; Joints hurt after 1st dose; Chills after first dose; Nausea after first dose; Diarrhea after first dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea after first dose), PAIN IN EXTREMITY (Right hand hurt after first dose), PAIN (Aches after 1st dose), HEADACHE (Slight headache after 1st dose) and PYREXIA (Fever after 1st dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007m21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Diabetes mellitus non-insulin-dependent. Concomitant products included IBUPROFEN for Arthritis, METFORMIN and LISINOPRIL for an unknown indication.    On 17-Feb-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 DIARRHOEA (Diarrhea after first dose), PAIN IN EXTREMITY (Right hand hurt after first dose), PAIN (Aches after 1st dose), HEADACHE (Slight headache after 1st dose), PYREXIA (Fever after 1st dose), ARTHRALGIA (Joints hurt after 1st dose), CHILLS (Chills after first dose) and NAUSEA (Nausea after first dose). At the time of the report, DIARRHOEA (Diarrhea after first dose), PAIN IN EXTREMITY (Right hand hurt after first dose), PAIN (Aches after 1st dose), HEADACHE (Slight headache after 1st dose), PYREXIA (Fever after 1st dose), ARTHRALGIA (Joints hurt after 1st dose) and CHILLS (Chills after first dose) had resolved and NAUSEA (Nausea after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included pain killers and fever reducers.   This case was linked to US-MODERNATX, INC.-MOD-2021-073210 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Added past medical history, event outcome and about vaccine second dose details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073210:
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Depression
Clinical narrative: More and more depressed; Other side effects; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (More and more depressed) and ADVERSE DRUG REACTION (Other side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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 DEPRESSION (More and more depressed) and ADVERSE DRUG REACTION (Other side effects).            No concomitant medications were not provided No treatment medication information were not provided   This case was linked to MOD-2021-073142 (Patient Link).   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: unsure if she got a full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (unsure if she got a full dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Hypertension. Concomitant products included CANDESARTAN for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to UNK dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (unsure if she got a full dose). On 08-Apr-2021, ACCIDENTAL UNDERDOSE (unsure if she got a full dose) had resolved.            Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: heart palpitatoins; mild chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (mild chest pain) and PALPITATIONS (heart palpitatoins) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CHEST PAIN (mild chest pain). On 08-Apr-2021, the patient experienced PALPITATIONS (heart palpitatoins). At the time of the report, CHEST PAIN (mild chest pain) and PALPITATIONS (heart palpitatoins) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided No concomitant medications were reported
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-years-old patient was given first dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-years-old patient was given first dose of Moderna Covid-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome. Concomitant products included LEVOTHYROXINE and VITAMIN D NOS (VITAMIN D) for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-years-old patient was given first dose of Moderna Covid-19 vaccine). On 14-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-years-old patient was given first dose of Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was supposed to receive second dose on 11-Apr-2021 but the nurse refused because of patient's age. The reporter informed that the patient was in risk group and did not have full immunity because of rejection of second dose.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Somnolence
Clinical narrative: Got really sick; really sleepy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick) and SOMNOLENCE (really sleepy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ILLNESS (Got really sick) and SOMNOLENCE (really sleepy). At the time of the report, ILLNESS (Got really sick) and SOMNOLENCE (really sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: soreness in arm; headache; slight fever; pain in arm which travelled from top of arm to tips of her fingers; pain in her chest (left chest/breast area); could not lay down on her left or right side; chest pain was really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in arm which travelled from top of arm to tips of her fingers), CHEST PAIN (pain in her chest (left chest/breast area)), PAIN IN EXTREMITY (could not lay down on her left or right side), CHEST PAIN (chest pain was really bad) and PAIN IN EXTREMITY (soreness in arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN (pain in arm which travelled from top of arm to tips of her fingers), CHEST PAIN (pain in her chest (left chest/breast area)), PAIN IN EXTREMITY (could not lay down on her left or right side), CHEST PAIN (chest pain was really bad) and PYREXIA (slight fever). On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm) and HEADACHE (headache). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (pain in arm which travelled from top of arm to tips of her fingers), CHEST PAIN (pain in her chest (left chest/breast area)), PAIN IN EXTREMITY (could not lay down on her left or right side), CHEST PAIN (chest pain was really bad), PAIN IN EXTREMITY (soreness in arm), PYREXIA (slight fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment with Ibuprofen and Tylenol were provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: first dose administered under age 18; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered under age 18) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for an unknown indication.     The patient's past medical history included No adverse event.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered under age 18).   At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered under age 18) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Apr-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment and concomitant medicines were not included  Action taken with mRNA-1273 in response to the event was unknown
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient did not get full dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient did not get full dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .3 milliliter. On 10-Apr-2021, the patient experienced UNDERDOSE (patient did not get full dose). At the time of the report, UNDERDOSE (patient did not get full dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  As the pharmacist was administering the vaccine to the patient the needle leaked out 0.1 - 0.2ml patient did not get full dose  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received: NNI
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Nausea, Pyrexia, Restless legs syndrome
Clinical narrative: Restless legs syndrome; Problems to stand up; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESS LEGS SYNDROME (Restless legs syndrome), DYSSTASIA (Problems to stand up), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced NAUSEA (Nausea). On 09-Apr-2021, the patient experienced RESTLESS LEGS SYNDROME (Restless legs syndrome), DYSSTASIA (Problems to stand up), PYREXIA (Fever) and CHILLS (Chills). On 11-Apr-2021, RESTLESS LEGS SYNDROME (Restless legs syndrome), DYSSTASIA (Problems to stand up) and PYREXIA (Fever) had resolved. At the time of the report, NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Localised oedema, Pain
Clinical narrative: Left collar bone has build up of fluid between neck and shoulder on the left side; Slight fever; Soreness at the injection site; Really bad headache; Tired; Chills; Swelling at the injection site; Aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Aches), LOCALISED OEDEMA (Left collar bone has build up of fluid between neck and shoulder on the left side), PYREXIA (Slight fever), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Really bad headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-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 08-Apr-2021, the patient experienced PAIN (Aches), PYREXIA (Slight fever), VACCINATION SITE PAIN (Soreness at the injection site), HEADACHE (Really bad headache), FATIGUE (Tired), CHILLS (Chills) and VACCINATION SITE SWELLING (Swelling at the injection site). On 09-Apr-2021, the patient experienced LOCALISED OEDEMA (Left collar bone has build up of fluid between neck and shoulder on the left side). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 09-Apr-2021, PAIN (Aches), PYREXIA (Slight fever), HEADACHE (Really bad headache), FATIGUE (Tired) and CHILLS (Chills) had resolved. At the time of the report, LOCALISED OEDEMA (Left collar bone has build up of fluid between neck and shoulder on the left side), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter contact detail was updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Left collar bone has build up of fluid between neck and shoulder on the left side; Slight fever; Soreness at the injection site; Really bad headache; Tired; Chills; Swelling at the injection site; Aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Aches), LOCALISED OEDEMA (Left collar bone has build up of fluid between neck and shoulder on the left side), PYREXIA (Slight fever), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Really bad headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-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 08-Apr-2021, the patient experienced PAIN (Aches), PYREXIA (Slight fever), VACCINATION SITE PAIN (Soreness at the injection site), HEADACHE (Really bad headache), FATIGUE (Tired), CHILLS (Chills) and VACCINATION SITE SWELLING (Swelling at the injection site). On 09-Apr-2021, the patient experienced LOCALISED OEDEMA (Left collar bone has build up of fluid between neck and shoulder on the left side). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 09-Apr-2021, PAIN (Aches), PYREXIA (Slight fever), HEADACHE (Really bad headache), FATIGUE (Tired) and CHILLS (Chills) had resolved. At the time of the report, LOCALISED OEDEMA (Left collar bone has build up of fluid between neck and shoulder on the left side), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter contact detail was updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Hypoaesthesia, Myalgia
Clinical narrative: Injection site hot; Tiredness / fatigue; Injection site red; Vaccination site itching; Every muscle in her body is hurting, muscle pain; legs started to hurt really bad; they're numb; she could not really walk; feet are still really hurting; is like her whole body is just hurting; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (they're numb), GAIT DISTURBANCE (she could not really walk), PAIN IN EXTREMITY (feet are still really hurting) and PAIN (is like her whole body is just hurting) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis (The patient had pretty severe osteoarthritis and did not have pain since December.). Concomitant products included GABAPENTIN for Leg cramps, SUMATRIPTAN for Migraine, TRAMADOL, QUETIAPINE FUMARATE (SEROQUEL) and ROPINIROLE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (severe headache). On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (they're numb), GAIT DISTURBANCE (she could not really walk), PAIN IN EXTREMITY (feet are still really hurting), PAIN (is like her whole body is just hurting) and MYALGIA (Every muscle in her body is hurting, muscle pain). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site hot), FATIGUE (Tiredness / fatigue), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PRURITUS (Vaccination site itching). The patient was treated with CORTISONE for Osteoarthritis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (they're numb), GAIT DISTURBANCE (she could not really walk), PAIN IN EXTREMITY (feet are still really hurting), PAIN (is like her whole body is just hurting), VACCINATION SITE WARMTH (Injection site hot), FATIGUE (Tiredness / fatigue), HEADACHE (severe headache), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PRURITUS (Vaccination site itching) and MYALGIA (Every muscle in her body is hurting, muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Added events such as Injection site red, injection site hot , itching, fatigue added.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site hot; Tiredness / fatigue; Injection site red; Vaccination site itching; Every muscle in her body is hurting, muscle pain; legs started to hurt really bad; they're numb; she could not really walk; feet are still really hurting; is like her whole body is just hurting; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (they're numb), GAIT DISTURBANCE (she could not really walk), PAIN IN EXTREMITY (feet are still really hurting) and PAIN (is like her whole body is just hurting) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis (The patient had pretty severe osteoarthritis and did not have pain since December.). Concomitant products included GABAPENTIN for Leg cramps, SUMATRIPTAN for Migraine, TRAMADOL, QUETIAPINE FUMARATE (SEROQUEL) and ROPINIROLE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (severe headache). On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (they're numb), GAIT DISTURBANCE (she could not really walk), PAIN IN EXTREMITY (feet are still really hurting), PAIN (is like her whole body is just hurting) and MYALGIA (Every muscle in her body is hurting, muscle pain). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site hot), FATIGUE (Tiredness / fatigue), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PRURITUS (Vaccination site itching). The patient was treated with CORTISONE for Osteoarthritis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (they're numb), GAIT DISTURBANCE (she could not really walk), PAIN IN EXTREMITY (feet are still really hurting), PAIN (is like her whole body is just hurting), VACCINATION SITE WARMTH (Injection site hot), FATIGUE (Tiredness / fatigue), HEADACHE (severe headache), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PRURITUS (Vaccination site itching) and MYALGIA (Every muscle in her body is hurting, muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Added events such as Injection site red, injection site hot , itching, fatigue added.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: exhausted the next day and tired and other stuff; 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 (exhausted the next day and tired and other stuff) 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 No adverse event.    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 FATIGUE (exhausted the next day and tired and other stuff). At the time of the report, FATIGUE (exhausted the next day and tired and other stuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throwing up; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (throwing up) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 09-Apr-2021, the patient experienced VOMITING (throwing up). At the time of the report, VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       CONcominant and Treatment drugs were not used, no lab data was given and no adverse reaction history was reported
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: diagnosed with shingles; shingle looking rash on her right side; This spontaneous case was reported by a consumer and describes the occurrence of RASH (shingle looking rash on her right side) and HERPES ZOSTER (diagnosed with shingles) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0C8A79(or z) 1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced RASH (shingle looking rash on her right side). On 05-Apr-2021, the patient experienced HERPES ZOSTER (diagnosed with shingles). At the time of the report, RASH (shingle looking rash on her right side) and HERPES ZOSTER (diagnosed with shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment medication was valacyclovir.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: had every side effect like having the virus.; difficult in breathing; runny nose; didn't want to eat; cough; headache; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (had every side effect like having the virus.), DYSPNOEA (difficult in breathing), RHINORRHOEA (runny nose), DECREASED APPETITE (didn't want to eat) and COUGH (cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had virus for 3 months).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced ADVERSE REACTION (had every side effect like having the virus.), DYSPNOEA (difficult in breathing), RHINORRHOEA (runny nose), DECREASED APPETITE (didn't want to eat), COUGH (cough), HEADACHE (headache), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, ADVERSE REACTION (had every side effect like having the virus.), DYSPNOEA (difficult in breathing), RHINORRHOEA (runny nose), DECREASED APPETITE (didn't want to eat), COUGH (cough), HEADACHE (headache), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-118963 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rhinorrhoea
Clinical narrative: had every side effect like having the virus.; difficult in breathing; runny nose; didn't want to eat; cough; headache; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (had every side effect like having the virus.), DYSPNOEA (difficult in breathing), RHINORRHOEA (runny nose), DECREASED APPETITE (didn't want to eat) and COUGH (cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had virus for 3 months).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced ADVERSE REACTION (had every side effect like having the virus.), DYSPNOEA (difficult in breathing), RHINORRHOEA (runny nose), DECREASED APPETITE (didn't want to eat), COUGH (cough), HEADACHE (headache), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, ADVERSE REACTION (had every side effect like having the virus.), DYSPNOEA (difficult in breathing), RHINORRHOEA (runny nose), DECREASED APPETITE (didn't want to eat), COUGH (cough), HEADACHE (headache), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-118963 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing). At the time of the report, COUGH (Coughing) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  The patient took allergy medications for the events.   This case was linked to MOD-2021-279502 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: The follow up document was received and had  significant information, that is the patient provided her email address.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Cough, Headache
Clinical narrative: Still not taken 2nd dose due to severe COVID-19 sypmtoms; Chills which became severe; Joint pain which became severe; headache; Cough; Attacked my legs with severe pain/Severe leg pain; Could not sleep for 4 days; Lower back hurt/Lower back pain; Legs are numb/ partially numb; Legs felt very weak; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN IN EXTREMITY (Attacked my legs with severe pain/Severe leg pain), INSOMNIA (Could not sleep for 4 days), BACK PAIN (Lower back hurt/Lower back pain) and HYPOAESTHESIA (Legs are numb/ partially numb) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder. Concomitant products included AMLODIPINE for Blood pressure management, SIMVASTATIN (NORVASTATIN) for Cholesterol.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COUGH (Cough), PAIN IN EXTREMITY (Attacked my legs with severe pain/Severe leg pain), INSOMNIA (Could not sleep for 4 days), BACK PAIN (Lower back hurt/Lower back pain), HYPOAESTHESIA (Legs are numb/ partially numb), MUSCULAR WEAKNESS (Legs felt very weak), CHILLS (Chills which became severe), ARTHRALGIA (Joint pain which became severe) and HEADACHE (headache). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Still not taken 2nd dose due to severe COVID-19 sypmtoms). At the time of the report, COUGH (Cough), PAIN IN EXTREMITY (Attacked my legs with severe pain/Severe leg pain), INSOMNIA (Could not sleep for 4 days), BACK PAIN (Lower back hurt/Lower back pain), CHILLS (Chills which became severe) and ARTHRALGIA (Joint pain which became severe) outcome was unknown, HYPOAESTHESIA (Legs are numb/ partially numb), MUSCULAR WEAKNESS (Legs felt very weak) and HEADACHE (headache) had not resolved and INTENTIONAL PRODUCT USE ISSUE (Still not taken 2nd dose due to severe COVID-19 sypmtoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: negative (Negative) Tested before vaccination.. On 26-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: New event (s) added. The outcome of the event (s) Muscular Weakness, Headache and hypoaesthesia changed from unknown to not resolved.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Intentional product use issue, Muscular weakness, Pain in extremity
Clinical narrative: Still not taken 2nd dose due to severe COVID-19 sypmtoms; Chills which became severe; Joint pain which became severe; headache; Cough; Attacked my legs with severe pain/Severe leg pain; Could not sleep for 4 days; Lower back hurt/Lower back pain; Legs are numb/ partially numb; Legs felt very weak; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN IN EXTREMITY (Attacked my legs with severe pain/Severe leg pain), INSOMNIA (Could not sleep for 4 days), BACK PAIN (Lower back hurt/Lower back pain) and HYPOAESTHESIA (Legs are numb/ partially numb) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder. Concomitant products included AMLODIPINE for Blood pressure management, SIMVASTATIN (NORVASTATIN) for Cholesterol.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COUGH (Cough), PAIN IN EXTREMITY (Attacked my legs with severe pain/Severe leg pain), INSOMNIA (Could not sleep for 4 days), BACK PAIN (Lower back hurt/Lower back pain), HYPOAESTHESIA (Legs are numb/ partially numb), MUSCULAR WEAKNESS (Legs felt very weak), CHILLS (Chills which became severe), ARTHRALGIA (Joint pain which became severe) and HEADACHE (headache). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Still not taken 2nd dose due to severe COVID-19 sypmtoms). At the time of the report, COUGH (Cough), PAIN IN EXTREMITY (Attacked my legs with severe pain/Severe leg pain), INSOMNIA (Could not sleep for 4 days), BACK PAIN (Lower back hurt/Lower back pain), CHILLS (Chills which became severe) and ARTHRALGIA (Joint pain which became severe) outcome was unknown, HYPOAESTHESIA (Legs are numb/ partially numb), MUSCULAR WEAKNESS (Legs felt very weak) and HEADACHE (headache) had not resolved and INTENTIONAL PRODUCT USE ISSUE (Still not taken 2nd dose due to severe COVID-19 sypmtoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: negative (Negative) Tested before vaccination.. On 26-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: New event (s) added. The outcome of the event (s) Muscular Weakness, Headache and hypoaesthesia changed from unknown to not resolved.