chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Dyspnoea
Clinical narrative: Intermittent mild chest pain and episodes of shortness of breath and a ?fluttering heart? sensation over a period of about 1 month after the second dose.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anti-thyroid antibody, Autoimmune thyroiditis, Blood thyroid stimulating hormone, Full blood count, Lymphadenopathy
Clinical narrative: Lymph node on left side collarbone and lymphatic fluid
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphoedema, Thyroxine, Thyroxine free, Tri-iodothyronine, Ultrasound scan
Clinical narrative: Lymph node on left side collarbone and lymphatic fluid
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Myalgia
Clinical narrative: hot with no fever; dizzy; achy and the vaccine is kicking his butt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot with no fever), DIZZINESS (dizzy) and MYALGIA (achy and the vaccine is kicking his butt) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0363B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot with no fever), DIZZINESS (dizzy) and MYALGIA (achy and the vaccine is kicking his butt). At the time of the report, FEELING HOT (hot with no fever), DIZZINESS (dizzy) and MYALGIA (achy and the vaccine is kicking his butt) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-may-2021 and no significant information was provided
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Fatigue, Injection site pain, Urticaria
Clinical narrative: Red Hives Circled around left arm approx. three inches below injections site.  Hives on right uppper arm. Hives on neck and chest.  Fatigue.  Abdominal pain.  Painful arm where shot given.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Condition aggravated, Crohn's disease, Diarrhoea, Eructation
Clinical narrative: Sharp pains all throughout body, extremely powerful headache, fever, pressure in chest, caused my Chron?s to flare and I have bowel spasms, sulfur burps, diarrhea, fatigue. For 48 hours.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal pain, Headache, Pain, Pyrexia
Clinical narrative: Sharp pains all throughout body, extremely powerful headache, fever, pressure in chest, caused my Chron?s to flare and I have bowel spasms, sulfur burps, diarrhea, fatigue. For 48 hours.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: I got what was diagnosed as gout in my right foot extremely bad. My diet was immaculate and I had never had goat before in my life.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Dyspnoea, Fatigue, Malaise
Clinical narrative: COVID symptoms while still maintaining negative test result for COVID. Fatigue, sore throat, congestion, runny nose, difficulty breathing, low blood oxygen levels, chest tightness. X-Ray showed clear lungs, send home with albuteral which made chest tightness and breathing worse. Trying to get appointment for cardiac monitoring and checking for heart issues.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Oxygen saturation decreased, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: COVID symptoms while still maintaining negative test result for COVID. Fatigue, sore throat, congestion, runny nose, difficulty breathing, low blood oxygen levels, chest tightness. X-Ray showed clear lungs, send home with albuteral which made chest tightness and breathing worse. Trying to get appointment for cardiac monitoring and checking for heart issues.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Feeling abnormal, Headache, Pain
Clinical narrative: High fever, chills, headache, body ache, brain fog, sensation of havimg neddles all over, stomach pain...
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: High fever, chills, headache, body ache, brain fog, sensation of havimg neddles all over, stomach pain...
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: vaccination site movement impairment; Pain in arm of the injection after 1st dose,had pain in the arm of the injection starting first day; pain is from her shoulder down into her arm; Pain from shoulder into arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment), VACCINATION SITE PAIN (Pain in arm of the injection after 1st dose,had pain in the arm of the injection starting first day), PAIN IN EXTREMITY (pain is from her shoulder down into her arm) and ARTHRALGIA (Pain from shoulder into arm after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment), VACCINATION SITE PAIN (Pain in arm of the injection after 1st dose,had pain in the arm of the injection starting first day), PAIN IN EXTREMITY (pain is from her shoulder down into her arm) and ARTHRALGIA (Pain from shoulder into arm after 1st dose). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment), VACCINATION SITE PAIN (Pain in arm of the injection after 1st dose,had pain in the arm of the injection starting first day), PAIN IN EXTREMITY (pain is from her shoulder down into her arm) and ARTHRALGIA (Pain from shoulder into arm after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-189035, MOD-2021-189035, MOD-2021-169696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: small red dot on foot; 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 ERYTHEMA (small red dot on foot) 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 ERYTHEMA (small red dot on foot). At the time of the report, ERYTHEMA (small red dot on foot) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Nonsignificant Followup received on 26 MAY 2021, no new information
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Headache, Lethargy
Clinical narrative: Coughing; Lethargy; Headache; Joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), LETHARGY (Lethargy), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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, 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), LETHARGY (Lethargy), HEADACHE (Headache) and ARTHRALGIA (Joint pain). At the time of the report, COUGH (Coughing), LETHARGY (Lethargy), HEADACHE (Headache) and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.   Reporter did not allow further contact
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: A sore arm; Patient received the second dose of the vaccine 13 days after the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (A sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 13 days after the first dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 13 days after the first dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (A sore arm). On 24-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 13 days after the first dose) had resolved. At the time of the report, PAIN IN EXTREMITY (A sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information reported. No treatment medication information reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Route of the suspect medication was added and event- a sore arm was added
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report an adverse event from a patient who received the 2 doses of Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Report an adverse event from a patient who received the 2 doses of Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 COMPLICATION (Report an adverse event from a patient who received the 2 doses of Moderna Covid-19 vaccine). At the time of the report, VACCINATION COMPLICATION (Report an adverse event from a patient who received the 2 doses of Moderna Covid-19 vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided. nurse called back to report an adverse event from a patient who received the 2 doses of the Moderna Covid-19 vaccine, but after to provided the old case number the communication was interrupted and because the consent for a follow-up call was not granted, agent did not call back the nurse.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow up received om 26-MAY-2021 Contains NNI
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; NA
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Headache
Clinical narrative: Headache; experienced a side effect.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and ADVERSE REACTION (experienced a side effect.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and ADVERSE REACTION (experienced a side effect.). At the time of the report, HEADACHE (Headache) and ADVERSE REACTION (experienced a side effect.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 26-MAY-2021 contains non-significant information.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Lymphadenopathy, Vaccination site induration
Clinical narrative: weakness; uncomfortable; crusty injection site; painful arm; tiredness; lump/lymph node in armpit; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (crusty injection site), VACCINATION SITE PAIN (painful arm) and FATIGUE (tiredness) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Enlarged prostate. Concurrent medical conditions included Drug allergy (allergic to  Tramadol and Plavix), Thyroid disorder and Cancer.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (weakness), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (crusty injection site), VACCINATION SITE PAIN (painful arm), FATIGUE (tiredness) and LYMPHADENOPATHY (lump/lymph node in armpit). At the time of the report, ASTHENIA (weakness), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (crusty injection site), VACCINATION SITE PAIN (painful arm), FATIGUE (tiredness) and LYMPHADENOPATHY (lump/lymph node in armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   other meds: concomitant medications include Vitamin D, Cancer medicines, enlarge prostate medicines, thyroid medicines, medicine to urinate and treatment medications include Antibiotics
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: weakness; uncomfortable; crusty injection site; painful arm; tiredness; lump/lymph node in armpit; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (crusty injection site), VACCINATION SITE PAIN (painful arm) and FATIGUE (tiredness) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Enlarged prostate. Concurrent medical conditions included Drug allergy (allergic to  Tramadol and Plavix), Thyroid disorder and Cancer.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (weakness), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (crusty injection site), VACCINATION SITE PAIN (painful arm), FATIGUE (tiredness) and LYMPHADENOPATHY (lump/lymph node in armpit). At the time of the report, ASTHENIA (weakness), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (crusty injection site), VACCINATION SITE PAIN (painful arm), FATIGUE (tiredness) and LYMPHADENOPATHY (lump/lymph node in armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   other meds: concomitant medications include Vitamin D, Cancer medicines, enlarge prostate medicines, thyroid medicines, medicine to urinate and treatment medications include Antibiotics
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: had my period 8 days earlier after my first shot; bleeded more than usual; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (had my period 8 days earlier after my first shot) and HEAVY MENSTRUAL BLEEDING (bleeded more than usual) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No Adverse Events.    On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (had my period 8 days earlier after my first shot) and HEAVY MENSTRUAL BLEEDING (bleeded more than usual). At the time of the report, MENSTRUATION IRREGULAR (had my period 8 days earlier after my first shot) and HEAVY MENSTRUAL BLEEDING (bleeded more than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-170358 (Patient Link).   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Sinusitis, Vaccination site pain
Clinical narrative: vaccination site pain; Sinus infection; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) and SINUSITIS (Sinus infection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain) and SINUSITIS (Sinus infection). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) and SINUSITIS (Sinus infection) 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.   The treatment information was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: did not get the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get the second shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get the second shot) outcome was unknown.            The patient opted not to receive the second dose due to the serious events experienced after first dose of the vaccine.   This case was linked to MOD-2021-102010 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: fatigue; Injection site pain; stomach pain, indigestion which she had to take acid reflux medicine.; felt like her head was on fire; burning in head; chills; dizziness; a vertigo episode.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain), ABDOMINAL PAIN UPPER (stomach pain, indigestion which she had to take acid reflux medicine.), FEELING ABNORMAL (felt like her head was on fire) and MIGRAINE (burning in head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no historical conditions provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain), ABDOMINAL PAIN UPPER (stomach pain, indigestion which she had to take acid reflux medicine.), FEELING ABNORMAL (felt like her head was on fire), MIGRAINE (burning in head), CHILLS (chills), DIZZINESS (dizziness) and VERTIGO (a vertigo episode.). At the time of the report, FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain), ABDOMINAL PAIN UPPER (stomach pain, indigestion which she had to take acid reflux medicine.), FEELING ABNORMAL (felt like her head was on fire), MIGRAINE (burning in head), CHILLS (chills), DIZZINESS (dizziness) and VERTIGO (a vertigo episode.) outcome was unknown. Not Provided          No Concomitant medications were provided No Treatment information provided    This case was linked to MOD21-096687 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vaccination site pain, Vertigo
Clinical narrative: fatigue; Injection site pain; stomach pain, indigestion which she had to take acid reflux medicine.; felt like her head was on fire; burning in head; chills; dizziness; a vertigo episode.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain), ABDOMINAL PAIN UPPER (stomach pain, indigestion which she had to take acid reflux medicine.), FEELING ABNORMAL (felt like her head was on fire) and MIGRAINE (burning in head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no historical conditions provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain), ABDOMINAL PAIN UPPER (stomach pain, indigestion which she had to take acid reflux medicine.), FEELING ABNORMAL (felt like her head was on fire), MIGRAINE (burning in head), CHILLS (chills), DIZZINESS (dizziness) and VERTIGO (a vertigo episode.). At the time of the report, FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain), ABDOMINAL PAIN UPPER (stomach pain, indigestion which she had to take acid reflux medicine.), FEELING ABNORMAL (felt like her head was on fire), MIGRAINE (burning in head), CHILLS (chills), DIZZINESS (dizziness) and VERTIGO (a vertigo episode.) outcome was unknown. Not Provided          No Concomitant medications were provided No Treatment information provided    This case was linked to MOD21-096687 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site indentation
Clinical narrative: indentation in left arm at site of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE INDENTATION (indentation in left arm at site of injection) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE INDENTATION (indentation in left arm at site of injection). At the time of the report, INJECTION SITE INDENTATION (indentation in left arm at site of injection) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: The follow up received on 25-MAY-2021.It does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: lump in my armpit; 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 AXILLARY MASS (lump in my armpit) 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 AXILLARY MASS (lump in my armpit). At the time of the report, AXILLARY MASS (lump in my armpit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up appended contain NNI
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (mild headache). On 30-Mar-2021, HEADACHE (mild headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-169843 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: This follow-up was received on 25-MAY-2021 which updated no new information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: terrible symptoms; 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 (terrible symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible symptoms). At the time of the report, VACCINATION COMPLICATION (terrible symptoms) outcome was unknown. Not Provided          Med Info Agent: Adverse Event reported through Chatbot.   Patient reports that after the second Moderna vaccine side effects started one hour after dose and continued until now 25May21 which is 24 days later.  There is no information on dose received or patient information.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up appended to MOD-2021-169806
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: arm is very stiff; low grade fever; At the injection site, it hurts; getting body aches,arm is very sore; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm is very stiff), PYREXIA (low grade fever), VACCINATION SITE PAIN (At the injection site, it hurts) and MYALGIA (getting body aches,arm is very sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm is very stiff), PYREXIA (low grade fever), VACCINATION SITE PAIN (At the injection site, it hurts) and MYALGIA (getting body aches,arm is very sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm is very stiff), PYREXIA (low grade fever), VACCINATION SITE PAIN (At the injection site, it hurts) and MYALGIA (getting body aches,arm is very sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant included vitamins was noted. No treatment medications are provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received included no new significant information. On 03-Aug-2021: Follow up received included outcome of events updated from not recovered to recovered.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Got the side affect; Covid positive on 3 day of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Got the side affect) and COVID-19 (Covid positive on 3 day of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Got the side affect) and COVID-19 (Covid positive on 3 day of the vaccine). At the time of the report, ADVERSE EVENT (Got the side affect) and COVID-19 (Covid positive on 3 day of the vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) COVID Test Positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Eye disorder, Headache, Ocular discomfort, Pyrexia
Clinical narrative: eyes wouldn't focus well; fever; headaches; back felt sore; eyes stuffy; This spontaneous case was reported by an other and describes the occurrence of OCULAR DISCOMFORT (eyes wouldn't focus well), EYE DISORDER (eyes stuffy), PYREXIA (fever), HEADACHE (headaches) and BACK PAIN (back felt sore) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced EYE DISORDER (eyes stuffy). On an unknown date, the patient experienced OCULAR DISCOMFORT (eyes wouldn't focus well), PYREXIA (fever), HEADACHE (headaches) and BACK PAIN (back felt sore). At the time of the report, OCULAR DISCOMFORT (eyes wouldn't focus well), EYE DISORDER (eyes stuffy), PYREXIA (fever), HEADACHE (headaches) and BACK PAIN (back felt sore) outcome was unknown.            This case was linked to MOD-2021-169804 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up document received on 25 May does not contain any new information
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: went in for my 2nd Pfizer and they accidently gave me a moderma vaccine; 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 PRODUCT ADMINISTRATION ERROR (went in for my 2nd Pfizer and they accidently gave me a moderma vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (went in for my 2nd Pfizer and they accidently gave me a moderma vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (went in for my 2nd Pfizer and they accidently gave me a moderma vaccine) outcome was unknown. Not Provided          No concomitant medications and treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up information was received on 26may2021 contains no significant information
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) 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 DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up was received on 25-MAY-2021 contain no significant information
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; 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 VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up was received on 25-MAY-2021 and contain no significant information
Sex: U
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: I have depression I can pit the vaccine; 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 DEPRESSION (I have depression I can pit the vaccine) 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 Depression.    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 DEPRESSION (I have depression I can pit the vaccine). At the time of the report, DEPRESSION (I have depression I can pit the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: follow up was received on 26-may-2021 and contain no significant information
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder is starting to hurt; 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 ARTHRALGIA (shoulder is starting to hurt) 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 ARTHRALGIA (shoulder is starting to hurt). At the time of the report, ARTHRALGIA (shoulder is starting to hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: follow up was received on 26-MAY-2021 and contain no significant information
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: The needle wasn't on tight and vaccine squirted out on to the patient; He is not sure how much vaccine they received, but estimated that it was less than half a dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (The needle wasn't on tight and vaccine squirted out on to the patient) and UNDERDOSE (He is not sure how much vaccine they received, but estimated that it was less than half a dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00321CA and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (The needle wasn't on tight and vaccine squirted out on to the patient) and UNDERDOSE (He is not sure how much vaccine they received, but estimated that it was less than half a dose). At the time of the report, DEVICE CONNECTION ISSUE (The needle wasn't on tight and vaccine squirted out on to the patient) and UNDERDOSE (He is not sure how much vaccine they received, but estimated that it was less than half a dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up was received on25-MAY-2021 and contain no significant information
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pruritus, Pyrexia, Urticaria
Clinical narrative: Felt lousy and did nothing all day; hives; itching; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt lousy and did nothing all day), URTICARIA (hives), PRURITUS (itching) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt lousy and did nothing all day), URTICARIA (hives), PRURITUS (itching) and PYREXIA (Fever). At the time of the report, MALAISE (Felt lousy and did nothing all day), URTICARIA (hives), PRURITUS (itching) and PYREXIA (Fever) had resolved.            No concomitant medication was reported. The treatment medication was antihistamine. Action taken with m-RNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-033781, MOD-2021-033781 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site mass, Vaccination site warmth
Clinical narrative: massive hard lump at injection site; warm to touch; massive hard lump at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (massive hard lump at injection site), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE INDURATION (massive hard lump at injection site) 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 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (massive hard lump at injection site), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE INDURATION (massive hard lump at injection site). At the time of the report, VACCINATION SITE MASS (massive hard lump at injection site), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE INDURATION (massive hard lump at injection site) outcome was unknown. Not Provided     I got my second shot on 23 May and have a massive hard lump at injection site, no redness, but warm to touch  Consent for follow-up unknown.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Followup
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: that it has been almost 7 weeks from the first dose; but I was sick on the day I was supposed to get the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (that it has been almost 7 weeks from the first dose) and ILLNESS (but I was sick on the day I was supposed to get the second) 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 07-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 PRODUCT DOSE OMISSION ISSUE (that it has been almost 7 weeks from the first dose) and ILLNESS (but I was sick on the day I was supposed to get the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (that it has been almost 7 weeks from the first dose) and ILLNESS (but I was sick on the day I was supposed to get the second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021, contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site reaction
Clinical narrative: Covid arm 8 days after the 1st dose; on and off nauseous after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (on and off nauseous after the 2nd dose) and VACCINATION SITE REACTION (Covid arm 8 days after the 1st dose) 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, the patient experienced NAUSEA (on and off nauseous after the 2nd dose) and VACCINATION SITE REACTION (Covid arm 8 days after the 1st dose). At the time of the report, NAUSEA (on and off nauseous after the 2nd dose) and VACCINATION SITE REACTION (Covid arm 8 days after the 1st dose) outcome was unknown.            No concomitant and no treatment medications are reported.   This case was linked to MOD-2021-170018 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up case booked in
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Modena Cocid-19 vaccine was possibly administered to less than 40 patients after potentially being stored in the refrigerator for 4 days over 30 day recommended storage period; 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 PRODUCT STORAGE ERROR (Modena Cocid-19 vaccine was possibly administered to less than 40 patients after potentially being stored in the refrigerator for 4 days over 30 day recommended storage period) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) 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) UNK dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Modena Cocid-19 vaccine was possibly administered to less than 40 patients after potentially being stored in the refrigerator for 4 days over 30 day recommended storage period). At the time of the report, PRODUCT STORAGE ERROR (Modena Cocid-19 vaccine was possibly administered to less than 40 patients after potentially being stored in the refrigerator for 4 days over 30 day recommended storage period) had resolved. Not Provided      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 were not provided. Treatment information were not provided.