chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Skin discolouration
Clinical narrative: dark discoloration on the palm of his hand; looks like a bruise /covers the entire palm of his hand; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN DISCOLOURATION (dark discoloration on the palm of his hand) and CONTUSION (looks like a bruise /covers the entire palm of his hand) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced SKIN DISCOLOURATION (dark discoloration on the palm of his hand) and CONTUSION (looks like a bruise /covers the entire palm of his hand). At the time of the report, SKIN DISCOLOURATION (dark discoloration on the palm of his hand) and CONTUSION (looks like a bruise /covers the entire palm of his hand) 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 medication details was reported. No treatment medication details was reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea
Clinical narrative: chest is tight; couldn't breath properly/couldn't get enough air/I woke up and felt like I couldn't breath; chronic cough/the feeling that patient is not getting enough air to the lungs; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest is tight), DYSPNOEA (couldn't breath properly/couldn't get enough air/I woke up and felt like I couldn't breath) and COUGH (chronic cough/the feeling that patient is not getting enough air to the lungs) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy (allergist ran some allergy test. Patient was allergic to a little bit of dust) since June 2021 and Allergy to plants (allergist ran some allergy test. Patient was allergic to some tree) since June 2021.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest is tight), DYSPNOEA (couldn't breath properly/couldn't get enough air/I woke up and felt like I couldn't breath) and COUGH (chronic cough/the feeling that patient is not getting enough air to the lungs). The patient was treated with BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Adverse event, at a dose of two pumps in the morning, two pumps at night. At the time of the report, CHEST DISCOMFORT (chest is tight), DYSPNOEA (couldn't breath properly/couldn't get enough air/I woke up and felt like I couldn't breath) and COUGH (chronic cough/the feeling that patient is not getting enough air to the lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received Asthma pump Symbicort (two pumps in the morning, two pumps at night) as a treatment but it did not work. Doctors wanted to give depressants but patient didn't want it. No concomitant medication were reported. cardiologist ran a bunch of tests. Patient also saw a pulmonologist. A couple of days later, patient got results, and doctors said there weren't any problems: heart is fine, lungs are fine. Second shot on 02Jul2021, given in left non-dominant arm. Lot number: 051C21A..
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Low grade fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Low grade fever) and MYALGIA (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0417018821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had COVID before her first dose).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (Headache), PYREXIA (Low grade fever) and MYALGIA (Body aches). On 15-Apr-2021, HEADACHE (Headache), PYREXIA (Low grade fever) and MYALGIA (Body aches) had resolved.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-060493 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination complication
Clinical narrative: he has tested positive for Covid-19; not feeling well; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (he has tested positive for Covid-19) and VACCINATION COMPLICATION (not feeling well) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced COVID-19 (he has tested positive for Covid-19) and VACCINATION COMPLICATION (not feeling well). At the time of the report, COVID-19 (he has tested positive for Covid-19) and VACCINATION COMPLICATION (not feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Ugly rash behind my ear/big rash behind my ear; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Ugly rash behind my ear/big rash behind my ear) 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 RASH (Ugly rash behind my ear/big rash behind my ear). At the time of the report, RASH (Ugly rash behind my ear/big rash behind my ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: Still feel like I am recovering (from surgery); Received first dose 6 weeks ago/ due to have her second shot two weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Still feel like I am recovering (from surgery)) and PRODUCT DOSE OMISSION ISSUE (Received first dose 6 weeks ago/ due to have her second shot two weeks ago) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery in July 2021.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received first dose 6 weeks ago/ due to have her second shot two weeks ago). On an unknown date, the patient experienced MALAISE (Still feel like I am recovering (from surgery)). In July 2021, PRODUCT DOSE OMISSION ISSUE (Received first dose 6 weeks ago/ due to have her second shot two weeks ago) had resolved. At the time of the report, MALAISE (Still feel like I am recovering (from surgery)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. Treatment information was not provided by the reporter.  It was reported that the patient's surgery was scheduled before she received the injection. However, she reported that she had it after the vaccination. Moreover, her physician advised her that it would be good to wait to get the second dose since her body is already going through the stress of recovery.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss after second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss after second vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 ALOPECIA (Hair loss after second vaccination). At the time of the report, ALOPECIA (Hair loss after second vaccination) outcome was unknown.            No Concomitant medications were reported.  No Treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (muscle aches), HEADACHE (headaches/foggy like it kind of feels like a headache) and FATIGUE (still felt fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), MYALGIA (muscle aches), HEADACHE (headaches/foggy like it kind of feels like a headache) and FATIGUE (still felt fatigued). At the time of the report, PYREXIA (fever), MYALGIA (muscle aches), HEADACHE (headaches/foggy like it kind of feels like a headache) and FATIGUE (still felt fatigued) outcome was unknown. Patient stated that she visited her health care provider and they stated that she needed to build her immune system back up. She also stated that she has a good immune system and regularly take vitamins like zinc. However, she stopped taking these before the vaccine. No treatment information was provided. No concomitant medication reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Rash
Clinical narrative: Red; Rash appear on the left breast/ Light rash; Sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), PAIN (Sore) and RASH (Rash appear on the left breast/ Light rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer survivor), Lymphadenectomy (Lymph nodes removed) in 2010 and Surgery in 2010. Concomitant products included ROSUVASTATIN for Cholesterol, CALCIUM and VALACICLOVIR for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red), PAIN (Sore) and RASH (Rash appear on the left breast/ Light rash). At the time of the report, ERYTHEMA (Red) and RASH (Rash appear on the left breast/ Light rash) had not resolved and PAIN (Sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient consulted her Oncologist and HCP.  No treatment information was provided.   This case was linked to MOD-2021-275069 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: concerned they received less than the full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (concerned they received less than the full dose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (concerned they received less than the full dose). At the time of the report, ACCIDENTAL OVERDOSE (concerned they received less than the full dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was given. The patient is concerned that he received less than the full dose because it looked as if his spouse's syringe had more content in it when they received the vaccinations together.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: sore throat; experiencing headache; This case was received via Agency Regulatory Authority (Reference number: US-irms-MOD21-126158) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and HEADACHE (experiencing headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and HEADACHE (experiencing headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and HEADACHE (experiencing headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: never received the second dose; Ringing in the ear became much louder after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ear became much louder after first vaccine) and PRODUCT DOSE OMISSION ISSUE (never received the second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Ringing in ears.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced TINNITUS (Ringing in the ear became much louder after first vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never received the second dose). At the time of the report, TINNITUS (Ringing in the ear became much louder after first vaccine) had not resolved and PRODUCT DOSE OMISSION ISSUE (never received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Hacking cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Hacking cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-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) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced COUGH (Hacking cough). At the time of the report, COUGH (Hacking cough) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Non-Significant Follow-up received on 20-AUG-2021: No new information received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: COVID-19; Missed dose; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID-19) and PRODUCT DOSE OMISSION ISSUE (Missed dose) 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.    In March 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, COVID-19 (COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product were reported No treatment information was provided.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (low grade fever) and CHILLS (chills). On 17-Mar-2021, PYREXIA (low grade fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination complication
Clinical narrative: Other mild side effects; Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other mild side effects) and INJECTION SITE PAIN (Pain in the 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Other mild side effects) and INJECTION SITE PAIN (Pain in the injection site). At the time of the report, VACCINATION COMPLICATION (Other mild side effects) and INJECTION SITE PAIN (Pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Left arm pain; Headache; Left arm pain that radiated to shoulder and to finger; Minor fatigue; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Left arm pain), HEADACHE (Headache), ARTHRALGIA (Left arm pain that radiated to shoulder and to finger) and FATIGUE (Minor fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm pain), HEADACHE (Headache), ARTHRALGIA (Left arm pain that radiated to shoulder and to finger) and FATIGUE (Minor fatigue). At the time of the report, VACCINATION SITE PAIN (Left arm pain), HEADACHE (Headache), ARTHRALGIA (Left arm pain that radiated to shoulder and to finger) and FATIGUE (Minor fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.     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 treatment information was provided.   This case was linked to MOD-2021-275288 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received the first dose of the Moderna vaccine in May but haven't received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna vaccine in May but haven't received the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna vaccine in May but haven't received the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna vaccine in May but haven't received the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Dizziness; Fever; Headaches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headaches) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headaches) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headaches) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fear of injection, Hypoaesthesia, Product dose omission issue
Clinical narrative: it's been at least 20 weeks since I got my 1st dose; few minutes later my arm went numb/face went numb; it kind of scared me for getting the 2nd one; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (few minutes later my arm went numb/face went numb), FEAR OF INJECTION (it kind of scared me for getting the 2nd one) and PRODUCT DOSE OMISSION ISSUE (it's been at least 20 weeks since I got my 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN (ZOCOR), VITAMIN B12 NOS, VITAMIN D [VITAMIN D NOS] and HYDROCODONE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HYPOAESTHESIA (few minutes later my arm went numb/face went numb) and FEAR OF INJECTION (it kind of scared me for getting the 2nd one). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it's been at least 20 weeks since I got my 1st dose). On 01-Apr-2021, HYPOAESTHESIA (few minutes later my arm went numb/face went numb) had resolved. At the time of the report, FEAR OF INJECTION (it kind of scared me for getting the 2nd one) and PRODUCT DOSE OMISSION ISSUE (it's been at least 20 weeks since I got my 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Took prednisone and the reaction went away.; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.  Based on the current case data, this case has been classified as invalid. This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of THERAPEUTIC RESPONSE UNEXPECTED (Took prednisone and the reaction went away.).     No Medical History information was reported.  On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Took prednisone and the reaction went away.). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Took prednisone and the reaction went away.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant drugs were used by patient.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Greater than 35 days between doses of Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of Moderna Covid-19 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.    In January 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 (Greater than 35 days between doses of Moderna Covid-19 Vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of Moderna Covid-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Muscular weakness, Vaccination complication
Clinical narrative: Delayed reaction; Feels dizzy; Weakness specially in the legs; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction), DIZZINESS (Feels dizzy), MUSCULAR WEAKNESS (Weakness specially in the legs) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION COMPLICATION (Delayed reaction), DIZZINESS (Feels dizzy), MUSCULAR WEAKNESS (Weakness specially in the legs) and CHILLS (Chills). At the time of the report, VACCINATION COMPLICATION (Delayed reaction), DIZZINESS (Feels dizzy), MUSCULAR WEAKNESS (Weakness specially in the legs) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Increased appetite
Clinical narrative: So hungry after returning this morning she ate again after eating breakfast before going.; A little dizzy for a second; 98.1 Fever; A little headache; Is tired; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED APPETITE (So hungry after returning this morning she ate again after eating breakfast before going.), DIZZINESS (A little dizzy for a second), PYREXIA (98.1 Fever), HEADACHE (A little headache) and FATIGUE (Is tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced INCREASED APPETITE (So hungry after returning this morning she ate again after eating breakfast before going.), DIZZINESS (A little dizzy for a second), PYREXIA (98.1 Fever), HEADACHE (A little headache) and FATIGUE (Is tired). At the time of the report, INCREASED APPETITE (So hungry after returning this morning she ate again after eating breakfast before going.), DIZZINESS (A little dizzy for a second), PYREXIA (98.1 Fever), HEADACHE (A little headache) and FATIGUE (Is tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Body temperature: 98.1 (High) 98.1 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: So hungry after returning this morning she ate again after eating breakfast before going.; A little dizzy for a second; 98.1 Fever; A little headache; Is tired; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED APPETITE (So hungry after returning this morning she ate again after eating breakfast before going.), DIZZINESS (A little dizzy for a second), PYREXIA (98.1 Fever), HEADACHE (A little headache) and FATIGUE (Is tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced INCREASED APPETITE (So hungry after returning this morning she ate again after eating breakfast before going.), DIZZINESS (A little dizzy for a second), PYREXIA (98.1 Fever), HEADACHE (A little headache) and FATIGUE (Is tired). At the time of the report, INCREASED APPETITE (So hungry after returning this morning she ate again after eating breakfast before going.), DIZZINESS (A little dizzy for a second), PYREXIA (98.1 Fever), HEADACHE (A little headache) and FATIGUE (Is tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Body temperature: 98.1 (High) 98.1 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary pain, Renal pain
Clinical narrative: kidney pain like she has a bladder infection; has pain in the injected arm that feels like someone used it as a punching bag; lung pain like she smoked a whole lot of cigarettes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (has pain in the injected arm that feels like someone used it as a punching bag), PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes) and RENAL PAIN (kidney pain like she has a bladder infection) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PAIN IN EXTREMITY (has pain in the injected arm that feels like someone used it as a punching bag) and PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes). On 30-Jul-2021, the patient experienced RENAL PAIN (kidney pain like she has a bladder infection). At the time of the report, PAIN IN EXTREMITY (has pain in the injected arm that feels like someone used it as a punching bag), PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes) and RENAL PAIN (kidney pain like she has a bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment included a warm bath that helped with the arm pain.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Took 1st vaccine back in April, but for certain reasons did not take the second vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Took 1st vaccine back in April, but for certain reasons did not take the second 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.    In April 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 (Took 1st vaccine back in April, but for certain reasons did not take the second vaccine.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Took 1st vaccine back in April, but for certain reasons did not take the second vaccine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.   Reporter did not allow further contact
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Sinusitis
Clinical narrative: sinus infection; pediatric patient receiving 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (pediatric patient receiving 1st dose of the vaccine) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was 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, the patient experienced SINUSITIS (sinus infection) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (pediatric patient receiving 1st dose of the vaccine). At the time of the report, SINUSITIS (sinus infection) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (pediatric patient receiving 1st dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment included an unknown over the counter medication for the sinus infection.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Little to no reaction; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Little to no reaction) 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 VACCINATION COMPLICATION (Little to no reaction). At the time of the report, VACCINATION COMPLICATION (Little to no reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received their first dose in march but never got a second dose; 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 DOSE OMISSION ISSUE (Received their first dose in march but never got a second dose) 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.    In March 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 DOSE OMISSION ISSUE (Received their first dose in march but never got a second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received their first dose in march but never got a second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Vaccination site pain
Clinical narrative: Dizziness; Blood Pressure 155/66; Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPERTENSION (Blood Pressure 155/66) and VACCINATION SITE PAIN (Sore left injection site arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVETIRACETAM for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). On 03-Aug-2021, the patient experienced DIZZINESS (Dizziness) and HYPERTENSION (Blood Pressure 155/66). At the time of the report, DIZZINESS (Dizziness), HYPERTENSION (Blood Pressure 155/66) and VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Blood pressure measurement: 155/66 (High) blood pressure of 155/66.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Limb discomfort, Peripheral swelling
Clinical narrative: stiff arm; red; swollen; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (stiff arm), ERYTHEMA (red), PERIPHERAL SWELLING (swollen) and ASTHENIA (felt weak) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced LIMB DISCOMFORT (stiff arm), ERYTHEMA (red), PERIPHERAL SWELLING (swollen) and ASTHENIA (felt weak). At the time of the report, LIMB DISCOMFORT (stiff arm), ERYTHEMA (red), PERIPHERAL SWELLING (swollen) and ASTHENIA (felt weak) had resolved.            Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-169811 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: over three months since the first dose of a COVID-19 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 DOSE OMISSION ISSUE (over three months since the first dose of a COVID-19 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 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 (over three months since the first dose of a COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (over three months since the first dose of a COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection is a little tender after receiving the dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection is a little tender after receiving the dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced VACCINATION SITE PAIN (Injection is a little tender after receiving the dose). At the time of the report, VACCINATION SITE PAIN (Injection is a little tender after receiving the dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient's arm was sore; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Patient's arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient's arm was sore). At the time of the report, VACCINATION SITE PAIN (Patient's arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-275210 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 6 Months after first dose and has not received the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (6 Months after first dose and has not received the second dose) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (6 Months after first dose and has not received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (6 Months after first dose and has not received the second dose) 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.   Concomitant medication list was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: felt like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (felt like she had the flu) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027CZ1A and 035C21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ESTRADIOL, LIOTHYRONINE, AMITRIPTYLINE, FLUOXETINE, GABAPENTIN, PROGESTERONE, SPIRONOLACTONE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), MONTELUKAST, LEVOTHYROXINE, FLUTICASONE, ZINC, ESSENTIAL OILS NOS and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced INFLUENZA (felt like she had the flu). The patient was treated with PREDNISONE for Flu, at a dose of 1 dosage form. At the time of the report, INFLUENZA (felt like she had the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-275237.