chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: at night woke up to go to the bathroom and almost felt; They don't know if they should take a Xanax or not, because they feels like they are having an anxiety atack; face is a little bit red; fells hot, forehead is warm; their hand are frizzing cold.; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (at night woke up to go to the bathroom and almost felt), ANXIETY (They don't know if they should take a Xanax or not, because they feels like they are having an anxiety atack), ERYTHEMA (face is a little bit red), FEELING HOT (fells hot, forehead is warm) and PERIPHERAL COLDNESS (their hand are frizzing cold.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history information was reported.  Concomitant products included METFORMIN, VALSARTAN, ALLOPURINOL, APIXABAN (ELIQUIS), AMLODIPINE, ATORVASTATIN, METOPROLOL and DULAGLUTIDE (TRULICITY) 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 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRESYNCOPE (at night woke up to go to the bathroom and almost felt), ANXIETY (They don't know if they should take a Xanax or not, because they feels like they are having an anxiety atack), ERYTHEMA (face is a little bit red), FEELING HOT (fells hot, forehead is warm), PERIPHERAL COLDNESS (their hand are frizzing cold.) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (at night woke up to go to the bathroom and almost felt), ANXIETY (They don't know if they should take a Xanax or not, because they feels like they are having an anxiety atack), ERYTHEMA (face is a little bit red), FEELING HOT (fells hot, forehead is warm), PERIPHERAL COLDNESS (their hand are frizzing cold.) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took blood pressure medications
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Tenderness
Clinical narrative: Tenderness at the SQ appearing anterior to the injections site; localized erythema near the vaccination site; This spontaneous case was reported by a physician and describes the occurrence of TENDERNESS (Tenderness at the SQ appearing anterior to the injections site) and ERYTHEMA (localized erythema near the vaccination 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness at the SQ appearing anterior to the injections site) and ERYTHEMA (localized erythema near the vaccination site). At the time of the report, TENDERNESS (Tenderness at the SQ appearing anterior to the injections site) and ERYTHEMA (localized erythema near the vaccination site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Patient noticed a localized erythema at the subcutaneous layer near the vaccination site (not exactly over it). It seems like the vaccine went there since the one who administered it pinched to arm.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Follow up received on 22 Nov 2021 contains significant information .Event added: Tiredness.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: After receiving both doses of the vaccine he had a sore arm for 3 days on the side he received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After receiving both doses of the vaccine he had a sore arm for 3 days on the side he received the vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced VACCINATION SITE PAIN (After receiving both doses of the vaccine he had a sore arm for 3 days on the side he received the vaccine). In June 2021, VACCINATION SITE PAIN (After receiving both doses of the vaccine he had a sore arm for 3 days on the side he received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient had a sore arm for 3 days on the side he received the vaccine.  No treatment medications were reported.   This case was linked to MOD-2021-390814 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Renal pain, Vomiting
Clinical narrative: severe kidney pain; feeling like he was literally dying; vomitting; body pain; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (severe kidney pain), FEELING ABNORMAL (feeling like he was literally dying), VOMITING (vomitting) and MYALGIA (body pain) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced RENAL PAIN (severe kidney pain), FEELING ABNORMAL (feeling like he was literally dying), VOMITING (vomitting) and MYALGIA (body pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, RENAL PAIN (severe kidney pain), FEELING ABNORMAL (feeling like he was literally dying), VOMITING (vomitting) and MYALGIA (body pain) outcome was unknown.            No concomitant medications were reported. Other treatment medications include Gatorade.   This case was linked to MOD-2021-390804 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Few of his immunocompromised patients (unknown #) who previously received the Janssen vaccine, received an additional dose of the moderna vaccine with a 0.5mL; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Few of his immunocompromised patients (unknown #) who previously received the Janssen vaccine, received an additional dose of the moderna vaccine with a 0.5mL) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen (Few of the patient previously received the Janssen vaccine and). Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Few of his immunocompromised patients (unknown #) who previously received the Janssen vaccine, received an additional dose of the moderna vaccine with a 0.5mL). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Few of his immunocompromised patients (unknown #) who previously received the Janssen vaccine, received an additional dose of the moderna vaccine with a 0.5mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that few of their immunocompromised patients who previously received the Janssen vaccine, received an additional dose of the Moderna vaccine with a 0.5mL dose. The reporter who was an HCP stated that some of their patients got 0.5mL of Moderna vaccine 3rd dose and reported that they do not want to call it as them receiving the booster dose of Moderna with 0.5mL dose but termed it as an additional dose.   No Concomitant product use was reported. No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: She is experiencing a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (she is experiencing a headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Rheumatoid arthritis. Concomitant products included ATOGEPANT from 12-Nov-2021 to an unknown date, UBROGEPANT (UBRELVY) and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Migraine.    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 HEADACHE (she is experiencing a headache). At the time of the report, HEADACHE (she is experiencing a headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Feeling abnormal, Headache
Clinical narrative: Didn't feel good, its had like the virus all over again; Dizzy; The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen; high fever of 102.9F; All her joints hurt; Nausea; Headache; Arm was hurting; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Didn't feel good, its had like the virus all over again), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was hurting), LYMPHADENOPATHY (The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen) and PYREXIA (high fever of 102.9F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had Covid-19 in August 2021 & got an antibody infusion) in August 2021.    On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting). On 17-Nov-2021, the patient experienced DIZZINESS (Dizzy), LYMPHADENOPATHY (The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen), PYREXIA (high fever of 102.9F), ARTHRALGIA (All her joints hurt), NAUSEA (Nausea) and HEADACHE (Headache). On 18-Nov-2021, the patient experienced FEELING ABNORMAL (Didn't feel good, its had like the virus all over again). At the time of the report, FEELING ABNORMAL (Didn't feel good, its had like the virus all over again) and HEADACHE (Headache) had not resolved and DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was hurting), LYMPHADENOPATHY (The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen), PYREXIA (high fever of 102.9F), ARTHRALGIA (All her joints hurt) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, Body temperature: 102.9f (High) 102.9F.     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.   No concomitant medications were reported. No treatment medications were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Didn't feel good, its had like the virus all over again; Dizzy; The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen; high fever of 102.9F; All her joints hurt; Nausea; Headache; Arm was hurting; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Didn't feel good, its had like the virus all over again), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was hurting), LYMPHADENOPATHY (The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen) and PYREXIA (high fever of 102.9F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had Covid-19 in August 2021 & got an antibody infusion) in August 2021.    On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting). On 17-Nov-2021, the patient experienced DIZZINESS (Dizzy), LYMPHADENOPATHY (The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen), PYREXIA (high fever of 102.9F), ARTHRALGIA (All her joints hurt), NAUSEA (Nausea) and HEADACHE (Headache). On 18-Nov-2021, the patient experienced FEELING ABNORMAL (Didn't feel good, its had like the virus all over again). At the time of the report, FEELING ABNORMAL (Didn't feel good, its had like the virus all over again) and HEADACHE (Headache) had not resolved and DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was hurting), LYMPHADENOPATHY (The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen), PYREXIA (high fever of 102.9F), ARTHRALGIA (All her joints hurt) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, Body temperature: 102.9f (High) 102.9F.     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.   No concomitant medications were reported. No treatment medications were provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment medications were not provided.   This case was linked to MOD-2021-391038 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination.     Previously administered products included for Psoriasis: Tremfaya (Not taken since 5 months).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm sore). At the time of the report, VACCINATION SITE PAIN (arm sore) outcome was unknown.            No concomitant  and treatment medications were reported.    This case was linked to MOD-2021-391180 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vertigo
Clinical narrative: Vertigo; Felt a little off/Felt a little tinge; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and MALAISE (Felt a little off/Felt a little tinge) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Bug bite (took an anti-itch medication for it). Previously administered products included for Psoriasis: Tremfya (not taken since 5 months and as per patient it was anti-immunosuppressant) in 2021. Past adverse reactions to the above products included No adverse reaction with Tremfya. Concurrent medical conditions included Itching and Psoriasis. Concomitant products included HYDRALAZINE for Itching.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VERTIGO (Vertigo) and MALAISE (Felt a little off/Felt a little tinge). At the time of the report, VERTIGO (Vertigo) had not resolved and MALAISE (Felt a little off/Felt a little tinge) outcome was unknown.            No treatment information was provided.  The patient came back from traveling and had a bug bite and took an anti-itch medication for it, called Hydralazine because their foot was itchy, and woke up this morning and had vertigo. After the booster dose, the patient felt a little off, not much else, and just felt a little tinge from it. The patient has taken this medication in the past and does not recall having vertigo at that time. Consumer thinks there may be a correlation between the Moderna COVID-10 vaccine, the hydralazine medication, and vertigo.   The patient also reported that they were taking a medication called Tremfaya for psoriasis but had not taken it for 5 months. It was an anti-immunosuppressant, according to the patient and reported that they were considered immunocompromised but did not receive the 3rd full dose for immunocompromised individuals as the patient was traveling to  and did not want to feel a lot of side effects, so they got the booster dose instead. The patient was still experiencing the effects of the vertigo and reported no reaction to the first dose of the vaccine.   This case was linked to MOD-2021-391143 (Patient Link).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: very mild symptoms; Slight discomfort; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (very mild symptoms), DISCOMFORT (Slight discomfort) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 046C1A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced VACCINATION COMPLICATION (very mild symptoms) and DISCOMFORT (Slight discomfort). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Discomfort, at a dose of UNK, two times. On 12-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION COMPLICATION (very mild symptoms) and DISCOMFORT (Slight discomfort) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-380656, MOD-2021-380656 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains new Event added and treatment medication added.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Started migraines about once a week and then they increased to about every other day; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Started migraines about once a week and then they increased to about every other day) in a 56-year-old female patient 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 11-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 MIGRAINE (Started migraines about once a week and then they increased to about every other day). The patient was treated with ATOGEPANT (oral) ongoing from November 2021 for Migraine, at a dose of 60 mg once a day. At the time of the report, MIGRAINE (Started migraines about once a week and then they increased to about every other day) had resolved. Not Provided          No concomitant medications were reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 16NOV2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 16NOV2021)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 16NOV2021)). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 16NOV2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Corneal defect
Clinical narrative: similar complaints of cornea issues; This spontaneous case was reported by a consumer and describes the occurrence of CORNEAL DEFECT (similar complaints of cornea issues) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CORNEAL DEFECT (similar complaints of cornea issues). At the time of the report, CORNEAL DEFECT (similar complaints of cornea issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash, but only on her legs; This spontaneous case was reported by a nurse and describes the occurrence of RASH (rash, but only on her legs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-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 RASH (rash, but only on her legs). At the time of the report, RASH (rash, but only on her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications were reported   This case was linked to MOD-2021-392143, MOD-2021-392096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received, Added reporter details and the document contains non significant information
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal
Clinical narrative: Feels Dizzy after booster shot; Off Balance; Does not feel normal; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feels Dizzy after booster shot), BALANCE DISORDER (Off Balance) and FEELING ABNORMAL (Does not feel normal) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 013M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced DIZZINESS (Feels Dizzy after booster shot), BALANCE DISORDER (Off Balance) and FEELING ABNORMAL (Does not feel normal). At the time of the report, DIZZINESS (Feels Dizzy after booster shot), BALANCE DISORDER (Off Balance) and FEELING ABNORMAL (Does not feel normal) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported. The patient felt  dizzy, and off balance. The patient got up to go to the bathroom and did not feel normal so he went back to bed.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: itching; slight little pain when the needle went in; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and VACCINATION SITE PAIN (slight little pain when the needle went in) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (itching) and VACCINATION SITE PAIN (slight little pain when the needle went in). On 05-Mar-2021, PRURITUS (itching) had resolved. At the time of the report, VACCINATION SITE PAIN (slight little pain when the needle went in) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided. Patient did not experienced any side effects after the booster dose.   This case was linked to MOD-2021-391901.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Fatigue, Feeling abnormal
Clinical narrative: blegh; Fatigue; aggravated hip bursitis; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (aggravated hip bursitis), FEELING ABNORMAL (blegh) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Achalasia (an autoimmune disorder of the esophagus), Swallowing disorder and Hip bursitis. Concomitant products included PREDNISOLONE and TRAZODONE for an unknown indication.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced BURSITIS (aggravated hip bursitis). On 23-Oct-2021, the patient experienced FEELING ABNORMAL (blegh) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, BURSITIS (aggravated hip bursitis), FEELING ABNORMAL (blegh) and FATIGUE (Fatigue) outcome was unknown.            Patient was given  an optional  7 day course of Concomitant medication of prednisolone for hip bursitis after her booster dose. However patient did not took prednisolone after booster dose.   This case was linked to MOD-2021-393446 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up document received,  Primary reporter detail, patient demographics, Other Relevant History, Suspect drug, Concomitant drug, Treatment drug ,events detail were included and i-Narrative Supplement   was  updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Muscular weakness
Clinical narrative: no strength to get up; so weak that when he got up to go to another room, after 3 step, collapsed.; They were very very weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no strength to get up), FALL (so weak that when he got up to go to another room, after 3 step, collapsed.) and MUSCULAR WEAKNESS (They were very very weak) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065E21A, 013A21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced ASTHENIA (no strength to get up), FALL (so weak that when he got up to go to another room, after 3 step, collapsed.) and MUSCULAR WEAKNESS (They were very very weak). At the time of the report, ASTHENIA (no strength to get up), FALL (so weak that when he got up to go to another room, after 3 step, collapsed.) and MUSCULAR WEAKNESS (They were very very weak) outcome was unknown.            Concomitant medications was not reported. Treatment medications was not reported The patient had the Moderna booster (lot 065E21A) on 17Nov2021. On 18Nov2021, he had a situation, really scary. His legs from his waist down, they die. They were very very weak, so weak that when he got up to go to another room, after 3 steps, he collapsed. He is 6 feet and 3 inches and weigh 350 pounds. He is 75. He had no strength to get himself up.   This case was linked to MOD-2021-391975 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little bit of soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little bit of soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 014M20A and 027O21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little bit of soreness). The patient was treated with LYSINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Little bit of soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-392147 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: booster dose given instead of 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (booster dose given instead of 1st dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced INCORRECT DOSE ADMINISTERED (booster dose given instead of 1st dose). On 18-Nov-2021, INCORRECT DOSE ADMINISTERED (booster dose given instead of 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with 0.25ml of booster dose instead of 0.5ml of first dose of Moderna COVID-19 Vaccine. Concomitant medications were not provided. Treatment information was not provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Rash erythematous, Vaccination site reaction
Clinical narrative: right leg feels numb; right leg feels tingly; right leg feels tingly, numb, and achy; red rash; covid arm on left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (right leg feels numb), PARAESTHESIA (right leg feels tingly), PAIN IN EXTREMITY (right leg feels tingly, numb, and achy), RASH ERYTHEMATOUS (red rash) and VACCINATION SITE REACTION (covid arm on left arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (right leg feels numb), PARAESTHESIA (right leg feels tingly), PAIN IN EXTREMITY (right leg feels tingly, numb, and achy), RASH ERYTHEMATOUS (red rash) and VACCINATION SITE REACTION (covid arm on left arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (right leg feels numb), PARAESTHESIA (right leg feels tingly), PAIN IN EXTREMITY (right leg feels tingly, numb, and achy), RASH ERYTHEMATOUS (red rash) and VACCINATION SITE REACTION (covid arm on left arm) outcome was unknown.            No concomitant medication was reported by the reporter. The patient had right leg has been feeling tingly, numb and achy.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Muscular weakness
Clinical narrative: They were very very weak; no strength to get up same incident as this [after first or second dose]; so weak that when he got up to go to another room, after 3 step, collapsed; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (They were very very weak), ASTHENIA (no strength to get up same incident as this [after first or second dose]) and FALL (so weak that when he got up to go to another room, after 3 step, collapsed) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (They were very very weak), ASTHENIA (no strength to get up same incident as this [after first or second dose]) and FALL (so weak that when he got up to go to another room, after 3 step, collapsed). At the time of the report, MUSCULAR WEAKNESS (They were very very weak), ASTHENIA (no strength to get up same incident as this [after first or second dose]) and FALL (so weak that when he got up to go to another room, after 3 step, collapsed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided. Patient had no strength to get himself up. This was 1 AM, so he had to call paramedics to help him up and get him to his bed. He thought this may have happened after the first or second shot; he was unsure of the date. He had the same incident as this.  This spontaneous case concerns a 75-year-old male patient with no relevant medical history who experienced non serious unexpected event of special interest (AESI) muscular weakness. The event occurred after the first or the second dose of the Moderna COVID-19 vaccine and reoccurred one day after the third, booster dose. Rechallenge was positive since the event reoccurred with the next dose.  The benefit-risk relationship of product is not affected by this report   This case was linked to MOD-2021-391921 (Patient Link).; Sender's Comments: This spontaneous case concerns a 75-year-old male patient with no relevant medical history who experienced non serious unexpected event of special interest (AESI) muscular weakness. The event occurred after the first or the second dose of the Moderna COVID-19 vaccine and reoccurred one day after the third, booster dose. Rechallenge was positive since the event reoccurred with the next dose.  The benefit-risk relationship of product is not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: having problems; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having problems) 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 third 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (having problems). At the time of the report, VACCINATION COMPLICATION (having problems) outcome was unknown.            Company Comment : This case concerns a patient with unknown age and sex who experienced non-serious , unexpected event of Vaccination complication which occurred on an unknown date after vaccination with the 3rd dose ( booster dose) of mRNA-1273 vaccine ( Moderna Covid 19 vaccine). The re-challenge for this case is not applicable since the outcom e of the event is unknown and also the event happened after the 3rd dose and no additional doses will be given. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.  No concomitant medications was reported. No treatment drug details was reported.; Sender's Comments: This case concerns a patient with unknown age and sex who experienced non-serious , unexpected event of Vaccination complication which occurred on an unknown date after vaccination with the 3rd dose ( booster dose) of mRNA-1273 vaccine ( Moderna Covid 19 vaccine). The re-challenge for this case is not applicable since the outcom e of the event is unknown and also the event happened after the 3rd dose and no additional doses will be given. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Myalgia
Clinical narrative: kept sleeping/I slept about 12 hrs, I think; no appetite; body aches/ still have body aches, but they're half better.; real tired; chills really bad; fever of 101.4°F; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (kept sleeping/I slept about 12 hrs, I think), DECREASED APPETITE (no appetite), MYALGIA (body aches/ still have body aches, but they're half better.), FATIGUE (real tired) and CHILLS (chills really bad) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack. Concurrent medical conditions included Heart disorder.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced SOMNOLENCE (kept sleeping/I slept about 12 hrs, I think), DECREASED APPETITE (no appetite), MYALGIA (body aches/ still have body aches, but they're half better.), FATIGUE (real tired), CHILLS (chills really bad) and PYREXIA (fever of 101.4°F). At the time of the report, SOMNOLENCE (kept sleeping/I slept about 12 hrs, I think), DECREASED APPETITE (no appetite), FATIGUE (real tired), CHILLS (chills really bad) and PYREXIA (fever of 101.4°F) outcome was unknown and MYALGIA (body aches/ still have body aches, but they're half better.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, Body temperature: 101.4 (High) 101.4°F.         No concomitant and treatment medication were reported. On18-Nov-2021, (that morning)  the patient felt real tired kept sleeping. Later on the patient had a fever of 101.4°F, body aches, chills really bad and no appetite. That night, the patient slept about 12 hrs. On 19-Nov2-021, the patient still have body aches, but they're half better.   This case was linked to MOD-2021-392019 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: kept sleeping/I slept about 12 hrs, I think; no appetite; body aches/ still have body aches, but they're half better.; real tired; chills really bad; fever of 101.4°F; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (kept sleeping/I slept about 12 hrs, I think), DECREASED APPETITE (no appetite), MYALGIA (body aches/ still have body aches, but they're half better.), FATIGUE (real tired) and CHILLS (chills really bad) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack. Concurrent medical conditions included Heart disorder.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced SOMNOLENCE (kept sleeping/I slept about 12 hrs, I think), DECREASED APPETITE (no appetite), MYALGIA (body aches/ still have body aches, but they're half better.), FATIGUE (real tired), CHILLS (chills really bad) and PYREXIA (fever of 101.4°F). At the time of the report, SOMNOLENCE (kept sleeping/I slept about 12 hrs, I think), DECREASED APPETITE (no appetite), FATIGUE (real tired), CHILLS (chills really bad) and PYREXIA (fever of 101.4°F) outcome was unknown and MYALGIA (body aches/ still have body aches, but they're half better.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, Body temperature: 101.4 (High) 101.4°F.         No concomitant and treatment medication were reported. On18-Nov-2021, (that morning)  the patient felt real tired kept sleeping. Later on the patient had a fever of 101.4°F, body aches, chills really bad and no appetite. That night, the patient slept about 12 hrs. On 19-Nov2-021, the patient still have body aches, but they're half better.   This case was linked to MOD-2021-392019 (Patient Link).