chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: BODY WAS KILLING; LEGS ARE KILLING; HEAD WAS KILLING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced body was killing, legs are killing, and head was killing. The action taken with covid-19 vaccine was not applicable. The outcome of the legs are killing, head was killing and body was killing was not reported. This report was non-serious.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Tachycardia
Clinical narrative: Rapid heartbeat; chest pain; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (Rapid heartbeat) and CHEST PAIN (chest pain) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ0A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced TACHYCARDIA (Rapid heartbeat) and CHEST PAIN (chest pain). The patient was treated with VERAPAMIL for Adverse event, at an unspecified dose and frequency. In March 2021, TACHYCARDIA (Rapid heartbeat) and CHEST PAIN (chest pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data includes blood tests with unknown results.  No relevant concomitant medications were reported.  Reporter stated that a month later, patient started having a rapid heartbeat and chest pain. He had A-Fib from before the vaccination, so she thought it was probably just A-fibrillation. There was no enlargement with the heart, and no issue with the lining of the heart, there was no diagnose of Myocarditis or Pericarditis. Chest pain and rapid heartbeat were the only symptoms reported by the caller.  Patient was not immunocompromised.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient administered second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose; Patient administered second dose of the Moderna COVID-19 vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose of the Moderna COVID-19 vaccine from an expired vial) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 054C21A) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.   On 10-May-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) (unknown route) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose of the Moderna COVID-19 vaccine from an expired vial). On 24-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose of the Moderna COVID-19 vaccine from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist reported that they had two vials of the Moderna COVID-19 vaccine which were received and refrigerated since 23JUN2021 . The vials did not experience a temperature excursion and were stored at the appropriate refrigerated temperatures through 30 days. The pharmacist wanted to know if the vials can be used beyond 30 days of storage in a refrigerator.The pharmacist asked whether the patient will have to be given the dose again, given that the dose administered was from an expired vial.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received contains, Mail Id and contact number updated, events outcome updated to recovered.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore shoulder). At the time of the report, ARTHRALGIA (sore shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Intravenous fluids (I.V) were given as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received contains additional treatment was added.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered BUD (on day 32); Vaccine administered BUD (on day 32); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) and PRODUCT STORAGE ERROR (Vaccine administered BUD (on day 32)) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) and PRODUCT STORAGE ERROR (Vaccine administered BUD (on day 32)). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) and PRODUCT STORAGE ERROR (Vaccine administered BUD (on day 32)) had resolved.        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 reported  Reporter was office manager.  Reporter wanted to hear from Moderna for instructions about what to do with the 8 patients who received a dose from a vial that was stored refrigerated for more than 30 days. Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit. HCP provided identifiers for all 8 patients. All patients were given their second dose, except for the last one that received their first dose. Patient didn't show signs of any side effect.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Suspect dosing details updated
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered BUD (on day 32); Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) and PRODUCT STORAGE ERROR (Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32)) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) and PRODUCT STORAGE ERROR (Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32)). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) and PRODUCT STORAGE ERROR (Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32)) had resolved.        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 reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received on 10-AUG-2021. contact information updated. On 02-Oct-2021: follow up received on 04-OCT-2021 contain information regarding first dose details.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered  (on day 32)/Vial was kept between 36 and 45.9 degrees Fahrenheit; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was kept between 36 and 45.9 degrees Fahrenheit) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was kept between 36 and 45.9 degrees Fahrenheit). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was kept between 36 and 45.9 degrees Fahrenheit) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO concomitant medications provided. NO treatment information provided .   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: F/U received on 04-OCT-2021 includes dose 1 information
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32).; 8 patients who received a dose from a vial that was stored refrigerated for more than 30 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32).) and PRODUCT STORAGE ERROR (8 patients who received a dose from a vial that was stored refrigerated for more than 30 days.) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32).) and PRODUCT STORAGE ERROR (8 patients who received a dose from a vial that was stored refrigerated for more than 30 days.). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32).) and PRODUCT STORAGE ERROR (8 patients who received a dose from a vial that was stored refrigerated for more than 30 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: F/U received on 04-OCT-2021 include dose administration information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 expired doses administered to 3 patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 expired doses administered to 3 patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 expired doses administered to 3 patient). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (3 expired doses administered to 3 patient) had resolved.      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.   Reporter mentioned vial was punctured on 05-AUG-2021 and left in refrigerator over night instead of being discarded.  No concomitant medications were reported.  Treatment information was not provided.  It was reported that, no adverse event occurred after administration of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow up received: Reporter updated as pharmacist and additional information added in inarrative.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nasopharyngitis, Pyrexia
Clinical narrative: cold; fever ramped up all day long; chills/shivering; horrible joint pain like its on fire; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), PYREXIA (fever ramped up all day long), CHILLS (chills/shivering) and ARTHRALGIA (horrible joint pain like its on fire) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (he might have COVID-19 in January 2021 but there were no available COVID-19 test that time) in January 2021, Intermittent fever from January 2021 to February 2021 and Fatigue from January 2021 to February 2021. Concurrent medical conditions included Blood disorder (makes her susceptible to Deep vein thrombosis) and Allergic reaction to antibiotics (Tetracycline and Clindamycin).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced NASOPHARYNGITIS (cold), PYREXIA (fever ramped up all day long), CHILLS (chills/shivering) and ARTHRALGIA (horrible joint pain like its on fire). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 UNK. On 13-Sep-2021, NASOPHARYNGITIS (cold), CHILLS (chills/shivering) and ARTHRALGIA (horrible joint pain like its on fire) had resolved. On 14-Sep-2021, PYREXIA (fever ramped up all day long) had resolved.            No concomitant medication information provided.   This case was linked to MOD-2021-320189 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Visual impairment
Clinical narrative: vison was not focusing; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of VISUAL IMPAIRMENT (vison was not focusing) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOVASTATIN, GLIPIZIDE, METFORMIN HYDROCHLORIDE (METFORMIN ER), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FUROSEMIDE, METOPROLOL and CLOPIDOGREL for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced VISUAL IMPAIRMENT (vison was not focusing). At the time of the report, VISUAL IMPAIRMENT (vison was not focusing) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pollakiuria
Clinical narrative: Frequent urination/going to the bathroom every hour/decrease in frequency of urination; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination/going to the bathroom every hour/decrease in frequency of urination), CHILLS (Chills) and FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043b21a, 007m20a and 010a21a) for COVID-19 vaccination.     Concomitant products included NIFEDIPINE (PROCARDIA [NIFEDIPINE]), PREDNISONE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) and ARACHIS HYPOGAEA OIL, METHYL SALICYLATE (FORTEX) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced POLLAKIURIA (Frequent urination/going to the bathroom every hour/decrease in frequency of urination), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, POLLAKIURIA (Frequent urination/going to the bathroom every hour/decrease in frequency of urination), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was mentioned.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Limb discomfort, Myalgia, Neck pain
Clinical narrative: neck pain; no energy; could not move arm; Knot in arm; pain in entire body; headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), ASTHENIA (no energy), LIMB DISCOMFORT (could not move arm), NODULE (Knot in arm) and MYALGIA (pain in entire body) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SOMATROPIN (NORDITROPINE FLEXPRO) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced NECK PAIN (neck pain), ASTHENIA (no energy), LIMB DISCOMFORT (could not move arm), NODULE (Knot in arm), MYALGIA (pain in entire body) and HEADACHE (headache). On 02-Mar-2021, NECK PAIN (neck pain), ASTHENIA (no energy), LIMB DISCOMFORT (could not move arm), NODULE (Knot in arm), MYALGIA (pain in entire body) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: neck pain; no energy; could not move arm; Knot in arm; pain in entire body; headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), ASTHENIA (no energy), LIMB DISCOMFORT (could not move arm), NODULE (Knot in arm) and MYALGIA (pain in entire body) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SOMATROPIN (NORDITROPINE FLEXPRO) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced NECK PAIN (neck pain), ASTHENIA (no energy), LIMB DISCOMFORT (could not move arm), NODULE (Knot in arm), MYALGIA (pain in entire body) and HEADACHE (headache). On 02-Mar-2021, NECK PAIN (neck pain), ASTHENIA (no energy), LIMB DISCOMFORT (could not move arm), NODULE (Knot in arm), MYALGIA (pain in entire body) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy arm; Redness where shot was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Redness where shot was) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, ROSUVASTATIN, PRIMIDONE, METOPROLOL and PROPAFENONE for an unknown indication.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Redness where shot was). At the time of the report, VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Redness where shot was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Patient stated  that she was on a blood thinner and received the vaccine.   This case was linked to MOD-2021-333693 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received vaccine). On 27-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: follow up received contains Non significant information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Feeling abnormal
Clinical narrative: Little tired; Foggy; Whirly imbalance while getting up to go the bathroom which went away away; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired), FEELING ABNORMAL (Foggy) and BALANCE DISORDER (Whirly imbalance while getting up to go the bathroom which went away away) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 17-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 FATIGUE (Little tired), FEELING ABNORMAL (Foggy) and BALANCE DISORDER (Whirly imbalance while getting up to go the bathroom which went away away). At the time of the report, FATIGUE (Little tired), FEELING ABNORMAL (Foggy) and BALANCE DISORDER (Whirly imbalance while getting up to go the bathroom which went away away) 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.   Treatment information does not provided .   This case was linked to MOD-2021-335705 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination complication, Vaccination site erythema, Vaccination site swelling
Clinical narrative: felt really sick for 3-4 days; their arm was really big and red; their arm swelled; felt they were about to freeze with 100.2°F fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt really sick for 3-4 days), VACCINATION SITE ERYTHEMA (their arm was really big and red), VACCINATION SITE SWELLING (their arm swelled) and PYREXIA (felt they were about to freeze with 100.2°F fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 last before getting the Moderna vaccine) in 2020. Concurrent medical conditions included COPD.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (felt really sick for 3-4 days), VACCINATION SITE ERYTHEMA (their arm was really big and red), VACCINATION SITE SWELLING (their arm swelled) and PYREXIA (felt they were about to freeze with 100.2°F fever). At the time of the report, VACCINATION COMPLICATION (felt really sick for 3-4 days), VACCINATION SITE ERYTHEMA (their arm was really big and red), VACCINATION SITE SWELLING (their arm swelled) and PYREXIA (felt they were about to freeze with 100.2°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 100.2 (High) 100.2°F fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided. Patient was reported to not have taken the second dose of vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Sweating; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) and CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) injection for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 07-Jun-2021, the patient started TREPROSTINIL SODIUM (REMODULIN) (Intravenous) .047. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HYPERHIDROSIS (Sweating) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (Sweating) and CHILLS (chills) outcome was unknown.            Treatment details were not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose of Moderna was administered/2nd dose administered 1 day after use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna was administered/2nd dose administered 1 day after use by date) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 034C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus NOS.   On 19-Aug-2021 at 10:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021 at 10:53 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna was administered/2nd dose administered 1 day after use by date). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna was administered/2nd dose administered 1 day after use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow-up document received contains non-significant information as it is similar to initial source documents. On 05-Oct-2021: Non-Significant follow-up received on 05-OCT-2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose was administered to a patient from a vial that was expired/ The vial was kept in refrigerator for 31 and a half days before administering; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient from a vial that was expired/ The vial was kept in refrigerator for 31 and a half days before administering) 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 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient from a vial that was expired/ The vial was kept in refrigerator for 31 and a half days before administering). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient from a vial that was expired/ The vial was kept in refrigerator for 31 and a half days before administering) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: 2nd not taken yet, beyond recommended interval; sweaty; I slept a lot; chest was hurting / Pain in the area where my heart at; sore; nausea; extremely tired; high grade fever 102.3; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), SOMNOLENCE (I slept a lot), CHEST PAIN (chest was hurting / Pain in the area where my heart at), MYALGIA (sore) and NAUSEA (nausea) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (for month I was horribly sick) in October 2020. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FISH OIL.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced HYPERHIDROSIS (sweaty), SOMNOLENCE (I slept a lot), CHEST PAIN (chest was hurting / Pain in the area where my heart at), MYALGIA (sore), NAUSEA (nausea), FATIGUE (extremely tired) and PYREXIA (high grade fever 102.3). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd not taken yet, beyond recommended interval). The patient was treated with IBUPROFEN in August 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweaty), SOMNOLENCE (I slept a lot), CHEST PAIN (chest was hurting / Pain in the area where my heart at), MYALGIA (sore), NAUSEA (nausea), FATIGUE (extremely tired), PYREXIA (high grade fever 102.3) and PRODUCT DOSE OMISSION ISSUE (2nd not taken yet, beyond recommended interval) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Body temperature: high (High) high grade fever 102.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Product dose omission issue, Pyrexia, Somnolence
Clinical narrative: 2nd not taken yet, beyond recommended interval; sweaty; I slept a lot; chest was hurting / Pain in the area where my heart at; sore; nausea; extremely tired; high grade fever 102.3; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), SOMNOLENCE (I slept a lot), CHEST PAIN (chest was hurting / Pain in the area where my heart at), MYALGIA (sore) and NAUSEA (nausea) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (for month I was horribly sick) in October 2020. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FISH OIL.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced HYPERHIDROSIS (sweaty), SOMNOLENCE (I slept a lot), CHEST PAIN (chest was hurting / Pain in the area where my heart at), MYALGIA (sore), NAUSEA (nausea), FATIGUE (extremely tired) and PYREXIA (high grade fever 102.3). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd not taken yet, beyond recommended interval). The patient was treated with IBUPROFEN in August 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweaty), SOMNOLENCE (I slept a lot), CHEST PAIN (chest was hurting / Pain in the area where my heart at), MYALGIA (sore), NAUSEA (nausea), FATIGUE (extremely tired), PYREXIA (high grade fever 102.3) and PRODUCT DOSE OMISSION ISSUE (2nd not taken yet, beyond recommended interval) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Body temperature: high (High) high grade fever 102.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Oropharyngeal pain, Pyrexia
Clinical narrative: Hot after 3rd shot; A little sore throat after 3rd shot; Chills after 3rd shot; Sore right arm after 3rd shot; Fever 101.5 F  after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot after 3rd shot), OROPHARYNGEAL PAIN (A little sore throat after 3rd shot), CHILLS (Chills after 3rd shot), VACCINATION SITE PAIN (Sore right arm after 3rd shot) and PYREXIA (Fever 101.5 F  after 3rd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced FEELING HOT (Hot after 3rd shot), OROPHARYNGEAL PAIN (A little sore throat after 3rd shot), CHILLS (Chills after 3rd shot), VACCINATION SITE PAIN (Sore right arm after 3rd shot) and PYREXIA (Fever 101.5 F  after 3rd shot). At the time of the report, FEELING HOT (Hot after 3rd shot), OROPHARYNGEAL PAIN (A little sore throat after 3rd shot), CHILLS (Chills after 3rd shot), VACCINATION SITE PAIN (Sore right arm after 3rd shot) and PYREXIA (Fever 101.5 F  after 3rd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2021, Body temperature: 101.5f (High) Fever 101.5F (Normal 97.5F).         No concomitant medication was reported. No treatment medication was reported.; Sender's Comments: This case concerns a 70 years old male patient, with no reported relevant medical history, who experienced the non-serious unexpected events of Feeling hot, Oropharyngeal pain and the non-serious expected events of vaccination site pain, Chills and Pyrexia. The events occurred 1 day after the third dose of Spikevax. The rechallenge was not applicable for the events as no additional dosing will be given. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Hot after 3rd shot; A little sore throat after 3rd shot; Chills after 3rd shot; Sore right arm after 3rd shot; Fever 101.5 F  after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot after 3rd shot), OROPHARYNGEAL PAIN (A little sore throat after 3rd shot), CHILLS (Chills after 3rd shot), VACCINATION SITE PAIN (Sore right arm after 3rd shot) and PYREXIA (Fever 101.5 F  after 3rd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced FEELING HOT (Hot after 3rd shot), OROPHARYNGEAL PAIN (A little sore throat after 3rd shot), CHILLS (Chills after 3rd shot), VACCINATION SITE PAIN (Sore right arm after 3rd shot) and PYREXIA (Fever 101.5 F  after 3rd shot). At the time of the report, FEELING HOT (Hot after 3rd shot), OROPHARYNGEAL PAIN (A little sore throat after 3rd shot), CHILLS (Chills after 3rd shot), VACCINATION SITE PAIN (Sore right arm after 3rd shot) and PYREXIA (Fever 101.5 F  after 3rd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2021, Body temperature: 101.5f (High) Fever 101.5F (Normal 97.5F).         No concomitant medication was reported. No treatment medication was reported.; Sender's Comments: This case concerns a 70 years old male patient, with no reported relevant medical history, who experienced the non-serious unexpected events of Feeling hot, Oropharyngeal pain and the non-serious expected events of vaccination site pain, Chills and Pyrexia. The events occurred 1 day after the third dose of Spikevax. The rechallenge was not applicable for the events as no additional dosing will be given. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: worse side effects than the previous side effects with 1st dose and 2 dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (worse side effects than the previous side effects with 1st dose and 2 dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (worse side effects than the previous side effects with 1st dose and 2 dose). At the time of the report, VACCINATION COMPLICATION (worse side effects than the previous side effects with 1st dose and 2 dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-335598, MOD-2021-335665 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: worse side effects than the previous side effects with the 1st and 2nd dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (worse side effects than the previous side effects with the 1st and 2nd dose.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient got treatment for the cancer months ago and the patient told that she currently does not have cancer.). Concomitant products included LOSARTAN, HCTZ and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (worse side effects than the previous side effects with the 1st and 2nd dose.). At the time of the report, VACCINATION COMPLICATION (worse side effects than the previous side effects with the 1st and 2nd dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitants medication also included Lexopril (5 mg 1 tablet once a day).   This case was linked to MOD-2021-335664, MOD-2021-335598 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Medical history, Concomitant medications and second dose date added.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Head discomfort, Hyperhidrosis, Pyrexia
Clinical narrative: drove 12 hours which led her not able to stand up; sweating; she had sever reaction after receiving 2nd dose; could not lift her head up off the pillow for 24 hours; had temperature; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (drove 12 hours which led her not able to stand up), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (she had sever reaction after receiving 2nd dose), HEAD DISCOMFORT (could not lift her head up off the pillow for 24 hours) and PYREXIA (had temperature) in a 67-year-old patient of an unknown gender 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 was provided by the reporter.  Concurrent medical conditions included Non-smoker. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (drove 12 hours which led her not able to stand up), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (she had sever reaction after receiving 2nd dose), HEAD DISCOMFORT (could not lift her head up off the pillow for 24 hours), PYREXIA (had temperature) and CHILLS (chills). At the time of the report, DYSSTASIA (drove 12 hours which led her not able to stand up), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (she had sever reaction after receiving 2nd dose), HEAD DISCOMFORT (could not lift her head up off the pillow for 24 hours), PYREXIA (had temperature) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-334391, MOD-2021-335707 (Patient Link).