chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Headache, Vaccination site pain
Clinical narrative: Dry Mouth; Dizziness; Headache; Pain in Left Hand ( This was the hand where the shot was administered); This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry Mouth), DIZZINESS (Dizziness), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in Left Hand ( This was the hand where the shot was administered)) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced DRY MOUTH (Dry Mouth), DIZZINESS (Dizziness), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in Left Hand ( This was the hand where the shot was administered)). At the time of the report, DRY MOUTH (Dry Mouth), DIZZINESS (Dizziness), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in Left Hand ( This was the hand where the shot was administered)) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-406420, MOD-2021-406421 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Due for booster; had COVID-19 infection 1 month ago; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Due for booster; had COVID-19 infection 1 month ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Due for booster; had COVID-19 infection 1 month ago). At the time of the report, COVID-19 (Due for booster; had COVID-19 infection 1 month ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  This is a spontaneous case concerning a female patient of unknown age with no medical history, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. At the time of the report patient was due for the booster, she is unclear when to have the booster as she had COVID-19 infection 1 month ago. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. At the time of the report patient was due for the booster, she is unclear when to have the booster as she had COVID-19 infection 1 month ago. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore injection arm (not sure which arm); Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore injection arm (not sure which arm)) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's thyroiditis.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection arm (not sure which arm)). At the time of the report, VACCINATION SITE PAIN (Sore injection arm (not sure which arm)) and FATIGUE (Fatigue) outcome was unknown.        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.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-406603, MOD-2021-406574 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A booster dose provided to a patient from a vial that was opened in the fridge, the first puncture to the vial was at 9:22am 12/6.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A booster dose provided to a patient from a vial that was opened in the fridge, the first puncture to the vial was at 9:22am 12/6.) 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 07-Dec-2021 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A booster dose provided to a patient from a vial that was opened in the fridge, the first puncture to the vial was at 9:22am 12/6.). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (A booster dose provided to a patient from a vial that was opened in the fridge, the first puncture to the vial was at 9:22am 12/6.) 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. Reporter did not allow further contact.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Hyperhidrosis, Night sweats
Clinical narrative: Weak; Tired; Chills; Sweating; Ended up sleeping all day; wakes up dripping wet with sweat; Fever/ Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), HYPERHIDROSIS (Sweating), SOMNOLENCE (Ended up sleeping all day), NIGHT SWEATS (wakes up dripping wet with sweat) and PYREXIA (Fever/ Feverish) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced HYPERHIDROSIS (Sweating), SOMNOLENCE (Ended up sleeping all day), NIGHT SWEATS (wakes up dripping wet with sweat) and PYREXIA (Fever/ Feverish). On 04-Dec-2021 at 3:00 AM, the patient experienced CHILLS (Chills). On 05-Dec-2021, the patient experienced ASTHENIA (Weak) and FATIGUE (Tired). At the time of the report, ASTHENIA (Weak), PYREXIA (Fever/ Feverish) and FATIGUE (Tired) had not resolved and HYPERHIDROSIS (Sweating), SOMNOLENCE (Ended up sleeping all day), NIGHT SWEATS (wakes up dripping wet with sweat) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-406703 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Weak; Tired; Chills; Sweating; Ended up sleeping all day; wakes up dripping wet with sweat; Fever/ Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), HYPERHIDROSIS (Sweating), SOMNOLENCE (Ended up sleeping all day), NIGHT SWEATS (wakes up dripping wet with sweat) and PYREXIA (Fever/ Feverish) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced HYPERHIDROSIS (Sweating), SOMNOLENCE (Ended up sleeping all day), NIGHT SWEATS (wakes up dripping wet with sweat) and PYREXIA (Fever/ Feverish). On 04-Dec-2021 at 3:00 AM, the patient experienced CHILLS (Chills). On 05-Dec-2021, the patient experienced ASTHENIA (Weak) and FATIGUE (Tired). At the time of the report, ASTHENIA (Weak), PYREXIA (Fever/ Feverish) and FATIGUE (Tired) had not resolved and HYPERHIDROSIS (Sweating), SOMNOLENCE (Ended up sleeping all day), NIGHT SWEATS (wakes up dripping wet with sweat) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-406703 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved.            The patient had no adverse event.  No concomitant medications were mentioned. No treatment details were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: after the first does they have an increase in their Tinnitus; first dose of the Moderna covid19 vaccine 8 months ago, and never getting the second; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (after the first does they have an increase in their Tinnitus) and PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna covid19 vaccine 8 months ago, and never getting the second) in a 56-year-old male 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 TINNITUS (after the first does they have an increase in their Tinnitus) and PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna covid19 vaccine 8 months ago, and never getting the second). At the time of the report, TINNITUS (after the first does they have an increase in their Tinnitus) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna covid19 vaccine 8 months ago, and never getting the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Nasopharyngitis, Pain, Tenderness, Vaccination site pain
Clinical narrative: got a cold; ache on that spot; pain in the right shoulder/pain radiated down and affected the arm between the elbow and the shoulder; pain started to came,still going on; a little tenderness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain started to came,still going on), TENDERNESS (a little tenderness in the left arm), NASOPHARYNGITIS (got a cold), VACCINATION SITE PAIN (ache on that spot) and ARTHRALGIA (pain in the right shoulder/pain radiated down and affected the arm between the elbow and the shoulder) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 026B21A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Unspecified disorder of knee joint. Concurrent medical conditions included Disability NOS. Concomitant products included HYDROXYZINE for Anxiety, CITALOPRAM HYDROBROMIDE for Depression, OMEPRAZOLE for GERD, OXYBUTYNIN CHLORIDE for Urinary tract disorder, NAPROXEN, LISINOPRIL, PARACETAMOL (ACETAMINOPHEN) and MULTIVITAMINS;MINERALS for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced PAIN (pain started to came,still going on), TENDERNESS (a little tenderness in the left arm) and VACCINATION SITE PAIN (ache on that spot). 06-Dec-2021, the patient experienced ARTHRALGIA (pain in the right shoulder/pain radiated down and affected the arm between the elbow and the shoulder). On an unknown date, the patient experienced NASOPHARYNGITIS (got a cold). The patient was treated with TROLAMINE SALICYLATE for Pain, at a dose of 10 % and CANNABIDIOL (CBD OIL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (pain started to came,still going on), TENDERNESS (a little tenderness in the left arm), VACCINATION SITE PAIN (ache on that spot) and ARTHRALGIA (pain in the right shoulder/pain radiated down and affected the arm between the elbow and the shoulder) had not resolved and NASOPHARYNGITIS (got a cold) outcome was unknown.            Concomitant medication include Holo Pain patches.  Treatment medication include pain relieving cream.  Patient had medical history of era loss.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment information was reported by the reporter.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered to patients 18 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass, Neck pain, Swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: Left side of her neck above the clavicle is sore; Left side of her neck above the clavicle is swollen; It's like a marble sized lump; Left arm was swollen at injection site; Left arm was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Left side of her neck above the clavicle is sore), SWELLING (Left side of her neck above the clavicle is swollen), NECK MASS (It's like a marble sized lump), VACCINATION SITE SWELLING (Left arm was swollen at injection site) and VACCINATION SITE PAIN (Left arm was sore at injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0291121B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Dec-2021, the patient experienced NECK PAIN (Left side of her neck above the clavicle is sore), SWELLING (Left side of her neck above the clavicle is swollen), NECK MASS (It's like a marble sized lump), VACCINATION SITE SWELLING (Left arm was swollen at injection site) and VACCINATION SITE PAIN (Left arm was sore at injection site). At the time of the report, NECK PAIN (Left side of her neck above the clavicle is sore), SWELLING (Left side of her neck above the clavicle is swollen), NECK MASS (It's like a marble sized lump), VACCINATION SITE SWELLING (Left arm was swollen at injection site) and VACCINATION SITE PAIN (Left arm was sore at injection site) outcome was unknown.            Patient also reported that the left side of her neck above the clavicle is sore and swollen like a marble sized lump. No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects/reactions similar to COVID symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms). At the time of the report, VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms) outcome was unknown.        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 was reported. No treatment drug details was reported.   This case was linked to MOD-2021-407006 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspepsia, Fear, Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (horrible pain in the heart area, chest, left side), BACK PAIN (horrible pain in back), MOBILITY DECREASED (couldn't change side when she was lying on bed), DYSPEPSIA (susceptible to heartburn.) and PAIN IN EXTREMITY (mild soreness in the arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 007AM20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), FAMOTIDINE, ALPRAZOLAM (XANAX), ALPRAZOLAM (XANAX), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced CHEST PAIN (horrible pain in the heart area, chest, left side), BACK PAIN (horrible pain in back), MOBILITY DECREASED (couldn't change side when she was lying on bed), DYSPEPSIA (susceptible to heartburn.), PAIN IN EXTREMITY (mild soreness in the arm), FEELING ABNORMAL (stabbing feeling on the left), FEAR (scary) and PAIN (shooting pain through the heart). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (horrible pain in the heart area, chest, left side), BACK PAIN (horrible pain in back), MOBILITY DECREASED (couldn't change side when she was lying on bed), DYSPEPSIA (susceptible to heartburn.), PAIN IN EXTREMITY (mild soreness in the arm), FEELING ABNORMAL (stabbing feeling on the left), FEAR (scary) and PAIN (shooting pain through the heart) outcome was unknown. Treatment Self medicated with Tylenol and a muscle relaxant. Patient said that she omitted Adderall.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (horrible pain in the heart area, chest, left side), BACK PAIN (horrible pain in back), MOBILITY DECREASED (couldn't change side when she was lying on bed), DYSPEPSIA (susceptible to heartburn.) and PAIN IN EXTREMITY (mild soreness in the arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 007AM20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), FAMOTIDINE, ALPRAZOLAM (XANAX), ALPRAZOLAM (XANAX), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced CHEST PAIN (horrible pain in the heart area, chest, left side), BACK PAIN (horrible pain in back), MOBILITY DECREASED (couldn't change side when she was lying on bed), DYSPEPSIA (susceptible to heartburn.), PAIN IN EXTREMITY (mild soreness in the arm), FEELING ABNORMAL (stabbing feeling on the left), FEAR (scary) and PAIN (shooting pain through the heart). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (horrible pain in the heart area, chest, left side), BACK PAIN (horrible pain in back), MOBILITY DECREASED (couldn't change side when she was lying on bed), DYSPEPSIA (susceptible to heartburn.), PAIN IN EXTREMITY (mild soreness in the arm), FEELING ABNORMAL (stabbing feeling on the left), FEAR (scary) and PAIN (shooting pain through the heart) outcome was unknown. Treatment Self medicated with Tylenol and a muscle relaxant. Patient said that she omitted Adderall.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects/reactions similar to COVID symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms). At the time of the report, VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-406964 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: lot of itching; hives all over body/ only a little bit of hives in the hands/patient broke out in hives/hives have been bad; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over body/ only a little bit of hives in the hands/patient broke out in hives/hives have been bad) and PRURITUS (lot of itching) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (hives all over body/ only a little bit of hives in the hands/patient broke out in hives/hives have been bad). On an unknown date, the patient experienced PRURITUS (lot of itching). The patient was treated with CLONAZEPAM (KLONOPIN) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over body/ only a little bit of hives in the hands/patient broke out in hives/hives have been bad) was resolving and PRURITUS (lot of itching) outcome was unknown.            The patient reported after 10 days of getting the booster, the patient broke out in hives. The patient was better now, only a little bit of hives in the hands was remaining. Reportedly, the patient did not have soreness or inflammation.  No Concomitant product use was reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MONTELUKAST SODIUM (SINGULAIR) for Allergy.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at injection site). At the time of the report, VACCINATION SITE PAIN (pain at injection site) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product included birth control (unspecified) medication taken daily via oral route from 1995. No treatment medication reported by reporter.   This case was linked to MOD-2021-405454, MOD-2021-407018 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: axillary lymph node swelling (L side underarm); pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (axillary lymph node swelling (L side underarm)) and VACCINATION SITE PAIN (pain at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MONTELUKAST SODIUM (SINGULAIR) for Allergy.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced LYMPHADENOPATHY (axillary lymph node swelling (L side underarm)) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, LYMPHADENOPATHY (axillary lymph node swelling (L side underarm)) and VACCINATION SITE PAIN (pain at injection site) had resolved.      Concomitant product use was not provided by the reporter.  No treatment information provided.  It was reported that Patient was taking Birth Control Pills for birth control on an unspecified date of 1995 daily by oral route which was still ongoing.   This case was linked to MOD-2021-407016 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: harsh reaction to Vax 2; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (harsh reaction to Vax 2) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (harsh reaction to Vax 2). At the time of the report, VACCINATION COMPLICATION (harsh reaction to Vax 2) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Sputum discoloured, Throat irritation
Clinical narrative: Started feeling sick; Itchy throat; Brown mucus; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started feeling sick), THROAT IRRITATION (Itchy throat) and SPUTUM DISCOLOURED (Brown mucus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced MALAISE (Started feeling sick), THROAT IRRITATION (Itchy throat) and SPUTUM DISCOLOURED (Brown mucus). At the time of the report, MALAISE (Started feeling sick), THROAT IRRITATION (Itchy throat) and SPUTUM DISCOLOURED (Brown mucus) outcome was unknown.            No concomitant medications were reported   No treatment information was provided   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: arm soreness; bad nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and NAUSEA (bad nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and NAUSEA (bad nausea). On 15-Mar-2021, NAUSEA (bad nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No medical history was provided by the reporter.  Treatment medications were included supplements for an unknown indication.   This case was linked to MOD-2021-407147, MOD-2021-407149 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: The vial was out of the fridge for over 12 hours; Given a second shot of 0.25ml of a vial taken out of the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was out of the fridge for over 12 hours) and EXTRA DOSE ADMINISTERED (Given a second shot of 0.25ml of a vial taken out of the fridge) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was out of the fridge for over 12 hours) and EXTRA DOSE ADMINISTERED (Given a second shot of 0.25ml of a vial taken out of the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was out of the fridge for over 12 hours) and EXTRA DOSE ADMINISTERED (Given a second shot of 0.25ml of a vial taken out of the fridge) 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Dyspepsia, Fatigue, Feeling abnormal
Clinical narrative: vaccine didn't do me any good; not well; bone pain; weakness; instability; area on his heart was burning; feeling a lot of movement; fever; tiredness; infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls; vertigo; high pressure; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls), VERTIGO (vertigo), HYPERTENSION (high pressure), VACCINATION COMPLICATION (vaccine didn't do me any good) and MALAISE (not well) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VERTIGO (vertigo) and HYPERTENSION (high pressure). On an unknown date, the patient experienced SYNOVIAL CYST (infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls), VACCINATION COMPLICATION (vaccine didn't do me any good), MALAISE (not well), BONE PAIN (bone pain), ASTHENIA (weakness), GAIT DISTURBANCE (instability), DYSPEPSIA (area on his heart was burning), FEELING ABNORMAL (feeling a lot of movement), PYREXIA (fever) and FATIGUE (tiredness). The patient was treated with DICLOXACILLIN for Ganglion, at an unspecified dose and frequency. At the time of the report, SYNOVIAL CYST (infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls), VERTIGO (vertigo) and HYPERTENSION (high pressure) had not resolved, VACCINATION COMPLICATION (vaccine didn't do me any good) and MALAISE (not well) outcome was unknown and BONE PAIN (bone pain), ASTHENIA (weakness), GAIT DISTURBANCE (instability), DYSPEPSIA (area on his heart was burning), FEELING ABNORMAL (feeling a lot of movement), PYREXIA (fever) and FATIGUE (tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) showed little balls (Ganglions).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included a lot of medication.   No treatment medications were reported.   This case was linked to MOD-2021-407287 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypertension, Malaise, Mammogram, Pyrexia
Clinical narrative: vaccine didn't do me any good; not well; bone pain; weakness; instability; area on his heart was burning; feeling a lot of movement; fever; tiredness; infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls; vertigo; high pressure; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls), VERTIGO (vertigo), HYPERTENSION (high pressure), VACCINATION COMPLICATION (vaccine didn't do me any good) and MALAISE (not well) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VERTIGO (vertigo) and HYPERTENSION (high pressure). On an unknown date, the patient experienced SYNOVIAL CYST (infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls), VACCINATION COMPLICATION (vaccine didn't do me any good), MALAISE (not well), BONE PAIN (bone pain), ASTHENIA (weakness), GAIT DISTURBANCE (instability), DYSPEPSIA (area on his heart was burning), FEELING ABNORMAL (feeling a lot of movement), PYREXIA (fever) and FATIGUE (tiredness). The patient was treated with DICLOXACILLIN for Ganglion, at an unspecified dose and frequency. At the time of the report, SYNOVIAL CYST (infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls), VERTIGO (vertigo) and HYPERTENSION (high pressure) had not resolved, VACCINATION COMPLICATION (vaccine didn't do me any good) and MALAISE (not well) outcome was unknown and BONE PAIN (bone pain), ASTHENIA (weakness), GAIT DISTURBANCE (instability), DYSPEPSIA (area on his heart was burning), FEELING ABNORMAL (feeling a lot of movement), PYREXIA (fever) and FATIGUE (tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) showed little balls (Ganglions).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included a lot of medication.   No treatment medications were reported.   This case was linked to MOD-2021-407287 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Synovial cyst, Vaccination complication, Vertigo
Clinical narrative: vaccine didn't do me any good; not well; bone pain; weakness; instability; area on his heart was burning; feeling a lot of movement; fever; tiredness; infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls; vertigo; high pressure; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls), VERTIGO (vertigo), HYPERTENSION (high pressure), VACCINATION COMPLICATION (vaccine didn't do me any good) and MALAISE (not well) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VERTIGO (vertigo) and HYPERTENSION (high pressure). On an unknown date, the patient experienced SYNOVIAL CYST (infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls), VACCINATION COMPLICATION (vaccine didn't do me any good), MALAISE (not well), BONE PAIN (bone pain), ASTHENIA (weakness), GAIT DISTURBANCE (instability), DYSPEPSIA (area on his heart was burning), FEELING ABNORMAL (feeling a lot of movement), PYREXIA (fever) and FATIGUE (tiredness). The patient was treated with DICLOXACILLIN for Ganglion, at an unspecified dose and frequency. At the time of the report, SYNOVIAL CYST (infarcted ganglions, ganglions next to his heart, little balls, mammography showed little balls), VERTIGO (vertigo) and HYPERTENSION (high pressure) had not resolved, VACCINATION COMPLICATION (vaccine didn't do me any good) and MALAISE (not well) outcome was unknown and BONE PAIN (bone pain), ASTHENIA (weakness), GAIT DISTURBANCE (instability), DYSPEPSIA (area on his heart was burning), FEELING ABNORMAL (feeling a lot of movement), PYREXIA (fever) and FATIGUE (tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) showed little balls (Ganglions).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included a lot of medication.   No treatment medications were reported.   This case was linked to MOD-2021-407287 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Influenza like illness, Musculoskeletal stiffness, Nausea
Clinical narrative: stiff arm; swelling; severe diarrhea; nausea; headache; flu-like symptoms; pain/achiness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), MUSCULOSKELETAL STIFFNESS (stiff arm), DIARRHOEA (severe diarrhea), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PAIN (pain/achiness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 008B212A and 046BZIA or 046BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021 at 5:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced VACCINATION SITE PAIN (pain/achiness). On 07-Dec-2021 at 2:00 AM, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (severe diarrhea), NAUSEA (nausea) and HEADACHE (headache). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff arm) and VACCINATION SITE SWELLING (swelling). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), MUSCULOSKELETAL STIFFNESS (stiff arm), DIARRHOEA (severe diarrhea), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (pain/achiness), NAUSEA (nausea) and HEADACHE (headache) had not resolved.      No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: stiff arm; swelling; severe diarrhea; nausea; headache; flu-like symptoms; pain/achiness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), MUSCULOSKELETAL STIFFNESS (stiff arm), DIARRHOEA (severe diarrhea), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PAIN (pain/achiness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 008B212A and 046BZIA or 046BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021 at 5:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced VACCINATION SITE PAIN (pain/achiness). On 07-Dec-2021 at 2:00 AM, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (severe diarrhea), NAUSEA (nausea) and HEADACHE (headache). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff arm) and VACCINATION SITE SWELLING (swelling). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), MUSCULOSKELETAL STIFFNESS (stiff arm), DIARRHOEA (severe diarrhea), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (pain/achiness), NAUSEA (nausea) and HEADACHE (headache) had not resolved.      No concomitant medication was reported by the reporter. No treatment was reported by the reporter.