chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Thirst
Clinical narrative: fell/tried to get up and fell again/he dropped/fell down; thirsty; did not feel any of his body parts/He was like twilight zone; can't drive; won't work for some days.; his legs gave out; bruised; Lost balance; injury in the shoulder; may be a fracture/breaks a bone; felt dizzy; the top of his shoulder is aching from the fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive) and IMPAIRED WORK ABILITY (won't work for some days.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2021.   On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 23-Dec-2021, the patient experienced FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive), IMPAIRED WORK ABILITY (won't work for some days.), LIMB DISCOMFORT (his legs gave out), CONTUSION (bruised), BALANCE DISORDER (Lost balance), LIMB INJURY (injury in the shoulder), FRACTURE (may be a fracture/breaks a bone), DIZZINESS (felt dizzy) and ARTHRALGIA (the top of his shoulder is aching from the fall). At the time of the report, FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive), IMPAIRED WORK ABILITY (won't work for some days.), LIMB DISCOMFORT (his legs gave out), CONTUSION (bruised), BALANCE DISORDER (Lost balance), LIMB INJURY (injury in the shoulder), FRACTURE (may be a fracture/breaks a bone), DIZZINESS (felt dizzy) and ARTHRALGIA (the top of his shoulder is aching from the fall) 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-2021-425596 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: had to have surgery; This spontaneous case was reported by a pharmacist and describes the occurrence of SURGERY (had to have surgery) 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 28-Jan-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 SURGERY (had to have surgery). At the time of the report, SURGERY (had to have surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.  The physician did want the patient to get the next dose until after they are healed. Today is the first day the patient can receive the dose, but other patients are scheduled to receive their second dose also. The patient will be outside the 42-day window
Sex: F
Vaccine: COVID19
Symptoms: Fall, Musculoskeletal pain
Clinical narrative: she fell; Pain in buttocks; This spontaneous case was reported by a consumer and describes the occurrence of FALL (she fell) and MUSCULOSKELETAL PAIN (Pain in buttocks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (she fell) and MUSCULOSKELETAL PAIN (Pain in buttocks). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, FALL (she fell) and MUSCULOSKELETAL PAIN (Pain in buttocks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: went on a hunting trip and said had leg cramps, too.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (went on a hunting trip and said had leg cramps, too.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced MUSCLE SPASMS (went on a hunting trip and said had leg cramps, too.). At the time of the report, MUSCLE SPASMS (went on a hunting trip and said had leg cramps, too.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.   No treatment information was provided by the reporter.  The patient got the Moderna COVID-19 Vaccines. Patient went on a hunting trip and had leg cramps.   Reporter did not allow further contact
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Feeling hot, Pain, Pain in extremity
Clinical narrative: feels some tightness in his chest; kind of an ache in his chest; soreness in the arm; ache; warmness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (feels some tightness in his chest), CHEST PAIN (kind of an ache in his chest), PAIN IN EXTREMITY (soreness in the arm), PAIN (ache) and FEELING HOT (warmness) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 036A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced PAIN (ache) and FEELING HOT (warmness). On 24-Dec-2021, the patient experienced CHEST DISCOMFORT (feels some tightness in his chest), CHEST PAIN (kind of an ache in his chest) and PAIN IN EXTREMITY (soreness in the arm). On 23-Dec-2021, PAIN (ache) and FEELING HOT (warmness) had resolved. At the time of the report, CHEST DISCOMFORT (feels some tightness in his chest), CHEST PAIN (kind of an ache in his chest) and PAIN IN EXTREMITY (soreness in the arm) had not resolved.            Concomitant medications were not provided. Treatment medication were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: chills; aching; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (aching) 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 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 23-Dec-2021, the patient experienced CHILLS (chills) and MYALGIA (aching). At the time of the report, CHILLS (chills) and MYALGIA (aching) outcome was unknown.            Concomitant medication of the patient was not reported.  In the evening of 23-Dec-2021 or early morning of 24-Dec-2021, the patient had chills and aching.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: administered a 0.25 mL booster dose to a patient instead of the 0.5 mL full dose for the patient's first dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (administered a 0.25 mL booster dose to a patient instead of the 0.5 mL full dose for the patient's first dose of the Moderna COVID-19 vaccine) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 24-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (administered a 0.25 mL booster dose to a patient instead of the 0.5 mL full dose for the patient's first dose of the Moderna COVID-19 vaccine). On 24-Dec-2021, ACCIDENTAL UNDERDOSE (administered a 0.25 mL booster dose to a patient instead of the 0.5 mL full dose for the patient's first dose of the Moderna COVID-19 vaccine) 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.   Patient was not experiencing any symptoms.  Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Went to the dermatologist because he has a problem with psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Went to the dermatologist because he has a problem with psoriasis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Went to the dermatologist because he has a problem with psoriasis). The patient was treated with SALICYLIC ACID, TRIAMCINOLONE ACETONIDE (KENALOG [SALICYLIC ACID;TRIAMCINOLONE ACETONIDE]) for Psoriasis, at a dose of 2.5 mg CC. At the time of the report, PSORIASIS (Went to the dermatologist because he has a problem with psoriasis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Taste disorder, Throat irritation
Clinical narrative: Bronchial type infection; His throat was irritated from the coughing; His taste didn't seem to be the same.  He couldn't taste the sugar in his coffee; Severe Coughing; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchial type infection), THROAT IRRITATION (His throat was irritated from the coughing), TASTE DISORDER (His taste didn't seem to be the same.  He couldn't taste the sugar in his coffee) and COUGH (Severe Coughing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 004C21A and 0471321A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced BRONCHITIS (Bronchial type infection), THROAT IRRITATION (His throat was irritated from the coughing), TASTE DISORDER (His taste didn't seem to be the same.  He couldn't taste the sugar in his coffee) and COUGH (Severe Coughing). In December 2021, COUGH (Severe Coughing) had resolved. At the time of the report, BRONCHITIS (Bronchial type infection), THROAT IRRITATION (His throat was irritated from the coughing) and TASTE DISORDER (His taste didn't seem to be the same.  He couldn't taste the sugar in his coffee) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided. Patient believe he had a low level of Omicron.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given more than 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given more than 12 hours after first puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given more than 12 hours after first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given more than 12 hours after first puncture) 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.   No concomitant medications reported. No treatment medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Surgery a few weeks ago and developed an allergic reaction to the adhesive used near her wounds; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Surgery a few weeks ago and developed an allergic reaction to the adhesive used near her wounds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Surgery a few weeks ago and developed an allergic reaction to the adhesive used near her wounds). The patient was treated with PREDNISONE for Allergic reaction, at a dose of 4 milligram, taper dose-pack to be used over 6 days. At the time of the report, HYPERSENSITIVITY (Surgery a few weeks ago and developed an allergic reaction to the adhesive used near her wounds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter  Patient calling regarding concerns about receiving her second Moderna dose tomorrow (10Mar2021). Patient reports having surgery a few weeks ago and has developed an allergic reaction to the adhesive used near her wounds. Patient saw her surgeon and was prescribed a Prednisone  Patient is concerned the steroids will interfere with the efficacy of her second Moderna dose. Patient has consulted with her surgeon, a doctor, a PA, and her pharmacist to help her determine if she should delay her second dose for a week. Patient's surgeon reportedly encouraged her to take the dose-pack and receive her Moderna vaccine as scheduled. Patient reports her surgeon stated that the dose-pack is considered a "low dose" steroid.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with the booster dose of the Moderna Covid-19 vaccine from a vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the booster dose of the Moderna Covid-19 vaccine from a vial which has been punctured for more than 12 hours) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the booster dose of the Moderna Covid-19 vaccine from a vial which has been punctured for more than 12 hours). On 24-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with the booster dose of the Moderna Covid-19 vaccine from a vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Bladder operation
Clinical narrative: Had a bladder procedure; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER OPERATION (Had a bladder procedure) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced BLADDER OPERATION (Had a bladder procedure). At the time of the report, BLADDER OPERATION (Had a bladder procedure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported. Elderly patient reported that she was about to receive her second dose of Moderna COVID-19 vaccine on 27-Feb-2021. Patient stated that she had a bladder procedure on 26-Feb-2021 and her doctor wanted her to start taking antibiotics. She was inquiring if it was okay for her to take the antibiotics along with he second COVID shot.
Sex: U
Vaccine: COVID19
Symptoms: Arterial disorder, Asthenia
Clinical narrative: Patient experienced peripheral artery disease; asthenia; This spontaneous case was reported by a physician and describes the occurrence of ARTERIAL DISORDER (Patient experienced peripheral artery disease) and ASTHENIA (asthenia) 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 ARTERIAL DISORDER (Patient experienced peripheral artery disease) and ASTHENIA (asthenia). At the time of the report, ARTERIAL DISORDER (Patient experienced peripheral artery disease) and ASTHENIA (asthenia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-229920 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: fully vaccinated last march, had a positive case in August; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (fully vaccinated last march, had a positive case in August) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (fully vaccinated last march, had a positive case in August). At the time of the report, COVID-19 (fully vaccinated last march, had a positive case in August) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Company comment: This case concerns a patient of unknow age and gender with no relevant medical history reported, who experienced the unexpected event of COVID-19. The event occurred approximately 4 months after the second dose of mRNA1273. As reported, the patient was fully vaccinated last march, had a positive case in August. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA1273  in not affected by this report.?; Sender's Comments: This case concerns a patient of unknow age and gender with no relevant medical history reported, who experienced the unexpected event of COVID-19. The event occurred approximately 4 months after the second dose of mRNA1273. As reported, the patient was fully vaccinated last march, had a positive case in August. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA1273  in not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Cardiac murmur, Computerised tomogram thorax, Expired product administered, Laboratory test
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21A and 003B21A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer ((ICD-V76.44) (ICD10-Z98.89)), Skin cancer ((ICD-V76.43) (ICD10-Z12.83)), Lung cancer ((ICD-V76.49) (ICD10-Z78.9)), Colon cancer ((ICD-V76.51) (ICD10-Z98.89)), Hypoxemia ((ICD-799.02) (ICD10-R09.02)), Lacunar infarction (small chronic (ICD-436) (ICD10-167.89)), Obstructive sleep apnea syndrome ((ICD-780.57) (ICD10-G47.30)), Myopathy (due to statins,  (ICD-359.9) (ICD 10- G72.9)), Hyperlipidemia ((ICD-272.4) (ICD 10- E78.5)), Gait disturbance ((ICD-781.2) (ICD 10- R26.9)), Cognitive impairment ((ICD-331.83) (ICD 10- G31.84)) and Pneumonia ((ICD-486) (ICD 10- J18.9)). Previously administered products included for Product used for unknown indication: Influenza vaccine (dose 1 (ICD-V04.81) (ICD 10- Z28.3)) on 25-Nov-2019 and Influenza vaccine (dose 2 (ICD-V04.81) (ICD 10- Z28.3)) on 21-Oct-2021. Past adverse reactions to the above products included No adverse event with Influenza vaccine and Influenza vaccine. Concurrent medical conditions included Type 2 diabetes mellitus ((ICD-250.00) (ICD 10- E11.9)). Concomitant products included METFORMIN HCL, FISH OIL, MONASCUS PURPUREUS (RED YEAST RICE) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: result not reported two times daily. On an unknown date, Cardiac murmur: result not reported. On an unknown date, Computerised tomogram thorax: CAD, non obstructive disease and furuncle furuncle. On an unknown date, Laboratory test: result not reported and result not reported. On an unknown date, Liver function test: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  It was reported that, the patient was not sick that day and he had no allergies to anything.  He had not testes positive for COVID-19 and had not received any treatment related to COVID-19.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21A and 003B21A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer ((ICD-V76.44) (ICD10-Z98.89)), Skin cancer ((ICD-V76.43) (ICD10-Z12.83)), Lung cancer ((ICD-V76.49) (ICD10-Z78.9)), Colon cancer ((ICD-V76.51) (ICD10-Z98.89)), Hypoxemia ((ICD-799.02) (ICD10-R09.02)), Lacunar infarction (small chronic (ICD-436) (ICD10-167.89)), Obstructive sleep apnea syndrome ((ICD-780.57) (ICD10-G47.30)), Myopathy (due to statins,  (ICD-359.9) (ICD 10- G72.9)), Hyperlipidemia ((ICD-272.4) (ICD 10- E78.5)), Gait disturbance ((ICD-781.2) (ICD 10- R26.9)), Cognitive impairment ((ICD-331.83) (ICD 10- G31.84)) and Pneumonia ((ICD-486) (ICD 10- J18.9)). Previously administered products included for Product used for unknown indication: Influenza vaccine (dose 1 (ICD-V04.81) (ICD 10- Z28.3)) on 25-Nov-2019 and Influenza vaccine (dose 2 (ICD-V04.81) (ICD 10- Z28.3)) on 21-Oct-2021. Past adverse reactions to the above products included No adverse event with Influenza vaccine and Influenza vaccine. Concurrent medical conditions included Type 2 diabetes mellitus ((ICD-250.00) (ICD 10- E11.9)). Concomitant products included METFORMIN HCL, FISH OIL, MONASCUS PURPUREUS (RED YEAST RICE) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: result not reported two times daily. On an unknown date, Cardiac murmur: result not reported. On an unknown date, Computerised tomogram thorax: CAD, non obstructive disease and furuncle furuncle. On an unknown date, Laboratory test: result not reported and result not reported. On an unknown date, Liver function test: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  It was reported that, the patient was not sick that day and he had no allergies to anything.  He had not testes positive for COVID-19 and had not received any treatment related to COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pruritus
Clinical narrative: little sore arm; a little itching; little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm), PRURITUS (a little itching) and FATIGUE (little tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for an unknown indication.     No medical history was provided by the reporter.  Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication.   On 13-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 PAIN IN EXTREMITY (little sore arm), PRURITUS (a little itching) and FATIGUE (little tired). At the time of the report, PAIN IN EXTREMITY (little sore arm), PRURITUS (a little itching) and FATIGUE (little tired) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No treatment information were given.   This case was linked to MOD-2021-402890, MOD-2021-402893 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: COVID arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) and RASH (Rash) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE REACTION (COVID arm) and RASH (Rash). At the time of the report, VACCINATION SITE REACTION (COVID arm) and RASH (Rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient is not on any concomitant medications.  Patient experienced adverse event 10 to 12 days later with her first dose.  Treatment medications included antihistamines.   This case was linked to MOD-2021-424489 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: body aches; arm pain from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and VACCINATION SITE PAIN (arm pain from the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pfizer (dose 2 of Pfizer) and pfizer (dose 1 of pfizer). Past adverse reactions to the above products included No adverse reaction with pfizer and pfizer.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced MYALGIA (body aches) and VACCINATION SITE PAIN (arm pain from the injection site). On 22-Dec-2021, MYALGIA (body aches) had resolved. At the time of the report, VACCINATION SITE PAIN (arm pain from the injection site) outcome was unknown.            No Concomitant product use was reported.  The reporter was calling on behalf of their daughter who was the patient. The patient got their 1st 2 doses of Pfizer and on 20-Dec-2021 got the booster dose of the Moderna Covid-19 vaccine. On 21-Dec-2021, the patient had body aches, until 22-Dec-2021, The patient also had arm pain from the injection site.  No treatment information was provided.   This case was linked to MOD-2021-424245 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL, HYDROCHLOROTHIAZIDE, MONTELUKAST, SIMVASTATIN, GLIMEPIRIDE, LEVOTHYROXINE, LEVOTHYROXINE, METOPROLOL, DILTIAZEM, GABAPENTIN and VITAMIN B12 NOS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (Aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-425592, MOD-2021-425599 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Muscle spasms, Pain in extremity
Clinical narrative: whole back gave out; muscle spasm; Little headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BACK PAIN (whole back gave out), MUSCLE SPASMS (muscle spasm) and HEADACHE (Little headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 011A21A and 015M21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (Little headache). On 24-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BACK PAIN (whole back gave out) and MUSCLE SPASMS (muscle spasm). The patient was treated with NAPROXEN SODIUM (ALEVE) for Headache, at an unspecified dose and frequency. In December 2021, HEADACHE (Little headache) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), BACK PAIN (whole back gave out) and MUSCLE SPASMS (muscle spasm) outcome was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hepatitis B, Pyrexia, Therapeutic response unexpected
Clinical narrative: tested Negative for Hepatitis B in April 2021 & July 2021; had a temperature of 99.4F.; This spontaneous case was reported by a nurse and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (tested Negative for Hepatitis B in April 2021 & July 2021) and PYREXIA (had a temperature of 99.4F.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis B (Patient get tested every 6 months.) in 1980.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (had a temperature of 99.4F.). In April 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (tested Negative for Hepatitis B in April 2021 & July 2021). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (tested Negative for Hepatitis B in April 2021 & July 2021) and PYREXIA (had a temperature of 99.4F.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Hepatitis B: positive (Positive) Positive. On 03-Feb-2021, Body temperature: 99.4 (High) 99.4. In April 2021, Hepatitis B: negative (Negative) Negative. In July 2021, Hepatitis B: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-425676 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine administered; Tiredness; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), MYALGIA (Body aches), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029h21b) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose) on 03-May-2021 and Pfizer (2nd dose) on 24-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included VITAMINS NOS for an unknown indication.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced FATIGUE (Tiredness), MYALGIA (Body aches) and PYREXIA (Fever). On 23-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, FATIGUE (Tiredness), MYALGIA (Body aches) and PYREXIA (Fever) had not resolved.            No medical history was provided by the reporter.  The patient reported following vaccination with the booster dose, the patient started to experience tiredness, body aches, fever and stated that the symptoms were ongoing.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Eye pain, Fatigue, Glossodynia, Lymphadenopathy
Clinical narrative: sore throat; mild chest pressure; neck feels puffy; sore in eye; sore in tongue; swollen glands; body ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (mild chest pressure), SWELLING (neck feels puffy), EYE PAIN (sore in eye ) and GLOSSODYNIA (sore in tongue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052FZ119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Endocrine disorder. Concomitant products included HYDROCORTISONE for Endocrine disorder.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (mild chest pressure), SWELLING (neck feels puffy), EYE PAIN (sore in eye ), GLOSSODYNIA (sore in tongue), LYMPHADENOPATHY (swollen glands), MYALGIA (body ache) and FATIGUE (fatigue). The patient was treated with ZINC for Adverse event, at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Ache, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (mild chest pressure), SWELLING (neck feels puffy), EYE PAIN (sore in eye ), GLOSSODYNIA (sore in tongue), LYMPHADENOPATHY (swollen glands), MYALGIA (body ache) and FATIGUE (fatigue) had not resolved.       The patient got booster dose and 5 days after that, she started with (and are still ongoing): sore throat, swollen glands, neck feels puffy, mild chest pressure, body ache, fatigue, sore in tongue, sore in eye; everything is mild to moderate.  Company comment: This case concerns a 71-year-old, female patient with medical history of endocrine disorder, who experienced the unexpected non serious events of oropharyngeal pain, chest discomfort, swelling, myalgia, eye pain, glossodynia, lymphadenopathy and fatigue. The events occurred approximately 5 days after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-403251, MOD-2021-403248 (Patient Link).; Sender's Comments: This case concerns a 71-year-old, female patient with medical history of endocrine disorder, who experienced the unexpected non serious events of oropharyngeal pain, chest discomfort, swelling, myalgia, eye pain, glossodynia, lymphadenopathy and fatigue. The events occurred approximately 5 days after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Swelling
Clinical narrative: sore throat; mild chest pressure; neck feels puffy; sore in eye; sore in tongue; swollen glands; body ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (mild chest pressure), SWELLING (neck feels puffy), EYE PAIN (sore in eye ) and GLOSSODYNIA (sore in tongue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052FZ119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Endocrine disorder. Concomitant products included HYDROCORTISONE for Endocrine disorder.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (mild chest pressure), SWELLING (neck feels puffy), EYE PAIN (sore in eye ), GLOSSODYNIA (sore in tongue), LYMPHADENOPATHY (swollen glands), MYALGIA (body ache) and FATIGUE (fatigue). The patient was treated with ZINC for Adverse event, at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Ache, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), CHEST DISCOMFORT (mild chest pressure), SWELLING (neck feels puffy), EYE PAIN (sore in eye ), GLOSSODYNIA (sore in tongue), LYMPHADENOPATHY (swollen glands), MYALGIA (body ache) and FATIGUE (fatigue) had not resolved.       The patient got booster dose and 5 days after that, she started with (and are still ongoing): sore throat, swollen glands, neck feels puffy, mild chest pressure, body ache, fatigue, sore in tongue, sore in eye; everything is mild to moderate.  Company comment: This case concerns a 71-year-old, female patient with medical history of endocrine disorder, who experienced the unexpected non serious events of oropharyngeal pain, chest discomfort, swelling, myalgia, eye pain, glossodynia, lymphadenopathy and fatigue. The events occurred approximately 5 days after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-403251, MOD-2021-403248 (Patient Link).; Sender's Comments: This case concerns a 71-year-old, female patient with medical history of endocrine disorder, who experienced the unexpected non serious events of oropharyngeal pain, chest discomfort, swelling, myalgia, eye pain, glossodynia, lymphadenopathy and fatigue. The events occurred approximately 5 days after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye injury, Occupational exposure to product
Clinical narrative: my left eye, is in fact dry; Eye injury; some of the diluted vaccine ended up getting squirted in her eye; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 14Dec2021, this case now contains serious adverse reaction.  This is a spontaneous report received from contactable reporter (nurse) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 15Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (medically significant) with onset 15Oct2021, outcome "unknown", described as "some of the diluted vaccine ended up getting squirted in her eye"; EYE INJURY (medically significant) with onset 15Oct2021 16:00, outcome "recovering", described as "Eye injury"; DRY EYE (medically significant), outcome "unknown", described as "my left eye, is in fact dry". The event "eye injury" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of occupational exposure to product, eye injury, dry eye.  Additional information: Nurse Practitioner said before she administered the Pfizer-BioNTech Covid-19 Vaccine. As she was drawing up diluted vaccine, some of it ended up getting squirted into her left eye. She flushed my eye with water. It felt uncomfortable for several days. It stills feels uncomfortable at times (dry). She saw an ophthalmologist on 22Nov2021 who examined her and he said that her left eye, is in fact dry. He advised her to apply warm compress to my eye and if no improvement, he Rx'd eye drops to apply.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Occupational exposure to product, dry eye, and eye injury and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.