chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Frequent bowel movements, Heart rate increased, Hyperthyroidism
Clinical narrative: In hindsight, developed a variety of symptoms in late May that continued until medical treatment was sought in July.  This included a general feeling of being unwell,  raising heart, lightheadedness,  easily tired,  weakness in lower body,  weight loss, increase in bowel frequency, heat intolerance,  trouble sleeping, anxious/nervous,  irritability.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Irritability, Laboratory test abnormal, Malaise, Muscular weakness
Clinical narrative: In hindsight, developed a variety of symptoms in late May that continued until medical treatment was sought in July.  This included a general feeling of being unwell,  raising heart, lightheadedness,  easily tired,  weakness in lower body,  weight loss, increase in bowel frequency, heat intolerance,  trouble sleeping, anxious/nervous,  irritability.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Specialist consultation, Temperature intolerance, Ultrasound thyroid abnormal, Weight decreased
Clinical narrative: In hindsight, developed a variety of symptoms in late May that continued until medical treatment was sought in July.  This included a general feeling of being unwell,  raising heart, lightheadedness,  easily tired,  weakness in lower body,  weight loss, increase in bowel frequency, heat intolerance,  trouble sleeping, anxious/nervous,  irritability.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Anxiety, Axillary pain, Burning sensation, C-reactive protein normal
Clinical narrative: 28YM with no past medical history who presented to the emergency department on 7/28  complaining of 2 days of numbness and burning pain in his right axilla, right hemithorax, right arm and leg. He also noticed weakness in his distal right leg.  Imaging consistent with MS.  Neurology was consulted and he was started on high dose steroids with improvement, but not resolution of symptoms.  He will follow up closely in the outpatient setting with Neurology.  He is very hopeful to get back to his regular activities including fishing/hunting.  On the day of discharge, he remains anxious but wants to get out of the hospital.  He still had some sensory changes in the right axilla and RLE slight foot drop, but overall was feeling much better than at presentation.    #Multiple demyelinating lesions consistent multiple sclerosis, relapsing-remitting.  Symptoms improving, not resolved by dc.  -CT of the head and neck was unremarkable.  -MRI of the brain demonstrates findings consistent with demyelinating disease such as multiple sclerosis including a masslike region in the subependymoma white matter adjacent to the right lateral ventricle.  MRI of the cervical spine demonstrates multiple cervical spine cord lesions including an enhancing focus at C7 most in keeping with demyelinating process. MRI of the thoracic and lumbar spines is unremarkable.  -HIV and syphilis are nonreactive. CRP is normal. Vitamin B12 level is normal. ANA screen negative.  ANCA were not sent.  -LP not indicated given that already meets criteria for relapsing-remitting multiple sclerosis with both enhancing and nonenhancing lesions demonstrating dissemination in time.  He also has lesions that are periventricular, juxtacortical and spinal cord demonstrating dissemination in space. -Completed solumedrol, dose 5/5. Discharged home on 8/1/21
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram head normal, Computerised tomogram neck, Demyelination, HIV test negative
Clinical narrative: 28YM with no past medical history who presented to the emergency department on 7/28  complaining of 2 days of numbness and burning pain in his right axilla, right hemithorax, right arm and leg. He also noticed weakness in his distal right leg.  Imaging consistent with MS.  Neurology was consulted and he was started on high dose steroids with improvement, but not resolution of symptoms.  He will follow up closely in the outpatient setting with Neurology.  He is very hopeful to get back to his regular activities including fishing/hunting.  On the day of discharge, he remains anxious but wants to get out of the hospital.  He still had some sensory changes in the right axilla and RLE slight foot drop, but overall was feeling much better than at presentation.    #Multiple demyelinating lesions consistent multiple sclerosis, relapsing-remitting.  Symptoms improving, not resolved by dc.  -CT of the head and neck was unremarkable.  -MRI of the brain demonstrates findings consistent with demyelinating disease such as multiple sclerosis including a masslike region in the subependymoma white matter adjacent to the right lateral ventricle.  MRI of the cervical spine demonstrates multiple cervical spine cord lesions including an enhancing focus at C7 most in keeping with demyelinating process. MRI of the thoracic and lumbar spines is unremarkable.  -HIV and syphilis are nonreactive. CRP is normal. Vitamin B12 level is normal. ANA screen negative.  ANCA were not sent.  -LP not indicated given that already meets criteria for relapsing-remitting multiple sclerosis with both enhancing and nonenhancing lesions demonstrating dissemination in time.  He also has lesions that are periventricular, juxtacortical and spinal cord demonstrating dissemination in space. -Completed solumedrol, dose 5/5. Discharged home on 8/1/21
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Muscular weakness
Clinical narrative: 28YM with no past medical history who presented to the emergency department on 7/28  complaining of 2 days of numbness and burning pain in his right axilla, right hemithorax, right arm and leg. He also noticed weakness in his distal right leg.  Imaging consistent with MS.  Neurology was consulted and he was started on high dose steroids with improvement, but not resolution of symptoms.  He will follow up closely in the outpatient setting with Neurology.  He is very hopeful to get back to his regular activities including fishing/hunting.  On the day of discharge, he remains anxious but wants to get out of the hospital.  He still had some sensory changes in the right axilla and RLE slight foot drop, but overall was feeling much better than at presentation.    #Multiple demyelinating lesions consistent multiple sclerosis, relapsing-remitting.  Symptoms improving, not resolved by dc.  -CT of the head and neck was unremarkable.  -MRI of the brain demonstrates findings consistent with demyelinating disease such as multiple sclerosis including a masslike region in the subependymoma white matter adjacent to the right lateral ventricle.  MRI of the cervical spine demonstrates multiple cervical spine cord lesions including an enhancing focus at C7 most in keeping with demyelinating process. MRI of the thoracic and lumbar spines is unremarkable.  -HIV and syphilis are nonreactive. CRP is normal. Vitamin B12 level is normal. ANA screen negative.  ANCA were not sent.  -LP not indicated given that already meets criteria for relapsing-remitting multiple sclerosis with both enhancing and nonenhancing lesions demonstrating dissemination in time.  He also has lesions that are periventricular, juxtacortical and spinal cord demonstrating dissemination in space. -Completed solumedrol, dose 5/5. Discharged home on 8/1/21
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peroneal nerve palsy, Relapsing-remitting multiple sclerosis, Spinal cord injury, Treponema test negative
Clinical narrative: 28YM with no past medical history who presented to the emergency department on 7/28  complaining of 2 days of numbness and burning pain in his right axilla, right hemithorax, right arm and leg. He also noticed weakness in his distal right leg.  Imaging consistent with MS.  Neurology was consulted and he was started on high dose steroids with improvement, but not resolution of symptoms.  He will follow up closely in the outpatient setting with Neurology.  He is very hopeful to get back to his regular activities including fishing/hunting.  On the day of discharge, he remains anxious but wants to get out of the hospital.  He still had some sensory changes in the right axilla and RLE slight foot drop, but overall was feeling much better than at presentation.    #Multiple demyelinating lesions consistent multiple sclerosis, relapsing-remitting.  Symptoms improving, not resolved by dc.  -CT of the head and neck was unremarkable.  -MRI of the brain demonstrates findings consistent with demyelinating disease such as multiple sclerosis including a masslike region in the subependymoma white matter adjacent to the right lateral ventricle.  MRI of the cervical spine demonstrates multiple cervical spine cord lesions including an enhancing focus at C7 most in keeping with demyelinating process. MRI of the thoracic and lumbar spines is unremarkable.  -HIV and syphilis are nonreactive. CRP is normal. Vitamin B12 level is normal. ANA screen negative.  ANCA were not sent.  -LP not indicated given that already meets criteria for relapsing-remitting multiple sclerosis with both enhancing and nonenhancing lesions demonstrating dissemination in time.  He also has lesions that are periventricular, juxtacortical and spinal cord demonstrating dissemination in space. -Completed solumedrol, dose 5/5. Discharged home on 8/1/21
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vitamin B12 normal, White matter lesion
Clinical narrative: 28YM with no past medical history who presented to the emergency department on 7/28  complaining of 2 days of numbness and burning pain in his right axilla, right hemithorax, right arm and leg. He also noticed weakness in his distal right leg.  Imaging consistent with MS.  Neurology was consulted and he was started on high dose steroids with improvement, but not resolution of symptoms.  He will follow up closely in the outpatient setting with Neurology.  He is very hopeful to get back to his regular activities including fishing/hunting.  On the day of discharge, he remains anxious but wants to get out of the hospital.  He still had some sensory changes in the right axilla and RLE slight foot drop, but overall was feeling much better than at presentation.    #Multiple demyelinating lesions consistent multiple sclerosis, relapsing-remitting.  Symptoms improving, not resolved by dc.  -CT of the head and neck was unremarkable.  -MRI of the brain demonstrates findings consistent with demyelinating disease such as multiple sclerosis including a masslike region in the subependymoma white matter adjacent to the right lateral ventricle.  MRI of the cervical spine demonstrates multiple cervical spine cord lesions including an enhancing focus at C7 most in keeping with demyelinating process. MRI of the thoracic and lumbar spines is unremarkable.  -HIV and syphilis are nonreactive. CRP is normal. Vitamin B12 level is normal. ANA screen negative.  ANCA were not sent.  -LP not indicated given that already meets criteria for relapsing-remitting multiple sclerosis with both enhancing and nonenhancing lesions demonstrating dissemination in time.  He also has lesions that are periventricular, juxtacortical and spinal cord demonstrating dissemination in space. -Completed solumedrol, dose 5/5. Discharged home on 8/1/21
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neck pain, Pain in jaw, Toothache
Clinical narrative: Left neck, jaw, and tooth pain and numbness that began about 15 minutes after injection and lasted 1-2 hours
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypertension
Clinical narrative: Within the past month my blood pressure has gone significantly higher, with no apparent connection to diet, alcohol consumption or other reason.  Physical activity has been limited by rainy weather and high heat index, which may be a reason.  My cardiologist has adjusted my medication to see if that helps.  I am only reporting this because you have asked us to report any changes in health since vaccination.  It is unlikely that the BP issue is connected to the vaccination since 6 months went by without any BP problems.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: IT WAS A VERY BUSY DAY ON A MONDAY AND I WAS GIVING MANY VACCINES. I HAD GIVEN 2 MODERNA SHOTS BACK TO BACK AND I THOUGHT THAT THIS WAS ALSO MODERNA BUT IT WAS SUPPOSED TO BE THE 2ND DOSE OF PFIZER.  I REALIZED IT AFTER I GAVE IT WHEN I WAS ABOUT TO GIVE THE CORRECT 2ND DOSE OF PFIZER TO HER MOM. MOMWAS NERVOUS AND A LITTLE UPSET.   I IMMEDIATELY APOLOGIZED AND DOUBLE CHECKED WITH THE OTHER RPh ON DUTY TO CONFIRM THAT THEY'RE BOTH INTERCHANGEABLE AND IT'S THE SAME FORMULATION.   MOM FELT BETTER AFTER HEARING THAT IT WAS OKAND NO HARM WOULD BE DONE TO HER DAUGHTER.  I APOLOGIZED AGAIN AND SHE WAS FINE AFTER THAT.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Lymphadenopathy, Menstrual disorder
Clinical narrative: Menstrual like cramps,  started an unexpected period just 2 weeks after the usual one, and has a swollen lymph node(s) under her arm.  The swollen lymph node(s) were still not gone when the 2nd shot was given.  The doctor said to go ahead and get the 2nd shot.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received a vac in another country, in immunization registry also received moderna in April 26, 2021.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: No
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hyperhidrosis, Syncope
Clinical narrative: Patient received the Pfizer vaccine. When patient rose to go to observation, he experienced a witnessed syncopal episode. The patient fell backward. Upon approach, patient's eyes were closed. Patient was diaphoretic. He was placed on a mat.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt received Pfizer as second dose, pt received Moderna for his first dose.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Electrocardiogram, Hypoaesthesia, Pain
Clinical narrative: Extreme ache in neck, shoulders, upper back.  Dizziness.  Fingers tingling and numb in both hands.  Heaviness on chest.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Extreme ache in neck, shoulders, upper back.  Dizziness.  Fingers tingling and numb in both hands.  Heaviness on chest.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Urticaria
Clinical narrative: Hives in patches all over body: legs, back, stomach, arms, neck. Taking Benadryl to no avail.  Also received my menstrual cycle 2 days after shot. This is out of my normal cycle.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased
Clinical narrative: Had a heartbeat of 119 BPM. I have never had a heartbeat this high before, even under stress. Additionally, after I went to the ER I got an unusual bruise after having an IV put in me. I have gotten an IV before but I never bruised this badly.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain
Clinical narrative: Chills,headache,body aches, soreness in arm,
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: Very bad body aches literally my whole body feet, head , back, arms, (everywhere). 102.6(F) fever. Light headed/ dizzy
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Joint swelling, Parosmia, Taste disorder
Clinical narrative: Within hours of vaccine joints swelled and felt warm and arthritic.  Recovered with in 72 hours.  Many foods now taste spoiled or metallic.  Many regularly encountered items now smell rancid.  Has not changed over the months since vaccination.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENT, PATIENT ATTESTED TO THIS BEING HIS 1ST COVID VACCINE BUT UPON BILLING AT END OF SHIFT, INSURANCE REJECTED CLAIM STATING THAT PATIENT HAS GOTTEN SERIES ALREADY (AT ANOTHER LOCATION)
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dysmenorrhoea, Headache, Insomnia
Clinical narrative: Insomnia, headache, menstrual like cramps/squishy poop, fever (101.7 from forehead thermometer), swollen lymph node(s) under arm, one instance of dizziness (saw spots/ arms legs tingling), nausea, and started an unexpected 3rd menstrual period (see report from shot # 1) just 2 weeks after the last one.  Called doctor who said it should all pass.  As of today, everything seems fine except the swollen lymph node(s) under the arm are decreased but not yet gone.  We are not sure what will happen with the disruptions to the menstrual cycle.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Menstruation irregular, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Insomnia, headache, menstrual like cramps/squishy poop, fever (101.7 from forehead thermometer), swollen lymph node(s) under arm, one instance of dizziness (saw spots/ arms legs tingling), nausea, and started an unexpected 3rd menstrual period (see report from shot # 1) just 2 weeks after the last one.  Called doctor who said it should all pass.  As of today, everything seems fine except the swollen lymph node(s) under the arm are decreased but not yet gone.  We are not sure what will happen with the disruptions to the menstrual cycle.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Insomnia, headache, menstrual like cramps/squishy poop, fever (101.7 from forehead thermometer), swollen lymph node(s) under arm, one instance of dizziness (saw spots/ arms legs tingling), nausea, and started an unexpected 3rd menstrual period (see report from shot # 1) just 2 weeks after the last one.  Called doctor who said it should all pass.  As of today, everything seems fine except the swollen lymph node(s) under the arm are decreased but not yet gone.  We are not sure what will happen with the disruptions to the menstrual cycle.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient was FIRST immunized 2 days ago on 08/20/2021.  Wife called on 08/22/2021 and indicated that patient has 101.3 degree fever.  Advised wife to have husband get a COVID test and/or seek medical attention immediately. Counseled wife on possibility of recent exposure to actual COVID virus and the timing of effectiveness of vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Lip blister, Lip erythema, Lip pain, Lip swelling
Clinical narrative: blood blister; one has a crack in one of the bumps and they hurt; blister on her lip makes it hard for her to talk; 6 spots on her lip that are red; 6 spots on her lip that are raised; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (blood blister), LIP PAIN (one has a crack in one of the bumps and they hurt), LIP BLISTER (blister on her lip makes it hard for her to talk), LIP ERYTHEMA (6 spots on her lip that are red) and LIP SWELLING (6 spots on her lip that are raised) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MELATONIN for Sleep disorder.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced BLOOD BLISTER (blood blister), LIP PAIN (one has a crack in one of the bumps and they hurt), LIP BLISTER (blister on her lip makes it hard for her to talk), LIP ERYTHEMA (6 spots on her lip that are red) and LIP SWELLING (6 spots on her lip that are raised). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, BLOOD BLISTER (blood blister), LIP PAIN (one has a crack in one of the bumps and they hurt), LIP BLISTER (blister on her lip makes it hard for her to talk), LIP ERYTHEMA (6 spots on her lip that are red) and LIP SWELLING (6 spots on her lip that are raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs include: Bipolar Medication, Depression Medication, Bladder Medication, Anxiety Medication. Treatment  include: Gargle with water
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose two weeks after first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose two weeks after first dose) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02521A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose two weeks after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose two weeks after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  No treatment medication was provided
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.            No concomitant medication was reported.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-155013 (Patient Link).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: Missed 2nd dose on recommended interval.; Soreness of arm after first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on recommended interval.) and VACCINATION SITE PAIN (Soreness of arm after first dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on recommended interval.) and VACCINATION SITE PAIN (Soreness of arm after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on recommended interval.) had resolved and VACCINATION SITE PAIN (Soreness of arm after first dose) 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.   Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: No new information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Pain, Thyroxine
Clinical narrative: soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The patient's past medical history included Graves' disease. Concomitant products included THIAMAZOLE (METHIMAZOLE) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Blood thyroid stimulating hormone: 2.51 normal. In January 2021, Thyroxine: 1.37. On 12-May-2021, Blood thyroid stimulating hormone: 0.075 (Low) Patient said numbers were off and numbers were perfect last year and in January. On 12-May-2021, Thyroxine: 1.79 Patient reported numbers were off.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported to have done T3, T4 and TSH tests (since he was reported to have Graves' disease in the past medical history) on 12-MAY-2021 and reported that the numbers were off which were perfect last year and in January.   Patient also reported that the medication regimen had not been changed and the only difference was getting the vaccine.   No treatment medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: potential AE, Possible to receive the 2nd  dose of Moderna vaccine 35 days after receiving the 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (potential AE, Possible to receive the 2nd  dose of Moderna vaccine 35 days after receiving the 1st dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (potential AE, Possible to receive the 2nd  dose of Moderna vaccine 35 days after receiving the 1st dose). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (potential AE, Possible to receive the 2nd  dose of Moderna vaccine 35 days after receiving the 1st dose) 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.   Concomitants was not reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Dizziness, Nausea, Pain in extremity
Clinical narrative: arm pain that has radiated to her breast with pain; dizziness; chills; nausea; arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm pain), BREAST PAIN (arm pain that has radiated to her breast with pain), DIZZINESS (dizziness), CHILLS (chills) and NAUSEA (nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 20-May-2021, the patient experienced BREAST PAIN (arm pain that has radiated to her breast with pain), DIZZINESS (dizziness), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (arm pain), BREAST PAIN (arm pain that has radiated to her breast with pain), DIZZINESS (dizziness), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Fatigue, Fibromyalgia, Loss of personal independence in daily activities, Oral mucosal blistering
Clinical narrative: feeling like she got ran over by a steam truck; blisters in mouth; Sores in the mouth.; feels like bottom lip is split open; Flared up my fibromyalgia; unable to do anything; very tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feeling like she got ran over by a steam truck), ORAL MUCOSAL BLISTERING (blisters in mouth), STOMATITIS (Sores in the mouth.), CHAPPED LIPS (feels like bottom lip is split open) and FIBROMYALGIA (Flared up my fibromyalgia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced FEELING HOT (feeling like she got ran over by a steam truck), ORAL MUCOSAL BLISTERING (blisters in mouth), STOMATITIS (Sores in the mouth.), CHAPPED LIPS (feels like bottom lip is split open), FIBROMYALGIA (Flared up my fibromyalgia), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (feeling like she got ran over by a steam truck), ORAL MUCOSAL BLISTERING (blisters in mouth), STOMATITIS (Sores in the mouth.), CHAPPED LIPS (feels like bottom lip is split open), FIBROMYALGIA (Flared up my fibromyalgia), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything) and FATIGUE (very tired) outcome was unknown.            No concomitants were reported.   This case was linked to MOD-2021-154996 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Stomatitis
Clinical narrative: feeling like she got ran over by a steam truck; blisters in mouth; Sores in the mouth.; feels like bottom lip is split open; Flared up my fibromyalgia; unable to do anything; very tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feeling like she got ran over by a steam truck), ORAL MUCOSAL BLISTERING (blisters in mouth), STOMATITIS (Sores in the mouth.), CHAPPED LIPS (feels like bottom lip is split open) and FIBROMYALGIA (Flared up my fibromyalgia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced FEELING HOT (feeling like she got ran over by a steam truck), ORAL MUCOSAL BLISTERING (blisters in mouth), STOMATITIS (Sores in the mouth.), CHAPPED LIPS (feels like bottom lip is split open), FIBROMYALGIA (Flared up my fibromyalgia), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (feeling like she got ran over by a steam truck), ORAL MUCOSAL BLISTERING (blisters in mouth), STOMATITIS (Sores in the mouth.), CHAPPED LIPS (feels like bottom lip is split open), FIBROMYALGIA (Flared up my fibromyalgia), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything) and FATIGUE (very tired) outcome was unknown.            No concomitants were reported.   This case was linked to MOD-2021-154996 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Mucosal discolouration, Oropharyngeal pain
Clinical narrative: sore throat; white dots on the back of throat; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and MUCOSAL DISCOLORATION (white dots on the back of throat) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 041B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ESCITALOPRAM for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and MUCOSAL DISCOLORATION (white dots on the back of throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and MUCOSAL DISCOLORATION (white dots on the back of throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include escitalopram   Reporter did not allow further contact
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: alopecia; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (alopecia) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 2 dosage form. In March 2021, the patient experienced ALOPECIA (alopecia). At the time of the report, ALOPECIA (alopecia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications included. No Treatment included.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling unwell) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling unwell). At the time of the report, MALAISE (feeling unwell) outcome was unknown.            No medical history was provided by the reporter
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Another balding spot; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Another balding spot) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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. In April 2021, the patient experienced ALOPECIA (Another balding spot). At the time of the report, ALOPECIA (Another balding spot) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-155071 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not get the 2nd dose within the recommended time frame; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not get the 2nd dose within the recommended time frame) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not get the 2nd dose within the recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not get the 2nd dose within the recommended time frame) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter. No Treatment Medications were Provided  by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-155407 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155407:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Expired product administered, Fatigue, Pain in extremity
Clinical narrative: weakness; Sore arm; tiredness; vaccine from expired vial has been administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered), ASTHENIA (weakness), PAIN IN EXTREMITY (Sore arm) and FATIGUE (tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered). On an unknown date, the patient experienced ASTHENIA (weakness), PAIN IN EXTREMITY (Sore arm) and FATIGUE (tiredness). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered) had resolved. At the time of the report, ASTHENIA (weakness), PAIN IN EXTREMITY (Sore arm) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to US-MODERNATX, INC.-MOD-2021-155542, US-MODERNATX, INC.-MOD-2021-155523 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Patient demographics (gender and ethnicity) and additional events Sore arm, tiredness, weakness were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155542: US-MODERNATX, INC.-MOD-2021-155523:
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Paraesthesia oral
Clinical narrative: Cannot taste anything; Tingling tongue; This spontaneous case was reported by a patient and describes the occurrence of AGEUSIA (Cannot taste anything) and PARAESTHESIA ORAL (Tingling tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced AGEUSIA (Cannot taste anything) and PARAESTHESIA ORAL (Tingling tongue). At the time of the report, AGEUSIA (Cannot taste anything) and PARAESTHESIA ORAL (Tingling tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-155168 (Linked Report).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Patient said his right arm where he got the Moderna vaccine then started hurting; Fever; Worsening of pain on a different arm where non Moderna Vaccine (Flu vaccine) was received./ still experiencing pain on both arms.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient said his right arm where he got the Moderna vaccine then started hurting), PYREXIA (Fever) and MYALGIA (Worsening of pain on a different arm where non Moderna Vaccine (Flu vaccine) was received./ still experiencing pain on both arms.) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLUZONE [INFLUENZA VACCINE] (redness on injection site and pain in arm.) on 22-Oct-2020. Concomitant products included VALSARTAN and HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) for Blood pressure high, ACETYLSALICYLIC ACID (ASPIRIN 81), CLOPIDOGREL and ISOSORBIDE MONONITRATE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Feb-2020, the patient experienced MYALGIA (Worsening of pain on a different arm where non Moderna Vaccine (Flu vaccine) was received./ still experiencing pain on both arms.). On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Patient said his right arm where he got the Moderna vaccine then started hurting) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 325 mg twice a day. On 20-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Patient said his right arm where he got the Moderna vaccine then started hurting) and MYALGIA (Worsening of pain on a different arm where non Moderna Vaccine (Flu vaccine) was received./ still experiencing pain on both arms.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 100.8 (Inconclusive) fever of 100.8.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Treatment included cold gel pack.  Patient reported no adverse event with dose 1. Patient reported physician prescribed lidocaine patch and Tylenol but didn't took lidocaine.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red and was moving to the back of the arm; itching; more swollen; hurt and at night it hurt more and couldn't lie on that side; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 20-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red and was moving to the back of the arm), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (hurt and at night it hurt more and couldn't lie on that side) and VACCINATION SITE SWELLING (more swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE PAIN (hurt and at night it hurt more and couldn't lie on that side). On an unknown date, the patient experienced ERYTHEMA (red and was moving to the back of the arm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (more swollen). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 500 mg. At the time of the report, ERYTHEMA (red and was moving to the back of the arm), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (hurt and at night it hurt more and couldn't lie on that side) and VACCINATION SITE SWELLING (more swollen) outcome was unknown.            Action taken with mRNA-1273 in response to the events was  not applicable. Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up information received on 20-May-2021 and included no new information
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Inappropriate schedule of product administration, Migraine, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Reported receipt of second dose > Day 35; Sore Throat; Can't Smell; Runny nose; Small migraine; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), ANOSMIA (Can't Smell), RHINORRHOEA (Runny nose), MIGRAINE (Small migraine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Reported receipt of second dose > Day 35) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), ANOSMIA (Can't Smell), RHINORRHOEA (Runny nose) and MIGRAINE (Small migraine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Reported receipt of second dose > Day 35). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), ANOSMIA (Can't Smell), RHINORRHOEA (Runny nose), MIGRAINE (Small migraine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Reported receipt of second dose > Day 35) outcome was unknown.            No treatment and concomitant medications were reported.