chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Gait disturbance, Headache, Pain
Clinical narrative: HAD TO WALK SLOWER; FELT A WOW EFFECT WHEN TURNED HEAD; CHILLS; HEADACHE THAT PROGRESSIVELY GOT WORSE; LITTLE PAIN; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's past medical history included: sinus infections, and concurrent conditions included: vitiligo, indoor allergies, environmental allergies, alcohol non-user, and non smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the patient experienced little pain. On 09-APR-2021, the patient experienced chills. On 09-APR-2021, the patient experienced headache that progressively got worse. On 10-APR-2021, the patient experienced had to walk slower. On 10-APR-2021, the patient experienced felt a wow effect when turned head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little pain, and chills on 09-APR-2021, and had to walk slower, felt a wow effect when turned head, and headache that progressively got worse on 11-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING ON TIP OF NOSE, JAW, HANDS AND UPPER EXTREMITIES; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: acute asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the patient experienced tingling on tip of nose, jaw, hands and upper extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling on tip of nose, jaw, hands and upper extremities on JUN-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: PAINS; FEVER; This spontaneous report received from a parent via a company representative concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pains, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and pains. This report was non-serious. This report was associated with product quality complaint: 90000207282.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea
Clinical narrative: FEELING AWFUL; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced feeling awful, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling awful, headache and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: 3 DOSES ADMINISTERED TO PATIENTS AFTER USE BY TIME; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 11-APR-2022) dose was not reported, administered on 14-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-DEC-2021, the patient experienced 3 doses administered to subjects after use by time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 3 doses administered to patients after use by time was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: CHEST CONGESTION; SHORTNESS OF BREATH; CHILLS; FEVER; HEADACHE ON THE RIGHT SIDE OF THE HEAD; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry:14-DEC-2021) dose was not reported, administered on 14-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-DEC-2021, the patient experienced chest congestion. On 14-DEC-2021, the patient experienced shortness of breath. On 14-DEC-2021, the patient experienced chills. On 14-DEC-2021, the patient experienced fever. On 14-DEC-2021, the patient experienced headache on the right side of the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, chest congestion, shortness of breath, and headache on the right side of the head. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Asthenia, Body temperature, Diarrhoea, Dizziness
Clinical narrative: DID NOT HAVE MENSTRUAL CYCLE FOR A PERIOD OF 6 MONTHS; DIZZINESS; FEVER; DIARRHEA; SWOLLEN LYMPH NODES; WEAKNESS; EXTREME HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced did not have menstrual cycle for a period of 6 months, dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache, and the outcome of did not have menstrual cycle for a period of 6 months was not reported. This report was non-serious. This case, from the same reporter is linked to 20211236008.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pyrexia
Clinical narrative: DID NOT HAVE MENSTRUAL CYCLE FOR A PERIOD OF 6 MONTHS; DIZZINESS; FEVER; DIARRHEA; SWOLLEN LYMPH NODES; WEAKNESS; EXTREME HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced did not have menstrual cycle for a period of 6 months, dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, fever, diarrhea, swollen lymph nodes, weakness, and extreme headache, and the outcome of did not have menstrual cycle for a period of 6 months was not reported. This report was non-serious. This case, from the same reporter is linked to 20211236008.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
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 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: Bursitis; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Paralysis arm, Crying uncontrollable, Tremor, Limping, Foot drop, Hip dislocation and Leg discomfort. Concurrent medical conditions included Multiple sclerosis relapse. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced BURSITIS (Bursitis). At the time of the report, BURSITIS (Bursitis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Breathing issues; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Breathing issues) 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 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced DYSPNOEA (Breathing issues) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Breathing issues) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Cardiac Catherization was performed on 16 november 2021.  Company comment:  This spontaneous case concerns a patient of unknown age and gender, with unknown medical history, who experienced the serious (hospitalization) unexpected event of DYSPNOEA. The event occurred approximately 4 days after receiving a booster dose of mRNA-1273. No information about previous vaccination schedule was provided. The rechallenge is not applicable considering missing information on other vaccination doses. It is reported that patient went to cardiac catherization on the same date of occurrence of the event. No diagnosis or information about hospitalization course has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with unknown medical history, who experienced the serious (hospitalization) unexpected event of DYSPNOEA. The event occurred approximately 4 days after receiving a booster dose of mRNA-1273. No information about previous vaccination schedule was provided. The rechallenge is not applicable considering missing information on other vaccination doses. It is reported that patient went to cardiac catherization on the same date of occurrence of the event. No diagnosis or information about hospitalization course has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired doses). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 10-Nov-2021, the vial was initially stored in the refrigerator.  The vial did not undergone any temperature excursions.  The patient administered dose of vaccine after 30 day use by date or after manufacturer date of expiry.  No treatment medication was provided.   This case was linked to MOD-2021-413275, MOD-2021-411099, MOD-2021-413238 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Follow up received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: same night at around 9pm she had fever of 102 degrees F; vomiting; injection site there was goose egg on arm and it's red and warm to touch and painful if touched; injection site there was goose egg on arm and it's red and warm to touch and painful if touched; injection site there was goose egg on arm and it's red and warm to touch and painful if touched; injection site there was  goose egg on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site there was goose egg on arm and it's red and warm to touch and painful if touched), VACCINATION SITE MASS (injection site there was  goose egg on arm), PYREXIA (same night at around 9pm she had fever of 102 degrees F), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) in a female patient of an unknown age 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 December 2020.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced PYREXIA (same night at around 9pm she had fever of 102 degrees F) and VOMITING (vomiting). In January 2021, the patient experienced VACCINATION SITE WARMTH (injection site there was goose egg on arm and it's red and warm to touch and painful if touched), VACCINATION SITE MASS (injection site there was  goose egg on arm), VACCINATION SITE ERYTHEMA (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) and VACCINATION SITE PAIN (injection site there was goose egg on arm and it's red and warm to touch and painful if touched). At the time of the report, VACCINATION SITE WARMTH (injection site there was goose egg on arm and it's red and warm to touch and painful if touched), VACCINATION SITE MASS (injection site there was  goose egg on arm), PYREXIA (same night at around 9pm she had fever of 102 degrees F), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) and VACCINATION SITE PAIN (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102 (High) fever of 102 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  Patient had stated that whether she just take Benadryl for events.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: same night at around 9pm she had fever of 102 degrees F; vomiting; injection site there was goose egg on arm and it's red and warm to touch and painful if touched; injection site there was goose egg on arm and it's red and warm to touch and painful if touched; injection site there was goose egg on arm and it's red and warm to touch and painful if touched; injection site there was  goose egg on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site there was goose egg on arm and it's red and warm to touch and painful if touched), VACCINATION SITE MASS (injection site there was  goose egg on arm), PYREXIA (same night at around 9pm she had fever of 102 degrees F), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) in a female patient of an unknown age 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 December 2020.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced PYREXIA (same night at around 9pm she had fever of 102 degrees F) and VOMITING (vomiting). In January 2021, the patient experienced VACCINATION SITE WARMTH (injection site there was goose egg on arm and it's red and warm to touch and painful if touched), VACCINATION SITE MASS (injection site there was  goose egg on arm), VACCINATION SITE ERYTHEMA (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) and VACCINATION SITE PAIN (injection site there was goose egg on arm and it's red and warm to touch and painful if touched). At the time of the report, VACCINATION SITE WARMTH (injection site there was goose egg on arm and it's red and warm to touch and painful if touched), VACCINATION SITE MASS (injection site there was  goose egg on arm), PYREXIA (same night at around 9pm she had fever of 102 degrees F), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) and VACCINATION SITE PAIN (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102 (High) fever of 102 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  Patient had stated that whether she just take Benadryl for events.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Chills, Lymphadenopathy, Pyrexia, Reaction to preservatives
Clinical narrative: reporting it was due to the preservatives in the COVID 19 vaccine; swelling of lymph nodes under her arm pit; Fever 104, fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of REACTION TO PRESERVATIVES (reporting it was due to the preservatives in the COVID 19 vaccine), LYMPHADENOPATHY (swelling of lymph nodes under her arm pit), PYREXIA (Fever 104, fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose. On an unknown date, the patient experienced REACTION TO PRESERVATIVES (reporting it was due to the preservatives in the COVID 19 vaccine), LYMPHADENOPATHY (swelling of lymph nodes under her arm pit), PYREXIA (Fever 104, fever) and CHILLS (Chills). At the time of the report, REACTION TO PRESERVATIVES (reporting it was due to the preservatives in the COVID 19 vaccine) outcome was unknown and LYMPHADENOPATHY (swelling of lymph nodes under her arm pit), PYREXIA (Fever 104, fever) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) high.         No concomitant medications were reported. No treatment medications were reported. It was reported that patient had the symptoms happened with the 2nd and 3rd shots and it was due to the preservatives in the COVID-19 Vaccine. She also reports issues with the flu vaccine with preservatives,but has no issues with the flu vaccine if it does not have preservatives in it.   This case was linked to MOD-2021-412027 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects from the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (side effects from the booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects from the booster). At the time of the report, VACCINATION COMPLICATION (side effects from the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment  medication was provided.   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis perforated, Surgery
Clinical narrative: Approximately 2 months later, suffered a severely perforated appendix requiring emergency surgery and 5 days in the hospital
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Chest pain and shortness of breath overnight. Not able to sleep, anxious. Overall feeling that something is not right in my body. Following evening muscle aches, little pain at injection site. Sore throat and headache. Took benedryl at night hoping it would help me sleep. It did not. Also, having to use my inhaler a few times each day.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Oropharyngeal pain, Sleep disorder
Clinical narrative: Chest pain and shortness of breath overnight. Not able to sleep, anxious. Overall feeling that something is not right in my body. Following evening muscle aches, little pain at injection site. Sore throat and headache. Took benedryl at night hoping it would help me sleep. It did not. Also, having to use my inhaler a few times each day.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis reactive, C-reactive protein, Erythema, Feeling hot, Full blood count normal
Clinical narrative: 7-8 days after receiving second dose of covid vaccine, patient developed erythema, warmth, and edema to bilateral ankles as well as fever. Consistent with reactive arthritis.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pyrexia, Red blood cell sedimentation rate, X-ray limb normal
Clinical narrative: 7-8 days after receiving second dose of covid vaccine, patient developed erythema, warmth, and edema to bilateral ankles as well as fever. Consistent with reactive arthritis.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vestibular neuronitis
Clinical narrative: Vestibular neuritis
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Individual was not eligible for booster due to age.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual cycle irregularity
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Got booster dose in right arm around noon 12/15. On 12/16 under right arm (armpit) swelling started. Swelling is egg sized.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: THERE WAS NO ADVERSE REACTION AFTER THE ADMINISTERED SHOT.  ONLY REPORTING BECAUSE THE VACCINE PFIZER FOR AGES 5-11 YEARS OLD WAS ADMINISTERED ON A 12 YEARS OLD AT OUR COVID VACCINATION SCHOOL OUTREACH CAMPAIGN.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Diarrhoea, Dizziness, Lymphadenitis
Clinical narrative: Diarrhea,vomits, several body pain, fever over 40 degrees, limphatic nodules inflammation , nausea chills dizziness, cellulitis in the left arm
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Diarrhea,vomits, several body pain, fever over 40 degrees, limphatic nodules inflammation , nausea chills dizziness, cellulitis in the left arm
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt received pediatric dose of Pfizer (10mcg, 0.2mL) at age 12.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Mechanical urticaria
Clinical narrative: Dermatographia, Dysphagia; Treated with Prednisone, Loratadine, Famotidine.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I developed tinnitus two weeks after second Pfizer shot. Shot was in my lef arm and tinnitus was only in my lef ear.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Asthenopia, Back pain, Chest pain
Clinical narrative: Incredibly sore/painful muscles, very painful joints, chest pain, back pain, neck pain, head congestion, eye strain, severe fatigue, mildly impaired cognitive function, severe pain at injection site, random shooting pains through various parts of my torso (including ribs, groin and abdomen) and extremities.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Fatigue, Groin pain, Injection site pain, Musculoskeletal chest pain
Clinical narrative: Incredibly sore/painful muscles, very painful joints, chest pain, back pain, neck pain, head congestion, eye strain, severe fatigue, mildly impaired cognitive function, severe pain at injection site, random shooting pains through various parts of my torso (including ribs, groin and abdomen) and extremities.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain, Pain in extremity, Sinus congestion
Clinical narrative: Incredibly sore/painful muscles, very painful joints, chest pain, back pain, neck pain, head congestion, eye strain, severe fatigue, mildly impaired cognitive function, severe pain at injection site, random shooting pains through various parts of my torso (including ribs, groin and abdomen) and extremities.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Vaccine given by a different clinic Right clavicular lymphadenopathy, mild but with some pain
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Back pain, Blood pressure increased, Chest discomfort, Dyspnoea
Clinical narrative: 12:10 pm, blood pressure 142/86; pulse 80. At 10:36 pm, blood pressure 162/89; pulse 92. 12/15/2021, local pain at injection site spread and got worse as the day went on. Then in evening, I had severe back pain, which progressed to chest tightness and heartache like heart and lungs being squeezed (versus stabbing pain). I had shortness of breath. I had to breathe thru my mouth to get enough air. About 10:40 pm, I called a nurse, as well as, a friend. I took two Aspirin 325mg at 10:38 pm. My friend came over so I was not alone. At 11:30 pm, I went and spent the night at my friend's house so I would not be alone. I used heat compress to relieve back pain/spasms and tried to relax to lower blood pressure and be able to breathe better. 12/16/2021, I woke 10 am with minimal back pain (mid-back), but have had slight heart ache (like muscle soreness after working out) all day and into the night. Breathing has been a lot better today - more normal than what occurred last night. Did not call 911 or emergency room due to potential exposure to COVID-19 virus on top of having adverse reaction to vaccination. I figured if I could get my blood pressure down in a safe environment with someone nearby in case things progressed even more, that was the safest option given the current circumstances at hospitals. I called my cardiologist today (12/16/2021) and told earliest appointment availability is late January. I could not get in sooner to verify all ok.  Will go to urgent care tomorrow if still having heart ache/abnormal feeling.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Muscle spasms
Clinical narrative: 12:10 pm, blood pressure 142/86; pulse 80. At 10:36 pm, blood pressure 162/89; pulse 92. 12/15/2021, local pain at injection site spread and got worse as the day went on. Then in evening, I had severe back pain, which progressed to chest tightness and heartache like heart and lungs being squeezed (versus stabbing pain). I had shortness of breath. I had to breathe thru my mouth to get enough air. About 10:40 pm, I called a nurse, as well as, a friend. I took two Aspirin 325mg at 10:38 pm. My friend came over so I was not alone. At 11:30 pm, I went and spent the night at my friend's house so I would not be alone. I used heat compress to relieve back pain/spasms and tried to relax to lower blood pressure and be able to breathe better. 12/16/2021, I woke 10 am with minimal back pain (mid-back), but have had slight heart ache (like muscle soreness after working out) all day and into the night. Breathing has been a lot better today - more normal than what occurred last night. Did not call 911 or emergency room due to potential exposure to COVID-19 virus on top of having adverse reaction to vaccination. I figured if I could get my blood pressure down in a safe environment with someone nearby in case things progressed even more, that was the safest option given the current circumstances at hospitals. I called my cardiologist today (12/16/2021) and told earliest appointment availability is late January. I could not get in sooner to verify all ok.  Will go to urgent care tomorrow if still having heart ache/abnormal feeling.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt received Pediatric dose of Pfizer (10mcg, 0.2mL) at age 12.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Pruritus, Rash, Urticaria
Clinical narrative: Rashes and hives on the entire body. Lip and eye swelling. Very itchy all over.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Rash erythematous, Rash papular
Clinical narrative: ?Covid arm? bruised feeling, slightly itchy, 2 inch diameter red raised circular rash
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Menstrual disorder, Oligomenorrhoea
Clinical narrative: Long and erratic menstrual cycles for multiple months now. 2 yeast infections between the first 2 cycles after the vaccine. Yeast infection has not returned on 3rd or 4th. Prior to vaccine my birth control pill had almost eliminated my cycle and I only spotted 2 days if one appeared. My entire life my cycles lasted 4 days they are now over a week long 7 to 12 days.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Axillary pain, Chills, Fatigue
Clinical narrative: 12/13/21 mild pain at injection site (left arm), sensitive stomach  12/14/21 mild pain at injection site, moderate pain in left armpit, sensitive stomach, low energy/exhaustion, chills 12/15/21 severe pain in left armpit, swollen lymph nodes, low energy/exhaustion, mild headache 12/16/21 moderate pain in left armpit, swollen lymph nodes, mild headache, low energy/exhaustion,
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Lymphadenopathy
Clinical narrative: 12/13/21 mild pain at injection site (left arm), sensitive stomach  12/14/21 mild pain at injection site, moderate pain in left armpit, sensitive stomach, low energy/exhaustion, chills 12/15/21 severe pain in left armpit, swollen lymph nodes, low energy/exhaustion, mild headache 12/16/21 moderate pain in left armpit, swollen lymph nodes, mild headache, low energy/exhaustion,
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: Awoke at 9:00 AM the day after vaccination feeling fatigue, body aches, and general malaise. I went back to sleep and woke at 11:00 AM feeling the same way.  Attempted to get work done (I have a marketing job and work from home) but ?brain fog? meaning difficulty concentrating on tasks and feeling forgetful of things I intended to do was a prominent part of the experience, making my tasks take longer. There was also muscle pain in my left arm near the injection site that I felt whenever I moved my arm. All symptoms besides arm pain began to lessen between 4 and 5 PM, and I felt mostly improved until about 10 PM, when the fatigue and body aches returned along with chills. I took 400mg ibuprofen and this helped; symptoms abated about 2 hours later.  I feel mostly recovered now at 2:00 AM 12/17/21, with only a mildly sore arm still.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Memory impairment, Pain, Pain in extremity
Clinical narrative: Awoke at 9:00 AM the day after vaccination feeling fatigue, body aches, and general malaise. I went back to sleep and woke at 11:00 AM feeling the same way.  Attempted to get work done (I have a marketing job and work from home) but ?brain fog? meaning difficulty concentrating on tasks and feeling forgetful of things I intended to do was a prominent part of the experience, making my tasks take longer. There was also muscle pain in my left arm near the injection site that I felt whenever I moved my arm. All symptoms besides arm pain began to lessen between 4 and 5 PM, and I felt mostly improved until about 10 PM, when the fatigue and body aches returned along with chills. I took 400mg ibuprofen and this helped; symptoms abated about 2 hours later.  I feel mostly recovered now at 2:00 AM 12/17/21, with only a mildly sore arm still.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Palpitations, Pyrexia
Clinical narrative: Fever, nausea, fatigue. Persisted for 2 weeks. Heart palpitations
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Speech disorder
Clinical narrative: Sudden confusion, in the form I know what I want to say but it feels as if I suddenly forgotten how to articulate, I stumble on words.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Respiratory failure
Clinical narrative: Admitted for hypoxic respiratory failure from covid19 pneumonia, despite vaccination with J&J April 2021.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Pericarditis
Clinical narrative: Diagnosed with pericarditis after having chest pains
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Urticaria
Clinical narrative: Hives (urticaria) randomly appearing all over body, sometimes spontaneously but sometimes in reaction to skin pressure. Hives seem to recur mostly in the morning, in the evening, and in the middle of the night. Hives mostly appear on legs, trunk, armpits, neck, scalp. Other symptoms include itchy palms and flushing in and around the ears. Managing symptoms successfully with Benadryl or 24-hr Zyrtec, usually taken before bed, and hydrocortisone cream.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm has been hurting/Pain did not get worse, but did not stop; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm has been hurting/Pain did not get worse, but did not stop) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 097c21a and 025c21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included COLECALCIFEROL (VIT D3), ASPIRIN [ACETYLSALICYLIC ACID] and VITAMIN E NOS for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced PAIN IN EXTREMITY (Arm has been hurting/Pain did not get worse, but did not stop). At the time of the report, PAIN IN EXTREMITY (Arm has been hurting/Pain did not get worse, but did not stop) had not resolved.            Concomitant drugs reported included ingestion pill and blood pressure pill.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395864 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Event date added, Event Outcome updated - Not Recovered/Not Resolved
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: went to put his sock on, pain in leg/ ongoing leg pain in both legs/like body aches; Fever; Put his sock on today and that "triggered" him to call. Says he cannot really ride; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Put his sock on today and that "triggered" him to call. Says he cannot really ride), MYALGIA (went to put his sock on, pain in leg/ ongoing leg pain in both legs/like body aches) and PYREXIA (Fever) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Put his sock on today and that "triggered" him to call. Says he cannot really ride) and PYREXIA (Fever). On an unknown date, the patient experienced MYALGIA (went to put his sock on, pain in leg/ ongoing leg pain in both legs/like body aches). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Put his sock on today and that "triggered" him to call. Says he cannot really ride) and PYREXIA (Fever) outcome was unknown and MYALGIA (went to put his sock on, pain in leg/ ongoing leg pain in both legs/like body aches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.   This case was linked to MOD-2021-396693 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Nausea, Pain in extremity, Suspected COVID-19
Clinical narrative: Pain in the arm; Can not lift up the arm; feels like having covid-19 desease; Also feels nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), HYPOKINESIA (Can not lift up the arm), SUSPECTED COVID-19 (feels like having covid-19 desease) and NAUSEA (Also feels nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-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 PAIN IN EXTREMITY (Pain in the arm), HYPOKINESIA (Can not lift up the arm), SUSPECTED COVID-19 (feels like having covid-19 desease) and NAUSEA (Also feels nausea). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), HYPOKINESIA (Can not lift up the arm), SUSPECTED COVID-19 (feels like having covid-19 desease) and NAUSEA (Also feels nausea) outcome was unknown.            No concomitant medication was provided  No treatment medication was provided This is a Spontaneous case concerns of female patient of unknown age   with no medical history, who experienced the unexpected Nonserious event of   Pain in extremity and Hypokinesia, unexpected   AESI of   Suspected   COVID-19 without laboratory confirmation and expected nonserious event of   Nausea from unknown date after   third dose of vaccination with mRNA-1273. No additional information is available at the time of this report. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment. The benefit-risk relationship of mRNA-1273 in not affected by this report.   This case was linked to MOD-2021-403865 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2021: follow up received contains non significant information: Email added; Sender's Comments: This is a Spontaneous case concerns of female patient of unknown age   with no medical history, who experienced the unexpected Nonserious event of   Pain in extremity and Hypokinesia, unexpected   AESI of   Suspected   COVID-19 without laboratory confirmation and expected nonserious event of   Nausea from unknown date after   third dose of vaccination with mRNA-1273. No additional information is available at the time of this report. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment. The benefit-risk relationship of mRNA-1273 in not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On 30November2021 the patient tested positive for Cocid-19; Slight fever after second dose; Chills after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (On 30November2021 the patient tested positive for Cocid-19), PYREXIA (Slight fever after second dose) and CHILLS (Chills after the second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Slight fever after second dose) and CHILLS (Chills after the second dose). On 30-Nov-2021, the patient experienced SARS-COV-2 TEST POSITIVE (On 30November2021 the patient tested positive for Cocid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (On 30November2021 the patient tested positive for Cocid-19), PYREXIA (Slight fever after second dose) and CHILLS (Chills after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient.  Company Comment-This spontaneous case concerns of 67 years -old female patient with no relevant medical history reported who, experienced non- serious unexpected event of special interest (AESI)of COVID-19 test positive. The event occurred  8 months 18 days after the second dose of properly scheduled dose of mRNA-1273 vaccine . In addition to that symptoms of pyrexia and chills were reported after the of second dose of mRNA-1273 vaccination whose outcome is unknown. The rechallenge is not applicable, as the event happened only after the second dose. The benefit -risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns of 67 years -old female patient with no relevant medical history reported who, experienced non- serious unexpected event of special interest (AESI)of COVID-19 test positive. The event occurred  8 months 18 days after the second dose of properly scheduled dose of mRNA-1273 vaccine . In addition to that symptoms of pyrexia and chills were reported after the of second dose of mRNA-1273 vaccination whose outcome is unknown. The rechallenge is not applicable, as the event happened only after the second dose. The benefit -risk relationship of drug is not affected by this report.