chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cerebral artery embolism, Cognitive test, Computerised tomogram abnormal, Dyspnoea
Clinical narrative: HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; PAIN CONTINUES ALL OVER BODY; HIP PAIN; LEFT KNEE DISCOMFORT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sickle cell trait.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: Unknown) dose was not reported,1 total administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021(10 days later), the patient experienced left knee discomfort and hip pain, for which patient visited primary doctor, who referred him to an orthopedic. Orthopedic prescribed meloxicam; however, the patient took ibuprofen daily instead of it . On an unspecified date, the patient experienced pain all over body for which patient took oxycodone hydrochloride/paracetamol but discontinued due to constipation and for constipation patient took casanthranol/docusate sodium, then patient checked blood pressure and it was found 148/106 mmHg (high) so patient visited to emergency room where patient firstly checked for covid -19 test which was negative. For high blood pressure patient took amlodipine 10 mg daily. The patient took paracetamol for unknown indication.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain continues all over body, and the outcome of left knee discomfort, hip pain, shortness of breath and high blood pressure was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210532847-COVID-19 VACCINE AD26.COV2. S - High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Hypertension, Laboratory test, Magnetic resonance imaging abnormal, Muscular weakness
Clinical narrative: HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; PAIN CONTINUES ALL OVER BODY; HIP PAIN; LEFT KNEE DISCOMFORT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sickle cell trait.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: Unknown) dose was not reported,1 total administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021(10 days later), the patient experienced left knee discomfort and hip pain, for which patient visited primary doctor, who referred him to an orthopedic. Orthopedic prescribed meloxicam; however, the patient took ibuprofen daily instead of it . On an unspecified date, the patient experienced pain all over body for which patient took oxycodone hydrochloride/paracetamol but discontinued due to constipation and for constipation patient took casanthranol/docusate sodium, then patient checked blood pressure and it was found 148/106 mmHg (high) so patient visited to emergency room where patient firstly checked for covid -19 test which was negative. For high blood pressure patient took amlodipine 10 mg daily. The patient took paracetamol for unknown indication.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain continues all over body, and the outcome of left knee discomfort, hip pain, shortness of breath and high blood pressure was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210532847-COVID-19 VACCINE AD26.COV2. S - High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Pain, SARS-CoV-2 test negative, Sickle cell anaemia with crisis, Transient ischaemic attack
Clinical narrative: HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; PAIN CONTINUES ALL OVER BODY; HIP PAIN; LEFT KNEE DISCOMFORT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sickle cell trait.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: Unknown) dose was not reported,1 total administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021(10 days later), the patient experienced left knee discomfort and hip pain, for which patient visited primary doctor, who referred him to an orthopedic. Orthopedic prescribed meloxicam; however, the patient took ibuprofen daily instead of it . On an unspecified date, the patient experienced pain all over body for which patient took oxycodone hydrochloride/paracetamol but discontinued due to constipation and for constipation patient took casanthranol/docusate sodium, then patient checked blood pressure and it was found 148/106 mmHg (high) so patient visited to emergency room where patient firstly checked for covid -19 test which was negative. For high blood pressure patient took amlodipine 10 mg daily. The patient took paracetamol for unknown indication.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain continues all over body, and the outcome of left knee discomfort, hip pain, shortness of breath and high blood pressure was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210532847-COVID-19 VACCINE AD26.COV2. S - High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan, Urine analysis
Clinical narrative: HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; PAIN CONTINUES ALL OVER BODY; HIP PAIN; LEFT KNEE DISCOMFORT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sickle cell trait.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: Unknown) dose was not reported,1 total administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021(10 days later), the patient experienced left knee discomfort and hip pain, for which patient visited primary doctor, who referred him to an orthopedic. Orthopedic prescribed meloxicam; however, the patient took ibuprofen daily instead of it . On an unspecified date, the patient experienced pain all over body for which patient took oxycodone hydrochloride/paracetamol but discontinued due to constipation and for constipation patient took casanthranol/docusate sodium, then patient checked blood pressure and it was found 148/106 mmHg (high) so patient visited to emergency room where patient firstly checked for covid -19 test which was negative. For high blood pressure patient took amlodipine 10 mg daily. The patient took paracetamol for unknown indication.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain continues all over body, and the outcome of left knee discomfort, hip pain, shortness of breath and high blood pressure was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210532847-COVID-19 VACCINE AD26.COV2. S - High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: CHILLS; MUSCLE ACHES; NAUSEA; SORENESS AT INJECTION SITE; HEADACHES; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced chills. On 17-MAY-2021, the subject experienced muscle aches. On 17-MAY-2021, the subject experienced nausea. On 17-MAY-2021, the subject experienced soreness at injection site. On 17-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on 17-MAY-2021, was recovering from muscle aches, and soreness at injection site, and had not recovered from headaches. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain
Clinical narrative: TIREDNESS; NECK PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included right leg broken, and concurrent conditions included leg nerve ending pain, and right leg pain, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced neck pain. On 07-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on MAY-2021, and had not recovered from neck pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a consumer via a company representative concerned a 63 year old male, race and ethnicity unspecified. The patient's height, and weight were not reported. The patient's medical history was not reported. The patient was very healthy, athletic and a marathon runner.   The patient's mother died last year of an aneurysm.  The patient's dad is in his 80's is very healthy.   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) 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 subject developed pulmonary embolism causing death six days after receiving the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date.   This report was serious (Death).; Sender's Comments: V0: 20210533144-covid-19 vaccine ad26.cov2.s- This case concerns to a 63 year old male. Pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: PULMONARY EMBOLISM
Sex: U
Vaccine: COVID19
Symptoms: Rash, Tongue eruption
Clinical narrative: PIMPLES ON TONGUE; SKIN RASH ON BODY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 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 MAY-2021, the subject experienced pimples on tongue. On MAY-2021, the subject experienced skin rash on body. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pimples on tongue, and skin rash on body. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Headache, Heart rate, Heart rate increased
Clinical narrative: HIGH BLOOD PRESSURE; HIGH PULSE RATE; BODY ACHE; BACK ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 103/69, 102/68, and Pulse rate (NR: not provided) High. On 17-MAY-2021 14:00, the subject experienced high blood pressure. On 17-MAY-2021 14:00, the subject experienced high pulse rate. On 17-MAY-2021 14:00, the subject experienced body ache. On 17-MAY-2021 14:00, the subject experienced back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, high blood pressure, high pulse rate, fever, body ache, and back ache. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pain, Pyrexia
Clinical narrative: HIGH BLOOD PRESSURE; HIGH PULSE RATE; BODY ACHE; BACK ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 103/69, 102/68, and Pulse rate (NR: not provided) High. On 17-MAY-2021 14:00, the subject experienced high blood pressure. On 17-MAY-2021 14:00, the subject experienced high pulse rate. On 17-MAY-2021 14:00, the subject experienced body ache. On 17-MAY-2021 14:00, the subject experienced back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, high blood pressure, high pulse rate, fever, body ache, and back ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test
Clinical narrative: LOSS OF SMELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient's past medical history included covid-19. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced loss of smell. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive diagnosis of Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss of smell was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN ON RIGHT CALF; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced pain on right calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on right calf. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vomiting
Clinical narrative: THREW UP TWICE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced threw up twice, and fever.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and threw up twice was not reported. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia, Vaginal haemorrhage
Clinical narrative: BODY PAIN; HEART PALPITATIONS; VAGINAL BLEEDING; FEVER; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and was not taking any medications. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 27A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced body pain. On 15-MAY-2021, the subject experienced heart palpitations. On 15-MAY-2021, the subject experienced vaginal bleeding. On 15-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, body pain, heart palpitations, and vaginal bleeding. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM WAS SORE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAY-2021, the subject experienced arm was sore. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from arm was sore. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: ERRONEOUSLY ADMINISTERED 1ML DOSE; This spontaneous report received from a health care professional concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included 4 months postpartum. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced erroneously administered 1ml dose. The action taken with covid-19 vaccine  was not applicable. The outcome of erroneously administered 1ml dose was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Blood blister, Nausea
Clinical narrative: BLOOD BLISTER IN THE TOP OF THE RIGHT ARM AND CLOSE TO ELBOW (LOOKED LIKE A SMALL SEA HORSE OF SIZE 1 INCH X 1 INCH AND QUARTER, MIGHT BE LONGER); QUEASY STOMACH; STOMACH UPSET; PAIN IN THE STOMACH; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included elevated blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for to prevent headache. On 13-MAR-2021, the subject experienced stomach upset. On 13-MAR-2021, the subject experienced pain in the stomach. On 13-MAR-2021, the subject experienced queasy stomach. On 14-MAR-2021, the subject experienced blood blister in the top of the right arm and close to elbow (looked like a small sea horse of size 1 inch x 1 inch and quarter, might be longer). The action taken with covid-19 vaccine  was not applicable. The patient recovered from stomach upset, pain in the stomach, and queasy stomach on 14-MAR-2021, and blood blister in the top of the right arm and close to elbow (looked like a small sea horse of size 1 inch x 1 inch and quarter, might be longer) on 01-MAY-2021. This report was non-serious.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: TIREDNESS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 54 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAY-2021, the subject experienced tiredness. On 16-MAY-2021, the subject experienced fatigue. On 16-MAY-2021, the subject experienced headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine  was not applicable. The patient recovered from headache on MAY-2021, and had not recovered from tiredness, and fatigue. This report was non-serious. This case, from the same reporter is linked to 20210535066.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Insomnia, Pain in extremity
Clinical narrative: TROUBLE SLEEPING; SORE BACK; CHILLS; SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) 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 subject experienced trouble sleeping, sore back, chills, and sore arm. The action taken with covid-19 vaccine  was not applicable. The outcome of the sore arm, chills, trouble sleeping and sore back was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Tremor
Clinical narrative: SEVERE SHAKING; 102 F FEVER; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not on birth control.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced severe shaking. On 17-MAY-2021, the subject experienced 102 f fever. On 17-MAY-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from severe shaking on 18-MAY-2021, and had not recovered from 102 f fever, and severe headache. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm on 05-MAY-2021. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: ERRONEOUSLY ADMINISTERED 1 ML DOSE; This spontaneous report received from a health care professional concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced erroneously administered 1 ml dose. The action taken with covid-19 vaccine  was not applicable. The outcome of erroneously administered 1 ml dose was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotonia, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: SLIGHTLY HOT TO TOUCH AT INJECTION SITE; DELTOID MUSCLE TONE LOSS; SWELLING BELOW INJECTION SITE; PAIN AT THE INJECTION SITE, PAIN IN BELLY OF LEFT DELTOID, LEFT DELTOID PAIN AT THE TIME OF INJECTION; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vascular necrosis of the hip, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced pain at the injection site, pain in belly of left deltoid, left deltoid pain at the time of injection. On an unspecified date, the subject experienced slightly hot to touch at injection site, deltoid muscle tone loss, and swelling below injection site. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain at the injection site, pain in belly of left deltoid, left deltoid pain at the time of injection, slightly hot to touch at injection site, deltoid muscle tone loss, and swelling below injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Eye swelling, Fatigue, Nausea
Clinical narrative: LEFT EYE SORENESS ON THE OUTER PART AROUND THE EYE AND SPREADING TO THE INSIDE; LEFT EYE SWELLING ON THE OUTER PART AROUND THE EYE AND SPREADING TO THE INSIDE; ACHES; CHILLS; FEVER; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced aches. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced nausea. On 07-MAY-2021, the subject experienced fatigue. On 08-MAY-2021, the subject experienced left eye soreness on the outer part around the eye and spreading to the inside. On 08-MAY-2021, the subject experienced left eye swelling on the outer part around the eye and spreading to the inside.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from aches, chills, fever, and nausea on 08-MAY-2021, was recovering from fatigue, and had not recovered from left eye soreness on the outer part around the eye and spreading to the inside, and left eye swelling on the outer part around the eye" and spreading to the inside. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: LEFT EYE SORENESS ON THE OUTER PART AROUND THE EYE AND SPREADING TO THE INSIDE; LEFT EYE SWELLING ON THE OUTER PART AROUND THE EYE AND SPREADING TO THE INSIDE; ACHES; CHILLS; FEVER; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced aches. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced nausea. On 07-MAY-2021, the subject experienced fatigue. On 08-MAY-2021, the subject experienced left eye soreness on the outer part around the eye and spreading to the inside. On 08-MAY-2021, the subject experienced left eye swelling on the outer part around the eye and spreading to the inside.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from aches, chills, fever, and nausea on 08-MAY-2021, was recovering from fatigue, and had not recovered from left eye soreness on the outer part around the eye and spreading to the inside, and left eye swelling on the outer part around the eye" and spreading to the inside. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: EXTREME PAIN IN RIGHT LEG; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced extreme pain in right leg. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Not reported. The action taken with covid-19 vaccine  was not applicable. The outcome of extreme pain in right leg was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: ARM PAIN; SHOULDER PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced shoulder pain. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from arm pain, and shoulder pain. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Paraesthesia
Clinical narrative: NUMBNESS AND TINGLING OF HANDS  AND LIPS; MUSCLE TWITCHING (ALL OVER BODY); This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1868609, and batch number: 1868609 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced muscle twitching (all over body). On 21-APR-2021, the subject experienced numbness and tingling of hands and lips. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from muscle twitching (all over body), and numbness and tingling of hands and lips. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: DRY LIPS; BURNING ON THE ROOF OF MOUTH; RUNNY NOSE; COUGH; SHORTNESS OF BREATH; DIZZINESS; KNEE PAIN; JOINT PAIN; FATIGUE; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included metal plate in ankle, and concurrent conditions included arthritis, pcos, penicillin allergy, and peanut/peanuts/garlic/tomatoes/walnuts/almonds allergy, and other pre-existing medical conditions included patient confirms she is allergic to almond. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced dry lips. On 14-MAY-2021, the subject experienced burning on the roof of mouth. On 14-MAY-2021, the subject experienced runny nose. On 14-MAY-2021, the subject experienced cough. On 14-MAY-2021, the subject experienced shortness of breath. On 14-MAY-2021, the subject experienced dizziness. On 14-MAY-2021, the subject experienced knee pain. On 14-MAY-2021, the subject experienced joint pain. On 14-MAY-2021, the subject experienced fatigue. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from runny nose, cough, shortness of breath, and dizziness on MAY-2021, was recovering from headache, and had not recovered from fatigue, nausea, dry lips, burning on the roof of mouth, knee pain, and joint pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip dry, Nausea, Oral discomfort, Rhinorrhoea
Clinical narrative: DRY LIPS; BURNING ON THE ROOF OF MOUTH; RUNNY NOSE; COUGH; SHORTNESS OF BREATH; DIZZINESS; KNEE PAIN; JOINT PAIN; FATIGUE; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included metal plate in ankle, and concurrent conditions included arthritis, pcos, penicillin allergy, and peanut/peanuts/garlic/tomatoes/walnuts/almonds allergy, and other pre-existing medical conditions included patient confirms she is allergic to almond. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced dry lips. On 14-MAY-2021, the subject experienced burning on the roof of mouth. On 14-MAY-2021, the subject experienced runny nose. On 14-MAY-2021, the subject experienced cough. On 14-MAY-2021, the subject experienced shortness of breath. On 14-MAY-2021, the subject experienced dizziness. On 14-MAY-2021, the subject experienced knee pain. On 14-MAY-2021, the subject experienced joint pain. On 14-MAY-2021, the subject experienced fatigue. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from runny nose, cough, shortness of breath, and dizziness on MAY-2021, was recovering from headache, and had not recovered from fatigue, nausea, dry lips, burning on the roof of mouth, knee pain, and joint pain. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: FROZEN (-1.7F TO 2F) AND THAWED VACCINE WAS GIVEN TO PATIENT; This spontaneous report received from a pharmacist concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced frozen (-1.7f to 2f) and thawed vaccine was given to subject. The action taken with covid-19 vaccine  was not applicable. The outcome of frozen (-1.7f to 2f) and thawed vaccine was given to patient was not reported. This report was non-serious. This case, from the same reporter is linked to 20210535717, 20210534639, 20210536001 and 20210536595.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: VACCINE HAD EXCEEDED THE 6 HOUR PERIOD AT REFRIGERATION BEFORE ADMINISTRATION (BEYOND SPECIFIED TEMPERATURE RANGE); VACCINE STORED BEYOND SPECIFIED TEMPERATURE RANGE (EXCEEDED THE 6 HOUR PERIOD AT REFRIGERATION); This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced vaccine stored beyond specified temperature range (exceeded the 6 hour period at refrigeration). On 18-MAY-2021, the subject experienced vaccine had exceeded the 6 hour period at refrigeration before administration (beyond specified temperature range). The action taken with covid-19 vaccine  was not applicable. The outcome of the vaccine had exceeded the 6 hour period at refrigeration before administration (beyond specified temperature range) and vaccine stored beyond specified temperature range (exceeded the 6 hour period at refrigeration) was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hypoaesthesia, Limb discomfort, Pain, Pyrexia
Clinical narrative: NUMBNESS IN THE RIGHT ARM; HEAVY RIGHT ARM; FEVER; BODY ACHES; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23/JUN/2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced body aches. On 16-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4. On 18-MAY-2021, the subject experienced numbness in the right arm. On 18-MAY-2021, the subject experienced heavy right arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fever on 17-MAY-2021, and had not recovered from body aches, numbness in the right arm, and heavy right arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a physician concerned a 12 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) 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 subject experienced product administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malignant melanoma, Pyrexia, Rash
Clinical narrative: melanoma; Fever under 100 degrees; very mild fatigue; Rash extending down left arm; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of MALIGNANT MELANOMA (melanoma) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's disease on 01-Jan-1961. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Allergy to antibiotic (Allergic to Levaquin, erthromyicin). Concomitant products included LEVOTHYROXINE and LIOTHYRONINE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced RASH (Rash). On 09-Feb-2021, the patient experienced RASH (Rash extending down left arm). On 10-Feb-2021, the patient experienced PYREXIA (Fever under 100 degrees) and FATIGUE (very mild fatigue). On 01-Mar-2021, the patient experienced MALIGNANT MELANOMA (melanoma) (seriousness criterion medically significant). On 09-Feb-2021, RASH (Rash extending down left arm) had resolved. On 10-Feb-2021, PYREXIA (Fever under 100 degrees) and FATIGUE (very mild fatigue) had resolved. At the time of the report, MALIGNANT MELANOMA (melanoma) outcome was unknown and RASH (Rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100 (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included diphenhydramine and famotidine prophylactically.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-09215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: case upgraded to serious from  NS; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-09215:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Oxygen saturation decreased
Clinical narrative: More breathing problems than normal/gasping; Oxygen level down to 80 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (More breathing problems than normal/gasping) and OXYGEN SATURATION DECREASED (Oxygen level down to 80 after 1st dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021 and Liver transplant. Concurrent medical conditions included COPD and Emphysema.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced DYSPNOEA (More breathing problems than normal/gasping) (seriousness criterion hospitalization) and OXYGEN SATURATION DECREASED (Oxygen level down to 80 after 1st dose) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (More breathing problems than normal/gasping) and OXYGEN SATURATION DECREASED (Oxygen level down to 80 after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment included oxygen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of COPD and COVID-19 infection are confounders; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of COPD and COVID-19 infection are confounders