chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: 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 bruise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruise was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Myalgia, Sciatica
Clinical narrative: TERRIBLE NERVE ISSUES; BRUISES ALL OVER MY LEGS AND ARMS; PAIN ALL OVER MY LEGS AND ARMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced terrible nerve issues. On MAR-2021, the subject experienced bruises all over my legs and arms. On MAR-2021, the subject experienced pain all over my legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible nerve issues, pain all over my legs and arms and bruises all over my legs and arms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: DIZZINESS; STOMACH PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUL-2021, the subject experienced dizziness. On 23-JUL-2021, the subject experienced stomach pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and stomach pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: 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 12-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: WORST FEVER EVER; This spontaneous report received from a consumer via a company representative 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 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 worst fever ever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worst fever ever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 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 chills, and fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Feeling cold, Injection site pain, Pyrexia
Clinical narrative: HEAVY; FELT REALLY COLD; FEVER; GENERALLY TIRED; SLIGHT PAIN IN THE INJECTION SITE; This spontaneous report received from a consumer 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 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 heavy, felt really cold, fever, generally tired, and slight pain in the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy, felt really cold, fever, and generally tired, and had not recovered from slight pain in the injection site. This report was non-serious. This case, from the same reporter is linked to 20210755580.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EFFECT FROM VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: 043A214, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced adverse effect from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse effect from vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dermatitis allergic
Clinical narrative: SKIN ALLERGIES; This spontaneous report received from a patient via a representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on APR-2021 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 skin allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin allergies was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HIGHER FEVER ALL NIGHT; This spontaneous report received from a consumer 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 not reported, batch number: Unk) 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 higher fever all night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of higher fever all night was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Dyspnoea, Headache, Heart rate
Clinical narrative: TROUBLE BREATHING; A RASH ALONG THE THIGHS LIKE SMALL SPOTS ON THE INNER THIGHS THE SIZE OF HALF DOLLAR WHEN IT FIRST STARTED IT SPREAD DOWN TO CALF TO STOMACH AND TORSO AND UP TO CHEST; NAUSEA; HEADACHE; FEVER SPIKED TO 102 F; BODY ACHES; HEART RATE WENT UP; This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known drug allergies and patient had no underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 02-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 02-MAY-2021, the subject experienced body aches. On 02-MAY-2021, the subject experienced heart rate went up. On 02-MAY-2021, the subject experienced a rash along the thighs like small spots on the inner thighs the size of half dollar when it first started it spread down to calf to stomach and torso and up to chest. On 02-MAY-2021, the subject experienced nausea. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fever spiked to 102 f. Laboratory data included: Heart rate (NR: not provided) from 115, 120 to125. On 03-MAY-2021, the subject experienced trouble breathing. Laboratory data included: Body temperature (NR: not provided) 102 F, Below 100 F, and Laboratory test (NR: not provided) unknown. On 04-MAY-2021, treatment medications included: salbutamol. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Unknown, and Laboratory test (NR: not provided) Unknown. Additional treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a rash along the thighs like small spots on the inner thighs the size of half dollar when it first started it spread down to calf to stomach and torso and up to chest, and fever spiked to 102 f on JUL-2021, and the outcome of nausea, heart rate went up, trouble breathing, headache and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210755447.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Laboratory test, Nausea, Pain, Pyrexia
Clinical narrative: TROUBLE BREATHING; A RASH ALONG THE THIGHS LIKE SMALL SPOTS ON THE INNER THIGHS THE SIZE OF HALF DOLLAR WHEN IT FIRST STARTED IT SPREAD DOWN TO CALF TO STOMACH AND TORSO AND UP TO CHEST; NAUSEA; HEADACHE; FEVER SPIKED TO 102 F; BODY ACHES; HEART RATE WENT UP; This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known drug allergies and patient had no underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 02-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 02-MAY-2021, the subject experienced body aches. On 02-MAY-2021, the subject experienced heart rate went up. On 02-MAY-2021, the subject experienced a rash along the thighs like small spots on the inner thighs the size of half dollar when it first started it spread down to calf to stomach and torso and up to chest. On 02-MAY-2021, the subject experienced nausea. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fever spiked to 102 f. Laboratory data included: Heart rate (NR: not provided) from 115, 120 to125. On 03-MAY-2021, the subject experienced trouble breathing. Laboratory data included: Body temperature (NR: not provided) 102 F, Below 100 F, and Laboratory test (NR: not provided) unknown. On 04-MAY-2021, treatment medications included: salbutamol. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Unknown, and Laboratory test (NR: not provided) Unknown. Additional treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a rash along the thighs like small spots on the inner thighs the size of half dollar when it first started it spread down to calf to stomach and torso and up to chest, and fever spiked to 102 f on JUL-2021, and the outcome of nausea, heart rate went up, trouble breathing, headache and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210755447.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: TROUBLE BREATHING; A RASH ALONG THE THIGHS LIKE SMALL SPOTS ON THE INNER THIGHS THE SIZE OF HALF DOLLAR WHEN IT FIRST STARTED IT SPREAD DOWN TO CALF TO STOMACH AND TORSO AND UP TO CHEST; NAUSEA; HEADACHE; FEVER SPIKED TO 102 F; BODY ACHES; HEART RATE WENT UP; This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known drug allergies and patient had no underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 02-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 02-MAY-2021, the subject experienced body aches. On 02-MAY-2021, the subject experienced heart rate went up. On 02-MAY-2021, the subject experienced a rash along the thighs like small spots on the inner thighs the size of half dollar when it first started it spread down to calf to stomach and torso and up to chest. On 02-MAY-2021, the subject experienced nausea. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fever spiked to 102 f. Laboratory data included: Heart rate (NR: not provided) from 115, 120 to125. On 03-MAY-2021, the subject experienced trouble breathing. Laboratory data included: Body temperature (NR: not provided) 102 F, Below 100 F, and Laboratory test (NR: not provided) unknown. On 04-MAY-2021, treatment medications included: salbutamol. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Unknown, and Laboratory test (NR: not provided) Unknown. Additional treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a rash along the thighs like small spots on the inner thighs the size of half dollar when it first started it spread down to calf to stomach and torso and up to chest, and fever spiked to 102 f on JUL-2021, and the outcome of nausea, heart rate went up, trouble breathing, headache and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210755447.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: BURNING IMMEDIATELY DURING VACCINE ADMINISTRATION; PAIN IMMEDIATELY DURING VACCINE ADMINISTRATION; This spontaneous report received from a pharmacist 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: Unknown) 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 burning immediately during vaccine administration, and pain immediately during vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning immediately during vaccine administration and pain immediately during vaccine administration was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain
Clinical narrative: DIZZINESS; BODY ACHES; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-MAY-2021, the subject experienced dizziness. On 02-MAY-2021, the subject experienced body aches. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 02-MAY-2021, and body aches, headache, and tiredness on 03-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210755420.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Malaise, Muscular weakness
Clinical narrative: NUMBNESS IN LEFT ARM; WEAKNESS IN LEFT ARM; NOT FEELING WELL; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced numbness in left arm. On JUL-2021, the subject experienced weakness in left arm. On JUL-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness in left arm, and numbness in left arm, and the outcome of not feeling well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder
Clinical narrative: HEALTH PROBLEMS; 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 not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced health problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of health problems was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: ACHES; FEVER; FATIGUE; HEADACHES; 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 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 an unspecified date, the subject experienced aches, fever, fatigue, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue, aches and headaches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia, SARS-CoV-2 test, Upper respiratory tract infection
Clinical narrative: SYMPTOMS OF UPPER RESPIRATORY INFECTION (COLD SYMPTOMS); TINGLING TO BACK WHICH SPREAD TO BOTH ARMS, HANDS AND LEGS; MILD HEADACHE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, non-smoker, and iodine allergy, and other pre-existing medical conditions included the patient had no past medical history, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) No results, and SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. On 16-JUL-2021, the subject experienced mild headache. On 22-JUL-2021, the subject experienced tingling to back which spread to both arms, hands and legs. On 24-JUL-2021, the subject experienced symptoms of upper respiratory infection (cold symptoms). Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) No results, and SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling to back which spread to both arms, hands and legs, and mild headache, and the outcome of symptoms of upper respiratory infection (cold symptoms) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: LEG SWELLING ON SAME SIDE OF BODY WHERE INJECTED WITH VACCINE; 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: Unknown) 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 leg swelling on same side of body where injected with vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg swelling on same side of body where injected with vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fibromyalgia, Injection site pain, Tension headache
Clinical narrative: FIBROMYALGIA LIKE FLARE UP FROM  HEAD TO TOES TO FINGERS; TENSION HEADACHE; PAIN IN THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 23-JUL-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 23-JUL-2021, the subject experienced fibromyalgia like flare up from head to toes to fingers. On 23-JUL-2021, the subject experienced tension headache. On 23-JUL-2021, the subject experienced pain in the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fibromyalgia like flare up from head to toes to fingers, tension headache, and pain in the injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Feeling cold, Injection site pain, Pyrexia
Clinical narrative: GENERALLY HEAVY; FEELING COLD; 14-HR FEVER AFTER 3 HRS; GENERALLY TIRED; SLIGHT PAIN IN THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) 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 generally heavy, feeling cold, 14-hr fever after 3 hrs, generally tired, and slight pain in the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generally heavy, feeling cold, 14-hr fever after 3 hrs, and generally tired, and had not recovered from slight pain in the injection site. This report was non-serious. This case, from the same reporter is linked to 20210755198.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: FELT VERY DIZZY; ARM WAS IN SO MUCH PAIN; FELT NAUSEOUS ALL DAY; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) 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 felt very dizzy, arm was in so much pain, felt nauseous all day, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm was in so much pain, felt very dizzy, felt nauseous all day and mild fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: LINGERING SYMPTOMS WERE REDUCED AND HAD IMPROVEMENT TO GUILLAIN-BARRE SYNDROME SYMPTOMS AFTER RECEIVED VACCINE; This spontaneous report received from a patient via a representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included fevers, multiple tumors, muscle aches, bronchitis, pink eye, ill with virus, neuromuscular symptoms, and tumor removed, and concurrent conditions included guillain-barre syndrome, symptoms from chest up, and blood pressure also went out of control, and other pre-existing medical conditions included the patient had lingering symptoms. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced lingering symptoms were reduced and had improvement to guillain-barre syndrome symptoms after received vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lingering symptoms were reduced and had improvement to guillain-barre syndrome symptoms after received vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Suspected COVID-19
Clinical narrative: SICK; COVID-19 SYMPTOMS (NAUSEA ,COUGHING, FATIGUE, COULD NOT FEEL TASTE OR COULD NOT SMELL); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 30-JUN-2021 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 JUL-2021, the subject experienced sick. On JUL-2021, the subject experienced covid-19 symptoms (nausea, coughing, fatigue, could not feel taste or could not smell). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, and had not recovered from covid-19 symptoms (nausea, coughing, fatigue, could not feel taste or could not smell). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: BODY MALAISE; SORENESS AT INJECTION SITE; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) 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 23-JUL-2021, the subject experienced fever. Treatment medications included: paracetamol. On an unspecified date, the subject experienced body malaise, soreness at injection site, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 25-JUL-2021, and nausea, and headache, was recovering from body malaise, and had not recovered from soreness at injection site. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Diarrhoea, Dysphagia, Headache
Clinical narrative: Difficulty swallowing; no energy for about 4 days; Diarrhea; Headache; Anaphylactic reaction; Hypersensitivity reaction; Got vaccine during during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever, Hives and Urticaria. Concurrent medical conditions included Asthma since 06-Feb-1996, Hypersensitivity reaction, Mite allergy, Allergy to molds (allergic to molds and mildew), Allergy to animal dander, Environmental allergy and Allergy since 06-Feb-1962.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during during pregnancy). On 03-Mar-2021 at 6:00 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant) and HYPERSENSITIVITY (Hypersensitivity reaction). On 04-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). On an unknown date, the patient experienced DYSPHAGIA (Difficulty swallowing) and ASTHENIA (no energy for about 4 days). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) on 03-Mar-2021 for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021 at 11:30 PM, ANAPHYLACTIC REACTION (Anaphylactic reaction) and HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, DIARRHOEA (Diarrhea), DYSPHAGIA (Difficulty swallowing), ASTHENIA (no energy for about 4 days), MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during during pregnancy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient may be allergic to polyethol glycol.  No relevant concomitant medications were reported.  Based on current available information and the temporal association between product sue and the start date  of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Additional information received on 21-JUL-2021 contains vaccination facility, new events and medical history. Outcome and causality of the event updated.; Sender's Comments: Based on current available information and the temporal association between product sue and the start date  of the events a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Maternal exposure during pregnancy
Clinical narrative: Difficulty swallowing; no energy for about 4 days; Diarrhea; Headache; Anaphylactic reaction; Hypersensitivity reaction; Got vaccine during during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever, Hives and Urticaria. Concurrent medical conditions included Asthma since 06-Feb-1996, Hypersensitivity reaction, Mite allergy, Allergy to molds (allergic to molds and mildew), Allergy to animal dander, Environmental allergy and Allergy since 06-Feb-1962.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during during pregnancy). On 03-Mar-2021 at 6:00 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant) and HYPERSENSITIVITY (Hypersensitivity reaction). On 04-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). On an unknown date, the patient experienced DYSPHAGIA (Difficulty swallowing) and ASTHENIA (no energy for about 4 days). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) on 03-Mar-2021 for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021 at 11:30 PM, ANAPHYLACTIC REACTION (Anaphylactic reaction) and HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, DIARRHOEA (Diarrhea), DYSPHAGIA (Difficulty swallowing), ASTHENIA (no energy for about 4 days), MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during during pregnancy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient may be allergic to polyethol glycol.  No relevant concomitant medications were reported.  Based on current available information and the temporal association between product sue and the start date  of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Additional information received on 21-JUL-2021 contains vaccination facility, new events and medical history. Outcome and causality of the event updated.; Sender's Comments: Based on current available information and the temporal association between product sue and the start date  of the events a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Constipation, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: pneumonia was hospitalized for 3 days,; we can NOT get the 2nd shot; constipation; Diarrhea; difficulty breathing; Chills; fatigue (slept for 5 days); Pain everywhere; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia was hospitalized for 3 days,) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia was hospitalized for 3 days,) (seriousness criteria hospitalization and medically significant), PRODUCT DOSE OMISSION ISSUE (we can NOT get the 2nd shot), CONSTIPATION (constipation), DIARRHOEA (Diarrhea), DYSPNOEA (difficulty breathing), CHILLS (Chills), FATIGUE (fatigue (slept for 5 days)) and MYALGIA (Pain everywhere). The patient was treated with LEVOFLOXACIN for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, PNEUMONIA (pneumonia was hospitalized for 3 days,), PRODUCT DOSE OMISSION ISSUE (we can NOT get the 2nd shot), CONSTIPATION (constipation), DIARRHOEA (Diarrhea), DYSPNOEA (difficulty breathing), CHILLS (Chills), FATIGUE (fatigue (slept for 5 days)) and MYALGIA (Pain everywhere) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not provided  Patient underwent treatment medication of levofloxacin, ibuprofen and 5 others in hospital.  Patient and her husband were told by Moderna, the state and the local health department that they could not get the 2nd shot and they could not start over.  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. This report also refers to a case of missed dose.   This case was linked to MOD-2021-080331 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up received- Event-missed dose added.; 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. This report also refers to a case of missed dose.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pneumonia, Product dose omission issue
Clinical narrative: pneumonia was hospitalized for 3 days,; we can NOT get the 2nd shot; constipation; Diarrhea; difficulty breathing; Chills; fatigue (slept for 5 days); Pain everywhere; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia was hospitalized for 3 days,) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia was hospitalized for 3 days,) (seriousness criteria hospitalization and medically significant), PRODUCT DOSE OMISSION ISSUE (we can NOT get the 2nd shot), CONSTIPATION (constipation), DIARRHOEA (Diarrhea), DYSPNOEA (difficulty breathing), CHILLS (Chills), FATIGUE (fatigue (slept for 5 days)) and MYALGIA (Pain everywhere). The patient was treated with LEVOFLOXACIN for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, PNEUMONIA (pneumonia was hospitalized for 3 days,), PRODUCT DOSE OMISSION ISSUE (we can NOT get the 2nd shot), CONSTIPATION (constipation), DIARRHOEA (Diarrhea), DYSPNOEA (difficulty breathing), CHILLS (Chills), FATIGUE (fatigue (slept for 5 days)) and MYALGIA (Pain everywhere) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not provided  Patient underwent treatment medication of levofloxacin, ibuprofen and 5 others in hospital.  Patient and her husband were told by Moderna, the state and the local health department that they could not get the 2nd shot and they could not start over.  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. This report also refers to a case of missed dose.   This case was linked to MOD-2021-080331 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up received- Event-missed dose added.; 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. This report also refers to a case of missed dose.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Vision blurred
Clinical narrative: little cataract; blurred vision after receiving the vaccine on 6April2021 and is still suffering from the symptom; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (little cataract) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VISION BLURRED (blurred vision after receiving the vaccine on 6April2021 and is still suffering from the symptom). On an unknown date, the patient experienced CATARACT (little cataract) (seriousness criterion medically significant). The patient was treated with CARMELLOSE SODIUM (REFRESH TEAR) at a dose of 1 dosage form. At the time of the report, CATARACT (little cataract) outcome was unknown and VISION BLURRED (blurred vision after receiving the vaccine on 6April2021 and is still suffering from the symptom) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Reporter states that  blur vision is still there but not like before.  Company Comment  This case concerns a 68-year-old female with a serious unexpected event of cataract, and nonserious vision blurred. Event latency within 24 hours after mRNA-1273. Events ongoing. Based on 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.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 24 Jul 2021 contains significant information: Treatment medication and event added.; Sender's Comments: This case concerns a 68-year-old female with a serious unexpected event of cataract, and nonserious vision blurred. Event latency within 24 hours after mRNA-1273. Events ongoing. Based on 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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, IgA nephropathy
Clinical narrative: diagnosed with IGA Nephropathy, still going on in both kidneys; peeing blood; This spontaneous case was reported by a consumer and describes the occurrence of IGA NEPHROPATHY (diagnosed with IGA Nephropathy, still going on in both kidneys) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced HAEMATURIA (peeing blood). On an unknown date, the patient experienced IGA NEPHROPATHY (diagnosed with IGA Nephropathy, still going on in both kidneys) (seriousness criterion medically significant). At the time of the report, IGA NEPHROPATHY (diagnosed with IGA Nephropathy, still going on in both kidneys) had not resolved and HAEMATURIA (peeing blood) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Patient had to seen multiple facilities for the testing and then was diagnosed with kidney disease.  She had a kidney biopsy, three computerized tomography scans preformed, blood work and a Cystoscopy done.  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. Very limited information regarding this events has been provided at this time. No further information is expected at this time   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: A serious event IgA nephropathy was added.; 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. Very limited information regarding this events has been provided at this time. No further information is expected at this time