chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Headache, Oropharyngeal pain
Clinical narrative: COUGHED UP BLOODY PHLEGM; MILD SORE THROAT; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, seasonal allergy, and tree pollen allergy. The patient experienced drug allergy when treated with nifedipine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced slight headache. On 15-APR-2021, the subject experienced coughed up bloody phlegm. On 15-APR-2021, the subject experienced mild sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughed up bloody phlegm, and mild sore throat on 15-APR-2021, and slight headache on 13-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN ON THE LEFT LEG RADIATING TO RIGHT SIDE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: 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 pain on the left leg radiating to right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on the left leg radiating to right side. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: ARM SORENESS IN THE SAME ARM AS THE INJECTION; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included hypercholesterolemia, and concurrent conditions included non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on 11-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a female (consumer's wife) of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, 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 patient experienced blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a female patient of unspecified age, who developed a blood clot an unspecified time after receiving the Janssen COVID-19 vaccine. No medical history or concomitant medications were provided.  There is insufficient information to make a meaningful medical assessment.  Additional information is being sought.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: SKIN REDNESS ON THE EARS ,LEFT KNEE AND RIGHT HAND; This spontaneous report received from a consumer 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: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced skin redness on the ears, left knee and right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin redness on the ears ,left knee and right hand. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Rash, Rash erythematous, Rash macular
Clinical narrative: BLOTCHY RASH ON THE TRUNK (STOMACH TO CHEST); RASH ON UPPER INSIDE THIGHS (BOTH SIDE); RASH FROM ELBOW TO WRIST (BOTH SIDES); SHOULDER PAIN (DULL); This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shoulder pain (dull). On 18-APR-2021, the subject experienced blotchy rash on the trunk (stomach to chest). On 18-APR-2021, the subject experienced rash on upper inside thighs (both side). On 18-APR-2021, the subject experienced rash from elbow to wrist (both sides). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shoulder pain (dull) on 12-APR-2021, and had not recovered from blotchy rash on the trunk (stomach to chest), rash from elbow to wrist (both sides), and rash on upper inside thighs (both side). This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: CHILLS; SEVERE HEADACHE; SEVERE NAUSEA; FEELING FATIGUE; BEING WEAK; This spontaneous report received from a patient concerned a 57 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced severe nausea. On APR-2021, the subject experienced feeling fatigue. On APR-2021, the subject experienced being weak. On 10-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 97.5 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, chills, feeling fatigue, and being weak, and the outcome of severe nausea was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: CHILLS; SEVERE HEADACHE; SEVERE NAUSEA; FEELING FATIGUE; BEING WEAK; This spontaneous report received from a patient concerned a 57 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced severe nausea. On APR-2021, the subject experienced feeling fatigue. On APR-2021, the subject experienced being weak. On 10-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 97.5 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, chills, feeling fatigue, and being weak, and the outcome of severe nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; This spontaneous report received from a pharmacist concerned multiple patients. 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: 1805031, and 041A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product storage error was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain, Paraesthesia, Pyrexia
Clinical narrative: RIGHT ARM NUMBNESS; RIGHT ARM TINGLING; CHILLS; FEVER; INTENSE PAIN FROM INJECTION SITE TO BACK OF EAR; This spontaneous report received from a patient concerned a 50 year old. 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 patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced intense pain from injection site to back of ear. On 21-MAR-2021, the subject experienced right arm numbness. On 21-MAR-2021, the subject experienced right arm tingling. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced 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 on 22-MAR-2021, had not recovered from right arm numbness, and right arm tingling, and the outcome of intense pain from injection site to back of ear was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: POSITIVE COVID-19 TEST; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-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 16-APR-2021, the subject experienced positive covid-19 test. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive covid-19 test was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: LOST SAVORY TASTEBUDS; NECK TIGHTNESS; SHOULDER TIGHTNESS; CHILLS; 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 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 lost savory tastebuds, neck tightness, shoulder tightness, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lost savory tastebuds, and the outcome of chills, neck tightness and shoulder tightness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Injection site pain
Clinical narrative: PAIN AT THE INJECTION LOCATION; FATIGUE; MILD 3 SECOND  HEADACHE; MILD 3 SECOND ABDOMINAL PAIN; 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced mild 3 second abdominal pain. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced mild 3 second headache. On 02-APR-2021, the subject experienced pain at the injection location. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild 3 second abdominal pain, and mild 3 second headache on APR-2021, and pain at the injection location on 02-APR-2021, and the outcome of fatigue was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: TWO BRUISE (ONE ON EACH LEG); This spontaneous report received from a consumer concerned a 20 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: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced two bruise (one on each leg). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two bruise (one on each leg). This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Feeling hot, Headache
Clinical narrative: STOMACH ACHE; FELT HOT INSIDE; THROWING UP; STARTED HAVING RUNS; CHILLS ON AND OFF; HEADACHE; This spontaneous report received from a patient concerned a 19 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: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced stomach ache. On APR-2021, the subject experienced felt hot inside. On APR-2021, the subject experienced throwing up. On APR-2021, the subject experienced started having runs. On APR-2021, the subject experienced chills on and off. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, headache, felt hot inside, chills on and off, throwing up, and started having runs. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: STOMACH ACHE; FELT HOT INSIDE; THROWING UP; STARTED HAVING RUNS; CHILLS ON AND OFF; HEADACHE; This spontaneous report received from a patient concerned a 19 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: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced stomach ache. On APR-2021, the subject experienced felt hot inside. On APR-2021, the subject experienced throwing up. On APR-2021, the subject experienced started having runs. On APR-2021, the subject experienced chills on and off. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, headache, felt hot inside, chills on and off, throwing up, and started having runs. This report was non-serious.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: SLEPT A LOT; FEELING VERY TIRED; This spontaneous report received from a consumer concerned an 89 year old male. The patient's height and weight were not reported. The patient's past medical history included artificial valve surgery, and pacemaker surgery, and concurrent conditions included non smoker, sepsis, cancer on shin bone and radiation burn and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A  and expiry: 23/JUN/2023) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included amoxicillin for sepsis. On APR-2021, the subject experienced slept a lot. On 13-APR-2021, the subject experienced feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling very tired on 15-APR-2021 and the outcome of slept a lot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: CAN'T RAISE ARM ABOVE SHOULDER; ARM HOT TO TOUCH; REDNESS AT INJECTION SITE; PAIN IN LEFT VACCINATED ARM; SWELLING OF ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A,  expiry: 23/JUN/2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced can't raise arm above shoulder. On 13-APR-2021, the subject experienced arm hot to touch. On 13-APR-2021, the subject experienced redness at injection site. On 13-APR-2021, the subject experienced pain in left vaccinated arm. On 13-APR-2021, the subject experienced swelling of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left vaccinated arm, redness at injection site, swelling of arm, arm hot to touch, and can't raise arm above shoulder. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Migraine, Nausea
Clinical narrative: BACK PAIN; MIGRAINE; BODY PAINS; SHOULDER PAIN; PROLONGED NAUSEA; FATIGUE; 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 past medical history included neck injury, and concurrent conditions included migraines. 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 15-MAR-2021 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 back pain, migraine, body pains, shoulder pain, prolonged nausea, and fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, was recovering from prolonged nausea, and fatigue, had not recovered from shoulder pain, and back pain, and the outcome of body pains was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BACK PAIN; MIGRAINE; BODY PAINS; SHOULDER PAIN; PROLONGED NAUSEA; FATIGUE; 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 past medical history included neck injury, and concurrent conditions included migraines. 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 15-MAR-2021 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 back pain, migraine, body pains, shoulder pain, prolonged nausea, and fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, was recovering from prolonged nausea, and fatigue, had not recovered from shoulder pain, and back pain, and the outcome of body pains was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING WELL; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 APR-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 not feeling well. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Hot flush, Muscle spasms, Renal pain
Clinical narrative: PAIN ON RIGHT KIDNEY AREA; MUSCLE CRAMPS ON RIGHT FOOT AND LEFT UPPER THIGH; HOT FLASHES; BACK PAIN; This spontaneous report received from a patient concerned a 60 year old male. 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, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced hot flashes. On 08-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced pain on right kidney area. On 09-APR-2021, the subject experienced muscle cramps on right foot and left upper thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on 09-APR-2021, and had not recovered from hot flashes, pain on right kidney area, and muscle cramps on right foot and left upper thigh. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Neck pain, Pain in extremity
Clinical narrative: NECK  PAIN; BACK PAIN; CHILLS; PAIN LEGS AND ARM; FEVER; HEADACHE; 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 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 neck pain, back pain, chills, pain legs and arm, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, back pain, and pain legs and arm, and the outcome of fever, chills and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NECK  PAIN; BACK PAIN; CHILLS; PAIN LEGS AND ARM; FEVER; HEADACHE; 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 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 neck pain, back pain, chills, pain legs and arm, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, back pain, and pain legs and arm, and the outcome of fever, chills and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHE AND FELT ACHY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced body ache and felt achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache and felt achy on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210436672.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Paraesthesia
Clinical narrative: PAIN ALL OVER THE BODY; TINGLING ALL OVER THE BODY; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included caller states she has no medical problems and takes no medications., and other pre-existing medical conditions included the patient had no medical problems and took no medications.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-APR-2021, the subject experienced pain all over the body. On 15-APR-2021, the subject experienced tingling all over the body. On 15-APR-2021, the subject experienced couldn't sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain all over the body, and tingling all over the body, and the outcome of couldn't sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Polymerase chain reaction
Clinical narrative: BURNING ON THE SOLES OF FEET; 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 concurrent conditions included non smoker, non alcoholic user, diabeties, high blood pressure, and gastritis, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes. On 08-JAN-2021, Laboratory data included: PCR (NR: not provided) Positive. On 15-APR-2021, the subject experienced burning on the soles of feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning on the soles of feet. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: PERSISTED MILD HEADACHE; This spontaneous report received from a patient concerned a 69 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced persisted mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persisted mild headache. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: chills; fever; muscle pain; fatigue; headache; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: 23/JUNE/2021) .5 ml, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced muscle pain. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle pain, fatigue, and headache on 09-APR-2021, and fever on 08-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210437057.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-MAR-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 2021, the subject experienced adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from adverse event on 2021. This report was non-serious. This case, from the same reporter is linked to 20210435762.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Unevaluable event
Clinical narrative: I FELT LIKE I COULD FIGHT someone OR TWO; CHILLS; TIRED; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-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 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced tired. On 14-APR-2021, the subject experienced I felt like I could fight someone or two. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and tired on APR-2021, and the outcome of I felt like I could fight someone or two was not reported. This report was non-serious. This case, from the same reporter is linked to 20210435862.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; CONTINUOUS HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: J2041H21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced continuous headache. On 12-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from continuous headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: TEMPERATURE EXCURSION EXPOSURE; This spontaneous report received from a pharmacist concerned a 30 year old female. The patient's height, and weight were not reported. The patient does not have any allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced temperature excursion exposure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion exposure was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Oropharyngeal pain, Productive cough, Rhinorrhoea
Clinical narrative: RUNNY NOSE; SORE THROAT; EAR PAIN; COUGHING UP WHITE PHLEGM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced runny nose. On 14-APR-2021, the subject experienced sore throat. On 14-APR-2021, the subject experienced ear pain. On 14-APR-2021, the subject experienced coughing up white phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from coughing up white phlegm, and had not recovered from runny nose, sore throat, and ear pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Anxiety, Chills, Headache, Pain
Clinical narrative: ANXIETY; SWOLLEN ARMS AND FINGERS; BLOATED STOMACH; BODY ACHES; CHILLS; FEVER; HEADACHE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 06:50 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. On 16-APR-2021, the subject experienced swollen arms and fingers. On 16-APR-2021, the subject experienced bloated stomach. On an unspecified date, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from body aches, chills, fever, and headache on 14-APR-2021, was recovering from swollen arms and fingers, and bloated stomach, and the outcome of anxiety was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: ANXIETY; SWOLLEN ARMS AND FINGERS; BLOATED STOMACH; BODY ACHES; CHILLS; FEVER; HEADACHE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 06:50 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. On 16-APR-2021, the subject experienced swollen arms and fingers. On 16-APR-2021, the subject experienced bloated stomach. On an unspecified date, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from body aches, chills, fever, and headache on 14-APR-2021, was recovering from swollen arms and fingers, and bloated stomach, and the outcome of anxiety was not reported. This report was non-serious.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea, Pain in extremity
Clinical narrative: MIGRAINE; SORE ARM; NAUSEA ON AND OFF; FATIGUE; This spontaneous report received from a patient concerned a 55 year old of unspecified 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 migraine, sore arm, nausea on and off, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, sore arm, nausea on and off, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: ARM PAIN; FEVER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 19 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced flu like symptoms. On 13-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and fever, and had not recovered from arm pain. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Ear pain, Headache, Neck pain
Clinical narrative: PULLING INSIDE OF HER NASAL  CAVITY; DIZZY WHEN STAND UP AND WALK; EARS FELL FULL; PAIN IN BACK OF HEAD/ HEADACHE; NECK PAIN; PAIN AROUND THE EARS; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included factor v ligand blood clotting disorder, and seasonal allergies, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 14-MAR-2021, the subject experienced neck pain. On 14-MAR-2021, the subject experienced pain around the ears. On 14-MAR-2021, the subject experienced ears fell full. On 14-MAR-2021, the subject experienced pain in back of head/ headache. On 14-APR-2021, the subject experienced pulling inside of her nasal cavity. On 14-APR-2021, the subject experienced dizzy when stand up and walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain, pain in back of head/ headache, pain around the ears, pulling inside of her nasal cavity, dizzy when stand up and walk, and ears fell full. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinalgia
Clinical narrative: PULLING INSIDE OF HER NASAL  CAVITY; DIZZY WHEN STAND UP AND WALK; EARS FELL FULL; PAIN IN BACK OF HEAD/ HEADACHE; NECK PAIN; PAIN AROUND THE EARS; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included factor v ligand blood clotting disorder, and seasonal allergies, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 14-MAR-2021, the subject experienced neck pain. On 14-MAR-2021, the subject experienced pain around the ears. On 14-MAR-2021, the subject experienced ears fell full. On 14-MAR-2021, the subject experienced pain in back of head/ headache. On 14-APR-2021, the subject experienced pulling inside of her nasal cavity. On 14-APR-2021, the subject experienced dizzy when stand up and walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain, pain in back of head/ headache, pain around the ears, pulling inside of her nasal cavity, dizzy when stand up and walk, and ears fell full. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Feeling jittery, Influenza virus test
Clinical narrative: MINOR STUFFY NOSE; COUGH; CHILLS; NAUSEA; FELT LIKE WAS HIT BY TRUCK; BRAIN FOG; SHAKY/JITTERY; ACHY; LETHARGIC; This spontaneous report received from a patient concerned a 49 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: 201A01A and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced brain fog. On APR-2021, the subject experienced shaky or jittery. On APR-2021, the subject experienced achy. On APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced felt like was hit by truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced minor stuffy nose. On 09-APR-2021, the subject experienced cough.  On 12-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative and Rapid influenza diagnostic test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt like was hit by truck, chills, minor stuffy nose, and cough, had not recovered from nausea, brain fog, shaky/jittery, and lethargic, and the outcome of achy was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nasal congestion, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: MINOR STUFFY NOSE; COUGH; CHILLS; NAUSEA; FELT LIKE WAS HIT BY TRUCK; BRAIN FOG; SHAKY/JITTERY; ACHY; LETHARGIC; This spontaneous report received from a patient concerned a 49 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: 201A01A and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced brain fog. On APR-2021, the subject experienced shaky or jittery. On APR-2021, the subject experienced achy. On APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced felt like was hit by truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced minor stuffy nose. On 09-APR-2021, the subject experienced cough.  On 12-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative and Rapid influenza diagnostic test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt like was hit by truck, chills, minor stuffy nose, and cough, had not recovered from nausea, brain fog, shaky/jittery, and lethargic, and the outcome of achy was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: MINOR STUFFY NOSE; COUGH; CHILLS; NAUSEA; FELT LIKE WAS HIT BY TRUCK; BRAIN FOG; SHAKY/JITTERY; ACHY; LETHARGIC; This spontaneous report received from a patient concerned a 49 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: 201A01A and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced brain fog. On APR-2021, the subject experienced shaky or jittery. On APR-2021, the subject experienced achy. On APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced felt like was hit by truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced minor stuffy nose. On 09-APR-2021, the subject experienced cough.  On 12-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative and Rapid influenza diagnostic test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt like was hit by truck, chills, minor stuffy nose, and cough, had not recovered from nausea, brain fog, shaky/jittery, and lethargic, and the outcome of achy was not reported. This report was non-serious.