chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound abdomen
Clinical narrative: FATIGUE; ACHY BONES; ACHY MUSCLES; TROUBLE SLEEPING; LYING IN BED ALL THE DAY; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, non smoker, unspecified antibiotic allergy, and no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced achy bones. On 13-MAR-2021, the subject experienced achy muscles. On 13-MAR-2021, the subject experienced trouble sleeping. On 13-MAR-2021, the subject experienced lying in bed all the day. Laboratory data (dates unspecified) included: Ultrasound abdomen (NR: not provided) Fatty liver, gall bladder removed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, achy bones, achy muscles, and trouble sleeping, and the outcome of lying in bed all the day was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Paraesthesia
Clinical narrative: TINGLING SENSATION ON LEFT SIDE OF BODY; BODY NUMBNESS; INCREASED HEART RATE; 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, and expiry: UNKNOWN) dose was not reported, administered on right arm on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced tingling sensation on left side of body. On 13-MAR-2021, the subject experienced body numbness. On 13-MAR-2021, the subject experienced increased heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body numbness, and had not recovered from increased heart rate, and tingling sensation on left side of body. This report was non-serious.; Sender's Comments: MAC Comment: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: ITCHINESS; SWELLING; REDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to tetanus vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included citalopram for drug used for unknown indication, and ergocalciferol for drug used for unknown indication. On MAR-2021, the subject experienced swelling. On MAR-2021, the subject experienced redness. On 12-MAR-2021, the subject experienced itchiness. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchiness, and the outcome of swelling and redness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: WOKE UP AT 2-3 AM WITH  EXTRA ACHINESS FROM NECK DOWN; CHILLS AT 2-3 AM; FEVER; This spontaneous report received from a patient concerned an adult 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: Unk) dose was not reported, administered on 13-MAR-2021 16:00 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced woke up at 2-3 am with extra achiness from neck down. On 14-MAR-2021, the subject experienced chills at 2-3 am. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from woke up at 2-3 am with extra achiness from neck down, and chills at 2-3 am on MAR-2021, and the outcome of fever was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER 100.9F; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, heart murmur (since child birth), no alcohol use, and non-smoker, 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, route of admin not reported, batch number: 1805029, 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 fever 100.9f. Laboratory data included: Body temperature (NR: not provided) 100.9 F, 98.4 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 100.9f on 13-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: RIGHT ARM PAIN; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-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 nausea, and right arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right arm pain and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Sluggishness
Clinical narrative: Sweats; Dizzy; Sluggish; Chills; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sweats, dizzy, sluggish, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sweats, dizzy, headache and sluggish was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: STOMACH CRAMPS; SORENESS; INJECTION SITE SORENESS; SEVERE HEADACHE; NAUSEA; TIREDNESS; 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: Unk) dose was not reported, administered on 12-MAR-2021 03:30 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 MAR-2021, the subject experienced stomach cramps. On MAR-2021, the subject experienced soreness. On MAR-2021, the subject experienced injection site soreness. On MAR-2021, the subject experienced severe headache. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site soreness, severe headache, nausea, stomach cramps, tiredness and soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: STOMACH CRAMPS; SORENESS; INJECTION SITE SORENESS; SEVERE HEADACHE; NAUSEA; TIREDNESS; 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: Unk) dose was not reported, administered on 12-MAR-2021 03:30 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 MAR-2021, the subject experienced stomach cramps. On MAR-2021, the subject experienced soreness. On MAR-2021, the subject experienced injection site soreness. On MAR-2021, the subject experienced severe headache. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site soreness, severe headache, nausea, stomach cramps, tiredness and soreness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: FATIGUE; HEADACHE; SORE ARM; 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, and batch number were not reported) dose was not reported, administered on 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 MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, headache and sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210326390.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: HARD UNDER THE SKIN AT INJECTION SITE; REDNESS AT INJECTION SITE; WARMTH AT INJECTION SITE; HEADACHE; BURNING AS INJECTION WAS GIVEN; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 44 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced burning as injection was given. On 10-MAR-2021, the subject experienced soreness at injection site. On 12-MAR-2021, the subject experienced hard under the skin at injection site. On 12-MAR-2021, the subject experienced redness at injection site. On 12-MAR-2021, the subject experienced warmth at injection site. On 12-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning as injection was given on 10-MAR-2021, and headache on 12-MAR-2021, and had not recovered from soreness at injection site, redness at injection site, warmth at injection site, and hard under the skin at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: HEADACHE; VOMITING; CHILLS; NAUSEA; STINGING AT INJECTION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 04:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced stinging at injection site. On 12-MAR-2021, the subject experienced vomiting. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021 08:30, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging at injection site, vomiting, chills, and nausea on 12-MAR-2021, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: BODY ACHES; SWEATS; CHILLS; FEVER; HEADACHES; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, sweats, chills, fever, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sweats, chills, fever, and headaches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Headache, Pyrexia
Clinical narrative: WEAKNESS; CHILLS (COULDN'T STOP SHAKING); FEVER (DELIRIOUS); HEADACHE; RED CHEEKS; 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced red cheeks. On 11-MAR-2021, the subject experienced fever (delirious). On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021 21:00, the subject experienced chills (couldn't stop shaking). On 12-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills (couldn't stop shaking), and headache, was recovering from fever (delirious), and had not recovered from weakness, and red cheeks. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; TIREDNESS; This spontaneous report received from a consumer . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) 0.5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced sore arm. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and tiredness was not reported. The reporter causality and Company causality between JNJ-78436735 and sore arm, tiredness was possible.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: ACHES; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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-MAR-2021 for prophylactic vaccination in left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache and aches was not reported. This report was non-serious. Additional information: No Additional information received.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: RUNNY NOSE; SNEEZING; ITCHY THROAT; 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, intramuscular, batch number: Unknown) dose was not reported, 1 total, administered on 14-MAR-2021 16:00 for prophylactic vaccination. Batch Number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced runny nose, sneezing, and itchy throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the runny nose, sneezing and itchy throat was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: SHORTNESS OF BREATH; SWEATS; COUGH; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included copd.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced shortness of breath. On 14-MAR-2021, the subject experienced sweats. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 14-MAR-2021, was recovering from sweats, and fatigue, and had not recovered from shortness of breath, cough, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SHORTNESS OF BREATH; SWEATS; COUGH; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included copd.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced shortness of breath. On 14-MAR-2021, the subject experienced sweats. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 14-MAR-2021, was recovering from sweats, and fatigue, and had not recovered from shortness of breath, cough, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: HEADACHE; CHILLS; 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and chills. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Paraesthesia oral
Clinical narrative: HEADACHE; FEVER; NAUSEA; TONGUE TINGLING; SKIN SENSITIVITY; BODY ACHES; This spontaneous report received from a consumer concerned a 26 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: Unk) dose was not reported, administered on 12-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 headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced tongue tingling. On MAR-2021, the subject experienced skin sensitivity. On MAR-2021, the subject experienced body aches. Laboratory data included: Body temperature (NR: not provided) 99.6. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, nausea, tongue tingling, skin sensitivity and body aches was not reported. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin
Clinical narrative: HEADACHE; FEVER; NAUSEA; TONGUE TINGLING; SKIN SENSITIVITY; BODY ACHES; This spontaneous report received from a consumer concerned a 26 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: Unk) dose was not reported, administered on 12-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 headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced tongue tingling. On MAR-2021, the subject experienced skin sensitivity. On MAR-2021, the subject experienced body aches. Laboratory data included: Body temperature (NR: not provided) 99.6. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, nausea, tongue tingling, skin sensitivity and body aches was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: IT DID A NUMBER ON FOR ABOUT 24 HRS; This spontaneous report received from a patient via a company representative concerned a 48 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: Unk) 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 it did a number on for about 24 hrs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it did a number on for about 24 hrs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: QUEASINESS; LIGHT-HEADEDNESS; FEELING LIKE GOING TO PASS OUT; 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced queasiness. On 11-MAR-2021, the subject experienced light-headedness. On 11-MAR-2021, the subject experienced feeling like going to pass out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from queasiness, light-headedness, and feeling like going to pass out. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain, Stress, Vertigo
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high blood pressure, high cholesterol, vertigo, ibs, and pace maker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced vertigo. On 11-MAR-2021, the subject experienced shoulder ache/arm sored. On 11-MAR-2021, the subject experienced fatigue/tiredness. On an unspecified date, the subject experienced stress, and body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue/tiredness, shoulder ache/arm sored, and vertigo, and the outcome of stress and body ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: RASH ON RIGHT LOWER ARM AND RASH SPOTS ALL OVER SKIN; ITCHINESS; 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: Unk) dose was not reported, administered on 04-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 11-MAR-2021, the subject experienced rash on right lower arm and rash spots all over skin. On 11-MAR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on right lower arm and rash spots all over skin and itchiness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Headache, Lacrimation increased
Clinical narrative: COUGH; STUFFY NOSE; WATERY EYES; RUNNY NOSE; SNEEZING; ITCHINESS ON NECK AND SHOULDERS; COLD; HEADACHE; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and drug allergy. The patient was allergic to sulfa drugs, ciprofloxacin, and iodine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced cold. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced itchiness on neck and shoulders. On 13-MAR-2021, the subject experienced runny nose. On 13-MAR-2021, the subject experienced watery eyes. On 13-MAR-2021, the subject experienced stuffy nose. On 13-MAR-2021, the subject experienced sneezing. On 13-MAR-2021, the subject experienced cough. Laboratory data included: Body temperature (NR: not provided) felt little warm and took temperature but reported no fever. Treatment medications included: diphenhydramine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, stuffy nose, sneezing, and cough on 13-MAR-2021, and cold, tired, and itchiness on neck and shoulders on 11-MAR-2021, was recovering from watery eyes, and had not recovered from runny nose. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pruritus, Rhinorrhoea, Sneezing
Clinical narrative: COUGH; STUFFY NOSE; WATERY EYES; RUNNY NOSE; SNEEZING; ITCHINESS ON NECK AND SHOULDERS; COLD; HEADACHE; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and drug allergy. The patient was allergic to sulfa drugs, ciprofloxacin, and iodine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced cold. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced itchiness on neck and shoulders. On 13-MAR-2021, the subject experienced runny nose. On 13-MAR-2021, the subject experienced watery eyes. On 13-MAR-2021, the subject experienced stuffy nose. On 13-MAR-2021, the subject experienced sneezing. On 13-MAR-2021, the subject experienced cough. Laboratory data included: Body temperature (NR: not provided) felt little warm and took temperature but reported no fever. Treatment medications included: diphenhydramine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, stuffy nose, sneezing, and cough on 13-MAR-2021, and cold, tired, and itchiness on neck and shoulders on 11-MAR-2021, was recovering from watery eyes, and had not recovered from runny nose. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Decreased appetite, Dizziness
Clinical narrative: COUGH; VERTIGO; DIZZINESS; LOSS OF APPETITE; SHOULDER PAIN; CHILLS; FEVER; NECK PAIN; MUSCLE ACHE; 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced neck pain. On 12-MAR-2021, the subject experienced muscle ache. On 12-MAR-2021, the subject experienced shoulder pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced cough. On 13-MAR-2021, the subject experienced vertigo. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-MAR-2021, had not recovered from cough, shoulder pain, and muscle ache, and the outcome of vertigo, dizziness, neck pain, loss of appetite and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pyrexia, Vertigo
Clinical narrative: COUGH; VERTIGO; DIZZINESS; LOSS OF APPETITE; SHOULDER PAIN; CHILLS; FEVER; NECK PAIN; MUSCLE ACHE; 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced neck pain. On 12-MAR-2021, the subject experienced muscle ache. On 12-MAR-2021, the subject experienced shoulder pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced cough. On 13-MAR-2021, the subject experienced vertigo. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-MAR-2021, had not recovered from cough, shoulder pain, and muscle ache, and the outcome of vertigo, dizziness, neck pain, loss of appetite and chills was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS AT INJECTION SITE AROUND 12 NOON; PAIN AT INJECTION SITE AROUND 12 NOON; RIGHT HAND SWELLING AROUND 12 NOON; BODY FEELS HOT "LIKE  FIRE" BUT WORSE IN THE ARMS/HANDS AROUND 12 NOON; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included weak immune system, penicillin allergy, latex tape allergy, sulfa allergy, bactrim allergy, non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with venlafaxine hydrochloride, and ondansetron.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: 02-MAY-2021) dose was not reported, administered on 13-MAR-2021  around 11:00 AM for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced redness at injection site around 12 noon. On 13-MAR-2021, the subject experienced pain at injection site around 12 noon. On 13-MAR-2021, the subject experienced right hand swelling around 12 noon. On 13-MAR-2021, the subject experienced body feels hot "like fire" but worse in the arms/hands around 12 noon. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at injection site around 12 noon, pain at injection site around 12 noon, right hand swelling around 12 noon, and body feels hot "like fire" but worse in the arms/hands around 12 noon. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Pain
Clinical narrative: Body ache; Diarrhea; Injection site pain; This spontaneous report received from a patient concerned a 70 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included myriad of digestive system issues.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, body ache, and diarrhea on 12-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: ARM IS STILL TENDER; SORE ARM; PAINFUL VACCINATION; 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced arm is still tender. On 12-MAR-2021, the subject experienced sore arm. On 12-MAR-2021, the subject experienced painful vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm is still tender, had not recovered from sore arm, and the outcome of painful vaccination was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: SHIVERING; FEVER 102 DEGREES; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced shivering. On 14-MAR-2021, the subject experienced fever 102 degrees. Laboratory data included: Body temperature (NR: not provided) 102 deg. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported and has been requested. The patient had not recovered from shivering, and fever 102 degrees. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: LOW GRADE FEVER; ACHES AND PAINS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had history of taking other medications for other ailments.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced low grade fever. On 13-MAR-2021, the subject experienced aches and pains. Laboratory data included: Body temperature (NR: not provided) 99.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, and aches and pains. This report was non-serious..
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: ACHINESS; FEVER; CHILLS; This spontaneous report received from a patient concerned a 42 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021;10:15 am on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F, 101.5 F. On 13-MAR-2021, the subject experienced achiness. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and achiness, and the outcome of chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FELT SICK / DID NOT FEEL GOOD; This spontaneous report received from a consumer concerned a female of unspecified age The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On 13-MAR-2021, the subject experienced felt sick / did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick / did not feel good was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Epistaxis, Influenza like illness, Pain
Clinical narrative: BLOODY NOSE; ACHES; CHILL; FEVER; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 60 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, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced flu-like symptoms. On 14-MAR-2021, the subject experienced bloody nose. On 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced chill. On 13-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chill, fever, aches, bloody nose, and flu-like symptoms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BLOODY NOSE; ACHES; CHILL; FEVER; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 60 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, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced flu-like symptoms. On 14-MAR-2021, the subject experienced bloody nose. On 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced chill. On 13-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chill, fever, aches, bloody nose, and flu-like symptoms. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Testicular disorder
Clinical narrative: TESTES HUNG LOW; BODY WAS WARM; 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, and batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 09-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 testes hung low. On MAR-2021, the subject experienced body was warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from testes hung low, and body was warm on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: LEFT ARM INJECTION SITE PAIN; This spontaneous report received from a patient concerned an adult 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: Unknown, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced left arm injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm injection site pain on 16-MAR-2021. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymph node pain, Lymphadenopathy, Ultrasound scan
Clinical narrative: I noticed my lymph node - there was a lump/bump there. My whole left side was sore - around the clavicle left side.. I consulted the health practitioner at work and she told me to go to my practitioner. My practitioner sent me to get a sonogram and a CT.  By then I got the second dose, 1/21/2021.  In time they all went back to normal (shrunk). It took about a month after the second vaccine for everything to subside and get back to normal. No treatment.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Injection site pain
Clinical narrative: Caller stated he recceived his 1st vaccine on 4/23/2021 around 2pm and about 1pm today 04/24/2021 he began having chills and injection site pain. He just took his temperature and was noted to have a  T of 101.0. Caller advised to take tylenol or Ibuprfen and maintain hydration. Also caller was informed if fever persists to call his PCP or seek in-person medical care. RN 4/24/2021 @1855
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Crohn's disease
Clinical narrative: After first shot became constipated. After second shot my Crohn's went into a full flare up. Been perfectly fine 10 year until now. No swollen arm or pain where shot was given.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Cold sweat, Insomnia, Lethargy
Clinical narrative: Severe chills, cold sweats, temp 99.4,  lethargy in whole body, left arm so sore unable to move on it?s own power, pain and chills and cold sweats so severe I couldn?t sleep more than 1 or 2 hours at a time. Wake up drenched in cold sweats every 2 hours, all night long.  Side effects from dose 1 - mildly sore L arm for 18 hours.  Side effects from dose 2 - severe, crippling, virtually intolerable. Hellish pain and suffering. No sleep. For 12 hours..
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Night sweats, Pain, Pain in extremity
Clinical narrative: Severe chills, cold sweats, temp 99.4,  lethargy in whole body, left arm so sore unable to move on it?s own power, pain and chills and cold sweats so severe I couldn?t sleep more than 1 or 2 hours at a time. Wake up drenched in cold sweats every 2 hours, all night long.  Side effects from dose 1 - mildly sore L arm for 18 hours.  Side effects from dose 2 - severe, crippling, virtually intolerable. Hellish pain and suffering. No sleep. For 12 hours..