chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: RASHES ON ARMS AND IT SPREAD TO LEGS WITH SEVERE ITCHING; RASHES ON ARMS AND IT SPREAD TO LEGS WITH SEVERE ITCHING; 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, and batch number were not reported) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced rashes on arms and it spread to legs with severe itching. On 01-APR-2021, the subject experienced rashes on arms and it spread to legs with severe itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rashes on arms and it spread to legs with severe itching and rashes on arms and it spread to legs with severe itching was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pain
Clinical narrative: MIGRAINE; BODY ACHES; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: UNKNOWN) dose was not reported, administered on 31-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 01-APR-2021, the subject experienced migraine. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, body aches and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate increased, Nausea, Pyrexia
Clinical narrative: VOMITING; HIGH HEART RATE; DIZZINESS; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical history. 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 to Left Arm 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 vomiting, high heart rate, dizziness, headache, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, vomiting, fever, high heart rate and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; HIGH HEART RATE; DIZZINESS; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical history. 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 to Left Arm 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 vomiting, high heart rate, dizziness, headache, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, vomiting, fever, high heart rate and dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nausea
Clinical narrative: FAST HEARTRATE; NAUSEA; 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered to left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced fast heartrate. On 03-APR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fast heartrate, and nausea. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye pruritus, Fatigue, Headache
Clinical narrative: BODY ACHE/PAIN; ITCHY EYES; SKIN SENSITIVE TO TOUCH; FLU LIKE SYMPTOMS; CHILLS; GENERAL JOINT PAIN; MILD HEADACHE; FEELING TIRED; This spontaneous report received from a patient 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: 01808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 14:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body ache/pain. On 03-APR-2021, the subject experienced itchy eyes. On 03-APR-2021, the subject experienced skin sensitive to touch. On 03-APR-2021, the subject experienced mild headache. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced feeling tired. On 03-APR-2021, the subject experienced flu like symptoms. On 03-APR-2021, the subject experienced general joint pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache/pain, itchy eyes, skin sensitive to touch, mild headache, chills, flu like symptoms, and general joint pain, and was recovering from feeling tired. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Influenza like illness, Pain
Clinical narrative: BODY ACHE/PAIN; ITCHY EYES; SKIN SENSITIVE TO TOUCH; FLU LIKE SYMPTOMS; CHILLS; GENERAL JOINT PAIN; MILD HEADACHE; FEELING TIRED; This spontaneous report received from a patient 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: 01808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 14:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body ache/pain. On 03-APR-2021, the subject experienced itchy eyes. On 03-APR-2021, the subject experienced skin sensitive to touch. On 03-APR-2021, the subject experienced mild headache. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced feeling tired. On 03-APR-2021, the subject experienced flu like symptoms. On 03-APR-2021, the subject experienced general joint pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache/pain, itchy eyes, skin sensitive to touch, mild headache, chills, flu like symptoms, and general joint pain, and was recovering from feeling tired. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: SWELLING OF LYMPH GLAND UNDER LEFT ARM (ARMPIT); This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, non smoker, and antibiotics, and other pre-existing medical conditions included the patient does not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered in Left Deltoid on 31-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021 10:30, the subject experienced swelling of lymph gland under left arm (armpit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of lymph gland under left arm (armpit). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lethargy, Nasal congestion, Pyrexia
Clinical narrative: LETHARGY; CONGESTION; SLEEPY; FEVER; FATIGUE; 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: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced lethargy. On 01-APR-2021, the subject experienced congestion. On 01-APR-2021, the subject experienced sleepy. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, lethargy, congestion, fever, and sleepy. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: LETHARGY; CONGESTION; SLEEPY; FEVER; FATIGUE; 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: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced lethargy. On 01-APR-2021, the subject experienced congestion. On 01-APR-2021, the subject experienced sleepy. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, lethargy, congestion, fever, and sleepy. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 41 year old male. 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, and batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and had not recovered from fever. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Chills, Chromaturia
Clinical narrative: BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 41 year old male. 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, and batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and had not recovered from fever. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Hepatic function abnormal, Metabolic function test, Nausea, Pain
Clinical narrative: BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 41 year old male. 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, and batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and had not recovered from fever. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 41 year old male. 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, and batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and had not recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Therapeutic response unexpected
Clinical narrative: UNEXPECTED BENEFICIAL THERAPEUTIC RESPONSE; PRETTY TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip pain, knee pain, and other aches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced pretty tired. On an unspecified date, the subject experienced unexpected beneficial therapeutic response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pretty tired on 01-APR-2021, and the outcome of unexpected beneficial therapeutic response was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: PAIN/PAIN IN BODY; FEELS COLD; PAIN IN MUSCLES; 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, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced pain/pain in body. On 02-APR-2021, the subject experienced feels cold. On 02-APR-2021, the subject experienced pain in muscles. On 02-APR-2021, the subject experienced fever. On 02-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 fever, headache, pain/pain in body, feels cold, and pain in muscles. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Coordination abnormal, Dizziness, Ear pain, Headache
Clinical narrative: HEADACHE; PAIN IN THE HEEL; FEVER; PAIN AT INJECTION SITE; FELLING UNCOORDINATED; PAIN RADIATING TO THE NECK; DIZZY; SHOOTING PAIN IN EAR; PAIN IN THE ANKLE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteo-arthritis, fibromyalgia, kidney stone, penicillin allergy, ibuprofen allergy, corticosteroid allergy and erythromycin allergy. 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 25-MAR-2021 14:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizzy. On 2021, the subject experienced shooting pain in ear. On 2021, the subject experienced pain in the ankle. On 2021, the subject experienced muscle pain. Treatment medications included: acetylsalicylic acid. On 25-MAR-2021, the subject experienced felling uncoordinated. On 25-MAR-2021, the subject experienced pain radiating to the neck. On 25-MAR-2021, the subject experienced pain at injection site. On 25-MAR-2021 20:00, the subject experienced fever. On 31-MAR-2021, the subject experienced pain in the heel. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, felling uncoordinated, and fever, had not recovered from headache, and the outcome of pain at injection site, pain in the heel, pain in the ankle, muscle pain, shooting pain in ear and pain radiating to the neck was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: HEADACHE; PAIN IN THE HEEL; FEVER; PAIN AT INJECTION SITE; FELLING UNCOORDINATED; PAIN RADIATING TO THE NECK; DIZZY; SHOOTING PAIN IN EAR; PAIN IN THE ANKLE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteo-arthritis, fibromyalgia, kidney stone, penicillin allergy, ibuprofen allergy, corticosteroid allergy and erythromycin allergy. 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 25-MAR-2021 14:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizzy. On 2021, the subject experienced shooting pain in ear. On 2021, the subject experienced pain in the ankle. On 2021, the subject experienced muscle pain. Treatment medications included: acetylsalicylic acid. On 25-MAR-2021, the subject experienced felling uncoordinated. On 25-MAR-2021, the subject experienced pain radiating to the neck. On 25-MAR-2021, the subject experienced pain at injection site. On 25-MAR-2021 20:00, the subject experienced fever. On 31-MAR-2021, the subject experienced pain in the heel. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, felling uncoordinated, and fever, had not recovered from headache, and the outcome of pain at injection site, pain in the heel, pain in the ankle, muscle pain, shooting pain in ear and pain radiating to the neck was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: LETHARGY; LUMP UNDER INJECTION SITE; TENDERNESS; ARM SORENESS; LITTLE HEAT RADIATING FROM THE INJECTION SIDE; FEVER; NAUSEA; INJECTION SITE REDNESS; CHILLS; BODY ACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, weight loss, and non smoker. 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 20-MAR-2021 14:30 at left deltoid for prophylactic vaccination. Concomitant medications included valaciclovir hydrochloride for depression, vortioxetine hydrobromide for depression, and phentermine for weight loss. On 20-MAR-2021, the subject experienced body ache. On 20-MAR-2021 23:30, the subject experienced chills. On 20-MAR-2021 23:30, the subject experienced injection site redness. On 20-MAR-2021 23:30, the subject experienced fever. On 20-MAR-2021 23:30, the subject experienced nausea. On 21-MAR-2021, the subject experienced lethargy. On 21-MAR-2021, the subject experienced lump under injection site. On 21-MAR-2021, the subject experienced tenderness. On 21-MAR-2021, the subject experienced arm soreness. On 21-MAR-2021, the subject experienced little heat radiating from the injection side. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy on 28-MAR-2021, body ache on 22-MAR-2021 23:30, chills, fever, and nausea on 22-MAR-2021, and injection site redness, was recovering from lump under injection site, arm soreness, and tenderness, and had not recovered from little heat radiating from the injection side. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: LETHARGY; LUMP UNDER INJECTION SITE; TENDERNESS; ARM SORENESS; LITTLE HEAT RADIATING FROM THE INJECTION SIDE; FEVER; NAUSEA; INJECTION SITE REDNESS; CHILLS; BODY ACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, weight loss, and non smoker. 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 20-MAR-2021 14:30 at left deltoid for prophylactic vaccination. Concomitant medications included valaciclovir hydrochloride for depression, vortioxetine hydrobromide for depression, and phentermine for weight loss. On 20-MAR-2021, the subject experienced body ache. On 20-MAR-2021 23:30, the subject experienced chills. On 20-MAR-2021 23:30, the subject experienced injection site redness. On 20-MAR-2021 23:30, the subject experienced fever. On 20-MAR-2021 23:30, the subject experienced nausea. On 21-MAR-2021, the subject experienced lethargy. On 21-MAR-2021, the subject experienced lump under injection site. On 21-MAR-2021, the subject experienced tenderness. On 21-MAR-2021, the subject experienced arm soreness. On 21-MAR-2021, the subject experienced little heat radiating from the injection side. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy on 28-MAR-2021, body ache on 22-MAR-2021 23:30, chills, fever, and nausea on 22-MAR-2021, and injection site redness, was recovering from lump under injection site, arm soreness, and tenderness, and had not recovered from little heat radiating from the injection side. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: LETHARGY; LUMP UNDER INJECTION SITE; TENDERNESS; ARM SORENESS; LITTLE HEAT RADIATING FROM THE INJECTION SIDE; FEVER; NAUSEA; INJECTION SITE REDNESS; CHILLS; BODY ACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, weight loss, and non smoker. 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 20-MAR-2021 14:30 at left deltoid for prophylactic vaccination. Concomitant medications included valaciclovir hydrochloride for depression, vortioxetine hydrobromide for depression, and phentermine for weight loss. On 20-MAR-2021, the subject experienced body ache. On 20-MAR-2021 23:30, the subject experienced chills. On 20-MAR-2021 23:30, the subject experienced injection site redness. On 20-MAR-2021 23:30, the subject experienced fever. On 20-MAR-2021 23:30, the subject experienced nausea. On 21-MAR-2021, the subject experienced lethargy. On 21-MAR-2021, the subject experienced lump under injection site. On 21-MAR-2021, the subject experienced tenderness. On 21-MAR-2021, the subject experienced arm soreness. On 21-MAR-2021, the subject experienced little heat radiating from the injection side. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy on 28-MAR-2021, body ache on 22-MAR-2021 23:30, chills, fever, and nausea on 22-MAR-2021, and injection site redness, was recovering from lump under injection site, arm soreness, and tenderness, and had not recovered from little heat radiating from the injection side. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Urticaria
Clinical narrative: HIVES; FATIGUE; FEVER; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021, the subject experienced fever. Treatment medications included: ibuprofen. On 03-APR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 03-APR-2021, was recovering from fatigue, and body aches, and had not recovered from hives. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Nausea, Pain
Clinical narrative: SHIVERING; SLIGHT NAUSEA; FATIGUE; ACHY; FELT COLDER; 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 01-APR-2021 16:55 for prophylactic vaccination. The batch number was not reported and has been requested.    No concomitant medications were reported. On 02-APR-2021, the subject experienced achy. On 02-APR-2021, the subject experienced felt colder. On 02-APR-2021, the subject experienced slight nausea. On 02-APR-2021, the subject experienced fatigue. On 02-APR-2021 05:00, the subject experienced shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shivering, fatigue, achy, slight nausea and felt colder was not reported. This report was non-serious.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: GENERAL ACHING; BAD HEADACHE; FEVER; This spontaneous report received from a patient concerned a 56 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: 1085031, and batch number: 1085031 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 12:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced general aching. On 03-APR-2021, the subject experienced bad headache. On 03-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from bad headache, and general aching. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: CHILLS; FEVER; MUSCLE ACHES; HEADACHE; 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: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced muscle aches. On 02-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 chills, and headache, and the outcome of fever and muscle aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hyperhidrosis, Insomnia
Clinical narrative: A COUPLE OF BRIEF DIZZY SPELLS; SWEATING; DIFFICULITY FALLING SLEEP; CHILLS; EXTREME TIREDNESS; 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) dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizzy spells, sweating, difficulty falling sleep, chills, and extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, extreme tiredness, difficulty falling sleep, sweating and dizzy spells was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: LARGE BLACK STOOLS; 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced large black stools. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from large black stools. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Oral candidiasis
Clinical narrative: THRUSH IN MOUTH; 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: not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced thrush in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrush in mouth was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Pain in extremity, Pyrexia
Clinical narrative: NO TASTE; SORE ARM; FEVER; CHILLS; This spontaneous report received from a parent concerned a 31 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. No concomitant medications were reported. The batch number was not reported and has been requested. On 2021, the subject experienced chills. On 03-APR-2021, the subject experienced no taste. On 03-APR-2021, the subject experienced sore arm. On 03-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and chills on 2021, and fever on 03-APR-2021, and had not recovered from no taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Myalgia
Clinical narrative: BODY ACHE; TREMORS; DIZZY; CHILLS; MUSCLE ACHE; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, augmentin allergy, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and  expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body ache. On 03-APR-2021, the subject experienced tremors. On 03-APR-2021, the subject experienced dizzy. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced muscle ache. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: acetylsalicylic acid, and ibuprofen. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors on 03-APR-2021, and had not recovered from muscle ache, body ache, fever, chills, headache, and dizzy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: BODY ACHE; TREMORS; DIZZY; CHILLS; MUSCLE ACHE; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, augmentin allergy, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and  expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body ache. On 03-APR-2021, the subject experienced tremors. On 03-APR-2021, the subject experienced dizzy. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced muscle ache. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: acetylsalicylic acid, and ibuprofen. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors on 03-APR-2021, and had not recovered from muscle ache, body ache, fever, chills, headache, and dizzy. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: FULL BODY ACHES; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:20 to left arm deltoid muscle for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 02-APR-2021 05:00, the subject experienced full body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body aches, chills, and headache on 02-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: VOMITING; HEADACHE; 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: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination .The Batch number was not reported. The company is unable to perform follow up to request batch/Lot number.  No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and vomiting. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: BURNING UP; HEADACHE; 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: Unk) 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 02-APR-2021, the subject experienced burning up. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning up and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; CHILLS; FEVER; LOST OF APPETITE; This spontaneous report received from a parent 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 28-MAR-2021 to left arm for prophylactic vaccination. the batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced lost of appetite. On 29-MAR-2021, the subject experienced chills. On 29-MAR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost of appetite on 01-APR-2021, was recovering from fever, and had not recovered from chills, and sore throat. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rash
Clinical narrative: FLU-LIKE SYMPTOMS; RASH ON THE NECK; This spontaneous report received from a consumer concerned a 50 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021at left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced flu-like symptoms. On 02-APR-2021, the subject experienced rash on the neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on the neck and flu-like symptoms was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Paraesthesia
Clinical narrative: BODY ACHES; TINGLING IN LEFT CHEEK; FATIGUE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tingling in left cheek. On APR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and the outcome of fatigue and tingling in left cheek was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Application site pain, Incorrect dose administered
Clinical narrative: MUSCLE SORENESS AT INJECTION SITE; SPILLED DOSE DURING ADMINISTRATION; 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 13-MAR-2021 for prophylactic vaccination at left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced spilled dose during administration. On 14-MAR-2021, the subject experienced muscle soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle soreness at injection site and spilled dose during administration was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: LOSS OF ABILITY TO TASTE FOOD AND METALLIC TASTE; EXCESSIVE SWEATING AT NIGHT; CHILLS; PAIN ON HER LEFT ARM; FATIGUE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient had no known drug 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, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced excessive sweating at night. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced pain on her left arm. On 31-MAR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced loss of ability to taste food and metallic taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive sweating at night, chills, and fatigue on 02-APR-2021, was recovering from pain on her left arm, and had not recovered from loss of ability to taste food and metallic taste. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: FELLING WARM TO TOUCH AT INJECTION SITE; INJECTION SITE SWOLLEN ARM; INJECTION SITE PAIN; REDNESS OF INJECTION SITE; This spontaneous report received from a patient 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced felling warm to touch at injection site, injection site swollen arm, injection site pain, and redness of injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site swollen arm, redness of injection site, felling warm to touch at injection site and injection site pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: ITCHY RASH ALL OVER THE BODY AND LOOK LIKE CHICKEN POX; RASH ALL OVER THE BODY; 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced itchy rash all over the body and look like chicken pox. On 24-MAR-2021, the subject experienced rash all over the body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, cetirizine hydrochloride, methylprednisolone, and hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash all over the body, and itchy rash all over the body and look like chicken pox. This report was non-serious.