chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vulvovaginal pruritus
Clinical narrative: VAGINAL ITCHING; DIARRHEA; LIGHT HEADED; CHILLS; FEVER; NAUSEA; HEADACHE; EXHAUSTION; This spontaneous report received from a patient concerned a 72 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) 1 in total, dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced diarrhea. On 10-MAR-2021, the subject experienced light headed. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced exhaustion. On 14-MAR-2021, the subject experienced vaginal itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaginal itching, headache, fever, chills, diarrhea, nausea, light headed and exhaustion was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hypokinesia, Pyrexia
Clinical narrative: FEVER; COULD NOT MOVE; 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced could not move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and could not move. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Injection site pain, Mass
Clinical narrative: HARD, WHITE, NON-PAINFUL LUMP ON HER UPPER GUM ABOVE HER FRONT TEETH WHICH PATIENT REFERRED TO AS MOUTH ULCERS; A COUPLE OF HOT FLASHES; TIREDNESS; SORE ARM WHERE VACCINATED; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031,  expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 in left arm  16:45 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced a couple of hot flashes. On 09-MAR-2021, the subject experienced tiredness. On 09-MAR-2021, the subject experienced sore arm where vaccinated. On 12-MAR-2021, the subject experienced hard, white, non-painful lump on her upper gum above her front teeth which subject referred to as mouth ulcers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a couple of hot flashes, tiredness, and sore arm where vaccinated on 09-MAR-2021, and had not recovered from hard, white, non-painful lump on her upper gum above her front teeth which patient referred to as mouth ulcers. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Furuncle, Headache, Nausea
Clinical narrative: LUMPS/BOIL ON GROIN AREA OUTSIDE VAGINAL SIDE; PAIN TO BOIL WHICH MAKES IT DIFFICULT TO WALK; CHILLS; TIRED; FEVER; FEELING OF THROWING UP; HEADACHE; SWELLING OF FINGERS; SWELLING OF TOES; 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 celiac disease, hashimoto's thyroiditis, and reactive arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced swelling of fingers. On 13-MAR-2021, the subject experienced swelling of toes. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced tired. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced feeling of throwing up. On 13-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced lumps/boil on groin area outside vaginal side. On 16-MAR-2021, the subject experienced pain to boil which makes it difficult to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of fingers, swelling of toes, chills, fever, feeling of throwing up, and headache on MAR-2021, was recovering from tired, and had not recovered from lumps/boil on groin area outside vaginal side, and pain to boil which makes it difficult to walk. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain, Peripheral swelling, Pyrexia
Clinical narrative: LUMPS/BOIL ON GROIN AREA OUTSIDE VAGINAL SIDE; PAIN TO BOIL WHICH MAKES IT DIFFICULT TO WALK; CHILLS; TIRED; FEVER; FEELING OF THROWING UP; HEADACHE; SWELLING OF FINGERS; SWELLING OF TOES; 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 celiac disease, hashimoto's thyroiditis, and reactive arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced swelling of fingers. On 13-MAR-2021, the subject experienced swelling of toes. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced tired. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced feeling of throwing up. On 13-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced lumps/boil on groin area outside vaginal side. On 16-MAR-2021, the subject experienced pain to boil which makes it difficult to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of fingers, swelling of toes, chills, fever, feeling of throwing up, and headache on MAR-2021, was recovering from tired, and had not recovered from lumps/boil on groin area outside vaginal side, and pain to boil which makes it difficult to walk. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling cold, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: FEELING COLD; SWEAT; BACK PAIN; LEG PAIN AND PAIN IN LEFT ARM; FEVER; Injection site pain; PAIN IN BACK OF HEAD; MUSCLE PAIN BOTH LEGS; 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: 805020,  expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced feeling cold. On MAR-2021, the subject experienced sweat. On MAR-2021, the subject experienced back pain. On MAR-2021, the subject experienced leg pain and pain in left arm. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced injection site pain. On MAR-2021, the subject experienced pain in back of head. On MAR-2021, the subject experienced muscle pain both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, leg pain and pain in left arm, pain in back of head, back pain, sweat, injection site pain, muscle pain both legs and feeling cold was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: FEELING COLD; SWEAT; BACK PAIN; LEG PAIN AND PAIN IN LEFT ARM; FEVER; Injection site pain; PAIN IN BACK OF HEAD; MUSCLE PAIN BOTH LEGS; 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: 805020,  expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced feeling cold. On MAR-2021, the subject experienced sweat. On MAR-2021, the subject experienced back pain. On MAR-2021, the subject experienced leg pain and pain in left arm. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced injection site pain. On MAR-2021, the subject experienced pain in back of head. On MAR-2021, the subject experienced muscle pain both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, leg pain and pain in left arm, pain in back of head, back pain, sweat, injection site pain, muscle pain both legs and feeling cold was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HIGH FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-MAR-2021. 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Haematuria, Injection site pain
Clinical narrative: INJECTION SITE PAIN; BLOOD IN URINE; ARM REDNESS; This spontaneous report received from a pharmacist 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, intramuscular, batch number: 1805031, expiry: 26-MAY-2021) 0.5 ml, administered on left arm on 15-MAR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced blood in urine. On MAR-2021, the subject experienced arm redness. On 15-MAR-2021, the subject experienced injection site pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood in urine, and the outcome of injection site pain and arm redness was not reported. 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: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE ARM ON THE SITE OF VACCINATION; 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) 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 sore arm on the site of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on the site of vaccination. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling abnormal, Heart rate increased
Clinical narrative: SENSITIVE TO TOUCH; SWELLING UNDER ARMPIT; FOGGY FEELING IN HEAD; PAIN BELOW INJECTION SITE; FAST HEART BEAT; SHOULDER PAIN; CHILLS; FEVER; 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: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.5 (units unspecified). On 16-MAR-2021 18:45, the subject experienced fast heart beat. On 16-MAR-2021 18:45, the subject experienced shoulder pain. On 16-MAR-2021 18:45, the subject experienced chills. On 16-MAR-2021 18:45, the subject experienced fever. On 17-MAR-2021, the subject experienced sensitive to touch. On 17-MAR-2021, the subject experienced swelling under armpit. On 17-MAR-2021, the subject experienced foggy feeling in head. On 17-MAR-2021, the subject experienced pain below injection site.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fast heart beat, fever, shoulder pain, foggy feeling in head, swelling under armpit, pain below injection site and sensitive to touch was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hyperaesthesia, Injection site pain, Pyrexia, Swelling
Clinical narrative: SENSITIVE TO TOUCH; SWELLING UNDER ARMPIT; FOGGY FEELING IN HEAD; PAIN BELOW INJECTION SITE; FAST HEART BEAT; SHOULDER PAIN; CHILLS; FEVER; 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: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.5 (units unspecified). On 16-MAR-2021 18:45, the subject experienced fast heart beat. On 16-MAR-2021 18:45, the subject experienced shoulder pain. On 16-MAR-2021 18:45, the subject experienced chills. On 16-MAR-2021 18:45, the subject experienced fever. On 17-MAR-2021, the subject experienced sensitive to touch. On 17-MAR-2021, the subject experienced swelling under armpit. On 17-MAR-2021, the subject experienced foggy feeling in head. On 17-MAR-2021, the subject experienced pain below injection site.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fast heart beat, fever, shoulder pain, foggy feeling in head, swelling under armpit, pain below injection site and sensitive to touch was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS, FEVER, BODY PAIN AND HEADACHE; This spontaneous report received from a consumer concerned a 24 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 16:30 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On 16-MAR-2021, the subject experienced flu-like symptoms, fever, body pain and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, fever, body pain and headache on MAR-2021. This report was non-serious.   Additional information was received from consumer on 24-MAR-2021 following information was updated and incorporated into case narrative: The outcome of the event flu-like symptoms, fever, body pain and headache was changed from recovering to recovered and event stop date added.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersensitivity, Pain
Clinical narrative: ACHY; FATIGUE; HEADACHE; SINUS-ALLERGY LIKE SYMPTOMS; 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 was not reported, administered on 12-MAR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-MAR-2021, the patient experienced achy, experienced fatigue, headache and sinus-allergy like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy, fatigue, headache and sinus-allergy like symptoms was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Headache, Myalgia, Neck pain
Clinical narrative: TEMPERATURE (FEVER); ACHING NECK; ACHING BACK; MUSCLE SORENESS ARMS; HEADACHE; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included atrial fibrillation, and other pre-existing medical conditions included patient had no known allergies and patient reported he had not done any exercise/physical activity or weight lifting the day prior to vaccination or after vaccination. the patient reported no prior history of reaction to vaccination in the past and no previous vaccination in the past 30 days.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 13:30 to Left Arm for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, and dofetilide for atrial fibrillation. On 16-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 16-MAR-2021 21:00, the subject experienced aching neck. On 16-MAR-2021 21:00, the subject experienced aching back. On 16-MAR-2021 21:00, the subject experienced muscle soreness arms. On 17-MAR-2021, the subject experienced temperature (fever). On 17-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature (fever) on 17-MAR-2021, and was recovering from aching neck, aching back, muscle soreness arms, and headache. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: TEMPERATURE (FEVER); ACHING NECK; ACHING BACK; MUSCLE SORENESS ARMS; HEADACHE; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included atrial fibrillation, and other pre-existing medical conditions included patient had no known allergies and patient reported he had not done any exercise/physical activity or weight lifting the day prior to vaccination or after vaccination. the patient reported no prior history of reaction to vaccination in the past and no previous vaccination in the past 30 days.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 13:30 to Left Arm for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, and dofetilide for atrial fibrillation. On 16-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 16-MAR-2021 21:00, the subject experienced aching neck. On 16-MAR-2021 21:00, the subject experienced aching back. On 16-MAR-2021 21:00, the subject experienced muscle soreness arms. On 17-MAR-2021, the subject experienced temperature (fever). On 17-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature (fever) on 17-MAR-2021, and was recovering from aching neck, aching back, muscle soreness arms, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: MILD SIDE EFFECTS AFTER THE SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 mild side effects after the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects after the shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dehydration, Pain, Pyrexia
Clinical narrative: Dehydrated; SHIVERING; Fever; Body aches; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 16-MAR-2021 21:00, the subject experienced body aches. On 16-MAR-2021 22:30, the subject experienced shivering. On 16-MAR-2021 22:30, the subject experienced fever. On 17-MAR-2021 01:30, the subject experienced dehydrated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and the outcome of fever, shivering and dehydrated was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itching was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM TO TOUCH IS STILL SORE 10 DAYS  LATER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced arm to touch is still sore 10 days later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm to touch is still sore 10 days later was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 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 16-MAR-2021, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness in arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.0 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: HEADACHE; NAUSEAS; FATIGUE; ALMOST FAINTING SENSATION; SWEATING; BLURRY VISION; COLD ARMS; This spontaneous report received from a patient 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: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on right deltoid. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced cold arms. On 16-MAR-2021, the subject experienced almost fainting sensation. On 16-MAR-2021, the subject experienced blurry vision. On 16-MAR-2021, the subject experienced sweating. On 16-MAR-2021, the subject experienced nauseas. On 16-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 17-MAR-2021, and had not recovered from almost fainting sensation, cold arms, blurry vision, sweating, nauseas, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vision blurred
Clinical narrative: HEADACHE; NAUSEAS; FATIGUE; ALMOST FAINTING SENSATION; SWEATING; BLURRY VISION; COLD ARMS; This spontaneous report received from a patient 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: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on right deltoid. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced cold arms. On 16-MAR-2021, the subject experienced almost fainting sensation. On 16-MAR-2021, the subject experienced blurry vision. On 16-MAR-2021, the subject experienced sweating. On 16-MAR-2021, the subject experienced nauseas. On 16-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 17-MAR-2021, and had not recovered from almost fainting sensation, cold arms, blurry vision, sweating, nauseas, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: STIFF NECK (CANT TURN HEAD TO THE RIGHT); RIGHT ARM PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 16-MAR-2021 18:39 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced stiff neck (cant turn head to the right). On 17-MAR-2021, the subject experienced right arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff neck (cant turn head to the right), and right arm pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: HEADACHE; MUSCLE AID; 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, vaccinated on left deltoid, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced muscle aid. On 16-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscle aid, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Sinus pain, Toothache
Clinical narrative: VOMITING; TEETH PAIN; SINUS PAIN; CHILLS; FEVER; NAUSEA; 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 shellfish allergy. 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced teeth pain. On 15-MAR-2021, the subject experienced sinus pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient was recovering from fever, chills, nausea, vomiting, teeth pain, and sinus pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; TEETH PAIN; SINUS PAIN; CHILLS; FEVER; NAUSEA; 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 shellfish allergy. 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced teeth pain. On 15-MAR-2021, the subject experienced sinus pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient was recovering from fever, chills, nausea, vomiting, teeth pain, and sinus pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; 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: ZM021B0101) 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. Concomitant medications included macitentan for drug used for unknown indication. On an unspecified date, the subject experienced rash. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness, Gait disturbance
Clinical narrative: fever; chills; body aches; DIZZY / LIGHT HEADED; SHAKING; barely walk; stomach cramps; diarrhea; 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 was not reported, administered on 16-MAR-2021 16:00 PM for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced barely walk. On 16-MAR-2021, the subject experienced stomach cramps. On 16-MAR-2021, the subject experienced diarrhea. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021 18:00 PM , the subject experienced dizzy / light headed. On 16-MAR-2021 18:00 PM, the subject experienced shaking. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy / light headed, shaking, barely walk, stomach cramps, diarrhea, fever, chills, body aches and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Tremor
Clinical narrative: fever; chills; body aches; DIZZY / LIGHT HEADED; SHAKING; barely walk; stomach cramps; diarrhea; 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 was not reported, administered on 16-MAR-2021 16:00 PM for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced barely walk. On 16-MAR-2021, the subject experienced stomach cramps. On 16-MAR-2021, the subject experienced diarrhea. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021 18:00 PM , the subject experienced dizzy / light headed. On 16-MAR-2021 18:00 PM, the subject experienced shaking. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy / light headed, shaking, barely walk, stomach cramps, diarrhea, fever, chills, body aches and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: EXTRACTING MORE THAN 5 DOSES; OFF LABEL USE; 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, start therapy date were not reported for prophylactic vaccination. The batch number is 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 extracting more than 5 doses, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extracting more than 5 doses and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a 63 year old of unspecified sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: LETHARGIC; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 53 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 02:48 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced lethargic. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, chills, and low grade fever. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: PAIN IN ARMPIT WHERE VACCINE WAS ADMINISTERED; DISCOMFORT IN ARMPIT WHERE VACCINE WAS ADMINISTERED; 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: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain in armpit where vaccine was administered, and discomfort in armpit where vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in armpit where vaccine was administered and discomfort in armpit where vaccine was administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: SWEATING; CHILLS; WEAKNESS; HEADACHE; SORENESS LEFT ARM; This spontaneous report received from a parent concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included occasional migraine headaches, and other pre-existing medical conditions included the patient has no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination, on left arm. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced soreness left arm. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced weakness. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021 19:00, treatment medications included: paracetamol. On 17-MAR-2021, the subject experienced sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness left arm, chills, weakness, headache and sweating was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: INCORRECT DOSE ADMINISTERED; 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: 1805020, and 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 incorrect dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of incorrect dose administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; FATIGUE; 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 13-MAR-2021 for prophylactic vaccination. The batch number is 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 sore arm. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: FLU SYMPTOMS; SORE ON THE INJECTION SITE; This spontaneous report received from a patient via Facebook account 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 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced flu symptoms, and sore on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms, and sore on the injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Headache, Nausea, Pyrexia
Clinical narrative: SHAKING; FREEZING; TEENSY BIT GROGGY; FEVER; BAD HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient 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 09-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 shaking. On MAR-2021, the subject experienced freezing. On MAR-2021, the subject experienced teensy bit groggy. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced bad headache. On MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.4 Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, freezing, teensy bit groggy, fever, and nausea on 14-MAR-2021, and had not recovered from bad headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: SHAKING; FREEZING; TEENSY BIT GROGGY; FEVER; BAD HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient 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 09-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 shaking. On MAR-2021, the subject experienced freezing. On MAR-2021, the subject experienced teensy bit groggy. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced bad headache. On MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.4 Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, freezing, teensy bit groggy, fever, and nausea on 14-MAR-2021, and had not recovered from bad headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Product colour issue
Clinical narrative: LIGHT-HEADEDNESS; VACCINE IN THE SYRINGE WAS PINK IN COLOR WHEN ADMINISTERED; 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: 180531, and batch number: 180531 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 vaccine in the syringe was pink in color when administered. On 13-MAR-2021, the subject experienced light-headedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headedness on 14-MAR-2021, and the outcome of vaccine in the syringe was pink in color when administered was not reported. This report was non-serious.