chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Herpes zoster, Hypertension, Injection site pruritus, Nervousness
Clinical narrative: SHINGLES; ELEVATED BLOOD PRESSURE; NERVOUSNESS; ANXIOUNESS; INJECTION SITE ITCHINESS; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder, and blood pressure disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029,  expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination to the right arm. No concomitant medications were reported. On 11-MAR-2021, the subject experienced injection site itchiness. On 13-MAR-2021, the subject experienced shingles. On 13-MAR-2021, the subject experienced elevated blood pressure. On 13-MAR-2021, the subject experienced nervousness. On 13-MAR-2021, the subject experienced anxiouness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shingles on 15-MAR-2021, and injection site itchiness, and had not recovered from elevated blood pressure, nervousness, and anxiouness. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; TEMPERATURE 103; HEADACHE; This spontaneous report received from a consumer concerned a 32 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced body ache. On 25-MAR-2021, the subject experienced temperature 103. On 25-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature 103, headache and body ache was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: WHOLE BODY HURTS; VOMITING; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 28 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:15 in left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, approximately at 16:00 the subject experienced whole body hurts. On 24-MAR-2021, approximately at 16:00 the subject experienced vomiting. On 24-MAR-2021, approximately at 16:00 the subject experienced fever. On 24-MAR-2021, approximately at 16:00 the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from whole body hurts, fever, headache, and vomiting. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: ARM PAIN; BED RIDDEN; FEVER; BODY ACHE; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 02:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 23-MAR-2021 22:00, the subject experienced headache. On 23-MAR-2021 22:00, the subject experienced body ache. On 24-MAR-2021, the subject experienced arm pain. On 24-MAR-2021, the subject experienced bed ridden. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body ache, arm pain, bed ridden and fever was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Nausea
Clinical narrative: CHILLS; LOW GRADE TEMP; STOMACH CHURNING; CONSTANT HEADACHE SINCE WAKING UP; BODY ACHES; WEAKNESS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included headaches. 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 left arm on 24-MAR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced weakness. On 24-MAR-2021, the subject experienced stomach churning. On 24-MAR-2021, the subject experienced constant headache since waking up. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced low grade temp. Laboratory data included: Body temperature (NR: not provided) 100.3 (unspecified unit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach churning, and had not recovered from body aches, low grade temp, chills, weakness, and constant headache since waking up. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: CHILLS; LOW GRADE TEMP; STOMACH CHURNING; CONSTANT HEADACHE SINCE WAKING UP; BODY ACHES; WEAKNESS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included headaches. 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 left arm on 24-MAR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced weakness. On 24-MAR-2021, the subject experienced stomach churning. On 24-MAR-2021, the subject experienced constant headache since waking up. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced low grade temp. Laboratory data included: Body temperature (NR: not provided) 100.3 (unspecified unit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach churning, and had not recovered from body aches, low grade temp, chills, weakness, and constant headache since waking up. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site discomfort, Injection site pain
Clinical narrative: MINIMAL DISCOMFORT AT THE INJECTION LOCATION; TIREDNESS; HEADACHE; SORE TO THE TOUCH ONLY; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient has blood type of a (RH negative).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on right arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced minimal discomfort at the injection location. On 21-MAR-2021, the subject experienced tiredness. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced sore to the touch only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from minimal discomfort at the injection location, tiredness, headache, and sore to the touch only. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: COUGHING; SORENESS; THROAT HURTS; WEAKNESS; NOT FEELING WELL; FACE IS SWOLLEN; TIREDNESS; This spontaneous report received from a consumer concerned a 60 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination vaccinated on left deltoid. No concomitant medications were reported. On an unspecified date, the subject experienced coughing, tiredness, soreness, throat hurts, weakness, not feeling well, and face is swollen. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the coughing, tiredness, soreness, throat hurts, weakness, not feeling well and face is swollen was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling face
Clinical narrative: COUGHING; SORENESS; THROAT HURTS; WEAKNESS; NOT FEELING WELL; FACE IS SWOLLEN; TIREDNESS; This spontaneous report received from a consumer concerned a 60 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination vaccinated on left deltoid. No concomitant medications were reported. On an unspecified date, the subject experienced coughing, tiredness, soreness, throat hurts, weakness, not feeling well, and face is swollen. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the coughing, tiredness, soreness, throat hurts, weakness, not feeling well and face is swollen was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Musculoskeletal stiffness, Pain
Clinical narrative: BODY ACHES; FEELING COLD; FEELING HOT; BODY STIFFNESS; This spontaneous report received from a parent concerned a 23 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 07:00 in left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced feeling cold. On 25-MAR-2021, the subject experienced feeling hot. On 25-MAR-2021, the subject experienced body stiffness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, feeling cold, feeling hot and body stiffness was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: INJECTION SITE PAIN; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced injection site pain. On 23-MAR-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, and had not recovered from swelling at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN ARMS AND HAND; 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, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced pain in arms and hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arms and hand. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; 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: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Vaccinated at left arm. No concomitant medications were reported. On 24-MAR-2021, the subject experienced headache. On 24-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 25-MAR-2021, and had not recovered from headache. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Bone pain, Injection site erythema, Injection site reaction
Clinical narrative: INJECTION SITE IS HARD AS A ROCK; GENERALLY DOES NOT FEEL WELL; ARMS HURT WHILE TRYING TO USE THEM; INJECTION SITE DOUBLE IN SIZE; INJECTION SITE BRIGHT RED; FEVER; FEELING WEAK; HURTS ALL OVER BODY; BONES ACHING (HAS ARTHRITIS); LEFT ARM USELESS; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included raynaud's disease, lupus, arthritis, penicillin allergy, and red dye 40 allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left arm useless. On 24-MAR-2021, the subject experienced trouble sleeping. On 24-MAR-2021, the subject experienced hurts all over body. On 24-MAR-2021, the subject experienced feeling weak. On 24-MAR-2021, the subject experienced bones aching (has arthritis). On 24-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 C. On 25-MAR-2021, the subject experienced injection site is hard as a rock. On 25-MAR-2021, the subject experienced generally does not feel well. On 25-MAR-2021, the subject experienced arms hurt while trying to use them. On 25-MAR-2021, the subject experienced injection site double in size. On 25-MAR-2021, the subject experienced injection site bright red. Laboratory data included: Body temperature (NR: not provided) 101.5 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling weak, injection site is hard as a rock, arms hurt while trying to use them, generally does not feel well, fever, bones aching (has arthritis), hurts all over body, left arm useless, injection site double in size, injection site bright red, and trouble sleeping. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Insomnia, Malaise, Movement disorder, Pain
Clinical narrative: INJECTION SITE IS HARD AS A ROCK; GENERALLY DOES NOT FEEL WELL; ARMS HURT WHILE TRYING TO USE THEM; INJECTION SITE DOUBLE IN SIZE; INJECTION SITE BRIGHT RED; FEVER; FEELING WEAK; HURTS ALL OVER BODY; BONES ACHING (HAS ARTHRITIS); LEFT ARM USELESS; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included raynaud's disease, lupus, arthritis, penicillin allergy, and red dye 40 allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left arm useless. On 24-MAR-2021, the subject experienced trouble sleeping. On 24-MAR-2021, the subject experienced hurts all over body. On 24-MAR-2021, the subject experienced feeling weak. On 24-MAR-2021, the subject experienced bones aching (has arthritis). On 24-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 C. On 25-MAR-2021, the subject experienced injection site is hard as a rock. On 25-MAR-2021, the subject experienced generally does not feel well. On 25-MAR-2021, the subject experienced arms hurt while trying to use them. On 25-MAR-2021, the subject experienced injection site double in size. On 25-MAR-2021, the subject experienced injection site bright red. Laboratory data included: Body temperature (NR: not provided) 101.5 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling weak, injection site is hard as a rock, arms hurt while trying to use them, generally does not feel well, fever, bones aching (has arthritis), hurts all over body, left arm useless, injection site double in size, injection site bright red, and trouble sleeping. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: INJECTION SITE IS HARD AS A ROCK; GENERALLY DOES NOT FEEL WELL; ARMS HURT WHILE TRYING TO USE THEM; INJECTION SITE DOUBLE IN SIZE; INJECTION SITE BRIGHT RED; FEVER; FEELING WEAK; HURTS ALL OVER BODY; BONES ACHING (HAS ARTHRITIS); LEFT ARM USELESS; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included raynaud's disease, lupus, arthritis, penicillin allergy, and red dye 40 allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left arm useless. On 24-MAR-2021, the subject experienced trouble sleeping. On 24-MAR-2021, the subject experienced hurts all over body. On 24-MAR-2021, the subject experienced feeling weak. On 24-MAR-2021, the subject experienced bones aching (has arthritis). On 24-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 C. On 25-MAR-2021, the subject experienced injection site is hard as a rock. On 25-MAR-2021, the subject experienced generally does not feel well. On 25-MAR-2021, the subject experienced arms hurt while trying to use them. On 25-MAR-2021, the subject experienced injection site double in size. On 25-MAR-2021, the subject experienced injection site bright red. Laboratory data included: Body temperature (NR: not provided) 101.5 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling weak, injection site is hard as a rock, arms hurt while trying to use them, generally does not feel well, fever, bones aching (has arthritis), hurts all over body, left arm useless, injection site double in size, injection site bright red, and trouble sleeping. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: ELEVATED HEARTBEAT; LIGHT-HEADEDNESS; SHORTNESS OF BREATH DURING THE NIGHT; 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 13:00 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the patient experienced shortness of breath during the night. On 25-MAR-2021, the patient experienced elevated heartbeat. On 25-MAR-2021, the patient experienced light-headedness. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Average of 120. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated heartbeat, and light-headedness, and the outcome of shortness of breath during the night was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: DIZZINESS; SWOLLEN LIPS; UPSET STOMACH; NUMB LIPS; CHILLS; MUSCLE ACHES; HEADACHE; FEVER; NAUSEA; FATIGUE/TIREDNESS; SWEATS; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Vaccinated at left arm. No concomitant medications were reported. On MAR-2021, the subject experienced sweats. On 20-MAR-2021, the subject experienced fatigue/tiredness. On 21-MAR-2021, the subject experienced swollen lips. On 21-MAR-2021, the subject experienced dizziness. On 21-MAR-2021, the subject experienced upset stomach. On 21-MAR-2021, the subject experienced numb lips. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced muscle aches. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lips, upset stomach, numb lips, muscle aches, headache, and nausea, and had not recovered from fatigue/tiredness, dizziness, fever, chills, and sweats. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia oral, Lip swelling, Myalgia, Nausea
Clinical narrative: DIZZINESS; SWOLLEN LIPS; UPSET STOMACH; NUMB LIPS; CHILLS; MUSCLE ACHES; HEADACHE; FEVER; NAUSEA; FATIGUE/TIREDNESS; SWEATS; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Vaccinated at left arm. No concomitant medications were reported. On MAR-2021, the subject experienced sweats. On 20-MAR-2021, the subject experienced fatigue/tiredness. On 21-MAR-2021, the subject experienced swollen lips. On 21-MAR-2021, the subject experienced dizziness. On 21-MAR-2021, the subject experienced upset stomach. On 21-MAR-2021, the subject experienced numb lips. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced muscle aches. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lips, upset stomach, numb lips, muscle aches, headache, and nausea, and had not recovered from fatigue/tiredness, dizziness, fever, chills, and sweats. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DIZZINESS; SWOLLEN LIPS; UPSET STOMACH; NUMB LIPS; CHILLS; MUSCLE ACHES; HEADACHE; FEVER; NAUSEA; FATIGUE/TIREDNESS; SWEATS; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Vaccinated at left arm. No concomitant medications were reported. On MAR-2021, the subject experienced sweats. On 20-MAR-2021, the subject experienced fatigue/tiredness. On 21-MAR-2021, the subject experienced swollen lips. On 21-MAR-2021, the subject experienced dizziness. On 21-MAR-2021, the subject experienced upset stomach. On 21-MAR-2021, the subject experienced numb lips. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced muscle aches. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lips, upset stomach, numb lips, muscle aches, headache, and nausea, and had not recovered from fatigue/tiredness, dizziness, fever, chills, and sweats. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site pain, SARS-CoV-2 test, Scar
Clinical narrative: HORIZONTAL LINE ON SKIN THAT LOOKED LIKE A SCAR ON ARM; COVID-19 (FATIGUE, HEADACHE, LOSS OF TASTE AND SMELL); TENDERNESS AT THE INJECTION SITE / ROPY FEELING AT THE INJECTION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 17:00 PM for prophylactic vaccination.  Batch number was not reported has been requested No concomitant medications were reported. On 06-MAR-2021, the subject experienced tenderness at the injection site / ropy feeling at the injection site. On 08-MAR-2021, the subject experienced covid-19 (fatigue, headache, loss of taste and smell). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAR-2021, the subject experienced horizontal line on skin that looked like a scar on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 (fatigue, headache, loss of taste and smell), and the outcome of horizontal line on skin that looked like a scar on arm and tenderness at the injection site / ropy feeling at the injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210329102.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE PAIN THROUGHOUT THE BODY; This spontaneous report received from a consumer concerned a 43 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, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced muscle pain throughout the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain throughout the body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Treatment noncompliance
Clinical narrative: PATIENT DID NOT TAKE THE PRODUCT AS DIRECTED; HEADACHE; FATIGUE; 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, and batch number were not reported) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced subject did not take the product as directed. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fatigue and patient did not take the product as directed was not reported. This report was non-serious. This case, from the same reporter is linked to 20210345977.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; PEDIATRIC ADMINISTRATION; This spontaneous report received from a health care professional concerned a 17 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 25-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 25-MAR-2021, the subject experienced pediatric administration. On an unspecified date, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pediatric administration and off label use was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eye pain, Fatigue, Headache, Injection site bruising
Clinical narrative: BODY ACHES; EYES HURT AND WERE SENSITIVE TO LIGHT; MUSCLE CRAMPS; EYES HURT; BRUISE AT INJECTION SITE; RASH AT INJECTION SITE; WEAKNESS; TIREDNESS; EXTREME HEADACHE; FEVER; This spontaneous report received from a patient concerned a 30 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: 1805018 expiry: UNKNOWN) dose was not reported, once a total administered on 23-MAR-2021 vaccinated at left arm, for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced eyes hurt and were sensitive to light. On 24-MAR-2021, the subject experienced muscle cramps. On 24-MAR-2021, the subject experienced eyes hurt. On 24-MAR-2021, the subject experienced bruise at injection site. On 24-MAR-2021, the subject experienced rash at injection site. On 24-MAR-2021, the subject experienced weakness. On 24-MAR-2021, the subject experienced tiredness. On 24-MAR-2021, the subject experienced extreme headache. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, extreme headache, muscle cramps, eyes hurt and were sensitive to light, bruise at injection site, rash at injection site, weakness, tiredness, body aches and eyes hurt was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Muscle spasms, Pain, Photophobia, Pyrexia
Clinical narrative: BODY ACHES; EYES HURT AND WERE SENSITIVE TO LIGHT; MUSCLE CRAMPS; EYES HURT; BRUISE AT INJECTION SITE; RASH AT INJECTION SITE; WEAKNESS; TIREDNESS; EXTREME HEADACHE; FEVER; This spontaneous report received from a patient concerned a 30 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: 1805018 expiry: UNKNOWN) dose was not reported, once a total administered on 23-MAR-2021 vaccinated at left arm, for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced eyes hurt and were sensitive to light. On 24-MAR-2021, the subject experienced muscle cramps. On 24-MAR-2021, the subject experienced eyes hurt. On 24-MAR-2021, the subject experienced bruise at injection site. On 24-MAR-2021, the subject experienced rash at injection site. On 24-MAR-2021, the subject experienced weakness. On 24-MAR-2021, the subject experienced tiredness. On 24-MAR-2021, the subject experienced extreme headache. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, extreme headache, muscle cramps, eyes hurt and were sensitive to light, bruise at injection site, rash at injection site, weakness, tiredness, body aches and eyes hurt was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Feeling abnormal, Myalgia, Pruritus
Clinical narrative: ITCHY; STRANGE; REDNESS ON HER FEET; WEAK; MUSCLE SORENESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included patient takes a vitamin b for her hair. 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 25-MAR-2021 10:00 in left deltoid for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced itchy. On 25-MAR-2021, the subject experienced strange. On 25-MAR-2021, the subject experienced redness on her feet. On 25-MAR-2021, the subject experienced weak. On 25-MAR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness on her feet, and the outcome of muscle soreness, itchy, weak and strange was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Pain
Clinical narrative: BODY PAIN; DIZZINESS; HEAD FOGNESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced body pain. On 22-MAR-2021, the subject experienced dizziness. On 22-MAR-2021, the subject experienced head fogness. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced headache. On 22-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, body pain, dizziness, head fogness, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY PAIN; DIZZINESS; HEAD FOGNESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced body pain. On 22-MAR-2021, the subject experienced dizziness. On 22-MAR-2021, the subject experienced head fogness. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced headache. On 22-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, body pain, dizziness, head fogness, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Rash
Clinical narrative: RASH ALL OVER BODY AND FACE; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included 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: 1805031, expiry: unknown) (vaccinated at right arm) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced rash all over body and face. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, headache, and fever on 20-MAR-2021, and had not recovered from rash all over body and face. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: ACHES; CHILLS; FATIGUE; HEADACHE; FEVERISH; 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, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced fatigue. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, fatigue, headache, and feverish on 25-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to peg.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 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 chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pain, Swelling
Clinical narrative: PAIN NEAR THE EAR AND UNDER THE CHIN; CANNOT  SLEEP; FEELS SWOLLEN; PAIN IN SHOULDER; 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced pain near the ear and under the chin. On 25-MAR-2021, the subject experienced cannot sleep. On 25-MAR-2021, the subject experienced feels swollen. On 25-MAR-2021, the subject experienced pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in shoulder, cannot sleep, pain near the ear and under the chin, and feels swollen. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Culture
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, Laboratory data included: Culture nose (NR: not provided) COVID-19 positive. On 26-MAR-2021, the subject experienced confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Injection site bruising, Injection site pain, Muscle spasms
Clinical narrative: LEG CRAMPS; SLEPT ALL DAY; FELT LIKE LITTLE BRUISE; PAIN WHERE NEEDLE PUNCTURED  SKIN; TIRED/EXHAUSTED/NEEDED A NAP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-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 an unspecified date, the subject experienced leg cramps, slept all day, felt like little bruise, pain where needle punctured skin, and tired/exhausted/needed a nap. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain where needle punctured skin, felt like little bruise, tired/exhausted/needed a nap, slept all day and leg cramps was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Fatigue, Headache, Pyrexia
Clinical narrative: STOMACH ACHE; FEVER; TIREDNESS; HEADACHE; PAIN IN LOWER BACK; This spontaneous report received from a patient concerned a 19 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 drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, 1 total, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced pain in lower back. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021 12:00, the subject experienced stomach ache. On 26-MAR-2021 12:00, the subject experienced fever. On 26-MAR-2021 12:00, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and had not recovered from headache, fever, stomach ache, and pain in lower back. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: DIZZINESS; HEADACHE; 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 not reported) dose was not reported, administered on 15-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 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, dizziness and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: SORENESS; CHILLS; LIGHT FEVER; This spontaneous report received from a patient via an unspecified company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The unspecified company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced soreness. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced light fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, soreness and light fever was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 57 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: expiry date: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced chills. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 2021. This report was non-serious.