chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SLIGHT FEVER; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight fever on 06-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dermatitis, Fatigue, Headache
Clinical narrative: Skin itchy; Skin inflamed; HANDS SWOLLEN; COUGH; NAUSEA; FATIGUE; SKIN IRRITATION; LOW GRADE TEMP; INJECTION SITE SORENESS; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included high blood pressure, and non allergic sinusitis, and allergy to codeine and black mold. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 10:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced headache, muscle aches, skin irritation left like skin itchy and skin inflamed but no rash, low grade temperature 99.9, injection site soreness.  On 05-MAR-2021, the patient experienced nausea. On 05-MAR-2021, the patient experienced fatigue and cough. On 06-MAR-2021, the patient experienced hands swollen. Treatment medications (dates unspecified) included: paracetamol for headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and cough on 06-MAR-2021, was recovering from headache, muscle aches, fatigue, and skin irritation, had not recovered from low grade temp, injection site soreness, and hands swollen, and the outcome of skin itchy and skin inflamed was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Skin itchy; Skin inflamed; HANDS SWOLLEN; COUGH; NAUSEA; FATIGUE; SKIN IRRITATION; LOW GRADE TEMP; INJECTION SITE SORENESS; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included high blood pressure, and non allergic sinusitis, and allergy to codeine and black mold. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 10:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced headache, muscle aches, skin irritation left like skin itchy and skin inflamed but no rash, low grade temperature 99.9, injection site soreness.  On 05-MAR-2021, the patient experienced nausea. On 05-MAR-2021, the patient experienced fatigue and cough. On 06-MAR-2021, the patient experienced hands swollen. Treatment medications (dates unspecified) included: paracetamol for headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and cough on 06-MAR-2021, was recovering from headache, muscle aches, fatigue, and skin irritation, had not recovered from low grade temp, injection site soreness, and hands swollen, and the outcome of skin itchy and skin inflamed was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin irritation
Clinical narrative: Skin itchy; Skin inflamed; HANDS SWOLLEN; COUGH; NAUSEA; FATIGUE; SKIN IRRITATION; LOW GRADE TEMP; INJECTION SITE SORENESS; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included high blood pressure, and non allergic sinusitis, and allergy to codeine and black mold. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 10:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced headache, muscle aches, skin irritation left like skin itchy and skin inflamed but no rash, low grade temperature 99.9, injection site soreness.  On 05-MAR-2021, the patient experienced nausea. On 05-MAR-2021, the patient experienced fatigue and cough. On 06-MAR-2021, the patient experienced hands swollen. Treatment medications (dates unspecified) included: paracetamol for headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and cough on 06-MAR-2021, was recovering from headache, muscle aches, fatigue, and skin irritation, had not recovered from low grade temp, injection site soreness, and hands swollen, and the outcome of skin itchy and skin inflamed was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer (patient's husband) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025) dose and vaccination anatomical site not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED ADVERSE EVENTS; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the subject experienced unspecified adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse events was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Acne, Pain in extremity
Clinical narrative: WHITE ZITS ON LEFT CHEEK; SORE ARM; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, the patient experienced sore arm. On 06-MAR-2021, the patient experienced white zits on left cheek. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 05-MAR-2021, and had not recovered from white zits on left cheek. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: LEG CRAMPS ON BOTH SIDES AND ARM CRAMPS ON LEFT SIDE (INJECTION SIDE); ARM PAIN ON LEFT SHOULDER AND LEG PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, anxiety, seasonal allergies, non smoker, and non drinker, and other pre-existing medical conditions included non drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 04:00 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021 04:00, the subject experienced arm pain on left shoulder and leg pain. On 06-MAR-2021 04:00, the subject experienced leg cramps on both sides and arm cramps on left side (injection side). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps on both sides and arm cramps on left side (injection side), and arm pain on left shoulder and leg pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Palpitations, Sensitive skin, Tremor
Clinical narrative: HEART POUNDING; SHAKING; FELT LIKE FLU; SKIN SENSITIVITY; 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced felt like flu. On 05-MAR-2021, the subject experienced skin sensitivity. Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 05-MAR-2021 21:00, the subject experienced shaking. On 05-MAR-2021 23:00, the subject experienced heart pounding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding on 06-MAR-2021, and was recovering from skin sensitivity, shaking, and felt like flu. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: HEADACHE; FEVER; MUSCLE ACHES; FATIGUE; NAUSEA; CHILLS; 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, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced muscle aches. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and chills on 06-MAR-2021, was recovering from headache, muscle aches, and fatigue, and had not recovered from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEADACHE; FEVER; MUSCLE ACHES; FATIGUE; NAUSEA; CHILLS; 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, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced muscle aches. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and chills on 06-MAR-2021, was recovering from headache, muscle aches, and fatigue, and had not recovered from fever. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Malaise, Pain, Pyrexia
Clinical narrative: BODY ACHE; DID NOT SLEEP; FEELING SICK; HEADACHE; FEVER; This spontaneous report received from a vaccine facility concerned a 20 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: Unknown) dose was not reported, administered on 05-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 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced did not sleep. On 06-MAR-2021, the subject experienced feeling sick. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, body ache, fever, and feeling sick, and the outcome of did not sleep was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: CHILLS; SHAKING; This spontaneous report received from a patient via a company representative (and wife of the patient) concerned a 56 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included non-smoker, and no alcohol use. The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, JNJ 1802068) dose was not reported, administered on 05-MAR-2021 at 4:00 PM to left deltoid for prophylactic vaccination. Concomitant medications included lisinopril.  On 06-MAR-2021, the patient experienced chills and shaking. A wife reported that her husband had side effects from the JnJ Covid-19 vaccine. He received the vaccine and experienced chills and shaking about 12 hours later. He was fine now. Action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills and shaking on 06-MAR-2021. The reporter considered the causality between the events (chills and shaking) and Covid-19 vaccine ad26.cov2.s as related. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Feeling abnormal
Clinical narrative: COUGH; GROIN PAIN; PELVIC PAIN; HIP PAIN; BODY PAIN; MUSCLE ACHES; FEVER; FEELING BAD; COLD/FREEZING; SHIVERING; 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 crohn's disease, and immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 08:45 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 16:30, the subject experienced feeling bad.  On 06-MAR-2021 16:30, the subject experienced cold/freezing. On 06-MAR-2021 16:30, the subject experienced shivering. On 06-MAR-2021 17:30, the subject experienced body pain. On 06-MAR-2021 17:30, the subject experienced muscle aches. On 06-MAR-2021 17:30, the subject experienced fever. On 06-MAR-2021 18:00, Laboratory data included: Body temperature (NR: not provided) 101 (units unspecified). On 06-MAR-2021 19:00, the subject experienced cough. On 06-MAR-2021 19:00, the subject experienced groin pain. On 06-MAR-2021 19:00, the subject experienced pelvic pain. On 06-MAR-2021 19:00, the subject experienced hip pain. On 06-MAR-2021 21:00, Laboratory data included: Body temperature (NR: not provided) 103.2 (units unspecified). On 06-MAR-2021 21:31, Laboratory data included: Body temperature (NR: not provided) 101.4 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from cold/freezing, feeling bad, muscle aches, body pain, cough, shivering, hip pain, groin pain, and pelvic pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Groin pain, Myalgia, Pain, Pelvic pain
Clinical narrative: COUGH; GROIN PAIN; PELVIC PAIN; HIP PAIN; BODY PAIN; MUSCLE ACHES; FEVER; FEELING BAD; COLD/FREEZING; SHIVERING; 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 crohn's disease, and immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 08:45 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 16:30, the subject experienced feeling bad.  On 06-MAR-2021 16:30, the subject experienced cold/freezing. On 06-MAR-2021 16:30, the subject experienced shivering. On 06-MAR-2021 17:30, the subject experienced body pain. On 06-MAR-2021 17:30, the subject experienced muscle aches. On 06-MAR-2021 17:30, the subject experienced fever. On 06-MAR-2021 18:00, Laboratory data included: Body temperature (NR: not provided) 101 (units unspecified). On 06-MAR-2021 19:00, the subject experienced cough. On 06-MAR-2021 19:00, the subject experienced groin pain. On 06-MAR-2021 19:00, the subject experienced pelvic pain. On 06-MAR-2021 19:00, the subject experienced hip pain. On 06-MAR-2021 21:00, Laboratory data included: Body temperature (NR: not provided) 103.2 (units unspecified). On 06-MAR-2021 21:31, Laboratory data included: Body temperature (NR: not provided) 101.4 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from cold/freezing, feeling bad, muscle aches, body pain, cough, shivering, hip pain, groin pain, and pelvic pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COUGH; GROIN PAIN; PELVIC PAIN; HIP PAIN; BODY PAIN; MUSCLE ACHES; FEVER; FEELING BAD; COLD/FREEZING; SHIVERING; 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 crohn's disease, and immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 08:45 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 16:30, the subject experienced feeling bad.  On 06-MAR-2021 16:30, the subject experienced cold/freezing. On 06-MAR-2021 16:30, the subject experienced shivering. On 06-MAR-2021 17:30, the subject experienced body pain. On 06-MAR-2021 17:30, the subject experienced muscle aches. On 06-MAR-2021 17:30, the subject experienced fever. On 06-MAR-2021 18:00, Laboratory data included: Body temperature (NR: not provided) 101 (units unspecified). On 06-MAR-2021 19:00, the subject experienced cough. On 06-MAR-2021 19:00, the subject experienced groin pain. On 06-MAR-2021 19:00, the subject experienced pelvic pain. On 06-MAR-2021 19:00, the subject experienced hip pain. On 06-MAR-2021 21:00, Laboratory data included: Body temperature (NR: not provided) 103.2 (units unspecified). On 06-MAR-2021 21:31, Laboratory data included: Body temperature (NR: not provided) 101.4 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from cold/freezing, feeling bad, muscle aches, body pain, cough, shivering, hip pain, groin pain, and pelvic pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oral mucosal discolouration
Clinical narrative: HEADACHE; MUSCLE ACHES/ BODY ACHES; PURPLE MOUTH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and batch number: 1802068 expiry: 25-MAR-2021) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced muscle aches/ body aches. On 05-MAR-2021, the subject experienced purple mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscle aches/ body aches, and purple mouth. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: 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, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: NAUSEA; FEELING  UNWELL; This spontaneous report received from patient concerns a male patient of unknown 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: 1805018, left deltoid) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination . No concomitant medications were reported.  On 05-MAR-2021, at 11:00 PM, the patient developed nausea and "feeling unwell".  The patient administered home remedies.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the nausea and feeling unwell was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Dyspepsia, Headache, Nausea
Clinical narrative: HEARTBURN; NAUSEA; FEVER 100 DEGREES; HEADACHE; MODERATE DISCOMFORT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 03:00 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced nausea. On 04-MAR-2021, the subject experienced heartburn. On 04-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced fever 100 degrees. On 05-MAR-2021, the subject experienced moderate discomfort. Laboratory data included: Body temperature (NR: not provided) 100 DEGREES. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, heartburn, headache, and fever 100 degrees, and the outcome of moderate discomfort was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEARTBURN; NAUSEA; FEVER 100 DEGREES; HEADACHE; MODERATE DISCOMFORT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 03:00 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced nausea. On 04-MAR-2021, the subject experienced heartburn. On 04-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced fever 100 degrees. On 05-MAR-2021, the subject experienced moderate discomfort. Laboratory data included: Body temperature (NR: not provided) 100 DEGREES. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, heartburn, headache, and fever 100 degrees, and the outcome of moderate discomfort was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Somnolence
Clinical narrative: FEVER; CHILLS; TIREDNESS; SLEEPINESS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies to biaxin and zoloft, The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025) dose was not reported, administered on 05-MAR-2021 at 9:00 am, to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the patient experienced fever, chills, tiredness, and sleepiness. Laboratory data included: Body temperature (NR: not provided) 99.6 F (at 5:45 pm) , 100.6 F (at 7:55 pm) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, tiredness, and sleepiness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered once on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced fever, headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache and tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Pain in extremity, Pharyngeal disorder, Rhinorrhoea
Clinical narrative: WATERY EYES; RUNNY NOSE; CONGESTION IN THROAT; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 18OSO18), dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021,the patient had a sore arm, but was not too painful.  On 06-MAR-2021, the morning after receiving the vaccine, the patient woke up with watery eye, runny nose, and congestion in throat.  The patient was inquiring if she should take Benadryl (dIphenhydramine) to help with those symptoms.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 06-MAR-2021, and had not recovered from watery eyes, runny nose, and congestion in throat. The patient assessed all of the events as as related to covid-19 vaccine ad26.cov2.s. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: SHIVER UNCONTROLABLLY; FEVER; CRUSHING 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 past medical history included fever, and sore throat, and other pre-existing medical conditions included the patient finished the last of a ten day antibiotic and the bacteria in "gut" were depleted. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, administered on 06-MAR-2021 11:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced crushing headache. On 06-MAR-2021, the subject experienced shiver uncontrollably. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shiver uncontrollably on 06-MAR-2021, and was recovering from fever, and crushing headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Injection site pain, Liquid product physical issue, Pyrexia
Clinical narrative: PAIN AT INJECTION SITE; FEVER; SEVERE BACK PAIN; HEADACHE; RINGING IN THE EAR; CLOUDY VIAL CONTENT; 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 concurrent conditions included non alcohol, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: L-1805020, and batch number: L-1805020 expiry: 25-MAY-2021) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced pain at injection site. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced severe back pain. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced ringing in the ear. On 05-MAR-2021, the subject experienced cloudy vial content. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and ringing in the ear on 06-MAR-2021, was recovering from severe back pain, had not recovered from pain at injection site, and fever, and the outcome of cloudy vial content was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: PAIN AT INJECTION SITE; FEVER; SEVERE BACK PAIN; HEADACHE; RINGING IN THE EAR; CLOUDY VIAL CONTENT; 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 concurrent conditions included non alcohol, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: L-1805020, and batch number: L-1805020 expiry: 25-MAY-2021) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced pain at injection site. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced severe back pain. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced ringing in the ear. On 05-MAR-2021, the subject experienced cloudy vial content. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and ringing in the ear on 06-MAR-2021, was recovering from severe back pain, had not recovered from pain at injection site, and fever, and the outcome of cloudy vial content was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 29 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) .5 ml, administered on 06-MAR-2021 09:45 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-MAR-2021, treatment medications included: paracetamol. On 06-MAR-2021 16:35, the subject experienced body aches. On 06-MAR-2021 16:35, the subject experienced chills. On 06-MAR-2021 16:35, the subject experienced headache. On 06-MAR-2021 16:35, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from fever, body aches, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: FEVER; BODY ACHES; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included declined to provide report for medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 04-MAR-2021 for prophylactic vaccination. batch and lot number were not provided hence requested. No concomitant medications were reported. On 04-MAR-2021, the patient experienced headache. On 05-MAR-2021, the patient experienced fever. On 05-MAR-2021, the patient experienced body aches. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 05-MAR-2021, and had not recovered from fever, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: HEADACHE; FEVER; BODY ACHES; This spontaneous report received from a patient concerned a 63 year old white ,Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: 05-MAR-2021) dose was not reported, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the patient experienced headache ,fever and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from fever, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: FEVER 103 F; BODY ACHES; HEADACHE; 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, intramuscular, batch number: Unknown, expiry: UNKNOWN) 0.5 ml, 1 total, administered on 05-MAR-2021 13:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced fever 103 f, body aches and 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 patient was recovering from fever 103 f, and had not recovered from body aches, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: HEADACHE; SHAKING; ACHY; NAUSEA; LOW GRADE FEVER; CHILLS; VOMITING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 05-MAR-2021 14:20 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the patient experienced headache, shaking, achy, nausea, low grade fever, experienced chills, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, nausea, low grade fever, chills, and vomiting on 06-MAR-2021, and had not recovered from headache, and achy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: HEADACHE; SHAKING; ACHY; NAUSEA; LOW GRADE FEVER; CHILLS; VOMITING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 05-MAR-2021 14:20 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the patient experienced headache, shaking, achy, nausea, low grade fever, experienced chills, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, nausea, low grade fever, chills, and vomiting on 06-MAR-2021, and had not recovered from headache, and achy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Heart rate, Heart rate increased
Clinical narrative: ELEVATED HEART RATE; HEADACHE; FEVER; CHILLS; FEELING REALLY COLD; 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, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced elevated heart rate. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced feeling really cold. Laboratory data included: Heart rate (NR: not provided) 144 /min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-MAR-2021, had not recovered from elevated heart rate, headache, and fever, and the outcome of feeling really cold was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ELEVATED HEART RATE; HEADACHE; FEVER; CHILLS; FEELING REALLY COLD; 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, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced elevated heart rate. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced feeling really cold. Laboratory data included: Heart rate (NR: not provided) 144 /min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-MAR-2021, had not recovered from elevated heart rate, headache, and fever, and the outcome of feeling really cold was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: HEADACHE BUT DID NOT FEEL LIKE AS SEVERE AS A MIGRAINE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 09:00 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021 11:00, the subject experienced nausea. On 06-MAR-2021 12:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 06-MAR-2021, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a female 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, intramuscular) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Influenza like illness
Clinical narrative: FELT LIKE CHEEKS WERE THROBBING; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, weight were not reported, and patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced flu-like symptoms. On 06-MAR-2021, the patient experienced felt like cheeks were throbbing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, and felt like cheeks were throbbing. This report was non-serious.  Additional information was received from patient on 06-Mar-2021 following information was updated and incorporated into case narrative: Batch number added, Outcome changed from recovering/resolving to not recovered/not resolved for the event flu-like symptoms, for event FELT LIKE CHEEKS WERE THROBBING onset date updated from 05 March to 06 March.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: THROAT NUMB; UVULA NUMB; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) .5 ml, administered on 06-MAR-2021 11:45 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 12:30, the patient experienced throat numb. On 06-MAR-2021 12:30, the patient experienced uvula numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throat numb, and uvula numb. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MALAGIA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced malagia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from malagia. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: SORE ARM; NAUSEA; FEVER; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, mental health, penicillin allergy, and sulfa allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fatigue. On 05-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, chills, and fatigue on 06-MAR-2021, was recovering from fever, and had not recovered from sore arm, and headache. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORE ARM; NAUSEA; FEVER; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, mental health, penicillin allergy, and sulfa allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fatigue. On 05-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, chills, and fatigue on 06-MAR-2021, was recovering from fever, and had not recovered from sore arm, and headache. This report was non-serious.