chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Nausea, Vertigo
Clinical narrative: VERTIGO; PAIN UNDER LEFT BREAST; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, borderline high blood pressure, seasonal allergies, and lactose intolerance. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced vertigo. On 09-MAR-2021, the subject experienced pain under left breast. On 09-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain under left breast, and had not recovered from dizziness, nausea, and vertigo. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Dizziness, Nausea, Vertigo
Clinical narrative: VERTIGO; PAIN UNDER LEFT BREAST; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, borderline high blood pressure, seasonal allergies, and lactose intolerance. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced vertigo. On 09-MAR-2021, the subject experienced pain under left breast. On 09-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain under left breast, and had not recovered from dizziness, nausea, and vertigo. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Migraine, Myalgia
Clinical narrative: HIVES; HEART RACING; SHORTNESS OF BREATH; BODY ACHES; CHILLS; NAUSEA; TIREDNESS; FEVER; SEVERE HEADACHES; This spontaneous report received from a patient concerned a 53 year old white not hispanic or latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068) dose was not reported, administered on 08-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced heart racing. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced tiredness. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced severe headaches. On 12-MAR-2021, the subject experienced hives. 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, tiredness, and hives, and the outcome of fever, chills, body aches, severe headaches, heart racing and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Paraesthesia, Pyrexia
Clinical narrative: HIVES; HEART RACING; SHORTNESS OF BREATH; BODY ACHES; CHILLS; NAUSEA; TIREDNESS; FEVER; SEVERE HEADACHES; This spontaneous report received from a patient concerned a 53 year old white not hispanic or latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068) dose was not reported, administered on 08-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced heart racing. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced tiredness. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced severe headaches. On 12-MAR-2021, the subject experienced hives. 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, tiredness, and hives, and the outcome of fever, chills, body aches, severe headaches, heart racing and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: HIVES; HEART RACING; SHORTNESS OF BREATH; BODY ACHES; CHILLS; NAUSEA; TIREDNESS; FEVER; SEVERE HEADACHES; This spontaneous report received from a patient concerned a 53 year old white not hispanic or latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068) dose was not reported, administered on 08-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced heart racing. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced tiredness. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced severe headaches. On 12-MAR-2021, the subject experienced hives. 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, tiredness, and hives, and the outcome of fever, chills, body aches, severe headaches, heart racing and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Palpitations, Pyrexia, Urticaria
Clinical narrative: HIVES; HEART RACING; SHORTNESS OF BREATH; BODY ACHES; CHILLS; NAUSEA; TIREDNESS; FEVER; SEVERE HEADACHES; This spontaneous report received from a patient concerned a 53 year old white not hispanic or latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068) dose was not reported, administered on 08-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced heart racing. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced tiredness. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced severe headaches. On 12-MAR-2021, the subject experienced hives. 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, tiredness, and hives, and the outcome of fever, chills, body aches, severe headaches, heart racing and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure via skin contact, Needle issue
Clinical narrative: STILL HAD DOUBT / WAS NOT CONFIDENT ABOUT DOSAGE IF FULLY VACCINATED.; This spontaneous report received from a patient concerned a,  female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On 11-MAR-2021, the subject experienced still had doubt / was not confident about dosage if fully vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of still had doubt / was not confident about dosage if fully vaccinated. was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: STILL HAD DOUBT / WAS NOT CONFIDENT ABOUT DOSAGE IF FULLY VACCINATED.; This spontaneous report received from a patient concerned a,  female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On 11-MAR-2021, the subject experienced still had doubt / was not confident about dosage if fully vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of still had doubt / was not confident about dosage if fully vaccinated. was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING IN THE EAR; This spontaneous report received from a patient via a company representative 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: 1805025, and expiry: /MAY/2021) dose was not reported, administered on 09-MAR-2021 approximately 18:15 to 18:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 approximately at 11:30 AM, the subject experienced ringing in the ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in the ear. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEAD FEELS HEAVIER THAN USUAL; SPOTTY SORENESS ALL OVER; NOT FEELING ENERGETIC; FEVER; MILD HEADACHE; 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 none, and other pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on left deltoid 09-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 10-MAR-2021, the subject experienced head feels heavier than usual. On 10-MAR-2021, the subject experienced spotty soreness all over. On 10-MAR-2021, the subject experienced not feeling energetic. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, head feels heavier than usual, and mild headache, and the outcome of not feeling energetic and spotty soreness all over was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Head discomfort, Headache, Pain
Clinical narrative: HEAD FEELS HEAVIER THAN USUAL; SPOTTY SORENESS ALL OVER; NOT FEELING ENERGETIC; FEVER; MILD HEADACHE; 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 none, and other pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on left deltoid 09-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 10-MAR-2021, the subject experienced head feels heavier than usual. On 10-MAR-2021, the subject experienced spotty soreness all over. On 10-MAR-2021, the subject experienced not feeling energetic. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, head feels heavier than usual, and mild headache, and the outcome of not feeling energetic and spotty soreness all over was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: HEAD FEELS HEAVIER THAN USUAL; SPOTTY SORENESS ALL OVER; NOT FEELING ENERGETIC; FEVER; MILD HEADACHE; 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 none, and other pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on left deltoid 09-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 10-MAR-2021, the subject experienced head feels heavier than usual. On 10-MAR-2021, the subject experienced spotty soreness all over. On 10-MAR-2021, the subject experienced not feeling energetic. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, head feels heavier than usual, and mild headache, and the outcome of not feeling energetic and spotty soreness all over was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event, Arthralgia, Blood cholesterol abnormal, Blood pressure measurement, Confusional state
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disorientation, Disturbance in attention, Dizziness, Dyspnoea, Fatigue
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flashback, Hallucination, Headache, Immunisation anxiety related reaction, Injection site erythema
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site hypoaesthesia, Injection site movement impairment, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Joint lock, Lethargy, Middle insomnia, Muscle rigidity
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Nasal congestion, Nausea, Nightmare
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Peripheral swelling, Rhinorrhoea, Sensory loss, Somnolence
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness, Thyroid function test, Vertigo, Vomiting
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced stiffness across shoulders, radiating pain from arm to the rest of the body, and pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at site of injection, stiffness across shoulders and radiating pain from arm to the rest of the body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Pain, Rash, Swelling
Clinical narrative: UNABLE TO GET ANY SLEEP; CHILLS OVER WHOLE BODY; PAIN FROM HEAD TO FEET; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 21:00, the subject experienced pain from head to feet. On 12-MAR-2021 21:00, the subject experienced chills over whole body. On an unspecified date, the subject experienced unable to get any sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain from head to feet, and chills over whole body on 13-MAR-2021 02:00, and the outcome of unable to get any sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Insomnia, Pain
Clinical narrative: UNABLE TO GET ANY SLEEP; CHILLS OVER WHOLE BODY; PAIN FROM HEAD TO FEET; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 21:00, the subject experienced pain from head to feet. On 12-MAR-2021 21:00, the subject experienced chills over whole body. On an unspecified date, the subject experienced unable to get any sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain from head to feet, and chills over whole body on 13-MAR-2021 02:00, and the outcome of unable to get any sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Pain, Rash, Swelling
Clinical narrative: PAIN GENERALIZED; CHILLS OVER WHOLE BODY; UNABLE TO GET ANY SLEEP; This spontaneous report received from a patient concerned a 64 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021 21:00, the subject experienced pain generalized. On 12-MAR-2021 21:00, the subject experienced chills over whole body. On 12-MAR-2021 21:00, the subject experienced unable to get any sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain generalized, chills over whole body and unable to get any sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Insomnia, Pain
Clinical narrative: PAIN GENERALIZED; CHILLS OVER WHOLE BODY; UNABLE TO GET ANY SLEEP; This spontaneous report received from a patient concerned a 64 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021 21:00, the subject experienced pain generalized. On 12-MAR-2021 21:00, the subject experienced chills over whole body. On 12-MAR-2021 21:00, the subject experienced unable to get any sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain generalized, chills over whole body and unable to get any sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Exposure via skin contact, Fear of disease, Syringe issue
Clinical narrative: NOT SURE IF RECEIVED SUFFICIENT QUANTITY OF VACCINE/ NEEDLE HUB LOOSE AND VACCINE LEAKED DOWN PATIENTS 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, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced not sure if received sufficient quantity of vaccine/ needle hub loose and vaccine leaked down subjects arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not sure if received sufficient quantity of vaccine/ needle hub loose and vaccine leaked down patients arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: NOT SURE IF RECEIVED SUFFICIENT QUANTITY OF VACCINE/ NEEDLE HUB LOOSE AND VACCINE LEAKED DOWN PATIENTS 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, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced not sure if received sufficient quantity of vaccine/ needle hub loose and vaccine leaked down subjects arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not sure if received sufficient quantity of vaccine/ needle hub loose and vaccine leaked down patients arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Erythema, Fatigue, Pruritus, Pyrexia
Clinical narrative: HIVES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced hives. On 14-MAR-2021 20:00, treatment medications included: diphenhydramine. On 14-MAR-2021 22:00, treatment medications included: diphenhydramine. Additional treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: HIVES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced hives. On 14-MAR-2021 20:00, treatment medications included: diphenhydramine. On 14-MAR-2021 22:00, treatment medications included: diphenhydramine. Additional treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: HIVES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced hives. On 14-MAR-2021 20:00, treatment medications included: diphenhydramine. On 14-MAR-2021 22:00, treatment medications included: diphenhydramine. Additional treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Feeling hot, Pain in jaw, Peripheral swelling, Swelling face
Clinical narrative: PUFFY EARS/JAW/CHEEKS; INFLAMMED EARS/CHEEKS; JAW INFLAMMATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced puffy ears/jaw/cheeks. On 13-MAR-2021, the subject experienced inflammed ears/cheeks. On 13-MAR-2021, the subject experienced jaw inflammation. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from puffy ears/jaw/cheeks, inflammed ears/cheeks, and jaw inflammation on 13-MAR-2021. This report was non-serious.; Sender's Comments: V0 -Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Osteitis, Swelling face
Clinical narrative: PUFFY EARS/JAW/CHEEKS; INFLAMMED EARS/CHEEKS; JAW INFLAMMATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced puffy ears/jaw/cheeks. On 13-MAR-2021, the subject experienced inflammed ears/cheeks. On 13-MAR-2021, the subject experienced jaw inflammation. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from puffy ears/jaw/cheeks, inflammed ears/cheeks, and jaw inflammation on 13-MAR-2021. This report was non-serious.; Sender's Comments: V0 -Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: RED EYES; PALPITATIONS; FLUSHING; BODY ACHE; FEVER; HEADACHE; MALAISE; 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, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced malaise. On 10-MAR-2021, the subject experienced palpitations. On 10-MAR-2021, the subject experienced flushing. On 11-MAR-2021, the subject experienced red eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, body ache, and malaise, and had not recovered from palpitations, flushing, and red eyes. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Immediate post-injection reaction, Influenza like illness, Injection site pain, Ocular hyperaemia
Clinical narrative: RED EYES; PALPITATIONS; FLUSHING; BODY ACHE; FEVER; HEADACHE; MALAISE; 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, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced malaise. On 10-MAR-2021, the subject experienced palpitations. On 10-MAR-2021, the subject experienced flushing. On 11-MAR-2021, the subject experienced red eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, body ache, and malaise, and had not recovered from palpitations, flushing, and red eyes. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, Tinnitus, Tremor
Clinical narrative: RED EYES; PALPITATIONS; FLUSHING; BODY ACHE; FEVER; HEADACHE; MALAISE; 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, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced malaise. On 10-MAR-2021, the subject experienced palpitations. On 10-MAR-2021, the subject experienced flushing. On 11-MAR-2021, the subject experienced red eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, body ache, and malaise, and had not recovered from palpitations, flushing, and red eyes. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: RED EYES; PALPITATIONS; FLUSHING; BODY ACHE; FEVER; HEADACHE; MALAISE; 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, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced malaise. On 10-MAR-2021, the subject experienced palpitations. On 10-MAR-2021, the subject experienced flushing. On 11-MAR-2021, the subject experienced red eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, body ache, and malaise, and had not recovered from palpitations, flushing, and red eyes. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: RED EYES; PALPITATIONS; FLUSHING; BODY ACHE; FEVER; HEADACHE; MALAISE; 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, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced malaise. On 10-MAR-2021, the subject experienced palpitations. On 10-MAR-2021, the subject experienced flushing. On 11-MAR-2021, the subject experienced red eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, body ache, and malaise, and had not recovered from palpitations, flushing, and red eyes. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Headache, Malaise, Ocular hyperaemia, Pain
Clinical narrative: RED EYES; PALPITATIONS; FLUSHING; BODY ACHE; FEVER; HEADACHE; MALAISE; 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, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced malaise. On 10-MAR-2021, the subject experienced palpitations. On 10-MAR-2021, the subject experienced flushing. On 11-MAR-2021, the subject experienced red eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, body ache, and malaise, and had not recovered from palpitations, flushing, and red eyes. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: RED EYES; PALPITATIONS; FLUSHING; BODY ACHE; FEVER; HEADACHE; MALAISE; 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, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced malaise. On 10-MAR-2021, the subject experienced palpitations. On 10-MAR-2021, the subject experienced flushing. On 11-MAR-2021, the subject experienced red eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, body ache, and malaise, and had not recovered from palpitations, flushing, and red eyes. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to food and latex allergy, and no chronic or long-term health conditions. The patient experienced drug allergy when treated with acetylsalicylic acid. 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 to left arm on 15-MAR-2021 approximately at 10:30 am for prophylactic vaccination. Concomitant medications included megestrol acetate. On 15-MAR-2021 approximately at 5:00pm, the subject experienced fever. On 15-MAR-2021 approximately at 5:00pm, the subject experienced fatigue. On 15-MAR-2021 approximately at 5:00pm, the subject experienced head ache. On 15-MAR-2021 approximately at 5:00pm, the subject experienced chills. On 15-MAR-2021 approximately at 5:00pm, the subject experienced body ache. Laboratory data included: Body temperature increased (NR: not provided) Temperature increased to 99.6 degree F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, head ache, and body ache, and the outcome of chills and fever was not reported. This report was non-serious.