chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: DIARRHEA; SEVERE 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 concurrent conditions included leukemia.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered in the left arm on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache and diarrhea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: ARM SHORNESS; CALLER IS NOT SURE IF HE RECEIVED FULL SHOT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced possible incorrect dose administered, and arm shorness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm shorness and possible incorrect dose administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: SHIVERING/CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 20-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, Laboratory data included: Body temperature (NR: not provided) Fever of 102 degree F. On 20-MAR-2021 22:00, the patient experienced shivering/chills fever and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering/chills on 20-MAR-2021, and had not recovered from fever, and headache. The reporter consider related causality between covid-19 vaccine ad26.cov2.s and event shivering/chills fever, and headache. company causality between  covid-19 vaccine ad26.cov2.s and event shivering/chills fever, and headache was possible.   This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-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 19-MAR-2021, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: RASH ON ARM AND RIGHT WRIST; BUMP ON WRIST; 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, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced rash on arm and right wrist. On MAR-2021, the subject experienced bump on wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on arm and right wrist and bump on wrist was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face
Clinical narrative: ITCHY; FACE SWOLLEN; RASH ON ARMS, CHEST AND LEGS - LITTLE DOTS; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced rash on arms, chest and legs - little dots. On 18-MAR-2021, the subject experienced face swollen. Treatment medications included: diphenhydramine hydrochloride. On 19-MAR-2021, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash on arms, chest and legs - little dots, and face swollen, and the outcome of itchy was not reported. 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: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: SEVERE CHILLS; This spontaneous report received from a vaccine facility concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cerebral palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 vaccinated on right arm at 12:55 PM for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hyperaesthesia, Injection site erythema, Injection site mass, Pain
Clinical narrative: PAIN; HARD LUMP AT INJECTION SITE; HARD LUMP SENSITIVE TO TOUCH; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced pain. On MAR-2021, the subject experienced hard lump at injection site. On MAR-2021, the subject experienced hard lump sensitive to touch. On MAR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hard lump at injection site, and hard lump sensitive to touch, and the outcome of pain and injection site redness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Migraine, Pain, Pyrexia
Clinical narrative: BODY ACHES; STOMACH CRAMPS; FACIAL SWELLING; MIGRAINE; HEADACHE; FEVER; 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 pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, stomach cramps, facial swelling, migraine, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial swelling, and fever, was recovering from stomach cramps, had not recovered from headache, and body aches, and the outcome of migraine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: BODY ACHES; STOMACH CRAMPS; FACIAL SWELLING; MIGRAINE; HEADACHE; FEVER; 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 pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, stomach cramps, facial swelling, migraine, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial swelling, and fever, was recovering from stomach cramps, had not recovered from headache, and body aches, and the outcome of migraine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: SURGE OF ENERGY; 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 and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced surge of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from surge of energy on MAR-2021. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Fatigue, Myalgia, Oral herpes, Pruritus
Clinical narrative: COLD SORE ON THE LIP; FEVER WHICH WAS DESCRIBED AS FLU LIKE SYMPTOMS; MUSCLE ACHE; FEELING TIRED; ITCHING; RASH THAT APPEARED ON MIDCHEST AREA BETWEEN THE STOMACH AND THE PECTORALS; RED BLOTCHES; This spontaneous report received from a patient concerned a 69 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, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 05-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced rash that appeared on midchest area between the stomach and the pectorals. On MAR-2021, the subject experienced red blotches. On 05-MAR-2021, the subject experienced fever which was described as flu like symptoms. On 05-MAR-2021, the subject experienced muscle ache. On 05-MAR-2021, the subject experienced feeling tired. On 10-MAR-2021, the subject experienced cold sore on the lip. On 17-MAR-2021, Laboratory data included: Biopsy (NR: not provided) UNKNOWN. Treatment medications (dates unspecified) included: fexofenadine, and triamcinolone acetonide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sore on the lip on 16-MAR-2021, and fever which was described as flu like symptoms, muscle ache, and feeling tired on 08-MAR-2021, and was recovering from rash that appeared on mid chest area between the stomach and the pectorals, red blotches, and itching. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: COLD SORE ON THE LIP; FEVER WHICH WAS DESCRIBED AS FLU LIKE SYMPTOMS; MUSCLE ACHE; FEELING TIRED; ITCHING; RASH THAT APPEARED ON MIDCHEST AREA BETWEEN THE STOMACH AND THE PECTORALS; RED BLOTCHES; This spontaneous report received from a patient concerned a 69 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, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 05-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced rash that appeared on midchest area between the stomach and the pectorals. On MAR-2021, the subject experienced red blotches. On 05-MAR-2021, the subject experienced fever which was described as flu like symptoms. On 05-MAR-2021, the subject experienced muscle ache. On 05-MAR-2021, the subject experienced feeling tired. On 10-MAR-2021, the subject experienced cold sore on the lip. On 17-MAR-2021, Laboratory data included: Biopsy (NR: not provided) UNKNOWN. Treatment medications (dates unspecified) included: fexofenadine, and triamcinolone acetonide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sore on the lip on 16-MAR-2021, and fever which was described as flu like symptoms, muscle ache, and feeling tired on 08-MAR-2021, and was recovering from rash that appeared on mid chest area between the stomach and the pectorals, red blotches, and itching. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Illness, Injection site reaction, Nausea, Rash
Clinical narrative: SMALLER HARD SORE BUMP; SICK; SHOT HURT GOING IN AND  STUNG; FELT TIRED; NAUSEOUS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced smaller hard sore bump. On MAR-2021, the subject experienced sick. On MAR-2021, the subject experienced shot hurt going in and stung. On MAR-2021, the subject experienced felt tired. On MAR-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, felt tired, and nauseous on MAR-2021, and the outcome of shot hurt going in and stung and smaller hard sore bump was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: FEVER (UNABLE  TO CHECK TEMPERATURE); FATIGUE; HEADACHE; MUSCLE ACHES; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 20-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced fever (unable to check temperature). On 21-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced muscle aches. On 21-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever (unable to check temperature), fatigue, headache, muscle aches and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Diarrhoea, Illness, Nausea, Pyrexia
Clinical narrative: NO TASTE; DIARRHEA; FEELING SICK; FEVER; NAUSEA; 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 16-MAR-2021 11:30 a.m. (vaccinated at right arm) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced no taste. On 17-MAR-2021, the subject experienced diarrhea. On 17-MAR-2021, the subject experienced feeling sick. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, no taste, diarrhea and feeling sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced soreness on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness on the injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Flushing, Influenza virus test, Injection site pain
Clinical narrative: MOUTH WATERING; MIGRAINE; SOMNOLENCE; FLUSHED FACE; CHILLS; EXTREME TIREDNESS/ FATIGUE; NAUSEA; LOW GRADE FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25/MAY/2021) dose was not reported, administered on 07-MAR-2021 09:30 for prophylactic vaccination.  The patient vaccinated at right arm. Concomitant medications included magnesium glycinate.  On 07-MAR-2021, the subject experienced somnolence. On 07-MAR-2021, the subject experienced flushed face. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced extreme tiredness/ fatigue. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced low grade fever. On 07-MAR-2021, the subject experienced injection site pain. On 09-MAR-2021, the subject experienced migraine. On 11-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Rapid influenza diagnostic test (NR: not provided) Negative. On an unspecified date, the subject experienced mouth watering. Treatment medications (dates unspecified) included: metoclopramide, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed face, and chills on 08-MAR-2021, and low grade fever, and injection site pain, and had not recovered from migraine, nausea, somnolence, extreme tiredness/ fatigue, and mouth watering. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pyrexia, SARS-CoV-2 test negative, Salivary hypersecretion
Clinical narrative: MOUTH WATERING; MIGRAINE; SOMNOLENCE; FLUSHED FACE; CHILLS; EXTREME TIREDNESS/ FATIGUE; NAUSEA; LOW GRADE FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25/MAY/2021) dose was not reported, administered on 07-MAR-2021 09:30 for prophylactic vaccination.  The patient vaccinated at right arm. Concomitant medications included magnesium glycinate.  On 07-MAR-2021, the subject experienced somnolence. On 07-MAR-2021, the subject experienced flushed face. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced extreme tiredness/ fatigue. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced low grade fever. On 07-MAR-2021, the subject experienced injection site pain. On 09-MAR-2021, the subject experienced migraine. On 11-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Rapid influenza diagnostic test (NR: not provided) Negative. On an unspecified date, the subject experienced mouth watering. Treatment medications (dates unspecified) included: metoclopramide, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed face, and chills on 08-MAR-2021, and low grade fever, and injection site pain, and had not recovered from migraine, nausea, somnolence, extreme tiredness/ fatigue, and mouth watering. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: MOUTH WATERING; MIGRAINE; SOMNOLENCE; FLUSHED FACE; CHILLS; EXTREME TIREDNESS/ FATIGUE; NAUSEA; LOW GRADE FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25/MAY/2021) dose was not reported, administered on 07-MAR-2021 09:30 for prophylactic vaccination.  The patient vaccinated at right arm. Concomitant medications included magnesium glycinate.  On 07-MAR-2021, the subject experienced somnolence. On 07-MAR-2021, the subject experienced flushed face. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced extreme tiredness/ fatigue. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced low grade fever. On 07-MAR-2021, the subject experienced injection site pain. On 09-MAR-2021, the subject experienced migraine. On 11-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Rapid influenza diagnostic test (NR: not provided) Negative. On an unspecified date, the subject experienced mouth watering. Treatment medications (dates unspecified) included: metoclopramide, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed face, and chills on 08-MAR-2021, and low grade fever, and injection site pain, and had not recovered from migraine, nausea, somnolence, extreme tiredness/ fatigue, and mouth watering. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Mobility decreased
Clinical narrative: CAN NOT MOVE; FLU LIKE SYMPTOMS/FEELING VERY WEAK/WARM TO TOUCH/FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included heart condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 deg. On 16-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 103 deg. On an unspecified date, the subject experienced can not move, and flu like symptoms/feeling very weak/warm to touch/fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99, 99.6. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from flu like symptoms/feeling very weak/warm to touch/fever, and the outcome of can not move was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: HEADACHE; FEVER; MUSCLE ACHE; FATIGUE; CHILLS; 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: 1806018,: UNKNOWN) dose was not reported, administered on left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, fever, muscle ache, fatigue, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from fever, muscle ache, fatigue, and chills, and the outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; FELT TIRED; SICK FEELING/GETTING SICK; DIZZINESS; SEVERE 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced severe vomiting. On 16-MAR-2021, the subject experienced sick feeling/getting sick. On 16-MAR-2021, the subject experienced felt tired. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt tired, severe vomiting, dizziness, chills, headache, body aches, and sick feeling/getting sick. This report was non-serious.; Sender's Comments: MAC- V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; FELT TIRED; SICK FEELING/GETTING SICK; DIZZINESS; SEVERE 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced severe vomiting. On 16-MAR-2021, the subject experienced sick feeling/getting sick. On 16-MAR-2021, the subject experienced felt tired. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt tired, severe vomiting, dizziness, chills, headache, body aches, and sick feeling/getting sick. This report was non-serious.; Sender's Comments: MAC- V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: BODY ACHES; CHILLS; FATIGUE; 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, headache and body aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN ARM AT SHOT LOCATION AND FELT LIKE WENT DOWN ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180/50/20/ expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination on Left Deltoid. No concomitant medications were reported. On MAR-2021, the subject experienced soreness in arm at shot location and felt like went down arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in arm at shot location and felt like went down arm on MAR-2021. This report was non-serious. Additional information was received from [reporter] on 23-MAR-2021.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, penicillin allergy, and seasonal allergies. 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 11-MAR-2021 10:00 in left deltoid for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.8 F. On 20-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: DID NOT FEEL WELL; Fever; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the subject experienced did not feel well. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and did not feel well was not reported. This report was non-serious. This case, from the same reporter is linked to 20210319252.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: DID NOT FEEL WELL; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced did not feel well. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and did not feel well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient had not known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26/MAY/2021) dose was not reported, administered on 08-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: CHILLY; ACHY; 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) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 2021, the subject experienced chilly. On 2021, the subject experienced achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chilly and achy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; 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 the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 17-MAR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) POSITIVE. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Disorientation, Dizziness, Lethargy, Myalgia
Clinical narrative: LOSS OF APPETITE; NAUSEA; MYAGLIA; DIZZINESS; LETHARGIC; DISORIENTATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pelvic pain from a previous surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced disorientation. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced lethargic. On 10-MAR-2021, the subject experienced myaglia. On 12-MAR-2021, the subject experienced loss of appetite. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from disorientation, and dizziness on 11-MAR-2021, and loss of appetite, and nausea on 18-MAR-2021, and was recovering from lethargic, and myaglia. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: LOSS OF APPETITE; NAUSEA; MYAGLIA; DIZZINESS; LETHARGIC; DISORIENTATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pelvic pain from a previous surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced disorientation. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced lethargic. On 10-MAR-2021, the subject experienced myaglia. On 12-MAR-2021, the subject experienced loss of appetite. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from disorientation, and dizziness on 11-MAR-2021, and loss of appetite, and nausea on 18-MAR-2021, and was recovering from lethargic, and myaglia. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Headache, Pyrexia
Clinical narrative: BACK ACHE; HEADACHE; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced back ache, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from back ache, headache, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Nasopharyngitis, Pain in extremity
Clinical narrative: RESTLESSNESS; DIZZINESS; SORENESS IN ARM; SORENESS IN LEGS; WEAKNESS; COLD; CHILLS; FEVER; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included overweight, and dull pain.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination at left arm. No concomitant medications were reported. On 21-MAR-2021, the subject experienced restlessness. On 21-MAR-2021, the subject experienced dizziness. On 21-MAR-2021, the subject experienced soreness in arm. On 21-MAR-2021, the subject experienced soreness in legs. On 21-MAR-2021, the subject experienced weakness. On 21-MAR-2021, the subject experienced cold. On 21-MAR-2021, the subject experienced chills. On 21-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 soreness in arm, soreness in legs, restlessness, dizziness, weakness, cold, chills, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness
Clinical narrative: RESTLESSNESS; DIZZINESS; SORENESS IN ARM; SORENESS IN LEGS; WEAKNESS; COLD; CHILLS; FEVER; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included overweight, and dull pain.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination at left arm. No concomitant medications were reported. On 21-MAR-2021, the subject experienced restlessness. On 21-MAR-2021, the subject experienced dizziness. On 21-MAR-2021, the subject experienced soreness in arm. On 21-MAR-2021, the subject experienced soreness in legs. On 21-MAR-2021, the subject experienced weakness. On 21-MAR-2021, the subject experienced cold. On 21-MAR-2021, the subject experienced chills. On 21-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 soreness in arm, soreness in legs, restlessness, dizziness, weakness, cold, chills, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension
Clinical narrative: HEART RATE INCREASED; BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) once a total dose was not reported, administered in right deltoid on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 130/something, 105/69 mmHg, and Heart rate (NR: not provided) 95-100 bpm. On 19-MAR-2021, the subject experienced heart rate increased. On 19-MAR-2021, the subject experienced blood pressure high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart rate increased, and had not recovered from blood pressure high. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER; MUSCLE PAIN ALL OVER CAN HARDLY SIT DOWN OR BEND OR USE STAIRS; BODY PAIN ALL OVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. On 06-MAR-2021, the subject experienced body pain all over. On an unspecified date, the subject experienced chills, fever, and muscle pain all over can hardly sit down or bend or use stairs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain all over, and the outcome of chills, fever and muscle pain all over can hardly sit down or bend or use stairs was not reported. This report was non-serious.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Palpitations
Clinical narrative: PALPITATIONS; COLDNESS; FATIGUE; This spontaneous report received from a patient concerned an 87 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced palpitations. On 11-MAR-2021, the subject experienced coldness. On 11-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from coldness, fatigue, and palpitations. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as Non-serious.