chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHING; CHILLS; ARM SORENESS; SLIGHT HEADACHE TOWARDS THE BACK OF HEAD; FEVERISH; 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 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 14:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced body aching. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced arm soreness. On 16-MAR-2021, the subject experienced slight headache towards the back of head. On 16-MAR-2021, the subject experienced feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feverish, chills, arm soreness, body aching, and slight headache towards the back of head. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Headache, Heart rate
Clinical narrative: RAPID HEART RATE; HOT FACE; WOKE HER UP AT NIGHT; UNCONTROLLABLE CHILLS; FEVER; CONSTANT HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. the patient have no history of drug abuse or illicit use. the patient had no fever history, no rapid heart rate, and no regular medication. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072) dose was not reported, once a total administered vaccinated on right arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 13-MAR-2021, the subject experienced rapid heart rate. On 13-MAR-2021, the subject experienced hot face. On 13-MAR-2021, the subject experienced woke her up at night. On 13-MAR-2021, the subject experienced uncontrollable chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced constant headache. Laboratory data included: Body temperature (NR: not provided) 103 F, and Heart rate (NR: not provided) 140 {beats}/min. On 15-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart rate, hot face, woke her up at night, and uncontrollable chills on 14-MAR-2021, and was recovering from fever, and constant headache. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia, Sleep disorder
Clinical narrative: RAPID HEART RATE; HOT FACE; WOKE HER UP AT NIGHT; UNCONTROLLABLE CHILLS; FEVER; CONSTANT HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. the patient have no history of drug abuse or illicit use. the patient had no fever history, no rapid heart rate, and no regular medication. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072) dose was not reported, once a total administered vaccinated on right arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 13-MAR-2021, the subject experienced rapid heart rate. On 13-MAR-2021, the subject experienced hot face. On 13-MAR-2021, the subject experienced woke her up at night. On 13-MAR-2021, the subject experienced uncontrollable chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced constant headache. Laboratory data included: Body temperature (NR: not provided) 103 F, and Heart rate (NR: not provided) 140 {beats}/min. On 15-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart rate, hot face, woke her up at night, and uncontrollable chills on 14-MAR-2021, and was recovering from fever, and constant headache. 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, Diarrhoea, Pain, Pyrexia
Clinical narrative: DIARRHEA; CHILLS; FEVER; BODY ACHE; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney disease stage 3, and other pre-existing medical conditions included the patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and chills on 12-MAR-2021, was recovering from fever, and had not recovered from diarrhea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Colostomy, Erythema, Feeding disorder, Joint swelling
Clinical narrative: ANKLE SWELLING; ARM  SWELLING, FOOT SWELLING; UNABLE TO EAT; GENERALIZED ITCHING; SWELLING; ARTHRITIS AGGRAVATED; REDNESS IN THE KNEES AND LEGS; NOT FEELING GOOD; PAIN; ARM TENDER, ARM 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 arthritis, and other pre-existing medical conditions included patient had bacteria on her side (pre-existing conditions). The patient was previously treated with codeine/paracetamol for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced ankle swelling. On MAR-2021, the subject experienced arm swelling, foot swelling. On MAR-2021, the subject experienced unable to eat. On MAR-2021, the subject experienced generalized itching. On MAR-2021, the subject experienced swelling. On MAR-2021, the subject experienced arthritis aggravated. On MAR-2021, the subject experienced redness in the knees and legs. On MAR-2021, the subject experienced not feeling good. On MAR-2021, the subject experienced pain. On MAR-2021, the subject experienced arm tender, arm pain. Treatment medications (dates unspecified) included: xipamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm swelling, foot swelling, had not recovered from pain, and arm tender, arm pain, and the outcome of ankle swelling, not feeling good, redness in the knees and legs, unable to eat, generalized itching, swelling and arthritis aggravated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: ANKLE SWELLING; ARM  SWELLING, FOOT SWELLING; UNABLE TO EAT; GENERALIZED ITCHING; SWELLING; ARTHRITIS AGGRAVATED; REDNESS IN THE KNEES AND LEGS; NOT FEELING GOOD; PAIN; ARM TENDER, ARM 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 arthritis, and other pre-existing medical conditions included patient had bacteria on her side (pre-existing conditions). The patient was previously treated with codeine/paracetamol for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced ankle swelling. On MAR-2021, the subject experienced arm swelling, foot swelling. On MAR-2021, the subject experienced unable to eat. On MAR-2021, the subject experienced generalized itching. On MAR-2021, the subject experienced swelling. On MAR-2021, the subject experienced arthritis aggravated. On MAR-2021, the subject experienced redness in the knees and legs. On MAR-2021, the subject experienced not feeling good. On MAR-2021, the subject experienced pain. On MAR-2021, the subject experienced arm tender, arm pain. Treatment medications (dates unspecified) included: xipamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm swelling, foot swelling, had not recovered from pain, and arm tender, arm pain, and the outcome of ankle swelling, not feeling good, redness in the knees and legs, unable to eat, generalized itching, swelling and arthritis aggravated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: ANKLE SWELLING; ARM  SWELLING, FOOT SWELLING; UNABLE TO EAT; GENERALIZED ITCHING; SWELLING; ARTHRITIS AGGRAVATED; REDNESS IN THE KNEES AND LEGS; NOT FEELING GOOD; PAIN; ARM TENDER, ARM 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 arthritis, and other pre-existing medical conditions included patient had bacteria on her side (pre-existing conditions). The patient was previously treated with codeine/paracetamol for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced ankle swelling. On MAR-2021, the subject experienced arm swelling, foot swelling. On MAR-2021, the subject experienced unable to eat. On MAR-2021, the subject experienced generalized itching. On MAR-2021, the subject experienced swelling. On MAR-2021, the subject experienced arthritis aggravated. On MAR-2021, the subject experienced redness in the knees and legs. On MAR-2021, the subject experienced not feeling good. On MAR-2021, the subject experienced pain. On MAR-2021, the subject experienced arm tender, arm pain. Treatment medications (dates unspecified) included: xipamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm swelling, foot swelling, had not recovered from pain, and arm tender, arm pain, and the outcome of ankle swelling, not feeling good, redness in the knees and legs, unable to eat, generalized itching, swelling and arthritis aggravated was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER OF 101.2; NAUSEOUS; WHOLE BODY ACHES; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 number. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.2 F. On an unspecified date, the subject experienced chills, fever of 101.2, nauseous, and whole body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, nauseous, whole body aches and fever of 101.2 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHINESS; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The reporter provided no causality assessment .company causality between covid-19 vaccine ad26.cov2.s and achiness was possible. The outcome of achiness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: CONGESTION; 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 allergic to almonds and hazelnuts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 15-MAR-2021, the patient experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from congestion. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LIGHT SORENESS ON ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 at around 11:00 AM for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-MAR-2021, the subject experienced light soreness on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of light soreness on arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: MIGRAINE; 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: 180502, and batch number: 180502 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cough, Illness, Nausea, Oropharyngeal pain
Clinical narrative: This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 188 pounds, and height was 174 centimeters. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included no allergies, no history of drug abuse, no any other medical history or relevant pre-existing conditions, no any other medication at the time of adverse event started, no past history of similar event, no history of allergy to vaccine, drug, or food, no adverse event after any previous vaccination(s), no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy. 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 09-MAR-2021 on muscle for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced very sick. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced sore throat. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced mild nausea. On 17-MAR-2021, Laboratory data included: PCR (NR: not provided) Negative, and SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick, runny nose, sore throat, weakness, and mild nausea on 19-MAR-2021, and was recovering from cough. This report was non-serious.  Additional information was received from the patient on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter's details (first, middle and last name, address, city, zip code, state and phone number), patient's details (date of birth, gender, disease tab, age at the time vaccination, height and weight), social history, events added (cough), details for all events (outcomes, start and end date), site of vaccination, therapy start date and end date and lab data were added.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Polymerase chain reaction, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 188 pounds, and height was 174 centimeters. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included no allergies, no history of drug abuse, no any other medical history or relevant pre-existing conditions, no any other medication at the time of adverse event started, no past history of similar event, no history of allergy to vaccine, drug, or food, no adverse event after any previous vaccination(s), no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy. 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 09-MAR-2021 on muscle for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced very sick. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced sore throat. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced mild nausea. On 17-MAR-2021, Laboratory data included: PCR (NR: not provided) Negative, and SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick, runny nose, sore throat, weakness, and mild nausea on 19-MAR-2021, and was recovering from cough. This report was non-serious.  Additional information was received from the patient on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter's details (first, middle and last name, address, city, zip code, state and phone number), patient's details (date of birth, gender, disease tab, age at the time vaccination, height and weight), social history, events added (cough), details for all events (outcomes, start and end date), site of vaccination, therapy start date and end date and lab data were added.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Malaise, Nausea, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 188 pounds, and height was 174 centimeters. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included no allergies, no history of drug abuse, no any other medical history or relevant pre-existing conditions, no any other medication at the time of adverse event started, no past history of similar event, no history of allergy to vaccine, drug, or food, no adverse event after any previous vaccination(s), no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy. 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 09-MAR-2021 on muscle for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced very sick. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced sore throat. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced mild nausea. On 17-MAR-2021, Laboratory data included: PCR (NR: not provided) Negative, and SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick, runny nose, sore throat, weakness, and mild nausea on 19-MAR-2021, and was recovering from cough. This report was non-serious.  Additional information was received from the patient on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter's details (first, middle and last name, address, city, zip code, state and phone number), patient's details (date of birth, gender, disease tab, age at the time vaccination, height and weight), social history, events added (cough), details for all events (outcomes, start and end date), site of vaccination, therapy start date and end date and lab data were added.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cough, Illness, Nausea, Oropharyngeal pain
Clinical narrative: SORE THROAT; RUNNY NOSE; FEEL VERY SICK; WEAKNESS; MILD NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 sore throat. On MAR-2021, the subject experienced runny nose. On MAR-2021, the subject experienced feel very sick. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced mild nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel very sick, sore throat, runny nose, weakness and mild nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Polymerase chain reaction, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: SORE THROAT; RUNNY NOSE; FEEL VERY SICK; WEAKNESS; MILD NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 sore throat. On MAR-2021, the subject experienced runny nose. On MAR-2021, the subject experienced feel very sick. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced mild nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel very sick, sore throat, runny nose, weakness and mild nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Malaise, Nausea, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: SORE THROAT; RUNNY NOSE; FEEL VERY SICK; WEAKNESS; MILD NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 sore throat. On MAR-2021, the subject experienced runny nose. On MAR-2021, the subject experienced feel very sick. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced mild nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel very sick, sore throat, runny nose, weakness and mild nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis
Clinical narrative: HAD A COLD IN MY NOSE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced had a cold in my nose, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a cold in my nose and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Skin lesion, Stomatitis
Clinical narrative: MOUTH SORES; SORES ON THE FACE; CHILLS; FEVER; HEADACHE; 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, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced mouth sores. On 15-MAR-2021, the subject experienced sores on the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 15-MAR-2021, and the outcome of headache, mouth sores and sores on the face was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FELT VERY TIRED; 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: unknown) dose was not reported, administered on 14-MAR-2021 08:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced felt very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt very tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F, 100 F. On 13-MAR-2021, treatment medications included: paracetamol. On 13-MAR-2021 02:00, the subject experienced fever. 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: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: MUSCLE ACHES; FATIGUE; LOW GRADE FEVER; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On 16-MAR-2021, the subject experienced muscle aches. On 16-MAR-2021, the subject experienced fatigue. On 16-MAR-2021, the subject experienced low grade fever. On 16-MAR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) 102 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, headaches, fatigue and muscle aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Injection site pain, Pain, Rash
Clinical narrative: LEFT BREAST SORE; LEFT ARMPIT SORE; BODY ACHES; RASH; INJECTION SITE SORE; This spontaneous report received from 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced left breast sore, left armpit sore, body aches, rash and injection site sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left breast sore, left armpit sore, injection site sore, body aches and rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain in extremity
Clinical narrative: FATIGUE; SORE ARM; CHILLS; INJECTION SITE PAIN; 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore arm. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced injection site pain. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and was recovering from injection site pain, fatigue, and sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Injection site pain, Pain
Clinical narrative: SHORTNESS OF BREATH WHILE WALKING; PAIN AT INJECTION SITE; BODY ACHES; TIRED; FEVER; 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 pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced tired. On MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced pain at injection site.  Laboratory data included: Body temperature (NR: not provided) 104.5 F. On 13-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-MAR-2021, the subject experienced shortness of breath while walking. Laboratory data included: Body temperature (NR: not provided) 101.9 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 pain at injection site, and had not recovered from body aches, fever, tired, and shortness of breath while walking. 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: Pyrexia
Clinical narrative: SHORTNESS OF BREATH WHILE WALKING; PAIN AT INJECTION SITE; BODY ACHES; TIRED; FEVER; 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 pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced tired. On MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced pain at injection site.  Laboratory data included: Body temperature (NR: not provided) 104.5 F. On 13-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-MAR-2021, the subject experienced shortness of breath while walking. Laboratory data included: Body temperature (NR: not provided) 101.9 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 pain at injection site, and had not recovered from body aches, fever, tired, and shortness of breath while walking. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: FEVER; EXHAUSTION; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fever, and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and exhaustion. This report was non-serious. This case, from the same reporter is linked to 20210331202, 20210332072, 20210331262, 20210331801 and 20210331104.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nasal disorder
Clinical narrative: KNOCKED OUT FOR 30 HOURS; BODY ACHES; HAD BEEN A LITTLE  NASAL; CHILLS; HEADACHE; FEVER; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced knocked out for 30 hours, body aches, had been a little nasal, chills, headache, fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the knocked out for 30 hours, chills, headache, fever, body aches, tired and had been a little nasal was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: KNOCKED OUT FOR 30 HOURS; BODY ACHES; HAD BEEN A LITTLE  NASAL; CHILLS; HEADACHE; FEVER; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced knocked out for 30 hours, body aches, had been a little nasal, chills, headache, fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the knocked out for 30 hours, chills, headache, fever, body aches, tired and had been a little nasal was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: MOVES ARM FEELS SOMETHING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced moves arm feels something. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of moves arm feels something was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; DIZZINESS; WEAKNESS; 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: 1805022) dose was not reported, once a total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced headache. On 13-MAR-2021 23:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, dizziness and weakness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: KNOT FORMING ON THE BEND INSIDE AREA OF RIGHT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced knot forming on the bend inside area of right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knot forming on the bend inside area of right arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: SORENESS; HEADACHE; NAUSEA/QUEASY; 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 15:10 in the left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced nausea/queasy. On 16-MAR-2021, the subject experienced soreness. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 16-MAR-2021, was recovering from soreness, and had not recovered from nausea/queasy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; 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 headaches occasionally.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested Concomitant medications included ibuprofen for headache. On MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; 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 penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Injection site pruritus
Clinical narrative: CHILLS; INJECTION SITE ITCHING; SHORTNESS OF BREATH; FEVER; HEADACHE; FATIGUE; MUSCLES ACHES; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and shellfish allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180522, expiry: 25-DEC-2021) dose was not reported, administered on 14-MAR-2021 10:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced injection site itching. On 14-MAR-2021, the subject experienced shortness of breath. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fatigue. On an unspecified date, the subject experienced muscles aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, injection site itching, shortness of breath, fever, headache, and fatigue on 16-MAR-2021, and muscles aches. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: CHILLS; INJECTION SITE ITCHING; SHORTNESS OF BREATH; FEVER; HEADACHE; FATIGUE; MUSCLES ACHES; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and shellfish allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180522, expiry: 25-DEC-2021) dose was not reported, administered on 14-MAR-2021 10:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced injection site itching. On 14-MAR-2021, the subject experienced shortness of breath. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fatigue. On an unspecified date, the subject experienced muscles aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, injection site itching, shortness of breath, fever, headache, and fatigue on 16-MAR-2021, and muscles aches. This report was non-serious.