chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope, Vomiting
Clinical narrative: FAINTING; DIZZINESS; VOMITING; NAUSEA; This spontaneous multiple patient report was received from physicians, consumer, media, and press release and concerned 11-13 adult male and female patients. Initial information received from a consumer on 07-APR-2021 was processed with additional information received from media and then obtained via follow up with physicians on 08-APR-2021, and from the physician and Department of Public Health and Environment press release on 09-APR-2021.  The patients' height and weight were not reported. The patients' concurrent conditions included anxiety and fainting. The patients received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration, dose, and site of vaccination not reported, batch number: 18008980 and 201A21A) administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, within 15 minutes of vaccination, 11-13 patients out of about 1700 who were vaccinated that day experienced varying symptoms including fainting, dizziness, vomiting, and nausea. The patients received vaccine at a "drive-up" vaccination event, then drove to a parking lot to wait for about 15 minutes with instructions to honk if they felt ill. Two or three patients were transported by EMS to the local hospital for observation. They were later released from the emergency department and were not admitted. Two patients were recommended to go to the hospital, but declined, and were observed and treated with juice and water along with other 7 patients at the site. The reporting physician did not feel that the reactions were due to the lot or the specific vaccine, but were rather due to vasovagal reactions. The press release stated that "the Food and Drug Administration has run the two lot numbers used at the site and found no worrying pattern of similar events with these lots." The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of the fainting, nausea, dizziness, and vomiting was not reported. This case is associated to product complaint PQMS# 90000175639. This case is linked as same patient to 20210415071. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 This report concerns multiple patients who experienced adverse events after receiving an injection at a "drive-up" vaccination site. On 07-APR-2021, within 15 minutes of vaccination, 11-13 patients out of about 1700 who were vaccinated that day experienced varying symptoms including fainting, dizziness, vomiting, and nausea. Two (or three) patients were transported to the hospital for observation. It was reported that some patients had concurrent anxiety and fainting. Given the close temporal relationship and the nature of the events, the events are considered possibly related to the vaccination, the "Drive-up" circumstance likely were a significant contributory factor.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE REACTIONS; This spontaneous report was received from a consumer via a newspaper article and concerned multiple patients.  The patients' weights, heights and medical histories were not reported. The patients received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of administration unspecified) on an unspecified date for prophylactic vaccination. Vaccination details were not reported. The batch numbers were not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced unspecified adverse reactions. It was not specified how many patients experienced reactions, but the staff at the site wanted to pause further vaccinations for the day "out of an abundance of caution".  The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Insomnia, Nausea
Clinical narrative: INSOMNIA; TINNITUS; CHILLS; SEVERE HEADACHES; MILD FEVER; NAUSEA; 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 alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 01-APR-2021, the subject experienced insomnia. On 01-APR-2021, the subject experienced tinnitus. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced severe headaches. On 01-APR-2021, the subject experienced mild fever. On 01-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, chills, severe headaches, mild fever, and nausea on APR-2021, and was recovering from tinnitus. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: INSOMNIA; TINNITUS; CHILLS; SEVERE HEADACHES; MILD FEVER; NAUSEA; 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 alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 01-APR-2021, the subject experienced insomnia. On 01-APR-2021, the subject experienced tinnitus. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced severe headaches. On 01-APR-2021, the subject experienced mild fever. On 01-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, chills, severe headaches, mild fever, and nausea on APR-2021, and was recovering from tinnitus. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: PAIN SPREAD THROUGHOUT THE SHOULDER; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 72 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included shoulder hurting, and neck hurting. 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 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced pain spread throughout the shoulder. On 22-MAR-2021, the subject experienced left arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain spread throughout the shoulder, and left arm pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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: not reported) dose was not reported, administered on 07-APR-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 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Pain
Clinical narrative: DIZZINESS; ACHES/PAIN; ARM SORENESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 03:30  around 15:30 vaccinated in left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced aches/pain. On 07-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, dizziness, headache, aches/pain, and arm soreness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: DIZZINESS; ACHES/PAIN; ARM SORENESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 03:30  around 15:30 vaccinated in left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced aches/pain. On 07-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, dizziness, headache, aches/pain, and arm soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: CHILLS; SORE ARM; FEVER; HEADACHE; EXHAUSTION; 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: not reported) dose was not reported, administered on 05-APR-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 APR-2021, the subject experienced chills. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache, exhaustion and sore arm was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: CHILLS; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle ache, and headache on 07-APR-2021. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, SARS-CoV-2 test
Clinical narrative: TERRIBLE HEADACHE; DIZZINESS AND LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included colonoscopy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included apixaban for blood thinner. On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 2021, the subject experienced dizziness and lightheadedness. On MAR-2021, the subject experienced terrible headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness and lightheadedness, and terrible headache on 2021. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eye pain, Fatigue, Headache
Clinical narrative: EYES HURT; DIZZINESS; FATIGUE; HEADACHE; ARM SORENESS; SEVERE CHILLS; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced eyes hurt. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, and dizziness, and had not recovered from severe chills, headache, eyes hurt, and fatigue. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: EYES HURT; DIZZINESS; FATIGUE; HEADACHE; ARM SORENESS; SEVERE CHILLS; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced eyes hurt. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, and dizziness, and had not recovered from severe chills, headache, eyes hurt, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: BODY ACHES; CHILLS; FEVER; RASH; This spontaneous report received from a patient via a company representative concerned a 37 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 19:15 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 07-APR-2021 16:00, the subject experienced rash. On an unspecified date, the subject experienced body aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, chills, rash, and fever. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Nausea
Clinical narrative: SWEATING; NAUSEA; EXTREME FATIGUE; This spontaneous report received from a parent concerned a 19 year old female. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced extreme fatigue. On 08-APR-2021, the subject experienced sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, extreme fatigue, and sweating. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported, administered on 07-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and had not recovered from fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: EXPLOSIVE DIARRHEA; PAIN IN LEFT ARM; HEADACHE; DIZZY; FOGGY; 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced dizzy. On 05-APR-2021, the subject experienced foggy. On 05-APR-2021, the subject experienced pain in left arm. On 05-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced explosive diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left arm, dizzy, foggy, explosive diarrhea, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: PAIN; SORE ARM; MUSCLE ACHES; HEADACHE; 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: not reported) dose was not reported, administered on 06-APR-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 06-APR-2021, the subject experienced pain. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, pain, headache, sore arm and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Pain, Pyrexia
Clinical narrative: BODY ACHES; 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) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever, and body aches. Laboratory data (dates unspecified) included: Body temperature increased (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body aches was not reported. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Hypoaesthesia oral, Malaise
Clinical narrative: FEELING VERY HOT; NUMB TONGUE; SHAKING; FEELING UNWELL; CHILLS/SHIVERING; FEVER; EXHAUSTION; This spontaneous report received from a parent concerned a 23 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced feeling very hot. On 08-APR-2021, the subject experienced numb tongue. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced feeling unwell. On 08-APR-2021, the subject experienced chills/shivering. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills/shivering, exhaustion, numb tongue, feeling unwell, feeling very hot, and shaking. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: FEELING VERY HOT; NUMB TONGUE; SHAKING; FEELING UNWELL; CHILLS/SHIVERING; FEVER; EXHAUSTION; This spontaneous report received from a parent concerned a 23 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced feeling very hot. On 08-APR-2021, the subject experienced numb tongue. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced feeling unwell. On 08-APR-2021, the subject experienced chills/shivering. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills/shivering, exhaustion, numb tongue, feeling unwell, feeling very hot, and shaking. This report was non-serious.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pyrexia
Clinical narrative: FEVER OFF AND ON; TIRED; LABORED BREATHING; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced labored breathing. On 01-APR-2021, the subject experienced tired. On 03-APR-2021, the subject experienced fever off and on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and fever off and on, and the outcome of labored breathing was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; CHILLS; FEVER; MUSCLE SORENESS; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 12:30 vaccinated in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 20:00, the subject experienced flu-like symptoms. On 06-APR-2021 20:00, the subject experienced chills. On 06-APR-2021 20:00, the subject experienced fever. On 06-APR-2021 20:00, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, muscle soreness and flu-like symptoms was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: COULD NOT SLEEP; SORE ARM; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered to left arm on 07-APR-2021 19:20 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 07-APR-2021, the subject experienced could not sleep. On 07-APR-2021, the subject experienced sore arm. Treatment medications included: diphenhydramine citrate/ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and the outcome of could not sleep was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER LIKE SYMPTOMS; This spontaneous report received from a health care professional 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fever like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever like symptoms on 09-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pain in extremity
Clinical narrative: BODY ACHES; NIGHT SWEATS; SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for drug used for unknown indication. 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 body aches, night sweats, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, night sweats, and sore arm. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site coldness
Clinical narrative: FATIGUE AND EXHAUSTION; COOL SENSATION AT INJECTION SITE; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) 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 13-MAR-2021, the subject experienced cool sensation at injection site. On 14-MAR-2021, the subject experienced fatigue and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cool sensation at injection site on MAR-2021, and fatigue and exhaustion on 21-MAR-2021. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site pain, Nausea, Pain
Clinical narrative: BODY ACHES; CHILLS; NAUSEA; FEVER; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old female. 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 14:00 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-APR-2021 19:00, the subject experienced body aches. On 06-APR-2021 19:00, the subject experienced chills. On 06-APR-2021 19:00, the subject experienced nausea. On 06-APR-2021 19:00, the subject experienced fever. On 06-APR-2021 19:00, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, nausea, and fever on 08-APR-2021, and had not recovered from soreness at injection site. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; CHILLS; NAUSEA; FEVER; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old female. 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 14:00 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-APR-2021 19:00, the subject experienced body aches. On 06-APR-2021 19:00, the subject experienced chills. On 06-APR-2021 19:00, the subject experienced nausea. On 06-APR-2021 19:00, the subject experienced fever. On 06-APR-2021 19:00, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, nausea, and fever on 08-APR-2021, and had not recovered from soreness at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Dizziness, Headache
Clinical narrative: COUGH; WHEEZING; DIZZINESS; ACHE/PAINS; CHILLS; SORE  ARM; 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, on 06-MAR-2021 administered at left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced cough. On 2021, the subject experienced wheezing. On 2021, the subject experienced dizziness. On 2021, the subject experienced ache/pains. On 2021, the subject experienced chills. On 2021, the subject experienced sore arm. On 2021, the subject experienced fever. On 2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, cough, wheezing, chills, ache/pains, sore arm, headache, and dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Wheezing
Clinical narrative: COUGH; WHEEZING; DIZZINESS; ACHE/PAINS; CHILLS; SORE  ARM; 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, on 06-MAR-2021 administered at left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced cough. On 2021, the subject experienced wheezing. On 2021, the subject experienced dizziness. On 2021, the subject experienced ache/pains. On 2021, the subject experienced chills. On 2021, the subject experienced sore arm. On 2021, the subject experienced fever. On 2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, cough, wheezing, chills, ache/pains, sore arm, headache, and dizziness. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound scan, Vasodilatation
Clinical narrative: SWELLING ARM; BULGING OF THE VEINS; ARM SORENESS/TENDERNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included cancer 11 year ago, and concurrent conditions included lymphedema in right arm, high blood pressure, penicillin allergy, and allergic to some high blood pressure medicine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced swelling arm. On 2021, the subject experienced bulging of the veins. On 2021, the subject experienced arm soreness/tenderness. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling arm, and arm soreness/tenderness, and the outcome of bulging of the veins was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: NECK PAIN; PAIN UP AND DOWN ARM/ARM PAIN; This spontaneous report received from a patient by a Business partner on 05-APR-2021 was received on 05-APR-2021 and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up tp request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced neck pain, and pain up and down her arm/arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain up and down her arm/arm pain and neck pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: ENTIRE BODY SORENESS; CHILLS; SLIGHT FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-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 APR-2021, the subject experienced entire body soreness. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the entire body soreness, chills and slight fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Urticaria
Clinical narrative: GENERAL BAD FEELING; HIVES; 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 01-APR-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 APR-2021, the patient experienced hives. On APR-2021, the patient  experienced general bad feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives and general bad feeling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: BODY SORENESS; FEELING MISERABLE; CHILLS; FEVER; HEADACHE; 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: not reported) dose was not reported, administered on 06-APR-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 07-APR-2021, the subject experienced body soreness. On 07-APR-2021, the subject experienced feeling miserable. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache, body soreness and feeling miserable was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Sensitive skin
Clinical narrative: SKIN VERY SENSITIVE; HEADACHE; TIREDNESS; 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced skin very sensitive. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, tiredness and skin very sensitive was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: CHILLS; FATIGUE; 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 16:30 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and the outcome of fever and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administration error, Underdose
Clinical narrative: MEDICATION ERROR; OFF LABEL USE; PARTIAL DRUG ADMINISTERED; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and  expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced medication error. On 08-APR-2021, the subject experienced off label use. On 08-APR-2021, the subject experienced partial drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error, off label use and partial drug administered was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 06:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 38. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, and fever. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Paraesthesia
Clinical narrative: INTENSE HEADACHE; FATIGUE; SENSATION LIKE PINS AND NEEDS RUNNING FROM THE SHOULDER TO THE FINGER TIPS; SORE ARM; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, chronic obstructive pulmonary disease, asthma, bone degeneration, cigarette smoker, and alcohol user, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sensation like pins and needs running from the shoulder to the finger tips. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced fatigue. Treatment medications included: paracetamol. On 07-APR-2021, the subject experienced intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, intense headache, and fatigue, and had not recovered from sensation like pins and needs running from the shoulder to the finger tips. This report was non-serious.