chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; 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 17-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 tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness. This report was non-serious.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 59 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Skin discolouration
Clinical narrative: LEFT HAND TURNING BLUE; CHILLS/ SHIVERING; 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: Unk) dose was not reported, administered on 18-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced shivering. On 18-MAR-2021, the subject experienced left hand turning blue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, shivering, and left hand turning blue. This report was non-serious.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: DIZZINESS; TINGLING IN THE ARMS; This spontaneous report received from a parent concerned a 24 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included autism, and allegry to clindamycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609) dose was not reported, administered in right deltoid on 18-MAR-2021 at 09:00 am for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced tingling in the arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and tingling in the arms. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site pain, Pyrexia
Clinical narrative: FEVER; HEADACHE; A LOT OF PAIN AT INJECTION SITE; 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 vaccinated on left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced a lot of pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a lot of pain at injection site on 18-MAR-2021, and had not recovered from fever, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: CHILLS; EXTREME TIREDNESS; MUSCLE ACHES; 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: 1808509, expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced extreme tiredness. On 18-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from extreme tiredness, and muscle aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: MINOR FLU LIKE SYMPTOMS; 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. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced minor flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from minor flu like symptoms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Product quality issue, Wrong technique in product usage process
Clinical narrative: MEDICATION ERROR; PRODUCT QUALITY ISSUE; WRONG TECHNIQUE IN DRUG USAGE PROCESS; 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. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On an unspecified date, the subject experienced wrong technique in drug usage process, medication error, and product quality issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong technique in drug usage process, medication error and product quality issue was not reported. This report was non-serious.   Additional information was received from patient on 16-MAR-2021. The following information was updated and incorporated in to the case narrative: Patient demographic details (DOB, age group, height, weight and Age at the time of vaccination). Product quality number was added, (90000173614).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; 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 past medical history included leukemia, and bone marrow transplant, and concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fever. On 18-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hypoaesthesia, Injection site pain, Nausea
Clinical narrative: NUMBNESS IN RIGHT HAND; CHILLS; NAUSEA; LOW-GRADE FEVER (100.2); SORE INJECTION SITE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021, and dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced low-grade fever (100.2). On 15-MAR-2021, the subject experienced sore injection site. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 16-MAR-2021, the subject experienced numbness in right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, and low-grade fever (100.2) on 16-MAR-2021, was recovering from sore injection site, and had not recovered from numbness in right hand. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NUMBNESS IN RIGHT HAND; CHILLS; NAUSEA; LOW-GRADE FEVER (100.2); SORE INJECTION SITE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021, and dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced low-grade fever (100.2). On 15-MAR-2021, the subject experienced sore injection site. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 16-MAR-2021, the subject experienced numbness in right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, and low-grade fever (100.2) on 16-MAR-2021, was recovering from sore injection site, and had not recovered from numbness in right hand. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; 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, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 15:53 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021 01:30, Laboratory data included: Body temperature (NR: not provided) 101.3. On 19-MAR-2021 02:02, Laboratory data included: Body temperature (NR: not provided) 101.7. On 19-MAR-2021 02:09, Laboratory data included: Body temperature (NR: not provided) 101.4. On an unspecified date, the subject experienced chills, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea and chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: ARM PAIN; PAINFUL VACCINE; EXTREME FATIGUE; 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 around 16:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced extreme fatigue. On 15-MAR-2021 around 16:00, the subject experienced painful vaccine. On 16-MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, had not recovered from extreme fatigue, and the outcome of painful vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Breast feeding
Clinical narrative: BREASTFEEDING GETTING VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination.The batch number was not reported, the company is unable to performed follow up to request batch/lot no. No concomitant medications were reported. On an unspecified date, the patient experienced breastfeeding getting vaccine. reporter inquired possibility passing of antibodies from his nursing wife to their baby. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breastfeeding getting vaccine was not reported. The reporter provided causality assessment between covid-19 vaccine ad26.cov2.s and event breastfeeding getting vaccine. Company causality between covid-19 vaccine ad26.cov2.s and event breastfeeding getting vaccine was possible. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: severe ringing in ears, sever fatigue still 8 days later, body aches, head ache, stomach upset, severe brain fog, weakness - all running for 8 days since I was vaccinated! What is the point of getting sick for 8 days and running?? Its like having covid again!!
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: severe ringing in ears, sever fatigue still 8 days later, body aches, head ache, stomach upset, severe brain fog, weakness - all running for 8 days since I was vaccinated! What is the point of getting sick for 8 days and running?? Its like having covid again!!
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Illness, Lung disorder, Pain, SARS-CoV-2 test
Clinical narrative: severe ringing in ears, sever fatigue still 8 days later, body aches, head ache, stomach upset, severe brain fog, weakness - all running for 8 days since I was vaccinated! What is the point of getting sick for 8 days and running?? Its like having covid again!!
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Tinnitus
Clinical narrative: severe ringing in ears, sever fatigue still 8 days later, body aches, head ache, stomach upset, severe brain fog, weakness - all running for 8 days since I was vaccinated! What is the point of getting sick for 8 days and running?? Its like having covid again!!
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Severe maculopapular rash, covering mostly arms, back, chest and legs. No mucosal lesions. No fever. Pt feels well but very itchy Did give Prednisone 60 mg daily x 5 days given extensiveness of rash Advised NOT to get 2nd dose due to concern for possible allergy-mediated response to vaccine Pt appears well but rash is extensive, likely have worse response with repeat exposure
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Severe maculopapular rash, covering mostly arms, back, chest and legs. No mucosal lesions. No fever. Pt feels well but very itchy Did give Prednisone 60 mg daily x 5 days given extensiveness of rash Advised NOT to get 2nd dose due to concern for possible allergy-mediated response to vaccine Pt appears well but rash is extensive, likely have worse response with repeat exposure
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainting
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Heart rate increased, Hypertension, Tremor
Clinical narrative: Reaction to A-Fib medications Metoprolol and flecainide. Rapid heart rate, high blood pressure, body shaking, loss of apatite. extreme exhaustion.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Rash erythematous
Clinical narrative: Per dermatologist, erythematous eczematous patches started right arm, then appeared on left arm and both legs and feet over the course of 3-4 days. The patches were itchy. Primary care physician prescribed Doxycycline 100 mg. 2 times daily for 10 days and prednisone 50 mg. daily for 5 days; however, a nose bleed developed after the 1st dose of prednisone and it was tapered off.  Coincidentally, an appointment was made with a dermatologist for an irritated seborrheic keratosis, and Betamethasone augmented 0.05% topical cream was prescribed. As of this date (4/24/2021), there are no new patches, the original patch on the arm is still present but much improved and the patches on the legs and feet are also improving.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: CHILLS; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) once a total dose was not reported, administered on 15-MAR-2021 at right arm 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 chills. On 16-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from muscle ache. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Acute hepatic failure, Blood test, Computerised tomogram, Hepatic pain, Loss of consciousness
Clinical narrative: Extreme and severe liver pain followed by loss of consciousness at home 14 hours after 2nd Moderna COVID-19 vaccine.  Rushed to local ER, life flighted out of State by helicopter in acute liver failure, hospitalized for 4 days.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance cholangiopancreatography, Ultrasound scan, Urine analysis, X-ray
Clinical narrative: Extreme and severe liver pain followed by loss of consciousness at home 14 hours after 2nd Moderna COVID-19 vaccine.  Rushed to local ER, life flighted out of State by helicopter in acute liver failure, hospitalized for 4 days.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Large, red skin rash near injection site
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever, chills, and overly tired from around 11:00pm on April 22 until around the early hours of the morning on April 24. Fever broke while asleep, but had to have been between 1:00am and 6:00am. At its highest (measured) point, the fever was 100.3 degrees. My normal body temperature floats somewhere between 96 and 97 degrees.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: at 2:30 am I woke up suddenly and violently vomited about 5 times, followed by cold chills and a weakness that I have never experienced before. Then had explosive diarrhea for another 5 to 6 hours.  Temperature was 96, usually 96.7 so no fever, but I was sweating and shivering. I drank water and sipped soda, slept all day and all night and woke up the following day as if nothing had happened. My arm never hurt and was not red.  This bad reaction was from 2:30am until 8:30am, the rest seemed to be normal or expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient received vaccine. Within 2 minutes, he felt lightheaded and sweaty. He stood up to go to the observation area. We had him sit-down and place his head lower than his chest. He almost immediately felt better. He had flown in. He mentioned he had not drank much water since, but he had eaten. He was fine after the observation period and left.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Skipped menstrual cycle. I am not pregnant, it would be impossible due to no intercourse and permanent birth control. As of this writing, I am 7 days late for my normal cycle.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 17 at time of administration- parents reported incorrect date of birth to sign up for vaccination- unaware of error until post vaccination when talking personally with patient and asked literal age number.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Hyperacusis, Tinnitus
Clinical narrative: Tinnitus, ringing in ears, sensitive to sound, pain.  Started after injection.  Was only given a vaccine card.  No information given on side effects to look for.  Was not aware until later that tinnitus was a side effect from vaccine
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dry throat
Clinical narrative: Chest pressure, dry throat. Evaluated by EMS-Cleared
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cough, Tremor
Clinical narrative: Client shaking followed and stated he felt anxious. MD advised client to wait in observation area for extended observation. Client developed  persistent dry non-productive cough. 50mg/1ml Benadryl ordered. Client symptoms improved. Client wife came to site to drive client home. Client declined transport to ER.  Client advised that if symptoms worsen to seek emergency services.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Heart rate, Nausea
Clinical narrative: HARD TO BREATHE; DIZZY; RASH; NAUSEA; This spontaneous report received from a vaccine facility concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included uti diagnosis, alcohol use, non smoker, and loss of hearing in left ear, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 09:45 on right arm for prophylactic vaccination. Concomitant medications included sulfamethoxazole/trimethoprim for uti. On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 136/76 mmHg, 168/95 mmHg, and Heart rate (NR: not provided) 127 BPM. On 18-MAR-2021, the subject experienced hard to breathe.  On 18-MAR-2021, the subject experienced dizzy. On 18-MAR-2021, the subject experienced rash. On 18-MAR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 192/117 mmHg, and Heart rate (NR: not provided) 129 BPM. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, dizzy, and hard to breathe, and had not recovered from rash. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: HARD TO BREATHE; DIZZY; RASH; NAUSEA; This spontaneous report received from a vaccine facility concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included uti diagnosis, alcohol use, non smoker, and loss of hearing in left ear, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 09:45 on right arm for prophylactic vaccination. Concomitant medications included sulfamethoxazole/trimethoprim for uti. On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 136/76 mmHg, 168/95 mmHg, and Heart rate (NR: not provided) 127 BPM. On 18-MAR-2021, the subject experienced hard to breathe.  On 18-MAR-2021, the subject experienced dizzy. On 18-MAR-2021, the subject experienced rash. On 18-MAR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 192/117 mmHg, and Heart rate (NR: not provided) 129 BPM. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, dizzy, and hard to breathe, and had not recovered from rash. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Headache
Clinical narrative: Continuance non stop daily headache since I got vaccinated on 4/8/21. Today is 4/24/21 and I still have headaches. Over the counter pain relief does not help.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain
Clinical narrative: Chest pain, back pain on meddle and left side.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Pain, Pain in extremity
Clinical narrative: About a week after vaccination, my left arm, which had the vacine, started throbbing up and down. I was wondering if I was having a heart attack. It lasted a few days.  A week or so later, that arm started hurting from back of shoulder down to my hand and my fingers are  numb/tingling. It feels like my muscles are in pain in that left arm. It has not disappated.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: About a week after vaccination, my left arm, which had the vacine, started throbbing up and down. I was wondering if I was having a heart attack. It lasted a few days.  A week or so later, that arm started hurting from back of shoulder down to my hand and my fingers are  numb/tingling. It feels like my muscles are in pain in that left arm. It has not disappated.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: About a week after vaccination, my left arm, which had the vacine, started throbbing up and down. I was wondering if I was having a heart attack. It lasted a few days.  A week or so later, that arm started hurting from back of shoulder down to my hand and my fingers are  numb/tingling. It feels like my muscles are in pain in that left arm. It has not disappated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Fatigue, Influenza, Night sweats
Clinical narrative: Day of second vaccine: weakness, fever, night sweats,  flu symptoms, arm pain for one week  Extreme fatigue weakness ,tiredness, and fatigue have not diminished and unable to do everyday task since second vaccine
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Day of second vaccine: weakness, fever, night sweats,  flu symptoms, arm pain for one week  Extreme fatigue weakness ,tiredness, and fatigue have not diminished and unable to do everyday task since second vaccine
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Sore, itchy, hot, raised area by injection site. About 5 cm diameter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein normal, Ecchymosis, Platelet count normal, Skin lesion, Tenderness
Clinical narrative: Approximately 6 hours post vaccination patient experienced spontaneous echymosis over ventral aspects of both hands---worse on thenar eminence.  Slightly painful to touch.  No other lesions noted and no other systemic symptoms with normal vital signs.  Lesions began to resolve about 18 hours after vaccination but were faintly apparent at 24 hours post vaccination.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: active COVID-19 infection
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: UPSET STOMACH; CHILLS; ARM SORENESS; FEVER; 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 alcohol use, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use. 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 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 18-MAR-2021, the subject experienced upset stomach. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced arm soreness. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, arm soreness, upset stomach, and headache. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years old.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: client stated she felt nauseous and had 1 episode of vomiting. After client vomited returned to baseline. observed for 10 more minutes and evaluated by MD. Client advised of follow up care and declined transport to ER for further evaluation. Patient noted to be back at baseline and father drove client home.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Bronchospasm, Cardiac discomfort, Chest X-ray normal
Clinical narrative: 4/22-preswnt: Body aches, nausea, vomiting, heart palpitations, chest spasms, pressure around heart, shoulder, arm and rib cage pain.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fibrin D dimer normal, Musculoskeletal chest pain, Nausea, Pain
Clinical narrative: 4/22-preswnt: Body aches, nausea, vomiting, heart palpitations, chest spasms, pressure around heart, shoulder, arm and rib cage pain.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Vomiting
Clinical narrative: 4/22-preswnt: Body aches, nausea, vomiting, heart palpitations, chest spasms, pressure around heart, shoulder, arm and rib cage pain.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever. Chills.  Muscle aches. Nausea. Vomiting.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Influenza
Clinical narrative: FLU SYMPTOMS; HAIR FALLING OUT / HAIR THINNING; 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 covid-19. The patient was previously treated with calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate. 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 and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced flu symptoms. On MAR-2021, the subject experienced hair falling out / hair thinning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu symptoms and hair falling out / hair thinning was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Took ibuprofen and drank 16 oz of water 1 hour prior to appointment Appointment at 2:30PM PST Felt fine immediately following vaccine (30 minutes after injection) At 4:30PM PST, I began feeling tired At 6PM PST I felt feverish, took temperature around 9PM PST and had mild fever of 99.4 (taken in ear) At 9PM PST body aches set in and moderate physical discomfort (couldn't get comfortable, took ibuprofen) 9:30PM PST (ish) fell asleep.  Woke up at 3:15AM PST when my fever broke, drenched in sweat. For the past five days I have had extreme exhaustion and a mild persistent headache (Tuesday - Saturday [today])
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Immediate post-injection reaction, Nausea, Swelling face
Clinical narrative: Immediately after shot - light headed, nausea, high blood pressure - treated (monitored) by paramedic at vaccine clinic and sent home; 3 hours later - swelling on the left side of face - treated at my physicians office
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever 2nd day of 101.8, went down and up over next 3 days. Chills, no appetite, very sore arm, fatigued for 3-4 days
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram normal, Fibrin D dimer increased, Headache
Clinical narrative: Chills and moderate headache within 6 hours of vaccine. Lasted about 6 hours  Severe headache 6 days later that lasted 1 day
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: headache chills weakness dizziness nausea no appetite body aches tingling in feet and hands pain in the arm that received shot sleepiness I kept hydrated took arnica and CBD cream on my arm  took a 2 hr nap which I never do felt better 14 hrs later with only headache and mild symptoms
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Paraesthesia, Somnolence
Clinical narrative: headache chills weakness dizziness nausea no appetite body aches tingling in feet and hands pain in the arm that received shot sleepiness I kept hydrated took arnica and CBD cream on my arm  took a 2 hr nap which I never do felt better 14 hrs later with only headache and mild symptoms
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Hangover, Headache, Pain
Clinical narrative: HEADACHE; FEELING HUNG OVER; BODY ACHES; PAIN BEHIND EYES; This spontaneous report received from a patient via a company representative concerned a 45 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 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 2021, the subject experienced headache. On 2021, the subject experienced feeling hung over. On 2021, the subject experienced body aches. On 2021, the subject experienced pain behind eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, feeling hung over, body aches and pain behind eyes was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dry skin, Rash, Rash papular, Rash pruritic
Clinical narrative: Itchy, burning,painful,fine papular rash,dry and rough.10 intertriginous areas.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Fatigue, Head discomfort
Clinical narrative: When I woke up on 04/23/2021, I felt a general feeling of malaise throughout. I had a massive headache, my joints were extremely painful and I had a lot of pressure in my head.  I went to work and later I went to lunch and as I was leaving the restaurant, I started to feel extremely sick as if my heart was exploding. I went to the restroom. I wear an Apple watch and checked my pulse. My heart rate which is normally in the 60-70 bpm was in the 120's. My chest felt like it could not hold my heart. I waited for about 20 minutes to see if my heart rate would slow down. My heart was working very hard and I felt like my head was going to burst. The feeling in my head subsided somewhat but my pulse continued to be basically very high as it was still in the 120's.  Eventually I drove myself home and my heart rate had not slowed down. I felt my entire left torso front back (ribs/chest and back on left side) to be very painful. This was due to the extreme pain I felt and the extreme muscle contractions I endured when my heart rate first started racing. I felt like I could not fit in my skin.  I tried to take it easy when I got home as I could not move, had extreme fatigue, no energy, pain everywhere where I was touched by something.  I went to bed early and continued wearing my Apple Watch through the night and had similar high heart rate (120's) through the night. When I woke up this morning. I saw that I had a heart rate in the 60-70 bpm's range for only 3 hours of sleep I had through the night.  I continued having a high heart rate through the first half of 04/24/21. It is not 9:40 in the eve and my heart rate has now finally settled down to  80+ bpm.  I plan on contacting my physician for an appointment Monday morning. They do not take appointments by phone on the weekend.  I am still not feeling 100%. I checked doctor appointment to be made below.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Malaise, Muscle contractions involuntary, Musculoskeletal chest pain
Clinical narrative: When I woke up on 04/23/2021, I felt a general feeling of malaise throughout. I had a massive headache, my joints were extremely painful and I had a lot of pressure in my head.  I went to work and later I went to lunch and as I was leaving the restaurant, I started to feel extremely sick as if my heart was exploding. I went to the restroom. I wear an Apple watch and checked my pulse. My heart rate which is normally in the 60-70 bpm was in the 120's. My chest felt like it could not hold my heart. I waited for about 20 minutes to see if my heart rate would slow down. My heart was working very hard and I felt like my head was going to burst. The feeling in my head subsided somewhat but my pulse continued to be basically very high as it was still in the 120's.  Eventually I drove myself home and my heart rate had not slowed down. I felt my entire left torso front back (ribs/chest and back on left side) to be very painful. This was due to the extreme pain I felt and the extreme muscle contractions I endured when my heart rate first started racing. I felt like I could not fit in my skin.  I tried to take it easy when I got home as I could not move, had extreme fatigue, no energy, pain everywhere where I was touched by something.  I went to bed early and continued wearing my Apple Watch through the night and had similar high heart rate (120's) through the night. When I woke up this morning. I saw that I had a heart rate in the 60-70 bpm's range for only 3 hours of sleep I had through the night.  I continued having a high heart rate through the first half of 04/24/21. It is not 9:40 in the eve and my heart rate has now finally settled down to  80+ bpm.  I plan on contacting my physician for an appointment Monday morning. They do not take appointments by phone on the weekend.  I am still not feeling 100%. I checked doctor appointment to be made below.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Fatigue, Tinnitus
Clinical narrative: Fatigue and chills since the day after vaccination.  Tight chest and shortness of breath by on and off since 4/9, about 3x/week. Ringing and echo in ears started occurring 4/18 or so, about 2x/ day
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Body temperature increased, Chills, Dizziness
Clinical narrative: Severe headache, blurr vision, dizziness, lips were numb, 103.7 temperature, chills, body aches, arm life both sides sore, joint pain, nausea, hard to walk because headache was that bad.. This happened the next day on the 23 rd. Following the headache day before.  Sought help at ER at 2:30 am on April 24th. Given iv fluid and norco and nausea med. For headache. As of 8:45 still have painful body aches chills and tiredness and arm pit pain.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Hypoaesthesia oral, Nausea
Clinical narrative: Severe headache, blurr vision, dizziness, lips were numb, 103.7 temperature, chills, body aches, arm life both sides sore, joint pain, nausea, hard to walk because headache was that bad.. This happened the next day on the 23 rd. Following the headache day before.  Sought help at ER at 2:30 am on April 24th. Given iv fluid and norco and nausea med. For headache. As of 8:45 still have painful body aches chills and tiredness and arm pit pain.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vision blurred
Clinical narrative: Severe headache, blurr vision, dizziness, lips were numb, 103.7 temperature, chills, body aches, arm life both sides sore, joint pain, nausea, hard to walk because headache was that bad.. This happened the next day on the 23 rd. Following the headache day before.  Sought help at ER at 2:30 am on April 24th. Given iv fluid and norco and nausea med. For headache. As of 8:45 still have painful body aches chills and tiredness and arm pit pain.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Photophobia
Clinical narrative: The day after my appointment, I woke up with an intense headache. Felt like my entire head was under pressure, and I was somewhat sensitive to light. I tried to take a nap, but it didn?t make the headache go away. However the pain went away by itself around 11pm. I didn?t take any pain relievers.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Pyrexia
Clinical narrative: DIZZINESS; WEAKNESS; FEVER; 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, and batch number: 180609 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced weakness. On 18-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ondansetron hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, dizziness, and weakness. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: light headed, dizziness, nausea
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Eye pruritus, Fatigue, Rhinorrhoea, Sneezing
Clinical narrative: After eating lunch approx. 24 hours after receiving the 1st dose of the vaccine, I began to cough suddenly. I then got itchy eyes, had some wheezing, and sneezed/got a runny nose. About a half hour after getting these symptoms, I took 10mg of children?s Benadryl (Diphenhydramine). I then found two hives/itchy bumps. One on my right arm near my elbow and one on the left side of my abdomen. About 20 minutes after taking the Benadryl, the symptoms mostly went away and I felt very tired. I still have some wheezing.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Wheezing
Clinical narrative: After eating lunch approx. 24 hours after receiving the 1st dose of the vaccine, I began to cough suddenly. I then got itchy eyes, had some wheezing, and sneezed/got a runny nose. About a half hour after getting these symptoms, I took 10mg of children?s Benadryl (Diphenhydramine). I then found two hives/itchy bumps. One on my right arm near my elbow and one on the left side of my abdomen. About 20 minutes after taking the Benadryl, the symptoms mostly went away and I felt very tired. I still have some wheezing.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Attention deficit hyperactivity disorder, Dysphagia, Electric shock sensation, Laboratory test, Nervousness
Clinical narrative: A few minutes after injection felt a quick electric-like shock across top of head and momentary faintness. A few minutes more, I began to have a tight feeling in my throat and swallowing was difficult. Felt the need to swallow frequently.  Got nervous so stayed past 15 minutes. At 30 minutes, it wasn't getting worse and my breathing felt fine so I left (foolishly) the vaccination site. Throat felt tight the rest of day. Kept feeling the the need to clear my throat. Sore. Hard to swallow. At 10:15pm, the tightness and swallowing issue abruptly stopped. Throat felt sore for next 2 weeks. Asked pulmonologist if my allergy and asthma medication could have suppressed a more insidious reaction. Did not know. Saw allergist. She did not know either but gave me an epi-pen if I was going to try shot 2. Also suggested J&J as an alternative. Ordered blood tests for reactivity to 2 chemicals close to PEG. (no blood test for it). Results not back. Noted that I was taking lisinopril which is an ACE inhibitor. Said they can cause swallowing problems. Cardiologist did not think so but changed my medication to a calcium channel blocker instead. Called Pfizer. They classified my reaction as an immediate adverse event and took a record of it. I canceled my second Pfizer shot appointment because the CDC site says not to take second shot if you have an immediate adverse reaction. Very disappointed and confused how to proceed. Mixed advice from doctors. Really wanted to be vaccinated. Really don't want to have a worse anaphylactic reaction which my pharmacist could happen if i tried it again. Don't feel safe trying it at the mass vaccination site at the beach.