chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Redness at vaccine site, arm pain, unable to move the arm of the vaccine, dizziness, headache, shivering, fever
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Hypopnoea, Myalgia
Clinical narrative: Severe chills, muscle and joint aches, fever (101.6). Short shallow breathing, 90% blood oxygen. Mild diarrhea. Lasted 24 hours so far. Still feeling symptoms. Taking ibuprofen and acetaminophen.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Severe chills, muscle and joint aches, fever (101.6). Short shallow breathing, 90% blood oxygen. Mild diarrhea. Lasted 24 hours so far. Still feeling symptoms. Taking ibuprofen and acetaminophen.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Smell is working but general air smells like masked ozone.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 48 hours after the vaccination, I woke up with itchiness at the injection site (lasted one day) and a localized reaction showing as red irritation and swelling extending approximately 3 inches underneath the injection site and approximately an inch wide. Area was tender like a bruise. Twenty-four hours later, area was no longer red and tender but was now itchy. On day 4, all itchiness and redness is gone.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid, Urticaria
Clinical narrative: Swollen upper and lower eyelids for 5 weeks; Hives on 4/24/2021
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Eye swelling, Hypersensitivity, Urticaria
Clinical narrative: Swollen upper and lower eyelids for 5 weeks; Hives on 4/24/2021
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Pain, Tenderness, Ultrasound scan
Clinical narrative: Egg size mass formed on right side mid-calf under skin of right leg - no known injury - no bruise - very painful to touch & even walk - no apparent improvement yet.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Nausea, Seizure like phenomena, Syncope
Clinical narrative: SEVERAL MINUTES AFTER GETTING THE VACCINE THE PATIENT FAINTED AND SEEMED TO BE HAVING A SEIZURE. THIS HAPPENED 4 TIMES AND EACH EPISODE LASTED ABOUT 10 SECONDS. AMBULANCE CAME RIGHT AWAY. PT HAD SEVERLY LOW BLOOD PRESSURE, SWEATING, NAUSEA. MOM CAME AND PICKED UP PATIENT, HE REFUSED TO GO TO HOSPITAL.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: 2 weeks after the shot I developed rash on my left arm. The rash is in the form of a circle and size of a palm. Red and itchy.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neck pain, Pain of skin, Pruritus, Rash
Clinical narrative: On 3/15/2021 my neck and scalp began to itch/hurt. . On 3/18/2021 my scalp broke out in rash consisting of blisters that wept and formed crusts. On 3/19/2021 I was diagnosed with shingles and started on an anti-viral medication and gabapentin.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: On 3/15/2021 my neck and scalp began to itch/hurt. . On 3/18/2021 my scalp broke out in rash consisting of blisters that wept and formed crusts. On 3/19/2021 I was diagnosed with shingles and started on an anti-viral medication and gabapentin.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: On Day 8 after the vaccine, I started getting headaches, fever & chills, extreme tiredness. The headaches continue to persist through day 16.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, mild swelling around site where Inject-Safe? Barrier Bandages was applied, itchiness in the site where bandage had been and beyond it, moderate fatigue, mild lightheadedness
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Dyspnoea, Erythema, Nausea
Clinical narrative: Approximately 5 minutes after administration of the covid-19 vaccine, the patient became dizzy/light headed. The patient laid down in the vaccination room, where we provided water, ice, and an epi-pen at stand by. patient became red in the face and stated she had difficulty breathing. Upon obstervation, she was also very clammy and shaking. After 30 minutes, patient stated she was starting to be unable to breathe and was nauseous, upon request by her and the patient's mother, an Epi-pen was adminitestered by myself, and the mother felt comfortable taking the patient to the hospital a few minutes later for observation. A second epi pen was not requested/needed/administered at our facility.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Approximately 5 minutes after administration of the covid-19 vaccine, the patient became dizzy/light headed. The patient laid down in the vaccination room, where we provided water, ice, and an epi-pen at stand by. patient became red in the face and stated she had difficulty breathing. Upon obstervation, she was also very clammy and shaking. After 30 minutes, patient stated she was starting to be unable to breathe and was nauseous, upon request by her and the patient's mother, an Epi-pen was adminitestered by myself, and the mother felt comfortable taking the patient to the hospital a few minutes later for observation. A second epi pen was not requested/needed/administered at our facility.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itchiness, warm to touch at injection site. Slightly over 3 inches in diameter. Injection site is approx 6 finger lengths below acromium process. Neosporin and bandage along with ice applied. 400mg ibuprofen taken. Chills also experienced in evening when shot administered.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Glassy eyes, Muscle spasms, Slow response to stimuli
Clinical narrative: VACCINE CONSENT FORM SHOWS NO ADR, NO SEIZURES OR NEUROLOGICAL CONDITIONS , NO SERIOUS REACTION TO VACCINE IN PAST, PT HAS BEEN EXAMINED BY PROVIDER IN PAST YEAR. AS VACCINE WAS BEING ADMINISTERED THE FATHER WHO ACCOMPANIED HIS SON THE PT SAID THAT THE PT WOULD PASS OUT.  THE PT DID NOT CONFIRM NOR DENY THIS, UPON ADMINISTRATION OF VACCINE PT BECAME QUIET, GLASSY EYED AND BEGAN TO GO LIMP. HE RESPONDED TO QUESTIONS UNCLEARLY. THE FATHER RESTRAINED PT FROM BEHIND CHAIR AND I IN FRONT OF HIS KNEES TO PREVENT HIM FROM FALLING TO FLOOR. AFTER APPROXIMATELY 3-4 MINUTES, HIS UPPER BODY MUSCLES SHOOK AND THEN THE LOWER BODY, MAYBE 10 SEC?, THEN HE OPENED HIS EYES AND SEEMED RECOVERED. HE WAS ASKED TO REMAIN IN THAT CHAIR UNTIL HE HAD TOTALLY RECOVERED, WHICH HE ASSERTED APPROX 15 MIN LATER. I REQUESTED THE PT AND HIS FATHER REMAIN ANOTHER 15 TO 20 MIN IN WAITING AREA AND TO CHECK OUT WITH ME BEFORE LEAVING. PT WALKED OUT WITHOUT ASSISTANCE, WITHOUT FALTERING OR DIZZINESS.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: violent vomiting
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills at 2 am. Fever of 100.4 at 6 am body aches and headache. Vomitting began at 1 pm, lasted until after 3 pm. Fever remained until 4/23. Fatigue continues. Slight headache still exists on 4/24.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills at 2 am. Fever of 100.4 at 6 am body aches and headache. Vomitting began at 1 pm, lasted until after 3 pm. Fever remained until 4/23. Fatigue continues. Slight headache still exists on 4/24.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling cold, Headache, Impaired work ability
Clinical narrative: On Apr. 17, I had a sore arm at the injection site and a slight headache. On Apr. 20, I began to be very tired and the headache became more intense.  Apr. 20 I has a mild night sweat. By mid day on Apr. 21, I have severe back pain, body aches and extreme fatigue, in addition to a continuous headache impacting my vision. Apr. 21 I had an extreme night sweat, requiring me to change in the middle night and constant chill. These symptoms persisted through Apr. 22. I was not able to work on Apr. 21 and 22. The symptoms continued but were mild on Apr. 23rd. The back pain, chills, fatigue and headache continued Apr. 24.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Night sweats, Pain, SARS-CoV-2 test negative, Visual impairment
Clinical narrative: On Apr. 17, I had a sore arm at the injection site and a slight headache. On Apr. 20, I began to be very tired and the headache became more intense.  Apr. 20 I has a mild night sweat. By mid day on Apr. 21, I have severe back pain, body aches and extreme fatigue, in addition to a continuous headache impacting my vision. Apr. 21 I had an extreme night sweat, requiring me to change in the middle night and constant chill. These symptoms persisted through Apr. 22. I was not able to work on Apr. 21 and 22. The symptoms continued but were mild on Apr. 23rd. The back pain, chills, fatigue and headache continued Apr. 24.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: HEADACHE; fever; muscle aches; nausea; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, once total 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 headache, fever, muscle aches, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, muscle aches and nausea was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Hypoaesthesia, Metabolic function test
Clinical narrative: Arm pain- unable to lift without deltoid pain in both arms, neck stiffiness, numbness and tingling in arm, at 3 weeks after it was extreme to need Medrol dose pack, gabapentin, lodine
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Arm pain- unable to lift without deltoid pain in both arms, neck stiffiness, numbness and tingling in arm, at 3 weeks after it was extreme to need Medrol dose pack, gabapentin, lodine
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Cold sweat, Dizziness, Fall, Loss of consciousness
Clinical narrative: Patient started to feel dizzy for about one minute. His father states that patient was sitting up on a chair and he started to fall backward, so his father caught him and lowered him to the ground. He did not hit his head. He was not responsive for approximately 10 seconds, per the father. Clinical monitors arrived and patient was alert and oriented to name, place, date/time. He was slightly pale and clammy but he denied any dizziness, chest pain, palpitations, shortness of breath, headache, changes in his vision/hearing, or nausea.  He was laying on his back on the ground with his legs elevated on a chair and he started to feel better, and his blood pressure and oxygen saturation were stable with mild bradycardia per the vital signs obtained by one RN. He said he was feeling better and he was smiling and joking with staff. He slowly started to sit up and sipped bottled water. Stated that he had not eaten since 11am, and he agreed to a snack.  I left to get him a snack, and RN said that he started to "zone out" and he lost consciousness again for approximately 20 seconds. When I came back, he was sitting up, conscious, and had spit up saliva and water onto his shirt. His breathing was steady.   He again stated that he was feeling better very quickly, again in good spirits, but his father and I agreed that it would be best to call 911 to transport him to the ER just to be safe. He did not hit his head. He denied dizziness, chest pain, palpitations, shortness of breath, nausea, changes in vision,  and headache. He was alert and oriented to name, place, and time. EMS was requested and they arrived, took his vitals, and he was transported to the Emergency Dept for futher care.   He and his father were confident that he would recover quickly as he had a history of syncopal episodes related to vaccines in the past.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Patient started to feel dizzy for about one minute. His father states that patient was sitting up on a chair and he started to fall backward, so his father caught him and lowered him to the ground. He did not hit his head. He was not responsive for approximately 10 seconds, per the father. Clinical monitors arrived and patient was alert and oriented to name, place, date/time. He was slightly pale and clammy but he denied any dizziness, chest pain, palpitations, shortness of breath, headache, changes in his vision/hearing, or nausea.  He was laying on his back on the ground with his legs elevated on a chair and he started to feel better, and his blood pressure and oxygen saturation were stable with mild bradycardia per the vital signs obtained by one RN. He said he was feeling better and he was smiling and joking with staff. He slowly started to sit up and sipped bottled water. Stated that he had not eaten since 11am, and he agreed to a snack.  I left to get him a snack, and RN said that he started to "zone out" and he lost consciousness again for approximately 20 seconds. When I came back, he was sitting up, conscious, and had spit up saliva and water onto his shirt. His breathing was steady.   He again stated that he was feeling better very quickly, again in good spirits, but his father and I agreed that it would be best to call 911 to transport him to the ER just to be safe. He did not hit his head. He denied dizziness, chest pain, palpitations, shortness of breath, nausea, changes in vision,  and headache. He was alert and oriented to name, place, and time. EMS was requested and they arrived, took his vitals, and he was transported to the Emergency Dept for futher care.   He and his father were confident that he would recover quickly as he had a history of syncopal episodes related to vaccines in the past.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus started in both ears the morning following the vaccine and has not stopped.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Red, hard, itching lump at injection site approx 1? diameter
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: Immediately after vaccination client passed out for approximately 20 sec. evaluated by MD and paramedics onsite. diaphoretic, with dizziness, nausea and vomiting x 1. Per client felt better. Client picked up from site by father and driven home.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Immediately after vaccination client passed out for approximately 20 sec. evaluated by MD and paramedics onsite. diaphoretic, with dizziness, nausea and vomiting x 1. Per client felt better. Client picked up from site by father and driven home.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Back pain, Chest pain, Pain in extremity
Clinical narrative: Had hart pain, chest pain, pain on back  where hart is, left shoulders and left hand pain . The pain was for 4-5 hours. Had to go to bed. Had to take nitroglycerin.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: SERIOUS JOINT PAIN IN HAND WRIST OF INOCULATED ARM; SERIOUS MUSCLE PAIN IN HAND WRIST OF INOCULATED ARM; MILD ACHINESS; This spontaneous report received from a patient concerned a 6 decade old male. The patient's weight was 205 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included type ii diabetes, and hypothyroidism, 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, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included dulaglutide for type ii diabetes. On MAR-2021, the subject experienced mild achiness. On 14-MAR-2021, the subject experienced serious joint pain in hand wrist of inoculated arm. On 14-MAR-2021, the subject experienced serious muscle pain in hand wrist of inoculated arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild achiness on MAR-2021, and the outcome of serious joint pain in hand wrist of inoculated arm and serious muscle pain in hand wrist of inoculated arm was not reported. This report was non-serious.   Additional information was received on 23-MAR-2021: The following information was updated and incorporated into the case: Patient Demographic details (height ,weight) , reporters details (Address , zip code ,city ,state ) was updated .; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced 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: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: BODY ACHES; VOMITING; COLD CHILLS; LEG PAIN; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. 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: 1805025 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced cold chills. On 13-MAR-2021, the subject experienced leg pain. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, cold chills, leg pain, nausea, and headache on 14-MAR-2021, was recovering from fever, and had not recovered from body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: BODY ACHES; VOMITING; COLD CHILLS; LEG PAIN; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. 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: 1805025 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced cold chills. On 13-MAR-2021, the subject experienced leg pain. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, cold chills, leg pain, nausea, and headache on 14-MAR-2021, was recovering from fever, and had not recovered from body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dyspnoea, Fatigue, Flatulence
Clinical narrative: SHORTNESS OF BREATH; NAUSEA; WOOZINESS/DIZZINESS; SICK TO HER STOMACH WITH GAS; FEVER; TIREDNESS; 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 asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tiredness. On 11-MAR-2021 12:00, the subject experienced wooziness/dizziness. On 11-MAR-2021 12:00, the subject experienced sick to her stomach with gas. On 11-MAR-2021 12:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 12-MAR-2021 12:00, the subject experienced shortness of breath. On 12-MAR-2021 12:00, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from wooziness/dizziness, sick to her stomach with gas, shortness of breath, and fever, and had not recovered from nausea, and tiredness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; NAUSEA; WOOZINESS/DIZZINESS; SICK TO HER STOMACH WITH GAS; FEVER; TIREDNESS; 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 asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tiredness. On 11-MAR-2021 12:00, the subject experienced wooziness/dizziness. On 11-MAR-2021 12:00, the subject experienced sick to her stomach with gas. On 11-MAR-2021 12:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 12-MAR-2021 12:00, the subject experienced shortness of breath. On 12-MAR-2021 12:00, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from wooziness/dizziness, sick to her stomach with gas, shortness of breath, and fever, and had not recovered from nausea, and tiredness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHES; 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, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: SLIGHTLY DIZZY; A SPLITTING HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced slightly dizzy. On 15-MAR-2021, the subject experienced a splitting headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slightly dizzy, and a splitting headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia
Clinical narrative: INCREASED HEART RATE; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On an unspecified date, the subject experienced increased heart rate, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle ache, and increased heart rate. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: INTENSE BURNING; RAISED BUMPS, RASH ON ABDOMEN AND LOWER ARMS; SKIN REDNESS ON FEET; ITCHINING ON TOP OF FEET; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have no known allergies.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 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. On 06-MAR-2021, the subject experienced itchining on top of feet. On 11-MAR-2021, the subject experienced skin redness on feet. On 14-MAR-2021, the subject experienced intense burning. On 14-MAR-2021, the subject experienced raised bumps, rash on abdomen and lower arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense burning, sore arm, itchining on top of feet, skin redness on feet, and raised bumps, rash on abdomen and lower arms on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; 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, intramuscular, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced body aches. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from chills, and body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE SORENESS IN LEFT DELTOID; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced injection site soreness in left deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness in left deltoid on 12-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Nausea
Clinical narrative: VOMITING; CHILLS; FEVER 103 AND 100.5 F; NAUSEA; HEADACHE; WEAKNESS; 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 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced fever 103 and 100.5 f. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 103 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 103 and 100.5 f, vomiting, chills, nausea, headache and weakness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: VOMITING; CHILLS; FEVER 103 AND 100.5 F; NAUSEA; HEADACHE; WEAKNESS; 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 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced fever 103 and 100.5 f. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 103 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 103 and 100.5 f, vomiting, chills, nausea, headache and weakness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: PRETTY  ACHY BACK; This spontaneous report received from a patient concerned a 77 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: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 22:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced pretty achy back. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pretty achy back on 14-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dizziness, Feeling abnormal, Headache
Clinical narrative: WEIRD; FELT NO CIRCULATION IN THE LEG, LEG FELT FUNNY, NOT WORKING 100 %, LEG FELT THUNDER TO TOUCH, NO COLOUR, PAIN IN THE LEG, LEG FELT WEIRD, AND SORE LEG; DIZZY/LIGHT HEAD; TINY COLD; CHILLS; PAIN ON THE ARM; HEADACHE/HEADACHE LIKE PRESSURE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced dizzy/light head. On 07-MAR-2021, the subject experienced tiny cold. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced pain on the arm. On 07-MAR-2021, the subject experienced headache/headache like pressure. On 07-MAR-2021, the subject experienced nausea. On 10-MAR-2021, Laboratory data included: COVID-19 (NR: not provided) Negative. On an unspecified date, the subject experienced felt no circulation in the leg, leg felt funny, not working 100 %, leg felt thunder to touch, no colour, pain in the leg, leg felt weird, and sore leg, and weird. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, metoclopramide, and ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiny cold, and chills, and pain on the arm on 10-MAR-2021, and had not recovered from headache/headache like pressure, dizzy/light head, nausea, felt no circulation in the leg, leg felt funny, not working 100 %, leg felt thunder to touch, no colour, pain in the leg, leg felt weird, and sore leg, and weird. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nasopharyngitis, Nausea, Pain in extremity
Clinical narrative: WEIRD; FELT NO CIRCULATION IN THE LEG, LEG FELT FUNNY, NOT WORKING 100 %, LEG FELT THUNDER TO TOUCH, NO COLOUR, PAIN IN THE LEG, LEG FELT WEIRD, AND SORE LEG; DIZZY/LIGHT HEAD; TINY COLD; CHILLS; PAIN ON THE ARM; HEADACHE/HEADACHE LIKE PRESSURE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced dizzy/light head. On 07-MAR-2021, the subject experienced tiny cold. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced pain on the arm. On 07-MAR-2021, the subject experienced headache/headache like pressure. On 07-MAR-2021, the subject experienced nausea. On 10-MAR-2021, Laboratory data included: COVID-19 (NR: not provided) Negative. On an unspecified date, the subject experienced felt no circulation in the leg, leg felt funny, not working 100 %, leg felt thunder to touch, no colour, pain in the leg, leg felt weird, and sore leg, and weird. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, metoclopramide, and ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiny cold, and chills, and pain on the arm on 10-MAR-2021, and had not recovered from headache/headache like pressure, dizzy/light head, nausea, felt no circulation in the leg, leg felt funny, not working 100 %, leg felt thunder to touch, no colour, pain in the leg, leg felt weird, and sore leg, and weird. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nausea, Pruritus, Skin exfoliation, Skin warm
Clinical narrative: FACE SWELLING; SKIN HOT TO TOUCH; SKIN FLAKY TO TOUCH; ITCHINESS; COUGH; NAUSEA; This spontaneous report received from a patient concerned a 75 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: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced cough. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced itchiness. On 14-MAR-2021, the subject experienced face swelling. On 14-MAR-2021, the subject experienced skin hot to touch. On 14-MAR-2021, the subject experienced skin flaky to touch. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, and nausea on 13-MAR-2021, and was recovering from itchiness, face swelling, skin hot to touch, and skin flaky to touch. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: FACE SWELLING; SKIN HOT TO TOUCH; SKIN FLAKY TO TOUCH; ITCHINESS; COUGH; NAUSEA; This spontaneous report received from a patient concerned a 75 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: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced cough. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced itchiness. On 14-MAR-2021, the subject experienced face swelling. On 14-MAR-2021, the subject experienced skin hot to touch. On 14-MAR-2021, the subject experienced skin flaky to touch. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, and nausea on 13-MAR-2021, and was recovering from itchiness, face swelling, skin hot to touch, and skin flaky to touch. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Pain, Restlessness
Clinical narrative: COUGHING; BODY ACHES AND PAIN; COULDN'T LAY STILL; CHILLS; FEELING BAD / FEELING CRAPPY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age.. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers  No concomitant medications were reported. On 14-MAR-2021, the subject experienced feeling bad / feeling crappy. On an unspecified date, the subject experienced coughing, body aches and pain, couldn't lay still, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling bad / feeling crappy, body aches and pain, chills, coughing and couldn't lay still was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Insomnia
Clinical narrative: SLUGGISH; TIRED; HEADACHE; BODY ACHES; SHAKING; MUSCLE ACHES; CHILLS; FEVER; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and other pre-existing medical conditions included the patient has no known drug the patient has no drug abuse or illicit drug usage the patient does not smoke. the has no diagnostic data available.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 14-MAR-2021 13:00 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 14-MAR-2021, the subject experienced did not sleep well. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021 23:30, the subject experienced body aches. On 14-MAR-2021 23:30, the subject experienced shaking. On 14-MAR-2021 23:30, the subject experienced muscle aches. On 14-MAR-2021 23:30, the subject experienced chills. On 14-MAR-2021 23:30, the subject experienced headache. On 15-MAR-2021, the subject experienced sluggish. On 15-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 15-MAR-2021 06:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shaking, muscle aches, chills, fever, and headache on 15-MAR-2021, had not recovered from sluggish, and tired, and the outcome of did not sleep well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Sluggishness, Tremor
Clinical narrative: SLUGGISH; TIRED; HEADACHE; BODY ACHES; SHAKING; MUSCLE ACHES; CHILLS; FEVER; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and other pre-existing medical conditions included the patient has no known drug the patient has no drug abuse or illicit drug usage the patient does not smoke. the has no diagnostic data available.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 14-MAR-2021 13:00 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 14-MAR-2021, the subject experienced did not sleep well. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021 23:30, the subject experienced body aches. On 14-MAR-2021 23:30, the subject experienced shaking. On 14-MAR-2021 23:30, the subject experienced muscle aches. On 14-MAR-2021 23:30, the subject experienced chills. On 14-MAR-2021 23:30, the subject experienced headache. On 15-MAR-2021, the subject experienced sluggish. On 15-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 15-MAR-2021 06:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shaking, muscle aches, chills, fever, and headache on 15-MAR-2021, had not recovered from sluggish, and tired, and the outcome of did not sleep well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Fatigue, Influenza like illness
Clinical narrative: BACK PAIN; FELT TIRED; CHILLS; FEVER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the patient experienced flu like symptoms, chills and fever. Laboratory data included: Body temperature (NR: not provided) 100.2-100.3. On 15-MAR-2021, the patient experienced back pain and felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, was recovering from felt tired, and flu like symptoms, and had not recovered from back pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BACK PAIN; FELT TIRED; CHILLS; FEVER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the patient experienced flu like symptoms, chills and fever. Laboratory data included: Body temperature (NR: not provided) 100.2-100.3. On 15-MAR-2021, the patient experienced back pain and felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, was recovering from felt tired, and flu like symptoms, and had not recovered from back pain. This report was non-serious.