chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in left ear beginning 3 weeks after first dose. Did not get worse following second does. Faint ringing still persists 2+ weeks after second dose.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cooling therapy, Feeling hot, Hyperhidrosis, Malaise
Clinical narrative: pt sat down after 15 minutes of getting imz then left....about 10 minutes after that pt came back and said he was not feeling well and holding his chest he said he had chest pain.....also complained of being hot, faint, and sweaty........we got cold compress for him.......pt was yawning and closed eyes....he wanted to lie down and we allowed him to do that....we got cold compress for him.........after 15 min he sat back up and we gave him water and took bp 123/71 HR 58.......temp 97.4......he said he felt better and left.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: pt sat down after 15 minutes of getting imz then left....about 10 minutes after that pt came back and said he was not feeling well and holding his chest he said he had chest pain.....also complained of being hot, faint, and sweaty........we got cold compress for him.......pt was yawning and closed eyes....he wanted to lie down and we allowed him to do that....we got cold compress for him.........after 15 min he sat back up and we gave him water and took bp 123/71 HR 58.......temp 97.4......he said he felt better and left.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, CSF test, Chills, Epidural blood patch, Headache
Clinical narrative: Second dose of Moderna vaccine 4-01-21 at 3:00pm.At 2:30 am high fever 39C walk me up,chills and big headache. 4-03-21 fills little  better but waking up every day with headache. 4-06-21 took half a day off from work because of a big headache. 4-07-21 morning lost speech ability and lost my consciousness. My husband call 911. they are taking me to a hospital I regain my consciousness and speech 2 days later. Diagnosis -Viral brain infection. Stayng in the hospital 7 days still every day with a big headache.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Loss of consciousness, Pyrexia, Viral infection
Clinical narrative: Second dose of Moderna vaccine 4-01-21 at 3:00pm.At 2:30 am high fever 39C walk me up,chills and big headache. 4-03-21 fills little  better but waking up every day with headache. 4-06-21 took half a day off from work because of a big headache. 4-07-21 morning lost speech ability and lost my consciousness. My husband call 911. they are taking me to a hospital I regain my consciousness and speech 2 days later. Diagnosis -Viral brain infection. Stayng in the hospital 7 days still every day with a big headache.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles .  Confirmed with doctor visit on Saturday 4/21. One side of body abdomen and back (right side)
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Loss of consciousness
Clinical narrative: patient passed out
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: On Saturday, April 17 at some point overnight I developed hives. The hives started  on my right thigh and left knee area lower back an buttocks.  On Sunday, April 18 the hives continued to spread throughout my kegs, then  in the evening at about 10PM worked their way to my arms and hands. I woke up with hives on my lower legs and feet face, and stomach. The hives remained until Monday, April 19 and Tuesday, April 20 but continued to lessen as the days progressed. The hives were gone by Wednesday, April 21. I took Benadryl to relieve symptoms.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: Patient suffered from an LOC with contractions. Vital signs were taken. BP 82/47, HR 44, O2 sat 100% on room air, glucose 89. Patient taken by ambulance to ER for evaluation.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein normal, Erythema, Joint swelling, Ultrasound scan
Clinical narrative: Right hand intermittent skin redness and joint swelling. This has persisted for 4 months. I saw a rheumatologist who stated likely chilblains.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Excessive pain at injection point
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Muscular weakness, Weight bearing difficulty
Clinical narrative: Moderna Covid-19 Vaccine --Approximately 4 days after the second dose was administered on 3/1/21, I woke up with a totally weak left leg.  I would have fallen down getting out of bed except I usually first grab a cane because that is also the same leg that I had TKR in about 2 years prior.  I wonder of the vaccine somehow affected the artificial knee--but the whole leg was not able to bare my weight--as if the muscles and tendons were gone.  I used a walker to slowly bring back the leg support over about 5 hours.  I told my knee doctor about this on 3/9/21  and he said one other patient of his who also had TKR 2 years ago (same as mine) told him about the same thing happening to him.  Now I am having a "tight knee" in that same leg and am very worried.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered vaccine in error prior to indicated age. Error was discovered upon arrival for second dose. Patient and father was advised not to receive second dose at this time and to wait until she turns 16 years or eligibility/CDC recommendations expand.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue, Urticaria
Clinical narrative: Right side of throat swelling, tongue swelling, and hives on face, neck, and chest.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Injection site pain
Clinical narrative: Sore arm at injection site beginning 4 hours after shot. Nausea, weakness, dizziness beginning 20 hours after injection. Fatigue, fever and chills beginning 22 hours after injection. Sore arm lasted about 4 days, all other symptoms subsided within about 24 hours from their onset.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Sore arm at injection site beginning 4 hours after shot. Nausea, weakness, dizziness beginning 20 hours after injection. Fatigue, fever and chills beginning 22 hours after injection. Sore arm lasted about 4 days, all other symptoms subsided within about 24 hours from their onset.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Syncope
Clinical narrative: Patient received vaccination and went to recovery area.  She all of the sudden fainted and fell out of her chair.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is warm to the touch, red in color, swollen and very  firm to the touch.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Hypoaesthesia eye, Migraine, Paraesthesia, Photopsia
Clinical narrative: Symptoms started approximately 23 hours after my first Pfizer dose.  I had a visual disturbance that lasted ten minutes.  First my vision went blurry at the edges, then I saw flashes of light and eventually I saw a zigzag pattern across my vision.  Since this happened the left side of my face primarily above and below my eye has been tingly and numb feeling, as well as slightly swollen.  I have also had vertigo for 11 days now that is getting worse instead of better.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred, Visual impairment
Clinical narrative: Symptoms started approximately 23 hours after my first Pfizer dose.  I had a visual disturbance that lasted ten minutes.  First my vision went blurry at the edges, then I saw flashes of light and eventually I saw a zigzag pattern across my vision.  Since this happened the left side of my face primarily above and below my eye has been tingly and numb feeling, as well as slightly swollen.  I have also had vertigo for 11 days now that is getting worse instead of better.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Chills, Decreased appetite, Feeling cold, Hyperhidrosis
Clinical narrative: Nausea,  cold chills, sweats, loos of appetite and memory.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nausea
Clinical narrative: Nausea,  cold chills, sweats, loos of appetite and memory.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness to arm that was vaccinated.  VS WNLs, symptoms improved after 30 minutes and pt cleared by medical provider.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness / Vertigo.  Began after sharp movements, has not subsided as of this date.  Mild to moderate. Symptoms. Still able to function.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Culture urine negative, Culture wound negative, Headache, Herpes simplex test negative
Clinical narrative: Arm soreness, headache day following vaccine. Two days following vaccine developed severe vulvar aphthous ulcer. Vulvar ulcerations have been recurrent following vaccination and are triggered by non-covid upper respiratory disease.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pain in extremity, Polymerase chain reaction, SARS-CoV-2 test negative
Clinical narrative: Arm soreness, headache day following vaccine. Two days following vaccine developed severe vulvar aphthous ulcer. Vulvar ulcerations have been recurrent following vaccination and are triggered by non-covid upper respiratory disease.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Sexually transmitted disease test, Vulval ulceration
Clinical narrative: Arm soreness, headache day following vaccine. Two days following vaccine developed severe vulvar aphthous ulcer. Vulvar ulcerations have been recurrent following vaccination and are triggered by non-covid upper respiratory disease.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN; 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, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 23:21 for prophylactic vaccination. The batch number was not reporting and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain. This report was non-serious. This case, from the same reporter is linked to 20210322154.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: SORE JOINTS; LOW GRADE FEVER; 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, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, start therapy date was 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 sore joints, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore joints, and low grade fever. This report was non-serious.; Sender's Comments: MAC- MAC not required per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: GOT PARTIAL DOSE; 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: G200707 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at around 15:35 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 at around 15:35, the subject experienced got partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got partial dose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; LOW GRADE 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 initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) start therapy date was 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 09-MAR-2021, the patient experienced low grade fever. On 09-MAR-2021, the patient experienced body aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and body aches on 10-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: LOW GRADE FEVER; BODY ACHES; 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 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 09-MAR-2021, the subject experienced low grade fever. On 09-MAR-2021, the subject experienced body aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and body aches on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: MILDLY SORE UPPER ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: UNKNOWN, expiry: UNKNOWN) 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 11-MAR-2021, the subject experienced mildly sore upper arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mildly sore upper arm was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: PAINFUL; RED; MOSTLY SWOLLEN; ITCHY AT SITE OF INJECTION; KNOT/BUMP AT THE SITE OF INJECTION; HEADACHE; LEFT ARM HURT; FELT TIRED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's (hypothyroidism) condition. The patient experienced drug allergy when treated with montelukast sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride. On 05-MAR-2021, the subject experienced left arm hurt. On 05-MAR-2021, the subject experienced felt tired. On 06-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced knot/bump at the site of injection. On 11-MAR-2021, the subject experienced itchy at site of injection. On an unspecified date, the subject experienced painful, red, and mostly swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and felt tired, was recovering from itchy at site of injection, had not recovered from knot/bump at the site of injection, and the outcome of left arm hurt, red, mostly swollen and painful was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: PAINFUL; RED; MOSTLY SWOLLEN; ITCHY AT SITE OF INJECTION; KNOT/BUMP AT THE SITE OF INJECTION; HEADACHE; LEFT ARM HURT; FELT TIRED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's (hypothyroidism) condition. The patient experienced drug allergy when treated with montelukast sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride. On 05-MAR-2021, the subject experienced left arm hurt. On 05-MAR-2021, the subject experienced felt tired. On 06-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced knot/bump at the site of injection. On 11-MAR-2021, the subject experienced itchy at site of injection. On an unspecified date, the subject experienced painful, red, and mostly swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and felt tired, was recovering from itchy at site of injection, had not recovered from knot/bump at the site of injection, and the outcome of left arm hurt, red, mostly swollen and painful was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain
Clinical narrative: TIRED; BODY ACHES; SWOLLEN GLANDS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 08:20 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced swollen glands. On 10-MAR-2021, the subject experienced tired. On 10-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen glands, tired, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear pain, Eye pain, Headache, Malaise
Clinical narrative: SHORTNESS OF BREATH; EYE PAIN; EAR PAIN; PAIN IN THE ARM; FEVER; NOT FEELING GOOD; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced pain in the arm. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced not feeling good. On 10-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced eye pain. On 11-MAR-2021, the subject experienced ear pain. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from pain in the arm, not feeling good, headache, eye pain, ear pain, and shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; EYE PAIN; EAR PAIN; PAIN IN THE ARM; FEVER; NOT FEELING GOOD; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced pain in the arm. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced not feeling good. On 10-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced eye pain. On 11-MAR-2021, the subject experienced ear pain. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from pain in the arm, not feeling good, headache, eye pain, ear pain, and shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES; FEVER; SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches and sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210322999.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a health care professional 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Fatigue, Headache
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; CHILLS; RAPID HEART BEAT; HEADACHE; MUSCLE ACHES; FATIGUE; This spontaneous report received from a parent 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, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced loss of taste. On 10-MAR-2021, the subject experienced loss of smell. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced rapid heart beat. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced muscle aches. On 10-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart beat on 10-MAR-2021, had not recovered from headache, loss of taste, loss of smell, muscle aches, and chills, and the outcome of fatigue was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; CHILLS; RAPID HEART BEAT; HEADACHE; MUSCLE ACHES; FATIGUE; This spontaneous report received from a parent 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, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced loss of taste. On 10-MAR-2021, the subject experienced loss of smell. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced rapid heart beat. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced muscle aches. On 10-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart beat on 10-MAR-2021, had not recovered from headache, loss of taste, loss of smell, muscle aches, and chills, and the outcome of fatigue was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Ear infection, Fatigue
Clinical narrative: NECK PAIN; BODY ACHES; BURNING SKIN; POSSIBLE SINUS INFECTION; POSSIBLE DOUBLE EAR INFECTION; FAST HEART RATE; SHORTNESS OF BREATH; SPLITTING HEADACHE; FATIGUE; DIZZINESS; VISION CHANGES; POOR SLEEP; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vasovagal syncope, postural orthostatic tachycardia syndrome, atypical asthma, ehlers-danlos syndrome, attention deficit hyperactivity disorder, hallucinations, and no allergies or reactions to previous vaccination. The patient experienced drug allergy when treated with hydrocodone for drug used for unknown indication, and drug allergy when treated with salbutamol.  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 10-MAR-2021 13:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, treatment medications included: levosalbutamol. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced vision changes. On 10-MAR-2021, the subject experienced poor sleep. Laboratory data included: Blood pressure (NR: not provided) 102/60 mmHg, and Pulse rate (NR: not provided) 72 pm. Treatment medications included: paracetamol. On 10-MAR-2021 22:00, the subject experienced splitting headache. On 10-MAR-2021 22:00, the subject experienced fatigue. On 10-MAR-2021 23:30, the subject experienced fast heart rate. On 10-MAR-2021 23:30, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced possible sinus infection. On 11-MAR-2021, the subject experienced possible double ear infection. On 11-MAR-2021, the subject experienced burning skin. On 11-MAR-2021 03:00, the subject experienced neck pain. On 11-MAR-2021 03:00, the subject experienced body aches. On 11-MAR-2021 07:45, treatment medications included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and splitting headache on 11-MAR-2021, and dizziness, and vision changes on 10-MAR-2021, was recovering from fatigue, burning skin, and possible double ear infection, had not recovered from fast heart rate, possible sinus infection, body aches, and neck pain, and the outcome of poor sleep was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Neck pain, Pain
Clinical narrative: NECK PAIN; BODY ACHES; BURNING SKIN; POSSIBLE SINUS INFECTION; POSSIBLE DOUBLE EAR INFECTION; FAST HEART RATE; SHORTNESS OF BREATH; SPLITTING HEADACHE; FATIGUE; DIZZINESS; VISION CHANGES; POOR SLEEP; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vasovagal syncope, postural orthostatic tachycardia syndrome, atypical asthma, ehlers-danlos syndrome, attention deficit hyperactivity disorder, hallucinations, and no allergies or reactions to previous vaccination. The patient experienced drug allergy when treated with hydrocodone for drug used for unknown indication, and drug allergy when treated with salbutamol.  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 10-MAR-2021 13:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, treatment medications included: levosalbutamol. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced vision changes. On 10-MAR-2021, the subject experienced poor sleep. Laboratory data included: Blood pressure (NR: not provided) 102/60 mmHg, and Pulse rate (NR: not provided) 72 pm. Treatment medications included: paracetamol. On 10-MAR-2021 22:00, the subject experienced splitting headache. On 10-MAR-2021 22:00, the subject experienced fatigue. On 10-MAR-2021 23:30, the subject experienced fast heart rate. On 10-MAR-2021 23:30, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced possible sinus infection. On 11-MAR-2021, the subject experienced possible double ear infection. On 11-MAR-2021, the subject experienced burning skin. On 11-MAR-2021 03:00, the subject experienced neck pain. On 11-MAR-2021 03:00, the subject experienced body aches. On 11-MAR-2021 07:45, treatment medications included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and splitting headache on 11-MAR-2021, and dizziness, and vision changes on 10-MAR-2021, was recovering from fatigue, burning skin, and possible double ear infection, had not recovered from fast heart rate, possible sinus infection, body aches, and neck pain, and the outcome of poor sleep was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Sinusitis, Skin burning sensation, Visual impairment
Clinical narrative: NECK PAIN; BODY ACHES; BURNING SKIN; POSSIBLE SINUS INFECTION; POSSIBLE DOUBLE EAR INFECTION; FAST HEART RATE; SHORTNESS OF BREATH; SPLITTING HEADACHE; FATIGUE; DIZZINESS; VISION CHANGES; POOR SLEEP; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vasovagal syncope, postural orthostatic tachycardia syndrome, atypical asthma, ehlers-danlos syndrome, attention deficit hyperactivity disorder, hallucinations, and no allergies or reactions to previous vaccination. The patient experienced drug allergy when treated with hydrocodone for drug used for unknown indication, and drug allergy when treated with salbutamol.  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 10-MAR-2021 13:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, treatment medications included: levosalbutamol. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced vision changes. On 10-MAR-2021, the subject experienced poor sleep. Laboratory data included: Blood pressure (NR: not provided) 102/60 mmHg, and Pulse rate (NR: not provided) 72 pm. Treatment medications included: paracetamol. On 10-MAR-2021 22:00, the subject experienced splitting headache. On 10-MAR-2021 22:00, the subject experienced fatigue. On 10-MAR-2021 23:30, the subject experienced fast heart rate. On 10-MAR-2021 23:30, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced possible sinus infection. On 11-MAR-2021, the subject experienced possible double ear infection. On 11-MAR-2021, the subject experienced burning skin. On 11-MAR-2021 03:00, the subject experienced neck pain. On 11-MAR-2021 03:00, the subject experienced body aches. On 11-MAR-2021 07:45, treatment medications included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and splitting headache on 11-MAR-2021, and dizziness, and vision changes on 10-MAR-2021, was recovering from fatigue, burning skin, and possible double ear infection, had not recovered from fast heart rate, possible sinus infection, body aches, and neck pain, and the outcome of poor sleep was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Heart rate increased, Pain
Clinical narrative: RACING HEARTBEAT; EXTREMELY ACHY BACK; BODY ACHES; FELT TO PASS OUT; SHAKING; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN)) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced racing heartbeat, extremely achy back, body aches, felt to pass out, shaking, chills, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, extremely achy back, body aches, headache, racing heartbeat, felt to pass out and shaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Presyncope, Tremor
Clinical narrative: RACING HEARTBEAT; EXTREMELY ACHY BACK; BODY ACHES; FELT TO PASS OUT; SHAKING; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN)) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced racing heartbeat, extremely achy back, body aches, felt to pass out, shaking, chills, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, extremely achy back, body aches, headache, racing heartbeat, felt to pass out and shaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pustule, Pyrexia
Clinical narrative: PUSTULES; RASHES; SWELLING; CHILLS; FEVER; PAIN; This spontaneous report received from a consumer concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast biopsy, and other pre-existing medical conditions included breast biopsy done.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 08-MAR-2021 09:15 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced pain. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rashes. On 09-MAR-2021, the subject experienced swelling. On 11-MAR-2021, treatment medications included: ibuprofen. On an unspecified date, the subject experienced pustules. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F. Additional treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, rashes, pain, chills, swelling, and pustules. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: PUSTULES; RASHES; SWELLING; CHILLS; FEVER; PAIN; This spontaneous report received from a consumer concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast biopsy, and other pre-existing medical conditions included breast biopsy done.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 08-MAR-2021 09:15 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced pain. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rashes. On 09-MAR-2021, the subject experienced swelling. On 11-MAR-2021, treatment medications included: ibuprofen. On an unspecified date, the subject experienced pustules. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F. Additional treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, rashes, pain, chills, swelling, and pustules. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: TIREDNESS; SEVERE BODY SHAKES WITH TEETH CHATTERING; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included alcohol use, and cigarette smoker, and other pre-existing medical conditions included patient had no known allergies the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 17:00, in left arm, for prophylactic vaccination. No concomitant medications were reported. On 10-JAN-2021, Laboratory data included: Blood test (NR: not provided) Normal. On 10-MAR-2021, the subject experienced severe body shakes with teeth chattering. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body shakes with teeth chattering on 11-MAR-2021, was recovering from chills, and headache, and had not recovered from fever, and tiredness. This report was non-serious.; Sender's Comments: V1: Medical assessment comments not required as per the standard procedure as the case is assessed as non serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: TIREDNESS; SEVERE BODY SHAKES WITH TEETH CHATTERING; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included alcohol use, and cigarette smoker, and other pre-existing medical conditions included patient had no known allergies the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 17:00, in left arm, for prophylactic vaccination. No concomitant medications were reported. On 10-JAN-2021, Laboratory data included: Blood test (NR: not provided) Normal. On 10-MAR-2021, the subject experienced severe body shakes with teeth chattering. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body shakes with teeth chattering on 11-MAR-2021, was recovering from chills, and headache, and had not recovered from fever, and tiredness. This report was non-serious.; Sender's Comments: V1: Medical assessment comments not required as per the standard procedure as the case is assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Epistaxis, Fatigue, Headache, Pain
Clinical narrative: BLOODY NOSE; LOSE STOOL; FEVER; FATIGUE; SEVERE HEADACHE; BODY 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced fatigue. On 08-MAR-2021, the subject experienced severe headache. On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced lose stool. On 11-MAR-2021, the subject experienced bloody nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, fever, lose stool, fatigue, and body aches, and the outcome of bloody nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BLOODY NOSE; LOSE STOOL; FEVER; FATIGUE; SEVERE HEADACHE; BODY 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced fatigue. On 08-MAR-2021, the subject experienced severe headache. On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced lose stool. On 11-MAR-2021, the subject experienced bloody nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, fever, lose stool, fatigue, and body aches, and the outcome of bloody nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced urinary tract infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of urinary tract infection was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: FEVER; MUSCLE ACHES; FATIGUE; 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) 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 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced muscle aches. On 11-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, muscle aches and fatigue was not reported. This report was non-serious.