chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Thrombosis
Clinical narrative: Shortness of breath, fatigue, blood clots in right lung diagnosed in ER, Medical Center
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Injection site bruising, Injection site pain, Pain
Clinical narrative: After first and second vaccine, are was very sore at injections site.  Right arm bruised after first vaccine for over a week. After first vaccine, menstrual cycle stopped. After second vaccine, starting at 12 hours after vaccine, severe chills, then fever 101.4 then  body aches then headache. 23 hours later, fever and body aches came back.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Polymenorrhoea, Pyrexia
Clinical narrative: After first and second vaccine, are was very sore at injections site.  Right arm bruised after first vaccine for over a week. After first vaccine, menstrual cycle stopped. After second vaccine, starting at 12 hours after vaccine, severe chills, then fever 101.4 then  body aches then headache. 23 hours later, fever and body aches came back.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: chest tightness, sweating, nausea, arm pain, light headedness, dizziness.  these symptoms were occurred minutes after receiving the vaccine and lasted for several minutes. was the patient was able, she was escorted by family members to the nearest urgent care clinic for further evaluation.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Left side of face is twitching almost constantly like spasms
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Bone pain, Bradyphrenia, Chest discomfort
Clinical narrative: Fever 101. 2 - 2 days  Diarrhea - 1 day  tightness in chest and harder to breathe  from the start and lasted 3 weeks - still gets tight and hard to breathe but not constant  Swelling of my feet (also felt like it was a sunburn) was worse than prior to the vaccine (I never had this problem until I had covid) l Could not sleep - wired - lasted at least 2 weeks - I'd wake up and was wide a wake after 2 hours of sleep.  Exhausted even when I could sleep some - still tire fairly easily  extreme leg pain , bone pain,  hip pain - lasted over 3 days then it was just really bad pain for 5 weeks horrible headache - really horrible for the first 3 days - headaches seem to be gone  Processing takes longer - words, thoughts, understanding - has continued from the beginning until now - but has improved  earache that comes and goes - no ear infection  4/12 started slurring my words - not all of them and not all day - lasted 4 days
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysarthria, Dyspnoea, Ear pain, Fatigue
Clinical narrative: Fever 101. 2 - 2 days  Diarrhea - 1 day  tightness in chest and harder to breathe  from the start and lasted 3 weeks - still gets tight and hard to breathe but not constant  Swelling of my feet (also felt like it was a sunburn) was worse than prior to the vaccine (I never had this problem until I had covid) l Could not sleep - wired - lasted at least 2 weeks - I'd wake up and was wide a wake after 2 hours of sleep.  Exhausted even when I could sleep some - still tire fairly easily  extreme leg pain , bone pain,  hip pain - lasted over 3 days then it was just really bad pain for 5 weeks horrible headache - really horrible for the first 3 days - headaches seem to be gone  Processing takes longer - words, thoughts, understanding - has continued from the beginning until now - but has improved  earache that comes and goes - no ear infection  4/12 started slurring my words - not all of them and not all day - lasted 4 days
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: Fever 101. 2 - 2 days  Diarrhea - 1 day  tightness in chest and harder to breathe  from the start and lasted 3 weeks - still gets tight and hard to breathe but not constant  Swelling of my feet (also felt like it was a sunburn) was worse than prior to the vaccine (I never had this problem until I had covid) l Could not sleep - wired - lasted at least 2 weeks - I'd wake up and was wide a wake after 2 hours of sleep.  Exhausted even when I could sleep some - still tire fairly easily  extreme leg pain , bone pain,  hip pain - lasted over 3 days then it was just really bad pain for 5 weeks horrible headache - really horrible for the first 3 days - headaches seem to be gone  Processing takes longer - words, thoughts, understanding - has continued from the beginning until now - but has improved  earache that comes and goes - no ear infection  4/12 started slurring my words - not all of them and not all day - lasted 4 days
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: neck started to have a burning feeling with itchyness, within minutes could feel it going into my face, then my arms.  It was a 30 minute drive to er, by that time the rash had spread to my whole body.  On the following wed. at about 12 pm again started to break out in a rash on my neck with burning and itchy, immediately took the perscriptions banophen and pepcid AC and it subsided.  On the following saturday the injection site developed a rash and itch lasted 24 hours and went away
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Skin discolouration
Clinical narrative: swollen injection site.  black-and-blue from injection site almost down to elbow
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: slight fever, headache, and joint pain 10 hours after injection. symptoms persisting next day at least 24 hours. tylenol taken
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Right sided facial swelling, left lip swelling
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Haemorrhage, Heavy menstrual bleeding, Thrombosis
Clinical narrative: First period after vaccine was very. very heavy! I was sent to the ER due to big clots and significant blood loss. Period started a week early on 4/22 and is still going on. Usually done within 5 days and not nearly as heavy with clots like this. ER suggested I report a possible correlation between that and the vaccine as they have seen it with other patients as well. ER doctor medicated with birth control hormones to slow down bleeding.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Tremor
Clinical narrative: After administering a covid vaccine, patient reported hot, weak & shaky. Temp: 97.6F ; BP/ HR: 157/98 (80); 136/86 (79); 150/92 (71) (1-10 min apart)
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Confusional state, Dissociation, Feeling abnormal, Hallucination
Clinical narrative: Over the course of 2 months, I experienced stabbing pain in my head. I slowly loss my sense of awareness. 2 weeks after receiving the COVID vaccine, I experienced a sharp pain in my center brain/ forehead region. After this, I experienced decrease in cognition for approximately three days. I experienced ring in the ears for 3 months. Continued stabbing pain in the center of the forehead. Looks of cognition and consciousness. Headache/ migraines, feeling of being detached from reality/ no emotion. Pressure in the center of the forehead. Hallucinations (images), voice in the subconscious mind and confusion. The side effects were triggered approximately 2 weeks after taking the vaccine and last 3 months. Some of the symptoms were come and go, some maintained over the course of 3 months, The hallucinations and confusions, brain fog lasted approximately  3 weeks.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Loss of consciousness, Migraine, Pain, Tinnitus
Clinical narrative: Over the course of 2 months, I experienced stabbing pain in my head. I slowly loss my sense of awareness. 2 weeks after receiving the COVID vaccine, I experienced a sharp pain in my center brain/ forehead region. After this, I experienced decrease in cognition for approximately three days. I experienced ring in the ears for 3 months. Continued stabbing pain in the center of the forehead. Looks of cognition and consciousness. Headache/ migraines, feeling of being detached from reality/ no emotion. Pressure in the center of the forehead. Hallucinations (images), voice in the subconscious mind and confusion. The side effects were triggered approximately 2 weeks after taking the vaccine and last 3 months. Some of the symptoms were come and go, some maintained over the course of 3 months, The hallucinations and confusions, brain fog lasted approximately  3 weeks.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Magnetic resonance imaging head abnormal, Migraine, Paranasal cyst, Photophobia
Clinical narrative: Since the day after 2nd dose, absolutely horrible migraines constantly. Present from the minute waking up to minute going to sleep. Had NEVER had headaches in the past. Seeked medical attention from my doctor. Sent for a contrast brain MRI. Showed a small cyst in sinuses. Tried amoxicillin.  Didn?t help at all. Have been taking Tylenol/excedrin for a month now. In intense discomfort everyday. I need some guidance as to what to do and how medical attention will be covered. I am extremely sensitive to light now since the 2nd dose. Again, I experienced no headaches before this 2nd dose
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Lump in right armpit painful when moving
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Cold sweat, Dizziness
Clinical narrative: Moderna COVID?19 Vaccine. While I was sitting, suddenly I had light-headedness for a second and then chest pain and rapid heart rate. Cold sweat started running over my face and wet my shirt. I went to the Emergency Department at the hospital. While I was waiting in the Emergency Room, all symptoms were gone after 1hr except rapid heart rate. Discharged around 11 pm after signing
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Heart rate increased, Sinus tachycardia, Troponin T
Clinical narrative: Moderna COVID?19 Vaccine. While I was sitting, suddenly I had light-headedness for a second and then chest pain and rapid heart rate. Cold sweat started running over my face and wet my shirt. I went to the Emergency Department at the hospital. While I was waiting in the Emergency Room, all symptoms were gone after 1hr except rapid heart rate. Discharged around 11 pm after signing
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Breast pain, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: She developed left arm pain the day she received the vaccine. The day after she received her vaccine she developed redness and swelling over her left shoulder and down over her left breast with left breast pain. Symptoms resolved on their own after about a week.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101.8 fever for 24 hours
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Intense pain in the right foot, at the level of the sole of the foot and between the toes. Difficulty walking, this same pain has risen to the leg for a while.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope, Vision blurred
Clinical narrative: Patient fainted while seated minutes after vaccine was given. Mother was next to her to prevent her from falling to floor. She complained of nausea and blurred vision. She was given water and Gatorade and began feeling better 5-10 minutes after fainting.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Covid Arm - Raised Red area around injection site.  Slight itch early but has lessened over time.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Herpes zoster
Clinical narrative: Shingles on left side of face, on upper lip, interior lip, nose, below left eye. Also left eye is aches, like a pulsating headache. Went to Urgent Care 4/28/2021. Prescription issued, Valacyclovir.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, COVID-19, Chest X-ray, Computerised tomogram head, Computerised tomogram spine
Clinical narrative: Had headaches and diziness following the shot.  On March 17th, blacked out getting up from the bed, fell and hit the left side of my head causing a concussion. Treatment - Emergency Room and overnight, Primary care doctor was seen and referred tio Concussion Doctor and he also requested Physical Therapy.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Concussion, Culture urine, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: Had headaches and diziness following the shot.  On March 17th, blacked out getting up from the bed, fell and hit the left side of my head causing a concussion. Treatment - Emergency Room and overnight, Primary care doctor was seen and referred tio Concussion Doctor and he also requested Physical Therapy.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Full blood count, Glycosylated haemoglobin, Head injury, Headache
Clinical narrative: Had headaches and diziness following the shot.  On March 17th, blacked out getting up from the bed, fell and hit the left side of my head causing a concussion. Treatment - Emergency Room and overnight, Primary care doctor was seen and referred tio Concussion Doctor and he also requested Physical Therapy.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lipids, Loss of consciousness, Magnetic resonance imaging head, Metabolic function test, SARS-CoV-2 antibody test positive
Clinical narrative: Had headaches and diziness following the shot.  On March 17th, blacked out getting up from the bed, fell and hit the left side of my head causing a concussion. Treatment - Emergency Room and overnight, Primary care doctor was seen and referred tio Concussion Doctor and he also requested Physical Therapy.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Troponin T, Ultrasound Doppler
Clinical narrative: Had headaches and diziness following the shot.  On March 17th, blacked out getting up from the bed, fell and hit the left side of my head causing a concussion. Treatment - Emergency Room and overnight, Primary care doctor was seen and referred tio Concussion Doctor and he also requested Physical Therapy.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Concussion, Dizziness, Fall, Head injury, Headache
Clinical narrative: Had headaches and diziness following the shot.  On March 17th, blacked out getting up from the bed, fell and hit the left side of my head causing a concussion. Treatment - Emergency Room and overnight, Primary care doctor was seen and referred tio Concussion Doctor and he also requested Physical Therapy.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, SARS-CoV-2 test
Clinical narrative: Had headaches and diziness following the shot.  On March 17th, blacked out getting up from the bed, fell and hit the left side of my head causing a concussion. Treatment - Emergency Room and overnight, Primary care doctor was seen and referred tio Concussion Doctor and he also requested Physical Therapy.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Dizziness, Epistaxis, Eye swelling, Fatigue
Clinical narrative: First day was arm pain, headache, achy feeling. Second day was swollen lymph nodes under arms, swollen injection site, migraine and tired to the point of exhaustion, dizzy. Third day was migraine, dizzy, nose bleed, exhausted, sleepy, rash started on neck then spread to face, chest and forearm, swollen eyes and throat, sores in mouth and on lips. Day 4 went to primary doctor. Day 5 and 6 rash starting to subside with prednisone, Benadryl.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Lymphadenopathy, Migraine, Pain
Clinical narrative: First day was arm pain, headache, achy feeling. Second day was swollen lymph nodes under arms, swollen injection site, migraine and tired to the point of exhaustion, dizzy. Third day was migraine, dizzy, nose bleed, exhausted, sleepy, rash started on neck then spread to face, chest and forearm, swollen eyes and throat, sores in mouth and on lips. Day 4 went to primary doctor. Day 5 and 6 rash starting to subside with prednisone, Benadryl.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pharyngeal swelling, Rash, Somnolence, Stomatitis
Clinical narrative: First day was arm pain, headache, achy feeling. Second day was swollen lymph nodes under arms, swollen injection site, migraine and tired to the point of exhaustion, dizzy. Third day was migraine, dizzy, nose bleed, exhausted, sleepy, rash started on neck then spread to face, chest and forearm, swollen eyes and throat, sores in mouth and on lips. Day 4 went to primary doctor. Day 5 and 6 rash starting to subside with prednisone, Benadryl.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: client received 1st Moderna COVID-19 Vaccine. Client was leaving observation room after fifteen mins when he informed RN he was feeling dizzy. RN had client sit down and began taking vitals. 15:52 vitals: blood pressure 142/84; pulse 64; oxygen 98%. Per client had only an orange all day and no water. RN gave client water. Client informed he would stay an additional 30 mins for observation, client agreed. PHN  arrived, client sitting in chair, alert and oriented. Per client no relevant medical history, no medications and no history of allergies. Per client does not follow up with provider and unsure if he has history of high blood pressure. 1557 vitals: blood pressure 138/96, pulse 73, oxygen 98%. Per client starting to feel better. 1602 vitals: blood pressure 141/88. pulse 74, oxygen 98%. Client denied chest pain, shortness of breath, blurry vision, or headache. Client aware blood pressure high. Vitals: blood pressure 146/85, pulse 62, oxygen 98%. Per client headache, pain 1/10. PHN advised to get primary doctor to follow up on high blood pressure. ER precautions also given. Vitals at 1624: blood pressure 143/78, pulse 63, oxygen 98%. No complaints. Last vitals at 1637: blood pressure 139/77, pulse 64. Client left facility with steady gait at 1640.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Pruritus, Rash
Clinical narrative: It was a very minimal reaction ...flushing itch and rash on arms / chest I was told I couldn?t do 2nd shot at facility and would need to do at a hospital here said they sent over information and til today no call so I?m assuming I am not able to take the 2nd it happened 20 minutes after shot and by the evening it was better
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: It was a very minimal reaction ...flushing itch and rash on arms / chest I was told I couldn?t do 2nd shot at facility and would need to do at a hospital here said they sent over information and til today no call so I?m assuming I am not able to take the 2nd it happened 20 minutes after shot and by the evening it was better
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under age at time of vaccination
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Severe lower leg cramping both right and left legs
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Slight ringing in ears began after first vaccination.  After the second vaccination, the ringing in ears intensified to about an 8 out of 10.  This has now been going on for almost a week.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: NO ADVERSE EVENT; dose of PEDV AX HIB was administered following temperature excursions; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, an dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T020615, expiration date 13-MAR-2023,0.5 milliliter (route and anatomical site of vaccination were not provided), for prophylaxis that was improper stored on 14-APR-2021.   Temperature 3/8: 49.29F FOR 15 MINUTES 3/17: 46.75FFOR 15 MINUTES 3/30: 46.71F FOR 15 MINUTES 4/2: 46.75F FOR 15 MINUTES Time frame: CUMULATIVE TIME: 1 HOUR Previous temperature excursion? YES Was call because of a "data logger"? (YIN) Y
Sex: U
Vaccine: ANTH
Symptoms: Expired product administered, Unevaluable event
Clinical narrative: Received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial; Spontaneous report received on 18APR2021.  Based on the information obtained from the nurse, two individual case safety reports 21000046SP and 21000047SP were created and cross-linked in the database.  The nurse reported that the patient "received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial" (PT: Vaccination error). The patient received BioThrax (anthrax vaccine adsorbed) (dose: 9, lot number: 300070, and expiry date: 26MAY2021) for immunisation. It was reported that a BioThrax vial was opened (first puncture) on 20FEB2021, and the 28-day expiry from the first puncture was on 20MAR2021. On 09APR2021, this patient received a dose of BioThrax vaccine from the same vial. This was series 9 of BioThrax for the patient.   Additionally, it was reported that as per the Centers for Disease Control and Prevention (CDC), multi-dose vials are to be discarded 28 days after ?rst puncture. Moreover, the nurse stated that "our specific training and guidance states BioThrax is to be discarded 28 days from ?rst puncture" but there was no information about recommendation to be discarded after 28 days from the first puncture with the product.  Action taken with BioThrax with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A patient received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial (vaccination error), and further details of the event are limited. BioThrax Vials are multi-dose vials and should not be used beyond 28 days of fist puncture. The causality of vaccination error is assessed as not applicable to BioThrax due to the nature of the event.; Sender's Comments: A patient received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial (vaccination error), and further details of the event are limited. BioThrax Vials are multi-dose vials and should not be used beyond 28 days of fist puncture. The causality of vaccination error is assessed as not applicable to BioThrax due to the nature of the event.
Sex: U
Vaccine: ANTH
Symptoms: Vaccination error
Clinical narrative: Received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial; Spontaneous report received on 18APR2021.  Based on the information obtained from the nurse two individual case safety reports 21000046SP and 21000047SP were created and cross-linked in the database.  The nurse reported that the patient "received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial" (PT: Vaccination error). The patient received BioThrax (anthrax vaccine adsorbed) (dose: 5, lot number: 300070, and expiry date: 26MAY2021) for immunisation. It was reported that a BioThrax vial was opened (first puncture) on 20FEB2021, and the 28-day expiry of the vial from the first puncture was on 20MAR2021. On 06APR2021, this patient received a dose of BioThrax vaccine from the same vial, which was beyond 28 days from the first puncture of the vial but within the expiration date as labelled on the vial. This was series 5 of BioThrax for the patient.   Additionally, it was reported that as per the Centers for Disease Control and Prevention (CDC), multi-dose vials are to be discarded 28 days after ?rst puncture. Moreover, the nurse stated that "our specific training and guidance states BioThrax is to be discarded 28 days from ?rst puncture" but there was no information about recommendation to be discarded after 28 days from the first puncture with the product.  Action taken with BioThrax with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A patient received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial (vaccination error), and further information on the event is limited. BioThrax Vials are multi-dose vials and should not be used beyond 28 days of fist puncture. The causality of vaccination error is assessed as not applicable to BioThrax due to the nature of the event.; Sender's Comments: A patient received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial (vaccination error), and further information on the event is limited. BioThrax Vials are multi-dose vials and should not be used beyond 28 days of fist puncture. The causality of vaccination error is assessed as not applicable to BioThrax due to the nature of the event.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Body temperature, Fatigue, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: TIREDNESS; UNEXPECTED THERAPEUTIC BENEFIT; FEVER; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included sensory neural hearing loss, tinnitus, and inner ear sepsis, and concurrent conditions included hearing aid user.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 12-APR-2021, the subject experienced unexpected therapeutic benefit. On 14-APR-2021, the subject experienced tiredness. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative, and Hearing test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 12-APR-2021, was recovering from tiredness, and the outcome of unexpected therapeutic benefit was not reported. This report was non-serious.; Sender's Comments: V1: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: TIREDNESS; UNEXPECTED THERAPEUTIC BENEFIT; FEVER; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included sensory neural hearing loss, tinnitus, and inner ear sepsis, and concurrent conditions included hearing aid user.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 12-APR-2021, the subject experienced unexpected therapeutic benefit. On 14-APR-2021, the subject experienced tiredness. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative, and Hearing test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 12-APR-2021, was recovering from tiredness, and the outcome of unexpected therapeutic benefit was not reported. This report was non-serious.; Sender's Comments: V1: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypersensitivity, Hypoaesthesia, Paraesthesia
Clinical narrative: PARTIAL FACE /HEAD PARALYSIS; NUMBNESS; TINGLING; ALLERGIC REACTION TO VACCINE; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, 5 days after vaccination, the patient had to go to the hospital because of numbness and tingling and partial face and head paralysis and they said it was an allergic reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness, tingling, partial face /head paralysis and allergic reaction to vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:  20210439359-covid-19 vaccine ad26.cov2.s-partial face /head paralysis, numbness, tingling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Ear pain, Electrocardiogram, Heart rate, Palpitations
Clinical narrative: BRUISED; SWELLING ON LEFT SIDE OF LOWER ABDOMEN; HEART PALPITATION; MINOR EAR ACHE; This spontaneous report received from a patient concerned a 59 year old female.  The patient's height, and weight were not reported. The patient's past medical history included heart stent, and concurrent conditions included rag weed allergy.  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,1 total administered to left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the patient experienced minor ear ache at night. On 24-MAR-2021, the patient experienced heart palpitation. On 17-APR-2021 the patient experienced again ear ache. On 13-APR-2021, the patient experienced swelling on left side of lower abdomen. She got on the shower and she found it , she put ice and the ice maintained the swelling. Patient explains her swelling as stuck out a good 2 inches, a size of a soft ball. On 14-APR-2021, the patient experienced bruising on left side of lower abdomen. On 01-APR-2021, Laboratory data included: EKG (Electrocardiogram) and it is Normal. On 18-APR-2021, Laboratory data included: Heart rate that was 20bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruised, had not recovered from minor ear ache, and heart palpitation, and the outcome of swelling on left side of lower abdomen was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: BRUISED; SWELLING ON LEFT SIDE OF LOWER ABDOMEN; HEART PALPITATION; MINOR EAR ACHE; This spontaneous report received from a patient concerned a 59 year old female.  The patient's height, and weight were not reported. The patient's past medical history included heart stent, and concurrent conditions included rag weed allergy.  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,1 total administered to left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the patient experienced minor ear ache at night. On 24-MAR-2021, the patient experienced heart palpitation. On 17-APR-2021 the patient experienced again ear ache. On 13-APR-2021, the patient experienced swelling on left side of lower abdomen. She got on the shower and she found it , she put ice and the ice maintained the swelling. Patient explains her swelling as stuck out a good 2 inches, a size of a soft ball. On 14-APR-2021, the patient experienced bruising on left side of lower abdomen. On 01-APR-2021, Laboratory data included: EKG (Electrocardiogram) and it is Normal. On 18-APR-2021, Laboratory data included: Heart rate that was 20bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruised, had not recovered from minor ear ache, and heart palpitation, and the outcome of swelling on left side of lower abdomen was not reported. 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: M
Vaccine: COVID19
Symptoms: Anxiety, Paraesthesia
Clinical narrative: ANXIETY; ARM TINGLING; This spontaneous report received from consumer via the VAERS (Vaccine Adverse Event Reporting System) concerned a 34 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfur allergy.The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, one total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced allergic reaction and anxiety. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety and arm tingling was not reported. This report was non-serious. This case, from the same reporter is linked to.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza, Skin discolouration
Clinical narrative: DIFFICULTIES IN BREATHING; FELT LIKE REALLY HAD BAD CASE OF FLU; TURNED PURPLE IN THE FACE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included very sick with covid symptoms, diarrhea, and fever, and concurrent conditions included asthma. 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 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced difficulties in breathing. On 2021, the subject experienced felt like really had bad case of flu. On 2021, the subject experienced turned purple in the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulties in breathing, felt like really had bad case of flu and turned purple in the face was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Fibrin D dimer, Ultrasound scan
Clinical narrative: DVT POST COVID INJECTION; This spontaneous report received from a patient concerned a 52 year (also reported as 53 year) old male. The patient's height, and weight were not reported. The patient's past medical history included provoked DVT (deep vein thrombosis) 10 years ago, and concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 into left deltoid for prophylactic vaccination. The product was properly stored from receipt to administration. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Patient received J&J vaccine at place of employment. After 24 hours on an unspecified date in APR-2021, the patient developed lower leg DVT (deep vein thrombosis) post COVID injection. It was confirmed by positive d-dimer (coded as Fibrin D dimer) and US (ultrasound scan). Exact results and date of the tests were not provided. The patient was started on rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of DVT post COVID injection was not reported (captured as unknown). This report was serious (Other Medically Important Condition).; Sender's Comments: This 52/53-year-old hypertensive male patient of unspecified ethnicity developed lower leg deep vein thrombosis (DVT) after 24 hours of receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The was prior history of "provoked" DVT 10 years ago.  No concomitant merdications reported.  The patient reported that D-Dimer was positive and ultrasound showed DVT.  The patient was started on rivaroxaban. No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-APR-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. On 22-APR-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 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 was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: ELEVATED D-DIMER; SHORTNESS OF BREATH; HEADACHE; CHEST PAINS; DECREASED APPETITE; FEVER; This spontaneous report received from a physician concerned a 25 year old female. The patient's height, weight and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose and batch number were not reported) administered on 07-APR-2021 for prophylactic vaccination. Batch number will be requested via follow up. Concomitant medications included unspecified oral contraceptives.  On 08-APR-2021, the subject experienced shortness of breath, headache, chest pains, fever, and decreased appetite.  Physician  saw the patient on 14-APR-2021 and ordered D-dimer which came back at "0.80" and again on 20-APR-2021 which came back "0.82" (units and normal range unspecified). Physician reported that the patient's platelet count had not been done yet, but the d-dimer was a little elevated and given her chest pains, he wanted to evaluate for a blood clot and possibly order CT (computed tomography) scan of her chest    The physician did mention VAERS report filed case # 446427.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, shortness of breath, and chest pains, and the outcome of decreased appetite, fever, and elevated d-dimer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This case concerns a 25-year-old female who had elevated d-dimer test results 7 days after receiving the Janssen Covid-19 vaccine. Full medical history was not provided. Concomitant medications included unspecified oral contraceptives. The day after vaccination, the patient experienced shortness of breath, headache, chest pains, fever and decreased appetite.  Seven days post-vaccination, she went to see her physician who ordered a d-dimer test which came back elevated at 0.80 (normal range not reported). Repeat d-dimer test 6 days later came back at 0.82. A platelet level had not been checked, nor other diagnostic tests to evaluate for possible thrombosis. As of the the time of this report, the outcome was unknown.  Based on the available information, the relationship with Janssen Covid-19 vaccine is considered unclassifiable. Further information (e.g. full medical history, social history, family history, CBC, doppler ultrasound, anti-platelet factor 4 antibodies, fibrinogen) will be requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: ELEVATED D-DIMER; SHORTNESS OF BREATH; HEADACHE; CHEST PAINS; DECREASED APPETITE; FEVER; This spontaneous report received from a physician concerned a 25 year old female. The patient's height, weight and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose and batch number were not reported) administered on 07-APR-2021 for prophylactic vaccination. Batch number will be requested via follow up. Concomitant medications included unspecified oral contraceptives.  On 08-APR-2021, the subject experienced shortness of breath, headache, chest pains, fever, and decreased appetite.  Physician  saw the patient on 14-APR-2021 and ordered D-dimer which came back at "0.80" and again on 20-APR-2021 which came back "0.82" (units and normal range unspecified). Physician reported that the patient's platelet count had not been done yet, but the d-dimer was a little elevated and given her chest pains, he wanted to evaluate for a blood clot and possibly order CT (computed tomography) scan of her chest    The physician did mention VAERS report filed case # 446427.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, shortness of breath, and chest pains, and the outcome of decreased appetite, fever, and elevated d-dimer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This case concerns a 25-year-old female who had elevated d-dimer test results 7 days after receiving the Janssen Covid-19 vaccine. Full medical history was not provided. Concomitant medications included unspecified oral contraceptives. The day after vaccination, the patient experienced shortness of breath, headache, chest pains, fever and decreased appetite.  Seven days post-vaccination, she went to see her physician who ordered a d-dimer test which came back elevated at 0.80 (normal range not reported). Repeat d-dimer test 6 days later came back at 0.82. A platelet level had not been checked, nor other diagnostic tests to evaluate for possible thrombosis. As of the the time of this report, the outcome was unknown.  Based on the available information, the relationship with Janssen Covid-19 vaccine is considered unclassifiable. Further information (e.g. full medical history, social history, family history, CBC, doppler ultrasound, anti-platelet factor 4 antibodies, fibrinogen) will be requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pericarditis
Clinical narrative: PERICARDITIS; MYALGIA; This spontaneous report received from a physician concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies and no known medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) with unspecified dose 1 total, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021 the patient had experienced fever, myalgia. On 20-APR-2021 the patient diagnosed with pericarditis, chest discomfort and was hospitalized, patient had reported these symptoms to health care professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pericarditis, fever, chest discomfort, and myalgia. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210448217-COVID-19 VACCINE AD26.COV2.S-Pericarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Hot flush
Clinical narrative: CHEST PAIN; SHORTNESS OF BREATH; TROUBLE FALLING ASLEEP; HOT FLASH; EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 60 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included progesterone for prevent breast cancer, and estradiol for prevent osteoporosis.  On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced trouble falling asleep. On 18-APR-2021, the subject experienced hot flash. On 18-APR-2021, the subject experienced extreme fatigue. On 18-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chest pain, and shortness of breath, and the outcome of extreme fatigue, trouble falling asleep and hot flash was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: CHEST PAIN; SHORTNESS OF BREATH; TROUBLE FALLING ASLEEP; HOT FLASH; EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 60 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included progesterone for prevent breast cancer, and estradiol for prevent osteoporosis.  On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced trouble falling asleep. On 18-APR-2021, the subject experienced hot flash. On 18-APR-2021, the subject experienced extreme fatigue. On 18-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chest pain, and shortness of breath, and the outcome of extreme fatigue, trouble falling asleep and hot flash was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.