chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injury associated with device
Clinical narrative: Patient presents with numbness of tip of right thumb, extending into CMC joint.  Numbness is strongest felt at distal site of thumb joint. As it radiates towards right wrist, it begins to  lessen in severity. Patient is a healthcare provider as well. She did experience needlestick injury to this thumb resulting in keflex antibiotic for treatment, however problem ongoing prior to injury. She is concerned regarding this symptom as several staff members in her office are experiencing the same, as well as her father in law. Problem ongoing for the past three weeks. Patient was vaccinated five weeks prior to R thumb numbness.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to an 11 year old patient, wrong birthday supplied on forms.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: Patient says the vaccine was administered in the middle of the upper arm (too low). Received vaccine ~2pm, by same day had redness, by next day a raised welt (goose egg). Pt happened to have MD appointment. MD concerned but didn't have pt take any meds. Pt had been icing, and continued icing. Resolved after 2-3 weeks. (NO MD visit as a direct result of adverse event, pt already had one scheduled and brought up incident at that appt)
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient's father, stated that patient's birthday was (withheld), confirming that he was 12 years old at the time of administration. When the date of birth was not working with the insurance coverage, father was repeatedly asked for the correct date of birth and continued to give the pharmacy staff the same birthdate for patient. The vaccine was administered without incident and there were no noticable adverse effects of vaccine administration. It was then discovered by pharmacy staff that the pharmacy was given the incorrect birthday and it appears, per the State Immunization Information System, that patient's actual birthday is (withheld), indicating that he was 11 years, 11 months at the date of administration.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Headache, Pain in extremity
Clinical narrative: Patient stated that his arm is very sore. He also stated that he has been disoriented and experiencing headaches and dizziness.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Premature ejaculation
Clinical narrative: premature ejactulation
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood electrolytes normal, Computerised tomogram head normal, Condition aggravated, Full blood count, Headache
Clinical narrative: HA and HTN 11 mins post vaccination, then resolved; returned to facility with ongoing HA and BP 170s on 8/9/21 stated HA had been ongoing since vaccination
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: HA and HTN 11 mins post vaccination, then resolved; returned to facility with ongoing HA and BP 170s on 8/9/21 stated HA had been ongoing since vaccination
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Erythema, Headache, Myalgia
Clinical narrative: bone pain, headache, blurred vision which i still have, itchy skin where i scratch to the point of red dots. dizziness muscle aches
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vision blurred
Clinical narrative: bone pain, headache, blurred vision which i still have, itchy skin where i scratch to the point of red dots. dizziness muscle aches
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive covid19 test after full vaccination
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abnormal faeces, Differential white blood cell count normal, Full blood count normal, Occult blood negative
Clinical narrative: Floating stool starting one month after 2nd dose. Has continued to present time. No other symptoms. Had abdominal ultrasound-June 2021-  normal   All routine blood work, urinalysis , occult stool test normal. No further follow up. Stool continues to float with every BM.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound abdomen normal, Urine analysis normal
Clinical narrative: Floating stool starting one month after 2nd dose. Has continued to present time. No other symptoms. Had abdominal ultrasound-June 2021-  normal   All routine blood work, urinalysis , occult stool test normal. No further follow up. Stool continues to float with every BM.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Fall, Syncope
Clinical narrative: The patient fainted shortly after receiving her first covid vaccine. She slumped out of her chair and fell on the floor. When arriving to the patients side, she was alert and aware but her blood pressure was 90//66. 911 was called, however after talking with the patient, we determined an ambulance would be unnecessary. We monitored the patient for another 15 minutes and gave her water and juice. Her blood pressure rose to 99/65 and she was able to leave on her own with her significant other. We suggested that they monitor her for the next few hours and if she begins to feel any worse to go to the nearest ER.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Cough, Dyspnoea, Influenza A virus test negative
Clinical narrative: cough, congestion and shortness of breath for 5 days; loss of smell since this morning
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza B virus test, Respiratory syncytial virus test negative, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: cough, congestion and shortness of breath for 5 days; loss of smell since this morning
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Loss of consciousness, Seizure
Clinical narrative: patient had seizure type reaction and passed out
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia
Clinical narrative: Right side facial numbness starting 10 days after vaccination.  Moved to feeling of right arm going to sleep a few days later.  Wednesday 8/4/21 moved to sleep feeling in right leg which now drags unless patient makes conscious effort when walking.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: red circle at injection site, itching and a full red circle that does not dissapear.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: vaso-vagal response assumed
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on my face
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Patient came back to office and received decadron, benadryl, toradol, and kenalog.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient's father stated that patient's birthday was 07/21/2009, confirming that she was 12 years old at the time of administration. When the date of birth was not working with the insurance coverage, father was repeatedly asked for the correct date of birth and continued to give the pharmacy staff the 7/21/2009 birthdate for patient. Patient herself, was asked to confirm her birthday prior to administration, and confirmed her birthdate was 07/21/2009. The vaccine was administered without incident and there were no noticeable adverse effects of vaccine administration. It was then discovered by pharmacy staff that the pharmacy was given the incorrect birthday and it appears, per the State Immunization Information System, that patient's actual birthday is different then what was given, indicating that she was 11 years old at the date of administration.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Limb discomfort, Muscle spasms, Neck pain
Clinical narrative: Spasms in leg, sore neck, joint pain, heavy legs, loss of memory
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: Spasms in leg, sore neck, joint pain, heavy legs, loss of memory
Age: 61.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Angiogram, Bell's palsy, Blood glucose, Computerised tomogram head, Electrocardiogram
Clinical narrative: First vaccine given on 5/22/2021  no adverse reaction at that time.   Second Vaccine given on 6/12/2021 no adverse reaction at the time of injection.  On 7/20/2021 came home from work around 10:30 PM when wife noticed the drooping in face like a stroke.   Was taken to Hospital emergency room by private vehicle.  Bloodwork and CT scan was preformed.  Diagnosed with Krames Bell's Palsy  Prescribed Acyclovir and Prednisone.  Released from emergency room
Age: 61.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Facial paralysis, Full blood count, International normalised ratio, Metabolic function test, Prothrombin time
Clinical narrative: First vaccine given on 5/22/2021  no adverse reaction at that time.   Second Vaccine given on 6/12/2021 no adverse reaction at the time of injection.  On 7/20/2021 came home from work around 10:30 PM when wife noticed the drooping in face like a stroke.   Was taken to Hospital emergency room by private vehicle.  Bloodwork and CT scan was preformed.  Diagnosed with Krames Bell's Palsy  Prescribed Acyclovir and Prednisone.  Released from emergency room
Age: 61.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Troponin, Troponin I
Clinical narrative: First vaccine given on 5/22/2021  no adverse reaction at that time.   Second Vaccine given on 6/12/2021 no adverse reaction at the time of injection.  On 7/20/2021 came home from work around 10:30 PM when wife noticed the drooping in face like a stroke.   Was taken to Hospital emergency room by private vehicle.  Bloodwork and CT scan was preformed.  Diagnosed with Krames Bell's Palsy  Prescribed Acyclovir and Prednisone.  Released from emergency room
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Middle ear effusion, Tinnitus
Clinical narrative: I was fine the night of the vaccine. The next morning I woke up with extreme tinnitus and it has not stopped. It has now been two weeks
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatologic examination abnormal, Ear, nose and throat examination abnormal, Erythema, Groin pain, Herpes zoster
Clinical narrative: - On 4/4/2021, received 1st Pfizer dose (lot number ER8734) at around 11:30am - On 4/22/2021, red marks started to appear on right thigh and right side of groin started to ache - On 4/25/2021, received 2nd Pfizer dose (lot number ER8735) at around 11:45am - On 4/27/2021, dermatologist diagnosed shingles and prescribed Valacyclovir which the patient started taking the next day - On 5/12/2021, dermatologist verified that the patient had recovered from shingles - On 6/16/2021, MD (ENT) diagnosed tinnitus; the patient started to notice this condition several months prior (which coincided with the vaccinations); the condition has not resolved
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: - On 4/4/2021, received 1st Pfizer dose (lot number ER8734) at around 11:30am - On 4/22/2021, red marks started to appear on right thigh and right side of groin started to ache - On 4/25/2021, received 2nd Pfizer dose (lot number ER8735) at around 11:45am - On 4/27/2021, dermatologist diagnosed shingles and prescribed Valacyclovir which the patient started taking the next day - On 5/12/2021, dermatologist verified that the patient had recovered from shingles - On 6/16/2021, MD (ENT) diagnosed tinnitus; the patient started to notice this condition several months prior (which coincided with the vaccinations); the condition has not resolved
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: patient was administered dose and went to the waiting area. patient loss consciousness for about 20 seconds. patients mother supported her in chair. after lightly shaking patient and call patients name she regained consciousness. patient was clammy and diaphoretic and pale. she was given water to drink and was back to normal in about 5 minutes
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Spinal pain
Clinical narrative: Increasing fatigue from June 2021 onward. Sudden onset. Muscle aches and joint pain, up and down the spine (June). Throughout July, really heavy fatigue.  Would need to nap when fatigue hits. can occur multiple times per day.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: pt passed out within a minute of receiving injection.  He became pale in color, eyes slowly rolled back. We called 911.  The chair had armrails.  He slowly slouched back in chair and then we placed him  comfortably as possible on the floor by his wife and pharmacy assistant. Once unresponsive to touch we called 911.  Within 10 seconds he began to respond slowly.  He drank some Gatorade that we offered.  He became alert and responsive while still on floor.  Paramedics arrived by approximately 335pm to take over.  Patient wanted to leave on his own accord.  Paramedics took him inside ambulance to evaluate.  The time now was about 442 pm.  (times are estimates)
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Feeling hot, Hyperhidrosis
Clinical narrative: After waking up I felt a pain in the right shoulder and tingle in the right hand fingers.  Had my coffee on the balcony and very soon after a heat rush took over my head and a general feeling of something not being ok. I started walking to the bathroom just as a precaution but didn't got there. My legs gave up and I collapsed in the middle of the leaving room. Woke up in a puddle of sweat, could have been 5 seconds or 10.  No chest pain, no rapid heart beat. Felt a little under the weather for the rest of the day but ok with the exception of the shoulder pain that didn't subside at all not even now, 2 days later.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Syncope
Clinical narrative: After waking up I felt a pain in the right shoulder and tingle in the right hand fingers.  Had my coffee on the balcony and very soon after a heat rush took over my head and a general feeling of something not being ok. I started walking to the bathroom just as a precaution but didn't got there. My legs gave up and I collapsed in the middle of the leaving room. Woke up in a puddle of sweat, could have been 5 seconds or 10.  No chest pain, no rapid heart beat. Felt a little under the weather for the rest of the day but ok with the exception of the shoulder pain that didn't subside at all not even now, 2 days later.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Neuralgic amyotrophy, Pain in extremity, Syncope
Clinical narrative: After waking up I felt a pain in the right shoulder and tingle in the right hand fingers.  Had my coffee on the balcony and very soon after a heat rush took over my head and a general feeling of something not being ok. I started walking to the bathroom just as a precaution but didn't got there. My legs gave up and I collapsed in the middle of the leaving room. Woke up in a puddle of sweat, could have been 5 seconds or 10.  No chest pain, no rapid heart beat. Felt a little under the weather for the rest of the day but ok with the exception of the shoulder pain that didn't subside at all not even now, 2 days later.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Pleural effusion, Thoracic cavity drainage
Clinical narrative: Pain in chest that moved around;initially misdiagnosed(on 6/29/2021) as musculoskeletal then on follow up in Emergency department 1 week later(7/5/2021) was referred for evaluation of possible traumatic injury due to bicycle accident 1 month prior. That MD ruled out traumatic injury and found Pleural Effusion. Drained fluid and on follow up CT scan on or about 8/9 and  was medically cleared
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure orthostatic, Chest discomfort, Chest pain, Condition aggravated
Clinical narrative: @1330 Pt was vaccinated on the gurney as a precaution d/t hx of syncope in the past. Pt was doing well.    @1340 Increased HOB. Fluids provided. Tol PO intake well.    @1350 Sitting on high fowlers position. Tol well. Denies any dizziness or any nausea. Encouraged to increased fluid intake and to finish water in the bottle. Pt agreed and finished water in bottle. HR 60 RR18 Hx of bradycardia   @1355 RN stood pt up and ambulated. Tol well. Per RN, pt denies any symptoms.    @1405 Sat pt in chair. Pt stated that he doesn't feel 100% right. Pt then had a syncopal episode, which lasted for about a minute. Transferred patient to gurney via two person assist. Placed on supine.    @1410 VS 140/80 (101) 63 95% RA 16. Resp even and unlabored. No s/sx of distress noted. No SOB noted. Pt is fluttering eyes but not spontaneously opening eyes. Pain stimuli applied, pt woke up.    @1415 VS 114/62 55 18 99% Pt is fully awake and talking. GCS 15. Placed on semi fowlers position. Pt complained of being dizzy. Pt stated that he was dizzy and nausea. Pt then complained of L chest pain 5/10 tightness. Made pt aware that nurse will have to send pt in the ED. Pt refused. Wants to wait 5 minutes to reassess situation.    @1420 Pt stated that his CP was resolved. Orthostatic BP done. Supine 123/73 (87) 58 97% Sitting 150/74 (99) 69 99% with dizziness and nausea. Made pt aware that he is positive orthostatics and might need to have additional fluid resuscitation that we cant offer while in the vaccination clinic. Encourage pt to go to the ED for further care and management since his symptoms are not better. Pt agreed. Called team alert and ED.    @1430 Gave report to RN from team alert and took pt to ED.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: @1330 Pt was vaccinated on the gurney as a precaution d/t hx of syncope in the past. Pt was doing well.    @1340 Increased HOB. Fluids provided. Tol PO intake well.    @1350 Sitting on high fowlers position. Tol well. Denies any dizziness or any nausea. Encouraged to increased fluid intake and to finish water in the bottle. Pt agreed and finished water in bottle. HR 60 RR18 Hx of bradycardia   @1355 RN stood pt up and ambulated. Tol well. Per RN, pt denies any symptoms.    @1405 Sat pt in chair. Pt stated that he doesn't feel 100% right. Pt then had a syncopal episode, which lasted for about a minute. Transferred patient to gurney via two person assist. Placed on supine.    @1410 VS 140/80 (101) 63 95% RA 16. Resp even and unlabored. No s/sx of distress noted. No SOB noted. Pt is fluttering eyes but not spontaneously opening eyes. Pain stimuli applied, pt woke up.    @1415 VS 114/62 55 18 99% Pt is fully awake and talking. GCS 15. Placed on semi fowlers position. Pt complained of being dizzy. Pt stated that he was dizzy and nausea. Pt then complained of L chest pain 5/10 tightness. Made pt aware that nurse will have to send pt in the ED. Pt refused. Wants to wait 5 minutes to reassess situation.    @1420 Pt stated that his CP was resolved. Orthostatic BP done. Supine 123/73 (87) 58 97% Sitting 150/74 (99) 69 99% with dizziness and nausea. Made pt aware that he is positive orthostatics and might need to have additional fluid resuscitation that we cant offer while in the vaccination clinic. Encourage pt to go to the ED for further care and management since his symptoms are not better. Pt agreed. Called team alert and ED.    @1430 Gave report to RN from team alert and took pt to ED.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Nausea, Pyrexia
Clinical narrative: Chills, fever, nausea, pain at injection site, tiredness
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cardiac discomfort, Dizziness, Heart rate increased
Clinical narrative: Pt received vaccine at 6:30pm. Patient felt pressure on her heart, fast heart rate (over 100) and dizziness when first reporting symptoms at 6:35pm. 6:59pm patients symptoms have reduced significantly. Pt was advised to lay down. BP 160 (high) at around 6:40. Heart rate at 70 at 6:55pm. BP was taken again at 7:03pm 130/80. Pt was advised to f/u with primary care.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion
Clinical narrative: About six weeks after the second dose I started to have a stuffy nose. I then got a cough which would not go away. I went to Urgent Care 07/02/2021. I was prescribed Azithromycin and Steroids. It was dry mostly and very hard to control the coughing spells. I had the cough for about six weeks and it improved after the medication. Currently it is still improving but I still get bouts of coughing.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Aphasia, Arthralgia, Deafness neurosensory, Deafness unilateral
Clinical narrative: May 10 - I awoke unable to hear out of my right ear. It was sudden. No symptoms prior. I have been treated  -1st - with OTC allergy med - daytime kind and night time kind and she prescribe a nasal spray for 3 times a day. That was on Monday and on Thursday I called her back and she said to take an antibiotic - she called in a prescription. I was a little better but not significant. ENT - tested: Said I have Sudden Sensorineural Hearing Loss and that doctor treated me with Prednisone - I was on it for 60 days (45 days or so on high dose and 10 days or so on a low dose).  Some of my hearing has come back but not all of it  - so now I have a hearing aid. I'm also having memory problems - I am forgetting words; they don't come to me right. People's names - People that I work with - I can't think of their names; they are not close coworkers but I still work with them.  I might call something a name and know it's the wrong name but it's what comes out of my mouth. I can tell it's wrong and I'll correct. I get stuck on a syllable and repeat it several times - like a stutter. I did get parts of my hearing back after being on Prednisone and an anti-viral med which she gave me, too. My hearing - when I lost it - I have tinnitus that I've had for years - 30 years ago. But when I lost the hearing - I could hear the tinnitus really loudly and it is very bothersome. It's much louder than it is in my right ear. I could not hear anything external in that right ear. When it started getting better, the tinnitus is still there and it is still louder. That only improves with my earing aid. The hearing aid prevents the tinnitus from being so loud. It is constant - it doesn't stop. I'm also having some joint pain in hands, fingers and feet. This pain inhibits my daily activities at work and at home. I didn't notice this pain until June.  I was having spasms in them - like when you get a Charlie horse in them. The spasms are settling down but I still have pain in the joints of my hands and my feet. I'm off steroids now and I'm still hurting. I don't know if these are vaccine related symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Ear, nose and throat examination, Impaired work ability, Loss of personal independence in daily activities, Memory impairment
Clinical narrative: May 10 - I awoke unable to hear out of my right ear. It was sudden. No symptoms prior. I have been treated  -1st - with OTC allergy med - daytime kind and night time kind and she prescribe a nasal spray for 3 times a day. That was on Monday and on Thursday I called her back and she said to take an antibiotic - she called in a prescription. I was a little better but not significant. ENT - tested: Said I have Sudden Sensorineural Hearing Loss and that doctor treated me with Prednisone - I was on it for 60 days (45 days or so on high dose and 10 days or so on a low dose).  Some of my hearing has come back but not all of it  - so now I have a hearing aid. I'm also having memory problems - I am forgetting words; they don't come to me right. People's names - People that I work with - I can't think of their names; they are not close coworkers but I still work with them.  I might call something a name and know it's the wrong name but it's what comes out of my mouth. I can tell it's wrong and I'll correct. I get stuck on a syllable and repeat it several times - like a stutter. I did get parts of my hearing back after being on Prednisone and an anti-viral med which she gave me, too. My hearing - when I lost it - I have tinnitus that I've had for years - 30 years ago. But when I lost the hearing - I could hear the tinnitus really loudly and it is very bothersome. It's much louder than it is in my right ear. I could not hear anything external in that right ear. When it started getting better, the tinnitus is still there and it is still louder. That only improves with my earing aid. The hearing aid prevents the tinnitus from being so loud. It is constant - it doesn't stop. I'm also having some joint pain in hands, fingers and feet. This pain inhibits my daily activities at work and at home. I didn't notice this pain until June.  I was having spasms in them - like when you get a Charlie horse in them. The spasms are settling down but I still have pain in the joints of my hands and my feet. I'm off steroids now and I'm still hurting. I don't know if these are vaccine related symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Sudden hearing loss, Tinnitus
Clinical narrative: May 10 - I awoke unable to hear out of my right ear. It was sudden. No symptoms prior. I have been treated  -1st - with OTC allergy med - daytime kind and night time kind and she prescribe a nasal spray for 3 times a day. That was on Monday and on Thursday I called her back and she said to take an antibiotic - she called in a prescription. I was a little better but not significant. ENT - tested: Said I have Sudden Sensorineural Hearing Loss and that doctor treated me with Prednisone - I was on it for 60 days (45 days or so on high dose and 10 days or so on a low dose).  Some of my hearing has come back but not all of it  - so now I have a hearing aid. I'm also having memory problems - I am forgetting words; they don't come to me right. People's names - People that I work with - I can't think of their names; they are not close coworkers but I still work with them.  I might call something a name and know it's the wrong name but it's what comes out of my mouth. I can tell it's wrong and I'll correct. I get stuck on a syllable and repeat it several times - like a stutter. I did get parts of my hearing back after being on Prednisone and an anti-viral med which she gave me, too. My hearing - when I lost it - I have tinnitus that I've had for years - 30 years ago. But when I lost the hearing - I could hear the tinnitus really loudly and it is very bothersome. It's much louder than it is in my right ear. I could not hear anything external in that right ear. When it started getting better, the tinnitus is still there and it is still louder. That only improves with my earing aid. The hearing aid prevents the tinnitus from being so loud. It is constant - it doesn't stop. I'm also having some joint pain in hands, fingers and feet. This pain inhibits my daily activities at work and at home. I didn't notice this pain until June.  I was having spasms in them - like when you get a Charlie horse in them. The spasms are settling down but I still have pain in the joints of my hands and my feet. I'm off steroids now and I'm still hurting. I don't know if these are vaccine related symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness exertional, Headache, Malaise
Clinical narrative: Patient said that she received a headache within 3o mins after receiving the vaccine. Patient became dizzy and just drunk some water. Patient said she that each day her dizziness gets worse. Patient said it hits her when she is walking or in the car. Patient also stated that it feels like she is falling and is starting to become sick to her stomach.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave Pfizer vaccine to patient 2 hours beyond expiration of vaccine
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient had swelling and extreme pain in the right arm. He also had fever. Patient went to ER.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Anaemia, Antibody test positive, Antineutrophil cytoplasmic antibody negative, Blood creatinine increased
Clinical narrative: Pt developed fatigue, headache, acute renal failure, and anemia shortly after the injection.   Cr was 2.0 on 3/9/21 and peaked at 2.5 on 4/28/21 and was last 1.2 on 7/26/21.  Saw nephrology who found no other cause of the acute renal failure.  Hgb was 10.6 on 3/9/21 with a low of 9.0 on 5/6/21 and was up to 10.6 on 7/26/21.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Computerised tomogram abdomen abnormal, Electrophoresis protein normal, Fatigue, Haemoglobin decreased
Clinical narrative: Pt developed fatigue, headache, acute renal failure, and anemia shortly after the injection.   Cr was 2.0 on 3/9/21 and peaked at 2.5 on 4/28/21 and was last 1.2 on 7/26/21.  Saw nephrology who found no other cause of the acute renal failure.  Hgb was 10.6 on 3/9/21 with a low of 9.0 on 5/6/21 and was up to 10.6 on 7/26/21.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hydronephrosis, Light chain analysis normal, Ultrasound kidney abnormal, Urine analysis normal
Clinical narrative: Pt developed fatigue, headache, acute renal failure, and anemia shortly after the injection.   Cr was 2.0 on 3/9/21 and peaked at 2.5 on 4/28/21 and was last 1.2 on 7/26/21.  Saw nephrology who found no other cause of the acute renal failure.  Hgb was 10.6 on 3/9/21 with a low of 9.0 on 5/6/21 and was up to 10.6 on 7/26/21.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received Shingrix shot #1 on 09-Dec-2020  / has not yet received dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th December 2020, intramuscularly in the left deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The patient reported case for himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not yet receive dose 2 of vaccine, which led to incomplete course of vaccination. The reporter did not have lot number available but did provide the pharmacy contact information. The VAERS details were reported for 1st dose. In March 2021, the patient received 1st and 2nd dose of Covid Moderna shots. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose had not been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (1st dose received on 5th January 2021, lot number:2A3Z9, expiry date: 14th October 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter called for recommendations regarding the next dose of Shingirx for a patient. Till the time of reporting, the patient did not receive second dose of vaccine, which led to incomplete course of vaccination.  The reporter consented to follow up by email.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 11 years old male patient / has received Infanrix; Did not receive the full dose as they realized / the wrong vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th August 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 5th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and incomplete dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The 11 years old patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administration. The nurse also reported that patient did not receive the full dose as they realized that it was the wrong vaccine which led to incomplete dose administered. The reporter consented to follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes virus infection
Clinical narrative: HERPES OUTBREAK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received guselkumab (solution for injection, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  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. No concomitant medications were reported. On an unspecified date, the patient experienced herpes outbreak. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The outcome of herpes outbreak was not reported. This report was non-serious. This report was associated with product quality complaint 90000188238. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed. Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight and height were not reported. No medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: unknown) dose, unspecified anatomical location, and 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 patient experienced Guillain-Barre syndrome (GBS). The patient was diagnosed with GBS and was hospitalized for a short period of time on an unspecified date.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This spontaneous report received from a consumer via company representative concerns a patient of unspecified age, gender, and ethnicity who was reported with Guillain Barre syndrome (GBS) after an unspecified duration from receiving the Janssen Covid-19 vaccine.  The patient was unspecified on an unspecified date.  No other pertinent information reported.  Information regarding other potential etiologies was insufficient, and the occurrence could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hypoacusis, Hypoaesthesia, Oropharyngeal pain
Clinical narrative: ALMOST TOTAL LOSS OF HEARING THAT CAME BACK; SHOOTING PAINS UP RIGHT LEG; TOTAL BLACK OUT OF VISION WITH A WHITE WINDOW THAT TURNED YELLOW BEFORE VISION RETURNED; NUMBNESS THAT COMES AND GOES; SHOOTING PAINS OUTSIDE OF BRAIN; EXTREME SORE THROAT FELT LIKE RAZOR BLADES; FELT SQUEEZING WINDPIPE; RINGING IN THE EARS THAT COMES AND GOES; BLURRED VISION THAT CAME BACK QUICKLY; SHORTNESS OF BREATHE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced shortness of breathe. On 11-APR-2021, the patient experienced blurred vision that came back quickly. On 15-APR-2021, the patient experienced ringing in the ears that comes and goes. On 15-MAY-2021, the patient experienced extreme sore throat felt like razor blades. On 15-MAY-2021, the patient experienced felt squeezing windpipe. On 18-JUL-2021, the patient experienced shooting pains outside of brain. On 18-JUL-2021, the patient experienced numbness that comes and goes. On 04-AUG-2021, the patient experienced total black out of vision with a white window that turned yellow before vision returned. On an unspecified date, the patient experienced almost total loss of hearing that came back, and shooting pains up right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting pains up right leg, was recovering from almost total loss of hearing that came back, extreme sore throat felt like razor blades, felt squeezing windpipe, and blurred vision that came back quickly, and had not recovered from shooting pains outside of brain, ringing in the ears that comes and goes, total black out of vision with a white window that turned yellow before vision returned, shortness of breathe, and numbness that comes and goes. This report was non-serious.; Sender's Comments: V0-Medical Assessment Comment is not required as per standard procedures, as the case was assessed as non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Tinnitus, Vision blurred, Visual impairment
Clinical narrative: ALMOST TOTAL LOSS OF HEARING THAT CAME BACK; SHOOTING PAINS UP RIGHT LEG; TOTAL BLACK OUT OF VISION WITH A WHITE WINDOW THAT TURNED YELLOW BEFORE VISION RETURNED; NUMBNESS THAT COMES AND GOES; SHOOTING PAINS OUTSIDE OF BRAIN; EXTREME SORE THROAT FELT LIKE RAZOR BLADES; FELT SQUEEZING WINDPIPE; RINGING IN THE EARS THAT COMES AND GOES; BLURRED VISION THAT CAME BACK QUICKLY; SHORTNESS OF BREATHE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced shortness of breathe. On 11-APR-2021, the patient experienced blurred vision that came back quickly. On 15-APR-2021, the patient experienced ringing in the ears that comes and goes. On 15-MAY-2021, the patient experienced extreme sore throat felt like razor blades. On 15-MAY-2021, the patient experienced felt squeezing windpipe. On 18-JUL-2021, the patient experienced shooting pains outside of brain. On 18-JUL-2021, the patient experienced numbness that comes and goes. On 04-AUG-2021, the patient experienced total black out of vision with a white window that turned yellow before vision returned. On an unspecified date, the patient experienced almost total loss of hearing that came back, and shooting pains up right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting pains up right leg, was recovering from almost total loss of hearing that came back, extreme sore throat felt like razor blades, felt squeezing windpipe, and blurred vision that came back quickly, and had not recovered from shooting pains outside of brain, ringing in the ears that comes and goes, total black out of vision with a white window that turned yellow before vision returned, shortness of breathe, and numbness that comes and goes. This report was non-serious.; Sender's Comments: V0-Medical Assessment Comment is not required as per standard procedures, as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram, Laboratory test, Nasopharyngitis, Pleurisy
Clinical narrative: PLEURISY; PINS FEELING IN CHEST; COLD SYMPTOMS; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. The patient's past medical history included: heart murmur as baby, and jaundice. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the patient experienced cold symptoms. On 01-JUN-2021, the patient experienced pleurisy. On 01-JUN-2021, the patient experienced pins feeling in chest. On 04-JUN-2021, Laboratory data included: Lab test (NR: not provided) diagnosed as pleurisy. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Normal, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms on 23-MAY-2021, and had not recovered from pins feeling in chest, and pleurisy. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: PLEURISY; PINS FEELING IN CHEST; COLD SYMPTOMS; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. The patient's past medical history included: heart murmur as baby, and jaundice. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the patient experienced cold symptoms. On 01-JUN-2021, the patient experienced pleurisy. On 01-JUN-2021, the patient experienced pins feeling in chest. On 04-JUN-2021, Laboratory data included: Lab test (NR: not provided) diagnosed as pleurisy. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Normal, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms on 23-MAY-2021, and had not recovered from pins feeling in chest, and pleurisy. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer contains multiple patients (6 patients) of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. All of them were vaccinated with 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, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients were hospitalized. They were tested and diagnosed positive for covid-19 (test and dates unspecified) [suspected covid-19 infection and suspected clinical vaccination failure]. All 6 patients were given Regeneron Infusion (not otherwise specified). Number of days hospitalized and discharge status were not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210807871 and 20210807550.; Sender's Comments: V0:20210808196-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure, Suspected covid-19 infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.