chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electroencephalogram, Epilepsy, Impaired driving ability, Quality of life decreased, Seizure
Clinical narrative: Approximately 28 days after receiving 2nd dose or 3rd dose*, (*if duplicate occurred), individual experienced 2 witnessed seizures and was hospitalized thereafter - has since been diagnosed with Epilepsy and treated with anti-seizure prescription medication in addition to receiving the following accompanying diagnoses: EPILEPSY, ATRIAL FIBRILLATION, PAROXYSMAL, ATHEROSCLEROSIS OF AORTA, LONG TERM CURRENT USE OF ORAL ANTICOAGULANT. Individual has since lost the ability to drive and had an overall significant decrease in quality of life and ability.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EVENTS OCCURED
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: NO ADVERSE EVENTS OCCURED
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram, Electrocardiogram, Electroencephalogram, Laboratory test
Clinical narrative: Rural Venous Sinus Thrombosis, Seizures.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Seizure, Venogram
Clinical narrative: Rural Venous Sinus Thrombosis, Seizures.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots at last two donations
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Rash
Clinical narrative: Approximately 17 days after receiving my booster dose of Pfizer vaccine I started to have severe low back pain with the L>R side. This lasted for 4-5 days and then I developed a rash over the area. I was not thinking of Shingles so did not go in to be seen until October   20th  where it was confirmed to be herpes zoster.
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: None stated.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccine positive rechallenge
Clinical narrative: Severe joint pain specifically in knees.  Required visit to orthopedist.  Could not diagnose.  At booster same chain of events occurred.  Identical replication
Sex: M
Vaccine: COVID19
Symptoms: Exposure to vaccinated person, Testicular pain
Clinical narrative: Testicular pain on left side after exposure to COVID vaccinated individuals, often severe. This has happened over a dozen times, pain disappearing for weeks then coming back within a day of exposure to COVID vaccinated.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Imaging procedure, Laparoscopic surgery, Ovarian cyst
Clinical narrative: Ovarian Cyst.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphoedema, Surgery
Clinical narrative: Developed Lymphodema post surgery - 11.5+ years
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Exposure to vaccinated person, Pain, Uterine pain
Clinical narrative: Stabbing pain in uterus immediately after exposure to COVID vaccinated individuals and chronic pain in ovaries since March 2021, which gets worse after exposure to COVID vaccinated individuals
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Interchange of vaccine products, Lymph node pain, Lymphadenopathy, Malaise
Clinical narrative: Had J&J vax in April. Had Moderna booster on 10/29.  Have a large bruise : rash in an oval shape around armpit under left arm that developed around 24 - 36 hours after shot. It is probably  8 inches long and 4 inches wide. Almost looks like the bulls eye thing you see on people after they get bitten by a tick with Lymes disease.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Had J&J vax in April. Had Moderna booster on 10/29.  Have a large bruise : rash in an oval shape around armpit under left arm that developed around 24 - 36 hours after shot. It is probably  8 inches long and 4 inches wide. Almost looks like the bulls eye thing you see on people after they get bitten by a tick with Lymes disease.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Pt had swelling/redness at site and swelling in lymphnodes
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram neck, Full blood count, Imaging procedure, Laboratory test
Clinical narrative: Lymphocele of the neck left side.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocele, Metabolic function test
Clinical narrative: Lymphocele of the neck left side.
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Urticaria on trunk of body (front and back). Timestamped images documented and sent to doctor via text message for provider's office.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiomegaly, Diastolic dysfunction, Diverticulitis, Echocardiogram abnormal
Clinical narrative: Within about 4 months of receiving the Pfizer COVID vaccine, the patient developed worsening lower extremity edema. This was first noted on 9/21/21 during a routine office visit, though her family reported that the edema had been progressing over the previous weeks/months. On 10/12/21, the patient was hospitalized for a UTI and diverticulitis, but developed acute diastolic dysfunction on or around 10/18/21, which prompted an Echoy, which showed moderate-severe pulmonary hypertension. She was discharged from the hospital on 10/22/21, only to be readmitted on 10/24/21 for acute hypoxic respiratory failure secondary to fluid overload.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Ejection fraction, Hypervolaemia, Oedema peripheral, Pulmonary hypertension, Urinary tract infection
Clinical narrative: Within about 4 months of receiving the Pfizer COVID vaccine, the patient developed worsening lower extremity edema. This was first noted on 9/21/21 during a routine office visit, though her family reported that the edema had been progressing over the previous weeks/months. On 10/12/21, the patient was hospitalized for a UTI and diverticulitis, but developed acute diastolic dysfunction on or around 10/18/21, which prompted an Echoy, which showed moderate-severe pulmonary hypertension. She was discharged from the hospital on 10/22/21, only to be readmitted on 10/24/21 for acute hypoxic respiratory failure secondary to fluid overload.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Neck pain, Pain
Clinical narrative: Severe neck pain radiating into skull causing migraine, constant since day after vaccine. Has not responded to any OTC remedies. Also has not responded to chiropractic care.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cyst, Hidradenitis, Inflammation, Rash
Clinical narrative: Significant hidradenitis flare over the next week, with increased inflammation, four raised cysts that erupted pus and blood.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Dizziness, Extra dose administered, Headache, Myalgia
Clinical narrative: dizzy, demencha like symptoms headachce joints & muscle achces bad dreams                                   ( had extra dose influenza with shingles) )first shot
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Neuropsychiatric symptoms, Nightmare
Clinical narrative: dizzy, demencha like symptoms headachce joints & muscle achces bad dreams                                   ( had extra dose influenza with shingles) )first shot
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Decreased appetite, Electrocardiogram normal, Fatigue, Injection site pain
Clinical narrative: Twelve hours following the second vaccine I experienced: fever, aches, fatigue, pain at injection site. Those all resolved after 2 days. Approximately 5 days after receiving the second Pfizer vaccine I had the following side effects: constant BURNING pain in my upper lungs with every breath. It kept me up at night with broken sleep. I went to Urgent Care after 2 weeks. They did a chest Xray and EKG. Both tests were negative. They couldn't find a cause.  Four days later I started a 14-day treatment of Prilosec to see if that would help. It has helped a little. The constant burning sensation has changed to the feeling of bread stuck in my throat. That discomfort exists all day and night. I have been sleeping with 3 pillows to be propped up. The discomfort has continued all day and night. I also had no appetite for 5 days and lost 3 lbs. I have read other similar accounts and those don't give me any hope of it ending anytime soon. It has been over 1 month thus far.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain, Painful respiration, Pulmonary pain, Pyrexia
Clinical narrative: Twelve hours following the second vaccine I experienced: fever, aches, fatigue, pain at injection site. Those all resolved after 2 days. Approximately 5 days after receiving the second Pfizer vaccine I had the following side effects: constant BURNING pain in my upper lungs with every breath. It kept me up at night with broken sleep. I went to Urgent Care after 2 weeks. They did a chest Xray and EKG. Both tests were negative. They couldn't find a cause.  Four days later I started a 14-day treatment of Prilosec to see if that would help. It has helped a little. The constant burning sensation has changed to the feeling of bread stuck in my throat. That discomfort exists all day and night. I have been sleeping with 3 pillows to be propped up. The discomfort has continued all day and night. I also had no appetite for 5 days and lost 3 lbs. I have read other similar accounts and those don't give me any hope of it ending anytime soon. It has been over 1 month thus far.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Weight decreased
Clinical narrative: Twelve hours following the second vaccine I experienced: fever, aches, fatigue, pain at injection site. Those all resolved after 2 days. Approximately 5 days after receiving the second Pfizer vaccine I had the following side effects: constant BURNING pain in my upper lungs with every breath. It kept me up at night with broken sleep. I went to Urgent Care after 2 weeks. They did a chest Xray and EKG. Both tests were negative. They couldn't find a cause.  Four days later I started a 14-day treatment of Prilosec to see if that would help. It has helped a little. The constant burning sensation has changed to the feeling of bread stuck in my throat. That discomfort exists all day and night. I have been sleeping with 3 pillows to be propped up. The discomfort has continued all day and night. I also had no appetite for 5 days and lost 3 lbs. I have read other similar accounts and those don't give me any hope of it ending anytime soon. It has been over 1 month thus far.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, Pallor
Clinical narrative: patient stated feeling dizzy, lightheaded, "stoned," and nauseous and was pale.  had the patient lay down with his feet up and supplied cold compresses. after a few minutes patient said he was feeling better and left the premises.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Headache, Incorrect dose administered, Injection site pain, Nausea
Clinical narrative: Was informed tonight by personnel about 8:10 pm tonight that I accidentally got 5x the recommended Pfizer vaccine booster dose due to failure of dilution with saline by vaccine administrator.  This error happened allegedly to everyone who got the covid vaccine (? only Pfizer) dose today starting from am till about 2 pm. Experiencing neck pain, intermittent headaches, body aches, some nausea and pain at injection site.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Pain, Product preparation error
Clinical narrative: Was informed tonight by personnel about 8:10 pm tonight that I accidentally got 5x the recommended Pfizer vaccine booster dose due to failure of dilution with saline by vaccine administrator.  This error happened allegedly to everyone who got the covid vaccine (? only Pfizer) dose today starting from am till about 2 pm. Experiencing neck pain, intermittent headaches, body aches, some nausea and pain at injection site.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Was informed tonight by personnel about 8:10 pm tonight that I accidentally got 5x the recommended Pfizer vaccine booster dose due to failure of dilution with saline by vaccine administrator.  This error happened allegedly to everyone who got the covid vaccine (? only Pfizer) dose today starting from am till about 2 pm. Experiencing neck pain, intermittent headaches, body aches, some nausea and pain at injection site.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Was informed tonight by personnel about 8:10 pm tonight that I accidentally got 5x the recommended Pfizer vaccine booster dose due to failure of dilution with saline by vaccine administrator.  This error happened allegedly to everyone who got the covid vaccine (? only Pfizer) dose today starting from am till about 2 pm. Experiencing neck pain, intermittent headaches, body aches, some nausea and pain at injection site.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: After patient receiving covid 19 pfizer vaccine, 5-8 minutes later he complained that he is hot, showed light sweating, and his skin color was pale. He was alert and kept saying  he is  " hot".  He was sitting on the floor when pharmacist was out to check on him, and later he laid on the floor while he was alert. I asked him if he needs more assistant or call 911, he declined ( he is minor and his mom was next to him).  Pharmacy staff gave him water and ice pack. After 3-4 minutes later of drinking water he was getting more alert and able to sit on the chair himself. I told patient to wait 15 more minutes. As he drink more water patient was getting better,hi mom said " he is better" , and left pharmacy with his mom.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient called around 230pm  to report to following adverse event.  After leaving pharmacy she experience numbing in the face.  There was no inflammation on the face and no hives.  Told her to follow up with PCP right away and if she cant  get a hold of doctor to see ER.   Patient will follow  up with PCP.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fever up to 102F, myalgia, arthralgia, fatigue, nausea, vomiting, HA. Swelling of arms and subjective feeling of swelling in face. No angioedema. No hives.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Swelling face, Vomiting
Clinical narrative: Fever up to 102F, myalgia, arthralgia, fatigue, nausea, vomiting, HA. Swelling of arms and subjective feeling of swelling in face. No angioedema. No hives.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Patient reports adverse event on arm where vaccine was injected  about a week later. She is experiencing swollen arm, warm to touch, red rashes, and itchiness.  Told patient to put cold compress and some hydrocortisone. Also to follow up with PCP.
Age: 11.0
Sex: M
Vaccine: FLUC4, HPV9, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions. Patient received 2 doses of flu on the same visit.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count abnormal, Lymph node pain, Lymphadenopathy, Mean platelet volume increased, Monocytosis
Clinical narrative: Painful, enlarged axillary lymph nodes and body aches about 36 hours after first shot, resolved after several days CBC shows monocytosis and high MPV
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: Painful, enlarged axillary lymph nodes and body aches about 36 hours after first shot, resolved after several days CBC shows monocytosis and high MPV
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Areflexia, Asthenia, Back pain
Clinical narrative: 4/27/21 loss of taste & smell 4/28-4/29/21 body aches, fever, headache, malaise 9/26/21 loss of taste & smell returns (approx. 4:00 PM) 9/28/21 (R) numbness & facial paralysis 9/28/21 paralysis progressing to (B) face, (B) trunk (B) legs numbness & tingling 9/28/21 hospitalization through ER Diagnosed with Guillan-Barre Syndrome (GBS) presenting with full (Bilateral=(B) facial paralysis, loss of taste/smell, body numbness & paralysis progressing through trunk out to limbs distally to hands/feet. Loss of (B) reflexes in lower extremeties, extreme weakness; loss of coordination lower limbs, speech impairement, choking risk (paralysis)  J&J suspected as possible trigger to GBS. Follow-up with PCP and Infectious Disease doctor, confirming Lymes disease bloodwork ordered. However stated lymes does not present with (B) symptions such as (B) full facial paralysis, radiating numbness, tingling, paralysis to limbs.  Guillian-Barre Syndrome diagnosed by neurologist through Medical Center. Between 4/27/21 (with reachons including loss of taste & smell, fatigue and body aches 7/10 pain level).  Back pain and leg pain persisted through hospitalization Gabapentin prescribed for severe pain 8-9/10 pain scale with visits to PCP 9/14/21 Urgent care 9/12/21 pain increasing Medical Center 9/26/21 MRI Admission to hospital with facial paralysis progressing quickly (R) to loss of taste/smell completely, trunk numbness progressing forward (B) diaphragm (life-threatening). Discharge Sat 10/2/21 with lingering symptoms PROGRESSING: More extremity numbness, tingling, decreased coordination  Difficulty concentrating Headache & (B) facial paralysis Tape eyes shut at night since GBS cannot close lids/stay closed during sleep (FOLLOWUP EXPECTED THROUGH DISEASE PROGRESSION)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: CSF test, Computerised tomogram head, Coordination abnormal, Diaphragmatic disorder, Diplegia
Clinical narrative: 4/27/21 loss of taste & smell 4/28-4/29/21 body aches, fever, headache, malaise 9/26/21 loss of taste & smell returns (approx. 4:00 PM) 9/28/21 (R) numbness & facial paralysis 9/28/21 paralysis progressing to (B) face, (B) trunk (B) legs numbness & tingling 9/28/21 hospitalization through ER Diagnosed with Guillan-Barre Syndrome (GBS) presenting with full (Bilateral=(B) facial paralysis, loss of taste/smell, body numbness & paralysis progressing through trunk out to limbs distally to hands/feet. Loss of (B) reflexes in lower extremeties, extreme weakness; loss of coordination lower limbs, speech impairement, choking risk (paralysis)  J&J suspected as possible trigger to GBS. Follow-up with PCP and Infectious Disease doctor, confirming Lymes disease bloodwork ordered. However stated lymes does not present with (B) symptions such as (B) full facial paralysis, radiating numbness, tingling, paralysis to limbs.  Guillian-Barre Syndrome diagnosed by neurologist through Medical Center. Between 4/27/21 (with reachons including loss of taste & smell, fatigue and body aches 7/10 pain level).  Back pain and leg pain persisted through hospitalization Gabapentin prescribed for severe pain 8-9/10 pain scale with visits to PCP 9/14/21 Urgent care 9/12/21 pain increasing Medical Center 9/26/21 MRI Admission to hospital with facial paralysis progressing quickly (R) to loss of taste/smell completely, trunk numbness progressing forward (B) diaphragm (life-threatening). Discharge Sat 10/2/21 with lingering symptoms PROGRESSING: More extremity numbness, tingling, decreased coordination  Difficulty concentrating Headache & (B) facial paralysis Tape eyes shut at night since GBS cannot close lids/stay closed during sleep (FOLLOWUP EXPECTED THROUGH DISEASE PROGRESSION)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Eyelid function disorder, Facial paralysis, Fatigue, Guillain-Barre syndrome
Clinical narrative: 4/27/21 loss of taste & smell 4/28-4/29/21 body aches, fever, headache, malaise 9/26/21 loss of taste & smell returns (approx. 4:00 PM) 9/28/21 (R) numbness & facial paralysis 9/28/21 paralysis progressing to (B) face, (B) trunk (B) legs numbness & tingling 9/28/21 hospitalization through ER Diagnosed with Guillan-Barre Syndrome (GBS) presenting with full (Bilateral=(B) facial paralysis, loss of taste/smell, body numbness & paralysis progressing through trunk out to limbs distally to hands/feet. Loss of (B) reflexes in lower extremeties, extreme weakness; loss of coordination lower limbs, speech impairement, choking risk (paralysis)  J&J suspected as possible trigger to GBS. Follow-up with PCP and Infectious Disease doctor, confirming Lymes disease bloodwork ordered. However stated lymes does not present with (B) symptions such as (B) full facial paralysis, radiating numbness, tingling, paralysis to limbs.  Guillian-Barre Syndrome diagnosed by neurologist through Medical Center. Between 4/27/21 (with reachons including loss of taste & smell, fatigue and body aches 7/10 pain level).  Back pain and leg pain persisted through hospitalization Gabapentin prescribed for severe pain 8-9/10 pain scale with visits to PCP 9/14/21 Urgent care 9/12/21 pain increasing Medical Center 9/26/21 MRI Admission to hospital with facial paralysis progressing quickly (R) to loss of taste/smell completely, trunk numbness progressing forward (B) diaphragm (life-threatening). Discharge Sat 10/2/21 with lingering symptoms PROGRESSING: More extremity numbness, tingling, decreased coordination  Difficulty concentrating Headache & (B) facial paralysis Tape eyes shut at night since GBS cannot close lids/stay closed during sleep (FOLLOWUP EXPECTED THROUGH DISEASE PROGRESSION)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging, Malaise
Clinical narrative: 4/27/21 loss of taste & smell 4/28-4/29/21 body aches, fever, headache, malaise 9/26/21 loss of taste & smell returns (approx. 4:00 PM) 9/28/21 (R) numbness & facial paralysis 9/28/21 paralysis progressing to (B) face, (B) trunk (B) legs numbness & tingling 9/28/21 hospitalization through ER Diagnosed with Guillan-Barre Syndrome (GBS) presenting with full (Bilateral=(B) facial paralysis, loss of taste/smell, body numbness & paralysis progressing through trunk out to limbs distally to hands/feet. Loss of (B) reflexes in lower extremeties, extreme weakness; loss of coordination lower limbs, speech impairement, choking risk (paralysis)  J&J suspected as possible trigger to GBS. Follow-up with PCP and Infectious Disease doctor, confirming Lymes disease bloodwork ordered. However stated lymes does not present with (B) symptions such as (B) full facial paralysis, radiating numbness, tingling, paralysis to limbs.  Guillian-Barre Syndrome diagnosed by neurologist through Medical Center. Between 4/27/21 (with reachons including loss of taste & smell, fatigue and body aches 7/10 pain level).  Back pain and leg pain persisted through hospitalization Gabapentin prescribed for severe pain 8-9/10 pain scale with visits to PCP 9/14/21 Urgent care 9/12/21 pain increasing Medical Center 9/26/21 MRI Admission to hospital with facial paralysis progressing quickly (R) to loss of taste/smell completely, trunk numbness progressing forward (B) diaphragm (life-threatening). Discharge Sat 10/2/21 with lingering symptoms PROGRESSING: More extremity numbness, tingling, decreased coordination  Difficulty concentrating Headache & (B) facial paralysis Tape eyes shut at night since GBS cannot close lids/stay closed during sleep (FOLLOWUP EXPECTED THROUGH DISEASE PROGRESSION)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia, Pain, Pain in extremity, Paraesthesia, Paralysis
Clinical narrative: 4/27/21 loss of taste & smell 4/28-4/29/21 body aches, fever, headache, malaise 9/26/21 loss of taste & smell returns (approx. 4:00 PM) 9/28/21 (R) numbness & facial paralysis 9/28/21 paralysis progressing to (B) face, (B) trunk (B) legs numbness & tingling 9/28/21 hospitalization through ER Diagnosed with Guillan-Barre Syndrome (GBS) presenting with full (Bilateral=(B) facial paralysis, loss of taste/smell, body numbness & paralysis progressing through trunk out to limbs distally to hands/feet. Loss of (B) reflexes in lower extremeties, extreme weakness; loss of coordination lower limbs, speech impairement, choking risk (paralysis)  J&J suspected as possible trigger to GBS. Follow-up with PCP and Infectious Disease doctor, confirming Lymes disease bloodwork ordered. However stated lymes does not present with (B) symptions such as (B) full facial paralysis, radiating numbness, tingling, paralysis to limbs.  Guillian-Barre Syndrome diagnosed by neurologist through Medical Center. Between 4/27/21 (with reachons including loss of taste & smell, fatigue and body aches 7/10 pain level).  Back pain and leg pain persisted through hospitalization Gabapentin prescribed for severe pain 8-9/10 pain scale with visits to PCP 9/14/21 Urgent care 9/12/21 pain increasing Medical Center 9/26/21 MRI Admission to hospital with facial paralysis progressing quickly (R) to loss of taste/smell completely, trunk numbness progressing forward (B) diaphragm (life-threatening). Discharge Sat 10/2/21 with lingering symptoms PROGRESSING: More extremity numbness, tingling, decreased coordination  Difficulty concentrating Headache & (B) facial paralysis Tape eyes shut at night since GBS cannot close lids/stay closed during sleep (FOLLOWUP EXPECTED THROUGH DISEASE PROGRESSION)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Speech disorder
Clinical narrative: 4/27/21 loss of taste & smell 4/28-4/29/21 body aches, fever, headache, malaise 9/26/21 loss of taste & smell returns (approx. 4:00 PM) 9/28/21 (R) numbness & facial paralysis 9/28/21 paralysis progressing to (B) face, (B) trunk (B) legs numbness & tingling 9/28/21 hospitalization through ER Diagnosed with Guillan-Barre Syndrome (GBS) presenting with full (Bilateral=(B) facial paralysis, loss of taste/smell, body numbness & paralysis progressing through trunk out to limbs distally to hands/feet. Loss of (B) reflexes in lower extremeties, extreme weakness; loss of coordination lower limbs, speech impairement, choking risk (paralysis)  J&J suspected as possible trigger to GBS. Follow-up with PCP and Infectious Disease doctor, confirming Lymes disease bloodwork ordered. However stated lymes does not present with (B) symptions such as (B) full facial paralysis, radiating numbness, tingling, paralysis to limbs.  Guillian-Barre Syndrome diagnosed by neurologist through Medical Center. Between 4/27/21 (with reachons including loss of taste & smell, fatigue and body aches 7/10 pain level).  Back pain and leg pain persisted through hospitalization Gabapentin prescribed for severe pain 8-9/10 pain scale with visits to PCP 9/14/21 Urgent care 9/12/21 pain increasing Medical Center 9/26/21 MRI Admission to hospital with facial paralysis progressing quickly (R) to loss of taste/smell completely, trunk numbness progressing forward (B) diaphragm (life-threatening). Discharge Sat 10/2/21 with lingering symptoms PROGRESSING: More extremity numbness, tingling, decreased coordination  Difficulty concentrating Headache & (B) facial paralysis Tape eyes shut at night since GBS cannot close lids/stay closed during sleep (FOLLOWUP EXPECTED THROUGH DISEASE PROGRESSION)
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Blood thyroid stimulating hormone, Fatigue, Full blood count, Glycosylated haemoglobin
Clinical narrative: Patient experienced nausea Following shot #2 - he  presented for physical & follow up of chronic medical issues on 10/13/2021 & was found to have anemia He has been more fatigued since taking 2nd shot
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Nausea
Clinical narrative: Patient experienced nausea Following shot #2 - he  presented for physical & follow up of chronic medical issues on 10/13/2021 & was found to have anemia He has been more fatigued since taking 2nd shot
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count, Fatigue, Laboratory test, Lymphocyte count increased, Malaise
Clinical narrative: o fatigue, body aches and felt "deathly ill" for several days o Now has low white blood cell count at 2.1 K and low platelets of 107 K diff shows 35 segs/46 lymphs/13 mono/5 cos/1 lymph ab
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monocyte count increased, Pain, Platelet count decreased, White blood cell count decreased
Clinical narrative: o fatigue, body aches and felt "deathly ill" for several days o Now has low white blood cell count at 2.1 K and low platelets of 107 K diff shows 35 segs/46 lymphs/13 mono/5 cos/1 lymph ab
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Mean cell haemoglobin decreased, Neutrophil percentage decreased, Presyncope
Clinical narrative: MCH on CBC - low at 26 neutrophils - low at 42 Symptoms - presyncopal episodes which began after 2nd shot
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Dizziness, Feeling hot, Flushing
Clinical narrative: The patient experienced major hot flashes and burning sensation all over her body that lasted about 20 minutes. She also experienced severe headache in the back left side of the head with a lot of unusual pressure and throbbing pain. After a shower her face started to burn and there was a needling/prickly down the center of the back, arms, and legs. The pores where especially enlarged on the skin.   Her face also look burned and was peeling like a sun burn.  She also experienced sore scalp and blistered (small bumps).  She does not use chemicals nor wear braids.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Hot flush, Nausea, Paraesthesia, Skin burning sensation
Clinical narrative: The patient experienced major hot flashes and burning sensation all over her body that lasted about 20 minutes. She also experienced severe headache in the back left side of the head with a lot of unusual pressure and throbbing pain. After a shower her face started to burn and there was a needling/prickly down the center of the back, arms, and legs. The pores where especially enlarged on the skin.   Her face also look burned and was peeling like a sun burn.  She also experienced sore scalp and blistered (small bumps).  She does not use chemicals nor wear braids.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Burning sensation, Dilated pores, Head discomfort, Headache
Clinical narrative: The patient experienced major hot flashes and burning sensation all over her body that lasted about 20 minutes. She also experienced severe headache in the back left side of the head with a lot of unusual pressure and throbbing pain. After a shower her face started to burn and there was a needling/prickly down the center of the back, arms, and legs. The pores where especially enlarged on the skin.   Her face also look burned and was peeling like a sun burn.  She also experienced sore scalp and blistered (small bumps).  She does not use chemicals nor wear braids.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Pain, Pain of skin, Paraesthesia, Rash erythematous
Clinical narrative: The patient experienced major hot flashes and burning sensation all over her body that lasted about 20 minutes. She also experienced severe headache in the back left side of the head with a lot of unusual pressure and throbbing pain. After a shower her face started to burn and there was a needling/prickly down the center of the back, arms, and legs. The pores where especially enlarged on the skin.   Her face also look burned and was peeling like a sun burn.  She also experienced sore scalp and blistered (small bumps).  She does not use chemicals nor wear braids.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation
Clinical narrative: The patient experienced major hot flashes and burning sensation all over her body that lasted about 20 minutes. She also experienced severe headache in the back left side of the head with a lot of unusual pressure and throbbing pain. After a shower her face started to burn and there was a needling/prickly down the center of the back, arms, and legs. The pores where especially enlarged on the skin.   Her face also look burned and was peeling like a sun burn.  She also experienced sore scalp and blistered (small bumps).  She does not use chemicals nor wear braids.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Influenza, Musculoskeletal discomfort, Nausea, Pain in jaw
Clinical narrative: slow onset of left earache; mild tooth/jaw pain on the left side of the mouth; mild flu symptoms but never ran a fever; shoulder discomfort and nausea; shoulder discomfort and nausea; left jaw discomfort; This is a spontaneous report from a contactable consumer. This consumer reported information for both husband and wife. This is the wife report.  A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm left on 03Feb2021 (at the age of 72-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. No covid prior vaccination. Patient did not have covid tested post vaccination. Other medications in two weeks included potassium. No other vaccine received in four weeks. The patient previously took bnt162b2 on 13Jan2021 for covid-19 immunisation, for ear pain, for toothache, for pain in jaw. On an unspecified date in Feb2021, the patient had slow onset of left earache, mild tooth/jaw pain on the left side of the mouth, mild flu symptoms but never ran a fever, shoulder discomfort and nausea. Reporter also mentioned that the patient experienced left jaw discomfort, which made suspect virus, discomfort quickly went away. The event clinical course was as follows: both reporter and his wife both received BNT162B2. The reporter had no known allergies, and medical history included artery disease, sleep apnea, acid reflux. The wife had slow onset of left earache, and reporter soon had "crinkle' sounds in left ear (AER 2021036063). And they both experienced mild tooth/jaw pain on the left side of the mouth. It was reported that if she had not matched my symptoms, reporter would not have attributed these two things to the vaccine. Their prescription meds did not match at all except for potassium. She had mild flu symptoms but never ran a fever. She experienced shoulder discomfort and nausea. Today (17Jan2021), all symptoms are gone except the reporter still had some "crinkle" in left ear. The reaction recur on re-administration of the product. Outcome of the event left jaw discomfort was recovered; while rest other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Toothache
Clinical narrative: slow onset of left earache; mild tooth/jaw pain on the left side of the mouth; mild flu symptoms but never ran a fever; shoulder discomfort and nausea; shoulder discomfort and nausea; left jaw discomfort; This is a spontaneous report from a contactable consumer. This consumer reported information for both husband and wife. This is the wife report.  A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm left on 03Feb2021 (at the age of 72-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. No covid prior vaccination. Patient did not have covid tested post vaccination. Other medications in two weeks included potassium. No other vaccine received in four weeks. The patient previously took bnt162b2 on 13Jan2021 for covid-19 immunisation, for ear pain, for toothache, for pain in jaw. On an unspecified date in Feb2021, the patient had slow onset of left earache, mild tooth/jaw pain on the left side of the mouth, mild flu symptoms but never ran a fever, shoulder discomfort and nausea. Reporter also mentioned that the patient experienced left jaw discomfort, which made suspect virus, discomfort quickly went away. The event clinical course was as follows: both reporter and his wife both received BNT162B2. The reporter had no known allergies, and medical history included artery disease, sleep apnea, acid reflux. The wife had slow onset of left earache, and reporter soon had "crinkle' sounds in left ear (AER 2021036063). And they both experienced mild tooth/jaw pain on the left side of the mouth. It was reported that if she had not matched my symptoms, reporter would not have attributed these two things to the vaccine. Their prescription meds did not match at all except for potassium. She had mild flu symptoms but never ran a fever. She experienced shoulder discomfort and nausea. Today (17Jan2021), all symptoms are gone except the reporter still had some "crinkle" in left ear. The reaction recur on re-administration of the product. Outcome of the event left jaw discomfort was recovered; while rest other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Toothache
Clinical narrative: slow onset of left earache; mild tooth/jaw pain on the left side of the mouth; mild flu symptoms but never ran a fever; shoulder discomfort and nausea; shoulder discomfort and nausea; left jaw discomfort; This is a spontaneous report from a contactable consumer. This consumer reported information for both husband and wife. This is the wife report.  A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm left on 03Feb2021 (at the age of 72-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. No covid prior vaccination. Patient did not have covid tested post vaccination. Other medications in two weeks included potassium. No other vaccine received in four weeks. The patient previously took bnt162b2 on 13Jan2021 for covid-19 immunisation, for ear pain, for toothache, for pain in jaw. On an unspecified date in Feb2021, the patient had slow onset of left earache, mild tooth/jaw pain on the left side of the mouth, mild flu symptoms but never ran a fever, shoulder discomfort and nausea. Reporter also mentioned that the patient experienced left jaw discomfort, which made suspect virus, discomfort quickly went away. The event clinical course was as follows: both reporter and his wife both received BNT162B2. The reporter had no known allergies, and medical history included artery disease, sleep apnea, acid reflux. The wife had slow onset of left earache, and reporter soon had "crinkle' sounds in left ear (AER 2021036063). And they both experienced mild tooth/jaw pain on the left side of the mouth. It was reported that if she had not matched my symptoms, reporter would not have attributed these two things to the vaccine. Their prescription meds did not match at all except for potassium. She had mild flu symptoms but never ran a fever. She experienced shoulder discomfort and nausea. Today (17Jan2021), all symptoms are gone except the reporter still had some "crinkle" in left ear. The reaction recur on re-administration of the product. Outcome of the event left jaw discomfort was recovered; while rest other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Epistaxis
Clinical narrative: very pronounced nose bleed really gushing; This is a spontaneous report from a contactable reporter via the Regulatory Authority. A contactable female patient (reporter) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Batch/ Lot number: Not reported) dose 1, via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, on 31Jan2021, 5 days later, she had a very pronounced nose bleed really gushing, which landed her in the ER, with the bleed having to be packed. She has since had cauterization done by two different ENTs to stop the residual bleeding. Her HCP said they did not believe the vaccine caused the nose bleed, and have given her the go-ahead to receive the second dose. She is asking if the interval between doses is too large, and if she should re-start the series. She had a bloody nose and it has continued till now. She never got second shot. Outcome for the event were unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.  This follow-up report is being submitted to amend previously reported information updated suspect product BNT162B2 using license.  This follow-up report is being submitted to amend previously reported information deleted the events Off label use and inappropriate schedule of vaccine administered and at risk classification.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epistaxis, Nasal cavity packing, Vascular cauterisation
Clinical narrative: very pronounced nose bleed really gushing; This is a spontaneous report from a contactable reporter via the Regulatory Authority. A contactable female patient (reporter) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Batch/ Lot number: Not reported) dose 1, via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, on 31Jan2021, 5 days later, she had a very pronounced nose bleed really gushing, which landed her in the ER, with the bleed having to be packed. She has since had cauterization done by two different ENTs to stop the residual bleeding. Her HCP said they did not believe the vaccine caused the nose bleed, and have given her the go-ahead to receive the second dose. She is asking if the interval between doses is too large, and if she should re-start the series. She had a bloody nose and it has continued till now. She never got second shot. Outcome for the event were unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.  This follow-up report is being submitted to amend previously reported information updated suspect product BNT162B2 using license.  This follow-up report is being submitted to amend previously reported information deleted the events Off label use and inappropriate schedule of vaccine administered and at risk classification.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epistaxis, Incomplete course of vaccination, Nasal cavity packing, Vascular cauterisation
Clinical narrative: very pronounced nose bleed really gushing; This is a spontaneous report from a contactable reporter via the Regulatory Authority. A contactable female patient (reporter) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Batch/ Lot number: Not reported) dose 1, via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, on 31Jan2021, 5 days later, she had a very pronounced nose bleed really gushing, which landed her in the ER, with the bleed having to be packed. She has since had cauterization done by two different ENTs to stop the residual bleeding. Her HCP said they did not believe the vaccine caused the nose bleed, and have given her the go-ahead to receive the second dose. She is asking if the interval between doses is too large, and if she should re-start the series. She had a bloody nose and it has continued till now. She never got second shot. Outcome for the event were unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.  This follow-up report is being submitted to amend previously reported information updated suspect product BNT162B2 using license.  This follow-up report is being submitted to amend previously reported information deleted the events Off label use and inappropriate schedule of vaccine administered and at risk classification.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest X-ray, Chills, Cough, Headache
Clinical narrative: High fever for 18 days; chills; elevated WBC and RBC; elevated WBC and RBC; night sweats; cough; flank pain on right side; organ inflammation (elevated creatine protein); organ inflammation (elevated creatine protein); high liver numbers; severe headache; This is a spontaneous report from a contactable consumer. A 69-year-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 16:00 AM as DOSE 2, SINGLE for covid-19 immunisation (at the age of 69-year-old). Medical history included glaucoma and High blood pressure from an unknown date and unknown if ongoing. Not known allergies. Concomitant medications included atorvastatin (ATORVASTATIN), brimonidine tartrate, timolol maleate (COMBIGAN), hydro-chlorothiazide, valsartan (DIOVAN HCT), latanoprost (XALATAN) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (Lot number EL9264) in Arm Left on 12Feb2021 16:00 AM as dose 1, single for covid-19 immunisation. On 13Mar2021 06:00 patient experienced High fever for 18 days, chills, night sweats, cough, flank pain on right side, high liver numbers, elevated WBC and RBC, organ inflammation (elevated creatine protein); severe headaches. After 4 weeks symptoms are starting to lessen. The patient underwent lab tests and procedures which included blood creatine: elevated, blood test: unknown, computerised tomo-gram: unknown, electrocardiogram: unknown, liver function test: high, red blood cell count: elevated, ultrasound scan: unknown, urine analysis: unknown, white blood cell count: elevated on an unspecified date, sars-cov-2 test negative (Nasal Swab) on 22Mar2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The received treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.