chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Wrong product administered
Clinical narrative: Patient came in and received the updated bivalent pfizer booster dose, but they actually needed the primary series or the first dose of their vaccine. So they were given the incorrect vaccine to start with. No adverse events have occurred.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PT came in for 2nd dose of pfizer. Staff administered booster instead of monovalent. Staff has been coached on proper verification of vaccine. Incident report is submitted within organization to address root cause, provider proper training, and address situation.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Disseminated intravascular coagulation, Hypertension, Hypoaesthesia, Influenza like illness, Pain
Clinical narrative: I had the usual pain after this booster, on day two, the usual flu type symptoms, but I woke up three times on Wednesday night, the 8th with my whole left side numb. It was frightening so I called the my Dr the next day and she had me come in. My blood pressure was high and she was very concerned with the numbness. Its would go away when I laid on my other side that night but for three nights in a row, if I laid on my left side - the side of the shot, my side went numb. My Dr. asked me of my history of high blood pressure - I had only had HBP when I had a retinal bleed on May 10th of 2021 in my left eye. I'd had my first booster (Prizer) on April the 2nd of 2021. When I went to the Urgent care they thought I was having a stroke because of my very high BP, but I explained that anyone with a bleed in their eye like mine would freak out! This was before I started seeing a Dr. on a regular basis - I started with Dr. in early 2022. Dr. thinks that my retinal bleed which came out of nowhere with no warning signs so soon after my booster may be related to the booster. She has diagnosed me with disseminated intravascular coagulation and has me scheduled for a carotid artery ultrasound and has me taking Xanax as needed to keep me calm as she's afraid I'll have a stroke or something. I',m also not supposed to lift anything or lower my head much. I've never had HBP before but it has been on the high end since I started taking it last week and at my two appointments with my Dr.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Retinal haemorrhage, Sleep disorder
Clinical narrative: I had the usual pain after this booster, on day two, the usual flu type symptoms, but I woke up three times on Wednesday night, the 8th with my whole left side numb. It was frightening so I called the my Dr the next day and she had me come in. My blood pressure was high and she was very concerned with the numbness. Its would go away when I laid on my other side that night but for three nights in a row, if I laid on my left side - the side of the shot, my side went numb. My Dr. asked me of my history of high blood pressure - I had only had HBP when I had a retinal bleed on May 10th of 2021 in my left eye. I'd had my first booster (Prizer) on April the 2nd of 2021. When I went to the Urgent care they thought I was having a stroke because of my very high BP, but I explained that anyone with a bleed in their eye like mine would freak out! This was before I started seeing a Dr. on a regular basis - I started with Dr. in early 2022. Dr. thinks that my retinal bleed which came out of nowhere with no warning signs so soon after my booster may be related to the booster. She has diagnosed me with disseminated intravascular coagulation and has me scheduled for a carotid artery ultrasound and has me taking Xanax as needed to keep me calm as she's afraid I'll have a stroke or something. I',m also not supposed to lift anything or lower my head much. I've never had HBP before but it has been on the high end since I started taking it last week and at my two appointments with my Dr.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Nasopharyngitis, Pain
Clinical narrative: Large red painful raised circle at injection site, achiness in upper body, cold symptoms
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Vaccination error
Clinical narrative: AN ERROR WAS MADE, THE PATIENT WAS 3 MONTHS AWAY FROM TURNING 6 AND WAS GIVEN A MODERNA 6-11 YEARS DOSE. NO ADVERSE EFFECTS, NO TREATMENT GIVEN
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination error
Clinical narrative: AN ERROR WAS MADE, PATIENT WAS 11 AT TIME OF VACCINATION, GUARDIAN REPORTED THEY WERE 12, PATIENT RECEIVED MODERNA 1ST DOSE FOR 12 + YEARS AND UP
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: 6 days after receiving the Moderna vaccine the patient went back into atrial fibrillation.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Amnesia, Computerised tomogram, Confusional state, Laboratory test normal
Clinical narrative: I lost my memory and could not retain any information or knowledge of what was happening for longer than about a minute or two. I was confused, repeated myself again and again. I am still unable to recall the 2 days prior to the amnesia event. While in the hospital, my memory came back in the late afternoon after having 911 called on me at about 9am.  I never lost consciousness, communicated during the entire event though with the inability to recall anything said to me or that I had said after a minute or so. I had no head injury prior to this event. I was at work and my coworkers noticed my odd behavior. Taken to the hospital, tests were ran and during the entire time in the ER I repeated myself and repeatedly wondered why I was there. I would be told, then just as soon forget again. I had all of the classic symptoms of TGA. The neurologist in the ER at first labeled me as having had a seizure, but all tests came back negative for seizure. He assumed this because I had told him (though i have no memory of this) that I had had a head injury as a child. ALL of my symptoms presented as TGA and my follow up visit with Dr she confirmed that I had not had a seizure, but had Transient Global Amnesia.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Transient global amnesia
Clinical narrative: I lost my memory and could not retain any information or knowledge of what was happening for longer than about a minute or two. I was confused, repeated myself again and again. I am still unable to recall the 2 days prior to the amnesia event. While in the hospital, my memory came back in the late afternoon after having 911 called on me at about 9am.  I never lost consciousness, communicated during the entire event though with the inability to recall anything said to me or that I had said after a minute or so. I had no head injury prior to this event. I was at work and my coworkers noticed my odd behavior. Taken to the hospital, tests were ran and during the entire time in the ER I repeated myself and repeatedly wondered why I was there. I would be told, then just as soon forget again. I had all of the classic symptoms of TGA. The neurologist in the ER at first labeled me as having had a seizure, but all tests came back negative for seizure. He assumed this because I had told him (though i have no memory of this) that I had had a head injury as a child. ALL of my symptoms presented as TGA and my follow up visit with Dr she confirmed that I had not had a seizure, but had Transient Global Amnesia.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Patient experienced redness, itchiness, and inflammation around injection site. It was bad enough that she went to the ER. There, she was given an antibiotic, cephalexin, for 7 days. Symptoms seem to be diminishing.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: syncope episode, patient immediately was alert and stayed seated, felt better
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deafness unilateral, Herpes zoster
Clinical narrative: Shingles. Both times I got a Covid-19 booster. First, last spring (2022) on my side, then in January in my ears. I?ve lost my hearing in one ear.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood creatinine increased, Blood urea increased, Bradycardia, Cardiomegaly
Clinical narrative: PATIENT PRESENTED TO ED WITH WEAKNESS AND SHORTNESS OF BREATH, ADMITTED ON 7/28/22.  WAS PREVIOUSLY ADMITTED TO HOPSITAL 6 DAYS PRIOR FOR OVER A MONTH WITH ALTERED MENTAL STATUS, BUT WAS STABLE ON DISCHARGE. PATIENT WAS BRADYCARDIA OF 66, TACHYPNEA OF 22, HTN. CBC WAS SIGNIFICANT FOR A GREATER THAN TWO-POINT DROP IN HEMOGLOBIN OVER 24 HOURS, CMP SHOWED BUN OF 72 AND CREATININE OF 1.59, AND D-DIMER AT 2593. CHEST XRAY SHOWED CARDIOMEGALY WITH FLUID OVERLOAD AND INTERSTITIAL EDEMA AND SMALL RIGHT-SIDE PLEURAL EFFUSION. MELENA HEMATEMESIS, BLOODY STOOL, HEMOGLOBIN DROPPED TO 7.6. FAMILY OPTED FOR COMFORT CARE. DIED ON 8/1/22.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Death, Dyspnoea, Fibrin D dimer, Full blood count abnormal
Clinical narrative: PATIENT PRESENTED TO ED WITH WEAKNESS AND SHORTNESS OF BREATH, ADMITTED ON 7/28/22.  WAS PREVIOUSLY ADMITTED TO HOPSITAL 6 DAYS PRIOR FOR OVER A MONTH WITH ALTERED MENTAL STATUS, BUT WAS STABLE ON DISCHARGE. PATIENT WAS BRADYCARDIA OF 66, TACHYPNEA OF 22, HTN. CBC WAS SIGNIFICANT FOR A GREATER THAN TWO-POINT DROP IN HEMOGLOBIN OVER 24 HOURS, CMP SHOWED BUN OF 72 AND CREATININE OF 1.59, AND D-DIMER AT 2593. CHEST XRAY SHOWED CARDIOMEGALY WITH FLUID OVERLOAD AND INTERSTITIAL EDEMA AND SMALL RIGHT-SIDE PLEURAL EFFUSION. MELENA HEMATEMESIS, BLOODY STOOL, HEMOGLOBIN DROPPED TO 7.6. FAMILY OPTED FOR COMFORT CARE. DIED ON 8/1/22.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haematemesis, Haematochezia, Haemoglobin decreased, Hypertension, Hypervolaemia
Clinical narrative: PATIENT PRESENTED TO ED WITH WEAKNESS AND SHORTNESS OF BREATH, ADMITTED ON 7/28/22.  WAS PREVIOUSLY ADMITTED TO HOPSITAL 6 DAYS PRIOR FOR OVER A MONTH WITH ALTERED MENTAL STATUS, BUT WAS STABLE ON DISCHARGE. PATIENT WAS BRADYCARDIA OF 66, TACHYPNEA OF 22, HTN. CBC WAS SIGNIFICANT FOR A GREATER THAN TWO-POINT DROP IN HEMOGLOBIN OVER 24 HOURS, CMP SHOWED BUN OF 72 AND CREATININE OF 1.59, AND D-DIMER AT 2593. CHEST XRAY SHOWED CARDIOMEGALY WITH FLUID OVERLOAD AND INTERSTITIAL EDEMA AND SMALL RIGHT-SIDE PLEURAL EFFUSION. MELENA HEMATEMESIS, BLOODY STOOL, HEMOGLOBIN DROPPED TO 7.6. FAMILY OPTED FOR COMFORT CARE. DIED ON 8/1/22.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Melaena, Mental status changes, Metabolic function test abnormal, Pleural effusion, Pulmonary oedema
Clinical narrative: PATIENT PRESENTED TO ED WITH WEAKNESS AND SHORTNESS OF BREATH, ADMITTED ON 7/28/22.  WAS PREVIOUSLY ADMITTED TO HOPSITAL 6 DAYS PRIOR FOR OVER A MONTH WITH ALTERED MENTAL STATUS, BUT WAS STABLE ON DISCHARGE. PATIENT WAS BRADYCARDIA OF 66, TACHYPNEA OF 22, HTN. CBC WAS SIGNIFICANT FOR A GREATER THAN TWO-POINT DROP IN HEMOGLOBIN OVER 24 HOURS, CMP SHOWED BUN OF 72 AND CREATININE OF 1.59, AND D-DIMER AT 2593. CHEST XRAY SHOWED CARDIOMEGALY WITH FLUID OVERLOAD AND INTERSTITIAL EDEMA AND SMALL RIGHT-SIDE PLEURAL EFFUSION. MELENA HEMATEMESIS, BLOODY STOOL, HEMOGLOBIN DROPPED TO 7.6. FAMILY OPTED FOR COMFORT CARE. DIED ON 8/1/22.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Tachypnoea
Clinical narrative: PATIENT PRESENTED TO ED WITH WEAKNESS AND SHORTNESS OF BREATH, ADMITTED ON 7/28/22.  WAS PREVIOUSLY ADMITTED TO HOPSITAL 6 DAYS PRIOR FOR OVER A MONTH WITH ALTERED MENTAL STATUS, BUT WAS STABLE ON DISCHARGE. PATIENT WAS BRADYCARDIA OF 66, TACHYPNEA OF 22, HTN. CBC WAS SIGNIFICANT FOR A GREATER THAN TWO-POINT DROP IN HEMOGLOBIN OVER 24 HOURS, CMP SHOWED BUN OF 72 AND CREATININE OF 1.59, AND D-DIMER AT 2593. CHEST XRAY SHOWED CARDIOMEGALY WITH FLUID OVERLOAD AND INTERSTITIAL EDEMA AND SMALL RIGHT-SIDE PLEURAL EFFUSION. MELENA HEMATEMESIS, BLOODY STOOL, HEMOGLOBIN DROPPED TO 7.6. FAMILY OPTED FOR COMFORT CARE. DIED ON 8/1/22.
Age: 1.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This vaccine is approved for age 18 and older and was inadvertently administered to 12 mo old child.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was administered the 6 months-4 y.o. MONOVALENT vaccine for her 3rd dose instead of the 6 months- 4  y.o. BIVALENT vaccine. No adverse reactions occurred. Pharmacist was contacted and informed pt is not indicated for redosing at this time. Pt should wait until a booster is recommended for age range to receive bivalent dose, or get 5-11 y.o.  bivalent dose when she turns 5. Pt waited 20 min after dose and was feeling well when she left.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Dermatitis contact, Dry eye, Eye complication associated with device, Eye irritation
Clinical narrative: About a month after my first Moderna dose (1 day after second dose), I woke up with unbearably burning and gritty feeling eyes ad eyelids. This was on April 28th, 2021. I had tried to put my contact lenses in and it hurt so bad, they would not stay in my eyes. As the day progressed I began to have blurry, hazy vision with blue and red lines around every object that I would look at. I went to the emergency room but they did not find anything wrong with my eyes. I have been to multiple eye doctors appointments, including an ophthalmologist, and no doctors can find anything wrong with my eyes. Certain treatments give me some relief, but the symptoms never fully go away. I have tried Cequa eye drops as well as Restasis eye drops for severe dry eye syndrome. I also have to use artificial tears about five times a day. Zaditor and Pataday allergy eye drops work somewhat. I can no longer wear contact lenses and I'm stuck in glasses. I cannot wear makeup or cosmetics any longer because they burn my eyes. I have swollen blood vessels in my eyes along with a swollen eyelid on my left eye as well as a swollen lacrimal caruncle in that eye. I still hope that one day I can find something to help me with this vaccine injury. This was definitely caused by the vaccine because of the timeline after which I received both my first and second dose. I cannot find any other reason that I would have just woken up with this eye pain one day. I am suffering every day. I need help. One optometrist did tell me that he thought this might be autoimmune in nature. I have had many blood tests done and now have significantly elevated rheumatoid factor along with sudden high blood pressure. I always used to have low blood pressure. I have telangiectasias in my eyes. (In my chart.)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eyelid irritation, Foreign body sensation in eyes, Hypertension, Rheumatoid factor increased
Clinical narrative: About a month after my first Moderna dose (1 day after second dose), I woke up with unbearably burning and gritty feeling eyes ad eyelids. This was on April 28th, 2021. I had tried to put my contact lenses in and it hurt so bad, they would not stay in my eyes. As the day progressed I began to have blurry, hazy vision with blue and red lines around every object that I would look at. I went to the emergency room but they did not find anything wrong with my eyes. I have been to multiple eye doctors appointments, including an ophthalmologist, and no doctors can find anything wrong with my eyes. Certain treatments give me some relief, but the symptoms never fully go away. I have tried Cequa eye drops as well as Restasis eye drops for severe dry eye syndrome. I also have to use artificial tears about five times a day. Zaditor and Pataday allergy eye drops work somewhat. I can no longer wear contact lenses and I'm stuck in glasses. I cannot wear makeup or cosmetics any longer because they burn my eyes. I have swollen blood vessels in my eyes along with a swollen eyelid on my left eye as well as a swollen lacrimal caruncle in that eye. I still hope that one day I can find something to help me with this vaccine injury. This was definitely caused by the vaccine because of the timeline after which I received both my first and second dose. I cannot find any other reason that I would have just woken up with this eye pain one day. I am suffering every day. I need help. One optometrist did tell me that he thought this might be autoimmune in nature. I have had many blood tests done and now have significantly elevated rheumatoid factor along with sudden high blood pressure. I always used to have low blood pressure. I have telangiectasias in my eyes. (In my chart.)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Telangiectasia, Vasodilatation, Vision blurred, Visual impairment
Clinical narrative: About a month after my first Moderna dose (1 day after second dose), I woke up with unbearably burning and gritty feeling eyes ad eyelids. This was on April 28th, 2021. I had tried to put my contact lenses in and it hurt so bad, they would not stay in my eyes. As the day progressed I began to have blurry, hazy vision with blue and red lines around every object that I would look at. I went to the emergency room but they did not find anything wrong with my eyes. I have been to multiple eye doctors appointments, including an ophthalmologist, and no doctors can find anything wrong with my eyes. Certain treatments give me some relief, but the symptoms never fully go away. I have tried Cequa eye drops as well as Restasis eye drops for severe dry eye syndrome. I also have to use artificial tears about five times a day. Zaditor and Pataday allergy eye drops work somewhat. I can no longer wear contact lenses and I'm stuck in glasses. I cannot wear makeup or cosmetics any longer because they burn my eyes. I have swollen blood vessels in my eyes along with a swollen eyelid on my left eye as well as a swollen lacrimal caruncle in that eye. I still hope that one day I can find something to help me with this vaccine injury. This was definitely caused by the vaccine because of the timeline after which I received both my first and second dose. I cannot find any other reason that I would have just woken up with this eye pain one day. I am suffering every day. I need help. One optometrist did tell me that he thought this might be autoimmune in nature. I have had many blood tests done and now have significantly elevated rheumatoid factor along with sudden high blood pressure. I always used to have low blood pressure. I have telangiectasias in my eyes. (In my chart.)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dysgraphia, Fine motor skill dysfunction, Mobility decreased, Nervous system disorder
Clinical narrative: 3 days post vaccination - burning in hands, followed by increased nerve impulses in hands and feet.  Patient was given 2 rounds of prednisone to calm the reaction, with not much relief.  Patient became unable to use right arm/hand for fine motor skills, and had to learn to use left hand for writing, eating, etc.  Patient was started on increasing doses of gabapentin in February 2022, and continues to take it.  He has recovered some use of his right hand and arm, but it has not improved 100%.
Age: 2.0
Sex: M
Vaccine: COVID19-2, HEPA, MMR
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Pfizer bivalent Booster (6m-4y) was given when doses 1 and 2 were Moderna.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy uterus abnormal, Dysmenorrhoea, Endometriosis, Fatigue, Hysterectomy
Clinical narrative: I feel there is an association of my post-menopausal diagnosis of endometriosis with the receiving mRNA COVID shots/boosters.  After a dozen years of menopause, I began having a period and cramping on 12.22.21.  I had a uterine biopsy and no cancer was found, but much bleeding was present. The cramping and exhaustion from the symptoms became worse over the months following, and I had diagnostic sonograms and exams by a GYN.  I had laparoscopic surgery on 5/31/22 and was diagnosed with endometriosis at age 65 and 9 months.  I noticed the initiation of this uterine abnormal reactivity was after my first booster shot (Pfizer 11.4.21).  The doctor removed endometriosis from my bladder, ovaries, and fallopian tubes and performed uterine curettage. I recovered from this surgery, and --reluctantly-obtained my 2nd booster (Moderna 6.23.22).  About two weeks later, on 7/9/22 I started bleeding and cramping again!  I couldn't believe it and this time the association really clicked. This pain (and associated fatigue) continued for 3 months.  I had a complete hysterectomy on 10/11/22.  Even after the laparascopic surgery and D/C, there was endometriosis present and my uterus was 2x normal size with hyper-proliferative lining.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laparoscopic surgery, Menstrual disorder, Pathology test, Ultrasound scan, Uterine dilation and curettage
Clinical narrative: I feel there is an association of my post-menopausal diagnosis of endometriosis with the receiving mRNA COVID shots/boosters.  After a dozen years of menopause, I began having a period and cramping on 12.22.21.  I had a uterine biopsy and no cancer was found, but much bleeding was present. The cramping and exhaustion from the symptoms became worse over the months following, and I had diagnostic sonograms and exams by a GYN.  I had laparoscopic surgery on 5/31/22 and was diagnosed with endometriosis at age 65 and 9 months.  I noticed the initiation of this uterine abnormal reactivity was after my first booster shot (Pfizer 11.4.21).  The doctor removed endometriosis from my bladder, ovaries, and fallopian tubes and performed uterine curettage. I recovered from this surgery, and --reluctantly-obtained my 2nd booster (Moderna 6.23.22).  About two weeks later, on 7/9/22 I started bleeding and cramping again!  I couldn't believe it and this time the association really clicked. This pain (and associated fatigue) continued for 3 months.  I had a complete hysterectomy on 10/11/22.  Even after the laparascopic surgery and D/C, there was endometriosis present and my uterus was 2x normal size with hyper-proliferative lining.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Uterine haemorrhage
Clinical narrative: I feel there is an association of my post-menopausal diagnosis of endometriosis with the receiving mRNA COVID shots/boosters.  After a dozen years of menopause, I began having a period and cramping on 12.22.21.  I had a uterine biopsy and no cancer was found, but much bleeding was present. The cramping and exhaustion from the symptoms became worse over the months following, and I had diagnostic sonograms and exams by a GYN.  I had laparoscopic surgery on 5/31/22 and was diagnosed with endometriosis at age 65 and 9 months.  I noticed the initiation of this uterine abnormal reactivity was after my first booster shot (Pfizer 11.4.21).  The doctor removed endometriosis from my bladder, ovaries, and fallopian tubes and performed uterine curettage. I recovered from this surgery, and --reluctantly-obtained my 2nd booster (Moderna 6.23.22).  About two weeks later, on 7/9/22 I started bleeding and cramping again!  I couldn't believe it and this time the association really clicked. This pain (and associated fatigue) continued for 3 months.  I had a complete hysterectomy on 10/11/22.  Even after the laparascopic surgery and D/C, there was endometriosis present and my uterus was 2x normal size with hyper-proliferative lining.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: PATIENT COMPLAINED OF SWELLING AND INFLAMMATION IN THE  ELBOW OF LEFT ARM EVEN AFTER ALMOST ONE MONTH, BEGINNING WITH THE FIRST DAY AFTER INJECTION
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer bivalent vaccine was expired on 2/16/23 (that were remaining in the refrigerator), and was accidently administered to patient on 2/21/23. According to Pfizer, patient would need to be readministered for an additional dose for full protection, and for patient to report any side effects if any.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer bivalent vaccine was expired on 2/16/23 (that were remaining in the refrigerator), and was accidently administered to patient on 2/21/23. According to Pfizer, patient would need to be readministered for an additional dose for full protection, and for patient to report any side effects if any.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Chest pain, Laboratory test abnormal, Myocarditis, Pain in extremity
Clinical narrative: Arms, chest & back began to ache.  No signs prior, felt fine, standing checking into my Dr.?s office for a regular checkup.  .  I was sent to urgent care & then to hospital .  Many tests were given.  Diagnosis was myocarditis.  My Heart Dr.  issued another text & the  result is apparently it has healed itself.  Very odd considering I have been extremely healthy only bring in a hospital 3 times.  Which were elective.  No heath issues whatsoever.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product use issue
Clinical narrative: Vaccine out of BUD date (2/16/23) was administered on 2/20/23 to patient. Vaccine was in the refrigerator which was not taken out of the fridge on 2/16/23. According to Pfizer, we should reach out to patient for readministration of the vaccine for full protection, and have patients report any side effects
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No sign of adverse event, vaccination given too early
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine out of BUD date (2/16/23) was administered on 2/20/23 to patient. Vaccine was in the refrigerator which was not taken out of the fridge on 2/16/23. According to Pfizer, we should reach out to patient for readministration of the vaccine for full protection, and have patients report any side effects
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product use issue
Clinical narrative: Vaccine out of BUD date (2/16/23) was administered on 2/20/23 to patient. Vaccine was in the refrigerator which was not taken out of the fridge on 2/16/23. According to Pfizer, we should reach out to patient for readministration of the vaccine for full protection, and have patients report any side effects
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product use issue
Clinical narrative: Vaccine out of BUD date (2/16/23) was administered on 2/20/23 to patient. Vaccine was in the refrigerator which was not taken out of the fridge on 2/16/23. According to Pfizer, we should reach out to patient for readministration of the vaccine for full protection, and have patients report any side effects
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in left cheek, jaw and neck (described feeling similar to having novocaine for a dental procedure)  Monitored for any changes in condition or if swelling or difficulty breathing developed
Age: 17.0
Sex: M
Vaccine: FLUC4, HPV9
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: patient became dizzy and lost consciousness.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Rash
Clinical narrative: PT broke out in a full body rash after 3 days of vaccine. No breathing issues.  . Start at feet and spread to full body.   Has benadryl at home and went to office today to get a medrol dose pack and started taking it.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: body rash
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PT DID NOT RECEIVE VACCINE FOLLOWING THE USUAL SCHEDULE.  THE FATHER STATES HE WAS INSTRUCTED TO COME BACK IN 6 MONTHS AFTER THE 1ST DOSE.  HE IS CONCERNED THAT HIS SON MUST RECEIVE ANOTHER SHOT.  HE STATES THAT HE IS VERY CONCERNED ABOUT HIS SON'S HEALTH AND WELLNESS AND INSISTS THAT HIS SON WAS ADMINISTERED THE WRONG VACCINE AND THAT THIS SHOULD BE A 2 DOSE SERIES.  I HAVE ASSURED HIM THAT THIS IS OK, HIS SON JUST NEEDS ONE MORE SHOT IN 6 MONTHS AND HIS SERIES WILL BE COMPLETE.  FATHER SAYS THIS IS UNPROFESSIONAL AND SOMETHING MUST BE DONE
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Gait disturbance, Pyrexia
Clinical narrative: temp 101 Right leg didn't want to walk Started 2115 afternoon Fever 101, meds, ice to leg
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Vomited x 1 about 3 hours after immunizations.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyskinesia, Headache, Magnetic resonance imaging, Muscle twitching
Clinical narrative: She tried to talk but was twitching stated that she was having pain. She continued to try to talk but nothing was making sense. She realized she wasn't speaking properly and began to get upset. She had a very bad headache and was complaining about the pain. As time went on, she began to mumble, and her mouth twisted sideways. She was coordinating events but was not functioning. It was a very brief episode lasting 15-20 minutes, but it was very intense. The second time wasn't as sharp and as long, but it happened again.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Speech disorder
Clinical narrative: She tried to talk but was twitching stated that she was having pain. She continued to try to talk but nothing was making sense. She realized she wasn't speaking properly and began to get upset. She had a very bad headache and was complaining about the pain. As time went on, she began to mumble, and her mouth twisted sideways. She was coordinating events but was not functioning. It was a very brief episode lasting 15-20 minutes, but it was very intense. The second time wasn't as sharp and as long, but it happened again.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received an unauthorized dose of Janssen (under 18, only approved for 18+)
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Bursitis, C-reactive protein increased, Chondromalacia, Inflammatory marker test
Clinical narrative: A few hours after the shot in my left arm/shoulder on June 2, 2022, my left arm /shoulder started to hurt much more than is typical for a vaccination.  Then, the next morning, I could not move my arm and had extreme pain.  Moving the arm upwards was impossible.  I could not dress myself, or use that arm at all.   The pain worsened over the next few weeks, and at two weeks after the shot, I informed my primary care provider of the shoulder/arm issue that had started as a result of the vaccination.  She did not respond to my message.  At three weeks with no improvement, I went into the clinic to be evaluated.  The PA ordered an MRI and referred me to an orthopedic doctor for further treatment and evaluation.  My first appointment with Dr. was on July 19, 2022, when I was given a cortisone shot in my left shoulder, and then had a Physical Therapy appointment on July 20, 2022.  I learned some exercises that might help, and purchased a pulley to do one particular exercise.  I performed the exercises twice a day for numerous months.  The exercise helped a little with range of motion, but not with the pain.  I was prescribed an opioid but had a bad reaction, so just used over the counter meds to deal with the pain.   I had never ever before had any issue with either shoulder.  I had never had pain, had an injury or had a reaction to a vaccination. My husband had told me the day I came home from the vaccination, that he thought the bandaid seemed very high.  On Jan. 3, 2023, I returned to see Dr., the orthopedic doctor again, who ordered another MRI, to see if it had improved.  He saw no improvement, and recommended surgery.  I am still experiencing very limited range of motion, and constant pain.  The pain increases with certain movement and raising my arm.    On February 13, 2023, I saw another orthopedic surgeon to get a second opinion.  As I was not interested in having surgery at this time, he recommended another cortisone shot in my shoulder, which I agreed to and had that same day.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Joint effusion, Magnetic resonance imaging abnormal, Osteoarthritis, Pain
Clinical narrative: A few hours after the shot in my left arm/shoulder on June 2, 2022, my left arm /shoulder started to hurt much more than is typical for a vaccination.  Then, the next morning, I could not move my arm and had extreme pain.  Moving the arm upwards was impossible.  I could not dress myself, or use that arm at all.   The pain worsened over the next few weeks, and at two weeks after the shot, I informed my primary care provider of the shoulder/arm issue that had started as a result of the vaccination.  She did not respond to my message.  At three weeks with no improvement, I went into the clinic to be evaluated.  The PA ordered an MRI and referred me to an orthopedic doctor for further treatment and evaluation.  My first appointment with Dr. was on July 19, 2022, when I was given a cortisone shot in my left shoulder, and then had a Physical Therapy appointment on July 20, 2022.  I learned some exercises that might help, and purchased a pulley to do one particular exercise.  I performed the exercises twice a day for numerous months.  The exercise helped a little with range of motion, but not with the pain.  I was prescribed an opioid but had a bad reaction, so just used over the counter meds to deal with the pain.   I had never ever before had any issue with either shoulder.  I had never had pain, had an injury or had a reaction to a vaccination. My husband had told me the day I came home from the vaccination, that he thought the bandaid seemed very high.  On Jan. 3, 2023, I returned to see Dr., the orthopedic doctor again, who ordered another MRI, to see if it had improved.  He saw no improvement, and recommended surgery.  I am still experiencing very limited range of motion, and constant pain.  The pain increases with certain movement and raising my arm.    On February 13, 2023, I saw another orthopedic surgeon to get a second opinion.  As I was not interested in having surgery at this time, he recommended another cortisone shot in my shoulder, which I agreed to and had that same day.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Synovitis, Tendon disorder, White blood cell count decreased
Clinical narrative: A few hours after the shot in my left arm/shoulder on June 2, 2022, my left arm /shoulder started to hurt much more than is typical for a vaccination.  Then, the next morning, I could not move my arm and had extreme pain.  Moving the arm upwards was impossible.  I could not dress myself, or use that arm at all.   The pain worsened over the next few weeks, and at two weeks after the shot, I informed my primary care provider of the shoulder/arm issue that had started as a result of the vaccination.  She did not respond to my message.  At three weeks with no improvement, I went into the clinic to be evaluated.  The PA ordered an MRI and referred me to an orthopedic doctor for further treatment and evaluation.  My first appointment with Dr. was on July 19, 2022, when I was given a cortisone shot in my left shoulder, and then had a Physical Therapy appointment on July 20, 2022.  I learned some exercises that might help, and purchased a pulley to do one particular exercise.  I performed the exercises twice a day for numerous months.  The exercise helped a little with range of motion, but not with the pain.  I was prescribed an opioid but had a bad reaction, so just used over the counter meds to deal with the pain.   I had never ever before had any issue with either shoulder.  I had never had pain, had an injury or had a reaction to a vaccination. My husband had told me the day I came home from the vaccination, that he thought the bandaid seemed very high.  On Jan. 3, 2023, I returned to see Dr., the orthopedic doctor again, who ordered another MRI, to see if it had improved.  He saw no improvement, and recommended surgery.  I am still experiencing very limited range of motion, and constant pain.  The pain increases with certain movement and raising my arm.    On February 13, 2023, I saw another orthopedic surgeon to get a second opinion.  As I was not interested in having surgery at this time, he recommended another cortisone shot in my shoulder, which I agreed to and had that same day.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Magnetic resonance imaging abnormal
Clinical narrative: A few hours after the shot in my left arm/shoulder on June 2, 2022, my left arm /shoulder started to hurt much more than is typical for a vaccination.  Then, the next morning, I could not move my arm and had extreme pain.  Moving the arm upwards was impossible.  I could not dress myself, or use that arm at all.   The pain worsened over the next few weeks, and at two weeks after the shot, I informed my primary care provider of the shoulder/arm issue that had started as a result of the vaccination.  She did not respond to my message.  At three weeks with no improvement, I went into the clinic to be evaluated.  The PA ordered an MRI and referred me to an orthopedic doctor for further treatment and evaluation.  My first appointment with Dr. was on July 19, 2022, when I was given a cortisone shot in my left shoulder, and then had a Physical Therapy appointment on July 20, 2022.  I learned some exercises that might help, and purchased a pulley to do one particular exercise.  I performed the exercises twice a day for numerous months.  The exercise helped a little with range of motion, but not with the pain.  I was prescribed an opioid but had a bad reaction, so just used over the counter meds to deal with the pain.   I had never ever before had any issue with either shoulder.  I had never had pain, had an injury or had a reaction to a vaccination. My husband had told me the day I came home from the vaccination, that he thought the bandaid seemed very high.  On Jan. 3, 2023, I returned to see Dr., the orthopedic doctor again, who ordered another MRI, to see if it had improved.  He saw no improvement, and recommended surgery.  I am still experiencing very limited range of motion, and constant pain.  The pain increases with certain movement and raising my arm.    On February 13, 2023, I saw another orthopedic surgeon to get a second opinion.  As I was not interested in having surgery at this time, he recommended another cortisone shot in my shoulder, which I agreed to and had that same day.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: A few hours after the shot in my left arm/shoulder on June 2, 2022, my left arm /shoulder started to hurt much more than is typical for a vaccination.  Then, the next morning, I could not move my arm and had extreme pain.  Moving the arm upwards was impossible.  I could not dress myself, or use that arm at all.   The pain worsened over the next few weeks, and at two weeks after the shot, I informed my primary care provider of the shoulder/arm issue that had started as a result of the vaccination.  She did not respond to my message.  At three weeks with no improvement, I went into the clinic to be evaluated.  The PA ordered an MRI and referred me to an orthopedic doctor for further treatment and evaluation.  My first appointment with Dr. was on July 19, 2022, when I was given a cortisone shot in my left shoulder, and then had a Physical Therapy appointment on July 20, 2022.  I learned some exercises that might help, and purchased a pulley to do one particular exercise.  I performed the exercises twice a day for numerous months.  The exercise helped a little with range of motion, but not with the pain.  I was prescribed an opioid but had a bad reaction, so just used over the counter meds to deal with the pain.   I had never ever before had any issue with either shoulder.  I had never had pain, had an injury or had a reaction to a vaccination. My husband had told me the day I came home from the vaccination, that he thought the bandaid seemed very high.  On Jan. 3, 2023, I returned to see Dr., the orthopedic doctor again, who ordered another MRI, to see if it had improved.  He saw no improvement, and recommended surgery.  I am still experiencing very limited range of motion, and constant pain.  The pain increases with certain movement and raising my arm.    On February 13, 2023, I saw another orthopedic surgeon to get a second opinion.  As I was not interested in having surgery at this time, he recommended another cortisone shot in my shoulder, which I agreed to and had that same day.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: blood clots in lung; short of breath/must stop and catch breath; cough; very tired; walking impaired 20 feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "blood clots in lung"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath/must stop and catch breath"; COUGH (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "very tired"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "walking impaired 20 feet".  Clinical course: Clinical course: I took you Covid vaccine x3 I now have long term covin. These are just some of my problems.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Gait disturbance, Pulmonary thrombosis
Clinical narrative: blood clots in lung; short of breath/must stop and catch breath; cough; very tired; walking impaired 20 feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "blood clots in lung"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath/must stop and catch breath"; COUGH (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "very tired"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "walking impaired 20 feet".  Clinical course: Clinical course: I took you Covid vaccine x3 I now have long term covin. These are just some of my problems.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Rash
Clinical narrative: I developed a rash on the tops of my feet on Saturday, February 18th after getting the vaccine on the 16th. Sunday, the rash moved up both legs all the way to the top. On Monday it was on my chest and neck. On Tuesday, it was on my face. On Tuesday I went to the doctor. My usual doctor wasn't there that day so I saw another doctor.  She did think it was a result of my vaccine. She gave me a steroid shot and a six day Medrol pack. I also visited with the pharmacist when I picked up my prescription. He told me I needed to report it to you. Today is Wednesday. The rash is getting better but it is definitely not gone.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Colitis, Colonoscopy abnormal, Haematochezia, Inflammatory bowel disease
Clinical narrative: Started having bright red blood in stool daily around January 2022. After 2 colonoscopies, was diagnosed with IBD in Nov 2022.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Stool analysis normal
Clinical narrative: Started having bright red blood in stool daily around January 2022. After 2 colonoscopies, was diagnosed with IBD in Nov 2022.
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional adverse event; administered after a temperature excursion; This spontaneous report was received from a medical assistant concerning a 15-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly on the left thigh as prophylaxis (strength, and indication were not provided), after a temperature excursion on 01-DEC-2022 at a temperature of 47.9 Fahrenheit degrees for 47 minutes (Product storage error). It was reported that the patient received 2 previous doses. No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009943:
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion of 47.9 F for 47 min on 01-DEC-2022; This spontaneous report was received from a certified medical assistant (CMA) and referred to an 18-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-DEC-2022, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596 has been verified to be a valid lot number, expiration date was reported as 11-OCT-2024, administered intramuscularly for prophylaxis in left thigh (strength and dose was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported (no adverse event).  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; RECOMBIVAX HB was administered after the labeled expiration date.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-FEB-2023 (also reported as "today"), the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #T025374, expiration date: 25-JAN-2023, administered as prophylaxis (strength, and route of administration were not provided), after the labeled expiration date (Expired product administered). No additional adverse events were reported.