chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: pharmacist who reported patient got an expired dose of ipol with no reported adverse event; Initial information was received on 06-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age/gender patient who got an expired dose of ipv (vero) [Ipol] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of expired suspect ipv (vero) Suspension for injection (lot number: U1C571M, expired date: 17-Jun-2023) (dose, route, administration site, strength: Unknown) Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome was Unknown for the event pharmacist who reported patient got an expired dose of ipol with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 20.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally gave expired IPOL with no reported adverse event; Initial information received on 06-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 20 years old male patient who was accidentally given expired IPV (VERO) [IPOL] with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine INACT, hepatitis B vaccine RHBSAG (yeast) (Twinrix) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for prophylactic vaccination.  On 06-Jul-2023, the patient accidentally received a standard expired dose of suspect IPV (VERO) Suspension for injection at a dose of 0.5 mL (lot U1C571N, expiry date- 17-JUN-2023) via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of a TENIVAC administered with no reported adverse event; Initial information received on 06-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 57 years old male patient for whom expired dose of a diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Jul-2023, the patient received a standard expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection at a dose of 0.5ML (lot U7092AA, expiry date- 24-JUN-2023) via unknown route in the left deltoid for  Immunization with no reported adverse event (expired product administered) (latency- same day). Caller would like to know if the dose should be readministered?  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 53.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Lethargy
Clinical narrative: Fever 101.5, light-headedness, moderate to severe muscle and joint aches, headache, tiredness, lethargy.  Symptoms lasted approximately 24 hrs.  Ibuprofen (400mg) helps with symptoms.
Age: 53.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever 101.5, light-headedness, moderate to severe muscle and joint aches, headache, tiredness, lethargy.  Symptoms lasted approximately 24 hrs.  Ibuprofen (400mg) helps with symptoms.
Age: 1.58
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given beyond the Before Use Date
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given beyond the Before Use Date
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given beyond the Before Use Date
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: No
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: About 14 hours after receiving the (second in series) Shingrx injection in my upper right arm, I began experiencing - fever, chills, and muscle ache throughout my body. I used blankets to stay warm, I slept, and took acetaminophen.  Symptoms abated after about 15 hours.  I also messaged (online) my physician's office of my side-effects from the vaccination.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: 7/8/2023 Soreness at injection site Headache Nausea Fever
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.  This is one of several reports received from the same source.; Sender Comments: US-009507513-2306USA011972:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.  This is one of several reports received from the same source. ; Sender Comments: US-009507513-2306USA011972:
Age: 73.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: pt presented with redness of arm, stated it was itchy and warm; started on wednesday 7/5/23-same day of getting vaccines. pt said this was worse than from shingrix #1 in 3/23/23; recommended pt watch and wait until monday to see if redness/itchiness will resolve because for pt's first shingrix shot, redness and itchiness resolved by day 5, if not resolving or getting worse, may need to see urgent care/ pcp. recommended to put cool compress for heat and cortisone for itchiness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: vaccine expired 7/6/2023 vaccine adminstered on 7/7/2023
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: THE SHOT WAS GIVEN 2/21/22. BUT ON 6/28/23 WE WERE NOTIFIED THAT THE EXPIRATION DATE OF THE VACCINE REPORTED TO BE GIVEN WAS 11/28/21??  THE PHARMACY HAS NO WAY TO PROVE THAT THIS WAS OR WAS NOT CORRECT SINCE IT HAPPENED 1 AND 1/2 YEARS AGO
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: THE SHOT WAS GIVEN 05/06/22.. BUT ON 6/28/23 WE WERE NOTIFIED THAT THE EXPIRATION DATE OF THE VACCINE REPORTED TO BE GIVEN WAS 4/17/22??  THE PHARMACY HAS NO WAY TO PROVE THAT THIS WAS OR WAS NOT CORRECT SINCE IT HAPPENED 1 AND 1/2 YEARS AGO
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and Erythema at site of injection - spreading daily to roughly 4"x4" circle by 7/8/2023.  Site is Painful and Itching.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Eye disorder, Immunisation reaction
Clinical narrative: After the vaccine, I got Covid arm with my left upper arm very red, hard to the touch and painful for several days. Then on May 5, I woke up with Bell's Palsy and was admitted to the E.R. as we were not sure what was happening.  I had Bell's Palsy for at least 6 weeks and am still experiencing eye issues from it. I believe the shot was what pre-empted the Bells Palsy.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Magnetic resonance imaging
Clinical narrative: After the vaccine, I got Covid arm with my left upper arm very red, hard to the touch and painful for several days. Then on May 5, I woke up with Bell's Palsy and was admitted to the E.R. as we were not sure what was happening.  I had Bell's Palsy for at least 6 weeks and am still experiencing eye issues from it. I believe the shot was what pre-empted the Bells Palsy.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINE HAD A BEYONG-USE-DATE OF 06/30/2023 AND WAS ADMINISTERED ON 07/03/2023; CONTACTED MODERNA AND THEY RESPONDED THAT THE VACCINE ADMINISTERED MAINTAINED THE ACTIVITY NECESSARY TO PROTECT AGAINST THE SARS-CoV-2 (COVID-19) VIRUS AT THE TIME OF ADMINISTRATION, THE CASE ID IS MI-00034087
Age: 60.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient scheduled for Mpox event, stated he had only received 1 previous dose, after dose was given, it was noted that patient had already received 2 previous doses, patient was observed for 15 minutes with no complications, MD spoke to patient and explained this was his 3rd dose and it is currently not recommended to receive more than 2 doses. No reactions was observed, patient is aware.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Fatigue, nausea, fever, body aches I took Tylenol and it relieved body aches and fever
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINE HAD A BEYOND-USE-DATE OF 06/30/2023 AND WAS ADMINISTERED ON 07/03/2023; CONTACTED MODERNA AND THEY RESPONDED THAT THE VACCINE ADMINISTERED MAINTAINED THE ACTIVITY NECESSARY TO PROTECT AGAINST THE SARS-CoV-2 (COVID-19) VIRUS AT THE TIME OF ADMINISTRATION, THE CASE ID IS MI-00034087
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in right arm since getting vaccine. Has lasted up to July 8, 2023
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in to Mpox event, stated he was here for his 2nd dose, received dose but after reconciliation of previous vaccines into EMR, it was noted patient had already received 2 previous doses and was informed that it not recommended to get 3 doses of Mpox, patient was observed for 15 minutes with no adverse effect.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Insomnia, Nausea, Pyrexia
Clinical narrative: Severe chills, shakes, shivering, fever (101.3 F), lightheadedness, nausea, sleeplessness
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Severe chills, shakes, shivering, fever (101.3 F), lightheadedness, nausea, sleeplessness
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered a 3rd dose of the Shingrix vaccine. Patient claimed no adverse effects.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no symptoms reported patient received vaccine only 3 years after previous
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Increase urination, sob, dizziness, Ha, fatigue, heart palpitations.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Palpitations, Pollakiuria, Procedural failure
Clinical narrative: Increase urination, sob, dizziness, Ha, fatigue, heart palpitations.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site indentation, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, Swelling, and itching from a little above the injection site almost down to patients elbow. Indentation in arm at injection site.  Dr. prescribed an antibiotic and antihistamine to treat reaction
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Somnolence
Clinical narrative: SLEEPINESS & DIZZINESS after HPV vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Agoraphobia, Anxiety, Cardiac stress test normal, Chest discomfort, Chest pain
Clinical narrative: About a week after my second injection I started getting heart palpitations and racing heart which eventually began to cause anxiety and trigger panic attacks. I had never before had panic attacks or anxiety symptoms. The palpitations tended to escalate a week before my menstrual cycle and at night while I was sleeping. I sometimes wake in the middle of the night with a racing heart or experience chest pain and shortness of breath at random times of day without provocation. It's been nearly 2 years and I still have racing heart and chest tightness. I began taking lexapro 2.5 mg for heart palpitations. I still experience panic feelings and agoraphobia, neither of which I experienced before the vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Palpitations, Panic attack, Sleep disorder
Clinical narrative: About a week after my second injection I started getting heart palpitations and racing heart which eventually began to cause anxiety and trigger panic attacks. I had never before had panic attacks or anxiety symptoms. The palpitations tended to escalate a week before my menstrual cycle and at night while I was sleeping. I sometimes wake in the middle of the night with a racing heart or experience chest pain and shortness of breath at random times of day without provocation. It's been nearly 2 years and I still have racing heart and chest tightness. I began taking lexapro 2.5 mg for heart palpitations. I still experience panic feelings and agoraphobia, neither of which I experienced before the vaccine.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None; patient received vaccine twice on separate occasions.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Neck pain, Product dose omission issue, Swelling
Clinical narrative: A MISSING VACCINE REQUIRED BY THE ELEMENTARY,  I was notified by phone that pt. needed the record updated as he was missing a shot.   We went to the health department, received the vaccine and began holiday. On the day to return to school he awoke in severe pain and swelling on one side the extent of his neck. The administrator stated there was only one vaccine left in stock. As time continued it was very clear that it was purposely done. I have received mailings regarding such as we were domestic violence victims under a protective order, whom have since endured targeted harassment, attacks, and environmental experimentation,   Crime, and terrorisms. Sterilizing was the motive
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: ...
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: adult dose of Hep B energix administered in error to 19 yr old patient. Indicated for 20 yrs of age and older.
Age: 63.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Abdominal pain, Blood test, Computerised tomogram abdomen, Computerised tomogram thorax, Electrocardiogram
Clinical narrative: She states she was having high fevers >101F, abdominal pain, fatigue, generally feeling "unwell." she was told at the hospital she had an abdominal "pocket full of blood" and her liver enzymes were elevated. She denies shortness of breath, tongue, lip throat swelling.
Age: 63.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Fatigue, Hepatic enzyme increased, Intra-abdominal haemorrhage, Malaise, Pyrexia
Clinical narrative: She states she was having high fevers >101F, abdominal pain, fatigue, generally feeling "unwell." she was told at the hospital she had an abdominal "pocket full of blood" and her liver enzymes were elevated. She denies shortness of breath, tongue, lip throat swelling.
Age: 63.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Urine analysis
Clinical narrative: She states she was having high fevers >101F, abdominal pain, fatigue, generally feeling "unwell." she was told at the hospital she had an abdominal "pocket full of blood" and her liver enzymes were elevated. She denies shortness of breath, tongue, lip throat swelling.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Rash, Rash pruritic
Clinical narrative: patient developed tiredness and nausea and a itchy rash extending from the midsection to knees. Rash has mostly resolved after 24 hours and other symptoms have subsided, Patient did not need or seek medical care.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Periarthritis, Product administered at inappropriate site
Clinical narrative: Immediate pain in arm, felt that the injection was given higher/deeper than usual.  My arm felt "full" like there was a lot of fluid injected.  The pain became excruciating quickly, and I lost mobility in my arm.  When speaking to a different pharmacist at a different location when receiving my Covid vaccine in my other arm, he mentioned that I could have bursitis and to have it checked out by a doctor if it didn't resolve.  Saw primary care doctor in January 2023 who diagnosed frozen shoulder and prescribed OTC pain relievers and physical therapy.  In spite of physical therapy, the pain and immobility persist.  Have referral to orthopedic doctor in July 2023.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory disturbance
Clinical narrative: Immediate pain in arm, felt that the injection was given higher/deeper than usual.  My arm felt "full" like there was a lot of fluid injected.  The pain became excruciating quickly, and I lost mobility in my arm.  When speaking to a different pharmacist at a different location when receiving my Covid vaccine in my other arm, he mentioned that I could have bursitis and to have it checked out by a doctor if it didn't resolve.  Saw primary care doctor in January 2023 who diagnosed frozen shoulder and prescribed OTC pain relievers and physical therapy.  In spite of physical therapy, the pain and immobility persist.  Have referral to orthopedic doctor in July 2023.
Age: 43.0
Sex: F
Vaccine: PNC15
Symptoms: Inflammation, Rash
Clinical narrative: Patient received the Vaxneuvance vaccine on 07/3/23. She stated later that evening she started to develop a localized rash and by the next day it had spread down her arm. She called the pharmacy on 7/9/23 stating the rash appeared to be moving to her other arm and there were small areas on her stomach. She stated she had started taking Benadryl when the rash first appeared and then started Benadryl cream on 7/8/23 when the rash became "unbearable." I recommended the patient start using hydrocortisone cream to help reduce the rash and inflammation along with continued use of the benadryl but if the rash became worse, I referred the patient to urgent care.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Pain, Trigger finger
Clinical narrative: Woke up the next morning with feet on fire.  I thought it was gout.  That lasted 3 weeks.  Two months after vaccine my joints on both hands started to ache and throb.  Its been 5 months since initial injection.  My joints on my hands continue to hurt.  I wake up with trigger finger in both my index fingers.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Only a slightly sore deltoid until 7/8/23 when the fronts of my ankles began hurting while doing field work as part of a butterfly survey. Tiredness set in about 3 PM.  After laying down, cramps began in my feet and legs. I arose to work out the cramps.  Then overall muscle pain developed to a pain level of 6 or 7, lasting for about an hour.  Muscle weakness and tiredness continues this afternoon on 7/9/23.  I am reporting before the incident has ceased.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient has limited mobility of arm and pain during movement
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Muscular weakness, Nausea, Pyrexia
Clinical narrative: Legs very weak, fever, shivers, nausea, diarrhea. Started at 3 pm lasted until midnight
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Hyperhidrosis, Insomnia, Nausea
Clinical narrative: Patient reports intermittent fever, sweats, fatigue, insomnia, decreased appetite, nausea, and vomiting after receiving 2nd series of Shingrix on 6/22/23. Symptoms were severe enough for patient to go to Emergency Department on 6/22/23; he was discharged home later that day. Symptoms slowly improved but still persisted until last date of contact on 6/30/23.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting, White blood cell count
Clinical narrative: Patient reports intermittent fever, sweats, fatigue, insomnia, decreased appetite, nausea, and vomiting after receiving 2nd series of Shingrix on 6/22/23. Symptoms were severe enough for patient to go to Emergency Department on 6/22/23; he was discharged home later that day. Symptoms slowly improved but still persisted until last date of contact on 6/30/23.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: left arm swelling and erythema
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Haemorrhage, Head injury, Loss of consciousness
Clinical narrative: Approximately 5 minutes after vaccine administration patient passed out in the waiting area of the pharmacy. She was unconscious for approximately 30 seconds to 1 minutes, regarding consciousness very quickly. Patient hit her head which resulted in minor bleeding. EMS was called immediately and arrived on site to evaluate the patient. Patient declined continuation of care and EMS left after full evaluating patient. The patient and her father remained at the pharmacy for approximately 15-20 mins after EMS left before going home.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd bivalent covid vaccination before when not yet indicated for patient's age
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site paraesthesia
Clinical narrative: tingling at the site of inject and burning sensation
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd covid 19 bivalent vaccine before indicated for patient's age
Age: 53.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Headache, Pyrexia, Sleep disorder
Clinical narrative: Pt stated they woke up @ 3am on 7/9/23 with a headache, fever, and chills.  They reported feeling gradually better throughout the day and felt back to normal by time of phone call around 5:15pm on 7/9/23
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Computerised tomogram head abnormal, Confusional state, Gait disturbance
Clinical narrative: Pt awoke aphasic, unsteady gait, confused.  Contacted neighbor.  EMS arrived, transported to stroke center.  Elapsed time from stroke s/s to ED was apx 2 hrs. CT positive for very recent CVA and additional previous CVA one opposite hemisphere.  unable to determine age of  first (older) CVA.  Pt was unaware of first CVA.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom
Clinical narrative: Pt awoke aphasic, unsteady gait, confused.  Contacted neighbor.  EMS arrived, transported to stroke center.  Elapsed time from stroke s/s to ED was apx 2 hrs. CT positive for very recent CVA and additional previous CVA one opposite hemisphere.  unable to determine age of  first (older) CVA.  Pt was unaware of first CVA.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Pyrexia
Clinical narrative: Fever/chills, elevated blood pressure (161/88) and elevated heart rate (105 bpm)
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram ambulatory, Heart rate increased, Heart rate irregular, Supraventricular tachycardia
Clinical narrative: RAPID AND EXTRA HEARTBEATS - DIAGNOSED AS SVT (SUPRAVENTRICULAR TACHYCARDIA) ONGOING
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroglobulin increased, Tumour marker increased
Clinical narrative: I was diagnosed with follicular thyroid cancer in August of 2015.  The thyroid was removed and in November of 2015 I had one RAI iodine pill treatment.  Until March of 2021, my thyroglobulun tumor marker was normal,  reading < .1 ng/mL, but in March of 2021 it  read .1 ng/ml and has continued to climb, now reading 3.3 ng/mL.   I have had a radio iodine scan when it read 2.1 ng/mL  but it didn't show any cancer.  Now, 3 months later, I am scheduled for a PET scan in a few weeks.  The tumor marker did not  go up in value until I either possibly had COVID or the vaccine or both.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis, Keratitis
Clinical narrative: Keratitis/conjunctivitis of left eye
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal menstrual clots, Blood test, Chest X-ray, Heavy menstrual bleeding, Infertility female
Clinical narrative: Heart Attack, Blood Clots, Infertility
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Myocardial infarction, Thrombosis
Clinical narrative: Heart Attack, Blood Clots, Infertility
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypothyroidism, Obstructive sleep apnoea syndrome, Transient ischaemic attack
Clinical narrative: G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/28/2023 HYPOTHYROIDISM G47.33 OBSTRUCTIVE SLEEP APNEA 4/28/2023 HYPOTHYROIDISM
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Physician assistant reported that a 15-year-old patient received first dose of GARDASIL 9 . No additional AE/no PQC.; No adverse event; The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2019 (reported as four years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, route of administration, lot number, expiration date, and route of administration were not provided).  It was reported that the patient received the first dose four years ago and returned for next dose (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No symptoms reported.; HCP called to report an expired dose of PROQUAD was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; PROQUAD adminitrated at 70 F for a time frame of: 0 Hours 9 Minutes 0 Seconds; This spontaneous report has been received from a pharmacist referring to a 4-year-old. The patient's medical history, concurrent condition, and concomitant therapies were not reported.  On 14-JUN-2023, the patient was vaccinated with an expired (conflicting information as upon internal review the vaccine was not expired) and improper storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, first dose, administered for prophylaxis (strength, dose and route of administration were not provided; lot number W024971 was considered as a valid number and expiration date reported as 02-JUN-2023 but upon internal reviewestablished as 05-FEB-2024) (expired product administered) (product storage error).  The excursion occurred with a temperature of 70 Farenheit (F) for 0 hours and 9 minutes and 0 seconds. There was no previous temperature excursion reported. No symptoms or adverse events reported.
Age: 18.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 14-JUN-2023, the patient was vaccinated with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, at a dose of 0.5 milliliters (ml), (strength, route of administration, and indication were not provided; lot number reported as W007180 and expiration date 01-MAR-2024, but upon internal review found not valid); and M-M-R II subcutaneous injection, at a dose of 0.5 milliliter, administered for prophylaxis (strength, and route of administration were not provided; lot number reported as W039703 and expiration date 15-AUG-2025). On that same date, the patient was administered a total volume of exactly 0.5 mL after it was reconstituted with the Merck supplied diluent, instead of the total reconstituted volume that was in the vial of 0.7 mL (product preparation error) (incorrect dose administered). No adverse events were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Suspected product quality issue
Clinical narrative: You are injecting poison to the people; You are injecting poison to the people; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED PRODUCT QUALITY ISSUE (You are injecting poison to the people), POOR QUALITY PRODUCT ADMINISTERED (You are injecting poison to the people) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED PRODUCT QUALITY ISSUE (You are injecting poison to the people), POOR QUALITY PRODUCT ADMINISTERED (You are injecting poison to the people) and NO ADVERSE EVENT (No adverse event). At the time of the report, SUSPECTED PRODUCT QUALITY ISSUE (You are injecting poison to the people), POOR QUALITY PRODUCT ADMINISTERED (You are injecting poison to the people) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported. Treatment medication was not reported.
Sex: M
Vaccine: HPV9, PNC20
Symptoms: No adverse event, Product confusion, Wrong product administered
Clinical narrative: she inadvertently administered PREVNAR 20 instead of GARDASIL-9 due to product confusion; no adverse event; Nurse calling to report that she inadvertently administered PREVNAR 20 instead of GARDASIL-9; This spontaneous report was received from Other Health Professional (nurse) and refers to an unknown age male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUN-2023, the nurse inadvertently administered pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (strength, formulation, lot #, expiry date, route of administration, and indication were not provided) instead of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to the patient (Wrong product administered) due to product confusion. The patient had already received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) previously and this was supposed to be his second dose. On an unspecified date in June 2023, the patient came back to the office and received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #u029033, expiration date: 13-MAR-2024 (strength, route of administration, and indication were not provided). The patient has no symptoms (no adverse event).   The causality between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms reported./ No additional AE; were given an extra dose of MMR-II and VARIVAX; This spontaneous report has been received from a registered nurse referring to a child patient of unknown age or gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 28-JUN-2023, the patient was vaccinated with an extra third dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W039697, expiration date: 13-DEC-2024, administered subcutaneously (SQ) for prophylaxis (strength was not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (extra dose administered). The reporter was looking for further guidance. No symptoms reported. No additional AE or PQC (no adverse event).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013345:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error, Wrong product administered
Clinical narrative: No Additional AE; the patient was given PROQUAD instead of MMR II.; The PROQUAD also suffered from a non supported temperature excursion.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age or gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 17-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD)  injection, lot #W029552, expiration date: 14-MAR-2024, administered for prophylaxis (strength, dose, and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, dose, lot #, expiry date, and route of administration were not provided) (wrong product administered). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) also suffered from a non supported temperature excursion (product storage error). It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was underwent temperature excursions at 8 degree Celsius (C) for 1320 hours. There were no previous temperature excursions. No additional AE or PQC was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Moderna bivalent vaccine was administered as Dose1; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as Dose1) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as Dose1). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as Dose1) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as Dose1).    No concomitant medications were reported.  Patient didn't report any adverse events. No treatment drug information was provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732160:same reporter
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MILD 2/24/2023 & 2/23/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dysaesthesia, Echocardiogram, Electrocardiogram, Laboratory test
Clinical narrative: PLEURTIC CHEST PAIN, TINNITUS, PERIPHERAL DYSESTHESIA OF ARMS AND LEGS.  CLINICAL DIAGNOSIS OF PLEURITIS AND SMALL FIBER NEUROPATHY CAUSED BY MRNA VACCINATION
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Pleurisy, Pleuritic pain, Small fibre neuropathy, Tinnitus
Clinical narrative: PLEURTIC CHEST PAIN, TINNITUS, PERIPHERAL DYSESTHESIA OF ARMS AND LEGS.  CLINICAL DIAGNOSIS OF PLEURITIS AND SMALL FIBER NEUROPATHY CAUSED BY MRNA VACCINATION
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None- Vaccine given beyond use date. Patient had no adverse events.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None - Vaccine given beyond use date. Patient had no adverse events.
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: None. Vaccine given beyond use date. Patient had no adverse events.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was not due to receive any vaccine at this visit but was mistakenly given a Bexsero that was intended for another patient. Her mother was informed of the error. Patient was unharmed by the vaccine. The vaccine is approved for her age.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Patient is experiencing severe stomach pain and diarrhea following first shingles vaccine - had to go into walk in clinic
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, UNSPECIFIED
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Angiogram, Anticoagulant therapy, COVID-19, Fibrin D dimer increased
Clinical narrative: COVID infection - with acute on chronic respiratory failure. Doing better, lungs clear and O2 down to 2L - is baseline. Continue steroids, Remdesevir - completing Remdesevir soon. . Home O2 is 2L. Has CPAP on at night for OSA. Rise in D-dimer persists- no CP, will need to r/o PE. CTA chest showed PE, he was started on eliquis at discharge.    OSA - on CPAP at night.    CAD - HX CABG and recent stent placement - stable. No CP. On ASA, Bblocker, Cozaar, statin, Demadex. .    DM - montior BS. BS better now with resuming home glucotrol. Will reduce insulin. Will need insulin on DC home. . On SSI.  Spouse will need teaching on use if DC home from here. Added sliding scale at discharge, resumed his jardiacne and also increased glipizide dose.    HX AS - seeing Dr. for prep for TAVR.    Seizures - not on meds.    HTN - monitor on meds.    Hypothyroid - on supplement.    Hx Bladder cancer   BPH - on flomax.    Recent skin cancer excision - can remove stitches R ear.     PT, OT to eval - recommending home with assist and home PT. Possible DC tomorrow.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pulmonary oedema, SARS-CoV-2 test positive
Clinical narrative: COVID infection - with acute on chronic respiratory failure. Doing better, lungs clear and O2 down to 2L - is baseline. Continue steroids, Remdesevir - completing Remdesevir soon. . Home O2 is 2L. Has CPAP on at night for OSA. Rise in D-dimer persists- no CP, will need to r/o PE. CTA chest showed PE, he was started on eliquis at discharge.    OSA - on CPAP at night.    CAD - HX CABG and recent stent placement - stable. No CP. On ASA, Bblocker, Cozaar, statin, Demadex. .    DM - montior BS. BS better now with resuming home glucotrol. Will reduce insulin. Will need insulin on DC home. . On SSI.  Spouse will need teaching on use if DC home from here. Added sliding scale at discharge, resumed his jardiacne and also increased glipizide dose.    HX AS - seeing Dr. for prep for TAVR.    Seizures - not on meds.    HTN - monitor on meds.    Hypothyroid - on supplement.    Hx Bladder cancer   BPH - on flomax.    Recent skin cancer excision - can remove stitches R ear.     PT, OT to eval - recommending home with assist and home PT. Possible DC tomorrow.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Discomfort, Erythema, Pruritus, Swelling
Clinical narrative: Vaccine given 7/5/2023  and on 7/6/2023 redness on upper thigh started. On 7/7/23 also had redness, swelling, discomfort and itching. Seem by provider and given Prednisolone orally for 5 days and Kenalog cream for 5 days. Also, advise could use ice.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Hypoxia, Symptom recurrence
Clinical narrative: ACUTE ST ELEVATION MI, RIGHT CORONARY ARTERY ACUTE NON ST ELEVATION MI HYPOXEMIA 1/26/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Coma scale, Computerised tomogram head normal, Electroencephalogram normal, Eye movement disorder, Laboratory test normal
Clinical narrative: HPI: 24yo F with no known significant neurologic history with new onset seizures with initial status epilepticus. She had a potential rabies exposure on Wednesday 3 May and, having had prior rabies vaccinations x 2, underwent post exposure prophylaxis for rabies exposure with 2 dose series of rabies vaccine. Within 5 minutes of the second dose of the vaccine on day 3 after exposure she felt unwell, then became unconscious, and had seizure-like activity with rapid eye movements and rhythmic shaking of the left arm at about 1330. She remained unconscious with GCS 3 for the next 3 hours with frequent episodes every 2-20 minutes of recurrent seizure activity lasting 15 seconds to 3+ minutes. She was treated initially with midazolam in recurrent boluses of 2mg up to 12mg in total. She was loaded with levetiracetam 4500mg IV and given an additional 10mg IM diazepam. She underwent CT head with and w/o IV contrast which was negative. She had a total of over 23 seizure-like events over about 3 hours. Over the next week she had progressive improvement in mental status. She had no further large events after about 24hrs and had only 1 very brief event.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Loss of consciousness, Magnetic resonance imaging normal, Malaise, Mental status changes, Scan with contrast normal
Clinical narrative: HPI: 24yo F with no known significant neurologic history with new onset seizures with initial status epilepticus. She had a potential rabies exposure on Wednesday 3 May and, having had prior rabies vaccinations x 2, underwent post exposure prophylaxis for rabies exposure with 2 dose series of rabies vaccine. Within 5 minutes of the second dose of the vaccine on day 3 after exposure she felt unwell, then became unconscious, and had seizure-like activity with rapid eye movements and rhythmic shaking of the left arm at about 1330. She remained unconscious with GCS 3 for the next 3 hours with frequent episodes every 2-20 minutes of recurrent seizure activity lasting 15 seconds to 3+ minutes. She was treated initially with midazolam in recurrent boluses of 2mg up to 12mg in total. She was loaded with levetiracetam 4500mg IV and given an additional 10mg IM diazepam. She underwent CT head with and w/o IV contrast which was negative. She had a total of over 23 seizure-like events over about 3 hours. Over the next week she had progressive improvement in mental status. She had no further large events after about 24hrs and had only 1 very brief event.