chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: White matter lesion
Clinical narrative: Presented to  ED on 2/13/2023 with a two day history of body aches, vomiting, fevers, headache, and myalgias Pt noted to be awake and alert, however acting strangely; neurologic status acutely decompensated tachycardic in 180s-190s and hypotensive, emergently intubated and started on norepi infusion.  CT as noted below.  Loaded with 1g Keppra. Neurosurgery consulted, exam notable for nonreactive pupils, no corneal/cough/gag reflexes and no motor response to noxious stimuli. Pt was taken emergently for decompressive hemicraniectomy. She received 100g mannitol intraoperatively. no recovery of brainstem reflexes. Loaded with Keppra and started on maintenance. Post op CToH with expected diffuse cerebral edema and diminished grey-white. LP performed 2/14 to evaluate infectious etiology which was negative. Terminal extubation on 2/15/23
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Asthenia, Blood ketone body absent, Blood lactic acid, Blood magnesium normal
Clinical narrative: This is a 67-year-old male patient that presents to the ER with a family member at the bedside complaints of cough, fever and confusion.  The current symptoms have been present for approximately 2 days.  The wife actually noticed the confusion this morning.  The patient was trying to drink his oatmeal out of a bowl this morning and then proceeded to urinate on the bathroom floor when he went to use the bathroom.  She states he as well was weaker requiring assistance to get up out of a chair and to go to the bathroom today.  The patient does have an extensive medical history including insulin-dependent diabetes, CAD, atrial fib, hypertension, hyperlipidemia as well as dementia.  The patient is alert and oriented x3 upon my presence in the room however was alert and oriented only x2 for the nurse stating that the month was August for her however answered it correctly for me.  The patient has no facial/focal weakness.  There is no headache, nausea or vomiting. Associated Symptoms: cough, fever, URI symptoms.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pH normal, COVID-19, Chest X-ray normal, Computerised tomogram head abnormal, Confusional state
Clinical narrative: This is a 67-year-old male patient that presents to the ER with a family member at the bedside complaints of cough, fever and confusion.  The current symptoms have been present for approximately 2 days.  The wife actually noticed the confusion this morning.  The patient was trying to drink his oatmeal out of a bowl this morning and then proceeded to urinate on the bathroom floor when he went to use the bathroom.  She states he as well was weaker requiring assistance to get up out of a chair and to go to the bathroom today.  The patient does have an extensive medical history including insulin-dependent diabetes, CAD, atrial fib, hypertension, hyperlipidemia as well as dementia.  The patient is alert and oriented x3 upon my presence in the room however was alert and oriented only x2 for the nurse stating that the month was August for her however answered it correctly for me.  The patient has no facial/focal weakness.  There is no headache, nausea or vomiting. Associated Symptoms: cough, fever, URI symptoms.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysstasia, Electrocardiogram abnormal, Encephalomalacia, Haemoglobin decreased
Clinical narrative: This is a 67-year-old male patient that presents to the ER with a family member at the bedside complaints of cough, fever and confusion.  The current symptoms have been present for approximately 2 days.  The wife actually noticed the confusion this morning.  The patient was trying to drink his oatmeal out of a bowl this morning and then proceeded to urinate on the bathroom floor when he went to use the bathroom.  She states he as well was weaker requiring assistance to get up out of a chair and to go to the bathroom today.  The patient does have an extensive medical history including insulin-dependent diabetes, CAD, atrial fib, hypertension, hyperlipidemia as well as dementia.  The patient is alert and oriented x3 upon my presence in the room however was alert and oriented only x2 for the nurse stating that the month was August for her however answered it correctly for me.  The patient has no facial/focal weakness.  There is no headache, nausea or vomiting. Associated Symptoms: cough, fever, URI symptoms.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Pyrexia, Respiratory symptom, SARS-CoV-2 test positive, Sinus bradycardia
Clinical narrative: This is a 67-year-old male patient that presents to the ER with a family member at the bedside complaints of cough, fever and confusion.  The current symptoms have been present for approximately 2 days.  The wife actually noticed the confusion this morning.  The patient was trying to drink his oatmeal out of a bowl this morning and then proceeded to urinate on the bathroom floor when he went to use the bathroom.  She states he as well was weaker requiring assistance to get up out of a chair and to go to the bathroom today.  The patient does have an extensive medical history including insulin-dependent diabetes, CAD, atrial fib, hypertension, hyperlipidemia as well as dementia.  The patient is alert and oriented x3 upon my presence in the room however was alert and oriented only x2 for the nurse stating that the month was August for her however answered it correctly for me.  The patient has no facial/focal weakness.  There is no headache, nausea or vomiting. Associated Symptoms: cough, fever, URI symptoms.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin, Ventricular extrasystoles, White blood cell count normal
Clinical narrative: This is a 67-year-old male patient that presents to the ER with a family member at the bedside complaints of cough, fever and confusion.  The current symptoms have been present for approximately 2 days.  The wife actually noticed the confusion this morning.  The patient was trying to drink his oatmeal out of a bowl this morning and then proceeded to urinate on the bathroom floor when he went to use the bathroom.  She states he as well was weaker requiring assistance to get up out of a chair and to go to the bathroom today.  The patient does have an extensive medical history including insulin-dependent diabetes, CAD, atrial fib, hypertension, hyperlipidemia as well as dementia.  The patient is alert and oriented x3 upon my presence in the room however was alert and oriented only x2 for the nurse stating that the month was August for her however answered it correctly for me.  The patient has no facial/focal weakness.  There is no headache, nausea or vomiting. Associated Symptoms: cough, fever, URI symptoms.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Dysphonia, Fatigue, Flushing, Gastrooesophageal reflux disease, Injection site erythema
Clinical narrative: Patient presented to pharmacy with redness and some raised bumps at injection site. Patient also reports had a flushing sensation later in the evening on same date vaccination received, felt flushing and lots of acid reflux. patient reports hoarsness in voice today is from the acid reflux she experienced night before after the vaccination received.  Today has hoarsness in voice, redness around injection site and feels warm but does not report fever.  Patient also states she feels tired
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to pharmacy with redness and some raised bumps at injection site. Patient also reports had a flushing sensation later in the evening on same date vaccination received, felt flushing and lots of acid reflux. patient reports hoarsness in voice today is from the acid reflux she experienced night before after the vaccination received.  Today has hoarsness in voice, redness around injection site and feels warm but does not report fever.  Patient also states she feels tired
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site rash
Clinical narrative: Rash on arm that vaccine was administered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 14.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Feeling abnormal
Clinical narrative: Pt left the clinic around 1230 after having a physical and vaccines. Pt received Varicella, Polio, Tdap, and MMR Vaccines. Nurses' station was called at 1238 from clerical stating pt was "not feeling right." As RNs were making their way to the lobby, a CODE was called on the intercom.  An interpreter was with the pt and her mother the entire time. APNs were present at 1239 along with 4 RNs. Vitals were taken at 1240. BP 97/65, Pulse 89, Respirations 21, and SpO2 98%.  Pt never lost consciousness. Pt was given water and juice to drink. Mother stated pt had only eating cereal that morning. By 1245, pt was feeling much better and was able to answer questions. Vitals taken again at 1250. BP 108/74, Pulse 96, SpO2 99%, and Respirations 18. Event was resolved at 1253. Pt instructed to wait 10  minutes in the lobby before standing up.
Age: 40.0
Sex: F
Vaccine: COVID19-2, FLU4, HEP
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Covid vaccine not viable due to improper temperature storage.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Facial paralysis, Lip swelling, Mouth swelling, Rash, Throat tightness
Clinical narrative: Rash, Lip and mouth swelling, face drooping, and throat tightness.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Administered. No adverse reactions reported.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Vaccine Administered. No adverse symptoms reported.
Age: 30.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered after the BUD of 2/18/23.- no symptoms reported at this time.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from other health care professional referring to a 4-year-old male patient. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 13-JAN-23, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W008711 has been verified to be a valid lot number, expiration date: 14-MAR-2024) (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported), and with diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (dose, route of administration, vaccination scheme frequency, anatomical location, indication, lot number, and expiration date were not reported). The administered doses of the vaccines experienced a temperature excursion at -10.5 degrees Celsius for 1 hour and 34 minutes. It was not mentioned if there was a data logger implied. There was no previous temperature excursion. No additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 0.75
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Cough, Diarrhoea, Influenza virus test negative, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Yellow  snot, cough,  fever, and loose stool 3-5 days Motrin/Tylenol
Age: 0.75
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Secretion discharge
Clinical narrative: Yellow  snot, cough,  fever, and loose stool 3-5 days Motrin/Tylenol
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Injection site erythema, No adverse event
Clinical narrative: Expired Vaccine Administered. Employee states increased redness at site. No other adverse symptoms reported.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine administered. no adverse symptoms reported.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Vaccine Administered. no adverse symptoms reported.
Age: 40.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Abdominal pain, Chills, Dyspnoea, Oropharyngeal pain, Pain
Clinical narrative: Patient with HIV and CD4-200 he started with pain, chilli sensation, pain on the throat and the body all nigth and  he experience short breath and severe pain in abdomen the next day after the Mpox vaccine shot. She was hospitalize the third day after the shot.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administration. No Adverse symptoms reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 9/6/22 pt to ED with SOB; found to be positive for COVID; COVID pneumonia with possible secondary bacterial pneumonia; given Decadron and ABX; comfort care decided upon for the pt; she passed away in the hospital
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered. no adverse symptoms reported.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient given bivalent instead of monovalent vaccine for second dose of primary series
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Cough, Dry throat, Dysgeusia
Clinical narrative: The symptoms started with a runny nose that was constant and clear. I started taking Mucinex. A day later, the I also developed a dry sore throat. The next day, I developed a severe headache and a cough. On day three, I tested positive for COVID-19. I reported it to my doctor via MyChart. She scheduled a telehealth appointment. I received a prescription to Paxlovid due to my high-risk status. I was told to stop taking Atorvastatin while on Paxlovid. I began taking the Paxlovid about 5 days after my symptoms started. I took three in the morning and three at night for five days. My symptoms improved almost immediately. By the second day, the symptoms were going away totally. I experienced a nasty metallic taste in my mouth for the full five days. On day 7 or 8 after testing positive for COVID-19, I tested negative. COVID-19 also effected my taste and energy levels and that has lingered.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Taste disorder
Clinical narrative: The symptoms started with a runny nose that was constant and clear. I started taking Mucinex. A day later, the I also developed a dry sore throat. The next day, I developed a severe headache and a cough. On day three, I tested positive for COVID-19. I reported it to my doctor via MyChart. She scheduled a telehealth appointment. I received a prescription to Paxlovid due to my high-risk status. I was told to stop taking Atorvastatin while on Paxlovid. I began taking the Paxlovid about 5 days after my symptoms started. I took three in the morning and three at night for five days. My symptoms improved almost immediately. By the second day, the symptoms were going away totally. I experienced a nasty metallic taste in my mouth for the full five days. On day 7 or 8 after testing positive for COVID-19, I tested negative. COVID-19 also effected my taste and energy levels and that has lingered.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Death, Periprosthetic fracture, Pneumonia, Pneumonia pneumococcal
Clinical narrative: Death report received indicating patient died on 11/23/2022, Immediate Cause:  BILATERAL PNEUMONIA (PNEUMOCOCCAL AND COVID-19) COMPLICATING LEFT PERIPROSTHETIC HIP FRACTURE Submitter does not have access to further medical records. If more information is needed, please contact the admitting hospital.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Death report received indicating patient died on 11/23/2022, Immediate Cause:  BILATERAL PNEUMONIA (PNEUMOCOCCAL AND COVID-19) COMPLICATING LEFT PERIPROSTHETIC HIP FRACTURE Submitter does not have access to further medical records. If more information is needed, please contact the admitting hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: Abnormal swelling at the injection site.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: I felt extreme tiredness and brain fog the day after my vaccine. I also had a sore left arm for two days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Rash
Clinical narrative: 1 day after vaccination patient states she developed a rash on her torso that was inflamed skin, not itchy. She took benadryl and said that did help
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Blood glucose increased, COVID-19, Fatigue, Hyperglycaemia
Clinical narrative: Patient is a 84 Y  male with history of advanced dementia, celiac disease, type 2 diabetes (on metformin, glipizide and NPH), history of metastatic melanoma, hypertension presented for fatigue and found to be hyperglycemic (BS >500) and COVID +. Patient's hyperglycemia was corrected with resuming his home medications and insulin. As for COVID, patient did not have any respiratory symptoms and can be considered asymptomatic. Evaluated by PT and patient demonstrated good mobility. Stable for discharge home on current home meds and follow up for dementia evaluation as outpatient.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient is a 84 Y  male with history of advanced dementia, celiac disease, type 2 diabetes (on metformin, glipizide and NPH), history of metastatic melanoma, hypertension presented for fatigue and found to be hyperglycemic (BS >500) and COVID +. Patient's hyperglycemia was corrected with resuming his home medications and insulin. As for COVID, patient did not have any respiratory symptoms and can be considered asymptomatic. Evaluated by PT and patient demonstrated good mobility. Stable for discharge home on current home meds and follow up for dementia evaluation as outpatient.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Bladder catheterisation, COVID-19, Cardiac failure, Condition aggravated
Clinical narrative: Hospital Course and Significant Findings: Patient is a 93 Y male with PMH coronary artery disease with ischemic cardiomyopathy s/p CABG, hyperlipidemia, HFrEF, LVEF 40%, hypothyroidism, urinary retention due to BPH presented with complaint of shortness of breath for 3-4 days. Patient was seen in urology clinic day of admission to hospital for placement of foley catheter due to urinary retention, earlier foley wsa obstructed and seen in clinic for replacement and sent to ED for evaluation of shortness of breath. Patient admitted with acute hypoxemic respiratory failure 2/2 COVID-19 and heart failure exacerbation.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Device occlusion, Dyspnoea, Urinary retention
Clinical narrative: Hospital Course and Significant Findings: Patient is a 93 Y male with PMH coronary artery disease with ischemic cardiomyopathy s/p CABG, hyperlipidemia, HFrEF, LVEF 40%, hypothyroidism, urinary retention due to BPH presented with complaint of shortness of breath for 3-4 days. Patient was seen in urology clinic day of admission to hospital for placement of foley catheter due to urinary retention, earlier foley wsa obstructed and seen in clinic for replacement and sent to ED for evaluation of shortness of breath. Patient admitted with acute hypoxemic respiratory failure 2/2 COVID-19 and heart failure exacerbation.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-myelin-associated glycoprotein associated polyneuropathy, Asthenia, Balance disorder, Blood immunoglobulin M, Blood test
Clinical narrative: Vaccine triggered what was peripheral neuropathy in both legs, into ANTI MAG NEUROPAHTY indicated by demylination of leg nerves, difficulty walking, balance, strength. Situation still continues. Was coping fine with regular neuropathy until this shift to autoimmune status and more severe symptoms
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chemotherapy, Demyelination, Gait disturbance, Infusion, Neuropathy peripheral
Clinical narrative: Vaccine triggered what was peripheral neuropathy in both legs, into ANTI MAG NEUROPAHTY indicated by demylination of leg nerves, difficulty walking, balance, strength. Situation still continues. Was coping fine with regular neuropathy until this shift to autoimmune status and more severe symptoms
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dehydration, Dyspnoea, Lactic acidosis
Clinical narrative: Patient initially presented with nausea vomiting dehydration was found to have COVID-19 disease however was not severe and did not require oxygen supplementation.  Patient was given IV fluids antiemetics with resolution of lactic acidosis and sepsis.  The following day the patient's nausea and vomiting had resolved she was able to tolerate a regular breakfast without difficulty.  Patient also had significant improvement of cough and shortness of breath.  Patient stated that she felt well enough to go home.  Patient was discharged with oral medications for cough and nausea control as needed.  Patient had 2 days total of remdesivir.  Patient was not given dexamethasone as inpatient or outpatient because she did not develop acute hypoxemic respiratory failure.  Patient was discharged home and follow-up with primary care to ensure continued resolution of infectious signs and symptoms and optimization of other medical issues.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Sepsis, Vomiting
Clinical narrative: Patient initially presented with nausea vomiting dehydration was found to have COVID-19 disease however was not severe and did not require oxygen supplementation.  Patient was given IV fluids antiemetics with resolution of lactic acidosis and sepsis.  The following day the patient's nausea and vomiting had resolved she was able to tolerate a regular breakfast without difficulty.  Patient also had significant improvement of cough and shortness of breath.  Patient stated that she felt well enough to go home.  Patient was discharged with oral medications for cough and nausea control as needed.  Patient had 2 days total of remdesivir.  Patient was not given dexamethasone as inpatient or outpatient because she did not develop acute hypoxemic respiratory failure.  Patient was discharged home and follow-up with primary care to ensure continued resolution of infectious signs and symptoms and optimization of other medical issues.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Given bivalent covid booster  on 2/13/2023 then discovered on the vaccination record show bivalent covid booster given through health department on 09/09/2022; attempted to contact patient with no answer. Message left on voicemail to call clinic back. Unknown if any adverse outcomes have occured.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: PT WAS VACCINATED WITH MODERNA BOOSTER AFTER ALREADY RECEIVING IT A MONTH PRIOR.  THE EVENT WAS INFORMED TO PT'S PROVIDER, PT WAS IMMEDIATELY CHECKED BY PROVIDER AND AFTER RECHECKING PT'S NORMAL VITALS AND ONCE TH PT ASSURED SHE WAS FEELING GOOD HEALTH WISE FOLLOWING BY  EXPLAINING TO HER NEXT STEPS SHE SHOULD TAKE IF INCASE PT FEELS SICK, PT WAS DISHCARGED.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: We gave a 2nd bivalent shot when patient was not eligible for it. Patient did not have an adverse reaction to it.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Discomfort, Palpitations, Pyrexia
Clinical narrative: Chest tightness, palpitations and discomfort. Fever, chills.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal uterine bleeding, Abortion spontaneous, Amenorrhoea, Endometrial atrophy, Infertility female
Clinical narrative: Pregnancy (30 days after second  Moderna vaccine) with in date, correctly placed, and fully functional IUD. Subsequent miscarriage in which a surgical D & C had to be performed for a missed miscarriage.  Amenorrhea and infertility sustained for 7 months in combination with uterine endometrial lining noted to be fairly thin at 5.5 mm during ultrasound with no plausible explanation or cause.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure before pregnancy, Pregnancy, Pregnancy test positive, Pregnancy with contraceptive device, Smear cervix
Clinical narrative: Pregnancy (30 days after second  Moderna vaccine) with in date, correctly placed, and fully functional IUD. Subsequent miscarriage in which a surgical D & C had to be performed for a missed miscarriage.  Amenorrhea and infertility sustained for 7 months in combination with uterine endometrial lining noted to be fairly thin at 5.5 mm during ultrasound with no plausible explanation or cause.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound uterus abnormal, Uterine dilation and curettage
Clinical narrative: Pregnancy (30 days after second  Moderna vaccine) with in date, correctly placed, and fully functional IUD. Subsequent miscarriage in which a surgical D & C had to be performed for a missed miscarriage.  Amenorrhea and infertility sustained for 7 months in combination with uterine endometrial lining noted to be fairly thin at 5.5 mm during ultrasound with no plausible explanation or cause.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Deep vein thrombosis Left leg
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid increased, Genital discolouration, Lactic acidosis, Sepsis, Testicular necrosis
Clinical narrative: Chief Complaint:    Comfort care    History of Present Illness: Patient is a 69 Y male, history of metastatic cancer:, Inguinal hernia, hypertension, failure to thrive.  Presented with severe testicular swelling for several days now with necrotic black discoloration, severe pain which not improving with oxycodone.  Patient has history of incarcerated left inguinal hernia in the colon cancer seen multiple times by surgery team who recommend   palliative care , as patient is nonsurgical  in the ED found to have sign of severe sepsis with lactic acidosis very elevated white cell count, lactic acid.  Patient was seen by surgery after discussion with the family not surgical candidate plan for comfort care.  Discussed with the family wife at the bedside who understand and agree to initiate comfort care. ,  Understanding possible eminent death with severe sepsis lactic acidosis
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain, Testicular swelling, White blood cell count increased
Clinical narrative: Chief Complaint:    Comfort care    History of Present Illness: Patient is a 69 Y male, history of metastatic cancer:, Inguinal hernia, hypertension, failure to thrive.  Presented with severe testicular swelling for several days now with necrotic black discoloration, severe pain which not improving with oxycodone.  Patient has history of incarcerated left inguinal hernia in the colon cancer seen multiple times by surgery team who recommend   palliative care , as patient is nonsurgical  in the ED found to have sign of severe sepsis with lactic acidosis very elevated white cell count, lactic acid.  Patient was seen by surgery after discussion with the family not surgical candidate plan for comfort care.  Discussed with the family wife at the bedside who understand and agree to initiate comfort care. ,  Understanding possible eminent death with severe sepsis lactic acidosis
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: received expired immunization- no reation- no complaints.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Vaccination error
Clinical narrative: Patient came into clinic with vaccine records in another language.  The vaccine nurse reviewed records and transcribed Pentavalente as doses of DtaP and IPV only given on 7/7/14, 8/10/14, 12/3/14.  Due to no transcribed vaccines given for Hep B, the patient was given what was supposed age-appropriate doses of Tdap, IPV, MMRV, Hep B, Hep A and Flu.  Upon chart review the PNP in-charge of clinic noted that Pentavalente may contain an additional antigen.  It was discovered with further research on the following websites that Pentavalente contains DTaP, Hep B, HiB.    This therefore rendered the Hep B given on 2/24/2023 as an additional dose and was a vaccine error.  This was reported to the parent/guardian who verified that the vaccines were given in another country in 2014.  The patient is well and will start school.  The vaccine records have also been corrected and a copy of the new records will be provided to the parent/guardian on an appointment for pick-up on 2/27/2023.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from other health care professional referring to a 16-month-old male patient. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 17-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W008711 has been verified to be a valid lot number, expiration date: 14-MAR-2024) (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (dose, route of administration, vaccination scheme frequency, anatomical location, indication, lot number, and expiration date were not reported), and  pneumococcal vaccine conj 7v (crm197) (PREVENAR) (dose, route of administration, vaccination scheme frequency, anatomical location, indication, lot number, and expiration date were not reported). The administered doses of the vaccines experienced a temperature excursion at -10.5 degrees Celsius for 1 hour and 34 minutes. It was not mentioned if there was a data logger implied. There was no previous temperature excursion. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA010765:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Aphasia, Bacterial infection, Confusional state, Dysarthria
Clinical narrative: Patient is a 75 yo M w/ hx of ESRD on HD MWF, OSA, DM-2, SSS s/p PPM, bladder ca on BCG Rx, CAD s/p CABG and PCI, asthma, HFrEF, HLD, OSA, recent discharge 2/14/23 for enterococcus bacteremia and MDR Ecoli UTI discharged to SNF to complete abx 2/19/23. Pt presents to ED today w/ confusion, being unable to finish a though, slurring speech, and jerking motions of both upper extremities. Currently pt recognizes he is in the hospital but is having word finding difficulties and is trying to climb out of bed. He denies any pain or trouble breathing. States he wants to go home.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Enterococcal bacteraemia, Escherichia urinary tract infection, Thinking abnormal
Clinical narrative: Patient is a 75 yo M w/ hx of ESRD on HD MWF, OSA, DM-2, SSS s/p PPM, bladder ca on BCG Rx, CAD s/p CABG and PCI, asthma, HFrEF, HLD, OSA, recent discharge 2/14/23 for enterococcus bacteremia and MDR Ecoli UTI discharged to SNF to complete abx 2/19/23. Pt presents to ED today w/ confusion, being unable to finish a though, slurring speech, and jerking motions of both upper extremities. Currently pt recognizes he is in the hospital but is having word finding difficulties and is trying to climb out of bed. He denies any pain or trouble breathing. States he wants to go home.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave the Bivalent , instead of the (second) monovalent  I administered the wrg vaccine
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt received expired immunization. pt denies complaint.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTIONS
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: received expired vaccine- no reaction
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: Severe dizziness headache fever congestion
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired vaccine- no adverse reation
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: pt received expired immunization. pt declines any negative/ unwanted signs or symptoms
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PT RECEIVED EXPIRED MEDICATION- DENIES ANY REACTION
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: PT RECEIVED EXPIRED IMMUNIZATION. PT DENIES ANY SIDE EFFECTS
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, IPV, RV5
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Incorrect vaccine given to patient. Pt received IPOL and Pentacel which has IPV as well. Pt received duplicate vaccine administration.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse referring to a 16 month old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 17-JAN-2023, the patient was vaccinated with an improperly stored of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot # W008711 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and established as 14-MAR-2024) (strength, dose, route of administration and anatomical location were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 7v (crm197) (PREVENAR) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  The temperature of storage and time frame of the excursion were -10.5° Celsius (C) for 1 hour and 34 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event was reported.; Sender's Comments:  US-009507513-2301USA010765:
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reported vaccines were administered after a temperature excursion.; This spontaneous report was received from a nurse referring to a 13 month old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-JAN-2023, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # W008711 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and established as 14-MAR-2024) (strength, dose, route of administration and anatomical location were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and hepatitis a vaccine, inactivated(VAQTA) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  The temperature of storage and time frame of the excursion were -10.5° Celsius (C) for 1 hour and 34 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.; Sender's Comments:  US-009507513-2301USA010765:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reported vaccines were administered after a temperature excursion.; This spontaneous report was received from a nurse referring to a 12 month old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-JAN-2023, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # W008711 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and established as 14-MAR-2024) (strength, dose, route of administration and anatomical location were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and hepatitis a vaccine, inactivated(VAQTA) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  The temperature of storage and time frame of the excursion were -10.5° Celsius (C) for 1 hour and 34 minutes respectively.  If a data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA010765:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and medical history provided. Concomitant medications included sterile diluent (manufacturer unknown). On 14-FEB-2023, the patient was vaccinated with improperly stored doses of VARIVAX subcutaneous injection, lot #W008904 has been verified to be valid, expiration date was reported as 15-MAR-2024; and M-M-R II subcutaneous injection, lot #W007180, expiration date: 01-MAR-2024, albumin status has been verified as recombinant human albumin (rHA) (strengths, doses, anatomical locations, and routes of administration were not provided) for prophylaxis. On 11-FEB-2023, VARIVAX was stored at temperature 7 Fahrenheit degrees (F) for 1 hours; and M-M-R II was stored at temperature 57.0 F for 2 hours (product storage error). No additional adverse events were reported.
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure to product, Exposure via eye contact, Occupational exposure to product
Clinical narrative: No additional AE reported; the patient moved and that caused the medication to squirt in the nurse's eye; the patient moved and that caused the medication to squirt in the nurse's eye; the patient moved and that caused the medication to squirt in the nurse's eye; This spontaneous report has been received from the patient's colleague (nurse) referring to a female patient of unknown age who was also a nurse. The nurse's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 16-FEB-2023, the nurse was administering measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (lot number W028558 has been verified to be valid, expiration date was reported and established as 06-MAR-2024 upon internal validation; dose and route of administration was not reported) to her patient, and while the nurse was injecting the medication, her patient moved and that caused the medication to squirt in the nurse's eye (exposure via eye contact, occupational exposure to product, accidental exposure to product). No further information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported.  This is one of two reports from the same reporter (link # US-009507513-2302USA005740).; Sender's Comments:  US-009507513-2302USA005740:Case Number 02337536
Age: 4.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; First dose of GARDASIL was administered whenever patient was 4 years old on Oct 3, 2014. Second dose of GARDASIL was administered whenever patient was 5 years old on Nov 18, 2015.; received the GARDASIL series at ages 4 and 5 years old; This spontaneous report was received from a medical assistant and refers to a 13 years old male patient.  The patient's current condition, medical history and concomitant medications were not provided.  On 03-OCT-2014, the patient was vaccinated with first dose ofquadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (expiration date, lot number, formulation, anatomical location, route of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). On 18-NOV-2015, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) dose 2 (expiration date, lot number, anatomical location, route of administration were not reported) for prophylaxis (Inappropriate schedule of product administration). No additional adverse event was reported. The patient was planing to received quadrivalent human papillomavirus (types 6,11,16,18, 31, 45, 52, 58) recomb. vaccine (GARDASIL-9). However, in system there was an information that the patient was already received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) series at ages 4 and 5. The reporter stated she was not sure if her system was accurate because she did not known how insurance would payed for reported vaccines with the patient at that young age
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 18-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from other health care professional referring to a 4-year-old male patient. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 13-JAN-23, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W008711 has been verified to be a valid lot number, expiration date: 14-MAR-2024) (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported), and with diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (dose, route of administration, vaccination scheme frequency, anatomical location, indication, lot number, and expiration date were not reported). The administered doses of the vaccines experienced a temperature excursion at -10.5 degrees Celsius for 1 hour and 34 minutes. It was not mentioned if there was a data logger implied. There was no previous temperature excursion. No additional adverse event (AE) reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA010765:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 13-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.