chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, COVID-19, Cardiac failure congestive, Chest discomfort, Condition aggravated
Clinical narrative: Narrative: Discharge DIAGNOSES: 1). CHF exacerbation 2). COVID 19 viral syndrome HPI: He reported several day history of increasing shortness of breath. He has a history of congestive heart failure and has been taking his medications intermittently. He did not take his medications today. He has some chest heaviness due to the swelling of his abdomen arms and legs. He has been seen here in December 2021 for similar problem. He continues to smoke tobacco products. He is on oxygen at home. History provided by: Patient, Medical Record PMH: CAD, CHF, Hypertension Obstructive sleep apnea
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Peripheral swelling, Tobacco user
Clinical narrative: Narrative: Discharge DIAGNOSES: 1). CHF exacerbation 2). COVID 19 viral syndrome HPI: He reported several day history of increasing shortness of breath. He has a history of congestive heart failure and has been taking his medications intermittently. He did not take his medications today. He has some chest heaviness due to the swelling of his abdomen arms and legs. He has been seen here in December 2021 for similar problem. He continues to smoke tobacco products. He is on oxygen at home. History provided by: Patient, Medical Record PMH: CAD, CHF, Hypertension Obstructive sleep apnea
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative: None Stated.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, End stage renal disease, Hypoxia, Metabolic encephalopathy
Clinical narrative: Narrative: 94 yo male presented to ED on 1/02/2022 with concerns for an episode of confusion and hypoxia. Pt placed on 2L nasal cannula. COVID positive. Treated with dexamethasone and supplemental oxygen. No remdesivir d/t ESRD. Metabolic encephalopathy secondary to Covid infection- Resolved. Discharged on 01/11/2022. PMH includes thrombocytopenia, ESRD/HD, recurrent venous thrombi, BPH, PAF and CHF.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative: 94 yo male presented to ED on 1/02/2022 with concerns for an episode of confusion and hypoxia. Pt placed on 2L nasal cannula. COVID positive. Treated with dexamethasone and supplemental oxygen. No remdesivir d/t ESRD. Metabolic encephalopathy secondary to Covid infection- Resolved. Discharged on 01/11/2022. PMH includes thrombocytopenia, ESRD/HD, recurrent venous thrombi, BPH, PAF and CHF.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Dyspnoea, Hypoxia
Clinical narrative: Narrative: Admitted 4/11 with SOB found to be hypoxic. Received Janssen vaccine x 1 on 6/21/21. Treated with dexamethasone 6mg orally x 4 days while inpatient and discharged on 3/14. She recieved 4 days of dexamethasone 4mg on discharge. Remdesivir was deferred due to AKI.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Decubitus ulcer, SARS-CoV-2 test positive, Septic shock
Clinical narrative: Narrative: Hospitalization-Fully vaccinated, admitted for septic shock due to bilateral decub ulcers. COVID positive on admission but no respiratory symptoms/chest x-ray clear.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Alanine aminotransferase normal, Allen's test, Anion gap, Aspartate aminotransferase normal
Clinical narrative: Narrative: Patient COVID positive despite 3 doses of vaccine. Admitted 4/27 - 4/28
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Base excess, Basophil count decreased, Basophil percentage decreased, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: Narrative: Patient COVID positive despite 3 doses of vaccine. Admitted 4/27 - 4/28
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bicarbonate normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine increased
Clinical narrative: Narrative: Patient COVID positive despite 3 doses of vaccine. Admitted 4/27 - 4/28
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pH increased, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: Narrative: Patient COVID positive despite 3 doses of vaccine. Admitted 4/27 - 4/28
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Carbon dioxide normal, Eosinophil count decreased, Eosinophil percentage decreased, Glomerular filtration rate normal
Clinical narrative: Narrative: Patient COVID positive despite 3 doses of vaccine. Admitted 4/27 - 4/28
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Granulocyte count, Granulocyte percentage, Haematocrit decreased, Haemoglobin decreased, Influenza A virus test negative
Clinical narrative: Narrative: Patient COVID positive despite 3 doses of vaccine. Admitted 4/27 - 4/28
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza B virus test, Laboratory test, Lymphocyte count decreased, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal
Clinical narrative: Narrative: Patient COVID positive despite 3 doses of vaccine. Admitted 4/27 - 4/28
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count increased, Monocyte percentage increased
Clinical narrative: Narrative: Patient COVID positive despite 3 doses of vaccine. Admitted 4/27 - 4/28
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: PCO2 decreased, PO2 decreased, Platelet count normal, Protein total normal, Red blood cell count decreased
Clinical narrative: Narrative: Patient COVID positive despite 3 doses of vaccine. Admitted 4/27 - 4/28
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Red cell distribution width normal, Respiratory syncytial virus test negative, SARS-CoV-2 test positive, White blood cell count increased
Clinical narrative: Narrative: Patient COVID positive despite 3 doses of vaccine. Admitted 4/27 - 4/28
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Cerebral haemorrhage, Cerebrovascular accident, Death, Hemiparesis
Clinical narrative: Narrative: Hospitalization - admitted for right-side weakness and found to have left occipital lobe intraparenchymal hemorrhage. Incidentally found to be COVID-positive on admission, asymptomatic. Fully vaccinated (not boosted). Pt died on 2/7/22 2/2 CVA.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative: Hospitalization - admitted for right-side weakness and found to have left occipital lobe intraparenchymal hemorrhage. Incidentally found to be COVID-positive on admission, asymptomatic. Fully vaccinated (not boosted). Pt died on 2/7/22 2/2 CVA.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Delirium, Impaired healing, Nausea, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated found COVID positive during admission. Patient presented with delirium, nausea/vomiting, and nonhealing sacral wound. Patient found to be COVID positive upon day 3 of admission due to patient not get testing initially. No hx of prior infection.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Narrative: Fully vaccinated found COVID positive during admission. Patient presented with delirium, nausea/vomiting, and nonhealing sacral wound. Patient found to be COVID positive upon day 3 of admission due to patient not get testing initially. No hx of prior infection.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis
Clinical narrative: Narrative: The patient is a 64-year-old male with PMH of alcohol use, tobacco use, HLD, depression, back pain, hepatitis, and COPD was seen at hospital for a deep vein thrombosis. This was attributed to his COVID-19 vaccine Moderna 100 mcg/0.5ml dose. The patient had received all three doses and the last administration was on 11/16/2021. The patient was started on rivaroxaban 15 mg twice a day for twenty-one days then started on 20mg by mouth once a day.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Malaise, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated COVID positive upon hospital admission. Presented to hospital with malaise and decreased appetite found to be COVID positive. Patient with hx of prior COVID infection.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Cough, Pyrexia
Clinical narrative: Narrative: Admitted on 2/27 for COVID-19 pneumonia with fever and cough. Received 4 days of dexamethasone and remdesivir. He improved with treatment and was discharged on 3/2
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Narrative: Admission Diagnosis:COVID-19 pneumonia, COPD exacerbation DIAGNOSIS: Primary Diagnosis: Pneumonia Secondary diagnosis: COVID-19, dyspnea, COPD
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling hot, Hyperhidrosis, Injection site erythema
Clinical narrative: SkinRash, Rash, Diarrhea, Sweating, Feeling hot and tired Narrative: Patient received 4th COVID vaccine on 5/2/22 and received 3 prior vaccines as well. Pt has a history of COVID in Jan 2021. After 4th dose, pt had a large local reaction with induration at the injection site (erythematous, swollen) with systemic symptoms including "feeling hot and sweaty and tired and had diarrhea"
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Rash
Clinical narrative: SkinRash, Rash, Diarrhea, Sweating, Feeling hot and tired Narrative: Patient received 4th COVID vaccine on 5/2/22 and received 3 prior vaccines as well. Pt has a history of COVID in Jan 2021. After 4th dose, pt had a large local reaction with induration at the injection site (erythematous, swollen) with systemic symptoms including "feeling hot and sweaty and tired and had diarrhea"
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Full blood count normal, Mouth haemorrhage, Palatal swelling, Pyrexia
Clinical narrative: FacialSwelling,PalatalPetechiaeaswellasPetechiaeonBuccalMucosaandgumline.Feverof100.8.AtthatpointpatientadvisedtotakeTylenolExtraStrengthbyPharmacist.AsofMay10,2022,redspotshavedecreasedinsizeandnumberbutcontinuetocomeandgo.Patientcomplainsoflumpinessincheek.FollowingtheAugust19,2021vaccine,bloodwork.requestedbyOncologistrevealedadrasticdecreaseinpatient'sCD3count.PriortoavaccineonAugust,theCD3counthadbeennormal.SinceAugustvaccineCD3hasneverreturnedtonormallevels.CD3cellswereonly618onAugust26,2021bloodtestperformedatLabsandthenfellfurtherto509on12/21
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Swelling face, T-lymphocyte count decreased
Clinical narrative: FacialSwelling,PalatalPetechiaeaswellasPetechiaeonBuccalMucosaandgumline.Feverof100.8.AtthatpointpatientadvisedtotakeTylenolExtraStrengthbyPharmacist.AsofMay10,2022,redspotshavedecreasedinsizeandnumberbutcontinuetocomeandgo.Patientcomplainsoflumpinessincheek.FollowingtheAugust19,2021vaccine,bloodwork.requestedbyOncologistrevealedadrasticdecreaseinpatient'sCD3count.PriortoavaccineonAugust,theCD3counthadbeennormal.SinceAugustvaccineCD3hasneverreturnedtonormallevels.CD3cellswereonly618onAugust26,2021bloodtestperformedatLabsandthenfellfurtherto509on12/21
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Brain scan normal, Impaired work ability, Malaise, Memory impairment
Clinical narrative: Patient began to feel very unwell the night of 5/1/21. He was unable to return to work that Monday and didn't bother to call. He disappeared into the garage on a cleaning spree for 3 days even polishing the furnace. (all out of character) Next weekend he drove himself to the emergency room as he had become enraged for something minor a friend had done and he couldn't calm himself down. He was sent to the crisis center where he was sent home with valium. (never happened before) Short term memory was not good but became non-existent.  He started having mood swings and takes a mood stabilizer. List goes on to this day and he is out of work
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Mood swings, Personality change
Clinical narrative: Patient began to feel very unwell the night of 5/1/21. He was unable to return to work that Monday and didn't bother to call. He disappeared into the garage on a cleaning spree for 3 days even polishing the furnace. (all out of character) Next weekend he drove himself to the emergency room as he had become enraged for something minor a friend had done and he couldn't calm himself down. He was sent to the crisis center where he was sent home with valium. (never happened before) Short term memory was not good but became non-existent.  He started having mood swings and takes a mood stabilizer. List goes on to this day and he is out of work
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Immediate post-injection reaction, Rash
Clinical narrative: head to toe rash; fatigue; episodes of dizziness; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced generalized rash, fatigue and dizziness. On an unknown date, the outcome of the generalized rash was recovered/resolved and the outcome of the fatigue and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash, fatigue and dizziness to be related to Shingrix.     Additional Information: GSK receipt date: 29 Apr 2022 Reporter's comment: The reporter was the daughter of the patient.  The reporter stated that the mother had the Shingrix vaccine a few months ago and shortly afterwards her mother experienced a head to toe rash on one side of her body.  The patient was now experiencing fatigue and episodes of dizziness. The patient referred to HCP. The reporter consented to follow up but could not provide HCP information, but did consent to follow up with the patient.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: ADAMTS13 activity decreased, ADAMTS13 inhibitor screen assay, Bell's palsy, Chest discomfort, Dizziness
Clinical narrative: Developed headache and easy bruising within days after first vaccine, associated with progressive fatigue and malaise. Never felt better after first vaccine. Then received second vaccine 8/1/2021.  The next day, developed facial numbness, left arm and hand numbness; diagnosed with Bells palsy. the next day developed chest pressure, shortness of breath and lightheadedness, prompting ER visit 8/6/2021. on presentation, hemoglobin 4.8, platelets 7, with evidence of thrombotic microangiopathy and . Ultimately diagnosed with acquired TTP when ADAMTS activity level returned undetectable and inhibitor was elevated. She underwent plasma exchange, received steroids, caplacizumab, and rituximab therapy.  TTP is now in remission, but she has daily headaches unrelieved with numerous medications, and has persistent Bells palsy on left face, causing speech impairment and inability to work.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Haemoglobin decreased, Headache, Hypoaesthesia
Clinical narrative: Developed headache and easy bruising within days after first vaccine, associated with progressive fatigue and malaise. Never felt better after first vaccine. Then received second vaccine 8/1/2021.  The next day, developed facial numbness, left arm and hand numbness; diagnosed with Bells palsy. the next day developed chest pressure, shortness of breath and lightheadedness, prompting ER visit 8/6/2021. on presentation, hemoglobin 4.8, platelets 7, with evidence of thrombotic microangiopathy and . Ultimately diagnosed with acquired TTP when ADAMTS activity level returned undetectable and inhibitor was elevated. She underwent plasma exchange, received steroids, caplacizumab, and rituximab therapy.  TTP is now in remission, but she has daily headaches unrelieved with numerous medications, and has persistent Bells palsy on left face, causing speech impairment and inability to work.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Increased tendency to bruise, Malaise, New daily persistent headache, Plasmapheresis
Clinical narrative: Developed headache and easy bruising within days after first vaccine, associated with progressive fatigue and malaise. Never felt better after first vaccine. Then received second vaccine 8/1/2021.  The next day, developed facial numbness, left arm and hand numbness; diagnosed with Bells palsy. the next day developed chest pressure, shortness of breath and lightheadedness, prompting ER visit 8/6/2021. on presentation, hemoglobin 4.8, platelets 7, with evidence of thrombotic microangiopathy and . Ultimately diagnosed with acquired TTP when ADAMTS activity level returned undetectable and inhibitor was elevated. She underwent plasma exchange, received steroids, caplacizumab, and rituximab therapy.  TTP is now in remission, but she has daily headaches unrelieved with numerous medications, and has persistent Bells palsy on left face, causing speech impairment and inability to work.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Speech disorder, Thrombotic microangiopathy, Thrombotic thrombocytopenic purpura
Clinical narrative: Developed headache and easy bruising within days after first vaccine, associated with progressive fatigue and malaise. Never felt better after first vaccine. Then received second vaccine 8/1/2021.  The next day, developed facial numbness, left arm and hand numbness; diagnosed with Bells palsy. the next day developed chest pressure, shortness of breath and lightheadedness, prompting ER visit 8/6/2021. on presentation, hemoglobin 4.8, platelets 7, with evidence of thrombotic microangiopathy and . Ultimately diagnosed with acquired TTP when ADAMTS activity level returned undetectable and inhibitor was elevated. She underwent plasma exchange, received steroids, caplacizumab, and rituximab therapy.  TTP is now in remission, but she has daily headaches unrelieved with numerous medications, and has persistent Bells palsy on left face, causing speech impairment and inability to work.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Malaise
Clinical narrative: COVID-19 infection, mild-to-moderate.  Fully vaccinated.  There have been several cases of COVID in the unit where patient is hospitalized.  On room air  experienced symptom onset overnight with HA and other symptoms including cough.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Malaise, Nausea
Clinical narrative: emergency department the patient was nontoxic-appearing but tachycardic to the 120s to 140s. had a fever last evening of 38.1
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: emergency department the patient was nontoxic-appearing but tachycardic to the 120s to 140s. had a fever last evening of 38.1
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: emergency department the patient was nontoxic-appearing but tachycardic to the 120s to 140s. had a fever last evening of 38.1
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 04/03/22 presents to ED for "Acute diarrhea". PMHx of "lung cancer, COPD, and diverticulitis "
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Diarrhoea, SARS-CoV-2 test positive
Clinical narrative: 04/03/22 presents to ED for "Acute diarrhea". PMHx of "lung cancer, COPD, and diverticulitis "
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aggression, COVID-19, SARS-CoV-2 test positive
Clinical narrative: 01/04/22 presents to ED "via EMS from his living facility due to aggressive behavior". PMHx of "tobacco use, paranoid schizophrenia, morbid obesity, HTN, prior pulmonary embolism, atrial fibrillation on Eliquis, and COPD"
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: My arm got really sore and it still hurts to this day. I had a fever of 100.3 as well and I had some aches and pains. I thought the pain in my arm went away about a week ago, but now it has started back and the pain is going down to my elbow and forearm.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: My arm got really sore and it still hurts to this day. I had a fever of 100.3 as well and I had some aches and pains. I thought the pain in my arm went away about a week ago, but now it has started back and the pain is going down to my elbow and forearm.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm pain after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain after previous doses) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Drug allergy, Cancer (Started 25 to 30 years ago), Blood pressure abnormal and High cholesterol.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain after previous doses). At the time of the report, VACCINATION SITE PAIN (arm pain after previous doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unknown blood pressure and high cholesterol medication.  No treatment medication reported.   This case was linked to MOD-2022-559342, MOD-2022-559589, MOD-2022-559608 (Patient Link).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported.; Caller reports a dose of MMR II was administered intramuscularly. No additional AE reported. No PQC reported.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not reported.  On 14-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) lot # U022983, expiration date: 22-JUL-2023, 0.5 milliliter, intramuscular for prophylaxis (incorrect route of product administration). No additional adverse events reported.  The lot # U022983 was verified to be valid number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (expiration date: 22-JUL-2023).
Age: 24.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: A medical assistant called to determine the valiidity of the dose of PROQUAD given to 24 year old; No additional AE's; This spontaneous report was received from a certified medical assistant and refers to a 24-year-old patient of unknown gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, lot number, expiration date, route of administration and anatomical location were not reported) for prophylaxis. The reporter called to determine the validity of this administered vaccine. No additional adverse events were reported.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA005463:
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; an adult dose of VAQTA was administered to a pediatric patient; This spontaneous report was received from a nurse and refers to a pediatric patient of unknown exact age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 19-MAR-2018, the patient was administered with an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered by device, No adverse event, Syringe issue, Underdose
Clinical narrative: No additional AE reported; an unknown amount of vaccine was injected to the patient and theyare not sure how much vaccine leaked out ofthe syringe; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On 19-APR-2022 (also reported as today), the patient was vaccinated with a partial dose of vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), at a dose of 0.5 milliliter, lot number U013278, expiration date: 26-OCT-2023, administered for prophylaxis (strength, frequency, route of administration and anatomical location  were not provided) due to a non-Merck syringe leaking during administration and the nurse was not sure how much vaccine leaked out of the syringe (incorrect dose administered by product) and how much amount of vaccine was injected to the patient. No adverse event was reported.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: An 82 year old man have this Prevnar 20 vaccine even though already have both the PPSV 23 and Prevnar 13; An 82 year old man have this Prevnar 20 vaccine even though already have both the PPSV 23 and Prevnar 13; No adverse event; This spontaneous report was received from a consumer via Pfizer concerning a 82-year-old male patient. The patient's medical history, concurrent conditions, previous drugs reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (indication, dose, frequency, route, lot # and expiration date not reported) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) for prophylaxis (frequency, route, lot # and expiration date not reported). However, even though he had already received both vaccines, on an unspecified day, the reporter though that the Pharmacist said he was not supposed to get it but he got it because it was write it as the prescription and he was vaccinated with Pneumococcal 20-valent Conjugate Vaccine (PREVNAR 20) for prophylaxis (dose, frequency, route, lot # and expiration date not reported) Product prescribing issue, (Inappropriate schedule of product administration) (Extra dose administered). No adverse event was seen.
Sex: M
Vaccine: MMR
Symptoms: Accidental exposure to product, Occupational exposure to product
Clinical narrative: No additional AEs filed.; the possibility of the caller experiencing an exposure to the live virus vaccine; when retracted the needle 2-3 drops of MMR II went to the air; he was a physician and administered the MMR II vaccine to his wife in their home/ possibility of the caller experiencing an exposure to the live virus vaccine; This spontaneous report was received from a male patient of unknown age, who was a physician and was reporting on himself. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 21-APR-2022, the physician administered Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, route of administration, injection site, lot number, expiration date and albumin status were not reported) as prophylaxis to his wife in their home. The reporter stated, that after he administered the vaccine, he retracted the needle, and 2-3 drops of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) "went into the air" (accidental exposure to product, occupational exposure while administering product). The physician wore gloves when he administered the virus. No additional adverse events were reported. It was unknown if the physician sought medical attention. The caller was very concerned about this possible exposure and was requesting an urgent call back.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007531:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller is a medical assistant who reports administration of vaccine following temperature excursion. Patient did not have any symptoms or adverse effects of receiving vaccine. No further information provided. No other AE/no PQC.         ?    Names; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs allergies and reactions were not provided. Concomitant medications included sterile diluent.  On 13-APR-2022, the patient was vaccinated with a wrongly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin  rHA) (PROQUAD) 0.5 milliliter/once, lot number U028179, expiration date reported as 08-MAR-2023, (strength, and route of administration were not provided) (product storage error). The patient did not have any symptoms or adverse effects for the administration of the vaccine. The temperature of the excursion of the vaccine was -13 Celsius degree (C) for a time of 1 hour.
Age: 1.17
Sex: U
Vaccine: MMRV, PNC13, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product use issue, Underdose, Wrong product administered
Clinical narrative: No additional AE reported; A nurse reported a patient inadvertently received PROQUAD instead of MMR II.Interchange of vaccine products; A nurse reported a patient inadvertently received PROQUAD instead of MMR II.; She also states only about half of the medication (0.25mL) was administered because the patient moved their leg during administration and the needle slipped out.; This spontaneous report was received from a nurse and refers to a 14-month-old patient, of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not provided.  On 24-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin-rHA) (PROQUAD), 0.25 ml administered, lot number U015480, expiration date: reported as 13-NOV-2022, (strength, and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong vaccine administered-drug use for unapproved schedule). Also, the patient only received the half of the vaccine dose (0.25 milligram (ml)) because the patient moved their leg during the administration and the needle slipped out (incomplete dose administered). On the same date, the patient was also vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX); and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13),(strength, formulation, dose description, lot number, expiry date, and route of administration were not provided for none on both), which the nurse reported that the patient received the full dose of both vaccines. No additional adverse event was reported.  .
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: Incorrect product storage; No additional AE; Nurse reporting patient administered PROQUAD and VARIVAX instead of MMRII.; overdose; This spontaneous report was received from a nurse, concerning to a patient of unknown age and gender.   The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 22-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  lot #W004694 has been verified to be a valid lot, expiration date 08-AUG-2023, administered for prophylaxis (strength, dose, route of administration  and anatomical location were not provided), and  varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided)  instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered, overdose). No additional adverse event were reported. The temperature was from 14 to 46  Fahrenheit  (also reported as -10 centigrade up to 8 centigrade), in addition the temperature was measured as 40 F for 120 hours. (product storage error).   .
Age: 21.0
Sex: F
Vaccine: COVID19, HEP
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Vaccine exposure before pregnancy; This spontaneous report was received from a consumer, concerning to herself, an approximately 21-years-old female patient.  The patient's medical history was not reported. Her concurrent conditions included allergy to messenger RNA (MRNA) vaccines and egg protein allergy. The concomitant therapies were not reported.  On an unknown date in 2001, the patient received the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscularly (IM) (dose, lot #, and expiry date not provided) as immunization from hepatitis B.  On an unknown date in 2001, the patient developed right arm numbness after the administration of the vaccine (Hypoaesthesia) (captured on MARRS#2204USA006755), that lasted approximately one month. She stated that after she could not lift or move her arm or hold a pencil (Injected limb mobility decreased) (captured on MARRS#2204USA006755). The patient was in the college at the time and had to have someone take class notes for her. She also experienced pain at the injection site and the area still "felt like a bruise" at that time (captured on MARRS#2204USA006755). These symptoms happened after the administration of the vaccine. Furthermore, the patient reported that on an unknown date in 2021 (also reported as recently), she found out she was allergic to egg protein and had experienced anaphylactic (also reported as anaphalatic) shock by being close to people who had received Coronavirus disease (Covid) vaccine (captured on MARRS#2204USA006755), and she was allergic to all MRNA vaccines. It was reported that at the moment of the administration of hepatitis B vaccine (RECOMBIVAX HB) (manufacturer unknown) she was not pregnant, but currently she was 4-month pregnant.  The action taken with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) was reported as discontinued, since after the administration of the first dose of the vaccine the patient did not finish the vaccination series.; Sender's Comments:  US-009507513-2204USA006755:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller is an office manager who reports administration of vaccine following temperature excursion. No adverse effects of administration. No further information provided. No other AE/no PQC.          ?    Names of vaccines involved (including lot/ex; Caller is an office manager who reports administration of vaccine following temperature excursion. No adverse effects of administration. No further information provided. No other AE/no PQC.          ?    Names of vaccines involved (including lot/ex; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml/once per oral route, lot #1821247, expiration date: 23-JUL-2022 (strength was not provided).   On 25-APR-2022, a product temperature excursion issue occurred, a call was made by an office manager who reported the administration of vaccine following temperature excursion. No adverse effects after administration. Temperature was 11.4 degree Celsius (C) time frame of 4 hours 45 minutes, prior excursion 10.7 C for 1 hour 15 minutes. No further information provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker reported that 14 patients received possibly improperly stored vaccines due to lack of temperature readings; Spontaneous information has been received from a healthcare worker concerning to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  A possible temperature excursion was reported for some stored vaccines due to the freezer temperature was not recorded since 10-JAN-2022.  On 04-APR-2022, the patient was administered a improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T028582, has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and validated as 04-MAR-2023) (route of administration and anatomical location were not provided) as prophylaxis (product storage error). No additional adverse events were reported (no adverse event).  This is one of 14 reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker reported that 1 patients received possibly improperly stored vaccines due to lack of temperature readings; This spontaneous information has been received from an other health care professional concerning to a patient of unknown age and gender.   The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  A possible temperature excursion was reported for some vaccines due to the freezer temperature was not recorded since 10-JAN-2022.  On 18-APR-2022, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U015476, has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and validated as 13-NOV-2022) (strength, route of administration and anatomical location were not provided) as prophylaxis (product storage error). No additional adverse events were reported (no adverse event). No previous temperature excursion was reported.  This is one of 14 reports from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The health care worker reported that 14 patients received possibly improperly stored vaccines due to lack of temperature readings; This spontaneous information has been received from an other health care professional concerning to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  A possible temperature excursion was reported for some vaccines due to the freezer temperature was not recorded since 10-JAN-2022.  On 14-JAN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(dosage regimen not provided) taken orally, lot # 1707593, expiration date 24-MAR-2022, administered as prophylaxis (product storage error). No additional adverse events were reported (no adverse event). The temperature excursion timeframe was reported (since 10-JAN-2022) under an unknown temperature, because since that day the temperatures were not recorded. No previous temperature excursion was reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA000553: US-009507513-2205USA000535: US-009507513-2205USA000545: US-009507513-2205USA000484: US-009507513-2205USA000525: US-009507513-2205USA000503: US-009507513-2205USA000524: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000533: US-009507513-2205USA000540: US-009507513-2205USA000544: US-009507513-2205USA000564: US-009507513-2205USA000560:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster reactivation, Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia; Multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation on 29-APR-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for the prevention of shingles. After the vaccine, the pt suffered multiple outbreaks of herpes zoster, and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care.. As a direct and proximate result the patient symptoms have resulted in physical limitations not present prior to using the vaccine. The pt also experience mental and emotional distress due to resulting physical limitations and serious condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of patients conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of herpes zoster reactivation and post herpetic neuralgia was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered herpes zoster reactivation and post herpetic neuralgia to be disabling events.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE information; LPN calling for stability data on vaccine that has been administered past expiration date.; This spontaneous report was received from a Licensed Practical Nurse (LPN) referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 30-APR-2022, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, (strength, dose, frequency, and route of administration were not provided); lot # T035721 has been verified to be a valid lot number with expiration date: 15-APR-2022, administered as prophylaxis. The reporter was calling for stability data on vaccine that had been administered past the expiration date (expired product administered). When asked about prior temperature excursions, was transferred to the person who was in charge of vaccine storage, and she confirmed that the expired administered vaccine was never stored at a temperature outside of its recommended storage range. No additional adverse event (AE) information. No product quality complaint (PQC) involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; Nurse reporting expired MMRII administered to patient.  No temperature excursion.  Read supported disclaimer.  No additional AE.  No PQC.; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 02-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (product administered) for prophylaxis (lot # t007231 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and established as 27-FEB-2022) (strength, dose, route of administration and anatomical location were not provided).   No adverse event reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; The vaccine was administered on 20-APR-2022 (expiration date 14-APR-2022); This spontaneous report was received from a registered nurse concerning a 4 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 20-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (expired product administered), subcutaneously, in the left arm, for prophylaxis, expiration date 14-APR-2022 (strength, dose and lot number were not provided) and with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) in the left deltoid, lot number E2L54, expiration date 03-MAR-2023 (strength, route of administration and indication were not provided).      No adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired vaccine used; This spontaneous report was received from a licensed practical nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.   On 03-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), at a dose of 0.5 milliliter (ml) (lot # S032825, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 16-OCT-2021) (frequency, route of administration, anatomical location and vaccination scheme were not reported) as prophylaxis (expired product administered). No additional adverse events were reported.