chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Optic neuritis
Clinical narrative: Optic neuritis of left eye; This clinical trial case, initially received on 26-Mar-2024 (including additional information received on 29-Mar-2024),  was reported by a health professional and concerns an elderly male subject. Weight: 101.7 kg; Height: 184.5 cm  The subject was enrolled in the study.  Past medical history included Squamous Cell Carcinoma on the Right Hand, Squamous Cell Carcinoma on the Right Hand Removal, Umbilical Hernia, Umbilical Hernia Repair. At the time of the event the subject had Alcohol Use, Hypercholesterolemia, Acid Reflux, Seasonal Allergies, Irritable Bowel syndrome, Generalized Body Aches. Concomitant medication: ibuprofen for generalized body aches and aches in right elbow, cetirizine, and fluticasone, both for seasonal allergies, Sennoside (sennoside a+b calcium) for irritable bowel syndrome, atorvastatin for hypercholesterolemia, omeprazole for acid reflux, guaifenesin, and pseudoephedrine, both for nasal congestion.  Administration of company suspect drug(s): On 28-Nov-2023, at 11:59, the subject received aQIVc HD vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatimical Location: Left Deltoid, Lot number: Unavailable. The study vaccine was administered as per the protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 20-Dec-2023, the subject experienced Optic neuritis of left eye (outcome: Recovered / Resolved, stop date: 30-Apr-2024).  Non-drug treatment/Other action taken:  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment: The Investigator assessed the event of Optic neuritis as moderate and non-serious adverse event of special interest (AESI). The event was assessed as not related to the study vaccine and the alternative cause for the event was reported as concomitant disease.  Follow up (15-May-2024) received from Investigator: Stop date added as '30-Apr-2024' and outcome updated from 'Not recovered / Not resolved' to 'Recovered / Resolved'. Narrative was amended accordingly.; Reporter's Comments: An elderly subject developed optic neuritis 22 days after receiving aQIVc HD vs QIVr vs aQIV. The Investigator's causality assessment was assessed as not related and the alternative cause for the event was reported as concomitant disease. The Sponsor causality was assessed as related based on the plausible temporal relationship of 22 days after receiving the study vaccine.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Breath sounds abnormal, Cough, Death, Hypotension
Clinical narrative: Observed lying in bed, hypotensive 76/46, O2sat of low 80at 5 liters, RR of 28 and PR of 107, and temp of 96.7. Responsive, denies any chest pain or short of breath when asked. Coughing noted but no phlegm expectorated. Breath sounds diminished, anterior right more than left lung filed. No wheezes or rales. 30 minutes later: Observed resident become unresponsive, even with sternal rub. But had spontaneous respiration and o2sat of low 80s. 20 minutes later: Observed lifeless, no pulse appreciated. Pronounced dead at 5:21 pm.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pulse absent, Unresponsive to stimuli
Clinical narrative: Observed lying in bed, hypotensive 76/46, O2sat of low 80at 5 liters, RR of 28 and PR of 107, and temp of 96.7. Responsive, denies any chest pain or short of breath when asked. Coughing noted but no phlegm expectorated. Breath sounds diminished, anterior right more than left lung filed. No wheezes or rales. 30 minutes later: Observed resident become unresponsive, even with sternal rub. But had spontaneous respiration and o2sat of low 80s. 20 minutes later: Observed lifeless, no pulse appreciated. Pronounced dead at 5:21 pm.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head normal, Eye irritation, Eyelid function disorder, Full blood count normal
Clinical narrative: Bell's Palsy, right side of face, involving right lower face (severe), inability to close right eyelids, and right forehead (initially not involved, but, by 12 hours later, moderate).  Symptoms first noted (right eye irritation--unusual in my previous experience) at about 2pm, on May 26, 2024
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Magnetic resonance imaging head
Clinical narrative: Bell's Palsy, right side of face, involving right lower face (severe), inability to close right eyelids, and right forehead (initially not involved, but, by 12 hours later, moderate).  Symptoms first noted (right eye irritation--unusual in my previous experience) at about 2pm, on May 26, 2024
Age: 46.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT DID NOT REPORT HAVING RECEIVED SHOTS IN THE LAST 14 DAYS AS HER QUESTIONAIRRE ASKED. SHE DOCUMENTED "NO" NEXT TO THAT. WHEN I ASKED HER IF SHE WANTED THE TETANUS SHOT SHE SAID "YES" AFTER ADMINISTERING TETANUS SHOT TO THE RIGHT ARM, I PROCEDED TO ADMINISTER HEPATITIS A/B SHOT IN LEFT ARM AND SAW TWO BANDAIDS. I ASKED HER ABOUT THAT AND SHE SAID THAT SAME DAY PHARMACY HAD GIVEN HER THE WHOOPING COUGH SHOT. I REALIZED SHE HAD BEEN GIVEN 2 OF THE SAME SHOTS ON THE SAME DAY AND INFORMED HER OF THIS. FOLLOW UP CALL WITH PATIENT ON 5/27/24 REVEALED NO ADVERSE EVENTS RELATED TO DUPLICATE SHOTS.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident v/s 149/75,138,34,98,6,79%5lpm, placed a call to facility on call spoke to FNP, ordered Morphine soln 20mg/ml and give 0.5ml=10mg SL now x 1 dose then may give 0.25ml=5mg every 3 hours prn Resident pronounced dead at 1:35am.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin increased, Blood creatinine normal, Blood glucose normal, Body temperature increased, Fall
Clinical narrative: 5.13.2024 at 11:30am Resident noted to have increased drowsiness this morning compared to baseline. Ambulating with stand by assist but resident gait unsteady. Resident then fell at 9:41pm on 5.13 and again at 4:10pm on 5.14 on 5/14 at 6:00pm noted resident to be tachycardic and had elevated temp. Fell again on 5.14 at 7pm, Resident started on IV fluids 5.14.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Gait disturbance, Metabolic function test, Somnolence, Tachycardia
Clinical narrative: 5.13.2024 at 11:30am Resident noted to have increased drowsiness this morning compared to baseline. Ambulating with stand by assist but resident gait unsteady. Resident then fell at 9:41pm on 5.13 and again at 4:10pm on 5.14 on 5/14 at 6:00pm noted resident to be tachycardic and had elevated temp. Fell again on 5.14 at 7pm, Resident started on IV fluids 5.14.
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Diabetic ketoacidosis, Intensive care, Laboratory test, Pollakiuria, Thirst
Clinical narrative: Patient was receiving her 2nd Dose of the COVID19 Moderna vaccine. Started developing excessive urination/thirst~ 1 week after 2nd vaccine. 2 weeks later was brought to ER with New onset of diabetes and was in DKA. Flown on a jet to ICU from hospital where was treated as new diabetic type I. Continues to be diabetic dependent on insulin for the rest of her life. No family history of DM and was never diagnosed with COVID19.
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Patient was receiving her 2nd Dose of the COVID19 Moderna vaccine. Started developing excessive urination/thirst~ 1 week after 2nd vaccine. 2 weeks later was brought to ER with New onset of diabetes and was in DKA. Flown on a jet to ICU from hospital where was treated as new diabetic type I. Continues to be diabetic dependent on insulin for the rest of her life. No family history of DM and was never diagnosed with COVID19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling hot, Peripheral venous disease, Tenderness, Varicophlebitis
Clinical narrative: Varicose veins on medial side of right knee became swollen inflamed and hot and sore to touch
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Allergy test positive, Blood immunoglobulin E, Blood immunoglobulin G, Condition aggravated, Eczema
Clinical narrative: Immediate symptoms less than 24 hours later included a severe rash on lower abdomen and bright red circles around eyes. Within 2-3 weeks, he presented with severe eczema widespread across his face, arms, abdomen, legs, and feet, along with persistent gastrointestinal issues. Within 6 months he presented with muscle weakness limiting gross motor mobility, increased allergies to both food and environment, and overactive immune system (frequent hives, itching, rashes).
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Food allergy, Gastrointestinal disorder, Hypersensitivity, Immune system disorder
Clinical narrative: Immediate symptoms less than 24 hours later included a severe rash on lower abdomen and bright red circles around eyes. Within 2-3 weeks, he presented with severe eczema widespread across his face, arms, abdomen, legs, and feet, along with persistent gastrointestinal issues. Within 6 months he presented with muscle weakness limiting gross motor mobility, increased allergies to both food and environment, and overactive immune system (frequent hives, itching, rashes).
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Motor dysfunction, Muscular weakness, Pruritus, Rash, Stool analysis abnormal
Clinical narrative: Immediate symptoms less than 24 hours later included a severe rash on lower abdomen and bright red circles around eyes. Within 2-3 weeks, he presented with severe eczema widespread across his face, arms, abdomen, legs, and feet, along with persistent gastrointestinal issues. Within 6 months he presented with muscle weakness limiting gross motor mobility, increased allergies to both food and environment, and overactive immune system (frequent hives, itching, rashes).
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Immediate symptoms less than 24 hours later included a severe rash on lower abdomen and bright red circles around eyes. Within 2-3 weeks, he presented with severe eczema widespread across his face, arms, abdomen, legs, and feet, along with persistent gastrointestinal issues. Within 6 months he presented with muscle weakness limiting gross motor mobility, increased allergies to both food and environment, and overactive immune system (frequent hives, itching, rashes).
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash on both forearms; resembles prickly heat.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Gingival recession, Skin exfoliation
Clinical narrative: Hip hurts think I need a hip replacement and my gums are receding fast also scaly skin
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: PATIENT REPORTED RASH ON HER ARM, POSSIBLE INFECTION, FEVER
Sex: U
Vaccine: HPV9
Symptoms: Device connection issue, Device issue, Needle issue, No adverse event, Product leakage
Clinical narrative: The patient did not reported any additional AEs; Pharmacist reported that after administering a dose of GARDASIL 9 to a patient, the needle "slipped off" the Luer lock attachment and some vaccine spilled.; Pharmacist stated she believes the issue was due to the brand of needle she was using, which may not have fully attached to the Luer lock while she was preparing the vaccine; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-MAY-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, dose reported as: 1 dose, lot #1967338, which had been verified to be a valid lot number, expiration date reported and confirmed as 26-JAN-2026, administered for prophylaxis (strength, exact dose, route of administration, and anatomical location were not provided).  On 21-MAY-2024, the pharmacist reported that after administering the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to the patient, the needle "slipped off" the Luer lock attachment and some vaccine spilled and believed the issue was due to the brand of needle she was using, which might not have fully attached to the Luer lock while she was preparing the vaccine (device connection issue ). The pharmacist reported that she was concerned that the patient did not potentially receive the full dose of the vaccine (underdose). No one was injured and the the patient did not reported any additional adverse event (no adverse event). In addition it was confirmed that it was not note any damage to the product before or after administration and product was not available for return, as it was discarded. Moreover, pictures were not available for the product, as the product was discarded before any were taken.  Detail description of the defect was reported as following: the syringe needle was attached to the syringe tip when the issue or breakage was noted or occurred but there was not a crack; the syringe was not broken into 2 or more pieces and did not have a broken component. In addition, there was no a difficulty attaching the syringe needle to the syringe and the syringe carton was undamage prior to use. The defect was noted immediately after giving the injection. Moreover, the syringe tip cat was attached properly prior to use; the syringe was intact and undamaged on receipt and the product came with a cellophane cover, which was covering the syringe tray intact and completely sealed.
Sex: U
Vaccine: HPV9
Symptoms: Underdose
Clinical narrative: The patient did not reported any additional AEs; Pharmacist reported that after administering a dose of GARDASIL 9 to a patient, the needle "slipped off" the Luer lock attachment and some vaccine spilled.; Pharmacist stated she believes the issue was due to the brand of needle she was using, which may not have fully attached to the Luer lock while she was preparing the vaccine; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-MAY-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, dose reported as: 1 dose, lot #1967338, which had been verified to be a valid lot number, expiration date reported and confirmed as 26-JAN-2026, administered for prophylaxis (strength, exact dose, route of administration, and anatomical location were not provided).  On 21-MAY-2024, the pharmacist reported that after administering the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to the patient, the needle "slipped off" the Luer lock attachment and some vaccine spilled and believed the issue was due to the brand of needle she was using, which might not have fully attached to the Luer lock while she was preparing the vaccine (device connection issue ). The pharmacist reported that she was concerned that the patient did not potentially receive the full dose of the vaccine (underdose). No one was injured and the the patient did not reported any additional adverse event (no adverse event). In addition it was confirmed that it was not note any damage to the product before or after administration and product was not available for return, as it was discarded. Moreover, pictures were not available for the product, as the product was discarded before any were taken.  Detail description of the defect was reported as following: the syringe needle was attached to the syringe tip when the issue or breakage was noted or occurred but there was not a crack; the syringe was not broken into 2 or more pieces and did not have a broken component. In addition, there was no a difficulty attaching the syringe needle to the syringe and the syringe carton was undamage prior to use. The defect was noted immediately after giving the injection. Moreover, the syringe tip cat was attached properly prior to use; the syringe was intact and undamaged on receipt and the product came with a cellophane cover, which was covering the syringe tray intact and completely sealed.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP calling to report that patient received inappropriately stored VARIVAX.; This spontaneous report was received from medical assistant and refers to an 1-year-old patient of unknown gender. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On 13-MAY-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, lot #X026789, expiration date: 14-NOV-2025 (who had been verified to be a valid number), administered for prophylaxis (strength, and route of administration were not provided).  It was reported that the vaccine was administered at temperature of 19.8 F with a time of 20 hours 15 minutes. There was no information about previous temperature excursion (product storage error).   No additional adverse events.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Confusional state, Dizziness, Dyskinesia
Clinical narrative: Body jerks like eclilepsy. Dizzy/vertigo trouble walking confusion blurred vision for 7 months now
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Gait disturbance, Magnetic resonance imaging, Sleep study, Ultrasound scan
Clinical narrative: Body jerks like eclilepsy. Dizzy/vertigo trouble walking confusion blurred vision for 7 months now
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: Body jerks like eclilepsy. Dizzy/vertigo trouble walking confusion blurred vision for 7 months now
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Immune system disorder, Inflammation, Loss of personal independence in daily activities
Clinical narrative: A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.  Heightened immune system causing inflamation throughout my body over the  past 3 years
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain management, X-ray
Clinical narrative: A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.  Heightened immune system causing inflamation throughout my body over the  past 3 years
Age: 78.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I administered Shingrix and Boostrix to a customer. At the time, she indicated that she had not received Shingrix or Tdap in the last 10 years. Today, she returned and apologized for providing incorrect information. She informed me that she had actually received two doses of Shingrix and Tdap 7 years ago. I advised her not to receive any further doses of Shingrix and to inform her primary care physician about this situation.  Please let me know if you have any questions about this information.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, body aches, and chills. Tylenol taken, somewhat helpful
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Injection site urticaria, Pain, Pyrexia, Rash
Clinical narrative: 24 hours after noticed small red bumps on upper arm below the injection site - saw primary care about 2 weeks later (estimate) as it was getting bigger and tighter. Diagnosed with hematoma. When the area worsened I returned to the doctor where I had also noticed a bump on my glute, one on my hip, and the ones on my arm remained. He ordered a ultrasound which could not rule out metastasis.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: 24 hours after noticed small red bumps on upper arm below the injection site - saw primary care about 2 weeks later (estimate) as it was getting bigger and tighter. Diagnosed with hematoma. When the area worsened I returned to the doctor where I had also noticed a bump on my glute, one on my hip, and the ones on my arm remained. He ordered a ultrasound which could not rule out metastasis.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Injection site nodule, Metastatic renal cell carcinoma
Clinical narrative: 24 hours after noticed small red bumps on upper arm below the injection site - saw primary care about 2 weeks later (estimate) as it was getting bigger and tighter. Diagnosed with hematoma. When the area worsened I returned to the doctor where I had also noticed a bump on my glute, one on my hip, and the ones on my arm remained. He ordered a ultrasound which could not rule out metastasis.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Condition aggravated, Injection site erythema, Injection site haematoma, Injection site rash
Clinical narrative: 24 hours after noticed small red bumps on upper arm below the injection site - saw primary care about 2 weeks later (estimate) as it was getting bigger and tighter. Diagnosed with hematoma. When the area worsened I returned to the doctor where I had also noticed a bump on my glute, one on my hip, and the ones on my arm remained. He ordered a ultrasound which could not rule out metastasis.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site reaction, Metastasis, Renal cancer metastatic, Swelling, Ultrasound scan abnormal
Clinical narrative: 24 hours after noticed small red bumps on upper arm below the injection site - saw primary care about 2 weeks later (estimate) as it was getting bigger and tighter. Diagnosed with hematoma. When the area worsened I returned to the doctor where I had also noticed a bump on my glute, one on my hip, and the ones on my arm remained. He ordered a ultrasound which could not rule out metastasis.
Age: 61.0
Sex: U
Vaccine: HEPA
Symptoms: Device issue, Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects were reported; the plunger would not move forward; attempting to administer VAQTA he put the needle in the patient's deltoid; Dose Frequency 50ml; This spontaneous report was received from a pharmacist referring to a 61-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 22-MAY-2024, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) 50U/ 1.0ML intramuscular injection (50 ml, lot #: X006702, expiration date: 01-OCT-2024; route of administration was not provided) for prophylaxis by a health professional (overdose). When attempting to administer Hepatitis A Vaccine, inactivated (VAQTA), the professional put the needle in the patient's deltoid and the plunger was stuck and would not move forward (device issue and product quality device used). When he removed the syringe, he tried again to push the plunger forward, but it would not move.  The plunger would not allow release of the product. The product was available for retrieval mailer requested. No adverse effects were reported (no adverse event). It was confirmed the patient did not miss a dose.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored PROQUAD.; This spontaneous report has been received form a medical assistant, regarding a 4-year-old patient of unspecified gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 14-MAY-2024, the patient was vaccinated with an improperly storage single dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROAQUAD) injection, as prophylaxis (lot number: Y003143, which was determined to be valid, with an expiration date on 27-JUL-2025. Therapy type: rHA) (strength, dose, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of 19.8 degrees Fahrenheit (F) for 20 hours and 15 minutes. No previous temperature excursion nor additional adverse events were reported.  This is one of reportedly 34 cases form the same reporter.; Sender's Comments:  US-009507513-2405USA007578:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored PROQUAD.; This spontaneous report has been received form a medical assistant, regarding a 4-year-old patient of unspecified gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 21-MAY-2024, the patient was vaccinated with an improperly storage single dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROAQUAD) injection, as prophylaxis (lot number: Y003143, which was determined to be valid, with an expiration date on 27-JUL-2025. Therapy type: rHA) (strength, dose, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of 19.8 degrees Fahrenheit (F) for 20 hours and 15 minutes. No previous temperature excursion nor additional adverse events were reported.  This is one of 34 cases form the same reporter.; Sender's Comments:  US-009507513-2405USA007573:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored VARIVAX.; This spontaneous report was received from a medical assistant concerning an 1-year-old patient of unknown gender. The patient's medical history, previous drug reactions or allergies, concurrent conditions, and concomitant therapies were not reported.  On 17-MAY-2024, the patient was vaccinated with an improperly stored single dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X026789, which had been verified to be a valid lot number, expiration date reported and confirmed as 14-NOV-2025, administered for prophylaxis (strength, dose, route of administration, and anatomical location was not provided) (Product storage error). Temperature excursion was reported as 19.8 degrees Fahrenheit (F) for 20 hours, 15 minutes. No previous temperature excursion nor adverse effects were reported (no adverse event).   Operator of device was a health care professional.  This is one of the 34 cases received from the same reporter.; Sender's Comments:  US-009507513-2405USA007454: US-009507513-2405USA007488: US-009507513-2405USA007573: US-009507513-2405USA007578: US-009507513-2405USA007600: US-009507513-2405USA007617: US-009507513-2405USA007648: US-009507513-2405USA007722: US-009507513-2405USA007720: US-009507513-2405USA007713: US-009507513-2405USA007692:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored PROQUAD.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history, previous drug reactions or allergies, concurrent conditions, and concomitant therapies were not reported.  On 21-MAY-2024, the patient was vaccinated with an improperly stored single dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA])(PROQUAD) injection, lot #Y003143,  which had been confirmed to be a valid lot number; expiration date reported and confirmed as 27-JUL-2025, administered for prophylaxis (strength, dose, route of administration, and anatomical location were not provided). Temperature excursion was reported as 19.8 degree Fahrenheit (F) for 20 hours, 15 minutes (product storage error). No previous temperature excursion not adverse effects were reported (no adverse event).   Operator of device was a health care professional.  This is one of the 34 cases received from the same reporter.; Sender's Comments:  US-009507513-2405USA007588: US-009507513-2405USA007454: US-009507513-2405USA007488: US-009507513-2405USA007573: US-009507513-2405USA007578: US-009507513-2405USA007617: US-009507513-2405USA007648: US-009507513-2405USA007667: US-009507513-2405USA007684: US-009507513-2405USA007791: US-009507513-2405USA008015: US-009507513-2405USA007935: US-009507513-2405USA007924: US-009507513-2405USA007916: US-009507513-2405USA007912: US-009507513-2405USA007911: US-009507513-2405USA007909: US-009507513-2405USA007905: US-009507513-2405USA007901: US-009507513-2405USA007841: US-009507513-2405USA007833:
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs were reported; Physician reported that one year old patient received PROQUAD and MMR II vaccine on the same day instead of VARIVAX and MMR II; This spontaneous report was received from a physician and refers to an 1-year-old patient of unknown gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 21-MAY-2024, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, lot # y000135, with expiration date not provided but upon internal validation confirmed as 01-JUL-2025, administered for prophylaxis (strength, frequency, route of administration, and anatomical location were not provided); and 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, lot # x020654, with expiration date: 21-OCT-2024, administered for prophylaxis (strength, frequency, route of administration and anatomical location were not provided), instead of varicella virus vaccine live (oka/merck) (VARIVAX) injection for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (accidental overdose).  No adverse events reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse effects reported; HCP calling to report that patient received inappropriately stored VARIVAX.; This spontaneous report was received from a medical assistant concerning a 1-year-old patient of unknown gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 15-MAY-2024, the patient was vaccinated a single dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X026789, expiration date: 14-NOV-2025, administered for prophylaxis (strength, dose, frequency, route of administration, and anatomical location were not provided).  The vaccine was improperly stored at a temperature of 19.8 degrees Fahrenheit (F) for a time frame of 20 hours and 15 minutes. There was no previous temperature excursion.  This is one of several cases from the same reporter.
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse event; Pharmacist called to report A patient received SHINGRIX when they were supposed to receive VARIVAX.; This spontaneous report was received from pharmacist and refers to a female patient of unknown age (conflicting information date of birth reported). No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 16-MAY-2024, the patient received varicella zoster vaccine rge (cho) (SHINGRIX) when they were supposed to received varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, doses, frequencies, lot numbers, expiry dates, and routes of administration were not provided) (wrong product administered).  No additional adverse event.  Lot number is being requested and will be submitted if received.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received inappropriately stored PROQUAD.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 20-MAY-2024, the patient was vaccinated with improperly storage vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, single dose, lot #Y003143, expiration date: 27-JUL-2025 (strength, exact dose and route of administration were not provided) administered for prophylaxis. The vaccine was involved in a temperature excursion of 19.8 F, during a time of 20 hours 15 minutes (Product storage error). There was no previous temperature excursion. The operator or the device was a health professional. No adverse effects and no product quality complaint (PQC) were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received inappropriately stored VARIVAX.; This spontaneous report was received from a medical assistant and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-MAY-2024, the patient was vaccinated with improperly storage varicella of virus vaccine live (oka/merck) (VARIVAX) injection, single dose, lot #X026789, expiration date: 14-NOV-2025, (strength, exact dose and route of administration were not provided) administered for prophylaxis. The vaccine was involved in a temperature excursion of 19.8 F during a time of 20 hours 15 minutes (Product storage error). There was no previous temperature excursion. The operator or the device was a health professional. No adverse effects and no product quality complaint reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received inappropriately stored PROQUAD.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 10-MAY-2024, the patient was vaccinated with improperly storage vaccine of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, single dose, lot #Y003143, expiration date reported and confirmed as 27-JUL-2025, (strength, exact dose and route of administration were not provided) administered for prophylaxis. The vaccine was involved in a temperature excursion of 19.8 F, during a time of 20 hours 15 minutes (Product storage error). There was no previous temperature excursion. The operator or the device was a health professional. No adverse effects and no product quality complaint (PQC) were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received inappropriately stored PROQUAD.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 10-MAY-2024, the patient was vaccinated with improperly storage vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, single dose, lot #Y003143, expiration date was reported and confirmed as: 27-JUL-2025 (strength, exact dose and route of administration were not provided) administered for prophylaxis. The vaccine was involved in a temperature excursion of 19.8 F, during a time of 20 hours 15 minutes (Product storage error). There was no previous temperature excursion. The operator or the device was a health professional. No adverse effects and no product quality complaint (PQC) were reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received inappropriately stored PROQUAD; This spontaneous report has been received from a medical assistant concerning to a 04-year-old female patient. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 14-MAY-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, single dose, lot number Y003143 that was verified to be a valid lot number (expiration date reported and validated as 27-JUL-2025) as prophylaxis (strength, specific dose, scheme, route, and anatomical location of administration were not provided) (product storage error). The dose was exposed to a temperature of 19.8 F, for 20 hours 15 minutes. There were no previous temperature excursions (TE). No adverse effects were reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received inappropriately stored PROQUAD; This spontaneous report has been received from a medical assistant concerning to a 04-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 14-MAY-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, single dose, lot number Y003143 that was verified to be a valid lot number (expiration date reported and validated as 27-JUL-2025) as prophylaxis (strength, specific dose, scheme, route, and anatomical location of administration were not provided) (product storage error). The dose was exposed to a temperature of 19.8 F, for 20 hours 15 minutes. There were no previous temperature excursions (TE). No adverse effects were reported (no adverse event).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received inappropriately stored VARIVAX; This spontaneous report has been received from a medical assistant concerning to a 01-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 09-MAY-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, single dose, lot number X026789 that was verified to be a valid lot number (expiration date reported and validated as 14-NOV-2025) as prophylaxis (strength, specific dose, scheme, route, and anatomical location of administration were not provided) (product storage error). The dose was exposed to a temperature of 19.8 F, for 20 hours 15 minutes. There were no previous temperature excursions (TE). No adverse effects were reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received inappropriately stored PROQUAD; This spontaneous report has been received from a medical assistant concerning to a 04-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 20-MAY-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, single dose, lot number Y003143 that was verified to be a valid lot number (expiration date reported and validated as 27-JUL-2025) as prophylaxis (strength, specific dose, scheme, route, and anatomical location of administration were not provided) (product storage error). The dose was exposed to a temperature of 19.8 F, for 20 hours 15 minutes. There were no previous temperature excursions (TE). No adverse effects were reported (no adverse event).
Sex: M
Vaccine: HPV4
Symptoms: Intensive care
Clinical narrative: Defecated within womb in which he inhaled and affected his breathing; Foetal exposure during pregnancy; Information has been received from a lawyer via fact sheet on 17-MAY-2024 referring a neonate male patient regarding a case in litigation (mother related cases 2405USA008164 and 2405USA008165). The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 14-JUL-2009, the patient's mother was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), with lot number 0653X, applied in left deltoid (dose and route of administration were not reported) (Foetal exposure during pregnancy).  On an unspecified date in 2020, during birth through a C-section, the patient experienced stress during the long labor causing him to defecate within the womb in which he inhaled and affected his breathing (meconium aspiration), due to this, the patient landed in the neonatal intensive care unit.  At the reporting time, the outcome of the event meconium aspiration was unknown. The patient's mother considered the event to be related to vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as claimed that vaccine affected her gynecological health in this way.  Upon internal review, the event meconium aspiration was determined to be medically significant.  This is one of several reports captured from the same source.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had a reaction which was like having covid again; had a reaction which was like having covid again; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Alpha Gal", start date: 2012 (ongoing), notes: Patient diagnosed with Alpha Gal in Jan of this year; however, had it since 2012.; "Covid", start date: 2020 (unspecified if ongoing), notes: Patient had Covid in the fall of 2020. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had a reaction which was like having covid again". Clinical course: Patient liked to get some information about the ingredients in our Covid Vaccines. patient would like to know if there were any mammal or mammal by-products in the vaccine. The reason patient was asking was that patient was diagnosed with Alpha Gal in Jan of this year; however, actually had it since 2012 and was misdiagnosed with IBS-D. Patient had Covid in the fall of 2020 before the vaccines became available and had all of the Covid vaccines except for the 2023. With each vaccines patient had a reaction which was like having Covid again. With the last vaccine patient took in 2022 the reaction was so bad that patient could not get out of bed for 24 hours. That was why patient had been hesitant to get any vaccines since. Now that patient knew that patient had Alpha Gal, was wondering if reactions are possibly from mammal or mamma' by-products being in the vaccines or a vaccine reaction. Would we also be able to send patient a list of our other vaccines that contain mammal or mammal by-products that can shared with patient's Alpha Gal groups. Unfortunately, mammal and mammal-by-products are in so many things that the medical community and public was not aware. This information would be greatly appreciated.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400068223 same patient and vaccine, different dose and AE;US-PFIZER INC-202400175580 same patient and vaccine, different dose and AE;US-PFIZER INC-202400175581 same patient and vaccine, different dose and AE;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: irregular menstrual cycle; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Lot number: EW0162) at the age of 41 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's hypothyroid", start date: 2009 (ongoing). Concomitant medication(s) included: SYNTHROID oral taken for hypothyroidism, start date: 2009 (ongoing). Vaccination history included: pfizer/biontech COVID-19 vaccine (DOSE 1; lot number: EP7534; in arm), administration date: 26Mar2021, when the patient was 41-year-old, for Covid-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Apr2021, outcome "not recovered", described as "irregular menstrual cycle". The event "irregular menstrual cycle" required physician office visit.  Additional information: Irregular menstrual cycles started early after covid vaccine dose in Apr2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400026231 Same patient and vaccine, different dose and event;US-PFIZER INC-202400175171 Same patient and vaccine, different dose and event;