chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Burning sensation, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Post Herpetic Neuralgia; abdominal pain and a burning rash, and was diagnosed with internal herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 09-MAR-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered abdominal pain and a burning rash, and was diagnosed with internal herpes zoster and post herpetic neuralgia (no information on who established the diagnoses or if treatment was provided). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her 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 of Company's wrongful conduct, 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 Company's conduct, the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of post herpetic neuralgia and herpes zoster visceral was not recovered. The reporter considered events to be related to zoster vaccine live (ZOSTAVAX). The lawyer assessed all events to be disabling.  Upon internal review, the event herpes zoster visceral was determined to be medically significant.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Daughter has just had first pap smear and it is "abnormal and positive for HPV"; This spontaneous report was received from the patient's mother and concerns an 18-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On unknown date in May 2011 at the age of 11, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis.  On unknown date in July 2011, the patient was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis.  On unknown date in November 2011, the patient was vaccinated with the third dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported for 3 doses) for prophylaxis.  On an unknown date after the vaccination cycle, the patient had her first pap smear. Result was reported as abnormal and positive for human papilloma virus (HPV) (smear cervix abnormal). Outcome of the event and causality assessment between the event and suspect drug was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other symptoms or adverse effects; Caller is a nurse who reports GARDASIL 9 given today, but expired yesterday 04/03/2022. Vaccine had no temperature excursions. Potency was supported by Post-Expiry Memo. Caller reported patient had no other symptoms or adverse effects. No other infor; This spontaneous report was received from a registered nurse and refers to a patient of unspecified age and gender. Pertinent medical history, current conditions, concomitant medications, past rug reactions or allergies were not reported.  On 04-APR-2022 (also reported as "today"), the patient was vaccinated with an expire dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (ml) with a frequency reported as "today" (vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number S028738 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 03-APR-2022) as prophylaxis (expired product administered).  It was reported that the vaccine had no temperature excursions and that the potency was supported by Post-Expiry Memo.  No other symptoms or adverse effects (no adverse event) (also reported as "no other AE") were reported.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Discomfort, Fatigue, Feeling abnormal, Gait inability
Clinical narrative: Brain fog; movement disorder; Could not walk; Autoimmune Disease; The patient experienced Postural Orthostatic Tachycardia Syndrome ("POTS") and Autonomic Dysfunction; The patient experienced Postural Orthostatic Tachycardia Syndrome ("POTS") and Autonomic Dysfunction; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 13-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 21-JUN-2017, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) for preventing cervical cancer.  In 2017, the mother noted manifestation of symptoms consistent with injury of autonomic dysfunction. As the months progressed, so did the injuries. She was seen by multiple physicians and specialists for her complaints which now included: Postural Orthostatic Tachycardia Syndrome ("POTS"), paralysis, neurological disorders, movement disorders, brain fog, and is unable to focus her eyes. Plaintiff has uncontrollable tremors during which she has little to no control over her movement. Her symptoms of POTS include seizures, fatigue, fainting, paralysis, blurred vision, chronic nausea, and headache. Plaintiff could not walk for a period. Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including, but not limited to, POTS and autonomic dysfunction.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Movement disorder, Nausea, Nervous system disorder, Paralysis
Clinical narrative: Brain fog; movement disorder; Could not walk; Autoimmune Disease; The patient experienced Postural Orthostatic Tachycardia Syndrome ("POTS") and Autonomic Dysfunction; The patient experienced Postural Orthostatic Tachycardia Syndrome ("POTS") and Autonomic Dysfunction; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 13-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 21-JUN-2017, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) for preventing cervical cancer.  In 2017, the mother noted manifestation of symptoms consistent with injury of autonomic dysfunction. As the months progressed, so did the injuries. She was seen by multiple physicians and specialists for her complaints which now included: Postural Orthostatic Tachycardia Syndrome ("POTS"), paralysis, neurological disorders, movement disorders, brain fog, and is unable to focus her eyes. Plaintiff has uncontrollable tremors during which she has little to no control over her movement. Her symptoms of POTS include seizures, fatigue, fainting, paralysis, blurred vision, chronic nausea, and headache. Plaintiff could not walk for a period. Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including, but not limited to, POTS and autonomic dysfunction.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Seizure, Syncope, Tremor, Vision blurred
Clinical narrative: Brain fog; movement disorder; Could not walk; Autoimmune Disease; The patient experienced Postural Orthostatic Tachycardia Syndrome ("POTS") and Autonomic Dysfunction; The patient experienced Postural Orthostatic Tachycardia Syndrome ("POTS") and Autonomic Dysfunction; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 13-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 21-JUN-2017, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) for preventing cervical cancer.  In 2017, the mother noted manifestation of symptoms consistent with injury of autonomic dysfunction. As the months progressed, so did the injuries. She was seen by multiple physicians and specialists for her complaints which now included: Postural Orthostatic Tachycardia Syndrome ("POTS"), paralysis, neurological disorders, movement disorders, brain fog, and is unable to focus her eyes. Plaintiff has uncontrollable tremors during which she has little to no control over her movement. Her symptoms of POTS include seizures, fatigue, fainting, paralysis, blurred vision, chronic nausea, and headache. Plaintiff could not walk for a period. Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including, but not limited to, POTS and autonomic dysfunction.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cerebrovascular accident, Myocardial infarction, Pain, Post herpetic neuralgia
Clinical narrative: Stroke; Heart attack; had experienced pain in Caller's Right Arm which feels like 'Shingles inside arm' with corresponding pain radiating down Caller's arm and up Caller's shoulder on unknown, previous date; Caller confirm pain was due to 'post-herpetic neuralgia'; This spontaneous report was received from a patient concerning herself, a 65-years-old female patient. Patient current conditions included penicillin allergy. Information regarding the patient's concomitant therapies, medical history and historical drug was not provided.   On 09-APR-2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) 0.65 milliliters subcutaneous route, lot number K020802 (expiration date was not provided) as prophylaxis.  On the same date, the patient experienced pain radiating up her shoulder and down; she reported to feel like "shingles inside arm", later it was confirmed that the pain was due to post-herpetic neuralgia.  On approximately October of 2015 (6 months after vaccine administration), patient confirmed to having experienced a stroke (cerebrovascular accident) and a heart attack (myocardial infarction.)  The outcome of the events was reported as not recovered. Causal relationship between Zoster Vaccine Live (ZOSTAVAX) and the events was not reported.  Upon internal review the events of myocardial infarction and cerebrovascular accident were considered to be medically significant.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product quality issue, Product storage error
Clinical narrative: No additional AEs were reported, no further information provided.; improperly stored; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 29-MAR-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (1 dose, lot # u026664 was evaluated and changed to the valid Lot #U026664, expiration date 24-FEB-2023 or lot# 1741817, expiration date 30-JUL-2022, oral, (exact dose number, route of administration and anatomical location were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 dose, lot # u026217 was evaluated and changed to the valid lot # U026217, expiration date 02-NOV-2023 (exact dose number, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The nurse did not know which specific lot of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient. There were no additional adverse events reported or product quality complaint reported. Administered doses of vaccines experienced the temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. There were no previous excursions reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA001791: US-009507513-2204USA001816: US-009507513-2204USA001821: US-009507513-2204USA001657:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported, no further information provided.; improperly stored; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 29-MAR-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (1 dose, lot # u026664 was evaluated and changed to the valid Lot #U026664, expiration date 24-FEB-2023 or lot# 1741817, expiration date 30-JUL-2022, oral, (exact dose number, route of administration and anatomical location were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 dose, lot # u026217 was evaluated and changed to the valid lot # U026217, expiration date 02-NOV-2023 (exact dose number, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The nurse did not know which specific lot of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient. There were no additional adverse events reported or product quality complaint reported. Administered doses of vaccines experienced the temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. There were no previous excursions reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA001791: US-009507513-2204USA001816: US-009507513-2204USA001821: US-009507513-2204USA001621:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; improperly stored vaccine was adminitrated; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 24-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (strength and route were not reported; lot # u026217 was evaluated and changed to the valid lot # U026217, expiration date: 02-NOV-2023) 1 dose for prophylaxis (product storage error).   It was reported that the suspect vaccine was exposed to a temperature of 34.3 Fahrenheit (F) for a time frame of 55 minutes. There were no previous temperature excursions.   No additional adverse event (AE) information was provided.   This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA001814:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; 33 patients received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 25-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, (lot # U026217 verified as valid with expiration date 02-NOV-2023) (exact dose number, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The temperature to which the vaccine was exposed was 34.3 Fahrenheit degrees for 55 minutes. There were no previous temperature excursions. It was unknown if a digital data logger was involved. No additional adverse events were reported (no adverse event).  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA001621: US-009507513-2204USA001657: US-009507513-2204USA001730: US-009507513-2204USA001821: US-009507513-2204USA001839: US-009507513-2204USA001926: US-009507513-2204USA001952: US-009507513-2204USA001980: US-009507513-2204USA001994: US-009507513-2204USA001998: US-009507513-2204USA002003: US-009507513-2204USA002007: US-009507513-2204USA002009: US-009507513-2204USA002052: US-009507513-2204USA002055: US-009507513-2204USA002072: US-009507513-2204USA002073: US-009507513-2204USA002074: US-009507513-2204USA002075:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE were reported; received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2022, the patient was vaccinated with an improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, lot #U026217, expiration date: 02-NOV-2023 (strength, exact dose, site and route of administration were not provided) for prophylaxis (Product storage error). On an unknown date, before the administration, vaccine underwent temperature excursion at 34.3 degrees Fahrenheit (F) for 55 minutes. No previous excursions were reported. No adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 29-MAR-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #U026664, expiration date: 24-FEB-2023 or lot# 1741817, expiration date: 30-JUL-2022 (the nurse did not know which specific lot of vaccines were administered to specific patients) (strength and exact route of administration were not provided) for prophylaxis (product storage error). The vaccines had been improperly stored in the temperature of 34.3 Fahrenheit degrees (F) for 55 minutes with no previous temperature excursion. It was unknown if digital data logger was involved. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001816: US-009507513-2204USA001821: US-009507513-2204USA001821: US-009507513-2204USA001621: US-009507513-2204USA001657: US-009507513-2204USA001730: US-009507513-2204USA001839: US-009507513-2204USA001848: US-009507513-2204USA001926: US-009507513-2204USA001952: US-009507513-2204USA001980: US-009507513-2204USA001994: US-009507513-2204USA001998: US-009507513-2204USA002003: US-009507513-2204USA002007: US-009507513-2204USA002009: US-009507513-2204USA002052: US-009507513-2204USA002055: US-009507513-2204USA002072: US-009507513-2204USA002073: US-009507513-2204USA002074: US-009507513-2204USA002075:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a pharmacist and concerns a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-APR-2022, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23); dose 0,5 ml; lot number: T021485; expiration date: 15-MAR-2022 (formulation, dose number, frequency, route of administration were not reported) for prophylaxis (expired product administered). Suspect drug did not experienced any temperature excursions.   No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE were reported; received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 21-MAR-2022, the patient was vaccinated with an improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, lot #U026217, expiration date: 02-NOV-2023 (strength, exact dose, site and route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose orally, lot #U026664, expiration date: 24-FEB-2023 or lot#1741817 expiration date: 30-JUL-2022 (strength, exact dose, site of administration were not provided), both of them for prophylaxis (Product storage error). The reporter was not sure, which specific lot# of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient. On an unknown date, before the administration, vaccines underwent temperature excursion at 34.3 degrees Fahrenheit (F) for 55 minutes. No previous excursions were reported. No adverse events were reported (No adverse event).  This is one of several cases from the same reporter.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patients received improperly stored vaccines/temperature: 34.3 F; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 28-MAR-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) route of administration defaulted to oral, lot # U026664, expiration date: 24-FEB-2023 or lot# 1741817, expiration date: 30-JUL-2022 (the nurse did not know which specific lot of vaccines were administered to specific patients) (strength and exact route of administration were not provided) for prophylaxis and improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U026217, expiration date: 02-NOV-2023 (strength and exact route of administration were not provided) for prophylaxis (product storage error). The vaccines had been improperly stored in the temperature of 34.3 Fahrenheit degrees (F) for 55 minutes with no previous temperature excursion. It was unknown if digital data logger was involved. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001621: US-009507513-2204USA001657: US-009507513-2204USA001730: US-009507513-2204USA001748: US-009507513-2204USA001791: US-009507513-2204USA001794: US-009507513-2204USA001805: US-009507513-2204USA001806: US-009507513-2204USA001814: US-009507513-2204USA001839: US-009507513-2204USA001848: US-009507513-2204USA001849: US-009507513-2204USA001865: US-009507513-2204USA001888: US-009507513-2204USA001926: US-009507513-2204USA001952: US-009507513-2204USA001980: US-009507513-2204USA001994: US-009507513-2204USA001998: US-009507513-2204USA002003: US-009507513-2204USA002007: US-009507513-2204USA002009: US-009507513-2204USA002019: US-009507513-2204USA002052: US-009507513-2204USA002055: US-009507513-2204USA002072: US-009507513-2204USA002073: US-009507513-2204USA002074: US-009507513-2204USA002075:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; 33 patients received improperly stored vaccines.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 31-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, lot # U026217, expiration date 02-NOV-2023 (exact dose number, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The temperature excursion was 34.3 degrees Fahrenheit for 55 minutes. There were no previous temperature excursions. No additional adverse events were reported (no adverse event).  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA001791: US-009507513-2204USA001621: US-009507513-2204USA001657: US-009507513-2204USA001730: US-009507513-2204USA001805: US-009507513-2204USA001839: US-009507513-2204USA001926: US-009507513-2204USA001952: US-009507513-2204USA001980: US-009507513-2204USA001994: US-009507513-2204USA001998: US-009507513-2204USA002003: US-009507513-2204USA002007: US-009507513-2204USA002009: US-009507513-2204USA002052: US-009507513-2204USA002055: US-009507513-2204USA002072: US-009507513-2204USA002073: US-009507513-2204USA002074: US-009507513-2204USA002075:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered after temperature excursion; 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, concomitant medications, drug reactions or allergies were not provided.  On 04-APR-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 0.5 ml, lot #U029148, expiration date: 16-MAR-2023 (anatomical location and route of administration were not provided) for prophylaxis (product storage error). The vaccine was stored at a temperature of 25.7 degrees Fahrenheit (F) for 2 hours and 36 minutes. The vaccine did not undergo previous temperature excursions. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; Improperly stored vaccine administered; This spontaneous report was received from the licensed practical nurse who refers to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 22-MAR-2022, the patient was vaccinated with an improperly stored 1 dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB); (lot number: U026217 verified as valid with expiration date: 02-NOV-2023 (route of administration was not reported). On the same date, the patient was also vaccinated with improperly stored 1 dose of rotavirus vaccine, live, oral liquid, pentavalent (ROTATEQ) administered via oral route (as default) (lot # u026664 verified as valid with expiration date: 24-FEB-2023 or lot # 1741817 verified as valid with expiration date: 30-JUL-2022 (the nurse didn't know, which exactly lot # was administered to this specific patient)) (product storage error). Strength, dose, dose number of aforementioned vaccines were not reported, all were administered for prophylaxis. The temperature to which the vaccines were exposed was 34.3 degree of Fahrenheit (34.3F) and the time frame was reported as 55 minutes. No previous temperature excursion was reported. It was unknown if a digital data logger was involved. No adverse symptoms were reported.  This is one of 33 reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001791: US-009507513-2204USA001816:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; 33 patients received improperly stored vaccines; This spontaneous report was received from licensed practical nurse (L.P.N.) and concerns a patient of unknown age an gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 31-MAR-2022, the patient was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB); lot number: U026217; expiration date: 02-NOV-2023 (formulation, strength, dose, dose number, frequency, route of administration were not reported) for prophylaxis (improper storage of product in use). Administered dose of vaccine experienced the temperature excursion of 34,3 degrees Fahrenheit (F) for 55 minutes. There was no adverse effect reported (no adverse event). There were no previous temperature excursions reported.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001791: US-009507513-2204USA001816:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patients received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 24-MAR-2022, the patient received one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, lot # 1741817, expiration date 30-JUL-2022 or lot # U026664, expiration date 24-FEB-2023 (strength, dose and frequency were not reported) for prophylaxis, and one dose of improperly stored haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # U026217, expiration date 02-NOV-2023, (strength, dose, frequency and route of administration were not reported) for prophylaxis (product storage error). The nurse did not know which specific lot of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient. There were no additional adverse events reported or product quality complaint reported. Administered doses of vaccines experienced the temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. There were no previous excursions reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: received improperly stored vaccine; No additional AEs were reported; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 18-MAR-2022, the patient was vaccinated with one dose of the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) route of administration defaulted to oral, lot#U026664, confirmed to be valid with expiration date: 24-FEB-2023 or lot#1741817, confirmed to be valid with expiration date: 30-JUL-2022 (the reporter did not know which specific lot# was administered to the patient) and Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 1 dose, lot# U026217, confirmed to be valid with expiration date: 02-NOV-2023 (dose number, route of administration, and anatomical location were not provided), both for prophylaxis. The vaccines underwent a temperature excursion of 34.3 degrees Fahrenheit for 55 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; an expired dose of VAQTA was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 milliliter, lot #T034003, expiration date: 28-MAR-2022, for prophylaxis (strength and route of administration was not provided). It was reported that hepatitis a vaccine, inactivated (VAQTA) did not experienced a temperature excursion. No additional events were reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a patient was administered VAQTA after the expiration date.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, lot #T040581, expiration date: 28-MAR-2022, for prophylaxis (strength and route of administration was not provided). It was reported that hepatitis a vaccine, inactivated (VAQTA) did not experienced a temperature excursion. No additional events were reported (no adverse event).
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient had no other adverse effects; A patient in their practice received a dose of MMR II intramuscularly rather than subcutaneously; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 05-APR-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter, one dose, intramuscular route (Incorrect route of product administration) lot number T029549 (rHA) expiration date 10-SEP-2022 administered as prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) 0.7 milliliter once lot number U015344 expiration date 23-SEP-2023.  No other adverse event was reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2204USA003586:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of PNEUMOVAX 23 was inadvertently administered after the labeled expiration date; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 05-APR-2022, the patient was inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T022294, expiration date 26-MAR-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The vaccine did not experience any temperature excursions. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired MMRII; Expired / Administered Vaccine; This spontaneous report was received from healthcare business professional and refers to a patient of unknown gender and age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 31-MAR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live) (recombinant Human albumin (rHA)) (M-M-R II), lot #T010650 was confirmed to be valid, expiration date: 26-MAR-2022, (strength, dose, route and site of administration were not provided) (expired product administered). No additional adverse event was reported (no adverse event)
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE; Medical assistant reported expired dose of VARIVAX administered to patient.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications or medical history was not provided.  On 30-MAR-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose of 0.5 mL once, lot number: t010311 was confirmed to be valid, expiration date: 24-MAR-2022 (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (dose, route of administration, lot number and expiration date were not provided). No additional adverse event (AE) (no adverse event). No product quality complaint (PQC). No additional information.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure via eye contact, Needle issue
Clinical narrative: No additional AE reported; assistant accidently pushed the plunger and reports that a few drops of VARIVAX sprayed into her eye; assistant accidently pushed the plunger and reports that a few drops of VARIVAX sprayed into her eye; a medical assistant was preparing a dose of VARIVAX to administer when the needle came off the syringe; This spontaneous report was received from a nurse referring to a female patient (medical assistant) of unknown age. The patient's concurrent conditions, medical history, concomitant medications, and drug reactions/allergies were not reported.     On 06-APR-2022, the patient was preparing a dose of varicella virus vaccine live (oka/merck) (VARIVAX) to administer when the needle came off the syringe. The reporter stated that when the needle came off the syringe, the patient accidently pushed the plunger and a few drops of varicella virus vaccine live (oka/merck) (VARIVAX) sprayed into her eye. No adverse events were reported.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: vision loss; Shingles; Information has been received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient (pt) of unknown gender. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On or about 31-OCT-2011, the pt was vaccinated, at a local pharmacy, with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported).  Subsequently, on an unknown date, pt was treated by local providers for the following injuries resulting from pt's zoster vaccine live (ZOSTAVAX) use: shingles and vision loss (blindness). At reporting time, the outcome of events was unknown.  Upon internal review, blindness was considered a medically significant event.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: She couldn't move her arm; arm was "so painful"; had a fever; This spontaneous report was received from a consumer, referring to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.     On 05-APR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis.   On 05-APR-2022, the patient had a reaction to the vaccine. She couldn't move her arm, it was "so painful" and had a fever. Fortunately, she was feeling better this morning on 06-APR-2022. The outcome of the events was unknown.  The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was related.
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No further adverse events; administered dose of expired PROQUAD; This spontaneous report was received from a medical assistant, referring to a 2-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 25-MAR-2022, the patient was vaccinated with 1 dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA, lot # T025506, expiration date: 23-JAN-2022, dose, strength and route were not provided) for prophylaxis (expired product administered).  No additional details provided. No further adverse events/no product quality complaints.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: a patient was administered an expired vaccine; This spontaneous report was received from a licensed vocational nurse (LVN), referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 06-APR-2022, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T024557, expiration date: 15-MAR-2022, dose, strength and route were not provided) for prophylaxis (expired product administered).
Sex: F
Vaccine: DTAP, HPV9
Symptoms: Dyspnoea
Clinical narrative: HCP reported patient received GARDASIL 9 and had "respiratory difficulties after injection; This spontaneous report was received from a physician referring to a 11-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date in 2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid(DTAP) for prohylaxis (doses, routes of administration, lot numbers and expiration dates not reported).      On an unknown date in 2022, reported as 3 or 4 months ago, the patient experienced respiratories difficulties (dyspnoea) and requiered an ambulance to take her to the hospital (hospitalization).      The outcome of dyspnoea and its causal relationship with the vaccine were not reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Injection site pain, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: I recently had a checkup and was discussing my reaction to my booster shot and was told I should report it.   On 02/05/2022 11:am at my local Pharmacy, I received my third Pfizer FJ6369 booster shot. As the day progressed (over 12 hours), the shot site was extra sore and developed a quarter sized hard bump. Then I went to bed at approximately 11:pm. Around 5:am on 02/06/2022 I awoke to extreme pain in both my hands, The middle fingers of both hands curled and cramped. As the morning progressed, I was able to finally move them. However, it left me with trigger fingers in both hands. Oddly, about 5 to 7 days later, the trigger finger in my right hand (none shot side) completely went away. And while it is improving (I sleep with a finger splint on left  hand) But, the left hand middle finger still has the trigger finger.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder, Trigger finger
Clinical narrative: I recently had a checkup and was discussing my reaction to my booster shot and was told I should report it.   On 02/05/2022 11:am at my local Pharmacy, I received my third Pfizer FJ6369 booster shot. As the day progressed (over 12 hours), the shot site was extra sore and developed a quarter sized hard bump. Then I went to bed at approximately 11:pm. Around 5:am on 02/06/2022 I awoke to extreme pain in both my hands, The middle fingers of both hands curled and cramped. As the morning progressed, I was able to finally move them. However, it left me with trigger fingers in both hands. Oddly, about 5 to 7 days later, the trigger finger in my right hand (none shot side) completely went away. And while it is improving (I sleep with a finger splint on left  hand) But, the left hand middle finger still has the trigger finger.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; the vaccine was administered after expiration; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 07-APR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot #1707499, expiration date 30-MAR-2022 (strength, and route of administration were not provided), for prophylaxis (expired product administered). No additional adverse event (AE) reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE information reported; expired MMR II vaccine, which expired on March 26, 2022 was administered to a patient on April 7, 2022; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 07-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) 0.5 milliliter (reported as .5 mL), lot #T010650, expiration date 26-MAR-2022 (strength, and route of administration were not provided), for prophylaxis (expired product administered). No additional adverse event (AE) information reported.