chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine administered after temperature excursion.; No adverse event; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-SEP-2021, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U015689 and expiration date 18-MAY-2023, 0.5 milliliter for prophylaxis (strength, route, frequency and anatomical location were unknown).      The administered dose of the vaccine was stored with a temperature of 25.9 degrees Fahrenheit, with a time frame of 1 hour and 30 minutes. There was no previous temperature excursion. No adverse event reported (product storage error and no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse events; Improper storage of product in use; This spontaneous report was received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 26-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T034829, that has been verified to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live , expiration date reported as 11-APR-2022, 1 dosage form for prophylaxis (strength and administration route were not provided) (product storage error).  The vaccine was exposed to a temperature above of less 3 Celsius degrees (C) for a time frame of 3 hours ; the vaccine did not experience previous temperature excursions. No adverse events were reported.; Sender's Comments:  US-009507513-2110USA001320: US-009507513-2110USA001321:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, concerning a 64-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 03-OCT-2017, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information, lot number and expiration date were not provided) for its intended purpose: the prevention of shingles (herpes zoster). Subsequently in November 2017, the patient suffered shingles, including any and all of its sequelae.  As a result of the receipt of the vaccination, the patient experienced sustained severe and permanent personal injuries, as well as significant pain, suffering, and emotional distress. The reporter considered the event of shingles to be related to suspect therapy. At the time of the report, the patient's outcome was not recovered.  Upon internal review, shingles was considered a disabling event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medication, and previous drug reactions or allergies.  On 27-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (SQ), at a dose of 0.5 milliliter (ml) (lot number U015689, which was verified to be a valid lot number, expiration date reported as 13-MAY-2023 but upon internal validation established as 18-MAY-2023), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported). The vaccine was administered after a temperature excursion of 25.9 F during a time frame of 1 hour and 30 minutes (product storage error). There was not a previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA000932: US-009507513-2110USA001023:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Amenorrhoea, Drooling, Extra dose administered, Fatigue
Clinical narrative: the patient received the first dose of GARDASIL 9 on 6MAY2021 and was inadvertently adminitered the second dose of GARDASIL 9 on 20MAY2021; was inadvertently administered the second dose of GARDASIL 9 on 20MAY2021; weird behavior; panic attacks; the patient has not had a menstrual cycle since she was vaccinated; constant drooling; spacing out; fatigue; This spontaneous report was received from a physician referring to an 11-year-old female patient. The patient had none pertinent medical history or concomitant medication. She had no known drug allergies.  On 06-MAY-2021 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number 1659422 has been verified to be valid, expiration date reported and validated as 04-SEP-2022), and on 20-MAY-2021, she was inadvertently administered with the second dose (product administration error and inappropriate schedule of product administration). Both doses were administered at a dose of 0.5 milliliter, via intramuscular for prophylaxis (anatomical location of administration was not reported).    Since an unknown date in 2021, the patient had been experiencing some weird behavior, along with panic attacks, constant drooling, fatigue, and she appeared to be "spacing out" (feeling abnormal). The patient's last menstrual cycle was right before she had her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and she had not had a menstrual cycle since then (amenorrhoea). The patient started with all these symptoms after her first dose with of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient did not seek for medical attention, neither underwent any diagnostic laboratory diagnostics or studies. By the time of the report, the patient had not recovered from the events.   The reporter did not provide a causal relationship between of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal, Panic attack
Clinical narrative: the patient received the first dose of GARDASIL 9 on 6MAY2021 and was inadvertently adminitered the second dose of GARDASIL 9 on 20MAY2021; was inadvertently administered the second dose of GARDASIL 9 on 20MAY2021; weird behavior; panic attacks; the patient has not had a menstrual cycle since she was vaccinated; constant drooling; spacing out; fatigue; This spontaneous report was received from a physician referring to an 11-year-old female patient. The patient had none pertinent medical history or concomitant medication. She had no known drug allergies.  On 06-MAY-2021 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number 1659422 has been verified to be valid, expiration date reported and validated as 04-SEP-2022), and on 20-MAY-2021, she was inadvertently administered with the second dose (product administration error and inappropriate schedule of product administration). Both doses were administered at a dose of 0.5 milliliter, via intramuscular for prophylaxis (anatomical location of administration was not reported).    Since an unknown date in 2021, the patient had been experiencing some weird behavior, along with panic attacks, constant drooling, fatigue, and she appeared to be "spacing out" (feeling abnormal). The patient's last menstrual cycle was right before she had her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and she had not had a menstrual cycle since then (amenorrhoea). The patient started with all these symptoms after her first dose with of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient did not seek for medical attention, neither underwent any diagnostic laboratory diagnostics or studies. By the time of the report, the patient had not recovered from the events.   The reporter did not provide a causal relationship between of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE or PQC reported; vaccine administered after temperature excursion.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 01-OCT-2021, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U015689 and expiration date 18-MAY-2023, 0.5 milliliter for prophylaxis (strength, route, frequency and anatomical location were unknown).      The administered dose of the vaccine was stored with a temperature of 25.9 degrees Fahrenheit, with a time frame of 1 hour and 30 minutes. There was no previous temperature excursion. No adverse event reported (product storage error and no adverse event).
Age: 1.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Rash, Viral test
Clinical narrative: rash to his trunk, arms, legs, and face; Information has been received from a medical assistant of a physician referring to a 12 months old male patient. The patient has not known drug allergy (NKDA). The patient had no concomitant medication and pertinent medical history.   On 29-SEP-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose 0.5 ml, lot# U015846, expiration date: 19-MAY-2021) subcutaneously for routine vaccination. No other vaccines were administered at that time. On 02-OCT-2021, the patient was seen at a urgent care facility for the rash he developed. The rash developed to his trunk, arms, legs, and face after vaccination with varicella virus vaccine live (Oka/Merck) (VARIVAX) and was prescribed oral diphenhydramine (BENADRYL). The physician was interested in varicella zoster virus (VZV) analysis by polymerase chain reaction (PCR) and wanted to send viral isolates. The outcome of rash to his trunk, arms, legs, and face was unknown.  The causality between the event and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product temperature excursion issue
Clinical narrative: No other AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 25-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U015689, expiration date 18-MAY-2023, 0.5 milliliter, subcutaneous) after temperature excursion for prophylaxis (product storage error). Temperature excursion was 25.9 Fahrenheit degree for 1 hour and 30 minutes. There was no previous temperature excursion. No adverse event was reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: including any and all of its sequelae/ other related health complications; shingles; Information has been received from a lawyer referring to a 62 years old female (inconsistent information, also reported as he) patient regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On 08-NOV-2016 (when she was 60 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in February 2018, the patient was caused to suffer serious and dangerous side effects including shingles and any and all of its sequelae(also reported as other related health complications) (ill-defined disorder), as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. In addition, the patient required and would continue to require healthcare and services. The patient also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. The patient had incurred and will continue to incur mental and physical pain and suffering. The outcome of the events was considered to be not recovered. The causality assessment between these events and zoster vaccine live (ZOSTAVAX) was related.   The lawyer considered the events shingles and ill-defined disorder to be disability.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 22-APR-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, anatomical location, lot# and expiration date unknown) by a physician at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and other zoster-related conditions (Ill-defined disorder). As a direct and proximate result of the use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles and other zoster-related conditions was considered as not recovered and causal relationship was assessed as related.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder, Inappropriate schedule of product administration
Clinical narrative: shingles; any and all of its sequelae/ other related health complications; was 47 (conflict information, also reported as 48) years old when he received the zoster vaccine live (ZOSTAVAX); Information has been received from a lawyer referring to a 47 years old male patient regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On 16-MAR-2017(conflict information, also reported as at 48 years old), the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, anatomical location, lot# and expiration date unknown) at a health facility for prophylaxis (Inappropriate schedule of product administration). On 08-OCT-2017, as a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer serious and dangerous side effects including shingles, including any and all of its sequelae (also reported as other related health complications)(Ill-defined disorder), as well as other severe and personal injuries. The patient had been caused to suffer other severe personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient required and/or would require more health care and services. The patient had incurred and would continue to incur medical and related expenses. The patient's direct medical losses and costs include physician care, monitoring, and treatment. The patient had also incurred and would continue to incur mental and physical pain and suffering. The outcome of shingles and ill-defined disorder was considered as not recovered.  These events of shingles and ill-defined disorder  were considered as disability by the lawyer.
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Cough, Nasopharyngitis, Rash, Rash erythematous
Clinical narrative: swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; cold and cough; This spontaneous report was received from a pharmacist and refers to a 37-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # U004713, expiration date 10-FEB-2023, for prophylaxis (exact dose, dose number, vaccination site and route of administration were not provided).  On an unknown date in 2021, the patient had a cold and cough. On 03-OCT-2021 (also reported as yesterday), the patient began developing following symptoms: swelling, rash, red itchy spots, blisters. The symptoms started at or around injection site and on an unknown date in October 2021 (reported as now) have spread to other unknown areas. The symptoms were at the time mainly in 3 locations, but reporter did not specify exact locations. The patient sought medical attention. The outcome of the events was reported as not recovered.  The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic, Swelling
Clinical narrative: swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; cold and cough; This spontaneous report was received from a pharmacist and refers to a 37-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # U004713, expiration date 10-FEB-2023, for prophylaxis (exact dose, dose number, vaccination site and route of administration were not provided).  On an unknown date in 2021, the patient had a cold and cough. On 03-OCT-2021 (also reported as yesterday), the patient began developing following symptoms: swelling, rash, red itchy spots, blisters. The symptoms started at or around injection site and on an unknown date in October 2021 (reported as now) have spread to other unknown areas. The symptoms were at the time mainly in 3 locations, but reporter did not specify exact locations. The patient sought medical attention. The outcome of the events was reported as not recovered.  The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Confirmed with customer no other AE occurred; a dose of ROTATEQ was administered to a patient after a temperature excursion; This spontaneous report was received from a medical assistant referring to a 10-week-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 04-OCT-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) oral, lot number 1707486, expiration date 20-MAR-2022 (dose not reported) for prophylaxis. No adverse event was reported.  The vaccine underwent a temperature excursion of 32.9 degrees Farhrenheit for 24 hour. No previous temperature excursions were detected.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of PNEUMOVAx 23 expired on 10/3/2021 and was administered on 10/5/2021; This spontaneous report was received from a nurse referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concomitant medication, previous drug reactions, or allergies was provided.  On 05-OCT-2021, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (lot number T021329 has been verified to be valid as vial formulation, expiration date reported and validated as 03-OCT-2021), at a dose of 0.5 milliliter (dose number, vaccination scheme, route of administration, and anatomical location of administration were not reported) as prophylaxis (expired product administered). No additional adverse events (AE) were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: ?? additional AEs were reported; ? nurse is reporting that a patient received an expired MMR II vaccine; This spontaneous report was received from a register nurse and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 05-OCT-2021, the patient was vaccinated with one (1) expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin) (M-M-R II) (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration were not reported; lot number S029454 that was verified to be a valid lot number with an expiration date reported and established as 19-SEP-2021) for prophylaxis (expired product administered).  It was reported that no additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: ?? additional ?? reported; Caller stated the vaccine was administered after being improperly stored.; This spontaneous report was received from a health business professional (HBP) (reporter as other) and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 11-SEP-2021, the product measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) (lot number U006313, that was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes. Then on an unspecified date in 2021, the vaccine experienced another temperature excursion, this time of 5.5 degrees Fahrenheit (F) during a time frame of 24 minutes and 30 seconds.  On 05-OCT-2021, the patient was vaccinated with this improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) 0.5 milliliter (ml) (dose number, vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).   It was reported that no additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient did not have any reactions to the MMR-II, no additional AE details provided; M-M-R-II was administered after it had expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 04-OCT-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA) (M-M-R II) (strength and route were not reported, 0.5 ml, lot # S029457, expiration date: 19-SEP-2021) for prophylaxis (expired product administered). The patient did not have any reactions to the vaccine, no additional adverse event details were provided (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; The patient inadvertently received her second dose today, 06OCT2021./ Early administration of second dose; This spontaneous report has been received from a nurse practitioner, via a company representative, concerning a 20 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 23-SEP-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot number and expiration date were not provided), administered for prophylaxis.  On 06-OCT-2021, the patient inadvertently received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot number and expiration date were not provided), administered for prophylaxis (inappropriate schedule of product administration). No additional information was known. No adverse event.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other AEs or PQC reported; immunocompetent patient received PNUEMOV AX 23 vaccine 9/18/2019 and again on 10/5/2021.; immunocompetent patient received PNUEMOV AX 23 vaccine 9/18/2019 and again on 10/5/2021.; This spontaneous report was received from a pharmacist referring to a 51 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 18-SEP-2019, the immunocompetent patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, intramuscular for prophylaxis. On 05-OCT-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, intramuscular again (product use issue, inappropriate schedule of product administration). No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: no additional AE was reported by patient.; PNEUMOVAX23 was inadvertently administered on 10/6/2021 with a labeled expiry of 10/3/2021; This spontaneous report was received from a Licensed Practical Nurse, who was also the practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 06-OCT-2021, the patient was inadvertently vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose 0.5 milliliter (mL), lot # T021329, expiration date: 03-OCT-2021 (formulation not reported, but upon internal validation established as vial; strength, dose number and route of administration were not reported) for prophylaxis (expired product administered).  There were no known temperature excursions. The reporter stated that no additional adverse event (AE) was reported by patient (no adverse event).  The outcome of medication error was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; An improperly stored MMR II was administered to a patient yesterday; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.    It was reported that on 06-OCT-2021 (reported as yesterday), one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) as prophylaxis (strength, formulation, dose number, route of administration, and anatomical location of vaccination were not reported; Lot No. T001211 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date was reported as 12-JAN-2022) was administered to the patient (product storage error). The temperature and time frame were reported as 47.6 °F (Fahrenheit) and 30 minutes, respectively; and the previous temperature excursion was at 47.1 °F for 30 minutes. No other adverse events reported. The outcome of the event product storage error was unknown.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Expired PNEUMOVAX 23 administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions or concomitant medications provided.  On 06-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T021329, expiration date 03-OCT-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No temperature excursion was reported for the administered vaccine. No adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; patient received an expired PNEUMOVAX 23; This spontaneous report was received from a Doctor of Pharmacy and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) 1 dose, lot # S012244, expiration date 09-FEB-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse events were reported.
Sex: M
Vaccine: HPV9
Symptoms: Chemotherapy, Neoplasm malignant
Clinical narrative: cancer; Information has been received from company representative concerning a 19 years old male patient. No information about the current condition, medical history or concomitant therapy was reported.    In 2017 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route and lot# were not reported) for prophylaxis.         The patient was diagnosed with unspecified cancer in 2020 and underwent chemotherapy as the treatment. The outcome of the event was not reported. The action taken with suspect vaccine was not applicable.   The causality between the suspect vaccine and the cancer was not reported. Upon internal review, the event of cancer was considered as medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; Information was received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. The patien's concurrent conditions, historical conditions and concurrent conditions were not reported. On or about April of 2012, patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider at health center for the long-term prevention of shingles and zoster-related conditions. Subsequent to patient's zoster vaccine live. As a direct and proximate result of patien's use of zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 5.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs reported; 5 year old patient was administered GARDASIL 9; This spontaneous report was received from a physician and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-OCT-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration). No additional adverse events were reported.
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AE; 2x Doses of GARDASIL 4, 10 years ago; This spontaneous report was received from certified medical assistant who was reporting on herself via company representative.  On an unknown dates in October 2011, the patient received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of vaccine administered). The reporter inquired if the patient should receive a single dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) to complete a series of 3 doses. There was no additional adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Expired vaccine administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 05-OCT-2021, the patient was vaccinated with expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S029457, expiration date 19-SEP-2021, 0.5 milliliter (concentration, formulation, dose number, anatomical location, frequency and route of administration were not reported) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Age: 0.17
Sex: U
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AEs or PQC reported; M-M-R II was administered to a 2 month old patient; This spontaneous report as received from a office manager  referring to a 2 month old patient, gender was not reported.The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.     On 11-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 milliliters, subcutaneously, lot # T001214, has been verified to be valid for measles, mumps, expiry date 12-JAN-2022 for prophylaxis (product administered to patient of inappropriate age).   No adverse event were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: PROQUAD that underwent a temperature excursion was admnistered; No additional adverse effects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, or concomitant medication were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot number T034612 with expiration date 10-APR-2022 (dosage, route of administration and anatomical location were not reported) for prophylaxis, which underwent a temperature excursion, at 14 to 46°F (33F) for 8 hours 0 minutes and 0 seconds. There was no previous temperature excursion.  No additional adverse effect reported.  This is one of two reports received from the same reporter.
Age: 6.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired dose of MMR II was administered; This spontaneous report was received from a medical assistant, referring to a six-year-old patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 08-OCT-2021, the patient was vaccinated by accident with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) single dose, lot # S029581 was confirmed to be valid, expiration date 22-SEP-2021 (albumin status rHA) (exact dose, route and site of administration were not reported) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; 1 dose of ROTATEQ was administered following a temperature excursion / temperature 50 F; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 08-OCT-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose orally, lot # 1707572, expiration date 11-MAR-2022 for prophylaxis (product storage error). The administered vaccine was stored in a temperature of 50 degrees Fahrenheit (F) for 39 hours and 47 minutes. No previous temperature excursion occurred. No adverse event (AE) was reported.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Two male patients received VARIVAX intramuscularly instead of subcutaneously; No additional AE were reported; This spontaneous report was received from a pharmacist, and refers to a male patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), intramuscularly instead of subcutaneously for prophylaxis (dose, lot number and expiration date were not reported). No adverse events were reported.  This is one of two cases received from the same source.; Sender's Comments:  US-009507513-2109USA003281:
Sex: U
Vaccine: FLUN4
Symptoms: Erythema, Pain, Scratch
Clinical narrative: SCRATCH; RED; SORE; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender of Unknown ethnic origin born in 1998.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced scratch (preferred term: Scratch). On an unknown date, the patient experienced red (preferred term: Erythema). On an unknown date, the patient experienced sore (preferred term: Pain).     Treatment with Flumist Quadrivalent (influenza vaccine live reassort 4v) was not changed.     At the time of reporting, the event of scratch, red and sore was ongoing.     The events were considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event: red, scratch and sore.      The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event: red, scratch and sore.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: ANTH
Symptoms: Disability, Gait inability, Hypersensitivity, Nerve injury, Wheelchair user
Clinical narrative: Nerve damage to hands, legs; Unable to walk; Allergic reaction to anthrax shot; On 26SEP2021, a spontaneous report was received from a company representative who provided information discovered on a social media website.   The reporter provided a video found on an online social media source which discussed a female of an unknown age that received BioThrax (anthrax vaccine adsorbed) on an unknown date and experienced an allergic reaction to the anthrax shot (PT: Drug hypersensitivity) causing disability due to nerve damage to her hands and legs (PT: Nerve injury) and an inability to walk (PT: Gait inability). The patient is seen on the video as being in a wheelchair. The reporter attributes the patient's allergic reaction, nerve damage, inability to walk and resulting disability as related to the anthrax shot. The outcome of the events were not reported.  The patient's medical history and concomitant medication use was not reported.   No additional information was available.  Company Comment:  The Company considers that it is possible that the patient had an allergic reaction as hypersensitivity as it is a known phenomenon that could occur with BioThrax; therefore assessed as "Possible". The assumption that the allergic reaction caused nerve damage to the legs and hands so severe that caused permanent disability is not possible to assess or confirm. It is not know that an allergic reaction could cause neuropathy and although other form of neuropathy like Bell's palsy, has been attributed to COVID 19 and influenza vaccine, it has not been associated to BioThrax nor general neuropathy; therefore, the nerve damage and the inability to walk are considered "Unassessable". More information will be sought.; Sender's Comments: The Company considers that it is possible that the patient had an allergic reaction as hypersensitivity as it is a known phenomenon that could occur with BioThrax; therefore assessed as "Possible". The assumption that the allergic reaction caused nerve damage to the legs and hands so severe that caused permanent disability is not possible to assess or confirm. It is not know that an allergic reaction could cause neuropathy and although other form of neuropathy like Bell's palsy, has been attributed to COVID 19 and influenza vaccine, it has not been associated to BioThrax nor general neuropathy; therefore, the nerve damage and the inability to walk are considered "Unassessable". More information will be sought.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Dehydration
Clinical narrative: Dehydrated; This case was reported by a physician via(Facebook)interactive digital media and described the occurrence of dehydration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 1st October 2021, the patient received the 1st dose of Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season. In October 2021, 1 day after receiving Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced dehydration. On an unknown date, the outcome of the dehydration was unknown.   It was unknown if the reporter considered the dehydration to be related to Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the physician. The age at vaccination was not reported. The patient had shingles vaccine at clinic. The patient reported that he/she glad its covered by his/her insurance. The patient also received his/her flu shot. At the time of reporting, the patient felt dehydrated and his/her body was in overdrive, but he/she hydrated with water. The patient stated no other side effects whatsoever. The follow-up would not possible as contact details not available.
Age: 71.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: received both Shingrix vaccines, shingles/ suspected vaccination failure; shingles/ Shingles 4-6 times a year; painful; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (got shingles 4 to 6 times a year, each debilitating).   On an unknown date, the patient received the 1st dose of Shingrix. On 3rd December 2018, the patient received the 2nd dose of Shingrix. On 20th July 2021, unknown after receiving Shingrix and 960 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received both the doses of Shingrix and still got shingles. The patient stated that the shingles she got in July 2021 were more painful which were along the right side of his/her neck moving to behind right ear. The patient also had mild symptoms in September 2021, refer case US2021AMR208041. The patient asked if GSK working on any booster option. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208041:same reporter