chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Per patient's mom, patient started developing a rash 2 days after immunization and started to move down the arm after a few days. Patient was seen by his primary care doctor, whom determined it to be an infection. He was promptly started on antibiotics. Per patient's mom, he had the same reaction last year, so an allergy note was put in patient's profile.
Age: 6.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Localised infection, Rash
Clinical narrative: Per patient's mom, patient started developing a rash 2 days after immunization and started to move down the arm after a few days. Patient was seen by his primary care doctor, whom determined it to be an infection. He was promptly started on antibiotics. Per patient's mom, he had the same reaction last year, so an allergy note was put in patient's profile.
Age: 78.0
Sex: F
Vaccine: FLUA3, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Shingles; Spots; This case was reported by a consumer via patient support programs and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2019, the patient received the 1st dose of Shingrix .5 ml. On 10th October 2019, 6 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with prednisone and antivirals nos. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. On 10th October 2019, Thursday, the patient seen spots forming. On 14th October 2019, the patient was diagnosed with shingles. No further information was reported. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: FLUA3, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Spots; This case was reported by a consumer via patient support programs and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2019, the patient received the 1st dose of Shingrix .5 ml. On 10th October 2019, 6 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with prednisone and antivirals nos. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. On 10th October 2019, Thursday, the patient seen spots forming. On 14th October 2019, the patient was diagnosed with shingles. No further information was reported. The reporter consented to follow up.
Sex: F
Vaccine: FLU3, FLU3, FLU4
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: pregnant patient who received Fluzone HD instead of Fluzone Quadrivalent as ordered, no AE; pregnant patient who received Fluzone HD instead of Fluzone Quadrivalent as ordered, no AE; pregnant patient who received Fluzone HD instead of Fluzone Quadrivalent as ordered, no AE; 31 years old pregnant patient who received Fluzone HD instead of Fluzone Quadrivalent as ordered, no AE; Initial and follow up information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 31-year-old female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in context of pregnant patient received Fluzone HD instead of Fluzone Quadrivalent as ordered, no AE (exposure during pregnancy) and (wrong product administered, inappropriate age at vaccine administration and overdose).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The gestation period was 36 weeks.   The date of last menstrual period was not reported.  The estimated due date was reported as in 4 weeks.  The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancy.  On 10-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in deltoid nos.  On an unknown date, the patient had exposure during pregnancy.  It was also a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose.  The patient did not experience any adverse event following vaccination at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3, FLU3, FLU4
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pregnant patient who received Fluzone HD instead of Fluzone Quadrivalent as ordered, no AE; pregnant patient who received Fluzone HD instead of Fluzone Quadrivalent as ordered, no AE; pregnant patient who received Fluzone HD instead of Fluzone Quadrivalent as ordered, no AE; 31 years old pregnant patient who received Fluzone HD instead of Fluzone Quadrivalent as ordered, no AE; Initial and follow up information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 31-year-old female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in context of pregnant patient received Fluzone HD instead of Fluzone Quadrivalent as ordered, no AE (exposure during pregnancy) and (wrong product administered, inappropriate age at vaccine administration and overdose).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The gestation period was 36 weeks.   The date of last menstrual period was not reported.  The estimated due date was reported as in 4 weeks.  The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancy.  On 10-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in deltoid nos.  On an unknown date, the patient had exposure during pregnancy.  It was also a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose.  The patient did not experience any adverse event following vaccination at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site nodule, Injection site pain
Clinical narrative: PAIN, SWELLING,  KNOT, BRUISING
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Contusion, Nodule, Pain, Swelling
Clinical narrative: PAIN, SWELLING,  KNOT, BRUISING
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Impaired work ability, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: I received the vaccine around noon on the 17th and by the evening (around 7) my hip was sore along with the injection site. By the next day I had severe muscle and joint pain on my right side and soreness, redness and slight swelling at the injection site (left bicep), the pain continued and was unable to work on Saturday, slight improvement on Sunday with taking Tylenol.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: I received the vaccine around noon on the 17th and by the evening (around 7) my hip was sore along with the injection site. By the next day I had severe muscle and joint pain on my right side and soreness, redness and slight swelling at the injection site (left bicep), the pain continued and was unable to work on Saturday, slight improvement on Sunday with taking Tylenol.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Acute respiratory failure, Blood gases, Blood lactic acid increased, Endotracheal intubation, Hypoxia
Clinical narrative: Acute Respiratory Failure, Hypoxia, pneumonia,  Intubated
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Pneumonia
Clinical narrative: Acute Respiratory Failure, Hypoxia, pneumonia,  Intubated
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Cystic fibrosis
Clinical narrative: Cystic Fibrosis Exacerbation needing hospitalzation
Age: 1.33
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: Approximately 33 hrs after receiving vaccination, almost entire thigh became reddish purple, swollen, hard, warm. Brought in to emergency department for evaluation, confirmed vaccination adverse reaction. Has had 2 doses of influenza vaccine last year without any issue, is also fully up to date with other vaccinations, has never had any adverse reaction to any other vaccination or medication.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: 33 hours after vaccination, about 5 inch area surrounding vaccination site noticed to be significantly erythematous, hard, warm. Has tolerated multiple flu shots in the past, as well as other vaccinations, has no allergies or intolerances. Brother had same reaction but more severe. Vaccinated at same pediatric clinic at the same time as brother. Brother brought in to emergency department, reaction confirmed- did not bring patient in as treatment was minimal.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Acute kidney injury, Bronchial obstruction, Condition aggravated, Cystic fibrosis
Clinical narrative: Cystic Fibrosis exacerbation, Bronch obstruction, Acute Kidney Failure
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Pneumonia, Pyrexia, Sepsis
Clinical narrative: Pneumonia, with Sepsis, Fevers, Short of Breath
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: COPD exacerbation
Age: 37.0
Sex: F
Vaccine: FLUR4
Symptoms: Condition aggravated, Cystic fibrosis, Fluid overload, Respiratory failure
Clinical narrative: Respiratory Failure, Cystic Fibrosis, Fluid overload,
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling of body temperature change, Myalgia, Pain
Clinical narrative: 6 hours after vaccination, began to have moderate body and muscle aches.  Tenderness was also at the vaccination site.   After 8 hours began to have uncontrollable chills and shivering in a 76 degree home.   After dressing in warm clothing (Denim jeans, sock, boots, beanie cap, mittens and fleece jacket) and applying a heating pad, the chills were controlled and muscle aches diminished.  After 12 hours, experienced hot and cold flashes, weakness in the body.  After 24 hours, symptoms were mostly diminished and was symptom free after 36 hours.   The above symptoms were experienced on both first and second Shingrix vaccinations.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site pain, Vaccine positive rechallenge
Clinical narrative: 6 hours after vaccination, began to have moderate body and muscle aches.  Tenderness was also at the vaccination site.   After 8 hours began to have uncontrollable chills and shivering in a 76 degree home.   After dressing in warm clothing (Denim jeans, sock, boots, beanie cap, mittens and fleece jacket) and applying a heating pad, the chills were controlled and muscle aches diminished.  After 12 hours, experienced hot and cold flashes, weakness in the body.  After 24 hours, symptoms were mostly diminished and was symptom free after 36 hours.   The above symptoms were experienced on both first and second Shingrix vaccinations.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Cough
Clinical narrative: At night started with cough. When to ER. MD administered antibiotic and prednisone. Discharged to home from ER.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Cardiac function test, Chest pain, Pericarditis
Clinical narrative: Pericarditis /chest pain/hospitalization
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Lethargy, Muscle rigidity
Clinical narrative: Approximately 10 minutes after vaccination, mother called out for help. Upon entry to the exam room, pt was noted to be sitting in a chair when he became rigid, lifted from the chair, and bent to the side.  Episode seemed to last a few seconds. APRN was able to lift the patient to the exam table and complete an assessment. Patient appeared lethargic, sweaty, and pale in color. A blood pressure, heart rate, O2, and blood glucose were all taken and all noted to be with normal limits. The patient was given crackers and juice and monitored for 30 minutes, until nausea and dizziness subsided. Education was given to parents for home care and symptoms to continue to watch for.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Nausea, Pallor
Clinical narrative: Approximately 10 minutes after vaccination, mother called out for help. Upon entry to the exam room, pt was noted to be sitting in a chair when he became rigid, lifted from the chair, and bent to the side.  Episode seemed to last a few seconds. APRN was able to lift the patient to the exam table and complete an assessment. Patient appeared lethargic, sweaty, and pale in color. A blood pressure, heart rate, O2, and blood glucose were all taken and all noted to be with normal limits. The patient was given crackers and juice and monitored for 30 minutes, until nausea and dizziness subsided. Education was given to parents for home care and symptoms to continue to watch for.
Age: 16.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MENB, MMRV, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Not recommended for use after age 7.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of GARDASIL9 was administered to the patient; No adverse effects; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N022952, expiration date: 14-JUN-2020, dose detail and route were not reported) for prophylaxis (product storage error). The vaccine was exposed below 36 Fahrenheit degrees (32.1 Fahrenheit degrees) for 8 hours. There was no previous temperature excursion and the call was because of data logger involved. No adverse effects were reported.
Sex: F
Vaccine: DTOX, MMR, PPV
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Corynebacterium test negative, Measles antibody negative
Clinical narrative: titers for MMR, duphtheria and pneumococcal IgG were undetectable despite prior vaccinations; Literature report:   This report has been received from the authors in a published article, tittle as stated above, concerning a 59-year-old female patient with history of stage 4 follicular lymphoma, treated with 6 cycles of rituximab and bendamustine followed by rituximab maintenance was observed by her PCP to have recurrent and refractory bacterial infections (including sinusitis, conjunctivitis, and a pneumonia) starting more than a year after completing treatment for the patient's cancer.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and diphtheria (doses, frequencies, routes, lot numbers and expiration dates were not provided) for prophylaxis.   On an unknown date, at 18 months post-treatment with rituximab, an immunofixation panel revealed undetectable IgA and IgM and IgG 356 (700-1600). The patient was referred to an immunologist. Assessment for immunoglobulin functionality revealed low IgG subclass 1 levels. The patient's titers for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and diphtheria were undetectable despite prior vaccinations (antibody test negative).  The outcome of antibody test negative was unknown. The reporter considered antibody test negative to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and diphtheria.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: DTOX, MMR, PPV
Symptoms: Mumps antibody test negative, Rubella antibody negative
Clinical narrative: titers for MMR, duphtheria and pneumococcal IgG were undetectable despite prior vaccinations; Literature report:   This report has been received from the authors in a published article, tittle as stated above, concerning a 59-year-old female patient with history of stage 4 follicular lymphoma, treated with 6 cycles of rituximab and bendamustine followed by rituximab maintenance was observed by her PCP to have recurrent and refractory bacterial infections (including sinusitis, conjunctivitis, and a pneumonia) starting more than a year after completing treatment for the patient's cancer.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and diphtheria (doses, frequencies, routes, lot numbers and expiration dates were not provided) for prophylaxis.   On an unknown date, at 18 months post-treatment with rituximab, an immunofixation panel revealed undetectable IgA and IgM and IgG 356 (700-1600). The patient was referred to an immunologist. Assessment for immunoglobulin functionality revealed low IgG subclass 1 levels. The patient's titers for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and diphtheria were undetectable despite prior vaccinations (antibody test negative).  The outcome of antibody test negative was unknown. The reporter considered antibody test negative to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown) and diphtheria.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Ataxia, Computerised tomogram normal, Dizziness, Dysphemia
Clinical narrative: dizziness; stuttering; ataxia; memory loss; This spontaneous report was received from a physician referring to a 11 years old female patient. The patient's concurrent included anxiety, depression and seasonal allergy. The patient's medical history included constipation. She had no concomitant medication or drug reactions/allergies.  On 01-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R019469, and expiration date 10-APR-2021) (strength and dose not reported) intramuscular for prophylaxis.  On 08-JUL-2019, the patient experienced dizziness, stuttering, ataxia and memory loss (not detailed further). On 01-AUG-2019 and 08-AUG-2019, she was seen by a neurologist, who prescribed propranolol (dose and frequency not specified). Magnetic resonance imaging (MRI) and computerized tomography (CT) scan were performed and showed negative results. On 29-AUG-2019, the patient recovered from dizziness, stuttering, ataxia and memory loss. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. No product quality compliance was reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Magnetic resonance imaging normal
Clinical narrative: dizziness; stuttering; ataxia; memory loss; This spontaneous report was received from a physician referring to a 11 years old female patient. The patient's concurrent included anxiety, depression and seasonal allergy. The patient's medical history included constipation. She had no concomitant medication or drug reactions/allergies.  On 01-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R019469, and expiration date 10-APR-2021) (strength and dose not reported) intramuscular for prophylaxis.  On 08-JUL-2019, the patient experienced dizziness, stuttering, ataxia and memory loss (not detailed further). On 01-AUG-2019 and 08-AUG-2019, she was seen by a neurologist, who prescribed propranolol (dose and frequency not specified). Magnetic resonance imaging (MRI) and computerized tomography (CT) scan were performed and showed negative results. On 29-AUG-2019, the patient recovered from dizziness, stuttering, ataxia and memory loss. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. No product quality compliance was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events; a patient was administered an improperly stored PEDVAXHIB; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.  On 23-SEP-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R036176 and  expiration date 08-OCT-2019)  (dose, frequency and route of administration were not provided) as prophylaxis (product storage error).  The vaccines were exposed to temperature above 47 degrees Fahrenheit/9 degree Celsius (11.3 degree Celsius) for 9 hours and 55 minutes and the data logger was involved. No previous excursions were reported. No adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; 6-month-old patient received VAQTA on 9/26/2019; This spontaneous report was received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.     On 26-SEP-2019, the 6 months old patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (strength, dose, dose of administration not reported; lot # S007769 and expiration date 24-JUL-2020) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; an adult patient was administered the pediatric strength of VAQTA; an adult patient was administered the pediatric strength of VAQTA; This spontaneous report has been received from a medical assistant referring to an adult patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 09-SEP-2019, the adult patient was administered the pediatric strength of hepatitis A Vaccine, Inactivated (VAQTA) one shot (route not reported, lot # S005725, expiration date: 10-JUL-2020) for prophylaxis (product administered to patient of inappropriate age, incorrect dose administered). No adverse effects were reported.
Sex: F
Vaccine: MMR, UNK
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via mucosa, Eye irritation, Nasal congestion
Clinical narrative: Eye irritation; Clogged nose; Plastic Syringe ( "Vanish Point" Syringe / "Retractable Technologies" Brand) malfunctioned while reconstituting the MMR  II vaccine; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; This spontaneous report was received from a pharmacist referring to a 49 year-old female patient. The patient's current conditions included sulfa allergy and latex sensitivity. The patient's medical history and concomitant therapies were not reported. On 03-OCT-2019, the patient was exposed with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) topically (lot # R036581 with expiry date of 17-DEC-2020) and sterile diluent (lot # S008565 with expiry date of 09-AUG-2021) (strength, doses, frequencies) which was indicated for prophylaxis. On 03-OCT-2019, the reporter reported that plastic syringe ("vanish point" syringe / "retractable technologies" brand) malfunctioned while reconstituting the MMR II (syringe issue), inadvertently splashed into the face of the provider who was exposed topically (accidental exposure to product) (occupational exposure to product), in the eyes (exposure via eye contact) and mucus membrane vaccine (exposure via mucosa) and experienced eye irritation and clogged nose. The events of eye irritation and nasal congestion did not recover at the time of report. The outcome of accidental exposure to product, exposure via skin contact, exposure via mucosa, exposure via eye contact and occupational exposure to product was unknown. Causality assessment was not provided.  This is one of the two reports obtained from the same reporter.; Sender's Comments:  US-009507513-1910USA005558:same reporter
Sex: F
Vaccine: MMR, UNK
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: Eye irritation; Clogged nose; Plastic Syringe ( "Vanish Point" Syringe / "Retractable Technologies" Brand) malfunctioned while reconstituting the MMR  II vaccine; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; This spontaneous report was received from a pharmacist referring to a 49 year-old female patient. The patient's current conditions included sulfa allergy and latex sensitivity. The patient's medical history and concomitant therapies were not reported. On 03-OCT-2019, the patient was exposed with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) topically (lot # R036581 with expiry date of 17-DEC-2020) and sterile diluent (lot # S008565 with expiry date of 09-AUG-2021) (strength, doses, frequencies) which was indicated for prophylaxis. On 03-OCT-2019, the reporter reported that plastic syringe ("vanish point" syringe / "retractable technologies" brand) malfunctioned while reconstituting the MMR II (syringe issue), inadvertently splashed into the face of the provider who was exposed topically (accidental exposure to product) (occupational exposure to product), in the eyes (exposure via eye contact) and mucus membrane vaccine (exposure via mucosa) and experienced eye irritation and clogged nose. The events of eye irritation and nasal congestion did not recover at the time of report. The outcome of accidental exposure to product, exposure via skin contact, exposure via mucosa, exposure via eye contact and occupational exposure to product was unknown. Causality assessment was not provided.  This is one of the two reports obtained from the same reporter.; Sender's Comments:  US-009507513-1910USA005558:same reporter
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions or allergies.  On an unknown date, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 1 dose, with lot # S003865 and expiration date on 08-AUG-2020, for prophylaxis (dose number, route of administration and anatomical injection site were not reported).  It was reported that on an unknown date, the vaccines were exposed to a temperature excursion of 32.5 Fahrenheit (F) degrees for 8 hours. There were no previous temperature excursions. The call was placed because of a Digital Data logger report.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report as received from a register nurse refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  The nurse reported that on 01-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number R019237 with expiration date 04-JUL-2020 or lot number S005078 with expiration date 19-FEB-2021(the nurse did not knew which lot number was administered to the patient) (dosage, route and anatomical location were not reported) for prophylaxis, which was exposed to temperature excursion of  -14°C to -10°C (-9.74°C) for an unknown time frame, because of data logger. There was no previous temperature excursion. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effects reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Joint stiffness, Pain in extremity, Rash
Clinical narrative: the patient developed joint stiffuess and soreness in the arm that had received the PNEUMOVAX injection; soreness in the arm; Then later that same day she developed a rash / the rash spread to the shoulders and back; a 3 inch lump at the site of PNEUMOVAX injection; This spontaneous report was received from a nurse concerning to a 46-year-old female patient. The patient's medical history included dysphagia, amnesia, myalgia, sleep apnoea syndrome, depression, chronic obstructive pulmonary disease, asthma, syncope, narcolepsy, hypertension, gastrooesophageal reflux disease, renal artery stenosis and back pain.  Concomitant therapies included bumetanide (BUMEX), clonazepam, dextroamphetamine, gabapentin, levalbuterol hydrochloride (XOPENEX), levothyroxine sodium, methylphenidate,  metoprolol succinate, morphine sulfate (MS CONTIN), omeprazole, potassium chloride, pravastatin, ranitidine, spironolactone, tramadol hydrochloride, triamterene, hydrochlorothiazide, and verapamil. The patient's drug reactions and allergies included amoxicillin, ciprofloxacin, prednisone, levofloxacin, sulfa and vancomycin (reaction: hives), olmesartan medoxomil(BENICAR) (reaction: anaphylaxis)(captured in marrs # 1910USA009138), codeine (reaction: hives, nausea, vomiting, and hallucinations).    On 07-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S012822 and expiration date 21-FEB-2021, intramuscular for prophylaxis (formulation, strength, and frequency were not reported). Then later at the same day, she developed a rash and a 3 inch lump at the site (injection site mass) of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection. On 08-OCT-2019, the rash spread to the shoulders and back (rash generalised), and the patient developed joint stiffuess (joint stiffness) and soreness in the arm (pain in extremity) that had received the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection. The patient started diphenhydramine hydrochloride (BENADRYL) (manufacturer unknown) on an unknown date. On 09-OCT-2019, the patient recovered from the events. The patient sought for medical attention. None laboratories or studies were performed.   The causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)was not provided.; Sender's Comments:  US-009507513-1910USA009138:
Sex: F
Vaccine: PPV
Symptoms: Breast swelling, Dizziness, Headache, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner, referring to a 67-year-old female patient. It was reported that the patient was not pregnant at the time of this report and that the patient was allergic to "sulfa". The patient's medical history was unknown by the reporter. Concomitant medications included meclizine, levothyroxine sodium and lidocaine patch.   On 23-SEP-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) intramuscular on her left arm for prophylaxis (reported as "routine, previous vaccination"), (lot# S018405 has been verified to be a valid lot number,and expiration date on 23-MAR-2021 :dose, strength and frequency were not reported).    On 25-SEP-2019, the patient complained at the nurse office that she was experiencing a rash and swelling at the injection site that extended to her left breast. Additionally, it was reported that the patient refused steroids.   On 07-OCT-2019, the patient was admitted to an unknown hospital for one night where she complained of dizziness, blurred vision and severe headaches; the patient received meclizine (also reported as concomitant medication) and cefuroxime axetil (FUROCEF) (reported as FUROCET) and was seen by an opthalmology . There were no laboratories or studies performed and the events were not related to cancer, overdose or a congenital anomaly.   At the time of this report, the patient was not recovered from the events. The causality assessment between the vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and the events, was not provided. It was reported that all events incurred in a significant disability or incapacity for the patient.
Sex: F
Vaccine: PPV
Symptoms: Rash, Vision blurred
Clinical narrative: This spontaneous report was received from a nurse practitioner, referring to a 67-year-old female patient. It was reported that the patient was not pregnant at the time of this report and that the patient was allergic to "sulfa". The patient's medical history was unknown by the reporter. Concomitant medications included meclizine, levothyroxine sodium and lidocaine patch.   On 23-SEP-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) intramuscular on her left arm for prophylaxis (reported as "routine, previous vaccination"), (lot# S018405 has been verified to be a valid lot number,and expiration date on 23-MAR-2021 :dose, strength and frequency were not reported).    On 25-SEP-2019, the patient complained at the nurse office that she was experiencing a rash and swelling at the injection site that extended to her left breast. Additionally, it was reported that the patient refused steroids.   On 07-OCT-2019, the patient was admitted to an unknown hospital for one night where she complained of dizziness, blurred vision and severe headaches; the patient received meclizine (also reported as concomitant medication) and cefuroxime axetil (FUROCEF) (reported as FUROCET) and was seen by an opthalmology . There were no laboratories or studies performed and the events were not related to cancer, overdose or a congenital anomaly.   At the time of this report, the patient was not recovered from the events. The causality assessment between the vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and the events, was not provided. It was reported that all events incurred in a significant disability or incapacity for the patient.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product dose omission
Clinical narrative: patient missed second dose of VAQTA on unspecified date; No adverse effects reported; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) lot # N020951, expiration date 15-OCT-2018 for prophylaxis (strength, dose, route and frequency were unknown).  On an unknown date, the patient missed the second dose of hepatitis a vaccine, inactivated (VAQTA). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Pharmacist states patient received dose of PNEUMOV AX 23 that was improperly stored.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information on pertinent medical history, concomitant medication and drug allergies/reactions was not reported.  On 07-OCT-2019 the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (Lot # S012246, expiration date 10-FEB-2021; dose, frequency and route were not provided) for prophylaxis.  The administered dose of the vaccine experienced a temperature of 68 Fahrenheit (F). Time frame was 8 hours. Previous temperature excursion was 57F for 2 hours. The digital data logger was involved.  No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was administered an improperly stored dose of  VARIVAX; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.       On 01-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S006022, expiration date: 27-FEB-2021; dose and route were not reported) for prophylaxis (improper storage of product in use). The vaccine was reconstituted with properly stored sterile diluent (lot # S026376, expiration date: 24-MAR-2022). No adverse effects were reported. The vaccine experienced the temperature excursion from 6 degree Fahrenheit to 14 degree Fahrenheit (7.2 F) for 2 hours. There were no previous temperature excursions. The digital data logger was involved.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a female Patient was administered her first dose ofGARDASIL 9 on an unspecified date when she was 12 years old, came back at 19 years of age to get her second dose of GARDASIL 9; No adverse effect; This spontaneous report was received from a pharmacist referring to a 19 years old female patient. The patient's pertinent medical history, concomitant therapies and drug reactions/allergies were not provided.  When the patient was 12 years old, on an unspecified date, 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) for prophylaxis (dose, unit, lot#, expiration date and route of administration were not reported). The patient came back at 19 years of age on an unspecified date to get her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, unit, lot#, expiration date and route were not reported) (inappropriate schedule of product administration). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Herpes zoster, Pain, Pneumonia
Clinical narrative: Bilateral pneumonia; Painful herpes zoster/shingles.; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation and refers to a male patient of unspecified age. Patient's medical history, concomitant medications, drug reactions or allergies were not reported. On or around 07-JUL-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the vaccine, the patient experienced painful herpes zoster (shingles). In addition, he was hospitalized due to shortness of breath and it was diagnosed with bilateral pneumonia. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient 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. The patient had incurred medical expenses, loss of accumulations and other economic and non-economic damages as a direct result of use of Zoster Vaccine Live (ZOSTAVAX). At the reporting time, the patient had not recovered from the events. The reporter considered the events of bilateral pneumonia and shingles (herpes zoster) to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event bilateral pneumonia was determined to be medically significant. The reporter considered bilateral pneumonia and shingles (herpes zoster) as disabling events.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered an improperly stored PEDVAXHIB; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 15-OCT-2019, the patient was administered an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) with lot number S000354 and expiration date on 18-OCT-2021, for prophylaxis (dose, dose number, route of administration and anatomical injection site were not reported).  It was reported that on an unknown date, the vaccine was exposed to a temperature excursion below 36 Fahrenheit (F) degrees/ 2 Celsius (C) degrees (34.5 F degrees) for 22 minutes and 30 seconds; and above 47 F degrees/ 9 C degrees (48.2 F degrees) for 10 hours and 45 minutes. There were no previous temperature excursions. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; Was administered inadvertently an expired dose; Information has been received from a medical assistant concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 15-OCT-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) (Lot. No R022983, exp. date 09-AUG-2019) (strength, dose and route not reported) for prophylaxis. No adverse events were reported. There was no temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.   On 01-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026391 and expiration date 09-JUL-2020; strength, dose, frequency and route were unknown) for prophylaxis (product storage error). It was stated that the vaccine was stored with the temperature of 32.9 Fahrenheit for 3 hours and 40 minutes. There was a digital data logger involved, there was no previous temperature excursion. No adverse effect was reported.