chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a contactable nurse. A 12-months-old female patient received, on 15May2019, the fourth dose of PREVNAR 13, (Lot. X62324, Expiration date: 30Nov2020) at 10:20 AM, intramuscularly, in the left thigh (left vastus lateralis), at single dose; hepatitis A vaccine (Lot. 9TL92, Expiration date: 27May2021, Manufacturer: GlaxoSmithKline) intramuscularly, in the right thigh (right vastus lateralis); PEDVAXHIB, (Lot. R027320, expiration date: 08Jul2021, Manufacturer: Merck) intramuscularly, in the left thigh (right vastus lateralis) and MMR, (Lot. R028004, Expiration date: 01Oct2020, Manufacturer: Merck) subcutaneously, in the right leg; all for immunization. Relevant medical history and concomitant medications were none. The patient previously received PREVNAR 13, first dose on 13Aug2018 (Lot. W11305, Expiration date: 30Apr2020), second dose on 24Sep2018 (Lot. W33491, Expiration date: 30Jun2020), and third dose on 26Nov2018 (Lot. X34315, Expiration date: 30Sep2020); all intramuscularly, in the left thigh, for immunization. On 15May2019, the patient experienced seizure and respiratory arrest. Patient had to have rescue breaths. It was reported that on an unspecified date, in May2019, the patient had a very high fever at the time of the seizure. The patient was hospitalized for seizure on 15May2019. The patient recovered from respiratory arrest on an unspecified date, in May2019, clinical outcome of seizure was recovering, while clinical outcome of fever was unknown. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of events high fever, seizure and respiratory arrest might not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Respiratory arrest, Resuscitation, Seizure
Clinical narrative: This is a spontaneous report from a contactable nurse. A 12-months-old female patient received, on 15May2019, the fourth dose of PREVNAR 13, (Lot. X62324, Expiration date: 30Nov2020) at 10:20 AM, intramuscularly, in the left thigh (left vastus lateralis), at single dose; hepatitis A vaccine (Lot. 9TL92, Expiration date: 27May2021, Manufacturer: GlaxoSmithKline) intramuscularly, in the right thigh (right vastus lateralis); PEDVAXHIB, (Lot. R027320, expiration date: 08Jul2021, Manufacturer: Merck) intramuscularly, in the left thigh (right vastus lateralis) and MMR, (Lot. R028004, Expiration date: 01Oct2020, Manufacturer: Merck) subcutaneously, in the right leg; all for immunization. Relevant medical history and concomitant medications were none. The patient previously received PREVNAR 13, first dose on 13Aug2018 (Lot. W11305, Expiration date: 30Apr2020), second dose on 24Sep2018 (Lot. W33491, Expiration date: 30Jun2020), and third dose on 26Nov2018 (Lot. X34315, Expiration date: 30Sep2020); all intramuscularly, in the left thigh, for immunization. On 15May2019, the patient experienced seizure and respiratory arrest. Patient had to have rescue breaths. It was reported that on an unspecified date, in May2019, the patient had a very high fever at the time of the seizure. The patient was hospitalized for seizure on 15May2019. The patient recovered from respiratory arrest on an unspecified date, in May2019, clinical outcome of seizure was recovering, while clinical outcome of fever was unknown. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of events high fever, seizure and respiratory arrest might not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia, Respiratory arrest, Resuscitation, Seizure
Clinical narrative: This is a spontaneous report from a contactable nurse. A 12-months-old female patient received, on 15May2019, the fourth dose of PREVNAR 13, (Lot. X62324, Expiration date: 30Nov2020) at 10:20 AM, intramuscularly, in the left thigh (left vastus lateralis), at single dose; hepatitis A vaccine (Lot. 9TL92, Expiration date: 27May2021, Manufacturer: GlaxoSmithKline) intramuscularly, in the right thigh (right vastus lateralis); PEDVAXHIB, (Lot. R027320, expiration date: 08Jul2021, Manufacturer: Merck) intramuscularly, in the left thigh (right vastus lateralis) and MMR, (Lot. R028004, Expiration date: 01Oct2020, Manufacturer: Merck) subcutaneously, in the right leg; all for immunization. Relevant medical history and concomitant medications were none. The patient previously received PREVNAR 13, first dose on 13Aug2018 (Lot. W11305, Expiration date: 30Apr2020), second dose on 24Sep2018 (Lot. W33491, Expiration date: 30Jun2020), and third dose on 26Nov2018 (Lot. X34315, Expiration date: 30Sep2020); all intramuscularly, in the left thigh, for immunization. On 15May2019, the patient experienced seizure and respiratory arrest. Patient had to have rescue breaths. It was reported that on an unspecified date, in May2019, the patient had a very high fever at the time of the seizure. The patient was hospitalized for seizure on 15May2019. The patient recovered from respiratory arrest on an unspecified date, in May2019, clinical outcome of seizure was recovering, while clinical outcome of fever was unknown. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of events high fever, seizure and respiratory arrest might not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia, Respiratory arrest, Resuscitation
Clinical narrative: This is a spontaneous report from a contactable nurse. A 12-months-old female patient received, on 15May2019, the fourth dose of PREVNAR 13, (Lot. X62324, Expiration date: 30Nov2020) at 10:20 AM, intramuscularly, in the left thigh (left vastus lateralis), at single dose; hepatitis A vaccine (Lot. 9TL92, Expiration date: 27May2021, Manufacturer: GlaxoSmithKline) intramuscularly, in the right thigh (right vastus lateralis); PEDVAXHIB, (Lot. R027320, expiration date: 08Jul2021, Manufacturer: Merck) intramuscularly, in the left thigh (right vastus lateralis) and MMR, (Lot. R028004, Expiration date: 01Oct2020, Manufacturer: Merck) subcutaneously, in the right leg; all for immunization. Relevant medical history and concomitant medications were none. The patient previously received PREVNAR 13, first dose on 13Aug2018 (Lot. W11305, Expiration date: 30Apr2020), second dose on 24Sep2018 (Lot. W33491, Expiration date: 30Jun2020), and third dose on 26Nov2018 (Lot. X34315, Expiration date: 30Sep2020); all intramuscularly, in the left thigh, for immunization. On 15May2019, the patient experienced seizure and respiratory arrest. Patient had to have rescue breaths. It was reported that on an unspecified date, in May2019, the patient had a very high fever at the time of the seizure. The patient was hospitalized for seizure on 15May2019. The patient recovered from respiratory arrest on an unspecified date, in May2019, clinical outcome of seizure was recovering, while clinical outcome of fever was unknown. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of events high fever, seizure and respiratory arrest might not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Ill-defined disorder, Rash, Vomiting
Clinical narrative: Rash, illness, vomiting, headache
Age: 1.33
Sex: M
Vaccine: HEPA
Symptoms: Irritability, Nasal congestion, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Head to toe Rash 10 days later, progressing into raised itchy welts, 101 fever, severe nasal congestion, irritability.
Age: 1.33
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Head to toe Rash 10 days later, progressing into raised itchy welts, 101 fever, severe nasal congestion, irritability.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Blood magnesium, Blood phosphorus, Chest X-ray, Differential white blood cell count, Dyspnoea
Clinical narrative: Tuesday (21MAY2019) the patient reported that he was in good health, with no medical issues or concerns and received the smallpox vaccination 15 jabs to his right shoulder at roughly 09:00am. Roughly two hours later by report of the patient he began experiencing difficulty breathing with shortness of breath and generalized muscle weakness and then drove himself to the hospital to be evaluated. From the hospital emergency dept. the patient was admitted to the intensive care unit for treatment of (CPA) community acquired pneumonia. Treating with have imaging, labs, and treating with antibiotics, serial vital signs
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Full blood count, Imaging procedure, Intensive care, Metabolic function test, Muscular weakness
Clinical narrative: Tuesday (21MAY2019) the patient reported that he was in good health, with no medical issues or concerns and received the smallpox vaccination 15 jabs to his right shoulder at roughly 09:00am. Roughly two hours later by report of the patient he began experiencing difficulty breathing with shortness of breath and generalized muscle weakness and then drove himself to the hospital to be evaluated. From the hospital emergency dept. the patient was admitted to the intensive care unit for treatment of (CPA) community acquired pneumonia. Treating with have imaging, labs, and treating with antibiotics, serial vital signs
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Pneumonia, Sputum culture
Clinical narrative: Tuesday (21MAY2019) the patient reported that he was in good health, with no medical issues or concerns and received the smallpox vaccination 15 jabs to his right shoulder at roughly 09:00am. Roughly two hours later by report of the patient he began experiencing difficulty breathing with shortness of breath and generalized muscle weakness and then drove himself to the hospital to be evaluated. From the hospital emergency dept. the patient was admitted to the intensive care unit for treatment of (CPA) community acquired pneumonia. Treating with have imaging, labs, and treating with antibiotics, serial vital signs
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site pain, Injection site warmth, Mobility decreased, Skin warm
Clinical narrative: Patient received Shingrix  shot on 5-19-2019 at 1:30pm and experienced pain at the injection site and later had a temp of 100.2. Later in the day around 5:30pm she had swelling and was unable to move her arm. It was hot even after applying ice. The area affected was where shot was given, but over time has moved down the arm. Patient saw her DR. on 5-22-2019 and received Doxycycline 100mg twice daily for 10 days. She will follow up with her DR. on 05-23-2019
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient received Shingrix  shot on 5-19-2019 at 1:30pm and experienced pain at the injection site and later had a temp of 100.2. Later in the day around 5:30pm she had swelling and was unable to move her arm. It was hot even after applying ice. The area affected was where shot was given, but over time has moved down the arm. Patient saw her DR. on 5-22-2019 and received Doxycycline 100mg twice daily for 10 days. She will follow up with her DR. on 05-23-2019
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Eye irritation, Eye swelling
Clinical narrative: The patient showed to the emergency room with swollen and irritated eyes
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Individual reported "painful to touch, warm red bump where I was given the shot - every time it is touched it hurts"
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; On 06-MAY-2019 a patient was administered an improperly stored PROQUAD.; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender.  Information on pertinent medical history, concomitant medications and drug reactions/allergies was not reported.   On 06-MAY-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, dose number, route, location of administration and frequency were not reported) (lot # R026350, expiration date: 15-MAR-2020) for prophylaxis.  The vaccine was exposed to temperatures from 15 degree Fahrenheit to 46 degree Fahrenheit for 77 hours. A data logger was not involved. There were no previous temperature excursions. No adverse event was reported.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: "I'm sure there are other healthcare providers who have patients who have received [quadrivalent] GARDASIL outside of the recommended dosing schedule; This non-valid spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  The physician stated that there were other healthcare providers who had patients who, on an unknown date, received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis outside of the recommended dosing schedule. The physician did not provide any additional information regarding these other patients and could not confirm any details. The physician refused to provide further information on the other healthcare providers and refused to answer further questions.  The case is non-valid due to lack of patients' identifiers.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA000257:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; One patient received improperly stored VARIVAX; This spontaneous report was received from a Nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 13-MAY-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, route, dose, frequency, and anatomical location were unknown) with  lot # N034556 and expiration date 05-DEC-2019 for prophylaxis and was reconstituted with an sterile diluent.  The administered dose of vaccine experienced the temperature excursion of  6°F to 14°F (-14°C to -10°C) (6.08F) degrees Fahrenheit for 1 hour 50 minutes. No previous temperature excursion and no adverse events were reported. There was a digital data logger involved.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; patient inadvertently received first dose of MMR II past its expiration date; This spontaneous report was received from a licensed practical nurse and refers to a 3 year old patient, of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 07-MAY-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) first dose, lot # N013869, expiration date 04-MAY-2019, subcutaneously (strength and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: on 5/1/2019, the patient was adrninistered one dose of MMR II and on 5/8/2019, the sarne patient was adrninistered one dose of VARIVAX; No adverse effects were reported; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.   On 01-MAY-2019, the patient was vaccinated with a one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. On 08-MAY-2019, the patient was vaccinated with a one dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number R029519, expiration date 14-OCT-2020 (dose, frequency and route of administration were not provided), that was reconstituted with a one dose of sterile diluent (DILUENT MRK) (dose, frequency, route of administration, lot number and expiration date were not provided), for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative, High-pitched crying, Screaming, Stridor
Clinical narrative: the patient had stridor and high-pitched screaming and high-pitched crying after was administered MMR II as child; High-pitched crying; High-pitched screaming; the patient had titers drawn which were low; This spontaneous report was received from a registered nurse and refers to a currently 32-years-old male patient. The patient's concurrent conditions included seizures, craniosynostosis syndrome and developmental delay. The patient's allergies include cheddar cheese, cottage cheese, cow's milk, mozzarella cheese, yogurt, brewers yeast, lettuce, mushrooms, peas, lima beans, peanuts, soybeans, cashews, safflower, sesame, coconut, lemon, watermelon, barley, bran, corn, gluten, malt, rye, wheat, and dill. The patient's concomitant medication included aspirin.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported).    On an unknown date, the patient experienced stridor and high-pitched screaming and high-pitched crying after was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) as a child. The patient was seen by the pediatrician on an unspecified date who recommended not to receive another dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). Since then the patient had titers drawn which were low. No treatment was received for the adverse events. The outcome of stridor, high-pitched crying and high-pitched screaming was recovered. The outcome of the adverse event the patient had titers drawn which were low was unknown at the moment of this report.  The relatedness between the events occurrence and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administration was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one dose of an improperly stored vaccine was administered to one patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided.    On 07-MAY-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, subcutaneously, lot # R034391 with expiration date on 27-NOV-2020 (frequency was not reported)  for prophylaxis. Concomitant therapies included sterile diluent (Merck Sharp & Dohme). The vaccine underwent  temperature excursion of 12.7 degrees Fahrenheit for 50 minutes. There was previous temperature excursion of 6.8 degrees Fahrenheit for 20 minutes on 01-MAY-2019. The digital data logger was involved in recording excursion details. Sterile diluent was stored in the correct temperature storage range. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA010267: US-009507513-1905USA010266:
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pallor, Rash morbilliform, Rash papular
Clinical narrative: This spontaneous report has been received from a nurse referring to a 13-month-old female patient with iodine allergy. The patient's medical history and concomitant therapies information was not provided. On 30-APR-2019, the patient was vaccinated with M-M-R II (rHA) (strength, dose and frequency were not reported), (lot# R030810, expiration date: 24-OCT-2020) intramuscularly as 12 month vaccines, with VARIVAX, VAQTA, PREVNAR 13, PEDVAXHIB and ATARAX (all strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The patient was seen in the office on 05-MAY-2019 for "blanchable, papular lesions on her body, that were measles like". The patient was seen again in the office on 08-MAY-2019 and 15-MAY-2019, because the rash had spread to the face. The patient was prescribed BENADRYL and ATARAX on unknown date. The outcome of the event was reported as "still has rash". The causality between the event and M-M-R II, VARIVAX and VAQTA, PREVNAR 13, PEDVAXHIB and ATARAX was not provided. The event was considered to be an event of medical significant by the reporter.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Inappropriate route of vaccination; This spontaneous report was received from a pharmacist and refers to a currently 57 years old female patient. The patient's pertinent medical history, allergies and concomitant drugs were unknown by the reporter. The patient's concurrent conditions were not provided.  On 17-MAY-2019 (also reported as 17-MAY-2009), the patient with an unknown Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccination history, who had measles antibody negative, mumps antibody test negative, and rubella antibody negative (no blood titer)  was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant Human albumin (rHA), one dose of 0.5 mL, intramuscular (Inappropriate route of vaccination) for prophylaxis (lot number R036580 with expiration date on 17-DEC-2020). The vaccine was given with properly store sterile diluent (lot number S005076 with expiration date on 05-NOV-2021). It was reported that the patient received treatment for the adverse event. However, no medical attention was sought. The outcome of the event inappropriate route of vaccination was unknown also reported as not recovered (discrepant information).
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling arm; This spontaneous report was received from a registered nurse which is also the patients mom and concerns to a male patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date (reported as a couple years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, anatomical site, lot# and expiration date were unknown) for prophylaxis.  On an unknown date (reported as a couple years ago), the patient had swelling of the entire upper arm (peripheral swelling). It was reported that no treatment was given to the patient.  At the reporting time, the outcome of peripheral swelling was unknown.  The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and peripheral swelling was not reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1905USA010094:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; inadvertently administered a dose of PNEUMOVAX 23 on 5/18/2019, that was expired; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 18-MAY-2019, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# N027629, expiry date: 11-MAY-2019) for prophylaxis (expired product administered). No adverse effects reported. Product quality complaint not involved.
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: no adverse event; a patient received a partial dose of MMR II because the two year old patient moved their arm while the injection was being attempted.; This spontaneous report was received from a nurse practitioner and refers to a 2 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 18-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) for prophylaxis, subcutaneously, lot # R027999 and expiration date 01-OCT-2020. The nurse practitioner reported that a patient received a partial dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) because the patient moved their arm while the injection was being attempted (incorrect dose administered by product). No adverse effects were reported in the patient.  The outcome of incorrect dose administered by product was not reported.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The nurse reports that on an unspecified date, a 17 year old male patient was inadvertenly administered one dose of PROQUAD; No adverse effects were reported; This spontaneous report was received from a nurse and refers to a 17 year old male patient. The patient's concomitant therapies included sterile diluent. No information was provided regarding the patient's concurrent conditions, medical history, or drugs reactions.   On an unknown date, the patient was inadvertenly administered one dose of vaccinated (Product administered to patient of inappropriate age)  with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) 1 dose, lot #R013126, expiration date of 04-NOV-2019, for prophylaxis (strength, anatomical site of injection and route of administration were not reported). No adverse effects were reported.   The outcome for the events was unknown.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; The patient was administered an expired dose of PNEUMOVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age.   No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.   On 21-MAY-2019, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly for prophylaxis, lot # N023651 which had expired on 20-05-2019.  No adverse effects were reported.  The outcome of expired product administered and no adverse event was unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects reported; patient received a pediatric dose; This spontaneous report as received from a registered nurse and refers to a 19 year old patient of gender. On 10-MAY-2010, the patient was vaccinated with an unspecified hepatitis A vaccine, (manufacturer, dose, lot#, expiration date were unknown). No other information was given regarding the patient's concomitant therapies or medical history.    On 16-MAY-2019, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) lot # R024007 with exíration date on 12-OCT-2019, 0.5 milliliter, intramuscular for prophylaxis. However, no adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one dose of an improperly stored vaccine was administered to one patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided.    On 07-MAY-2019, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, subcutaneously, lot # R034391 with expiration date on 27-NOV-2020 (frequency was not reported)  for prophylaxis. Concomitant therapies included sterile diluent (Merck Sharp & Dohme). The vaccine underwent  temperature excursion of 12.7 degrees Fahrenheit for 50 minutes. There was previous temperature excursion of 6.8 degrees Fahrenheit for 20 minutes on 01-MAY-2019. The digital data logger was involved in recording excursion details. Sterile diluent was stored in the correct temperature storage range. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA007760: US-009507513-1905USA010267:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one dose of an improperly stored vaccine was administered to one patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided. On 02-MAY-2019, the patient was vaccinated with one dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, subcutaneously, lot # R017799 with expiration date on 19-DEC-2019 (frequency was not reported) for prophylaxis. Concomitant therapies included sterile diluent (Merck Sharp & Dohme). The vaccine underwent temperature excursion of 12.7 degrees Fahrenheit for 50 minutes. There was previous temperature excursion of 6.8 degrees Fahrenheit for 20 minutes on 01-MAY-2019. The digital data logger was involved in recording excursion details. Sterile diluent was stored in the correct temperature storage range. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA007760: US-009507513-1905USA010266:
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash across the mid section of his chest; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife. The patient received the dose of Shingrix and experienced rash across the mid-section of his chest. The reporter could not found any information, if this was common or should he be concerned, and not get a second dose.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Renal pain
Clinical narrative: Kidney pain; can barely move; This case was reported by a consumer via patient support programs and described the occurrence of renal pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received Shingrix .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced renal pain and mobility decreased. On an unknown date, the outcome of the renal pain and mobility decreased were unknown.   It was unknown if the reporter considered the renal pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient experienced kidney pain and barely move after receiving the Shingrix. The case did not have any product complaint. The reporter gave consent to contact the safety physician and provided contact details for the same. The case has been linked with the case US2019AMR089167, reported by same reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: flu like shymptoms; redness at injection site; swollen at injection site; feverish at injection site; tender at injection site; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   On 3rd May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the influenza-like symptoms, injection site erythema, injection site swelling, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: On 6th May 2019, the patient back into physician's office due to flu like shymptoms, Red, swollen, tender and feverish at injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Groin pain, Lymphadenopathy, Oral herpes
Clinical narrative: swollen lymph nodes; chills; cold sore on his mouth; Groin pain; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a month after receiving Shingrix, the patient experienced enlargement of lymph nodes, chills, cold sore mouth and groin pain. On an unknown date, the outcome of the enlargement of lymph nodes, chills, cold sore mouth and groin pain were not recovered/not resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, chills, cold sore mouth and groin pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. Three weeks ago, from the reporting date the patient received a dose of Shingrix. The patient experienced has swollen lymph nodes in groin and chills. The reporter asked, whether it was common to get cold sore and have swollen lymph nodes after getting the shot. The reporter stated, the patient also experienced cold sore on his mouth and was having groin pain with swollen lymph nodes. The reporter further inquired whether this could be related to Shingrix. And the representative replied that the cold sore, groin pain, or swollen lymph glands are not reported in the prescribing information and recommended to the patient's wife to speak with healthcare provider (HCP) regarding the events occurred. The healthcare provider will determine the right treatment plan for the patient. The reporter stated, she would speak with the patient's HCP, however she wanted to seek the input of manufacturers too.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: pruritic rash on her back; This case was reported by a physician via sales rep and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced mildly pruritic rash on her back. The reporter agreed for the follow up and would like guidance on series completion.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Injection site swelling
Clinical narrative: injection site swelling; injection site pain; lower back pain; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FD3N, expiry date 7th July 2021) for prophylaxis.   On 7th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th May 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site pain and low back pain. On an unknown date, the outcome of the injection site swelling, injection site pain and low back pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain and low back pain to be related to Shingrix.  Additional details were provided as follows:  The patient received the 1st dose of Shingrix in the right deltoid.  The patient reported with 24 hours on 8th May2019, he developed persistent injection site swelling, pain and lower left back pain.  The events were reported as ongoing.
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Pruritus generalised, Tri-iodothyronine increased
Clinical narrative: itching from her hips up all over her body; elevated T3 levels; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced generalized pruritus and tri-iodothyronine increased. On an unknown date, the outcome of the generalized pruritus and tri-iodothyronine increased were unknown.   It was unknown if the reporter considered the generalized pruritus and tri-iodothyronine increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced itching from her hips up all over her body and had blood chemistries drawn and T3 was three times normal value. The reporter stated that, the patient had no sign of rash and was seen by dermatologist and endocrinologist. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Pain
Clinical narrative: bad reaction; pain/soreness all over body; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction and general body pain. On an unknown date, the outcome of the adverse reaction and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the adverse reaction and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine and was experienced a bad reaction including severe pain and soreness all over her entire body.  The reporter refused to provide any additional details or demographic information. The reporter did not consent to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness
Clinical narrative: dizziness; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, 2 days after receiving Shingrix, the patient experienced dizziness and upset stomach. On an unknown date, the outcome of the dizziness and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the dizziness and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left arm.  The patient gave consent to contact the safety physician and provided contact details for the same. There is a discrepancy in the reporting the outcome was reported in the Argus structured field (not recovered) and the outcome reported in the source document (recovering/resolving).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Product supply issue
Clinical narrative: inappropriate schedule of vaccine; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2018, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In June 2018, the patient received 1st dose of Shingrix and develop shingles in October 2018.  The shingles had resolved. At the time of this report, the 2nd dose of Shingrix had not been administered  The Shingrix was administered at another facility with supply issues, but the reporter also mentioned later in the call that his facility might also be having supply issues which impact the timing of the patients' second doses. The reporting pharmacist did not have any other information. The reporter did not consent to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: shingles-like rash; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th May 2019, the patient received the 2nd dose of Shingrix. On 11th May 2019, 5 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: On 4th March 2019, the patient received 1st dose of Shingrix. After vaccination, the patient experienced a shingles-like rash.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On 20th April 2019, the patient received the 2nd dose of Shingrix. On 21st April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: There were no events discussed with dose number 1 of Shingrix. The patient experienced a sore arm beginning about a day after Shingrix vaccination. The patient continued to experience arm soreness. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Chromaturia, Discomfort, Feeling cold, Headache
Clinical narrative: By evening I was stiff and shivering all night could not get warm or stop shivering.  Terrible headache.  Lasted until 5/23/2019.  Just a slight headache this morning and my stem is still sore but not as bad as the last two days.  Was not functional on the second day.  My urine was dark and red like a period last night and dark this morning.  Seems to be lightening up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: By evening I was stiff and shivering all night could not get warm or stop shivering.  Terrible headache.  Lasted until 5/23/2019.  Just a slight headache this morning and my stem is still sore but not as bad as the last two days.  Was not functional on the second day.  My urine was dark and red like a period last night and dark this morning.  Seems to be lightening up.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Fatigue, Hyperhidrosis
Clinical narrative: I had extreme weakness and a temperature of 103 that spiked in the night so likely higher than that. I could not eat even a bite of food. In the night I woke up dripping in sweat. I was fine the next morning just very tired.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Headache, muscle and joint pain, slight fever, pain at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Bruising, redness, warmth & soreness to RUE. Bruising to localized area of injection. Redness, warmth & soreness radiating downward to elbow. Patient told to take Aleve/Ibuprofen, use cold/warm compresses and take benadryl.