chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site abscess
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of abscess limb in a 66-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date unknown) for prophylaxis. On 8th February 2019, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced abscess limb (serious criteria GSK medically significant), ulcer of upper extremity, injection site ulcer and injection site abscess. On an unknown date, the outcome of the abscess limb, ulcer of upper extremity, injection site ulcer and injection site abscess were recovered/resolved. It was unknown if the reporter considered the abscess limb, ulcer of upper extremity, injection site ulcer and injection site abscess to be related to SHINGRIX. Additional details were reported as follows: Two months before the time of reporting, the patient received a dose of SHINGRIX. In 2019, after vaccination, the patient experienced her shoulder, arms , down to hands on the left side had sores or abscesses. Also the side of the injection. The symptoms were lasted approximately ten day before resolving. The patient was alerted her provider of the event. No additional details were provided.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abscess limb, Injection site abscess, Injection site ulcer, Skin ulcer
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of abscess limb in a 66-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date unknown) for prophylaxis. On 8th February 2019, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced abscess limb (serious criteria GSK medically significant), ulcer of upper extremity, injection site ulcer and injection site abscess. On an unknown date, the outcome of the abscess limb, ulcer of upper extremity, injection site ulcer and injection site abscess were recovered/resolved. It was unknown if the reporter considered the abscess limb, ulcer of upper extremity, injection site ulcer and injection site abscess to be related to SHINGRIX. Additional details were reported as follows: Two months before the time of reporting, the patient received a dose of SHINGRIX. In 2019, after vaccination, the patient experienced her shoulder, arms , down to hands on the left side had sores or abscesses. Also the side of the injection. The symptoms were lasted approximately ten day before resolving. The patient was alerted her provider of the event. No additional details were provided.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Pruritus, Rash pustular
Clinical narrative: He is the person who received smallpox vaccination a day ago (20190415) and presented to the immunization clinic with erythematous pustules on chest, upper back, and shoulder today. Received the vaccine 0900 and symptoms started 1200-1230 during lunch time. The person also c/o itching sensation last night. He otherwise is healthy male who denies recent infection including skin, use of any meds, new exposure to anything or no recent travelling / insect or animal bites. No allergy or shaving on the area recently. He was given antihistamines / H2 blocker / epipen along with precaution for ER or RTC
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza virus test, Injection site erythema
Clinical narrative: Pain, redness, soreness, swelling at injection site, headache, muscle aches, fever, shivering, fatigue.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Pain, redness, soreness, swelling at injection site, headache, muscle aches, fever, shivering, fatigue.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Musculoskeletal stiffness
Clinical narrative: Headache and shivering upon waking, general stiffness the following day.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: a patient had an unspecified blood test to determine the VARIVAX titre on an unspecified date in "12/2018" which yielded an unspecified "low titre".; Information has been received from a nurse practitioner referring to a 25 years old female patient. There were no medical history, concomitant medication, or drug reactions/allergies.  On an unknown date, the patient was vaccinated with an unknown number of varicella virus vaccine live (Oka/Merck) (VARIVAX) (injection, lot #, expiration date, dose, strength, route and frequency were not reported) for prophylaxis.   On an unknown date in December 2018, the patient had an unspecified blood test to determine the varicella virus vaccine live (Oka/Merck) (VARIVAX) titre which yielded an unspecified low titre. There was no treatment given for the event. The patient had sought medical attention. The outcome of the event was not reported as not recovered. Causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; administration of one dose of an improperly stored vaccine, VARIVAX, to one patient; Information has been received from a physician referring to a patient of unknown age and gender. Information about concurrent condition, concomitant therapies and medical history of the patient was not provided.  On 22-MAR-2019, the patient received one dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (from either Lot# reported as R827995 (invalid for varicella virus vaccine live (oka/merck) (VARIVAX)) with expiration date 01-OCT-2020 or Lot # R024023 with expiration date 21-AUG-2020; strength, dose, route were unknown) for prophylaxis. It was clear that it came from one of these Lot Numbers but could not say which one. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported.   The temperature excursion was 15.4 degrees Fahrenheit (F) for 10 minutes on 22-MAR-2019. Previous temperature excursion was 6 F for 20 minutes on 20-MAR-2019 and 7.7 F for 20 minutes on 21-MAR-2019. Digital data logger was involved.  This is one of two linked cases received from the same reporter.; Sender's Comments:  US-009507513-1904USA007137:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: one dose of ROTATEQ administered to patient outside of approved age indicated for use; No adverse effects; This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (strength, dose, frequency, lot number and expiration date were not reported) for prophylaxis. It was reported that the patient was outside of approved age indicated for use. No adverse effects were reported in association with this administration.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac disorder, Cerebral haemorrhage, Deafness unilateral, Migraine with aura, Neuropathy peripheral
Clinical narrative: Information has been received on 05-APR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for the prevention of shingles (herpes zoster.) On an unknown date after receiving ZOSTAVAX, the patient experienced optic migraines, loss of hearing in her left ear, neuropathy, cardiac issues and a cerebral brain bleed. As a result of these symptoms, the patient presented to a medical provider. As a result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitation not present prior to using ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Optic migraines, loss of hearing in her left ear, neuropathy, cardiac issues and a cerebral brain bleed were considered to be disabling. Upon internal review, loss of hearing in her left ear, neuropathy and a cerebral brain bleed were considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.  The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.  On or about 23-OCT-2013 (patient was 60 years old at this time), the patient was administered zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (dose, route, and lot # not provided).  On an unspecified date, the patient was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster.  The outcome of the event was unknown.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 09-APR-2019, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly, lot # N020501 with expiration date 03-MAR-2019, for prophylaxis (anatomical location was not provided). No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; her daughter received one dose of MMR II intramuscular; This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age, who was her daughter. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On an unspecified date in March 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscular route in the left deltoid (lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Syringe issue
Clinical narrative: No adverse effect reported; at the moment of vaccination, an unspecified "syringe problem" occurred; at the moment of vaccination, an unspecified "syringe problem" occurred; the pharmacist was not sure that the patient received the full dose of the vaccine; This spontaneous case was received from a pharmacist referring to a 60-year-old patient.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 13-APR-2019 (reported as "yesterday"), the patient would be vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #N034002 and expiration date: 04-DEC-2019) 0.5 mL, subcutaneously (frequency not reported) for prophylaxis.  On that day, at the moment of vaccination, an unspecified "syringe problem" (syringe issue, product quality issue) occurred and the pharmacist was not sure that the patient received the full dose of the vaccine due to this (inappropriate dose of vaccine administered). No adverse effect was reported. The outcome of the syringe issue and the product quality issue were not reported.  The causal relationship of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) with syringe issue and product quality issue was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; A patient received an expired dose M-M-R II; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's medical history, concomitant medication and concurrent conditions was not reported.   On 12-APR-2019 the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N024696, expiration date 07-APR-2019, subcutaneous for prophylaxis.    No adverse event was reported.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 11-JUL-2017, at age 68, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2012, at approximately age 66, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 25-JUL-2013, at age 59, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (twice since 2012). Previously administered products included SHINGRIX (1st dose received in January 2019). Concurrent medical conditions included meniere's disease (diagnosed in 2013). On 5th April 2019, the patient received the 2nd dose of SHINGRIX. On 8th April 2019, 3 days after receiving SHINGRIX, the patient experienced ear pain. In April 2019, the patient experienced flu like symptoms, slight temperature, tiredness and pain localized. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the flu like symptoms, slight temperature, tiredness, ear pain and pain localized were recovering/resolving. It was unknown if the reporter considered the flu like symptoms, slight temperature, tiredness, ear pain and pain localized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 years or 61 years. The case was reported by the patient for himself. The patient stated the reason for the delay of 2nd dose was due to back order and could not find any pharmacy that carried it. Even his provider could not get his hands on any for his patients. Twelve hours after the SHINGRIX, the patient started to have strong flu-like symptoms. He also had a slight temperature and was extremely tired. Less than a week after vaccination, the patient expereinced shingles like pain. One thing that concerned the patient was he experienced shingles like pain in some areas on his body. On the day of reporting, he had several episodes of sharp pain in his right middle ear. The patient took 3 Advils and got some relief. The patient asked whether he should expect long term pain in the ear.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 61-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHIGNRIX at an unknown dose. On an unknown date, 122 days after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.  It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX 4 months ago from time of reporting. At the time of report, the patient had Bell's palsy. The patient wasnted to known the cause of the adverse reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Malaise, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness, headache and vomiting. On an unknown date, the outcome of the sickness, headache and vomiting were unknown. It was unknown if the reporter considered the sickness, headache and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Recently from the reporting date, the patient got the SHINGRIX vaccine for shingles. The patient was very sick, and experienced headache and vomiting. The patient inquired, what will happen if not received the 2nd dose of SHINGRIX.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Thyroid disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of thyroid disorder in a 62-year-old male patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 2nd February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced thyroid disorder. The patient was treated with iodine (131 i) (Radioactive Iodine). On an unknown date, the outcome of the thyroid disorder was unknown. It was unknown if the reporter considered the thyroid disorder to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received radioactive Iodine 1 to 2 months before the date of reporting for a thyroid condition after receiving the SHINGRIX vaccine. The pharmacist considered it as unknown specifics of the condition and if possibly related to receiving the vaccine. No additional Information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in several adult patients who received 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 injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist reported that, several patients experienced redness at the injection site after receiving a dose of SHINGRIX. The pharmacist did not believe the redness was lasted greater than 2 or 3 days. The inside sales representative was unsure of how to collect the adverse events as the health care professional declined to be transferred to medical information for further handling or share patient information as he was in a hurry. Thus no additional information was collected. No additional details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site induration, Injection site pruritus, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site redness, injection site itching and injection site induration. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site redness, injection site itching and injection site induration were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site redness, injection site itching and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received SHINGRIX and during that week had a reaction of red arm and swollen, itching, hard from injection site down to where a short sleeve would end. The pharmacist asked if any information was available and gathered the patient information.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Influenza like illness, Rash papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX (batch number CA374, expiry date 28th June 2021) for prophylaxis. On 5th April 2019, the patient received SHINGRIX (intramuscular) .5 ml. In April 2019, less than a week after receiving SHINGRIX, the patient experienced shingles, influenza-like symptoms, blister and erythropapular rash. On an unknown date, the outcome of the shingles and influenza-like symptoms were unknown and the outcome of the blister and erythropapular rash were not recovered/not resolved. It was unknown if the reporter considered the shingles, influenza-like symptoms, blister and erythropapular rash to be related to SHINGRIX. Additional details were provided as follows: The patient had general flu like symptoms, but she was concerned because she was getting blisters and red bumps under her right breast. It was reported that the patient believed that she had shingles from SHINGRIX. The reporter did not want to share date of birth nor additional details.
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 83-year-old male patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. Co-suspect products included umeclidinium bromide, vilanterol trifenatate (Anoro) inhalation powder (batch number HM8D, expiry date 31st July 2020) for chronic obstructive pulmonary disease and salbutamol sulphate (Ventolin Hfa) inhaler (batch number 8ZP7790, expiry date 31st May 2019) for chronic obstructive pulmonary disease. Concurrent medical conditions included cancer and chronic obstructive pulmonary disease. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular), Anoro (inhaled) 1 puff(s) once daily (1 puff(s) daily) and Ventolin Hfa (inhaled) at an unknown dose and frequency. On 31st March 2019, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season and not applicable after starting Anoro and Ventolin Hfa, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the patient experienced shortness of breath and missed dose. The patient was treated with oseltamivir phosphate (Tamiflu). On an unknown date, the outcome of the vaccination failure, shortness of breath and missed dose were unknown and the outcome of the influenza was recovering/resolving. It was unknown if the reporter considered the vaccination failure, influenza and shortness of breath to be related to FLUARIX QUADRIVALENT 2018-2019 season, Anoro and Ventolin Hfa. Additional details were reported as follows: This case was reported by the patient's wife. The patient was receiveing Anoro and Ventolin for chronic obstructive pulmonary disease (COPD) for several years. The patient received a flu shot during the current season, date and name of flu shot unavailable. Around 31st March 2019, the patient expereinced flu. Several years after receiving Ventolin HFS and Anoro, the patient experienced flu and shortness of breath. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The patient was treated with Tamiflu and had improved. The patient did not received Anoro for most of March 2019 (missed dose) as his prescription ran out and he forgot to get a refill. The reporter declined consent for follow up.
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: had a booster rabies vaccine of two doses at that time; Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age patient who had a booster rabies vaccine of two doses at that time, while he/she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In September 2018, the patient received a  dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route.  It was a case of actual medication error due to Incomplete course of vaccination.  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.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: 15 minutes after temp excursion started 2 doses were given to twin boys from opened vial of IPOL/ No reported side effects; Initial information received on 10-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA103574 same reporter.  This case involves a four years old male patient who received vaccine IPV (VERO) [IPOL] lot PIA461M, expiry date: 03-May-2020 via unknown route in the right deltoid On 09-Apr-2019.  It was reported that, excursion for 60 minutes with max temperature 9.11 Celsius. Products: ActHIB, Daptacel, IPV (excursions-open - 2 unopened), Pentacel, Tubersol, Adacel, Menactra.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to Incorrect product storage.  It was reported that, excursion yesterday afternoon around at 14:15 for 60 minutes with max temperature 9.11 Celsius. Products: ActHIB, Daptacel, IPV (excursions-open - 2 unopened), Pentacel, Tubersol, Adacel, Menactra. Caller reports that 2 patient got IPOL vaccination form open IPOL at 14:30  No reported side effects.   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.  Documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: 15 minutes after temp excursion started 2 doses were given to twin boys from opened vial of IPOL/ No reported side effects; Initial information received on 10-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA103572 same reporter.  This case involves a four years old male patient who received vaccine IPV (VERO) [IPOL] lot PIA461M, expiry date: 03-May-2020 via unknown route in the right deltoid On 09-Apr-2019.  It was reported that, excursion for 60 minutes with max temperature 9.11 Celsius. Products: ActHIB, Daptacel, IPV (excursions-open - 2 unopened), Pentacel, Tubersol, Adacel, Menactra.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to Incorrect product storage.  It was reported that, excursion yesterday afternoon around at 14:15 for 60 minutes with max temperature 9.11 Celsius. Products: ActHIB, Daptacel, IPV (excursions-open - 2 unopened), Pentacel, Tubersol, Adacel, Menactra. Caller reports that 2 patient got IPOL vaccination form open IPOL at 14:30  No reported side effects.   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.  Documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Expired Tenivac given to patient/nurse; Initial information received on 10-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 44 years old female patient who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot U5526AA, expiry date- 15-Dec-2018 via unknown route in unknown administration site On an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Expired vaccine used.  It was reported that, gave a vaccine to a patient and then found that it expired 12/15/18.  It was unknown if any adverse event was occurred.  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.  Documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: a 3 year old 10 month old child received only 0.25 mL of Fluzone Quad instead of 0.5; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 3 years old female patient (also reported as 3 year old 10 month or 4 year) who received only 0.25 ml of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of 0.5 ml, which was an intended dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was taken.  On 01-Feb-2019, the patient received a 0.25 ml single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6315UA via unknown route in left thigh.  It was of actual medication error due to vaccine underdose.  It was unknown if any adverse event was reported.  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.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Fluzone High-dose was given today (10 Apr 2019), EXP: 3/9/19; Initial information received on 10-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age patient who received and expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 10 Apr 2019 which was expired on 09-Mar-2019 (lot number not reported via unknown route.).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.   It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced.  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 and Module VI of the 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.
Age: 18.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: The patient was seen for routine office visit. It was identified by the nurse, that the patients Health Maintenance was not up to date, it indicated that the 18 year old patient had not started her HPV vaccine series. It was identified after the patient went home, that her mother called back upset that her daughter was given a vaccine whose series had already been completed. It was identified in looking at database that this patient, in fact, had received all 3 doses of the HPV series with the last and final dose being given 5/19/2014. Hours after the injection the patient was not known to have had any adverse reactions to the vaccine. Called the patient again this morning 4/16/19 at 8am she was noted to have a slight fever, she also received the flu vaccine at her visit yesterday as well. The patient states that she read that it was a common side effect to develop a fever with HPV vaccine. She will call clinic back if she develops any other symptoms.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient was seen in the ER 1 day post vaccination for redness and swelling at the injection site. He was diagnosed with cellulitis at the injection site and prescribed Keflex 500mg Q12hrs for 8 days.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, Laboratory test, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Two days after the shot I started having pain in my middle finger on my left hand. It got worse as the days went on swelled and would not bend. It the. Was in majority of my fingers. NSAIDS were not helping. My neck and jaw as well. Fingers swelled double their size and would not bend or open all the way. Now is in my right ankle. Have a hard time doing my activities of daily living.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity, Pain in jaw, Peripheral swelling, Swelling
Clinical narrative: Two days after the shot I started having pain in my middle finger on my left hand. It got worse as the days went on swelled and would not bend. It the. Was in majority of my fingers. NSAIDS were not helping. My neck and jaw as well. Fingers swelled double their size and would not bend or open all the way. Now is in my right ankle. Have a hard time doing my activities of daily living.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Two days after the shot I started having pain in my middle finger on my left hand. It got worse as the days went on swelled and would not bend. It the. Was in majority of my fingers. NSAIDS were not helping. My neck and jaw as well. Fingers swelled double their size and would not bend or open all the way. Now is in my right ankle. Have a hard time doing my activities of daily living.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Contusion
Clinical narrative: Cellulitis and bruised.
Sex: U
Vaccine: HEPA, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a certified medical assistantand refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date,  multiple patients were vaccinated with improperly stored GARDASIL 9 (Doses, route of administration and anatomical location of vaccine were not provided) (lot # R023606 , expiration date 06-MAY-2021 and Lot # R020949, expiration date 04-MAY-2021), VAQTA (Doses, route of administration and anatomical location of vaccine were not provided) (Lot # R023606, expiration date 23-NOV-2019) and ROTATEQ, Orally (Doses was not provided) (lot # R021390 and expiration date 23-MAY-2020, Lot # R017932 and expiration date 1-MAY-2020); all vaccines were administered for prophylaxis. The administered doses of the vaccines experienced a temperature excursion at (-40.0 Fahrenheit) for a time frame of 3 minutes. There was no previous temperature excursion. This report was called because of a data logger. There were no adverse effects reported. This case is a non-valid, since there were no patient identifiers reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at approximately age 61, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In May 2017, at approximately age 71, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at an urgent care center for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Head discomfort, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 50-year-old female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. On 8th April 2019, the patient received the 1st dose of SHINGRIX. On 8th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain and heaviness of head. On 9th April 2019, the patient experienced blister and erythema. On 9th April 2019, the outcome of the pain and heaviness of head were recovered/resolved. On an unknown date, the outcome of the blister and erythema were not reported. It was unknown if the reporter considered the pain, heaviness of head, blister and erythema to be related to SHINGRIX. Additional information was reported as follows:  The pharmacist reported that the patient experienced feeling achey, and having a heavy head after receiving 1st dose of SHINGRIX vaccine. The patient told her she was feeling better. 1 day after vaccination, the patient noticed that she had developed a red bubble blister on her right wrist.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Next am Parent noticed redness, swelling and warmth of entire upper Left arm with some redness under same arm area. Child complained of some itching at area but did not seem to have pain per Parent. Child was taken to his PCP. No treatment given or recommended per Parent. States Dr. examined child and told Parent that child might have had a reaction to a "preservative" in the vaccine. Parent states symptoms have gradually  improved over the course of the week. Parent denied any anaphylactic type symptoms at any time after vaccines given.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: PT STATED SHE NOTICED HER ARM HOT AND RED WITH SWELLING ON THE NIGHT OF 4/15/19, STATED RT ARM GHAS BEEN HURTING SINCE RECIEVING VACCINE ON 4/10/19, PT EVALUATED BY PHYSICIAN ON 4/16/19
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure increased, Skin warm, Urticaria
Clinical narrative: hives, elevated blood pressure and warm to the touch
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fatigue, Headache, Neurological examination normal, Pain in extremity
Clinical narrative: About 4 hours after vaccination, he developed fatigue and headache, mild arm soreness. He slept off and on for the next 16 hours. Was seen in clinic on 4/16 at 0900 and still had fatigue and frontal headache, but normal neurologic exam, vital signs. No injection site swelling or redness.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Generalised erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain and swelling at injection site. Redness to skin on full body and swelling of face. Pain to full body and joints. Low grade fever.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling face
Clinical narrative: Pain and swelling at injection site. Redness to skin on full body and swelling of face. Pain to full body and joints. Low grade fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Urticaria
Clinical narrative: SLIGHT URTICARIA BEGINNING 4/15/19 & WORSENING AROUND 0400 4/16/19