chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Urticaria
Clinical narrative: Fatigue; Urticaria; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS# 777335) concerning a female patient of 22-year-old. Information on the patient's concurrent illness, other medications and prior vaccinations were not reported.   On 05-OCT-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # N035032 and expiration date 24-SEP-2020) (dose number 2) intramuscular in the left arm. On 06-OCT-2018, on the next day, the patient experienced fatigue and developed hives first on extremities and then on her face (urticaria). No self care was taken for this. The patient denied respiratory or throat symptoms. Now the patient had hives only on the face. He never had hives in the past. The outcome of fatigue and urticaria was reported as not recovered. Causality of the events was not reported.  An investigation into the manufacture of (lot# N035032) was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Influenza like illness
Clinical narrative: within 30 minutes of receiving shot my arm become sore and stiff making it difficult to move.  Within 6 hours I was in a lot of pain and I took a  tylenol 500 and placed a heat pad on the area.  I was extremely tired and by 1am I had flu like symptoms with body aches, and severe shivering and could not get warm.  I was light headed and unable to lift left arm at all.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: within 30 minutes of receiving shot my arm become sore and stiff making it difficult to move.  Within 6 hours I was in a lot of pain and I took a  tylenol 500 and placed a heat pad on the area.  I was extremely tired and by 1am I had flu like symptoms with body aches, and severe shivering and could not get warm.  I was light headed and unable to lift left arm at all.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Insomnia, Pain in extremity
Clinical narrative: That night I woke up with my legs aching.  It felt like when you have the flu.  My arm was very sore, but the legs were hurting so bad I could not sleep.  I went to work the next day and had to take an advil.  When I can come from work I was so tired and my legs still hurt.  I went to bed at 7pm and sleep until 5:30 the next day.  My arm is a little sore, but my legs are fine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Headache; Chills; Tiredness; & Upset stomach.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 697927) under the Freedom of Information Act and refers to a 14-year-old female patient with no concurrent illness or medical history. The patient had no concomitant medications. On 24-MAY-2017, the patient was vaccinated with the second dose of GARDASIL 9, intramuscularly in the left deltoid, lot # M041212, (dose and expiry date were not provided) for prophylaxis. The patient and her mom left office approximately 10 minutes after injection. Front desk employee came back stating that the patient fainted in elevator. The patient was given water and dextrose, electrolytes (unspecified) (PEDIALYTE). The physician stayed with the patient and her mom until she was feeling better. Blood pressure was checked; however, no result was provided. No other laboratory tests were performed. It was also reported that the patient had not eaten since 10:00 o'clock that day (24-MAY-2017). The outcome of the event was reported as recovered on the same day. Causality assessment was not provided. Follow up information was received from a licensed practical nurse via FDA on 15-APR-2019. The primary reporter was updated to a licensed practical nurse. The patient had no illness at the time of vaccination. Follow up information has been received from the licensed practical nurse on 02-MAY-2019. The reporter stated that was unable to locate the patient shared in the letter. Upon internal review, syncope was now considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect reported; the 43-year-old patient recieved a dose of Gardasil 9 four months ago.; This spontaneous report has been received from a pharmacist regarding to a 43-year-old female patient. The patient's concurrent condition, medical history, concomitant medication, drug allergies or reaction were not reported.   On an unspecified day in December 2018 (reported as "4 months ago"), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular (lote #, expiration day, dose and anatomical location of vaccine were not reported) for prophylaxis (Inappropriate age at vaccine administration). No adverse effects were reported.
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: no adverse effects reported; patient received VARIVAX and PROQUAD instead of VARIVAX and M-M-R II; patient received VARIVAX and PROQUAD instead of VARIVAX and M-M-R II; This spontaneous report was received from a registered nurse and refers to a 19-month-old male patient. There was no information about patient's concurrent conditions or pertinent medical history.  Concomitant therapy included sterile diluent.  On 15-APR-2019, the child patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot number R021377 with expiration date 25-JUL-2020 in the left thigh, and mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), in the right thigh, lot not reported, (dose and route not reported for both vaccines) both vaccines for prophylaxis; instead of varicella virus vaccine live (oka/merck)(VARIVAX) and measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine  Live (M-M-R II).  No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was vaccinated with an improperly stored and expired dose of GARDASIL on 24-APR-2019; The patient was vaccinated with an improperly stored and expired dose of GARDASIL on 24-APR-2019; This spontaneous report was received from a Nurse referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, or concomitants medications were not reported.  On 24-APR-2019, the patient was vaccinated for prophylaxis with an improperly stored and expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dosage regimen and route of administration were not provided) lot number: M017983 and expiration date: 30-MAY-2018.   The improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced a temperature above 47 Fahrenheit Degrees / 9 Celsius Degrees (66 Fahrenheit Degrees) for 5 hours. The vaccine did not experience any previous temperature excursion and the digital data logger was not involved. No adverse effects were reported.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse affects reported.; unspecified 17 year old patient received adult dose of VAQTA instead of pediatric dose.; unspecified 17 year old patient received adult dose of VAQTA instead of pediatric dose.; Information has been received from a pharmacist referring to a 17 year old unknown gender patient. Information about concomitant medication, pertinent medical history and drug reactions/allergies of patient were not provided.  On 24-APR-2019, the patient was vaccinated with adult dose of hepatitis a vaccine, inactivated(VAQTA) 50/1.0 U/ml instead of pediatric dose intramuscularly (dose, frequency, lot# and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age and incorrect dose administered). No adverse affects reported.
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 10-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Sex: F
Vaccine: HEPA
Symptoms: Injection site extravasation
Clinical narrative: the pharmacist noticed that a "couple of drops" leaked from the injection site; While giving the Vaqta, the pharmacist noticed that a "couple of drops" leaked from the injection site/she was unclear if the medication was leaking from the syringe itself or from the patient's arm; This spontaneous report was received from a pharmacist, regarding a 48-year-old female patient. The patient had no relevant medical history, concomitant medications, or drug history. The patient's concurrent conditions and drug reactions/allergies were not provided.   On 27-APR-2019, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) intramuscularly, 1 milliliter, lot # R025518, for prophylaxis (strength, frequency, anatomical location and expiration date were not provided). Lot No. R025518 has been verified to be a valid lot number for hepatitis a vaccine, inactivated(VAQTA) and even expiration date was not reported, upon internal validation was established as 15-NOV-2019. While giving the hepatitis a vaccine, inactivated(VAQTA) injection, the pharmacist noticed that a "couple of drops" leaked from the injection site (injection site extravasation) and one of these drops hit the floor. However it was unclear if the medication was leaking from the syringe itself or from the patient's arm. The syringe the patient used was a BD lntegra Retractable 3ml, 25 gauge, 1 inch syringe. Because of this the pharmacist wanted to know if the patient should be re-vaccinated. At the reporting time, the outcome of injection site extravasation was unknown.  The reporter did not assess the relatedness between injection site extravasation and the hepatitis a vaccine, inactivated(VAQTA).
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Product use in unapproved indication
Clinical narrative: Used as treatment for multiple recalcitrant warts on his hands, back, and genital area; Information has been received from the authors in a published literature article, title as below, referring to a 40 year old male patient. The patient's medical history included heart transplant, in 2011.     On an unspecified date, reported as "during the previous 5 years", the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manfuacturer unknown), for multiple recalcitrant warts on his hands, back, and genital area (product use in unapproved indication).  The authors stated that the patient had been unresponsive to multiple treatments including  HPV vaccination.
Sex: F
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: patient "jerked" and needle came out of patient arm while still administering; This spontaneous report had been received from a nurse reporting a 3 year-old female patient. The patient did not have medical history, drug reactions, allergies, concomitant medications or concurrent conditions to be reported.  On 15-MAR-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength and dose not reported) administered subcutaneously as "school shot" (immunisation). Lot number T7E48 was an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD); however expiration date was reported as 20-JUN-2020.  It was reported that on that day during the administration of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) the patient "jerked" and the needle came out of the patient's arm while the vaccine was still being administered (accidental underdose). The patient did not seek for medical attentions, did not received any treatment for the occurred and no lab studied were performed. The occurred was considered resolved. No product quality complaint (PQC) was reported.
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; first dose in MArch 2018, second dose in April 2019; 36 year old male patient received two doses of PROQUAD; This spontaneous report was received from an administrator via a company representative, refers to a 36-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in March 2018, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis (product administered to patient of inappropriate age). The second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered on April 2019 (inappropriate schedule of product administration). No adverse effects were reported.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, Injection site erythema, Injection site swelling
Clinical narrative: patient recived a dose of pneumovax23 that was expired; patient had developed redness and swelling at injection site; patient had developed redness and swelling at injection site; This spontaneous report was received from a medical assistant refers to a 9-year-old female patient. The patient had a history of vaccination with a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (lot number and expiration date unknown by the reporter) on an unknown date. The patient was found to have low titres for pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) when tested on an unknown date. No concomitant medication was reported.  On 01-MAY-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and frequency unknown) lot # N030111, expiry: 21-APR-2019 (expired product administered), intramuscular for prophylaxis.  On an unknown date after the vaccination in May 2019, the patient experienced redness (injection site erythema) and swelling at the injection site (vaccination site swelling). The outcome of injection site erythema and vaccination site swelling was reported as not recovered. Causality assessment was not reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; patient (...) was administered a dose of improperly stored MMR II; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. On 01-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N014635, expiration date 11-MAY-2019 (dose and route of administration were not reported), albumin status rHA (recombinant Human albumin). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (78 degrees Fahrenheit) for 5 hours. Data logger was not involved. There were no previous excursions reported.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a nurse refers to a 3-year-old male patient. The patient had no pertinent medical history, drug reactions or allergies or concomitant medications. On 23-APR-2019, the patient was vaccinated with M-M-R II lot # R024907, expiration date: 30-AUG-2020, subcutaneously (dose was not reported), for prevention of measles,mumps and rubella which was reconstituted in sterile diluent (STERILE DILUENT), lot # S002623, expiration date 28-OCT-2021. On 01-MAY-2019, the patient experienced seizure lasting 10 to 15 minutes. On the same day, the patient recovered from seizure. The patient sought medical attention by calling a physician. No treatment was given for the event. No lab diagnostics or studies were performed. The causality assessment was not provided. Upon internal review, the event of seizure was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received dosing of GARDASIL 9 outside of the recommended dosing schedule/at 0, 1 and 3 months; no adverse effects; This spontaneous report was received from a pharmacist concerning a patient of unknown age, gender and race.  The patient's medical history, concomitant medications, concurrent conditions, drug reactions/allergies or historical drugs were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dosage form (first dose), intramuscular (anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, one month after the first dose, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dosage form (second dose), intramuscular (anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, 3 months after the first dose, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dosage form (third dose), intramuscular (anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was  vaccinated with improperly stored PNEUMOVAX 23; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 22-FEB-2019, the patient was vaccinated with an improperly stored dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # N025563 and expiration date 08-APR-2019 for prophylaxis (dosage schedule, route, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, as recorded by a data logger.There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  1905USA002678: 1905USA002684: 1905USA002685: 1905USA002686: 1905USA002687: 1905USA002688: 1905USA002689: 1905USA002690: 1905USA002691: 1905USA002692: 1905USA002693: 1905USA002694: 1905USA002695: 1905USA002696: 1905USA002679: 1905USA002680: 1905USA002697: 1905USA002698: 1905USA002699: 1905USA002700: 1905USA002701: 1905USA002702: 1905USA002703: 1905USA002704: 1905USA002705: 1905USA002706: 1905USA002707: 1905USA002708: 1905USA002709: 1905USA002710: 1905USA002711: 1905USA002683: 1905USA002712: 1905USA002681: 1905USA002682:
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: the results were low titre levels; the results were low titre levels; the results were low titre levels; This spontaneous report was received from a pharmacist, who was also a 59 year old female patient, reporting on herself. The patient had no pertinent medical history, concomitant medications, drug reactions or allergies. Information regarding the patient's pertinent concurrent conditions was not provided  On an unknown date, reported as years ago, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, anatomical location, route, lot # and expiration date were not provided) for prophylaxis. In approximately 2009, reported as "possibly 10 years ago", she had an unspecified blood titre test performed for mumps, measles and rubella and the results were low titre levels (measles antibody negative)(rubella antibody negative)(mumps antibody test negative). Therefore, on an unspecified date, the patient was administered a second measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) series. It was reported that the patient sought medical attention and treatment was given for the events.  The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was reported as resolved. The causality between the events and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: U
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects for the patient; A patient was administered one separate dose of an improperly stored vaccine, MMR II; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age an gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 02-MAY-2019, the patient was vaccinated with an improperly stored separate dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R001659, expiration date: 17-JAN-2020 (dose, strenght and anatomical location were not provided) administered subcutaneously for prophylaxis. The vaccine was reconstitued with a properly stored sterile diluent (lot # N030415, expiration date: 13-JUL-2020).On an unspecified date, the patient also received  an improperly stored dose of diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (KINRIX).   Both vaccine underwent a temperature of 42.26 fahrenheit (F) degrees during a time frame of 45 minutes as recorded by digital data logger. It was reported previous temperature excursion of 50.396 F for 1 hour and 15 minutes (on 29-APR-2019). In addition, diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (KINRIX), also underwent a temperature of 33.6 F for 45 minutes (during the month of December 2018). No adverse effects were reported to the patient.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: Titres were were found to be positive for measles and rubella, but negative for mumps; This spontaneous report as received from a nurse refers to a currently 24-year-old female patient. The patient had no pertinent medical history. Her concurrent conditions included allergy to amoxicillin (+) clavulanate potassium (AUGMENTIN). The patient's concomitant medications included venlafaxine.   On 17-JAN-1996 and 12-JAN-2000, the patient was vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneously, doses and lot #s were not reported. On unknown date, titres were drawn and were found to be positive for measles and rubella, but negative for mumps. Another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered on 22-APR-2019, albumin status rHA, lot # R031628, expiry date 01-NOV-2020 via subcutaneous route. There was reported that the patient sought medical attention by consulting physician. The outcome of mumps antibody test negative was reported as not recovered. The causality assessment was not provided.
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: an unspecified patient had an unspecified allergic reaction to PNEUMOVAX 23; This spontaneous report was received from a pharmacist concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis(dose #, route, lot # and expiration date were unknown).  On an unknown date, the patient had an unspecified allergic reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).   At the time of reporting, the outcome of the allergy to vaccine was unknown.     The reporter considered allergy to vaccine to be related to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was  vaccinated with improperly stored PNEUMOVAX 23; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 21-MAR-2019, the patient was vaccinated with an improperly stored dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R018136 and expiration date 10-JUL-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion below2 degrees Celsius (1.18 C) for 23 hours and 30 minutes, as recorded by a data logger.There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was  vaccinated with improperly stored PNEUMOVAX 23; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 12-APR-2019 , the patient was vaccinated with an improperly stored dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot #R018136 and expiration date 10-JUL-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion below2 degrees Celsius (1.18 C) for 23 hours and 30 minutes, as recorded by a data logger.There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was  vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 16-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above  1.18 degrees Celsius for 33 hours, as recorded by a data logger.There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was  vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 16-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above  1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was  vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 21-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above  1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was  vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 23-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Age: 51.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects were reported.; Pharmacist reported patient, 51 years of age, inadvertently received PROQUAD, instead of M-M-R II, on 5/3/2019; This spontaneous report was received from a pharmacist referring to a 51 years old patient of unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 03-MAY-2019, the patient inadvertently received measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5ml (therapy type: recombinant Human albumin (rHA); lot # R017800 with expiration date 19-DEC-2019; strength was not reported) subcutaneously instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (wrong vaccine administered). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reconstituted with properly stored sterile diluent. No adverse effects were reported. The causality was not provided.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: two or three unspecified patients and one patient received improperly stored doses of VARIVAX; no adverse effect; This spontaneous report as received from a physician refers to a female patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R011805, expiry date 23-APR-2020, R029517, 14-OCT-2020) for prophylaxis which was reconstituted with properly stored sterile diluent(lot# and expiry date unknown). No adverse effects were reported. Temperature range was 6 degree Fahrenheit to 14 degree Fahrenheit (minus 14 degree centigrade to minus 10 degree centigrade)(minus 14 to 11 centigrade). Time frame of 24 minutes. There was no previous excursion. Data logger was yes.  This is one of the two reports received by the same reporter.; Sender's Comments:  US-009507513-1905USA003086:
Sex: U
Vaccine: MENB
Symptoms: Headache
Clinical narrative: headache; This case was reported by a other health professional via sales rep and described the occurrence of headache in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than a year after receiving Bexsero, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter had not given permission to follow up. This case has been linked with the case US2019AMR067916, reported by same reporter.
Sex: U
Vaccine: MENB
Symptoms: Headache
Clinical narrative: headache; This case was reported by a other health professional via sales rep and described the occurrence of headache in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than a year after receiving Bexsero, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. Medical Assistant mentioned a patient had experienced headaches and contacted their office. The reporter had not given permission to follow up. This case has been linked with the case US2019AMR067915, reported by same reporter.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: I can't lift my arm any higher than my shoulder; Injection site pain; Injection site swelling; Injection site erythema; muscle pain; Tiredness; headache; shivering; fever; dizziness; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019 16:30, the patient received the 1st dose of Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, headache, shivering, fever and dizziness. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, headache, shivering, fever and dizziness were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, headache, shivering, fever and dizziness to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix yesterday and the patient not able to lift his arm any higher than the shoulder, had pain , swelling , redness at injection site and all also had other side effects muscle pain, tiredness, headache, shivering, fever and dizziness. The patient enquired that how long should he expect the events. The permission has been given to reporter to contact patient's physician.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: I can't lift my arm any higher than my shoulder; Injection site pain; Injection site swelling; Injection site erythema; muscle pain; Tiredness; headache; shivering; fever; dizziness; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019 16:30, the patient received the 1st dose of Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, headache, shivering, fever and dizziness. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, headache, shivering, fever and dizziness were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, headache, shivering, fever and dizziness to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix yesterday and the patient not able to lift his arm any higher than the shoulder, had pain , swelling , redness at injection site and all also had other side effects muscle pain, tiredness, headache, shivering, fever and dizziness. The patient enquired that how long should he expect the events. The permission has been given to reporter to contact patient's physician.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: vaccine reaction; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. Two years before the reporting date (in 2017), the patient had flu vaccine and had a reaction to it so refused one flu vaccine, last year.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Kawasaki's disease, Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of kawasaki's disease in a 11-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, 7 days after receiving Meningococcal B vaccine, the patient experienced kawasaki's disease (serious criteria hospitalization and GSK medically significant) and sickness (serious criteria hospitalization). On an unknown date, the outcome of the kawasaki's disease and sickness were unknown. It was unknown if the reporter considered the kawasaki's disease and sickness to be related to Meningococcal B vaccine. Additional details were provided as follows: The reporter stated that, my oldest daughter got the meningococcal b vaccine when she was 11 to start fifth grade. A week later, she was sicker than she ever been in her entire life and a few days after that she was being admitted to the children hospital with all the symptoms of Kawasakis disease. The reporter stated that I owe this vaccine a giant thank you for opening my eyes.
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.   On 14th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was the caller's wife. The patient received the dose of Shingrix and experienced mild arm soreness.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel mixed With sterile water Instead of Hib/ mixed with unknown solution, only gave the ACTHIB portion/ patient had no reaction; Based on information received on 02-May-2019, the report previously considered as non-valid became valid due to identifiable patient.  Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case concerns a 8-month-old male patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number: C5594AA) via intramuscular route in the left thigh on 27-Mar-2019.  It was an actual medication error due to Inappropriate reconstitution technique because Pentacel mixed With sterile water Instead of HiIB/ mixed with unknown solution, only gave the ACTHIB portion.  Patient had no reaction.  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.  Follow-up information was received from  a other healthcare professional.  Patients demographics, case validity, dosage information of suspect vaccine, information about adverse event was updated and changes made in the field and narrative accordingly.  Documents held by the sender: none.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: acthib reconstituted with sterile water/no AE; Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old female patient who received only sterile water of vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Mar-2019, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot UI944AA via intramuscular route in unknown administration site.  It was of actual medication error due to Inappropriate reconstitution technique.  No 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 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.  List of documents held by sender: none.