chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported for the patient.; administration of one dose of an improperly stored vaccine, VAQTA, to one patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.     On 06-NOV-2019, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (one dose, 5 milliliter, lot # S009943, expiration date 26-JUL-2020, route of administration was not provided) for prophylaxis. The vaccine experienced temperature excursion of 58.5 degrees Fahrenheit (F) for 10 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported.; one patient received GARDASIL 9 that expired on 10/29/2019; This spontaneous report has been received from a medical assistant, referring to a 16-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported.  On 11-NOV-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9); by intramuscular route for prophylaxis; lot number R024264 and expiration date 29-OCT-2019 (expired product administered). Information about strength, dose, formulation and frequency was not provided.  No adverse effects were reported. The therapy was stored properly with no temperature excursions
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: redness, warmlh and a knot at the injection site; redness, warmlh and a knot at the injection site; redness, warmlh and a knot at the injection site; This spontaneous report was received from a medical assistant referring to a 53 years old female patient. The patient was allergic to levofloxacin (LEVAQUIN). The patient had no concomitant medication or pertinent medical history.  On 16-MAY-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dosage detail, strength, lot # and expiration date were not reported) subcutaneously for prophylaxis and no reaction was expired for the first vaccination. On 17-OCT-2019, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # was reported as R026583, expiration date was reported as 17-DEC-2020, dosage detail and strength were not reported) subcutaneously for prophylaxis. On 18-OCT-2019 (reported as within 24 hours of the second vaccination), the patient experienced injection site reactions, had redness, warmth and a knot at the injection site. On 12-NOV-2019, the patient sought medical attention. There was no treatment or laboratory tests were performed for the events. It was reported that the therapy was continued. The outcome of the events was reported as not recovered. Causality assessment was not provided.  Lot number R026583 is not valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; administered an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical condition and drug reactions/allergies were not reported.   On 12-NOV-2019, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot # S012470, expiration date 20-OCT-2020; strength, dose, frequency and route were not reported) for prophylaxis (Product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent.  The administered dose of the vaccine experienced a temperature excursion at -9 degree Celsius to 8 degree Celsius (0.9C) for 6 hours and 1 min; No previous temperature excursions. The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA005701:
Sex: F
Vaccine: PPV
Symptoms: Coxiella test positive
Clinical narrative: Per the patient, she tested positive for "coxiella burnetii" on 09/24/2019 and believes it is a result of having had lhe PNEUMOVAX 23 vaccine.; This spontaneous report was received from a 38 years old female patient referring to herself. The patient had asthma. Concomitant medications included beclomethasone dipropionate (QVAR) inhaler. The patient had no other pertinent medical history or drug reaction/allergy.       In approximately September 2018 (reported as fall of 2018), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage detail, strength, lot # and expiration date were not reported) intramuscularly for prophylaxis. On 24-SEP-2019, the patient had a blood work with result of positive for coxiella burnetii. On 08-NOV-2019, the patient was also vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage detail, strength, lot # and expiration date were not reported) intramuscularly for prophylaxis.  The patient did not sought medical attention. The outcome of the event was reported as not recovered.   The reporter believed the event was as the result of having had the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects.; a patient received an improperly stored dose of GARDASIL 9; This spontaneous report was received from a nurse referring a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 18-NOV-2019, the patient received an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R032768 and expiration date 31-AUG-2021; strength, dose and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. The vaccine underwent temperature 10.1 Celsius for a duration of 1 hour. There was a previous temperature excursion at 10.6 Celsius for a duration of 15 minutes. The call was because of data logger.
Sex: F
Vaccine: HPV9
Symptoms: Accidental exposure to product, Injury, Skin laceration, Syringe issue
Clinical narrative: nurse cut an unspecified finger on GARDASIL 9 syringe; nurse cut an unspecified finger on GARDASIL 9 syringe that the finger flange had broken off; the finger flage had broken off; the nurse did not notice the broken finger flange until she administered the vaccine to a patient; nurse cut an unspecified finger on GARDASIL 9 syringe that the finger flange had broken off; This spontaneous report was received from a registered nurse referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 13-NOV-2019, the nurse cut an unspecified finger on a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number R027576  and expiration date on 23-JUN-2021 for prophylaxis) (dose, dose number, route of administration and anatomical injection site were not reported) syringe that the finger flange had broken off (skin laceration, injury, accidental exposure to product and syringe issue). The nurse cleansed the finger with an unspecified antiseptic wash, applied and unspecified antibiotic cream and unspecified bandage. The nurse did not notice the broken finger flange until she administered the vaccine to a patient (poor quality product administered). The patient sought for medical attention and no diagnostic laboratories or studies were performed.  At the time of the report, the patient recovered from the events and the causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  with skin laceration and injury was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported.; the patient was "administered the first dose of GARDASIL 9 on 09/19/2019, then administered the second dose of GARDASIL 9 on 10/17/2019 and then administered the third dose ofGARDASIL 9 today, 11/21/2019."; the patient was "administered the first dose of GARDASIL 9 on 09/19/2019, then administered the second dose of GARDASIL 9 on 10/17/2019 and then administered the third dose ofGARDASIL 9 today, 11/21/2019."; This spontaneous report was received from a physician referring to a 25 years old female patient. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.        On 19-SEP-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis.  On 17-OCT-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered).  On 21-NOV-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered).  No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: shingles; post herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On an unknown date the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after injection, the patient suffered multiple painful blistering rashes, and pain after rashes subsided. As a result of her symptoms, patient presented to a medical provider and was diagnosed with shingles and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition.   The events of shingles and post herpetic neuralgia were determined to be disable by the lawyer.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient did not experience any symptoms; A patient was administered one dose of VARIVAX only 27 days after having recieved the MMR II vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On 20-NOV-2019, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S012036 and expiration date: 17-APR-2021) subcutaneously for prophylaxis only 27 days after having received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (inappropriate schedule of product administration). The patient did not experience any symptoms (no adverse event). No product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; The patient  received two doses of the pneumonia vaccine within the last two months; This spontaneous case was received from a female consumer who at the time of the report was 70 years regarding on herself. The patient denied having concurrent conditions, historical conditions or allergies however, she reported to take levothyroxine sodium (SYNTHROID), unspecified blood pressure, and cholesterol medications as concomitant medications.   On an unspecified date in October 2019 (reported as at the end of October), the patient was vaccinated with the first dose of vaccine, polyvalent (23-valent)(PNEUMOVAX23) and on 26-NOV-2019 she received the second dose of vaccine, polyvalent (23-valent)(PNEUMOVAX23) (inappropriate schedule of product administration) indication reported as "Doctor suggested it" and route administration reported as injection, (strength, lot number and expiration date were not reported). No additional symptoms were reported and no adverse events.  Furthermore, no laboratory diagnostics or studies were performed, and the patient did not sought for medical attention.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an improperly stored PROQUAD; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 21-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S021324 a,d expiration date 05-JAN-2021, for prophylaxis (dose, strength, route of administration and frequency were not reported). Sterile Diluent used was properly stored.      The patient experienced no adverse events. It was reported that the vaccine had a temperature excursion of 6°F to 14°F (7.5 F) for 11 hours and 30 minutes. Previous excursion of 6°F to 14°F (40 F) for 18 hours was reported. No digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of Proquad; This spontaneous report was received from a Medical Assitant referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.  On 25-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S013715, expiration date: 01-NOV-2020) route not reported for prophylaxis. The diluent (lot # S026378, expiration date 15-MAY-2022) used to reconstitute the vaccine was properly stored.   The call was because of a digital data logger. There was no previous temperature excursion. It was unknown if there were multiple temperature excursions involved or the time frame of the temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain
Clinical narrative: Severe herpes outbreaks once a year; outbreaks that are quite painful; condition aggrevated; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (experienced around 30 years with occasional mild outbreaks once a year and even sometimes longer like every two years.). Concomitant products included valaciclovir hydrochloride (Valtrex).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced shingles, pain and condition aggravated. Shingrix was discontinued. On an unknown date, the outcome of the shingles, pain and condition aggravated were unknown.   It was unknown if the reporter considered the shingles, pain and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix two and half months before the date of reporting. It was reported that, since receiving Shingrix the patient experienced severe herpes outbreaks about every two weeks. It was reported that since the patient had received Shingrix the patient had been having horrendous outbreaks that were quite painful. The patient received fifth dose of Valtrex in late August. The patient considered talking the attorney about the issue and would like some feedback from the reporter as to how long the event would,  and asked if therewas some time when it would stop or would continued to suffer from these frequent outbreaks. The patient would not receive the 2nd dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: Really tired; A little bit of muscle pain; Feel kind of week; Headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019 19:00, the patient received the 1st dose of Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced fatigue, myalgia, weakness and headache. On an unknown date, the outcome of the fatigue, myalgia, weakness and headache were unknown.   It was unknown if the reporter considered the fatigue, myalgia, weakness and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A day before reporting in the evening at about 7 PM, the patient got Shingrix On the day of reporting, the patient was really tired, felt kind of week, had a little bit of muscle pain and a headache. The patient asked whether these were normal side effects and how long would these symptoms last.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pain, Rash macular
Clinical narrative: Large red splotch on my arm below the injection site; Below the injection site that is a bit swollen; Below the injection site that is a bit warm; Moderate pain; This case was reported by a consumer and described the occurrence of red blotches in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced red blotches, local swelling, skin warm and pain. On an unknown date, the outcome of the red blotches was not recovered/not resolved and the outcome of the local swelling and skin warm were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the red blotches, local swelling, skin warm and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shangrix and stated everything seemed to go as expected. The patient developed a large red splotch on arm below the injection site and was a bit swollen and warm.  The patient stated that, one could understand if it was on the injection site but it was not. The splotch was at 2 to 3 inches below the injection site and went from being the size of a quarter to about 3 inches in diameter at the time of reporting. The patient also stated, most of the moderate pain had receded but splotch was same.
Sex: U
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Large red splotch on my arm below the injection site; Below the injection site that is a bit swollen; Below the injection site that is a bit warm; Moderate pain; This case was reported by a consumer and described the occurrence of red blotches in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced red blotches, local swelling, skin warm and pain. On an unknown date, the outcome of the red blotches was not recovered/not resolved and the outcome of the local swelling and skin warm were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the red blotches, local swelling, skin warm and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shangrix and stated everything seemed to go as expected. The patient developed a large red splotch on arm below the injection site and was a bit swollen and warm.  The patient stated that, one could understand if it was on the injection site but it was not. The splotch was at 2 to 3 inches below the injection site and went from being the size of a quarter to about 3 inches in diameter at the time of reporting. The patient also stated, most of the moderate pain had receded but splotch was same.
Sex: M
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: Pain during injection/soreness at injection site/burning feeling while vaccine injected; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult at an unknown dose. On an unknown date, immediately after receiving Havrix adult, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Havrix adult.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had pain during injection, burning feeling while vaccine was injected and soreness at injection site.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: swelling; had the shringrix shot thurs, and am wondering how long before the redness subside; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown.   It was unknown if the reporter considered the swelling and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced redness and swelling. The patient was inquiring how long would it take to resolve.  The reporter consented to follow up.
Sex: U
Vaccine: DTP
Symptoms: Allergy to vaccine, Hypersensitivity, Near death experience
Clinical narrative: Allergic to the Pertussis part; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine, the patient experienced allergic reaction (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to DTP vaccine.  Additional information was received as follows: The age at vaccination was not reported. The patient took the DPT shot when during childhood. The patient was allergic to the Pertussis part of it and it almost killed the patient and was in the hospital for a long time. The patient enquired whether there were any alternatives. The patient the hospital for a long time.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles 3 days after first dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The reporter Consented to follow up. The reporter did not have lot or expiration date of Shingrix at time of call.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: joint pain in left arm and left shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   On 24th October 2019, the patient received the 1st dose of Shingrix .5 ml. On 24th October 2019, less than a day after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in left arm. The patient complained of joint pain in his left arm and left shoulder.  The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: chicken pox like rash from neck to toes; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th November 2019, 6 days after receiving Shingrix, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The patient received 2 of Shingrix and developed a chicken pox like rash from neck to toes. The patient had been seen by an urgent care clinic. The reporter consented to follow-up. No other information available at the time of reporting.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Movement disorder, Pain
Clinical narrative: Pain/ hurting/hurt when moving a certain way; Discomfort; This case was reported by a nurse via call center representative and described the occurrence of pain in a 44-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3DE4L, expiry date 30th June 2020) for prophylaxis.   On 16th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 6th November 2019, 21 days after receiving Fluarix Quadrivalent 2019-2020 season and an unknown time after starting ibuprofen, the patient experienced pain. In November 2019, the patient experienced movement disorder and discomfort. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain, movement disorder and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the pain, movement disorder and discomfort to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received Fluarix Quadrivalent 2019-2020 season in her right arm. The patient explained that, she was still in a lot of pain with no bruising or swelling but it hurt when moving a certain way. The patient was instructed by her primary care physician to rotate between Ibuprofen and Tylenol but she still had discomfort. The reporter consented to follow up. This case has been linked with case US2019209098, reported by the same reporter.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: hurting/pain/ it only hurts with movement; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 47-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 11th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 3 months after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient was an employee and she quickly reported the adverse events to the nurse practitioner. The patient received Fluarix in her right arm. The patient's arm was still hurting where she got the shot. She had no swelling and no discoloration and it only hurts with movement. No additional details were provided. The reporter consented to follow up. This case has been linked with US2019209098 and US2019209636, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Paraesthesia, Pruritus
Clinical narrative: burning sensation; tingling; itching; stinging sensation; This case was reported by a nurse via call center representative and described the occurrence of burning sensation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced burning sensation, tingling, pruritus and stinging. On an unknown date, the outcome of the burning sensation, tingling, pruritus and stinging were unknown.   It was unknown if the reporter considered the burning sensation, tingling, pruritus and stinging to be related to Shingrix.  Additional details was provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix, and experienced burning, tingling, itching, stinging sensation. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance
Clinical narrative: Doctor thought it might have been spinal stenosis but she was not officially diagnosed; Trouble walking; This case was reported by a pharmacist via call center representative and described the occurrence of spinal stenosis in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On 2nd July 2019, the patient received the 1st dose of Shingrix .5 ml. On 3rd July 2019, 1 days after receiving Shingrix, the patient experienced spinal stenosis and walking difficulty. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the spinal stenosis was unknown and the outcome of the walking difficulty was recovered/resolved.   It was unknown if the reporter considered the spinal stenosis and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient had trouble walking the day after receiving the vaccine. It lasted a while and her doctor thought it might have been spinal stenosis but she was not officially diagnosed with that condition. She was treated with steroids and the symptom has resolved. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm was swollen to the point he could not put on a shirt; This case was reported by a physician via call center representative and described the occurrence of swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling. The patient was treated with prednisone. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced unusual reaction to Shingrix described as the patient's arm was swollen to the point he could not put on a shirt. It was reported that no lymph swelling and worried if patient is administered prednisone that it would inactivate Shingrix vaccine. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Facial bones fracture, Fall
Clinical narrative: falling; This case was reported by a physician via call center representative and described the occurrence of fall in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fall. On an unknown date, the outcome of the fall was unknown.   It was unknown if the reporter considered the fall to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient fell and broke his or her nose.  The doctor would not provide any additional information.  The reporter did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth, Rash papular
Clinical narrative: raised rash at injection site; raised rash at injection site; hot at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M2C7, expiry date 19th December 2021) for prophylaxis.   The patient's past medical history included anaphylactic reaction (the patient has a history of anaphylactic reaction to bees.).   On 15th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site rash and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient received Shingrix and experienced a raised red hot rash at the injection site on her left arm that has been traveling up and down her arm over the last couple of days. The patient has a history of anaphylactic reaction to bees. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: arm is still red; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 17th October 2021) for prophylaxis.   On 25th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The patient received Shingrix three weeks ago and their arm was still red. It was not sore or painful, just red at the injection site. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash in her arm; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm. The patient experienced rash in her arm. The permission to follow up was denied.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In November 2019, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 73 or 74 years. The batch number and expiry date of Shingrix were not provided. It was reported that, an year before the date of reporting, the patient received two doses of Shingrix. At the time of reporting, the patient experienced shingles. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation were unknown.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes, Psoriasis
Clinical narrative: More problems with psoriasis; Having more cold sores than usual; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores and psoriasis. Previously administered products included Shingrix (1st dose received on 2nd May 2019).   On 8th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced cold sores. On an unknown date, the patient experienced psoriasis aggravated. On an unknown date, the outcome of the cold sores and psoriasis aggravated were recovering/resolving.   It was unknown if the reporter considered the cold sores and psoriasis aggravated to be related to Shingrix.  Additional details were provided as follows Within 1 week of receiving the 2nd dose she started having more cold sores than usual. The less than a month after receiving 2nd Shingrix, the patient experienced having more problems with psoriasis but menopause they have not caused her problems except for the past 1.5 months. The reporter consented to follow up.
Sex: F
Vaccine: RAB
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
Clinical narrative: Won´t be able to assist to the second dose; This case was reported by a nurse via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a female patient who would receive Rabies NVS (RabAvert) (batch number ARB6631A, expiry date 20th November 2021) for prophylaxis.   Previously administered products included Rabavert (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced circumstance or information capable of leading to medication error. On an unknown date, the outcome of the circumstance or information capable of leading to medication error was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient won´t be able to assist to the second dose of Rabavert.  So, they ask if it would it be correct to administer one day before or one day after, which led to circumstance or information capable of leading to medication error. The reporter consented to follow up.  Nurse provided consent to follow up. All patient identifiers were given as well as the batch number and expiration date for Rabavert.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at injection site; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 20th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Influenza vaccine Quadrivalent 2019-2020 season and not applicable after receiving Shingrix, the patient experienced injection site pain. On 20th November 2019, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose oh Shingrix and Flu vaccine on the left arm. On 20th november 2019, less than a day after vaccination with dose of shingrix vaccine, the patient experienced injection site pain. The patient received dose of Flu vaccine(unknown manufacturer) and experienced injection site pain. The reporter consented to follow up. This is 1 of the 3 cases reported by same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller reported that she was aware of a female patient that had the Shingrix and experienced flu like symptoms. At the time of this report, limited information was provided. This is 1 of the 3 cases reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated, she was aware of a female patient that had the Shingrix and experienced headache. At the time of this report, limited information was provided. This is 1 of the 3 cases reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: tiredness; flu like symptoms; sore arm; This case was reported by a consumer via sales rep and described the occurrence of tiredness in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness, influenza-like symptoms and pain in arm. On an unknown date, the outcome of the tiredness, influenza-like symptoms and pain in arm were unknown.   It was unknown if the reporter considered the tiredness, influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not The case was reported by a GSK field employee overheard a staff member, who was patient's daughter. The patient experienced flu like symptoms consisting of tiredness and a sore arm. The reporter did not consent to follow-up.  The reporter declined to provide their own information.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's relative. The age at vaccination was not reported. On an unspecified date in 2019, the patient received a dose of Shingrix. The patient felt sick (unknown symptoms) that lasted for one week.  No further information was available. The caller wanted to be anonymous and did not want any further contact. The reporter did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Swelling of eyelid
Clinical narrative: face turned red/eyes swelled shut about a day and a half after she received her second dose of shingrix
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient has an outbreak of shingles. He received both doses of Shingrx