chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: gotten the flu vaccine but had still gotten the flu; lack of efficacy; Based on information previously received on 03-Dec-2019, the following information [case classification: updated from Non-Case to Valid and updated from 04-Dec-2019 to 03-Dec-2019] have been amended.  Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case is linked to case 2020SA010875 (same reporter).  This case involves a child female patient of unknown age who experienced flu (Influenza), while she received vaccine INFLUENZA VACCINE.  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was a case of vaccination failure.  Detailed laboratory examination was not provided.  Final diagnosis was influenza.   It was not reported if the patient received a corrective treatment.  The patient's outcome was not reported.  The information on the batch number was requested.  Addendum: Based on information previously received on 03-Dec-2019, the following information [case classification: updated from Non-Case to Valid and updated from 04-Dec-2019 to 03-Dec-2019] have been amended.; Sender's Comments: This case concerns a Child female patient who presented with influenza after and despite vaccination with Influenza vaccine (an Influenza containing vaccine). The time to onset is unknown. However, there is no information regarding patient's condition at time of vaccination, immune status, congenital predisposition to infections. Based upon the reported information, the role of the vaccine and a case of confirmed vaccination failure cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: squirted all over the patient, no AE; Leaking at the base of the needle hub to the tip of the syringe, could not turn the needle any further on the syringe, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6686NA expiry date 30-Jun-2020 via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of exposure via skin contact and syringe issue.   It was stated the needle was on the syringe tight because when reporter checked it after she attempted the injection and it had squirted all over the patient. She checked the needle and could not turn the needle any further on the syringe. The patient stated she did not feel any of the injection go into her arm.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: gotten the flu vaccine but had still gotten the flu.; gotten the flu vaccine but had still gotten the flu.; Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case is linked to case 2019SA340023 (same reporter).  This case involves a child female patient of unknown age who experienced flu (Influenza), while she received vaccine INFLUENZA VACCINE.  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was a case of vaccination failure.  Detailed laboratory examination was not provided.  Final diagnosis was influenza.   It was not reported if the patient received a corrective treatment.  The patient's outcome was not reported.  The information on the batch number was requested.; Sender's Comments: This case concerns a Child female patient who presented with influenza despite vaccination with Influenza vaccine (an Influenza containing vaccine). The time to onset is unknown. However, there is no information regarding patient's condition at time of vaccination, immune status, confirmatory laboratory reports,of confirmed vaccination failure cannot be assessed.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event, Product quality issue, Wrong product administered
Clinical narrative: Fluvirin from 16/17 season; Fluad for above 65 years of age and instead got this Fluvirin from 16/17 season; This is a spontaneous case initial and follow up received from other health professional (nurse) on 30-Nov-2018 (both the versions being processed together), concerning an 85-year-old, elderly female patient.  It was reported that on September, 3 vials of vaccine under 65 years of age and Fluad for above 65 years of age was ordered and instead got Fluvirin from 2016-2017 season. When the nurse went to record the information from the vial is when it was a different name and was expired.  On 19-Nov-2018, the patient was administered an expired vaccine Fluvirin (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 162030 and expiry date: 31-May-2017) instead of Fluad (explicitly coded as expired vaccine used and wrong vaccine administered) for influenza prophylaxis.  The patient did not experience any adverse events after vaccination.  This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1036115. Based on the QA investigation, it was reported that, the returned sample showed evidence of use and the most likely root cause was a lack of stock inventory management at the complainant resulting in expired material being used. Considering there was no root cause associated with either Seqirus or Agency there was no product impact from this complaint.  The reporter assessed the case as non-serious.  Follow up received from Quality Assurance Department on 11-Jan-2019: The QA investigation report was added. The narrative was amended accordingly.  Non-significant follow up received from other health professional on 18-Feb-2019: The reporter refused to provide the patient details and it was confirmed that the patient had not experienced any adverse events. Med info number was updated in the additional information tab. No changes were made in the narrative.; Reporter's Comments: An 85-yearold, female patient was administered an expired vaccine Fluvirin Thiomersal instead of Fluad (coded as expired vaccine used and wrong vaccine administered). The company assessed the causality of the events as not related to the suspect vaccine considering the events as an accidental nature of the event.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5, UNK
Symptoms: Asthenia, Diarrhoea, Hypotonia, Lethargy, Moaning
Clinical narrative: My son became very lethargic, weak, limp, and breathing was slow and he began to turn very pale/grey color. He was moaning and then began to have diarrhea. After about seven minutes of being very weak and having this scary episode we were getting ready to call 911 or rush to ER, but I was able to start nursing him and after a few minutes of nursing his color came back and he started to respond.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5, UNK
Symptoms: Pallor, Respiratory rate decreased, Skin discolouration, Unresponsive to stimuli
Clinical narrative: My son became very lethargic, weak, limp, and breathing was slow and he began to turn very pale/grey color. He was moaning and then began to have diarrhea. After about seven minutes of being very weak and having this scary episode we were getting ready to call 911 or rush to ER, but I was able to start nursing him and after a few minutes of nursing his color came back and he started to respond.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Severe chills, fever and headache 12 hours after the vaccine
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Nodule, Skin warm
Clinical narrative: Warm, raised circle with knot on right arm.  4 inches in diameter.  Steroid shot at doctor's office and antibiotics called in to pharmacy
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: fever, chills, body aches, fatigue
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Pain, Swelling
Clinical narrative: Redness, swelling, soreness, back muscle aches.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Peripheral swelling, Rash, Skin warm
Clinical narrative: Yesterday she received pneumonia & Tdap. Tody she call to the clinic because arm was swollen war, Rash was 11x15cm. Ranitidine & Benadryl given. If worsen patient will come back.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Nausea, Pyrexia, Rash erythematous, Urticaria
Clinical narrative: Patient complained of headache and nausea. Ran a low fever. We noticed some red spots on his face, and shortly after found hives all over his body, especially arms, ankles,  and buttocks. Took him to the ER and they suggested OTC Benadryl. He had a small amount ( was asleep by then) and hives were gone in the morning.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Severe rigors 1 am - 2am. Wife wanted to bring me to hospital. Feverish, but temperature not taken.  Subsequent muscle aches, sweating/chills, headache to degree couldn't get to work for first time in many years. Very surprised by severity.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe rigors 1 am - 2am. Wife wanted to bring me to hospital. Feverish, but temperature not taken.  Subsequent muscle aches, sweating/chills, headache to degree couldn't get to work for first time in many years. Very surprised by severity.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant soreness in arm at injection site for about 3-4 days.  Swollen and red at injection site for 1-2 days.  Flu type symptoms started about 24 hours after injection and lasted for a day.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Impaired work ability, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Patient called the office the morning of 01/15/2020 stating at 8:30 pm her right arm started swelling and becoming painful from the top of the arm to her hand. States she could not lift her arm. States she felt like she had a fever but didn't  have a way to take it. She came to the office on 01/15/2020 at 4pm to have Dr. and myself look at the arm. The upper right arm was only slightly swollen but did have pain to touch. The right hand was red, slightly swollen and cool to touch. She was only able to lift her right arm a few inches. Dr. instructed her to take Benadryl for the swelling, Advil for pain, warm compress to the hand and to keep the hand elevated. Called pt. this am at 11am. States she took Benadryl 25 mg every 4 hours after she went home. The swelling is getting less, the pain is better-she was able to sleep during the night and she is able to lift her arm a little farther this am. States she has not taken any Advil for pain . She was given a note to stay off work until Monday. She will call the office in the am for another update on her condition.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral coldness, Peripheral swelling, Pyrexia
Clinical narrative: Patient called the office the morning of 01/15/2020 stating at 8:30 pm her right arm started swelling and becoming painful from the top of the arm to her hand. States she could not lift her arm. States she felt like she had a fever but didn't  have a way to take it. She came to the office on 01/15/2020 at 4pm to have Dr. and myself look at the arm. The upper right arm was only slightly swollen but did have pain to touch. The right hand was red, slightly swollen and cool to touch. She was only able to lift her right arm a few inches. Dr. instructed her to take Benadryl for the swelling, Advil for pain, warm compress to the hand and to keep the hand elevated. Called pt. this am at 11am. States she took Benadryl 25 mg every 4 hours after she went home. The swelling is getting less, the pain is better-she was able to sleep during the night and she is able to lift her arm a little farther this am. States she has not taken any Advil for pain . She was given a note to stay off work until Monday. She will call the office in the am for another update on her condition.
Age: 5.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Abdominal pain upper, Angina pectoris, Chills, Erythema, Fatigue
Clinical narrative: Red 1-inch diameter slightly raised bump with hard center showed 24 hours after injections. The circle expanded to nearly 4-inches diameter within 72 hours. On day four a majority of redness was gone and major itching began; we applied cortisone 10 and Benadryl gel, and cold compress. On the morning of day 5, no sign of any redness or itching. That afternoon, fifth day post-vac, she woke from nap with fever 101.7 and had throughout the day complained of stomach ache, chills, and tiredness. We administered 7mg Tylenol at 5pm and 5mg Motrin at 745pm.  At 915pm she said mommy my heart hurts. At 2am on 1/15 daughter was thirsty and given room temp water. She then vomited. She was tested for flu at 8am, which was negative. They ordered rest and clear fluids. Since, her stomach hurts and she is hot and cold and demure. Normally A very active child.
Age: 5.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Feeling of body temperature change, Induration, Influenza virus test negative, Pruritus, Pyrexia
Clinical narrative: Red 1-inch diameter slightly raised bump with hard center showed 24 hours after injections. The circle expanded to nearly 4-inches diameter within 72 hours. On day four a majority of redness was gone and major itching began; we applied cortisone 10 and Benadryl gel, and cold compress. On the morning of day 5, no sign of any redness or itching. That afternoon, fifth day post-vac, she woke from nap with fever 101.7 and had throughout the day complained of stomach ache, chills, and tiredness. We administered 7mg Tylenol at 5pm and 5mg Motrin at 745pm.  At 915pm she said mommy my heart hurts. At 2am on 1/15 daughter was thirsty and given room temp water. She then vomited. She was tested for flu at 8am, which was negative. They ordered rest and clear fluids. Since, her stomach hurts and she is hot and cold and demure. Normally A very active child.
Age: 5.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Swelling, Thirst, Vomiting
Clinical narrative: Red 1-inch diameter slightly raised bump with hard center showed 24 hours after injections. The circle expanded to nearly 4-inches diameter within 72 hours. On day four a majority of redness was gone and major itching began; we applied cortisone 10 and Benadryl gel, and cold compress. On the morning of day 5, no sign of any redness or itching. That afternoon, fifth day post-vac, she woke from nap with fever 101.7 and had throughout the day complained of stomach ache, chills, and tiredness. We administered 7mg Tylenol at 5pm and 5mg Motrin at 745pm.  At 915pm she said mommy my heart hurts. At 2am on 1/15 daughter was thirsty and given room temp water. She then vomited. She was tested for flu at 8am, which was negative. They ordered rest and clear fluids. Since, her stomach hurts and she is hot and cold and demure. Normally A very active child.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: LARGE AREA OF UPPER RIGHT ARM WAS RED AND WARM TO THE TOUCH
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Rash
Clinical narrative: 7x7 cm area of cellulitis to left deltoid
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Expected reaction to 2nd of two inoculations; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, after expected reaction to 2nd of two inoculations and no reaction from  the 1st dose of Shingrix and asked if it was possible if the  previous version of shingles vaccine was administered. It was also reported that, was it possible to have no reaction after receiving 1st dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Constantly feel a deep, dull soreness at the site of injection; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced in the past for a few painful months about 10 years before the date of reporting).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 64 or 65 years. The patient was very happy to have the opportunity of receiving Shingrix. The patient experienced constantly felt a deep, dull soreness at the site of injection, as if received Shingrix few days before the date of reporting. The patient wondered whether to receive 2nd dose of Shingrix and if not, whether the first dose would offer any protection at all. The patient was enthusiastic about Shingrix, and was first to report this adverse effect, which was not very debilitating, but alarming in its constancy. The patient appreciated the recommendation, especially since the doctor had little to say since the vaccine was quite new.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Injection site pain, Injection site swelling, Lymph node pain
Clinical narrative: felt a stinging sensation inside the node; the injection site after receiving both the first and second dose of the Shingrix vaccine was sore; Swelling; did not receive the second dose of the Shingrix vaccine until a year and eight months after receiving the first dose; Fever of 101.4; lymph node under her left arm, in the arm pit, was swollen; Chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in April 2018, refer case US2020002523.).   In December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced chills, fever, axillary lymph nodes enlarged, lymph node pain, injection site pain, injection site swelling and drug dose administration interval too long. The patient was treated with non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, fever, axillary lymph nodes enlarged, injection site pain and injection site swelling were recovered/resolved and the outcome of the lymph node pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the chills, fever, axillary lymph nodes enlarged, lymph node pain, injection site pain and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and developed chills, a fever of 101.4, and the lymph node under her left arm, in the arm pit, was swollen. She described that she felt a stinging sensation inside the node. She had to prop her arm up most of the night because of the lymph node.  The lymph node swelling lasted for 2-3 days. The fever resolved within 8 hours and the chills were gone after 36 hours. They started during the night, however, she immediately put an ice pack on the injection site and in the arm pit this kept the lymph node from being as painful and there was less swelling. She indicated that the injection site after receiving Shingrix vaccine was sore but she did not remember for how long because she was preoccupied with the other symptoms she was experiencing. The reporter did not receive the second dose of the Shingrix vaccine until a year and eight months after receiving the 1st dose, which led to lengthening of vaccination schedule.  The reporter consented to follow up. The reporter gave permission for her physician to be contact.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: felt a stinging sensation inside the node; the injection site after receiving both the first and second dose of the Shingrix vaccine was sore; Swelling; did not receive the second dose of the Shingrix vaccine until a year and eight months after receiving the first dose; Fever of 101.4; lymph node under her left arm, in the arm pit, was swollen; Chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in April 2018, refer case US2020002523.).   In December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced chills, fever, axillary lymph nodes enlarged, lymph node pain, injection site pain, injection site swelling and drug dose administration interval too long. The patient was treated with non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, fever, axillary lymph nodes enlarged, injection site pain and injection site swelling were recovered/resolved and the outcome of the lymph node pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the chills, fever, axillary lymph nodes enlarged, lymph node pain, injection site pain and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and developed chills, a fever of 101.4, and the lymph node under her left arm, in the arm pit, was swollen. She described that she felt a stinging sensation inside the node. She had to prop her arm up most of the night because of the lymph node.  The lymph node swelling lasted for 2-3 days. The fever resolved within 8 hours and the chills were gone after 36 hours. They started during the night, however, she immediately put an ice pack on the injection site and in the arm pit this kept the lymph node from being as painful and there was less swelling. She indicated that the injection site after receiving Shingrix vaccine was sore but she did not remember for how long because she was preoccupied with the other symptoms she was experiencing. The reporter did not receive the second dose of the Shingrix vaccine until a year and eight months after receiving the 1st dose, which led to lengthening of vaccination schedule.  The reporter consented to follow up. The reporter gave permission for her physician to be contact.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Erythema, Skin infection
Clinical narrative: pain in the joints; lot of pain at the back; The skin around the wound and the immediate area was infected; wound area was red in color; This case was reported by a other health professional and described the occurrence of joint pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included leg injury (on 14th June 2019 while exercising.).   On 18th June 2018, the patient received the 1st dose of Shingrix. On 20th June 2018, 2 days after receiving Shingrix, the patient experienced joint pain, back pain, skin infection and erythema. The patient was treated with antibiotics nos (Iv Antibiotics (Nos)). On an unknown date, the outcome of the joint pain, back pain, skin infection and erythema were unknown.   It was unknown if the reporter considered the joint pain, back pain, skin infection and erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had leg injury and was an abrasion to her lower leg shin and below the knee. She struck her leg in that area on some exercise equipment. The wound area was an abrasion and when she got home it was not actively bleeding and was bandaged. The reporter was paramedic and cleaned the wound and rebandaged it.  The patient checked the wound and it was in the healing process.The wound was almost healed. The patient received Shingrix and day we checked her leg wound over, cleaned it and rebandaged the wound. The reporter checks the patient leg and the skin around the wound and the immediate area was infected and red in color. The patient was complaining of pain in the joints and took her to the emergency room for evaluation. At the emergency room they evaluated her problem situation. She was administered intravenous and was given prescriptions for antibiotics. She took the antibiotics for 3 weeks following the emergency room visit. After a few days on antibiotics her leg wound started to look better. She also had a lot of pain in the joints and back area after the vaccine. She received physical therapy for the pain but it did not produce any relief. The patient was due for her second vaccine my sister and did not allow her to get it.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness; Swelling; Itchiness; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 55-year-old 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 erythema, swelling and pruritus. On an unknown date, the outcome of the erythema, swelling and pruritus were unknown.   It was unknown if the reporter considered the erythema, swelling and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had erythema, swelling and pruritus. The reporter asked should the patient get the 2nd dose.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: mild case of Shingles on her face; This case was reported by a physician via sales rep and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2019, the patient received the 1st dose of Shingrix .5 ml. In November 2019, 1 month after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). 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 case details were reported as follows: The patient received Shingrix in left deltoid and one month post vaccination the patient experienced a mild case of Shingles on her face.  The patient sought medical treatment at an urgent care and was given Valtrex.  The patient stated that the shingles were mild but went across her face.  The patient did not seek any other medical treatment after seeing the urgent care.  At the time of reporting she presented to primary care doctor for a regular appointment and mentioned what had happened after receiving the first dose of shingrix.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Ataxia, Blood lactic acid increased, Cold sweat, Hypotension, Pain in extremity
Clinical narrative: arm soreness; low blood pressure; ataxic; clammy; tremors; high lactic acid level; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included sepsis (sepsis infection requiring 23 days of hospitalization 6 months ago). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in early November 2019, refer case US2020002561). Concomitant products included hydrochlorothiazide.   On 2nd January 2020, the patient received the 2nd dose of Shingrix. On 2nd January 2020, 5 hrs after receiving Shingrix, the patient experienced low blood pressure, ataxia, clamminess, tremor and blood lactic acid increased. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the low blood pressure, ataxia, clamminess, tremor and blood lactic acid increased were recovered/resolved.   It was unknown if the reporter considered the pain in arm, low blood pressure, ataxia, clamminess, tremor and blood lactic acid increased to be related to Shingrix.  Additional case details were reported as follows: The patient experienced arm soreness which has yet to resolve.   After dose 2, about 5 hours after, the husband went to the gym.   He reports a drop in blood pressure,feeling clammy, and ataxic.  The patient also had low systolic blood pressure of 90 and tremors. The patient was taken to the emergency department and was assessed. He was given 2 liters of fluids, which stabilized him. During the emergency room visit, his pressure went back up to systolic.  The patient also had a lactic acid level at 2.6, which went back to normal after hydration to 1.2.   The patient was not admitted and discharged. All events have resolved except the arm soreness.The reporter consented to follow up. Emergency room visit required.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: arm soreness; low blood pressure; ataxic; clammy; tremors; high lactic acid level; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included sepsis (sepsis infection requiring 23 days of hospitalization 6 months ago). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in early November 2019, refer case US2020002561). Concomitant products included hydrochlorothiazide.   On 2nd January 2020, the patient received the 2nd dose of Shingrix. On 2nd January 2020, 5 hrs after receiving Shingrix, the patient experienced low blood pressure, ataxia, clamminess, tremor and blood lactic acid increased. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the low blood pressure, ataxia, clamminess, tremor and blood lactic acid increased were recovered/resolved.   It was unknown if the reporter considered the pain in arm, low blood pressure, ataxia, clamminess, tremor and blood lactic acid increased to be related to Shingrix.  Additional case details were reported as follows: The patient experienced arm soreness which has yet to resolve.   After dose 2, about 5 hours after, the husband went to the gym.   He reports a drop in blood pressure,feeling clammy, and ataxic.  The patient also had low systolic blood pressure of 90 and tremors. The patient was taken to the emergency department and was assessed. He was given 2 liters of fluids, which stabilized him. During the emergency room visit, his pressure went back up to systolic.  The patient also had a lactic acid level at 2.6, which went back to normal after hydration to 1.2.   The patient was not admitted and discharged. All events have resolved except the arm soreness.The reporter consented to follow up. Emergency room visit required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure / got a Shingrix shot a month ago and was diagnosed with shingles yesterday; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received Shingrix. On 8th January 2020, less than 2 months after receiving 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 recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles 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 selected adult as per vaccine indication. The patient got a Shingrix shot a month ago and was diagnosed with shingles on day before reporting. The patient was not very happy that a shingles shot apparently gave him or her shingles. The patient's primary care physician suggested that to get the shingles shot so he or she did and on day before reporting had shingles. This case was considered as suspected vaccination failure as details regarding full vaccination schedule was unknown at the time of reporting. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 6 months after receiving the second dose of Shingrix, patient developed Shingles; Shingles; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 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. On an unknown date, unknown after receiving Shingrix and 6 months after receiving 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 case details were reported as follows: The age at vaccination was not reported. On an unknown date the patient received 1st and 2nd dose of vaccine. About 6 months after receiving the second dose of Shingrix, patient developed Shingles. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: He had arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included prinzmetal angina, rhizotomy and ophthalmic herpes zoster.   On 20th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months 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 case details were reported as follows: The patient received vaccine in unknown arm. The patient reported that when he got his first vaccine, that was mixed it right in front of him. The patient had arm soreness, and at the time of reporting it was recovered. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020002543.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: redness at injection site going towards her shoulder and elbow; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2019, the patient received Shingrix. On 30th December 2019, less than a day after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient has redness at injection site going towards her shoulder and elbow from Shingrix injection.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Swelling
Clinical narrative: Arm where received the vaccine was killing her; Arm pit became swollen; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received Shingrix. On 2nd January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. In January 2020, the patient experienced local swelling. On an unknown date, the outcome of the local swelling and pain in arm were recovering/resolving.   It was unknown if the reporter considered the local swelling and pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The ptient experienced injection site swelling and injection site pain after receiving Shingrix vaccine. The patient reported that the arm where she received the vaccine was killing her the day of the vaccine. The patient refused to answer any questions stating that she was not sure that the swelling was caused by the vaccine. The patient will see her doctor and if he thinks it is a side effect, she will call to report it. The reporter did not consent to follow-up. There was a discrepancy between the outcome reported in the structured field and in source document.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Rash
Clinical narrative: Rash; Painful Blister; Nerve pain on one side of torso; "Sounds like Shingles"; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 3E7B2, expiry date 4th March 2022) for prophylaxis.   On 31st December 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash, blister, nerve pain and shingles. On an unknown date, the outcome of the rash, blister, nerve pain and shingles were unknown.   It was unknown if the reporter considered the rash, blister, nerve pain and shingles to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and few days experienced rash, painful blisters and nerve pain on one side of torso. The reporter stated sounds like Shingles. The reporter asked was this common after 1st dose. Adverse event was collected. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Tenderness
Clinical narrative: Injection site had 3 x 2 inch red circle/oval; Injection site was hard; Injection site was hot; if it was touched and slight soreness; Arm not hurt much, but only if it was touched and slight soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st January 2020, the patient received the 1st dose of Shingrix. On 4th January 2020, 3 days after receiving Shingrix, the patient experienced injection site erythema, injection site induration and injection site warmth. In January 2020, the patient experienced injection site pain and tenderness. On an unknown date, the outcome of the injection site pain, injection site induration, injection site warmth and tenderness were unknown and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site induration, injection site warmth and tenderness to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left arm and reported it did not hurt much afterwards, but only if it was touched and slight soreness.  The patient not observing her arm until 4th January 2020 where the injection site had 3 by 2 red circle and oval that was hard, hot and very red.  The patient reported that the area was approximately one third to half its original size and that it was light red and light pink. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: Arm is itchy; Red rash; Burning; soreness in left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2019, the patient received the 1st dose of Shingrix. On 29th December 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 3rd January 2020, the patient experienced itchy upper limbs, red rash and burning sensation. On an unknown date, the outcome of the pain in arm, itchy upper limbs, red rash and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, itchy upper limbs, red rash and burning sensation to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had soreness in her left arm for a few days which was resolving.   The patient got up and her arm was itchy and she still has a red rash that was burning. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: a little headache; blister on forearm; chills; fever; tiredness; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 2nd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 6th January 2020, 4 days after receiving Shingrix, the patient experienced headache and blister. In January 2020, the patient experienced chills, fever and tiredness. On an unknown date, the outcome of the chills and fever were unknown and the outcome of the tiredness, headache and blister were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, tiredness, headache and blister to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced chills, fever and tiredness the day after the vaccine, till the time of reporting the patient was tired and has a little headache. On 6th January 2020 at morning patient noticed a blister on her forearm on the arm where she received the vaccine. Reporter did not consent to follow-up.
Age: 86.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Was recommended to get the Bexsero; received his first dose on January 7,2019 and second dose on Oct 30, 2019; This case was reported by a consumer via call center representative and described the occurrence of off label use in a 86-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included pancreatic cancer (in January 2018 (for pancreatic cancer)) and splenectomy.   On 7th January 2019, the patient received the 1st dose of Bexsero. On 30th October 2019, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero and Bexsero, the patient experienced off label use and inappropriate age at vaccine administration. On an unknown date, the outcome of the off label use and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient was recommended to get the Bexsero in the hospital which led to off label use and inappropriate age at vaccine administration. The follow up consent was granted.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 4 months 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 reported as follows: The patient received 1st dose of Shingrix and was diagnosed with Shingles in December 2019. Reporter inquired how to proceed with 2nd dose of Shingrix. Reporter did not consent to follow up.