chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray
Clinical narrative: Patient had sever pain could not lift arm for a week after vaccine. Patients states doctor said could possibly be shoulder injury will get x-rays and possible physical therapy . was put on pain medication
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Patient came to clinic with complaint of rash and pain near injection site. SHINGRIX was given 3 weeks ago, left deltoid. Symptoms include red band of discoloration around arm-approximately 3" below the site of injection. Warm to touch, burning-sharp pain. Continues with symptoms at time of visit.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray limb
Clinical narrative: Ever since I got Flu vaccine on 9/23/2018 my right arm has been frozen with sever pain. I received a cortisone shot but not much relief.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Very sore arm, fatigue.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chest X-ray normal, Febrile convulsion, Generalised oedema, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Patient's parents describe fever and full body shaking (possible seizure activity) beginning 4/16/19 at approximately 1700.  He received Ativan (unknown if he received Diastat rectally or an IV dose of Ativan) while in the ambulance.  Parents report hives/full body swelling upon patient's arrival to hospital.  He was given Tylenol and Benadryl.  He was diagnosed with a febrile seizure and discharged home at approximately 2130 on 4/16/19.  He has had no fevers or other symptoms today.  I saw patient today (4/17/19) and his exam is WNL and he looks great.  Will refer to peds neurology for further workup.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, Tremor, Urticaria
Clinical narrative: Patient's parents describe fever and full body shaking (possible seizure activity) beginning 4/16/19 at approximately 1700.  He received Ativan (unknown if he received Diastat rectally or an IV dose of Ativan) while in the ambulance.  Parents report hives/full body swelling upon patient's arrival to hospital.  He was given Tylenol and Benadryl.  He was diagnosed with a febrile seizure and discharged home at approximately 2130 on 4/16/19.  He has had no fevers or other symptoms today.  I saw patient today (4/17/19) and his exam is WNL and he looks great.  Will refer to peds neurology for further workup.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Mild fever, approximately 28 hours after injection.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Mother   stated  baby   started throwing up  last night and she gave Pedialyte,  Infant  started having  a fever this morning.  Infant had 2 loose stool and vomited 3 times since this morning . Mother continued to give Pedialyte . Mother claimed  there are 2 other babies that are sick living in the   shelter.   Advise mother to go see  PMD.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Back pain, Loss of personal independence in daily activities, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Severe pain in entire right arm, shoulder, collarbone, neck and back resulting in difficulty to perform basic functions. Pain persists at rest and is worsened by touch or movement.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Severe pain in entire right arm, shoulder, collarbone, neck and back resulting in difficulty to perform basic functions. Pain persists at rest and is worsened by touch or movement.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Lingering pain in left arm that has not completely gone away. Patient reports that ever since she received the vaccine, she has had a pain in her upper left arm. She has since seen her physician and has been checked out normal, yet she still fills the pain slightly.
Age: 45.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Joint stiffness, Paraesthesia
Clinical narrative: Developed stiffening joints and then tingling and numbness in feet a few weeks after getting vaccine. Went to Rheumatologist, then endocrinologist, then neurologist, and recently diagnosed with post vaccine Guillain-Barre Syndrome.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Pain
Clinical narrative: Patient experienced Large local reaction w/ erythema and significant pain 1 day s/p Biothrax injection IMRD. Local reaction was identified and erythema was noted from upper should area throughout the arm to the lower tricep/near elbow area. Symptoms began resolving with time.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Generalised erythema, Sunburn
Clinical narrative: The patient reported that within 1-2 hours of getting the vaccine he started to turn red all over his body (like he had a sunburn), he began to have problems breathing, his chest got tight, and he got a sore throat. He came back to the pharmacy to speak with the administering pharmacist between 5 and 6 to speak about the vaccine.  The patient reported he was concerned because the vaccine administration sheet had asked about latex, which he does have an allergy to, and he was afraid it was in the vaccine. The pharmacist spoke with the patient about that (the patient thinks the pharmacist said there is no latex in the vaccine) and the patient left. The symptoms persisted so he went to the emergency room to seek treatment.  The patient did have bloodwork done, but he was never given the results.  The hospital prescribed medication to treat the allergic reaction.  The hospital told him they were concerned there may be latex in the vaccine and they said he should not have gotten the vaccine because it interacted with his other medications (meaning the prednisone).  They also said the patient should not have had the vaccine at his age.  I consulted with my clinical team after the conversation with the patient and the vaccine is indicated in someone his age because he is a smoker, there is actually no latex in the vaccine, and although the patient was using prednisone, you can get inactive vaccinations while using prednisone, although the immune response might possibly not be as great.  Because of this, we believe the patient has an allergy to the vaccine or one of its components. I followed up with the patient today to let him know what we feel happened and to see how he was feeling.  He reported he still isn't feeling the best but he is slowly recovering.
Age: 4.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: My son who received the immunizations complained about his leg hurting.  I assumed it was all typical pain but gave him some Tylenol to help with the pain. A little over 24 hours after receiving immunizations,  he was still complaining about pain, and I looked at his leg and realized he had a rash developing. We gave him benedryl and a bath. The next day it looked a little worse but that night it progressed to a raised, hot-to-the-touch rash that covered almost his entire front and side left thigh. We called the nurse who said to put ice on it and make an appointment the next day if it didn't get better. We went into the pediatrician's office the next day and  it had lessened a little in heat and color by that point. They said to keep an eye on it and make sure it didn't get any bigger. He's still complaining of pain, it's warm to the touch, and it's terribly frightening to look at. I'm very concerned and don't know what to think at this point.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Significant round rashes inferior to the injection site, with diameters of approximately 7 cm and 3 cm respectively.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Pain
Clinical narrative: Patient noticed soreness that began a few hours after receiving the vaccine. The pain went away over night, but she developed a large red area on her upper right arm the following day. Two days after vaccination, patient presented to Urgent Care with extreme redness (4" area) on upper right arm for 2 days after receiving SHINGRIX and was diagnosed with cellulitis. Pus pockets did not appear to be present. She was treated with 7 day course of cephalexin.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Intense (R) arm pain, nausea.
Age: 31.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Patient experienced hives 3 days after receiving vaccine. Patient received DEPO MEDROL 80 mg in office visit and recommended OTC ALLEGRA.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Irritability, Muscle twitching, Pyrexia, Vomiting
Clinical narrative: Intermittent fevers for past 24 hours. Max temp 102. Temp does respond to tylenol. Excessive irritability. Twitching with falling asleep. Vomited x3 on 4/16/19 Received Dtap Hib Prevnar 13 4/16/19. Mom reports an hour after vaccines started with excessive irritability. Temp intermittent since vaccines - high 102. Temp does respond to tylenol. 4/16 -3 episodes of vomiting 4/17 seen in office for symptoms.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Gait inability, Pyrexia, Tremor
Clinical narrative: fever 103-several hours after vaccine-unable to walk-favoring legs-shaking
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Sleep disorder
Clinical narrative: Arm started hurting immediately after shot was given. Pain was from shoulder joint down to mid arm. In the daytime, it hurts with physical labor and impedes range of motion. Pain at night wakes him up. Pain has not improved since November, and has gotten worse.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Malaise
Clinical narrative: Patient had a large red swollen area at injection site that was hard for 3-4 days, overall patient didn't feel well.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: Received on Thursday, injection site red 1.5 inches around site. Redness lasted till Monday, patient felt very tired, site itching.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash maculo-papular
Clinical narrative: gave Benadryl 160mg/5ml Allergy childrens Liquid gave 2.5 ml,po gave acetaminophen 160mg/5ml oral solution 3.5ml,po  -At the injection site of MMR & varicella in lateral (L) thigh: Developing swelling & redness with satellite rash surrounding (papules & macules)  Monitor for 15-20 min, no other systemic signs, rash improved Here for catch up of 12 month shots. also mother concerns that he just recently got teeth on the bottom, no other concerns. Hx of flat head, improved with cranial helmet.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Chills, Fear, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, concerning a 17-year-old female patient. The patient's medical history included allergic rhinitis. Concurrent conditions were not reported. Current illnesses were unknown. Prior vaccinations were not reported. On 16-OCT-2017, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, in the left arm, lot number N013276, expiration date 21-JAN-2020 (exact dose was not provided). The patient had no concomitant medications at the time of immunization. On 17-OCT-2017, the patient experienced abdominal pain, and at the same day, fever and chills. It was also reported that the patient was scared per mom. There were no lab diagnostic data provided. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and GARDASIL 9 was not reported. Follow up information has been received from the agency on 25-FEB-2019. The patient's demographics and reporter information were updated. The patient had never had an adverse event following any previous vaccine. There were no known drug allergies. The date of vaccination was updated to 16-OCT-2017 at 16:38, and the events, onset was updated to 17-OCT-2017 at 18:00. Follow-up information has been received from the Nurse on 16-APR-2019. The Nurse reported that she was unable to identify the patient. The date of vaccination was provided to the Nurse to try to locate the patient identification information and the details regarding the reported events. The Nurse reported that she would be submitting the details on a later date.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone contusion, Bone disorder, Contusion, Pain, Soft tissue injury
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of contusion in a 65-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included adverse event. On 15th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced contusion, swelling, pain, bone contusion, soft tissue injury and bone disorder. On an unknown date, the outcome of the contusion, swelling, pain, bone contusion, soft tissue injury and bone disorder were not recovered/not resolved. It was unknown if the reporter considered the contusion, swelling, pain, bone contusion, soft tissue injury and bone disorder to be related to SHINGRIX. Additional details were provided as follows: The patient had been experiencing side effects for the past 11 months including bruising, swelling, pain, bone bruising, bone tuberosity soft tissue damage and ongoing medical issues. The patient received the vaccine from pharmacy. The reporter gave consent to follow up. No lot or expiry provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of contusion in a 65-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included adverse event. On 15th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced contusion, swelling, pain, bone contusion, soft tissue injury and bone disorder. On an unknown date, the outcome of the contusion, swelling, pain, bone contusion, soft tissue injury and bone disorder were not recovered/not resolved. It was unknown if the reporter considered the contusion, swelling, pain, bone contusion, soft tissue injury and bone disorder to be related to SHINGRIX. Additional details were provided as follows: The patient had been experiencing side effects for the past 11 months including bruising, swelling, pain, bone bruising, bone tuberosity soft tissue damage and ongoing medical issues. The patient received the vaccine from pharmacy. The reporter gave consent to follow up. No lot or expiry provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Left Arm very sore within 2 hours same day, joint and muscle aching the next day and today. Extreme fatigue.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Irritability, Mucous stools
Clinical narrative: Presented with increased irritability, especially with feeds, as well as bloody stools mixed with mucus that started approximately one week following 2 month immunizations. Abdominal ultrasound showed target sign in right lower quadrant. Contrast enema performed with reduction of small right ileocolic intussusception.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Presented with increased irritability, especially with feeds, as well as bloody stools mixed with mucus that started approximately one week following 2 month immunizations. Abdominal ultrasound showed target sign in right lower quadrant. Contrast enema performed with reduction of small right ileocolic intussusception.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Ear pruritus, Ear swelling, Erythema, Skin discolouration
Clinical narrative: I have my left ear that has started to itch. Soon it became red and inflated to double volume. Then she turned green for half a day before returning to normal.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Axillary pain, Chills, Discomfort, Insomnia
Clinical narrative: Extremely sore shoulder and arm, even to barely touch. Very sore underarm area, next to her breast tissue. Feeling weak and chilly without noticable fever. Discomfort started gradually and then quickly continued to worsen. Difficulty sleeping due to amount of discomfort.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal pain, Pain in extremity, Spinal pain, Tenderness
Clinical narrative: Extremely sore shoulder and arm, even to barely touch. Very sore underarm area, next to her breast tissue. Feeling weak and chilly without noticable fever. Discomfort started gradually and then quickly continued to worsen. Difficulty sleeping due to amount of discomfort.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received on 09-APR-2019 from a lawyer regarding a case in litigation concerning a male patient (age unknown).  The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.   In 2015, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (lot# and route not specified) by a pharmacist.  On an unspecified date, the patient was treated by a physician  for herpes zoster as a result of vaccination with zoster vaccine live (ZOSTAVAX). The outcome was not provided.   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received on 09-APR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown).  The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.  In 2007, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (lot# and route not specified) by a healthcare provider.  On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with zoster vaccine live (ZOSTAVAX).  The outcome was not provided.   Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 49 years old patient of unknown gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 12-DEC-2013, the patient was administered the ZOSTAVAX vaccine. The patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: Herpes Zoster. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the event was unknown. Causality assessments were related.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: breach of implied warranty; shingles; products liability - defective design; products liability - manufacturing defect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a elderly female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 20-NOV-2014, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) vaccine by a pharmacist. The patient was treated by a physician for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the event was not recovered/not resolved. Causality assessments were related.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: breach of implied warranty; shingles; products liability - defective design; products liability - manufacturing defect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a elderly patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2016, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) vaccine by a pharmacist. The patient was treated by a healthcare provider for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles. The patient claimed damages as a result of: Injury to themselves; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the event was not recovered/not resolved. Causality assessments were related.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: breach of implied warranty; shingles; products liability - defective design; products liability - manufacturing defect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-MAY-2015, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) vaccine by a pharmacist. The patient was treated by a physician for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles. The patient claimed damages as a result of: Injury to themselves; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the event was not recovered/not resolved. Causality assessments were related.
Sex: F
Vaccine: HPV9
Symptoms: Exposure via skin contact, Peripheral swelling, Skin discolouration
Clinical narrative: This spontaneous report was received from a consumer (a daughter reported about her mother who is the 54-year-old patient as well as the physician). The patient's pertinent medical history included breast cancer few years ago. The patient's concomitant medications included medicines for breast cancer. On 13-APR-2019 (also reported as Saturday), the physician attempted to administer GARDASIL 9 injection to another unspecified patient and the content of the vaccine leaked onto the physician' s finger. The physician's finger "swelled and some of the vaccine content got under her skin which resulted in her skin to turn purple which occurred within only a few seconds." The swelling of the physician' s finger has lessened but the skin is still purple. The physician treated herself (accidental exposure to product, skin discolouration, peripheral swelling and exposure via skin contact). The outcome of skin discolouration and peripheral swelling was recovering. Causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional referring to a 27-year-old female patient. Her concomitant medications and drug reactions/allergies were not reported. Historical drug included GARDASIL. It was reported that the patient when she was 20 years old, received complete 3 dose series of GARDASIL on unspecified dates in the beginning of 2012 for prophylaxis. The reporter also stated that the patient was currently in the physician's office to receive the first dose of GARDASIL 9 for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration were not reported) (product administered to patient of inappropriate age). The patient has not yet received GARDASIL 9 (circumstance or information capable of leading to medication error). No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse affects reported; expired dose of PNEUMOVAX 23 was administered; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 14-MAR-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with lot # N020501, expiry date: 03-MAR-2019 intramuscularly for prophylaxis (dosing details not reported). No adverse effects reported. No product quality complaint (PQC) identified.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; Patient inadvertently received an expired dose of MMR II; This spontaneous report as received from a nurse refers to a patient of unknown age.    On 17-APR-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N024696 for prophylaxis.    Concomitant therapies included sterile diluent(STERILE DILUENT).   On 17-APR-2019, 1 day after onset of therapy the patient experienced expired product administered.  On an unknown date the patient experienced no adverse event.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old male patient who received SHINGRIX for prophylaxis. In 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and injection site warmth. On an unknown date, the outcome of the pain in arm and injection site warmth were recovered/resolved. It was unknown if the reporter considered the pain in arm and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in September 2018 or October 2018 and forgot about it because he has been working and busy. The caller also stated that after he got the shot, his arm was sore for about 4 days. It was also warm for a couple days or so at the spot where it was given. The patient was not sure how long after the shot it started. For tolerance to 2nd dose, refer case US2019065893.
Sex: U
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 91 days after receiving SHINGRIX, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). On an unknown date, the outcome of the polymyalgia rheumatica was unknown. It was unknown if the reporter considered the polymyalgia rheumatica to be related to SHINGRIX. Additional 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 reporter's physician indicated that, he had other patients that were diagnosed with polymyalgia rheumatica. The reporter was going to talk to her rheumatologist and get the names of the other patients that were diagnosed with polymyalgia rheumatica three months after vaccination. The reporter was considering filing a lawsuit. This case has been linked with case US2019065952, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included pneumonitis hypersensitivity (diagnosed in 2014). In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), injection site pain, injection site swelling, injection site erythema, general body pain, injected limb mobility decreased and joint range of motion decreased. The patient was treated with prednisone. On an unknown date, the outcome of the polymyalgia rheumatica, injected limb mobility decreased and joint range of motion decreased were not recovered/not resolved and the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved and the outcome of the general body pain was unknown. It was unknown if the reporter considered the polymyalgia rheumatica, injection site pain, injection site swelling, injection site erythema, general body pain, injected limb mobility decreased and joint range of motion decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on an unknown arm. It was hurt during injection. After the vaccination, the patient experienced the injection site was swollen and became red. These symptoms were resolved after several days. Since the vaccination, the patient was not able to straighten her left, could not raise her arm and was achy all over. The patient went to her general practice physician and her chiropractor. The patient recently went to a rheumatologist and was diagnosed with polymyalgia rheumatica. The patient's prescribed a Prednisone and was told that would need to take it for one year. The patient's physician told that did not receive the 2nd dose of the product. The reporter was considering filing a lawsuit. The reporter did not consent to follow-up. This case has been linked with case US2019GSK070689, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Polymyalgia rheumatica
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included pneumonitis hypersensitivity (diagnosed in 2014). In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), injection site pain, injection site swelling, injection site erythema, general body pain, injected limb mobility decreased and joint range of motion decreased. The patient was treated with prednisone. On an unknown date, the outcome of the polymyalgia rheumatica, injected limb mobility decreased and joint range of motion decreased were not recovered/not resolved and the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved and the outcome of the general body pain was unknown. It was unknown if the reporter considered the polymyalgia rheumatica, injection site pain, injection site swelling, injection site erythema, general body pain, injected limb mobility decreased and joint range of motion decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on an unknown arm. It was hurt during injection. After the vaccination, the patient experienced the injection site was swollen and became red. These symptoms were resolved after several days. Since the vaccination, the patient was not able to straighten her left, could not raise her arm and was achy all over. The patient went to her general practice physician and her chiropractor. The patient recently went to a rheumatologist and was diagnosed with polymyalgia rheumatica. The patient's prescribed a Prednisone and was told that would need to take it for one year. The patient's physician told that did not receive the 2nd dose of the product. The reporter was considering filing a lawsuit. The reporter did not consent to follow-up. This case has been linked with case US2019GSK070689, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 71-year-old female patient who received SHINGRIX (batch number BF4J5, expiry date 5th July 2021) for prophylaxis. On 5th April 2019, the patient received the 1st dose of SHINGRIX(intramuscular). On 6th April 2019, 1 days after receiving SHINGRIX, the patient experienced itchy rash and skin warm. On an unknown date, the outcome of the itchy rash and skin warm were unknown. It was unknown if the reporter considered the itchy rash and skin warm to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist reported that the patient received SHINGRIX and about one day later experienced an itchy rash on the torso that felt hot like a sunburn.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Oral herpes, Pain in extremity, Skin discolouration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in an 81-year-old female patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 16th May 2018 and it was well tolerated). On 12th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cold sores, pain in toe, skin discoloration and neuropathic pain. On an unknown date, the outcome of the cold sores, pain in toe, skin discoloration and neuropathic pain were not recovered/not resolved. It was unknown if the reporter considered the cold sores, pain in toe, skin discoloration and neuropathic pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist called to report on behalf of one of their patients. Since the 2nd dose of SHINGRIX, the patient had a lot of symptoms like cold sores, terrible pain in one toe, she got a red or bluish circle that kept coming back on her toe. The pharmacist said that the patient seemed to have neuropathic pain. The pharmacist could not retrieve the lot number for the 1st dose. No further information was provided.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Injection site cellulitis; This is a spontaneous report received from a contactable Physician.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration from an unspecified date at single dose for immunisation .  The patient medical history  and concomitant medications were not reported.  The patient experienced injection site cellulitis non-serious on an unspecified date with outcome of unknown.  The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018499708 Same reporter/product/event, different patient.
Sex: F
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: vaccine had been expired when it was given; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked with 2019SA106109  This case involves a 45 years old female patient who was inadvertently vaccinated with an expired dose of 0.5 ml RABIES VACCINE[IMOVAX RABIES] lot N1B902M via unknown route in the right deltoid on 01-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; and POLIO VACCINE (POLIO VACCINE).  It was an actual medication error due to expired vaccine used. It was reported that the reporter noted that the first vaccine had been expired when it was given.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: first vaccine had been expired when it was given; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA106093.  This case involves a 20 years old female patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and reported that first vaccine had been expired when it was given.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Apr-2019, the patient received a dose of suspect 0.5 ml RABIES (HDC) VACCINE (lot number: N1B902M and expiry date: 18-Mar-2019) via unknown route in the right deltoid.  It was a case of actual medication error due to expired vaccine used.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: received a Daptacel vaccine from a expired vial today/ no side effects; Initial information received on 15-Apr-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) via phone.  This case involves a 4 months old female patient who was vaccinated with 0.5 ml single second dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5180BA and expiry date: 06-Apr-2019) via intramuscular route in the left thigh on 15-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  No side effects noted.  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.   Documents held by the sender: none.
Age: 42.0
Sex: F
Vaccine: FLU4, IPV, TDAP, UNK
Symptoms: Product storage error
Clinical narrative: an opened vial of Tubersol was used for a patient's TB test after an excursion for 3 hours at 52.8F; Initial information received on 15-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional via phone.  This case involves a 42 years old female patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], IPV (VERO) [IPOL] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and while treated with 0.1 ml dose of TUBERCULIN TEST [TUBERSOL] (batch number: C5562AA and expiry date: 13-Feb-2021) in left forearm for Tuberculin test on 15-Feb-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to incorrect product storage because an excursion for 3 hours at 52.8F.  It was unknown if any adverse event occurred or not following the vaccination.  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.   Documents held by the sender: none.
Age: 12.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 12 year old patient got a dose of Quadracel today; Initial information received on 15-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.   This case involves a 12 years old patient (gender not reported) who was vaccinated with 0.5 ml once dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number: C5500CA, expiry date, dose in series and route of administration were not reported) in the left arm on 15-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) on an unspecified date.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if any adverse event occurred or not following the vaccination.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: experienced adverse reactions after receiving flu vaccines; Initial information received on 13-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves male patient of an unknown age who experienced adverse reactions after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), 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 non-serious adverse reaction after receiving flu vaccines (adverse event) following the administration of INFLUENZA VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was adverse reactions after receiving flu vaccines.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: On 04/17/2019, nine days after receiving the SHINGRIX vaccine, I developed a rash on the left side of my back, which was diagnosed by my physician as shingles. I was prescribed valacyclovir.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Swelling
Clinical narrative: On 04/17/2019, nine days after receiving the SHINGRIX vaccine, I developed a rash on the left side of my back, which was diagnosed by my physician as shingles. I was prescribed valacyclovir.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Woke up today (04/19/2019) with hives/itchiness on head, abdomen, ankles.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: 2 days after the vaccine, patient developed swelling of left arm from shoulder down to forearm, with increased warmth, and redness. No fever, minimal pain. Patient seen in office after this developed, and swelling has already started to decrease.
Age: 25.0
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: right upper extremity cellulitis at injection site