chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: This will probably just be filed away and forgotten about, but I have some serious concerns about the HPV vaccine, GARDASIL 9, and whether or not I have permanent damage because of it. I received the first dose when I was 9 year-old, then a big media scare turned my mom off from getting me the rest of the series(bless her soul). I'm 22 now and decided to finish the series or restart it. I got my second dose over a month and a half ago and my arm (the site of injection) is still stiff and sore. Why is this? I've seen other people online comment with the same side effect. Do the creators of this vaccine even truly know its affects/aids effects? I'm terrified it will never go away and I could develop other underlying side effects. The doctors don't know why my arm is still sore, does anyone?
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Muscle spasms, Myalgia, Tremor
Clinical narrative: First injection of SHINGRIX was given on May 3, 2018. I did not experience any side effects except mild soreness at the injection site. On July 19, 2018, Pharmacist administered the second dosage of SHINGRIX. That evening, I had a mild upset stomach which was relieved by my taking TUMS. During the night of July 19, 2018, I experienced significant shivering and muscle pain, starting at 12:30AM, I was shaking uncontrollable. The shivering lasted approximately 6 hours. The muscles of both feet and legs spasmed for a couple of hours despite my getting out of bed, stretching the muscles, and massaging my feet and legs. This morning by 7AM, the symptoms subsided.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site irritation, Injection site pruritus, Injection site rash
Clinical narrative: Localized rash with irritation to site, and, itching.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Injection site bruising, Injection site injury
Clinical narrative: Patient experienced significant bruising and damage to area of the leg where both vaccines were given. No recommendations on a decrease dose of product when the patient is a micropremie.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Pt. has 7 vesicular spots/rashes randomly on his body. They don't seem to bother him and don't seem itchy.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Influenza like illness, Mobility decreased, Pain, Pain in extremity
Clinical narrative: 5 hours after injection of PREVNAR it started with pain and then pt could not raise her arm and her arm was very painful. The next morning pt had body aches, no appetite and felt like she had the flu. Pt felt fine by the end of the 2nd day.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Immediate post-injection reaction, Presyncope, Syncope, Vomiting
Clinical narrative: Client experienced a vasovagal event immediately after receiving vaccine. Prior to this immunization had received BEXSERO #1, and Hepatitis A #2. Fainted for 3-5 seconds, helped to a reclining position. BP 90/50. Vomited, then felt better, about 15-20 later. Retained fluids given. BP 110/60..escorted home with parent. Total time recovering about 35 minutes.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Full blood count, Metabolic function test, Rash erythematous, Rash generalised, Rash vesicular
Clinical narrative: Generalized vesicular, erythematous rash no fever.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dyspnoea, Vaccination site vesicles
Clinical narrative: Patient received vaccine, was monitored 15 minutes and sent home. At home while doing yardwork patient began to have self-described blisters around the vaccination site that traveled down his arm, then spread across body. Patient began to have difficulty breathing and went to the emergency room where he was treated with steroids, epinephrine, and antihistamines and released.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: Had small rash develop day after vaccine, then it started to spread from side of buttocks and back to side of groin. Rash is raised papules, similar to shingles rash; it is painful, blistered, tingling, and itchy.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: Fatigue 10 hours after vaccine, shiver/chills 12 hours after vaccine. side effects subsided after 12 hours. Soreness at injection site. Continuing.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Pt was vaccinated with an extra dose of PROQUAD.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache, Joint range of motion decreased, Nausea
Clinical narrative: Severe soreness in upper arm preventing full range of movement, headache severe, fever, lower back pain, hip pain, right leg pain nausea. 48 hours, still dealing with some of it.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe soreness in upper arm preventing full range of movement, headache severe, fever, lower back pain, hip pain, right leg pain nausea. 48 hours, still dealing with some of it.
Age: 31.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 31 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 28-JUN-2018, the patient was vaccinated with an adolescent/pediatric formulation of RECOMBIVAX HB, lot # M003658, expiry date: 02-JUN-2018, once, intramuscularly for prophylaxis. The patient was given an additional 0.5ml of the pediatric/adolescent dose. The patient experienced no adverse event.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # M045393, expiry date: 14-NOV-2018, subcutaneously, for prevention of measles, mumps and rubella. Concomitant therapies included sterile diluent. On an unknown date, the patient's postvaccination serologic testing was negative for an immune response. The outcome of the event was unknown. Causality assessment was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 17 year old patient on an unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, due to human error, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (strength, route of administration, lot# and expiration date were not reported) for prophylaxis, instead of MENVEO. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-NOV-2012, the patient was inoculated by a physician with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-MAR-2014, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX, ibuprofen, and TYLENOL for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-FEB-2014, the patient was inoculated at a physician office with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-MAY-2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster along with neurological pain from herpes. The patient was prescribed VALTREX, tramadol, and triamcinolone for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a male patient who received SHINGRIX for prophylaxis. On 12th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site itching and pruritus. On an unknown date, the outcome of the injection site itching and pruritus were unknown. It was unknown if the reporter considered the injection site itching and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe itching in arm where the vaccine was given as well as across the top of back and also in scalp. The patient did not associate these effects with the vaccine. This is 1 of 2 cases, reported by the same reporter for same patient.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient experienced pain at injection site aprox 2-3 hours post injection. Then approximately 10 hrs post injection the site became red and feverish. The redness was approximately tennis ball in circumference. The pt treated this with ice pack which helped resolve the pain and inflammation temporarily. He did not take any oral meds for the pain. As of 7-24-18 the pain and redness has subsided some but not totally.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Patient developed chills and headache a few hours after injection and then severe diarrhea and muschle ache in th emiddle of the first night. Symptoms lasted 3 to 4 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Right deltoid area edema and erythema. 6x8cm. apply ice and motrin prn.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Extreme soreness at site. Bruise at site. Swelling at site. Headache. Body aches. Overall fatigue.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Extreme soreness at site. Bruise at site. Swelling at site. Headache. Body aches. Overall fatigue.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Immediate post-injection reaction, Syncope, Tonic convulsion
Clinical narrative: Pt. developed 2 episodes of tonic seizures following short syncope - immediately after administration of vaccines. Symptoms resolved in 5 min., was observed for 45 min - back to usual state of health. Hx of multiple fainting during vaccinations and blood drawing.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a consumer via company representative concerning an unknown age niece. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-JUN-2018, reported as "a month ago", the patient was vaccinated with a second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The reporter mentioned that the patient fainted (syncope) after receiving the 2nd dose of GARDASIL 9, approximately on 16-JUN-2018.The reporter spoke with the nurse manager of the pediatric group who reported that the "provider stated that the everything medically appropriate being was done". The patient sought  unspecified medical attention and the patient received an unknown treatment for the adverse event. The outcome of the event fainted and the causal relationship between the event and therapy with GARDASIL 9 were not reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Skin burning sensation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 64-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th July 2018, 2 days after receiving SHINGRIX, the patient experienced erythematous rash, burning skin and itchy rash. On an unknown date, the outcome of the erythematous rash, burning skin and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the erythematous rash, burning skin and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient experienced red, itchy, burning rash on her neck, stomach and chest. The pharmacist was referred to the patient's physician for treatment recommendations.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema urticarial in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 2 days after receiving SHINGRIX, the patient experienced erythema urticarial and eye swelling. In July 2018, the outcome of the erythema urticarial and eye swelling were recovered/resolved. It was unknown if the reporter considered the erythema urticarial and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The pharmacy student reported that one of their patients received the SHINGRIX vaccine. Two days after the patient complained about red welts on his legs and swollen eyes. The patient recovered after 6 days. The reporter's call was transferred to medical information.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The lot number and expiration date was not available. No additional information was available because healthcare professional had to go. The healthcare professional on call was not the healthcare professional who administered vaccine. This case has been linked with the case US2018128790, reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Autoimmune hepatitis, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of autoimmune hepatitis in a 59-year-old female patient who received SHINGRIX (batch number NR4Z4, expiry date 11th October 2020) for prophylaxis. The patient's past medical history included polymyalgia rheumatica (diagnosed in 2014, however the patient was otherwise normally healthy and active). On 1st June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced autoimmune hepatitis (serious criteria GSK medically significant), feeling bad, influenza-like symptoms and presyncope. On 25th June 2018, the patient experienced light headedness and fatigue. On an unknown date, the patient experienced weakness, increased activity and excessive eating. SHINGRIX was discontinued (Dechallenge was negative). On an unknown date, the outcome of the autoimmune hepatitis, feeling bad, influenza-like symptoms, presyncope, light headedness, fatigue, weakness, increased activity and excessive eating were recovering/resolving. It was unknown if the reporter considered the autoimmune hepatitis, feeling bad, influenza-like symptoms, presyncope, light headedness, fatigue, weakness, increased activity and excessive eating to be related to SHINGRIX. Additional details were details were provided as follows: It was reported that the patient generally felt bad the next day after administration however began developing flu-like symptoms over the next couple of days (several days) which eventually led to a near syncopal event. The patient slightly recovered however while traveling on 25th June 2018 (24 days after receiving vaccination), the patient became light-headed and fatigued. Less than a year after receiving vaccination, thereafter the patient was seen for a physician visit on 13th July 2018 reporting interval episodes of light-headedness and weakness which was exacerbated by increased activity and eating however symptoms lessened with rest. The health care professional performed laboratory test, inclusive of liver function panel which results yielded "elevated liver enzymes and decreased liver function. At this time it was reported that the patient was recovering, however symptoms had not completely resolved. No further information was reported regarding the event. The health care professional reported there was no plan to continue with second dose in series based on patient's reaction to initial dose. Lab Comments: Liver function panel was done, which resulted yielded elevated liver enzymes and decreased liver function.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased, Hyperphagia, Incomplete course of vaccination, Influenza like illness, Liver function test abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of autoimmune hepatitis in a 59-year-old female patient who received SHINGRIX (batch number NR4Z4, expiry date 11th October 2020) for prophylaxis. The patient's past medical history included polymyalgia rheumatica (diagnosed in 2014, however the patient was otherwise normally healthy and active). On 1st June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced autoimmune hepatitis (serious criteria GSK medically significant), feeling bad, influenza-like symptoms and presyncope. On 25th June 2018, the patient experienced light headedness and fatigue. On an unknown date, the patient experienced weakness, increased activity and excessive eating. SHINGRIX was discontinued (Dechallenge was negative). On an unknown date, the outcome of the autoimmune hepatitis, feeling bad, influenza-like symptoms, presyncope, light headedness, fatigue, weakness, increased activity and excessive eating were recovering/resolving. It was unknown if the reporter considered the autoimmune hepatitis, feeling bad, influenza-like symptoms, presyncope, light headedness, fatigue, weakness, increased activity and excessive eating to be related to SHINGRIX. Additional details were details were provided as follows: It was reported that the patient generally felt bad the next day after administration however began developing flu-like symptoms over the next couple of days (several days) which eventually led to a near syncopal event. The patient slightly recovered however while traveling on 25th June 2018 (24 days after receiving vaccination), the patient became light-headed and fatigued. Less than a year after receiving vaccination, thereafter the patient was seen for a physician visit on 13th July 2018 reporting interval episodes of light-headedness and weakness which was exacerbated by increased activity and eating however symptoms lessened with rest. The health care professional performed laboratory test, inclusive of liver function panel which results yielded "elevated liver enzymes and decreased liver function. At this time it was reported that the patient was recovering, however symptoms had not completely resolved. No further information was reported regarding the event. The health care professional reported there was no plan to continue with second dose in series based on patient's reaction to initial dose. Lab Comments: Liver function panel was done, which resulted yielded elevated liver enzymes and decreased liver function.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Liver function test decreased, Presyncope, Psychomotor hyperactivity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of autoimmune hepatitis in a 59-year-old female patient who received SHINGRIX (batch number NR4Z4, expiry date 11th October 2020) for prophylaxis. The patient's past medical history included polymyalgia rheumatica (diagnosed in 2014, however the patient was otherwise normally healthy and active). On 1st June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced autoimmune hepatitis (serious criteria GSK medically significant), feeling bad, influenza-like symptoms and presyncope. On 25th June 2018, the patient experienced light headedness and fatigue. On an unknown date, the patient experienced weakness, increased activity and excessive eating. SHINGRIX was discontinued (Dechallenge was negative). On an unknown date, the outcome of the autoimmune hepatitis, feeling bad, influenza-like symptoms, presyncope, light headedness, fatigue, weakness, increased activity and excessive eating were recovering/resolving. It was unknown if the reporter considered the autoimmune hepatitis, feeling bad, influenza-like symptoms, presyncope, light headedness, fatigue, weakness, increased activity and excessive eating to be related to SHINGRIX. Additional details were details were provided as follows: It was reported that the patient generally felt bad the next day after administration however began developing flu-like symptoms over the next couple of days (several days) which eventually led to a near syncopal event. The patient slightly recovered however while traveling on 25th June 2018 (24 days after receiving vaccination), the patient became light-headed and fatigued. Less than a year after receiving vaccination, thereafter the patient was seen for a physician visit on 13th July 2018 reporting interval episodes of light-headedness and weakness which was exacerbated by increased activity and eating however symptoms lessened with rest. The health care professional performed laboratory test, inclusive of liver function panel which results yielded "elevated liver enzymes and decreased liver function. At this time it was reported that the patient was recovering, however symptoms had not completely resolved. No further information was reported regarding the event. The health care professional reported there was no plan to continue with second dose in series based on patient's reaction to initial dose. Lab Comments: Liver function panel was done, which resulted yielded elevated liver enzymes and decreased liver function.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 51-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced varicella-like rash and pain. On an unknown date, the outcome of the varicella-like rash and pain were unknown. It was unknown if the reporter considered the varicella-like rash and pain to be related to SHINGRIX. Additional details were reported as follows: The reporter was not a healthcare professional. The patient received 1st dose of the new vaccine a little over 2 months ago. The patient's 1st injection was very little pain. Over a month after receiving the 1st dose the patient got a rash with chicken pox looking sores over part of his chest and one large chicken pox like mark on the waist. This case has been linked with case, reported by the same reporter for 2nd dose.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 51-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced varicella-like rash and pain. On an unknown date, the outcome of the varicella-like rash and pain were unknown. It was unknown if the reporter considered the varicella-like rash and pain to be related to SHINGRIX. Additional details were reported as follows: The reporter was not a healthcare professional. The patient received 1st dose of the new vaccine a little over 2 months ago. The patient's 1st injection was very little pain. Over a month after receiving the 1st dose the patient got a rash with chicken pox looking sores over part of his chest and one large chicken pox like mark on the waist. This case has been linked with case, reported by the same reporter for 2nd dose.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old male patient who received SHINGRIX for prophylaxis. On 11th July 2018, the patient received the 2nd dose of SHINGRIX. On 12th July 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The reporter was not a healthcare professional. Not one that was bothered by side effects very often. The next day the patient woke up it felt like his arm had been punched several times and was very sore. The patient's arm was still sore 3 days later but nothing like it was the morning after received the 2nd shot. The patient was wondering if these bumps would come back like they did with the 1st dose. Have you had this reported with the chicken pox like rash. The patient stated that it was a good month after receiving the 1st dose. This case has been linked with case US2018GSK126361, reported by the same reporter for 1st dose.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: 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 51-year-old male patient who received SHINGRIX for prophylaxis. On 11th July 2018, the patient received the 2nd dose of SHINGRIX. On 12th July 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The reporter was not a healthcare professional. Not one that was bothered by side effects very often. The next day the patient woke up it felt like his arm had been punched several times and was very sore. The patient's arm was still sore 3 days later but nothing like it was the morning after received the 2nd shot. The patient was wondering if these bumps would come back like they did with the 1st dose. Have you had this reported with the chicken pox like rash. The patient stated that it was a good month after receiving the 1st dose. This case has been linked with case US2018GSK126361, reported by the same reporter for 1st dose.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Pruritus
Clinical narrative: Systemic itching: current. Shortness of breath (SOB): 1st week. Redness in face: 1st - 2nd week.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and intramuscular formulation administered by other route. The patient was treated with hydrocortisone and BENADRYL. On an unknown date, the outcome of the injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX subcutaneously rather than intramuscularly, which led to inappropriate route of vaccination. The patient experienced a coffee cup sized localized redness and swelling reaction at the site of the SHINGRIX administration. The route, dose and frequency of treatment drugs BENADRYL and Hydrocortisone were unknown. The patient was also told to apply ice to the affected area. The reporter agreed to have follow up contact. This case was linked with the case US2018GSK126432, reported by the same reporter.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Hypersensitivity
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a 83-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported for the reporter's mother. The patient had an allergic reaction to SHINGRIX. As per packaging, to discontinue the vaccine if experience allergic to any of the SHINGRIX ingredients. The reporter asked to provide this information so that he could move forward in relieving the discomfort the patient was experiencing.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Tenderness
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of injection site warmth in a female patient who received SHINGRIX for prophylaxis. On 5th July 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site warmth, tenderness and band sensation. On an unknown date, the outcome of the injection site warmth, tenderness and band sensation were unknown. It was unknown if the reporter considered the injection site warmth, tenderness and band sensation to be related to SHINGRIX. Additional details were reported as follows. The age at vaccination was not reported. The patient stated that after injection they felt tenderness and a band formed around the arm about 3 inches below the injection site. The band was about 3 inches around and 1 inch wide. The injection site was warm to touch. Till the time of reporting the issue did not resolve.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 16th May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site itching and pruritus. The patient was treated with triamcinolone acetonide, SCALPICIN, prednisone and steroid shot (nos). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site itching and pruritus were unknown. It was unknown if the reporter considered the injection site itching and pruritus to be related to SHINGRIX. Additional details were provided as follows: The itching was intensified at the same points on body and in scalp. The patient realized that effects were tied directly to the shingles vaccine. The dermatologist prescribed Prednisone and that also gave temporary relief during the time the medication was taken but the side effects returned after taking this medication. It had been a little over 5 months since my initial shot and I had experienced no decrease in effects whatsoever. The patient had experienced an adverse reaction to any sort of inoculation. The patient would greatly appreciate any suggestions to overcome these unpleasant and annoying side effects.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from a nurse on 13-Jul-2018. This case involves a 20-year-old female patient who received an expired dose of 0.5 ml MENACTRA lot number: U5523AA, expiration date: not reported via intramuscular route in the right deltoid on 12-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was not known 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 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: 12.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness of left (deltoid) arm. Hard to touch and hot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen arm and redness from the vaccine.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Migraine, Neck pain, Paraesthesia
Clinical narrative: Pt given vaccine on 7/10/18. Came in 7/13/18(approx. 3pm) to report tingling sensation in arm, radiating pain from injection site up side of neck, and migraine. I advised Pt to take TYLENOL or IBU. She could also seek medical attn. Pt seemed unsatisfied with these answers.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Heart rate increased
Clinical narrative: Painful shot, difficult to lift arm for 2 days, shivers, 102 degree fever, fast hearthbeat within a couple of hours lasting till morning weakness, tired, no appetite (might be sick but wasn't) lasted for about 1 1/2 weeks.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Pyrexia
Clinical narrative: Painful shot, difficult to lift arm for 2 days, shivers, 102 degree fever, fast hearthbeat within a couple of hours lasting till morning weakness, tired, no appetite (might be sick but wasn't) lasted for about 1 1/2 weeks.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Pain, swelling, itching and lots of redness.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site warmth
Clinical narrative: MENVEO given SubQ when it should have been given IM. Patient experienced warmth and pink coloration spreading at injection site. No induration, pus, fever, or chills noted. Patient to monitor for fever, chills, and to monitor site if it gets red or hot and if so needs to be seen.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Anxiety, Circumstance or information capable of leading to medication error, Erythema, Nervousness, Skin warm
Clinical narrative: Dad reports patient had syncope that lasted only a few seconds after the vaccines that was not brought to the attention of the nurse at that visit. He was fine afterwards with no further presyncope or syncope. He was very nervous about these shots and the shots were given in the same arm right deltoid because he was not cooperative and anxious and pulling away from dad who was having trouble holding him.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Dad reports patient had syncope that lasted only a few seconds after the vaccines that was not brought to the attention of the nurse at that visit. He was fine afterwards with no further presyncope or syncope. He was very nervous about these shots and the shots were given in the same arm right deltoid because he was not cooperative and anxious and pulling away from dad who was having trouble holding him.
Age: 32.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Herpes zoster
Clinical narrative: He developed Shingles.
Age: 73.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blood creatinine normal, Blood urea normal, Cough, Dysphonia, Escherichia test positive
Clinical narrative: 1 week ( 7/6/2018) after the SHINGRIX injection ( 29/18) given at a pharmacy, patient noted "lumps under her skin", in and around area where she received the injection. Skin rash noted- described as reddish, then bacsme  blister-like. pus-like discharge when lesion opened up. Rash spread to opposite arm, upper chest, face and few on lower extremities. Lesions are sore.  Pt reports " rash reminded her of chicken pox". Pt was seen in office 7/16/2018, then 7/19/2019.   She reported scratchy throat ,sorethroat and hoarseness , dry cough with chest congestion for 3 days . Pt reports (+)  exposure  to family members dx of parainfluenza Type 3. Parainfluenza  Virus 3 titer was done 7/19/2018 and came back (+). Same time urine culture grew (+) E. coli pansensitive to antibiotics. Pt reports continuing to have new rashes.
Age: 73.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Glomerular filtration rate normal, Haemoglobin normal, Injection site mass, Metabolic function test normal, Oropharyngeal pain
Clinical narrative: 1 week ( 7/6/2018) after the SHINGRIX injection ( 29/18) given at a pharmacy, patient noted "lumps under her skin", in and around area where she received the injection. Skin rash noted- described as reddish, then bacsme  blister-like. pus-like discharge when lesion opened up. Rash spread to opposite arm, upper chest, face and few on lower extremities. Lesions are sore.  Pt reports " rash reminded her of chicken pox". Pt was seen in office 7/16/2018, then 7/19/2019.   She reported scratchy throat ,sorethroat and hoarseness , dry cough with chest congestion for 3 days . Pt reports (+)  exposure  to family members dx of parainfluenza Type 3. Parainfluenza  Virus 3 titer was done 7/19/2018 and came back (+). Same time urine culture grew (+) E. coli pansensitive to antibiotics. Pt reports continuing to have new rashes.
Age: 73.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Parainfluenzae virus infection, Platelet count normal, Rash, Rash erythematous, Rash vesicular
Clinical narrative: 1 week ( 7/6/2018) after the SHINGRIX injection ( 29/18) given at a pharmacy, patient noted "lumps under her skin", in and around area where she received the injection. Skin rash noted- described as reddish, then bacsme  blister-like. pus-like discharge when lesion opened up. Rash spread to opposite arm, upper chest, face and few on lower extremities. Lesions are sore.  Pt reports " rash reminded her of chicken pox". Pt was seen in office 7/16/2018, then 7/19/2019.   She reported scratchy throat ,sorethroat and hoarseness , dry cough with chest congestion for 3 days . Pt reports (+)  exposure  to family members dx of parainfluenza Type 3. Parainfluenza  Virus 3 titer was done 7/19/2018 and came back (+). Same time urine culture grew (+) E. coli pansensitive to antibiotics. Pt reports continuing to have new rashes.
Age: 73.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Respiratory tract congestion, Respirovirus test positive, Secretion discharge, Throat irritation, White blood cell count normal
Clinical narrative: 1 week ( 7/6/2018) after the SHINGRIX injection ( 29/18) given at a pharmacy, patient noted "lumps under her skin", in and around area where she received the injection. Skin rash noted- described as reddish, then bacsme  blister-like. pus-like discharge when lesion opened up. Rash spread to opposite arm, upper chest, face and few on lower extremities. Lesions are sore.  Pt reports " rash reminded her of chicken pox". Pt was seen in office 7/16/2018, then 7/19/2019.   She reported scratchy throat ,sorethroat and hoarseness , dry cough with chest congestion for 3 days . Pt reports (+)  exposure  to family members dx of parainfluenza Type 3. Parainfluenza  Virus 3 titer was done 7/19/2018 and came back (+). Same time urine culture grew (+) E. coli pansensitive to antibiotics. Pt reports continuing to have new rashes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever, headache, nausea. All for 2 days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, aches and pains all over body and very sore at site!
Age: 28.0
Sex: F
Vaccine: HEPA, MMR, TYP
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Pallor, Vision blurred
Clinical narrative: Patient complained of dizziness, feeling "hot" and blurred vision after injection of the third vaccine, typhim Vi. Staff RN noted the patient to be pale and diaphoretic and immediately rang for assistance and elevated patient's legs and began vital signs. Dr. and Dr. were immediately available for assistance. Patient assisted to reclining table and placed in trendelenberg position with vital sign monitoring until stable. Patient discharged from the Health Center by Dr. after 30 minutes in stable condition.
Age: 0.83
Sex: F
Vaccine: HIBV, RV1
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: MICR was not available. RN tried to accommodate a walk in appointment for an immunizations update. Assessment of immunizations due was incorrect by RN. The 3rd dose of Rotavirus was given to client who has since aged out and it no longer eligible to receive the 3rd and final dose. HIB #3 was also administered to client, however considering the alternative schedule baby was actually not due for HIB #3 until 08-24-2018. No adverse effects noted.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Pain, Peripheral swelling
Clinical narrative: 100 degrees F temp - 20 days. Left arm red and swollen - 1 week. Nauseous- 2 days. Achy - 2 days.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nodule, Pain in extremity, Pruritus generalised, Swelling face
Clinical narrative: Patient called the next day and complained of knot in her arm that was sore to the touch. She also states she experienced facial swelling, headache and itching all over.
Age: 14.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, muscle aches, slight headache.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Child tolerated injections x3 very well. Stood up from the table after sitting for a minute. Became syncopal after standing. Was assisted to the floor by her father.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Nausea, Pain, Sleep disorder
Clinical narrative: Flu like symptoms--nausea, very achy all over my body, headache; disrupted sleep; felt better after about 18 hours from onset.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Pain
Clinical narrative: Pharmacist administered SHINGRIX vaccine dose 1 to patient on 7/20/18 at around 9:50AM. Patient experienced swelling and pain at injection site. Patient also felt tired and had pains all over body including her knuckles. She experienced these side effects for about 3 days and the symptoms prevented her from doing her regular everyday activities. She came in on 7/24/18 to report thse adverse effects to pharmacist on duty (reporter) and patient stated that she is feeling better now and these symptoms went away.
Sex: F
Vaccine: MMR
Symptoms: Serology test
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender referring to him/herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided refers to a female patient of unknown age. On unknown dates, at age 1 and 10 years old, the patient was vaccinated with unspecified doses of (wistar ra 27-3) M-M-R II (exact dose, roue of administration, lot# and expiry date were not reported) for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date, the patient reported having postvaccination serologic testing with results that were not clearly positive. No adverse effects were reported. The outcome of the event was unknown. Causality assessment was not provided.