chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Glomerulonephritis acute, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosus in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed systemic lupus erythematosus. Serious criteria included GSK medically significant. The outcome of systemic lupus erythematosus was unknown. It was unknown if the investigator considered the systemic lupus erythematosus to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of systemic lupus erythematosus in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled post-licensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. In this study, the risk window was 1-85 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination. Comparison window was defined as the period from the end of the risk period (1-84 days) up to 1 year after vaccination or to disenrollment, whichever came first.) No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, an unknown period post index vaccination, the patient was identified from automated algorithm with acute glomerulonephritis. Later, the patient was confirmed for systemic lupus erythematosus. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of systemic lupus erythematosus and MENVEO. The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50,000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.
Age: 21.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Chromaturia, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of rhabdomyolysis in a 21-year-old male patient who received ENGERIX B adult (batch number UNK, expiry date unknown). Concomitant products included dTpa vaccine. On 2nd December 2016, the patient received the 1st dose of ENGERIX B adult 1 ml. On an unknown date, the dose was an unknown dose. On 2nd December 2016, less than a day after receiving ENGERIX B adult, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), myositis (serious criteria hospitalization) and generalized muscle aches (serious criteria hospitalization). On 4th December 2016, the patient experienced urine discoloration (serious criteria hospitalization). On 10th January 2017, the outcome of the rhabdomyolysis was recovered/resolved. On an unknown date, the outcome of myositis, generalized muscle aches and urine discoloration were recovered/resolved. It was unknown if the reporter considered the rhabdomyolysis, myositis, generalized muscle aches and urine discoloration to be related to ENGERIX B adult. Additional details were reported as follows: On 2nd December 2016, the patient received ENGERIX B and Tdap (brand unknown) vaccinations. On that day, the patient was also engaged in exercise including leg lifts and push-ups for approximately 20 minutes and was also involved in moving some furniture. The patient noted mild generalized muscle soreness over 2nd to 3rd December 2016. On 4th December 2016, the patient noted pink urine. By 5th December 2016, the patient described that his urine was having the appearance of motor oil. The patient presented to a hospital and was admitted and subsequently and diagnosed with rhabdomyolysis and myositis. The patient was having elevated blood creatine phosphokinase (159, 180), aspartate aminotransferase (1701), alanine aminotransferase (434) and white blood cell count (16,000). The patient was treated with fluids and standard care. The patient was discharged on 9th December 2016 with blood creatine phosphokinase (11,000), aspartate aminotransferase (368), and alanine aminotransferase (278). He was noted to be recuperated with no sequelae. According to the follow-up of 10th January 2017 the patient was cleared for full activity. The physician was unable to provide the lot number and expiration date of the ENGERIX B and the brand of Tdap administered or the details of the administration.
Age: 21.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Myositis, Rhabdomyolysis, White blood cell count increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of rhabdomyolysis in a 21-year-old male patient who received ENGERIX B adult (batch number UNK, expiry date unknown). Concomitant products included dTpa vaccine. On 2nd December 2016, the patient received the 1st dose of ENGERIX B adult 1 ml. On an unknown date, the dose was an unknown dose. On 2nd December 2016, less than a day after receiving ENGERIX B adult, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), myositis (serious criteria hospitalization) and generalized muscle aches (serious criteria hospitalization). On 4th December 2016, the patient experienced urine discoloration (serious criteria hospitalization). On 10th January 2017, the outcome of the rhabdomyolysis was recovered/resolved. On an unknown date, the outcome of myositis, generalized muscle aches and urine discoloration were recovered/resolved. It was unknown if the reporter considered the rhabdomyolysis, myositis, generalized muscle aches and urine discoloration to be related to ENGERIX B adult. Additional details were reported as follows: On 2nd December 2016, the patient received ENGERIX B and Tdap (brand unknown) vaccinations. On that day, the patient was also engaged in exercise including leg lifts and push-ups for approximately 20 minutes and was also involved in moving some furniture. The patient noted mild generalized muscle soreness over 2nd to 3rd December 2016. On 4th December 2016, the patient noted pink urine. By 5th December 2016, the patient described that his urine was having the appearance of motor oil. The patient presented to a hospital and was admitted and subsequently and diagnosed with rhabdomyolysis and myositis. The patient was having elevated blood creatine phosphokinase (159, 180), aspartate aminotransferase (1701), alanine aminotransferase (434) and white blood cell count (16,000). The patient was treated with fluids and standard care. The patient was discharged on 9th December 2016 with blood creatine phosphokinase (11,000), aspartate aminotransferase (368), and alanine aminotransferase (278). He was noted to be recuperated with no sequelae. According to the follow-up of 10th January 2017 the patient was cleared for full activity. The physician was unable to provide the lot number and expiration date of the ENGERIX B and the brand of Tdap administered or the details of the administration.
Sex: U
Vaccine: MNQ
Symptoms: Iridocyclitis, Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of iridocyclitis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed iridocyclitis. Serious criteria included GSK medically significant. The outcome of iridocyclitis was unknown. The investigator considered the iridocyclitis to be unlikely related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of iridocyclitis (uveitis) in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled postlicensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient belonged to the risk window. [In this study, the risk window was 1-42 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination)]. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, between 1 and 42 days post index vaccination, the patient developed iridocyclitis (uveitis) which was found to be parasitic. Treatment was unknown. The outcome of the event was not reported. The authors considered the event of iridocyclitis (uveitis) to be highly unlikely related to MENVEO. The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50 000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Meningococcal infection, Vaccination failure
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a adolescent subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included meningococcal infection with serious criteria of GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included meningococcal infection (unknown). It was unknown if the investigator considered the vaccination failure and meningococcal infection to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of suspected vaccination failure in an adolescent of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date in or after 2010, the patient received MENVEO (administration route and site unspecified; dosage unknown; batch number not provided). On an unspecified date, an unknown period after vaccination, the patient developed meningococcal disease. This case has been considered as suspected vaccination failure being time to onset and full schedule was unknown. This case has been considered serious due to suspected vaccination failure. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of meningococcal disease and MENVEO. The authors concluded that "MenACWY-D was effective in the first year after vaccination but effectiveness waned 3 to less than 8 years post-vaccination. The estimates of VE from this evaluation informed the Advisory Committee on Immunization Practices in its decision to add a booster dose of MenACWY".
Sex: U
Vaccine: FLU4, MNQ
Symptoms: Cough, Facial paralysis, Upper respiratory tract infection
Clinical narrative: This case was reported in a literature article and described the occurrence of Bell's palsy in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine and Flu Seasonal QIV Dresden, the subject developed Bell's palsy. Serious criteria included GSK medically significant. The outcome of Bell's palsy was recovered/resolved. The investigator considered the Bell's palsy to be possibly related to Meningococcal ACWY-CRM vaccine and Flu Seasonal QIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of Bell's palsy in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline) and unspecified influenza vaccine (manufacturer unknown). The patient was part of a self-controlled post licensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient belonged to the risk window. [In this study, the risk window was 1-84 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination)]. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO and unspecified influenza vaccination (administration route and site unknown; dosages unknown; batch number not provided for both) at a participating medical centre. On an unspecified date, between 1 and 84 days post index vaccination, the patient had upper respiratory tract infection/ cough. Subsequently, the patient was diagnosed with Bell's palsy. In this study, cases in the risk window occurred primarily between 5 and 10 weeks after vaccination. Treatment was unknown. The event resolved completely. The authors considered the event of Bell's palsy to be temporally associated to MENVEO and unspecified influenza vaccine. The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50,000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Facial paralysis, Nasopharyngitis
Clinical narrative: This case was reported in a literature article and described the occurrence of Bell's palsy in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed Bell's palsy. Serious criteria included GSK medically significant. Additional event(s) included cold symptoms. The outcome of Bell's palsy was recovered/resolved. The outcome(s) of the additional event(s) included cold symptoms (recovered/resolved). It was unknown if the investigator considered the Bell's palsy and cold symptoms to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of Bell's palsy in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled postlicensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient belonged to the risk window. [In this study, risk window was 1-84 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination)]. The patient had not received any concomitant vaccine. (In this study, 3 of the 8 Bell's palsy patients in the risk window had comorbidities and infections that could be a prelude to the condition). No information on patient's medical history or family history or concurrent condition was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, between 1 and 84 days post index vaccination, the patient had cold like symptoms. Subsequently, the patient was diagnosed with Bell's palsy. In this study, cases in the risk window occurred primarily between 5 and 10 weeks after vaccination. Treatment was unknown. The event resolved completely. The authors stated that "there is no clear biological plausibility for a causal relationship between vaccination and Bell's palsy." The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50 000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Glomerulonephritis acute
Clinical narrative: This case was reported in a literature article and described the occurrence of acute glomerulonephritis in a subject who received Meningococcal ACWY-CRM vaccine. The subject's past medical history included streptococcal infection. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed acute glomerulonephritis. Serious criteria included GSK medically significant. The outcome of acute glomerulonephritis was unknown. It was unknown if the investigator considered the acute glomerulonephritis to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute glomerulonephritis in a patient aged between 11 and 21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was part of a self-controlled post licensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient had a history of recurrent streptococcal infection. The patient belonged to the risk window. [In this study, the risk window was 1-42 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination)]. No information on patient's family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date between 1 and 42 days post index vaccination, the patient had acute glomerulonephritis. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of acute glomerulonephritis and MENVEO. However, the authors commented that "the patient may have had pre-existing disease, but this cannot be confirmed because no urinalysis tests were available before vaccination". The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50,000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bells' palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bells' palsy". This is 1 of the 8 valid cases reported in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Immune thrombocytopenic purpura
Clinical narrative: This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 43 days after receiving Meningococcal ACWY-CRM vaccine, the subject developed idiopathic thrombocytopenic purpura. Serious criteria included GSK medically significant. The outcome of idiopathic thrombocytopenic purpura was unknown. It was unknown if the investigator considered the idiopathic thrombocytopenic purpura to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura (ITP) in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled postlicensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient belonged to the comparison window. Comparison window was defined as the period from the end of the risk period (1-42 days) up to 1 year after vaccination or to disenrollment, whichever came first. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, between 43-365 days (comparison window), the patient developed ITP. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of ITP and MENVEO. The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50 000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Facial paralysis
Clinical narrative: This case was reported in a literature and described the occurrence of Bell's Palsy in a subject who received Meningococcal ACWY-CRM vaccine. Concurrent medical conditions included eczema. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed Bell's Palsy. Serious criteria included GSK medically significant. The outcome of Bell's Palsy was recovered/resolved. It was unknown if the investigator considered the Bell's Palsy to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of Bell's Palsy in a patient aged 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled post licensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort age 11 to 21 years. The patient belonged to the risk window. [In this study, the risk window was 1-84 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination)]. The patient's concurrent condition was eczema. The patient had not received any concomitant vaccine. No information on patient's family history or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, between 1 and 84 days post index vaccination, the patient developed Bell's Palsy. In this study, cases in the risk window occurred primarily between 5 and 10 weeks after vaccination. Treatment was unknown. The event resolved completely. The authors stated that "there is no clear biological plausibility for a causal relationship between vaccination and Bell's Palsy." The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50 000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's Palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's Palsy". This is 1 of the 8 valid cases reported in the same literature article.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Blood glucose increased, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: Received PREVNAR 13 pneumonia vaccine and 1 1/2 hour after receiving shot, I got very hot, weak, short of breath, and fatigued. I laid down to see if I would feel better and I did not. I have continued to feel this way ever since. Also my I am diabetic and my blood sugars have been elevated even though I have increased my insulin dosage.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given dose of 0.5 mL instead of pediatric dose of 0.25mg of FLUZONE (Sanofi).
Age: 44.0
Sex: M
Vaccine: FLUX, TDAP, FLUX, IPV, TDAP
Symptoms: Neck pain, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Severe pain in right arm, that radiates to the neck. Went to chiropractor twice, Emergency room, Urgent Care, and neurologist for treatment. Given gabapentin TYLENOL #3 prednisone.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, X-ray
Clinical narrative: I received the flu vaccine on 11/29/16 and woke up on 11/30/16 with intense pain in shoulder. I had decreased range of motion until after Christmas. I had an X-Ray saw my PCP and they sent me to orthopedist, who is monitoring and considering dif treatments, possible injections (steroid).
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient had received flu in past years with no problem. Once patient received flu shot about 20 mins later pharmacy was notified that patient had passed out and ambulance called. Patient came to right away. Patient reported to EMT that he hadn't eat yet today. EMT thought that was why the episode occurred. Patient did not leave in ambulance.
Age: 63.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Musculoskeletal pain
Clinical narrative: Cont shoulder pain since vax [2 mos now] slightly improving. Pain was occurring without arm movement in 1st month.
Age: 63.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Cont shoulder pain since vax [2 mos now] slightly improving. Pain was occurring without arm movement in 1st month.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: Patient had acute erythema and induration occur at injection site. Area was 6.5cm in diameter at 48 hrs. also she developed systemic body aches.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Day after vaccination pt got small, pink, very itchy spots all over chest, torso and upper arms. Looked like adult chicken pox. Very itchy! Still itchy and given antivirals and oral prescription, creams and prednisone.
Age: 20.0
Sex: M
Vaccine: ANTH, MMR, TYP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Woke up with local redness, heat, tenderness, hardened on (R) arm over deltoid. Screened by provider and cleared as strong immune response.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Severe headache (curled up in dark room type) about 1-3 hours after injection. HA lasted 3-4 hours and slowly resolved. TX with ibuprofen-800 mg and TYELNOL 30 min later. Called Pharmacy where sot administered-no help-called GP and told to take MOTRIN/TYLENOL-Dr MD
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Circumstance or information capable of leading to medication error, Injection site erythema, Injection site inflammation
Clinical narrative: (L) Deltoid inflammation and redness (patient would not hold still when shot was administered).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Pain, inflammation and redness beneath injection site beginning 1 1/2 inches beneath injection site. Each day lowering to elbow. Pain (severe) (and extreme chills first night and 5 days after). (Pain and inflammation).
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Angina pectoris, Back pain, Chest pain, Pain in extremity, Pain in jaw
Clinical narrative: Angina. Pharmacy was suppose to give me PREVNAR 13 (by doctors order) and they made a mistake and gave me PNEUMOVAX 23. I was fine when I went to bed. I woke up at 1:15 A.M. with chest pain, pain in my arm, jaw and back on 11-2 - I lay still until the pain went away, I had another episode on 12-7 and I was admitted to the hospital.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Angina. Pharmacy was suppose to give me PREVNAR 13 (by doctors order) and they made a mistake and gave me PNEUMOVAX 23. I was fine when I went to bed. I woke up at 1:15 A.M. with chest pain, pain in my arm, jaw and back on 11-2 - I lay still until the pain went away, I had another episode on 12-7 and I was admitted to the hospital.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Patient developed hives approximately 8 hours after administration of her 6 month vaccines. Patient was given BENADRYL at 9:57 am the next morning at doctor's office. Mom reports hives resolved overnight 1/14/17-1/15/17.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Vaccines given at 2 months of age had fever 102 x 72 hours. No other (11-7-16) symptoms. Vaccines given at 4 month (1/4/17) of age had fever again of 103.2 x 18-24 hours.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Seizure
Clinical narrative: 3 seizure activity between Saturday 1/21 and Sunday 1/22.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore arm and shoulder joint.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Aching pain in left shoulder and arm.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Reported swelling approximately 2 in, redness, warmth and itching to injection site. Cold compress applied 1/25/17 by school health aide.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Rash onset for 2 days. Erythematous and itchy. Denies aggravating and relieving factors. No SOB. T: 97.5 on 8/24/16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness around KINRIX site was given.
Age: 70.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Provider ordered pediatric Hep B and M.A. gave to patient. Patient notified and will return to clinic for correct vaccine.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Hives for 2-3 days on chin, neck, and buttocks. No tx for this reaction.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site induration
Clinical narrative: Difficult to move Left arm, can move hand. No fever, not hot, no redness, small hard spot where given.
Age: 48.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Axillary pain, Breast pain, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Indurated, inflamed site of injection with pain spreading to (L) ribs, breast and axilla.
Age: 48.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Musculoskeletal chest pain
Clinical narrative: Indurated, inflamed site of injection with pain spreading to (L) ribs, breast and axilla.
Age: 64.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Computerised tomogram normal, Headache, Hypoaesthesia, Laboratory test normal, Migraine
Clinical narrative: Client called reporting "massive" HA and sweats overnight; followed by "queasy" stomach and left-sided facial numbness. Denied numbness interfered with breathing or talking. Advised to seek medical eval. 1/25/17 Reported persistent numbness.
Age: 64.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Nausea, Night sweats
Clinical narrative: Client called reporting "massive" HA and sweats overnight; followed by "queasy" stomach and left-sided facial numbness. Denied numbness interfered with breathing or talking. Advised to seek medical eval. 1/25/17 Reported persistent numbness.
Age: 61.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness in arm and neck. Pt has had tetanus vaccine previously with no side effects.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Patient came into the pharmacy after the vaccine was administered with a large erythema on her left arm. Pt purchased hydrocortisone cream.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: On 1/23/17 patient was given a second dose of PROQUAD. The family was contacted and advised to watch for symptoms and to return in 1 month for KINRIX.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case PHEH2016US024377 is an initial spontaneous report received from healthcare professional on 20 Sep 2016. This case refers to unknown demographics patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with expired FLUVIRIN (batch number: not reported, expiry date: not reported) at a dose of 0.5 ml single dose intramuscular on 20 Sep 2016. No adverse event was reported following this medication error.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Musculoskeletal stiffness, Pain
Clinical narrative: Case number PHEH2016US024439, is an initial spontaneous report received from a pharmacist on 20 Sep 2016. This report refers to a 39 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 08 Sep 2016. On the same day after vaccination, the patient experienced arm discomfort. The patient also experienced stiffness of the arm and shooing pain for 2 weeks from an unknown date. The outcome of the event arm discomfort was reported as unknown and for the events stiffness of arm and shooting pain was not reported. The seriousness of the event arm discomfort was reported as non serious and for the events stiffness of arm and shooting pain was not reported. The causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2016US024500, is an initial spontaneous report received from a pharmacist on 21 Sep 2016. This report refers to a 34 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported)  at a dose of 0.5ml intramuscularly on 20 Sep 2016. On 21 Sep 2016, the patient experienced arm swelling and was very hot to touch. The patient also experienced erythema on an unknown date. The outcome of the events arm swelling and very hot to touch was reported as unknown for the event erythema was not reported. The seriousness and causality of the events was not reported.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye irritation
Clinical narrative: Case PHEH2016US024547, is an initial spontaneous report received from a pharmacist on 21 Sep 2016. This report refers to a 33 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated wit FLUVIIRN (unknown whether seasonal or pandemic, batch number: 1618701) at an unknown dose on an unknown date. On 21 Sep 2016, the pharmacist stated that when administering FLUVIRIN vaccine needle retracted and splashed back in eye. The pharmacist splashed water in patient eye. The eye seemed irritated. The outcome of the event was unknown. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case PHEH2016US024662 is an initial spontaneous report received from medical assistant on 22 Sep 2016. This report refers to the unknown demographics patient. Past medical history and concomitant medication was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: not reported, expiry date: Jun 2016) at a dose of 0.5 ml single dose intramuscular on 19 Sep 2016. No adverse event was reported following this medication error.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US024792 is an initial spontaneous report received from a pharmacist on 21 Sep p2016. This report refers to 58 year male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618701, expiry date: not reported) at a dose of 0.5 ml intramuscular on 20 Sep 2016. On the same day, the patient had vaccine error patient was administered vaccine after temperature excursion. No adverse event was reported following this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case PHEH2016US024895 is an initial spontaneous report received from a pharmacist on 23 Sep 2016. This report refers to unknown demographics patient. Medical history and concomitant medication was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: not reported, expiry date: not reported) at a dose of 0.5 ml single dose intramuscular on 22 Sep 2016. No adverse event was reported following this medication error.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case PHEH2016US025949, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to a 44 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618521) at a dose of 1 ml intramuscularly on 26 Sep 2016. The nurse stated that, she discovered that 9 patients received 1.0 ml of FLUVIRIN rather than 0.5 ml. No adverse event was reported after this maladministration (accidental overdose). The case was lost to follow up at initial.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental overdose
Clinical narrative: Case PHEH2016US025952, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to a 90 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618521) at a dose of 1 ml intramuscularly on 27 Sep 2016. The nurse stated that, she discovered that 9 patients received 1.0 ml of FLUVIRIN rather than 0.5 ml. No adverse event was reported after this maladministration (accidental overdose). The case was lost to follow up at initial.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case PHEH2016US025983 is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to 87 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618521) at a dose of 1.0 ml intramuscularly on 27 Sep 2016. No adverse event was reported following this medication error.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case PHEH2016US026066, is an initial spontaneous report received from a pharmacist on 05 Oct 2016. This report refers to a 80 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 168804) at an unknown dose intramuscularly on 05 Oct 20016. The pharmacist stated that, partial dose of FLUVIRIN PFS syringe was given to patient. The barrel on the PFS locked up and the pharmacist could not deliver the entire dose of FLUVIRIN. No adverse event was reported following this administration error (underdose).
Age: 0.83
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US026125 is an initial spontaneous report received from a nurse on 26 Sep 2016. This report refers to a 10 months old patient of an unknown gender. Medical history and concomitant medications were not reported. The patient under the age of 4 years was vaccinated with FLUVIRIN (batch number: 1620201) at a dose of 0.5 ml (intramuscular) on 26 Sep 2016. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error, No adverse event
Clinical narrative: Case PHEH2016US024281 is an initial spontaneous report received from consumer on 19 Sep 2016. This case refers to 5 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported, expiry date: not reported) on an unknown date. It was reported that the patient received FLUVIRIN last year from her allergist in split doses 30 minutes apart and she was fine. No adverse event was reported following this medication error.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Case PHEH2016US024325 is an initial spontaneous report received from pharmacist on 20 Sep 2016. This case refers to female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. It was reported that, the patient felt like she did not get the full dose and felt splash during administration of FLUVIRIN on an unspecified date. No adverse event was reported following this medication error (underdose).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHEH2016US024326, is an initial spontaneous report received from pharmacist on 21 Sep 2016. This case also contains QA reference number: 1016946). This report refers to a 71 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with first dose of FLUVIRIN (batch number: 168701, expiry date: Apr 2017) (patient was supposed to received 0.5 ml), into right arm, intramuscularly on 20 Sep 2016 at 14:15 pm. It was reported that, the pharmacist injected the vaccine and the solution was not fully injected into the patient and leaked out of the syringe where the needle attaches on 20 Sep 2016 at 14:15 pm. Pharmacists states the needle was firmly attached to the syringe. Partial dose was administered to the patient. No adverse event was reported following this medication error. Follow up report received from a pharmacist on 12 Oct 2016: Added patient demographics (patient initial, date of birth and gender), suspect product information (vaccination date and time, dose, route of administration and vaccination site) and updated reporter information. Following an internal review done for the data received on 22 Oct 2016, the case PHEH2016US025678 was found to be a duplicate of case PHEN2016US024326. Hence, all the information from the case PHEH2016US025678 has been merged into the case PHEN2016US024326, and the case PHEH2016US025678 has been deactivated. The reporter was updated and seriousness of the events was updated as non serious.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US025943, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to a 92 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1517601) at a dose of 0.5 ml, intramuscularly on 04 Oct 2016. The nurse stated that, 02 patients were administered FLUVIRIN from last year. It was reported that, patient did not experienced any adverse effects and vaccinated with last year dose of FLUVIRIN. No adverse event was reported following this medication error (expired product administered). The case was assessed as non serious by the nurse. Follow up report received from a nurse on 02 Nov 2016: Added reporter comments.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case PHEH2016US025851, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to an adult female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618521) at a dose of 1 ml intramuscularly on 03 Oct 2016. The nurse stated that, she discovered that 9 patients received 1.0 ml of FLUVIRIN rather than 0.5 ml. No adverse event was reported after this maladministration (accidental overdose). The case was lost to follow up at initial.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2016US025901, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to a female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (lot number: 1618521) at a dose of 1 ml (accidental overdose) intramuscularly on 03 Oct 2016. Nurse reported that 9 patients received 1.0mL of FLUVIRIN rather than 0.5mL. No adverse event was reported following this medication error (accidental overdose).