chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Back pain, Chills, Erythema, Headache
Clinical narrative: injection site rash; numerous red blemishes on body; body ache; headache; Back ache; Canker sores; Tooth pain; Sore throat; Chills; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills. On an unknown date, the outcome of the injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills were unknown.   It was unknown if the reporter considered the injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe reaction, rash at injection site, numerous red blemished on body, body aches, headache, backache, canker sore, tooth pain and sore throat chills. It was unknown if the reporter consented to follow up.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Oropharyngeal pain, Pain, Toothache
Clinical narrative: injection site rash; numerous red blemishes on body; body ache; headache; Back ache; Canker sores; Tooth pain; Sore throat; Chills; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills. On an unknown date, the outcome of the injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills were unknown.   It was unknown if the reporter considered the injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe reaction, rash at injection site, numerous red blemished on body, body aches, headache, backache, canker sore, tooth pain and sore throat chills. It was unknown if the reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node; This case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary lymph nodes enlarged was unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient asked that can a swollen lymph node under arm be a side effect of Shingles vaccine. It was unknown if reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Does shingles vaccine cause leg cramps?; This case was reported by a consumer via call center representative and described the occurrence of leg cramps in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced leg cramps. On an unknown date, the outcome of the leg cramps was unknown.   It was unknown if the reporter considered the leg cramps to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The age group was not reported but was selected as adult as per vaccine indication. The patient asked that does Shingles vaccine cause leg cramps. It was unknown if reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: injection site pain; general sense of malaise; This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and malaise. On an unknown date, the outcome of the injection site pain and malaise were unknown.   It was unknown if the reporter considered the injection site pain and malaise to be related to Shingrix.  Additional details were provided as follows: The patient reported that he had seen higher frequency of pain at the injection site for the second dose of Shingrix in his overall population. The patients had also stated a general sense of malaise after vaccination. The reporter did not agree to follow-up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills probably grade 2; This case was reported by a pharmacist via sales rep and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided but the patient was in 50s. The patient had experienced chills for about 24 hours after receiving Shingrix. The patient did not experienced any other adverse effect. It was unknown if the reporter consented to follow-up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Feeling hot, Irritability, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong Vaccine Administered; Inappropriate Age at Vaccine Administration; Fussy; Felt warm; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: A 4 month old infant received a dose of Kinrix instead of Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The nurse declined to provide patient information. The reporter consented to follow up.   Follow up information was received from nurse on 6th November 2019: The patient's demographic details were updated. The clinical staff error in drawing up wrong vaccine based on the patient's age. No back up labeling on the vaccine fridge to verify correct age range. The reporter was denied that any adverse reaction in patient. Less than weeks after vaccination, the patient experienced fussy and felt warm. The events were resolved two days after vaccination. The reporter also thoroughly educated herself with CDC and vaccine information. It was unknown if the reporter considered the fussy and felt warm to be related to Kinrix.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Immediate post-injection reaction, Skin laceration
Clinical narrative: Finger prick while handling adjuvant vial of Shingrix vaccine; Inadvertent exposure to vaccine; exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of laceration of finger in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced laceration of finger, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the laceration of finger, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the laceration of finger to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist who reported finger prick while handling adjuvant vial of Shingrix vaccine, which led to laceration of finger, inadvertent exposure to vaccine and exposure via skin contact. The caller declined to provide more information for GlaxoSmithKline safety report and mentions she has reported it to her corporate department.  Limited details were provided.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Colonoscopy abnormal, Constipation, Endoscopy abnormal, Flatulence
Clinical narrative: Has a muscle that gives nerve pain; Back was in such pain; severe stomach problems; Full of gases; Constipated; such agony; This case was reported by a consumer via call center representative and described the occurrence of gastric disorder in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). In February 2019, less than 4 months after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced gastric disorder, pain, gas in stomach and constipation. On 5th November 2019, the patient experienced nerve pain. In November 2019, the patient experienced back pain. On an unknown date, the outcome of the gastric disorder, pain, gas in stomach, constipation and back pain were recovered/resolved and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the gastric disorder, pain, gas in stomach, constipation, back pain and nerve pain to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The caller was the patient. The patient stated that last October she got a flu shot. She was calling from work and the paperwork was at home so she did not know the name of the flu shot. Therefore, she did not know if it was a GlaxoSmithKline flu shot or not. But this year her employer was offering Flulaval so she thinks that might have been what they used last year. She said she can call us back when she gets home to give us the name of the vaccine and to see if any of the paperwork has the lot number on it. She stated that she got the Flu shot 2018-2019 in October 2018. The injection was given intramuscularly in an unspecified arm. She said that starting in February 2019 she developed severe stomach problems. She was in such agony for 2 months. She was constipated and full of gases. She said it felt like she had golf balls swimming in her stomach and she thought she they were tumors but she would press on them and they would dissipate. She had a colonoscopy and an endoscopy and it showed gases the stomach and nothing else. The gallbladder was normal. She states that at the time of reporting she had a muscle that gives me nerve pain on that same side. She stated that she went to physical therapy because her back was in such pain. She had different symptoms are gases in stomach was first and that resolved, then constipation, and eventually that got better. She had no prior history of constipation. She said that she was not blaming the flu vaccine but she was researching some ingredients that are in flu shots and was calling at the time of reporting to inquire about different ingredients in Flulaval. The reporter spoke per Package insert.  The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Gastric disorder, Neuralgia, Pain
Clinical narrative: Has a muscle that gives nerve pain; Back was in such pain; severe stomach problems; Full of gases; Constipated; such agony; This case was reported by a consumer via call center representative and described the occurrence of gastric disorder in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). In February 2019, less than 4 months after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced gastric disorder, pain, gas in stomach and constipation. On 5th November 2019, the patient experienced nerve pain. In November 2019, the patient experienced back pain. On an unknown date, the outcome of the gastric disorder, pain, gas in stomach, constipation and back pain were recovered/resolved and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the gastric disorder, pain, gas in stomach, constipation, back pain and nerve pain to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The caller was the patient. The patient stated that last October she got a flu shot. She was calling from work and the paperwork was at home so she did not know the name of the flu shot. Therefore, she did not know if it was a GlaxoSmithKline flu shot or not. But this year her employer was offering Flulaval so she thinks that might have been what they used last year. She said she can call us back when she gets home to give us the name of the vaccine and to see if any of the paperwork has the lot number on it. She stated that she got the Flu shot 2018-2019 in October 2018. The injection was given intramuscularly in an unspecified arm. She said that starting in February 2019 she developed severe stomach problems. She was in such agony for 2 months. She was constipated and full of gases. She said it felt like she had golf balls swimming in her stomach and she thought she they were tumors but she would press on them and they would dissipate. She had a colonoscopy and an endoscopy and it showed gases the stomach and nothing else. The gallbladder was normal. She states that at the time of reporting she had a muscle that gives me nerve pain on that same side. She stated that she went to physical therapy because her back was in such pain. She had different symptoms are gases in stomach was first and that resolved, then constipation, and eventually that got better. She had no prior history of constipation. She said that she was not blaming the flu vaccine but she was researching some ingredients that are in flu shots and was calling at the time of reporting to inquire about different ingredients in Flulaval. The reporter spoke per Package insert.  The reporter consented to follow up.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: Decreased arm mobility; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 88-year-old male patient who received Herpes zoster (Shingrix) (batch number EE924, expiry date 29th January 2022) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMOVAX).   On 6th November 2019, the patient received Shingrix (intramuscular). On 6th November 2019, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was unknown.   It was unknown if the reporter considered the injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that the patient was vaccinated with both Shingrix and Pneumovax. In the arm that had the Shingrix administered, within hours the patient was unable to move his arm from the shoulder down. Within a few more hours, it was only decreased mobility from shoulder to elbow. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: shivering; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2019, the patient received the 1st dose of Shingrix. On 23rd September 2019, less than a day after receiving Shingrix, the patient experienced shivering and influenza-like symptoms. On 26th September 2019, the outcome of the shivering and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the shivering and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced shivering and flu like symptoms.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Asthenia, Disorientation, Headache, Joint swelling
Clinical narrative: Swelling in ankle / Swelling in knee; discomfort / discomfort in leg; discomfort / discomfort in knee; arthritic reaction; headache; disorientation /he wasn't as aware or sharp in his mind; fever; decreased strength; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than 4 months after receiving Shingrix, the patient experienced strength loss of. On 24th July 2019, the patient experienced disorientation and fever. On 25th July 2019, the patient experienced headache. On 27th July 2019, the patient experienced leg discomfort, discomfort in joints and arthritis. On 4th November 2019, the patient experienced ankle swelling. The patient was treated with analgesic, nos (Pain Reliever (Drug Name Unknown)). On 25th July 2019, the outcome of the fever was recovered/resolved. On 27th July 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the disorientation and strength loss of were recovered/resolved and the outcome of the leg discomfort and discomfort in joints were not recovered/not resolved and the outcome of the arthritis and ankle swelling were unknown.   It was unknown if the reporter considered the headache, disorientation, fever, strength loss of, leg discomfort, discomfort in joints, arthritis and ankle swelling to be related to Shingrix.  Additional case details were reported as follows: The patient had his first dose of Shingrix in July.  Initially right after the vaccine he noted his was disoriented, meaning he wasn't as aware or sharp in his mind. It stated the day after the vaccine but resolved within a day. The patient had a fever the same day but that resolved the next day of vaccination. Headache that started the day after the vaccination but resolved two days later. The patient noted an all over decreased body strength but that resolved quickly as well. On 27th July 2019, 3 days after vaccination noted discomfort in his right knee and leg, he called it an arthritic reaction.  The patient continued to have those issues, and also noted on November 4th he experienced swelling in his ankle and believed he also had experienced knee swelling. The patient saw his physician for the issues on September 10th, but didn't let the physician knew he felt like they were related to the vaccine. The physician prescribed a pain reliever. The emergency room visit was required. The reporter consent to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Musculoskeletal discomfort, Pyrexia
Clinical narrative: Swelling in ankle / Swelling in knee; discomfort / discomfort in leg; discomfort / discomfort in knee; arthritic reaction; headache; disorientation /he wasn't as aware or sharp in his mind; fever; decreased strength; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than 4 months after receiving Shingrix, the patient experienced strength loss of. On 24th July 2019, the patient experienced disorientation and fever. On 25th July 2019, the patient experienced headache. On 27th July 2019, the patient experienced leg discomfort, discomfort in joints and arthritis. On 4th November 2019, the patient experienced ankle swelling. The patient was treated with analgesic, nos (Pain Reliever (Drug Name Unknown)). On 25th July 2019, the outcome of the fever was recovered/resolved. On 27th July 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the disorientation and strength loss of were recovered/resolved and the outcome of the leg discomfort and discomfort in joints were not recovered/not resolved and the outcome of the arthritis and ankle swelling were unknown.   It was unknown if the reporter considered the headache, disorientation, fever, strength loss of, leg discomfort, discomfort in joints, arthritis and ankle swelling to be related to Shingrix.  Additional case details were reported as follows: The patient had his first dose of Shingrix in July.  Initially right after the vaccine he noted his was disoriented, meaning he wasn't as aware or sharp in his mind. It stated the day after the vaccine but resolved within a day. The patient had a fever the same day but that resolved the next day of vaccination. Headache that started the day after the vaccination but resolved two days later. The patient noted an all over decreased body strength but that resolved quickly as well. On 27th July 2019, 3 days after vaccination noted discomfort in his right knee and leg, he called it an arthritic reaction.  The patient continued to have those issues, and also noted on November 4th he experienced swelling in his ankle and believed he also had experienced knee swelling. The patient saw his physician for the issues on September 10th, but didn't let the physician knew he felt like they were related to the vaccine. The physician prescribed a pain reliever. The emergency room visit was required. The reporter consent to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain, Red blood cell count decreased
Clinical narrative: Patient is also feeling extremely tired; Muscle aches; Pains; Low red blood cell count; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced tiredness, muscle pain, pain and red blood cell count decreased. On an unknown date, the outcome of the tiredness, muscle pain, pain and red blood cell count decreased were recovering/resolving.   It was unknown if the reporter considered the tiredness, muscle pain, pain and red blood cell count decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The reporter stated that the patient red blood cell count was lower than it should be, and also felt extremely tired, with muscle aches and pain. The patient had lab work done on 1st October 2019 and he had the appointment with the endocrinologist on 9th October 2019. The endocrinologist recommended the patient to the hematologist because the blood cell count was low enough that it merits an hematologist. The reporter stated that the patient thinks the red blood cell count was around 110,000. This case has been linked with case US2019202829, reported by the same reporter.      Lab Comments: The red blood cell count was around 110,000
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Skin discolouration
Clinical narrative: Rash on neck; Spot on buttock that feels hot; Spot on finger is red; Itching; White spots on rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 17 days after receiving Shingrix, the patient experienced rash, feeling hot, erythema of extremities, pruritus and skin discoloration. On an unknown date, the outcome of the rash, feeling hot, erythema of extremities, pruritus and skin discoloration were unknown.   It was unknown if the reporter considered the rash, feeling hot, erythema of extremities, pruritus and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient after vaccination experienced rash on neck, itching, white spots, spot on buttock feels hot, spot on finger was red. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling; Warmth; Pain; Red blister; Injection site redness; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date unknown) for prophylaxis.   On 8th November 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 8th November 2019, unknown after receiving Shingrix, the patient experienced inappropriate route of vaccination. On 10th November 2019, the patient experienced injection site swelling, injection site warmth, injection site pain and injection site blisters. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site pain, injection site blisters and inappropriate route of vaccination were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site pain and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix subcutaneously and went on to experience swelling, warmth, pain, and a red blister at the injection site.  The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Swelling; Warmth; Pain; Red blister; Injection site redness; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date unknown) for prophylaxis.   On 8th November 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 8th November 2019, unknown after receiving Shingrix, the patient experienced inappropriate route of vaccination. On 10th November 2019, the patient experienced injection site swelling, injection site warmth, injection site pain and injection site blisters. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site pain, injection site blisters and inappropriate route of vaccination were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site pain and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix subcutaneously and went on to experience swelling, warmth, pain, and a red blister at the injection site.  The reporter did not consent to follow-up.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally administered Fluzone High Dose to 7 patient between the ages of 36-54 with no AE; accidentally administered Fluzone High Dose to 7 patient between the ages of 36-54 with no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 40 years old female patient who received a 0.5 ml dose of vaccine vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] Prefilled Syringe (lot: UJ285AA, expiry date: 02-Jun-2020), via intramuscular route in the right arm on 21-Oct-2019.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to product administered to patient of inappropriate age and overdose. It was reported that the medical Assistant accidentally administered Fluzone High Dose to 7 patient between the ages of 36-54 year.  At the time of reporting, the patient had no 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered Fluzone High Dose to seven patients ranging from age 36-54/ no adverse event; administered Fluzone High Dose to seven patients ranging from age 36-54/ no adverse event; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 43 years old female patient who accidently received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ285AA via intramuscular route in the left arm on 21-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to overdose and product administered to patient of inappropriate age.  it was reported that a Medical assistant accidentally administered Fluzone High Dose to 7 patient's between the ages of 36-54.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally administered Fluzone High Dose to 7 patient's between the ages of 36-54/no AE; accidentally administered Fluzone High Dose to 7 patient's between the ages of 36-54/no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient age ranging from 36-54 years (adult)  who received a 0.5 ml dose of vaccine  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE lot: UJ285AA, expiry date: 02-Jun-2020), (prefilled syringe) via intramuscular route in the left arm  accidentally, on 21-Oct-2019.  The patient past medical history, medical treatments, vaccinations and family history were not provided.  No other vaccine was given.  It was a case of actual medication error due to overdose and product administered to patient of inappropriate age It was reported that patient was accidentally administered Fluzone high dose to patient between ages of 36-54   At the time of reporting, the patient had no adverse event.  No further relevant information was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: fluzone HD was given to a 2 year old patient, no AE; fluzone HD was given to a 2 year old patient, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old patient who experienced a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number, expiry date, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on batch number is requested.
Age: 6.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Six year old boy received Fluzone HD instead of Fluzone Quadrivalent. No adverse effects have been; Six year old boy received Fluzone HD instead of Fluzone Quadrivalent. No adverse effects have been; Six year old boy received Fluzone HD instead of Fluzone Quadrivalent. No adverse effects have been; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 6 years old male patient who was vaccinated with 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot #UJ280AA, exp; 24 May 2020) via intramuscular route in the left arm  instead of INFLUENZA VACCINE INACT SPLIT VIRION 3V on 24 Oct 2019.  Patients medical history included sick.   It was a case of actual medication error due to Wrong vaccine administered, Inappropriate age at vaccine administration and overdose.   At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Upon second medical examination of the case during internal review on 23-Oct-2019, a significant correction was performed on 15-Nov-2019 to correct the case as valid from non-valid.  Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 62 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Addendum on 23-Oct-2019: a significant correction was performed on 15-Nov-2019 to correct the case as valid from non-valid.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was administered to a 15 year old patient, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 years old male patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: unknown, expiry date: unknown) via unknown route, on 02-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient was given Flublok in the left deltoid, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1915, expiry date: 30-Jun-2020 via unknown route in the left deltoid, on 02-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting the patient had no 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11 year old old was vaccinated with Flublok during a fair today, no adverse event; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked with 2019SA294934 (same reporter)  This case involves a 11 years old male patient who received a dose of influenza quadrivalent recombinant vaccine [Flublok QIV] during a flu fair (Product administered to patient of inappropriate age).  On 22-Oct-2019, the patient received a dose of suspect influenza quadrivalent recombinant vaccine [Flublok QIV] (lot QFAA1930, expiration date: 30-Jun-2020) via intramuscular route in the left arm.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patient vaccinated with Fluzone HD, which experienced a delay in transit/No AE; patient vaccinated with Fluzone HD, which experienced a delay in transit/No AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2019SA309913 (same reporter).  This case involves an 80 years old female patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ290AB, expiry date- 09-Jun-2020 via intramuscular route in the left deltoid on 04-Nov-2019, which had a delay in transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and delay in transit.  At the tome of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient vaccinated with Fluzone HD, which experienced a delay in transit/no AE; vaccinated with Fluzone HD, which experienced a delay in transit/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2019SA309821 (same reporter).  This case involves an 80 years old female patient who was vaccinated with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ290AB, expiry date- 09-06-2020 via intramuscular route in the left deltoid on 04-Nov-2019, the vaccine had a delay in transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and delay in transit.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quad is administerd to the 9 month old patient, no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA309992 (same reporter).  This case involves a 9 months old patient who was vaccinated with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number not reported via unknown route in unknown administration site), on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  The physician stated that the standard packaging for both the Flublok Quad and the Fluzone Quad look the same.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on batch number is requested.