chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (five years ago) and shingles (five years ago). Concurrent medical conditions included eye pain. In November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, 10 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema and injection site pain. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of the SHINGRIX in late November 2018 at around 2:00 pm, on a Sunday. Approximately 10 to 12 hours after receiving the vaccine, the patient began to experience flu like symptoms which included, body aches, fever, fatigue, he could not bend down. The injection site was red and sore. Around 2:00 pm on Monday, the patient started to feel significantly better, with lingering soreness and redness at the injection site, and body aches, and everything started to resolve by Thursday or Friday. The reporter did not give consent to follow up. This case has been linked to the US2019GSK031818, reported for the dose 1 of the same patient.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received SHINGRIX (batch number ZN22Z, expiry date 28th February 2021) for prophylaxis. On 30th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left deltoid.
Age: 4.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Expired product administered, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old male patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number M73CE, expiry date 30th June 2019) for prophylaxis. Co-suspect products included HAVRIX (batch number N37Z5, expiry date 10th November 2018) for prophylaxis. On 20th December 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) and HAVRIX (intramuscular). On 20th December 2018, not applicable after receiving FLUARIX QUADRIVALENT 2019 season and unknown after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site swelling and expired vaccine used were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FLUARIX QUADRIVALENT 2018-2019 season and HAVRIX. Additional details were provided as follows: The nurse, who was also working as a pharmacy technician, reported that the patient received HAVRIX in right deltoid was expired on 10th November 2018, which led to Expired vaccine used. The reporter also indicates that this patient was administered FLUARIX in right deltoid and a Sanofi vaccine right deltoid (both within the expiration dates) in the same site on the same date. The reporter stated the patient experienced raised redness in the arm of injection after receiving the injections. The agent advised caller to contact Sanofi to report the raised redness for the vaccine that was administered. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Sanofi vaccine as well.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced flu symptoms, tiredness, groggy, injection site erythema, pain in extremity and injected limb mobility decreased. On an unknown date, the outcome of the flu symptoms, tiredness, groggy and injection site erythema were recovered/resolved and the outcome of the pain in extremity and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the flu symptoms, tiredness, groggy, injection site erythema, pain in extremity and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient felt mild flu symptoms and was tired and groggy for the first two days which then resolved. The patient also reported that her arm was red at the injection site, it did not hurt to the touch but it ached which resulted in not always being able to turn it; it ached or hurt deep inside the arm right around the injection site. The reporter provided the consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced flu symptoms, tiredness, groggy, injection site erythema, pain in extremity and injected limb mobility decreased. On an unknown date, the outcome of the flu symptoms, tiredness, groggy and injection site erythema were recovered/resolved and the outcome of the pain in extremity and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the flu symptoms, tiredness, groggy, injection site erythema, pain in extremity and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient felt mild flu symptoms and was tired and groggy for the first two days which then resolved. The patient also reported that her arm was red at the injection site, it did not hurt to the touch but it ached which resulted in not always being able to turn it; it ached or hurt deep inside the arm right around the injection site. The reporter provided the consent for follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of feels awful in a adult female patient who received SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feels awful and influenza-like symptoms. On an unknown date, the outcome of the feels awful and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the feels awful and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated after 1st dose of SHINGRIX, she felt horrible and had bad flu like symptoms. The patient stated all symptoms resolved within hours to a day following vaccination. Did not collect the lot or expiration date of the vaccine. No additional details were provided. This case has been linked to the US2019GSK031922, reported for the dose 2 of the same patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash maculo-papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of maculopapular rash in a 66-year-old female patient who received SHINGRIX (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis. Concomitant products included montelukast sodium and loratadine. On 8th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th February 2019, 3 days after receiving SHINGRIX, the patient experienced maculopapular rash. On an unknown date, the outcome of the maculopapular rash was unknown. It was unknown if the reporter considered the maculopapular rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right deltoid. At the time of this report, the patient was experiencing macular papular rash on her neck, abdomen, legs, arms and back. No further details were provided.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old male patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. On 25th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th November 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. The patient was treated with Oral Steroids. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left deltoid. Approximately 2 days after receiving SHINGRIX, a red band appeared around the arm and there was swelling at the injection site. The patient was seen by their doctor who prescribed oral steroids, and the events resolved within 7 days. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received SHINGRIX. On 12th February 2019, 1 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient was vaccinated with SHINGRIX and presented with shingles symptoms. Clinical manager from urgent care center reported the patient presented to the center the day of reporting for treatment of shingles. Batch number and expiration date were unavailable as the vaccine was administered at an outside facility. Address and contact information of administering facility were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Rash, Rash generalised, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received SHINGRIX for prophylaxis. On 8th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, weakness, rash, facial swelling, generalized rash and hives. On an unknown date, the outcome of the shivering, weakness, rash, facial swelling, generalized rash and hives were recovered/resolved. It was unknown if the reporter considered the shivering, weakness, rash, facial swelling, generalized rash and hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shivering, weakness, rash on her left torso and some face swelling which resolved within 2 to 3 days. The patient reported that since the shot she seems to be having more cases of rash and hives on her body which resolved within a day. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received SHINGRIX for prophylaxis. On 8th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, weakness, rash, facial swelling, generalized rash and hives. On an unknown date, the outcome of the shivering, weakness, rash, facial swelling, generalized rash and hives were recovered/resolved. It was unknown if the reporter considered the shivering, weakness, rash, facial swelling, generalized rash and hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shivering, weakness, rash on her left torso and some face swelling which resolved within 2 to 3 days. The patient reported that since the shot she seems to be having more cases of rash and hives on her body which resolved within a day. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown. It was unknown if the reporter considered the swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Lot number and expiration date was unknown during call. The pharmacist stated swelling was not extreme or anything. Reporter declined to provide initials or date of birth, as well as complete full safety report at time of reporting.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 78-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date). Concurrent medical conditions included diabetes. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling bad, pain and unwell. On an unknown date, the outcome of the feeling bad and pain were recovered/resolved and the outcome of the unwell was unknown. It was unknown if the reporter considered the feeling bad, pain and unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. In October or November 2018, the patient received of SHINGRIX on an unknown arm. The patient felt bad for a couple of days following the injection. The patient also felt a little under the weather and experienced some achiness. The reporter did not consent to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient received a dose in the 1st week of November and she said it felt like she was punched in the arm. The soreness lasted for 4 to 5 days. Consent to follow up was provided.
Age: 43.0
Sex: F
Vaccine: MNQ
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal oedema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a 43-year-old female patient who received MENVEO (batch number X17054, expiry date unknown) for prophylaxis. On 28th August 2018, the patient received the 1st dose of MENVEO. On 28th August 2018, less than an hour after receiving MENVEO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), throat swelling and shortness of breath. The patient was treated with BENADRYL. On an unknown date, the outcome of the anaphylactic reaction, throat swelling and shortness of breath were recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction, throat swelling and shortness of breath to be related to MENVEO. Additional details were provided as follows: The patient had an anaphylactic like reaction which included throat swelling and shortness of breath within an hour after vaccination. The reporter stated that she was not completely certain if the patient was pregnant. She said initially that the patient was not pregnant. The pharmacist asked about administering the 2nd dose to the patient which has not happened till the reporting time. The pharmacist asked about diluting MENVEO or administering small amounts of MENVEO to desensitize the patient. The reporter stated that it has not been administered this way to the patient at time of reporting. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of herpes zoster (received after age of 60 and was still getting shingles every 3 to 4 months). On an unknown date, the patient received the 1st dose of SHINGRIX. In November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and drug dose administration interval too long. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 67 or 68 years old. In 2018, the patient received 1st dose of SHINGRIX, but the patient could not recall the date. The patient believed that, her 2nd dose exceeded the 2 to 6 months of recommended time frame, which led to lengthening of the vaccination schedule. At the time of reporting, the patient was again experienced another breakout. The shingles breakout always occurred in the same area on her right hip. The reporter consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of faint in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 13th February 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness. On 13th February 2019, the patient experienced pain, shivering and cold. On 14th February 2019, the patient experienced feeling unwell. In February 2019, the patient experienced faint (serious criteria GSK medically significant) and sleep disturbance. On an unknown date, the outcome of the faint, tiredness, pain, shivering, cold and feeling unwell were recovering/resolving and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the faint, tiredness, pain, shivering, cold, feeling unwell and sleep disturbance to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the right arm. At around 2:00 PM, the patient experienced felt tired, achy and started shivering. The patient went to bed at approximately 10:00 PM. The patient would wake up every hour because he had cold. At around 2:30 AM, the patient woke up and felt faint so the patient lay on the floor for four or five minutes. Then, the patient got back into his bed. The patient woke up in the morning but did not feel good. However, at the time of reporting the patient was starting to feel better now. The reporter consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain, Poor quality sleep, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of faint in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 13th February 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness. On 13th February 2019, the patient experienced pain, shivering and cold. On 14th February 2019, the patient experienced feeling unwell. In February 2019, the patient experienced faint (serious criteria GSK medically significant) and sleep disturbance. On an unknown date, the outcome of the faint, tiredness, pain, shivering, cold and feeling unwell were recovering/resolving and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the faint, tiredness, pain, shivering, cold, feeling unwell and sleep disturbance to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the right arm. At around 2:00 PM, the patient experienced felt tired, achy and started shivering. The patient went to bed at approximately 10:00 PM. The patient would wake up every hour because he had cold. At around 2:30 AM, the patient woke up and felt faint so the patient lay on the floor for four or five minutes. Then, the patient got back into his bed. The patient woke up in the morning but did not feel good. However, at the time of reporting the patient was starting to feel better now. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of passed out in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The clinic notified to the reporter that they recently gave the patient a dose of SHINGRIX and the patient experienced passing out. No further details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Hyperhidrosis, Influenza like illness, Myalgia, Pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of passed out in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The clinic notified to the reporter that they recently gave the patient a dose of SHINGRIX and the patient experienced passing out. No further details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Vertigo
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of passed out in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The clinic notified to the reporter that they recently gave the patient a dose of SHINGRIX and the patient experienced passing out. No further details were available.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included fluticasone furoate, vilanterol trifenatate (Breo Ellipta) inhalation powder for product used for unknown indication and fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder for product used for unknown indication. On an unknown date, the patient received Flu vaccine at an unknown dose, Breo Ellipta at an unknown dose and frequency and Trelegy Ellipta at an unknown dose and frequency. On an unknown date, unknown after receiving Flu vaccine and not applicable after starting Breo Ellipta and Trelegy Ellipta, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. The action taken with Breo Ellipta was unknown. The action taken with Trelegy Ellipta was unknown. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine. It was unknown if the reporter considered the influenza to be related to Breo Ellipta and Trelegy Ellipta. Additional details were provided as follows: The age at vaccination was not reported. The nurse practitioner reported this case for one of their patients. The patient had a flu shot in the past but did not know which flu vaccine it was. The field representative did not remember if the patient was on Breo Ellipta or Trelegy Ellipta but stated that it was very unlikely that the patient was on both the products at the same time, but it was not confirmed with the nurse practitioner. The patient developed flu while on Breo Ellipta or Trelegy Ellipta. This case was considered as suspected vaccination failure case as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting. No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of adverse event in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date was not reported. The patient received 1st dose and had some systemic side effects. For tolerance to 2nd dose, refer case US2019GSK030801.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Injection site erythema, Injection site pain, Injection site urticaria, Uveitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of uveitis in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ophthalmic herpes zoster (shingles on ophthalmic nerve). On 7th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site wheal. On 7th February 2019, the patient experienced uveitis (serious criteria GSK medically significant) and eye pain. The patient was treated with antivirals for systemic use (Antiviral). On 17th January 2019, the outcome of the injection site pain, injection site erythema and injection site wheal were recovered/resolved. On 9th February 2019, the outcome of the uveitis and eye pain were recovered/resolved. It was unknown if the reporter considered the uveitis, injection site pain, injection site erythema, injection site wheal and eye pain to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired medical researcher. The patient received SHINGRIX vaccine in her left arm. On 7th February 2019, 31 days after receiving SHINGRIX the patient experienced uveitis and eye pain. The patient reported that she was seen by her physician for her eye and was prescribed an antiviral. The patient planned to continue follow-up with her physician on an unknown date. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed cellulitis after receiving SHINGRIX. The reporter stated she believed the cellulitis was physician diagnosed but was not sure. She did not see it first hand. The reporter did not consent to follow-up.
Sex: U
Vaccine: FLUX, PPV, TTOX
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable prescribing physician (MD) for a patient enrolled in Pfizer-sponsored program, this report is regarding an event reported in the patient's past medical history. A currently 60-year-old patient of an unspecified gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), tetanus vaccine (MANUFACTURER UNKNOWN), and influenza vaccine (FLU); all vaccines were given via unspecified route on unspecified dates at single doses for immunization; and clarithromycin (MANUFACTURER UNKNOWN) and erythromycin ethylsuccinate (E-MYCIN); both were taken via an unspecified route of administration from unspecified dates at unknown doses for unspecified indications. Medical history included allergy to penicillin (PCN) and allergy to Sulfa drugs. The patient's concomitant medications were not reported. On unknown dates, the patient experienced drug allergy to clarithromycin, e-mycin, flu vaccine, pneumonia vaccine, and tetanus. The action taken in response to the event for the vaccines was not applicable, and for clarithromycin and erythromycin ethylsuccinate was unknown. The clinical outcome for the event was unknown. Pfizer is a Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report in cases where another Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported for a 71-year-old female patient received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced drug allergies: PCV 13 on an unspecified date. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of an unspecified age (reported as Age: 18, Year: Unspecified) received TRUMENBA; (batch number unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had a fever of 104 degrees on an unspecified date which took place after use of product. The outcome of the event was unknown. Information on the batch number has been requested.
Age: 56.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Oral herpes
Clinical narrative: This is a spontaneous report from a contactable pharmacist and other healthcare professional via a sales representative. A 56-year-old female patient started to receive PREVNAR 13 at a single dose and FLU VACCINE VII at an unspecified dose; both via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had broken out in fever blisters around her mouth. Outcome of the event was unknown. Information on the lot/batch number has been requested.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid serious case received from a Physician. This case involves a 07-year-old male patient who experienced anaphylaxis reaction to the vaccine, while he received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLUZONE QUADRIVALENT and did not have a reaction. The patient's past medical history, medical treatment(s), family history and concomitant therapy were not provided. On 13-Nov-2017, the patient received a single dose of suspect FLUZONE QUADRIVALENT lot number not reported via unknown route. On an unknown date in 2017-2018, The patient developed a serious anaphylaxis reaction to the vaccine (anaphylactic reaction) and had to go to the emergency department for treatment following the administration of INFLUENZA FLUZONE QUADRIVALENT. This event was assessed as medically significant (IME). Physician also mentioned that "in cases where there is an allergic reaction to a flu vaccine, the protocol is to tell the patient to not receive anymore Flu vaccines". (Other relevant tests included no lab test.) Final diagnosis was anaphylaxis reaction to the vaccine. It was not reported if the patient received a corrective treatment. The patient outcome was not reported for the event. Sender's Comments: A 7-year-old male patient presented with anaphylaxis reaction to the vaccine after vaccination with FLUZONE QUADRIVALENT. Time to onset is not clearly defined. Patient received FLUZONE QUADRIVALENT in the past and well tolerated. However, further information including patient's medical history, concomitant medications, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to case 2019SA037139 (same reporter). This case involves a 10 months old male patient who received vaccine FLUZONE lot number UI983AA, expiry date: 30-Jun-2019 via unknown route in unknown administration site on 04-Dec-2018. 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 poor quality product administered. It was reported that temperature excursion on the following vaccines: FLUZONE QUADRIVALENT, IPOL, TDAP, ADACEL. Temperature 19-Nov-2018 32 F through 19-Nov-2018, and Dec-2018 33 F through 28-Jan-2019. 28-Jan-2019 to present 31F. FLUZONE QUAD was not viable at the time it was administered. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown demographic patient who was inadvertently vaccinated with two injections of ADACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date in three weeks time period. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to extra dose administered. It was reported that the patient had inadvertently received two injections of ADACEL in a three week time period. It was unknown whether the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to 2019SA035905 and 2019SA037139 (same reporter). This case involves a female patient (age not reported) who was vaccinated a dose of ADACEL lot U5980DA via unknown route in unknown administration site on 02-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to incorrect product storage and deteriorated drug administered. It was reported that the patient was vaccinated which was not viable and had a temperature excursion on 19-Nov-2018 at 32 F. It was unknown whether the patient had any harm or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves an 18 months old male patient received PENTACEL instead of HEPATITIS B. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE. On 04-Feb-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number, expiry date and dose in series was not reported) via intramuscular route in left leg. It was a case of actual medication error due to extra dose administered and wrong vaccine administered. It was also reported that a 18 month old patient received a 5th PENTATCEL injection instead of receiving the Hep B vaccine. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a five months old male patient who experienced low grade fever, while he received second dose of vaccine PENTACEL. The patient's medical history not reported and concomitant medications included ROTATEQ for Immunisation. The patient received 0.5 ml first and second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE on 21-Nov-2018 and 03-Dec-2018 respectively (lot C5527AA and Exp. Date 04-OCT-2019) via intramuscular route in the left thigh. It was an actual medication error case due to inappropriate schedule of vaccine administered. On an unknown date, the patient developed non-serious event of low grade fever following the administration of second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. As per reporter, no medical intervention was necessary. On an unknown date, the patient had recovered from low grade fever. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Product preparation error
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA036951 and 2019SA036960 same reporter. This case involves a 16 months old patient who received 0.5 mL dose of vaccine ACT-HIB lot UI914AA, expiry date- 28-Nov-2019 via unknown route in the left thigh on 21-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that three patients received ACTHIB. One of these patients received it incorrectly, it was reconstituted with a Merck diluent. It is unknown which of these patients received it. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
Sex: U
Vaccine: HIBV, MMR
Symptoms: Product preparation error
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA036951 and 2019SA036959 same reporter. This case involves a 15 months old patient who received 0.5 mL dose of vaccine ACT-HIB lot UI914AA, expiry date- 28-Nov-2019 via unknown route in the left thigh on 09-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that three patients received ACTHIB. One of these patients received it incorrectly, it was reconstituted with a Merck diluent. It is unknown which of these patients received it. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.