chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Extensive swelling of vaccinated limb, Fatigue, Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 55-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of heart rate increased (1st dose received on an unknown date, refer case id US2019006908). On 14th January 2019, the patient received the 2nd dose of SHINGRIX. On 14th January 2019, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping and drug dose administration interval too long. On 15th January 2019, the patient experienced heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, tiredness, weakness, groggy, shivering and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, difficulty sleeping, tiredness, weakness, groggy, shivering, influenza-like symptoms and drug dose administration interval too long were unknown. It was unknown if the reporter considered the heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, difficulty sleeping, tiredness, weakness, groggy, shivering and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: On 14th January 2019, the patient got his SHINGRIX in the left arm, which led to lengthening of vaccination schedule.  The last night he didn't sleep well. The patient was tired, weak and groggy today (15th January 2019), he was shivering in the shower this morning, his resting heart rate was up from 52 to 72/80 range. The patient left arm was swollen between the top of the sholder and just above the elbow (extensive swelling of vaccinated limb) and it was tender. The patient was feels like he had the flu since this morning. The reporter was consented to follow up. This case has been linked to case US2019006908, having same patient and reported by same reporter (For tolerance of 1st dose).
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 55-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of heart rate increased (1st dose received on an unknown date, refer case id US2019006908). On 14th January 2019, the patient received the 2nd dose of SHINGRIX. On 14th January 2019, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping and drug dose administration interval too long. On 15th January 2019, the patient experienced heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, tiredness, weakness, groggy, shivering and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, difficulty sleeping, tiredness, weakness, groggy, shivering, influenza-like symptoms and drug dose administration interval too long were unknown. It was unknown if the reporter considered the heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, difficulty sleeping, tiredness, weakness, groggy, shivering and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: On 14th January 2019, the patient got his SHINGRIX in the left arm, which led to lengthening of vaccination schedule.  The last night he didn't sleep well. The patient was tired, weak and groggy today (15th January 2019), he was shivering in the shower this morning, his resting heart rate was up from 52 to 72/80 range. The patient left arm was swollen between the top of the sholder and just above the elbow (extensive swelling of vaccinated limb) and it was tender. The patient was feels like he had the flu since this morning. The reporter was consented to follow up. This case has been linked to case US2019006908, having same patient and reported by same reporter (For tolerance of 1st dose).
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 55-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of heart rate increased (1st dose received on an unknown date, refer case id US2019006908). On 14th January 2019, the patient received the 2nd dose of SHINGRIX. On 14th January 2019, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping and drug dose administration interval too long. On 15th January 2019, the patient experienced heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, tiredness, weakness, groggy, shivering and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, difficulty sleeping, tiredness, weakness, groggy, shivering, influenza-like symptoms and drug dose administration interval too long were unknown. It was unknown if the reporter considered the heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, difficulty sleeping, tiredness, weakness, groggy, shivering and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: On 14th January 2019, the patient got his SHINGRIX in the left arm, which led to lengthening of vaccination schedule.  The last night he didn't sleep well. The patient was tired, weak and groggy today (15th January 2019), he was shivering in the shower this morning, his resting heart rate was up from 52 to 72/80 range. The patient left arm was swollen between the top of the sholder and just above the elbow (extensive swelling of vaccinated limb) and it was tender. The patient was feels like he had the flu since this morning. The reporter was consented to follow up. This case has been linked to case US2019006908, having same patient and reported by same reporter (For tolerance of 1st dose).
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Product complaint, Product container issue, Skin laceration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of laceration of finger in a 43-year-old female while preparation of SHINGRIX (batch number B37G7, expiry date 23rd May 2021) for prophylaxis. This case was associated with a product complaint. On 15th January 2019, the patient received SHINGRIX. On 15th January 2019, immediately after receiving SHINGRIX, the patient experienced laceration of finger, accidental occupational exposure to product and exposure via skin contact. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger, accidental occupational exposure to product, exposure via skin contact and pharmaceutical product complaint 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. It was stated that two SHINGRIX adjuvant vials were broken when they opened the carton. The patient (staff member) at the pharmacy opened the carton and was getting ready to prepare for administration when she noticed the broken vials. The staff member that opened the box, pricked her finger on the glass pieces, which led to accidental occupational exposure to product, exposure via skin contact. The vials were shattered and there were pieces of glass in the carton. The blister tray nor carton were damaged and there was no evidence of leakage or product in the carton. The vials had been discarded so reporter did not have any additional information regarding the appearance of the vials. The package condition was not damaged or open upon receipt. Vials not available for return to GlaxoSmithKline. The reporter requested credit for two doses of SHINGRIX.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. On 22nd October 2018, 4 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. Approximately 4 days after her injection, she experienced a rash on the right upper chest that resolved after 4 additional days. The patient stated that, the representative she spoke to was knowledgeable, but he was unable to help the patient with her problem, which was a reaction to SHINGRIX, and the patient did not know whether to have it again or have the second shot, or not.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult male patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 26th September 2018, 1 days after receiving SHINGRIX, the patient experienced nausea, vomiting, general body pain and fever. On 28th September 2018, the outcome of the nausea, vomiting, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX in an unknown deltoid. The reporter gave consent to follow up. This case has been linked to the case US2019007963, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Poor quality sleep, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and poor sleep. In July 2018, the outcome of the chills, fever and poor sleep were recovered/resolved. It was unknown if the reporter considered the chills, fever and poor sleep to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in the right arm and indicated that at midnight after receiving the SHINGRIX vaccine she experienced chills and a mild fever. These symptoms caused her to not be able to sleep well that night.  All symptoms resolved after 7am. The patient did not consent to follow-up. The patient was unable to provide additional information. This case was linked with US2019008944, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Poor quality sleep, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and poor sleep. In July 2018, the outcome of the chills, fever and poor sleep were recovered/resolved. It was unknown if the reporter considered the chills, fever and poor sleep to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient at midnight after receiving the SHINGRIX vaccine experienced chills and a mild fever. These symptoms caused him to not be able to sleep well that night. All symptoms resolved after 7am. The reporter did not consent to follow-up. The reporter was unable to provide additional information. This case was linked with US2019008939, reported by the same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness of head in a 72-year-old male patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced numbness of head. On an unknown date, the outcome of the numbness of head was unknown. It was unknown if the reporter considered the numbness of head to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated that, the patient developed numbness on one side of head after receiving SHINGRIX. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 4 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: About 4 to 5 days post vaccination, the patient developed a rash on her neck. The rash continued to get worse as the months passed. It went to her left shoulder, then right shoulder. It went to her left thigh, then right thigh. Around October 2018, the rash went crazy and now her whole back was full of rash. She saw a dermatologist for this rash, but nothing has gotten it under control. The reporter did not consent to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product complaint
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 76-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. This case was associated with a product complaint. Concomitant products included SHINGRIX. On 16th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a week after receiving SHINGRIX and an unknown time after receiving SHINGRIX, the patient experienced injection site tenderness. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site tenderness was not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were reported as follows: A day before the date of reporting, the patient received 2nd dose of SHINGRIX in the left deltoid. After receiving the 2nd dose of SHINGRIX, the patient experienced tenderness at the injection site. The reporter did not consent to follow up. This case was one of the 5 cases, reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling hot, Lethargy, Malaise, Product complaint
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling hot in a 75-year-old male patient who received SHINGRIX (batch number 49R72, expiry date 13th February 2021) for prophylaxis. This case was associated with a product complaint. Concomitant products included SHINGRIX. On 16th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a day after receiving SHINGRIX, the patient experienced feeling hot, lethargy and feeling unwell. On an unknown date, the patient experienced feels awful and pharmaceutical product complaint. On an unknown date, the outcome of the feeling hot, lethargy, feels awful and feeling unwell were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the feeling hot, lethargy, feels awful and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. On 12th November 2018, the patient received the 1st dose of 0.5ml SHINGRIX (batch number 49R72, expiry date 13th February 2021) intramuscularly. The patient received the dose of the SHINGRIX vaccine in the left deltoid. The morning after receiving the SHINGRIX vaccine, the patient did not feel good, he felt like he had a fever, he was lethargic and had been in been all day. The patient in the background during the phone call said that he felt horrible. The reporter did not consent to follow-up. This case was 1 of 5 cases, reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling hot in a 75-year-old male patient who received SHINGRIX (batch number 49R72, expiry date 13th February 2021) for prophylaxis. This case was associated with a product complaint. Concomitant products included SHINGRIX. On 16th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a day after receiving SHINGRIX, the patient experienced feeling hot, lethargy and feeling unwell. On an unknown date, the patient experienced feels awful and pharmaceutical product complaint. On an unknown date, the outcome of the feeling hot, lethargy, feels awful and feeling unwell were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the feeling hot, lethargy, feels awful and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. On 12th November 2018, the patient received the 1st dose of 0.5ml SHINGRIX (batch number 49R72, expiry date 13th February 2021) intramuscularly. The patient received the dose of the SHINGRIX vaccine in the left deltoid. The morning after receiving the SHINGRIX vaccine, the patient did not feel good, he felt like he had a fever, he was lethargic and had been in been all day. The patient in the background during the phone call said that he felt horrible. The reporter did not consent to follow-up. This case was 1 of 5 cases, reported by the same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Pain, Product complaint, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th January 2021) for prophylaxis. This case was associated with a product complaint. On 9th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 9th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema. In January 2019, the patient experienced fever, welts, rash, general body pain and influenza-like symptoms. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fever, welts, rash, general body pain, injection site erythema and influenza-like symptoms were recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the fever, welts, rash, general body pain, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. The patient had defined red ring around the injection site that started the evening after receiving vaccine. Less than a week after receiving vaccination, the patient had a fever and body temperature was recorded as  102 degrees F.  The patient developed whelps and a rash that went up and down her arm. The patient hurt all over her body like she had the flu. All symptoms resolved after three days. The reporter did not consent to follow up. This case was 3 of 4 cases reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th January 2021) for prophylaxis. This case was associated with a product complaint. On 9th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 9th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema. In January 2019, the patient experienced fever, welts, rash, general body pain and influenza-like symptoms. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fever, welts, rash, general body pain, injection site erythema and influenza-like symptoms were recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the fever, welts, rash, general body pain, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. The patient had defined red ring around the injection site that started the evening after receiving vaccine. Less than a week after receiving vaccination, the patient had a fever and body temperature was recorded as  102 degrees F.  The patient developed whelps and a rash that went up and down her arm. The patient hurt all over her body like she had the flu. All symptoms resolved after three days. The reporter did not consent to follow up. This case was 3 of 4 cases reported.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Product complaint, Pruritus, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 72-year-old male patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 31st October 2018; batch number: 49R72, expiry date: 13th March 2021). On 16th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a day after receiving SHINGRIX, the patient experienced pruritus and hives. On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with medication unknown. On an unknown date, the outcome of the pruritus and hives were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the pruritus and hives to be related to SHINGRIX. Additional details were reported as follows: The patient was the reporter's father. The patient received a 1st dose of SHINGRIX 0.5ml intramuscularly. A day before the date of reporting, the patient received a 2nd dose of SHINGRIX on the left deltoid. The patient woke up during the night because he was itching and the patient found that he had hives all over his body, included in his scalp. The patient went to his physician today and received unknown medication. The reporter did not consent to follow-up. This is one of the 5 cases reported by same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th January 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site blisters and malaise. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site blisters and malaise were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site blisters and malaise to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The patient experienced flu-like symptoms after receiving the SHINGRIX vaccination. The reporter did not consent to follow-up. The reporter would not provide any additional details. This case was one of the 5 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In January 2019, less than a year 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 age at vaccination was not reported. The patient was diagnosed with shingles a week before the date of reporting.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye movement disorder, Eyelid function disorder, Facial paralysis, Speech disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a male patient who received SHINGRIX for prophylaxis. On 20th October 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a month after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced speech disorder and eye movement disorder. The patient was treated with prednisone. On an unknown date, the outcome of the bell's palsy was not recovered/not resolved and the outcome of the speech disorder and eye movement disorder were unknown.  It was unknown if the reporter considered the bell's palsy, speech disorder and eye movement disorder to be related to SHINGRIX. Additional details were reported as follows:  The age at vaccination was not reported. The patient and his spouse received a 1st dose of SHINGRIX. In early November 2018, the patient was diagnosed with bell's palsy. The patient also reported that, had a hard time with speaking and his left eye could not blink. The patient's physician put him on Prednisone but it did not really help at all. The reporter gave permission for safety to contact his healthcare professional for additional information. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Initial information received on 17-Jan-2019 regarding an unsolicited valid serious case received from a nurse. This case involves a male patient (under 65 years of age) who was tested positive of Influenza A virus after he got flu post receiving vaccine, FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapies were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. On an unknown date, the patient developed flu and after tested of having rapid flu, it came back positive for A-strain (Influenza) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. Patient was in the hospital and tested by nasal swab for the flu A strain. Patient was on droplet precautions at the facility and reportedly could be reached from 10-6 (unspecified unit).  Final diagnosis was Influenza A virus infection. The patient was treated with oseltamivir phosphate (Tamiflu) and an unknown antiviral. Outcome of the event was not reported. List of documents held by sender: none.; Sender's Comments: This case concerns an adult patient who was tested positive for Influenza A after and despite vaccination with a Influenza containing vaccine. The time to onset is not known. Moreover, there is no information regarding patient's condition at time of vaccination, immune status, predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 17-Jan-2019 regarding an unsolicited valid non-serious case received from physician. This case involves a 13 years old male patient who received a dose vaccine FLUZONE QUADRIVALENT (lot UI078AA and 30-Jun-2019) via unknown route in the right deltoid on 17-Jan-2019. It was also reported that the patient also received the same vaccine 2 weeks ago at a pharmacy. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient didn't receive any other vaccinations or medications. It was a case of actual medication error due to Extra dose administered. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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. List of documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Exposure via skin contact, Needle issue
Clinical narrative: Initial information received on 17-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient with unknown demographics who received a dose of TYPHIM VI injection suspension (Batch number: N1K811M, expiration date: 19-Oct-2019, route and site of administration was not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to vaccine underdose. It was also a case of exposure via skin contact and needle issue. The needle leaked between the hub and the attachment site of the pre-filled syringe. She said that she had tightened it on the syringe appropriately. That part of the pre-filled syringe dose leaked out and down the patients arm and they did not get a full dose. It was unknown whether patient experienced any adverse event following vaccination. Agency number reported as 100003385. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Cyanosis, Sensory loss
Clinical narrative: Initial information received on 18-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves Adult patient who experienced blue color limbs and loss of feeling in the extremities, while received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious blue color limbs and loss of feeling in the extremities (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data). Final diagnosis was loss of feeling in the extremities and blue color limbs. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Cough, Nasopharyngitis, Upper-airway cough syndrome
Clinical narrative: Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from a company via consumer/non-health care professional. This case involves a 62 years old female patient who experienced nasal drip, cold and cough, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose, dose in series not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious nasal drip, cold and cough following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No lab data was reported. Final diagnosis was cough, cold and nasal drip. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for cough, as Unknown for nasal drip and as Unknown for cold. List of document held: none.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site pruritus, Pain, Swelling
Clinical narrative: Severe itching at injection site, severe pain with heat, swelling and redness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Heart rate increased, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness & swelling at shot site, severe chills, fever of 100, fast heartbeat, nausea, thirst. Extreme fatigue the following 2 days afterwards.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pyrexia, Thirst
Clinical narrative: Pain, redness & swelling at shot site, severe chills, fever of 100, fast heartbeat, nausea, thirst. Extreme fatigue the following 2 days afterwards.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Headache, fever, muscle aches. Soreness at injection site- received vaccine in the morning and started feeling symptoms that evening.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Coronary artery dilatation, Ear infection, Febrile convulsion, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: Symptoms started as an abnormally high fever after the vaccines. Fever got higher and would not break under 102 degrees. This went on for four days before he went back and was diagnosed with an ear infection and put on antibiotics. Started antibiotics, symptoms got worse and fever got higher. Fever was 105.2 degrees when he had the first febrile seizure, which was followed by two more and then categorized as complex febrile seizures. We was taken to ED via ambulance. There he was admitted. August 26, 2018, he was diagnosed with Kawasaki Disease with a 2.6mm dilation in his right coronary artery. IVIG was given, symptoms reversed. November 19, 2018, his dilation was closed and he has been considered Kawasaki free.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Symptoms started as an abnormally high fever after the vaccines. Fever got higher and would not break under 102 degrees. This went on for four days before he went back and was diagnosed with an ear infection and put on antibiotics. Started antibiotics, symptoms got worse and fever got higher. Fever was 105.2 degrees when he had the first febrile seizure, which was followed by two more and then categorized as complex febrile seizures. We was taken to ED via ambulance. There he was admitted. August 26, 2018, he was diagnosed with Kawasaki Disease with a 2.6mm dilation in his right coronary artery. IVIG was given, symptoms reversed. November 19, 2018, his dilation was closed and he has been considered Kawasaki free.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Visual impairment
Clinical narrative: This spontaneous report was received from a male consumer of unknown age who was reporting on himself. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were provided. On 17-JAN-2013, the patient was vaccinated with ZOSTAVAX injection, subcutaneously (dose, lot # and expiry date were not provided) for prevention of herpes zoster. On unknown date in 2014 (reported as "one year later"), the patient experienced shingles and vision problems. On an unknown date, he sought medical attention by visiting ophthalmologist. The outcome of the events was reported as not recovered. The relatedness between ZOSTAVAX and the events was not provided.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 17-year-old male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSSERO. Additional information was provided as follows: The age at vaccination was not reported, but it could be 16 or 17 years. The patient received BEXSERO and experienced injection site pain lasted a week. The reporter gave consent to follow up. This case linked with case US2019GSK015211, reported by same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 60-year-old female patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to Flu vaccine. Additional details were reported as follows: This case was reported by the patient who herself was the Nurse. The age at vaccination was not reported. In the past, the patient received flu vaccines and she normally gets headaches. The patient did not know the brand of the vaccine. The patient did not want to provide her address. The reporter told that, the representative could call her if needed. The reporter consented to follow up. This is 1 of the 2 cases reported by same reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 9th November 2018, the patient received the 1st dose of SHINGRIX. On 9th November 2018, less than a year after receiving SHINGRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, his nurse had seen more side effects with 2nd dose of SHINGRIX compared to 1st dose of SHINGRIX. The patient did not consent to follow-up. For tolerance to 2nd dose of SHINGRIX refer case US2019009734.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Headache, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 69-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 9th November 2018, for tolerance refer case: US2019GSK013766). On 17th January 2019, the patient received the 2nd dose of SHINGRIX. On 17th January 2019, 12 hrs after receiving SHINGRIX, the patient experienced injection site tenderness, chills, feeling hot, pain and headache. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site tenderness, chills, feeling hot, pain and headache were recovered/resolved. It was unknown if the reporter considered the injection site tenderness, chills, feeling hot, pain and headache to be related to SHINGRIX. Additional details were provided as follows: At 10:30 AM, the patient received SHINGRIX. After 12 hours of vaccination (at around midnight) the patient experienced headache, chilled, felt hot, and tenderness at the injection site. The patient stated that, his nurse had seen more side effects with 2nd dose of SHINGRIX compared to 1st dose of SHINGRIX. The patient did not consent to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 69-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 9th November 2018, for tolerance refer case: US2019GSK013766). On 17th January 2019, the patient received the 2nd dose of SHINGRIX. On 17th January 2019, 12 hrs after receiving SHINGRIX, the patient experienced injection site tenderness, chills, feeling hot, pain and headache. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site tenderness, chills, feeling hot, pain and headache were recovered/resolved. It was unknown if the reporter considered the injection site tenderness, chills, feeling hot, pain and headache to be related to SHINGRIX. Additional details were provided as follows: At 10:30 AM, the patient received SHINGRIX. After 12 hours of vaccination (at around midnight) the patient experienced headache, chilled, felt hot, and tenderness at the injection site. The patient stated that, his nurse had seen more side effects with 2nd dose of SHINGRIX compared to 1st dose of SHINGRIX. The patient did not consent to follow-up.
Age: 68.0
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 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received the ZOSTAVAX vaccine in the past). On 30th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was reporting an adverse event for herself. She received a dose of SHINGRIX and experienced a sore arm which lasted for a total of 3 days. Did not consent to follow up. No further details were provided. This is 1 of the 2 cases reported by same reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Chest pain, Headache, Herpes zoster, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 30th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th January 2019, 17 days after receiving SHINGRIX, the patient experienced blister, rash and chest pain. On an unknown date, the patient experienced shingles, injection site pain, headache, influenza-like symptoms and pain in arm. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles, blister, rash and chest pain were unknown and the outcome of the injection site pain, headache, influenza-like symptoms and pain in arm were recovered/resolved. It was unknown if the reporter considered the shingles, injection site pain, headache, influenza-like symptoms, pain in arm, blister, rash and chest pain to be related to SHINGRIX. Additional information was provided as follows: The reporter was reporting adverse event for her husband. The patient received a dose of SHINGRIX and experienced pain at injection site, headache, flu like symptoms, and sore arm. Everything lasted for one day except the sore arm which lasted for about 3 days. About 2 weeks post vaccination the patient experienced a rash, blisters and chest pain from rib cage to the neck and to the back area. He went to the doctor right away on 16th January 2019. He was then diagnosed with Shingles and he was started on antiviral medications. Consented to follow up was provided. No further details were provided. This is 1 of the 2 cases reported by same reporter. There is an inconsistent information provided by the reporter with respect time to onset. As per reported statement (About 2 weeks post vaccination) it is 14 days for a rash, blisters and chest pain; however, as per narrative description (He went to the doctor right away on 16th January 2019) it is 17 days. As the patient went right away to the physician after experiencing the adverse events the time to onset has been kept according to it.