chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site discomfort in a patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number M73CE, expiry date June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On an unknown date, less than 3 weeks after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site discomfort, injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site discomfort, injection site swelling, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site discomfort, injection site swelling, injection site erythema and injection site pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information was reported as follows: The age at vaccination was not reported. The nurse reported that the patient experienced injection site discomfort, swelling, pain and redness after vaccination with the same batch number of FLUARIX. The patient was the staff member of the reported facility. This is 1 of the 10 cases reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX (batch number DD43M, expiry date unknown) for prophylaxis. On 6th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 2 weeks after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain and injection site induration. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and injection site induration were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The reporter had a consumer that received the SHINGRIX vaccination in left deltoid and had experienced a hard red area approximately 2 inches in diameter, arm pain, and swelling at the injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient states she experienced pain at the injection the second day post vaccination. The pain lasted for total of 2 days. The patient had denied permission to contact their physician. No further details were provided by the patient. It was reported that the SHINGRIX went onto backorder, and the patient need his second dose of SHINGRIX at the time of reporting. The had already called hundreds of places for SHINGRIX vaccine and he could not get it, which led to product supply issue.
Sex: M
Vaccine: HEP, MNQ
Symptoms: Asthenia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of weakness in a adolescent male patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Meningitis ACWY vaccine (potential MENVEO) for prophylaxis. Concurrent medical conditions included nervous. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and Meningitis ACWY vaccine (potential MENVEO) at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine and Meningitis ACWY vaccine (potential MENVEO), the patient experienced weakness. On an unknown date, the outcome of the weakness was unknown. It was unknown if the reporter considered the weakness to be related to Hepatitis B vaccine and Meningitis ACWY vaccine (potential MENVEO). Additional details were provided as follows: The age at the vaccination was not reported. The health care professional reported that after the patient received Hepatitis-B and MCV4 vaccines he became weak. Brand was not specified, but likely ENGERIX-B and MENVEO. The health care professional stated that this was not a reaction to the vaccine but was a result of the patient being very nervous and the accompanying parent expressing anti-vaccine sentiment during the visit. The health care professional stated that the patient was overwhelmed. No further details were provided.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of dizziness in a 16-year-old female patient who received BEXSERO (batch number 16B601, expiry date 29th February 2020) for prophylaxis. Concomitant products included MENVEO and GARDASIL 9. On 31st August 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 31st August 2018, less than an hour after receiving BEXSERO, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was recovered/resolved. It was unknown if the reporter considered the dizziness to be related to BEXSERO. Additional details were provided as follows: On 31st August 2018, the patient received MENVEO (batch number AMAA041A, expiry date 30th October 2019) in the right deltoid. On the same day, the patient received 1st dose of GARDASIL 9 in the left deltoid. At 11:45, the patient received BEXSERO in the left arm. And within 5 minutes, the patient began to experience dizziness which resolved within 10 to 15 minutes.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site muscle pain in a 16-year-old female patient who received BEXSERO (batch number 16B601, expiry date 29th February 2020) for prophylaxis. Concomitant products included GARDASIL 9. On 11th August 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 11th August 2018, 2 hrs after receiving BEXSERO, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved. It was unknown if the reporter considered the injection site muscle pain to be related to BEXSERO. Additional details were provided as follows: The patient received GARDASIL 9 (batch number R001262, expiry date 30th November 2020) in the right deltoid. At 12:30, the patient received BEXSERO in the left deltoid. The patient experienced severe arm pain in the deltoid muscle approximately two hours after receiving BEXSERO. The event resolved within 2 to 3 days.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of syncope vasovagal in a 17-year-old male patient who received BEXSERO (batch number 16B601, expiry date 29th February 2020) for prophylaxis. Concomitant products included MENVEO. On 15th August 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 15th August 2018, less than a minute after receiving BEXSERO, the patient experienced syncope vasovagal. On an unknown date, the outcome of the syncope vasovagal was recovered/resolved. It was unknown if the reporter considered the syncope vasovagal to be related to BEXSERO. Additional details were provided as follows: On 15th August 2018, the patient received MENVEO (batch number M17077, expiry date 30th July 2019) in the left deltoid. At 13:00, the patient received BEXSERO in the right deltoid. Within 30 seconds after receiving BEXSERO, the patient experienced vasovagal syncope which resolved within 30 to 45 seconds.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week 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 provided as follows: The age at the vaccination was not reported. The patient reported that she received a dose of the SHINGRIX a day before the date of reporting, and she experienced flu like symptoms. The patient did not want to provide demographics nor answer any further questions.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Incorrect dose administered, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of night sweat in a 58-year-old male patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX. On 4th September 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 5th September 2018, the patient experienced night sweat, fever, chills and unwell. In September 2018, the patient experienced headache, general body pain and sweating. On an unknown date, the outcome of the night sweat and fever were recovering/resolving and the outcome of the chills, general body pain and unwell were not recovered/not resolved and the outcome of the headache, sweating, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the night sweat, fever, chills, headache, general body pain, unwell and sweating to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that the patient had only received the adjuvant of the SHINGRIX vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient said that he experienced night sweating, chills and a low grade fever the next day after receiving the vaccine. After 3 days, the patient still had the same symptoms from the injection including body ache, headache and sweating. The patient called the office back on 10th September 2018. He said that after 3 days, the patient still had the same symptoms from the injection including body ache, headache and sweating. The patient was still unwell that day, but it was the first day he started to feel better after the vaccination. The patient called the office back on the date of reporting, he went through some of the same side effects again with chills, body aches and pain.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Pain, Product preparation issue, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of night sweat in a 58-year-old male patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX. On 4th September 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 5th September 2018, the patient experienced night sweat, fever, chills and unwell. In September 2018, the patient experienced headache, general body pain and sweating. On an unknown date, the outcome of the night sweat and fever were recovering/resolving and the outcome of the chills, general body pain and unwell were not recovered/not resolved and the outcome of the headache, sweating, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the night sweat, fever, chills, headache, general body pain, unwell and sweating to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that the patient had only received the adjuvant of the SHINGRIX vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient said that he experienced night sweating, chills and a low grade fever the next day after receiving the vaccine. After 3 days, the patient still had the same symptoms from the injection including body ache, headache and sweating. The patient called the office back on 10th September 2018. He said that after 3 days, the patient still had the same symptoms from the injection including body ache, headache and sweating. The patient was still unwell that day, but it was the first day he started to feel better after the vaccination. The patient called the office back on the date of reporting, he went through some of the same side effects again with chills, body aches and pain.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of myalgia in a elderly female patient who received SHINGRIX for prophylaxis. On 14th September 2018, the patient received the 2nd dose of SHINGRIX. On 14th September 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia, shivering and headache. On 16th September 2018, the patient experienced fatigue. On an unknown date, the outcome of the myalgia, shivering, fatigue and headache were recovered/resolved. It was unknown if the reporter considered the myalgia, shivering, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient via After Hours Voicemail (AHVM). The age at vaccination was not reported. 2 days after receiving SHINGRIX, the patient experienced fatigue. The patient reported that she contacted her pharmacist. Limited information was provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 29th March 2018, the patient received the 1st dose of SHINGRIX. On 30th March 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, feeling abnormal and headache. On an unknown date, the outcome of the general body pain, feeling abnormal and headache were recovered/resolved. It was unknown if the reporter considered the general body pain, feeling abnormal and headache to be related to SHINGRIX. Additional details were provided as follows: Next day after vaccination around noon (at 12:00 hours), the patient experienced body aches, a headache and feeling out of sorts. The symptoms were resolved after a day.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Fatigue, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 14th September 2018, the patient received the 1st dose of SHINGRIX. On 14th September 2018, 4 hrs after receiving SHINGRIX, the patient experienced tiredness and injection site pain. In September 2018, the patient experienced influenza-like symptoms, fever and bone pain. On 16th September 2018, the outcome of the tiredness, influenza-like symptoms, fever, injection site pain and bone pain were recovered/resolved. It was unknown if the reporter considered the tiredness, influenza-like symptoms, fever, injection site pain and bone pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm on Friday at around noon. On the same day, starting at around 4 PM, the patient experienced tiredness, pain at the injection site. Overnight (15th September 2018), she started to experience deep bone pain, fever and felt like she had the flu. The patient stated that by Sunday morning she was back to normal.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash, Product supply issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site bruising in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site bruising, injection site rash and product supply issue. On an unknown date, the outcome of the injection site bruising and injection site rash were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site bruising and injection site rash to be related to SHINGRIX. It was unknown if the reporter considered the product supply issue to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported the case for herself. The healthcare professional had concerned about being late for the second dose of the SHINGRIX series due to the product supply issue. The healthcare professional reported that she had developed a rash and bruising near the injection site 1 to 2 days after the first dose of the SHINGRIX series. The healthcare professional did not have supply vaccine information.
Age: 70.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 70-year-old female patient who received BOOSTRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 1st August 2018, the patient received BOOSTRIX and SHINGRIX. On 3rd August 2018, 2 days after receiving BOOSTRIX and SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the itchy rash to be related to BOOSTRIX and SHINGRIX. Additional details were provided as follows: A few days after having both the BOOSTRIX and SHINGRIX vaccinations, the patient developed a rash on her head which then spread to her back. It then spread to her buttocks and her legs, and it was very itchy. The patient went to her primary care doctor, a dermatologist and a neurologist and none could diagnose exactly what had caused the rash. The patient was treated it with medications including corticosteroids. The rash had improved and at the time of reporting it was mostly around the waist of her back but she noticed some on her leg on the day of reporting. The patient spoke to her pharmacist who said they had not seen anything of this nature due to the SHINGRIX or BOOSTRIX vaccination. The contact details of the physician was provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 72-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date unknown) for prophylaxis. On 18th September 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain and injection site erythema. On 18th September 2018, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site swelling, injection site pain and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that, the patient received SHINGRIX closer to the back of her left arm and not in her deltoid, which led to vaccine administered at inappropriate site. The health care professional was not sure if this was given subcutaneous but thought it might had, which led to inappropriate route of vaccination.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 78-year-old male patient who received SHINGRIX for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. On 17th August 2018, 92 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were recovering/resolving. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that her father (patient) was diagnosed with a shingles rash after vaccination. Lot number and expiration date were not available but HCP stated that vaccine administering pharmacy could be called at provided number.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Malaise, 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 adult male patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, tremor, shivers, influenza-like symptoms and sickness. On an unknown date, the outcome of the pain in arm, tremor, shivers, influenza-like symptoms and sickness were recovered/resolved. It was unknown if the reporter considered the pain in arm, tremor, shivers, influenza-like symptoms and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at approximately 9:30 AM in the right arm. The patient claimed that his arm killed him for the first week and he experienced pain at the injection site. The patient also reported shivers the first night and shakes which he described like getting the flu or being sick. The patient also reported that he had many friends with similar experiences (refer case US2018GSK176619). The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, tremor, shivers, influenza-like symptoms and sickness. On an unknown date, the outcome of the pain in arm, tremor, shivers, influenza-like symptoms and sickness were recovered/resolved. It was unknown if the reporter considered the pain in arm, tremor, shivers, influenza-like symptoms and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at approximately 9:30 AM in the right arm. The patient claimed that his arm killed him for the first week and he experienced pain at the injection site. The patient also reported shivers the first night and shakes which he described like getting the flu or being sick. The patient also reported that he had many friends with similar experiences (refer case US2018GSK176619). The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of adverse event in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. 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. No additional information was reported. Follow up attempt was made to call patient.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a male 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 day after receiving SHINGRIX, the patient experienced swelling arm and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm and injected limb mobility decreased were unknown. It was unknown if the reporter considered the swelling arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The age vaccination was not reported. The patient received SHINGRIX on an unknown deltoid. The caller stated that the physician reported to him that the patient experienced severe swelling in the arm in which he received the SHINGRIX vaccine. The patient's swelling started either the same day or the day after receiving the injection. The caller stated that the patient had limited use of his arm and had to go to physical therapy. The caller stated that the physician said that he could be reached for more details regarding the event.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 26th December 2017, the patient received SHINGRIX (subcutaneous). On 26th December 2017, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The GlaxoSmithKline (GSK) medical liaison reported adverse event that, he heard from one of his account pharmacists told him that another pharmacist administered the SHINGRIX vaccine to a patient. The pharmacist claimed that he administered the vaccine to a patient via intramuscularly. However, the patient complained about pain, redness and swelling at the injection site. Patient said that the pharmacist gave her the vaccine subcutaneously in the back of her arm instead of the deltoid muscle in the front. This led to possible intramuscular formulation administered by other route. The field representative did not have the pharmacy address of his reporting pharmacist but he had the address where the pharmacist works as an educator and name of pharmacist that administered the vaccine. These events were just brought to the attention of the pharmacist who reported it and the field employee. The reporter stated that, there was a lawsuit going on involving the pharmacist who administered the vaccine and the patient. The reporter did not have any additional information regarding the event or lawsuit.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 17th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week 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 provided as follows: After receiving SHINGRIX, the patient experienced local injection site pain which was still tender to the touch but not with movement or well sitting. The reporter agreed to receive follow up from GSK.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 10th September 2018, the patient received the 2nd dose of SHINGRIX. On 10th September 2018, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm, weakness, headache, stomach pain, influenza-like symptoms, chills and feeling unwell. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, weakness, headache, stomach pain, influenza-like symptoms, chills and feeling unwell were recovering/resolving. It was unknown if the reporter considered the pain in arm, weakness, headache, stomach pain, influenza-like symptoms, chills and feeling unwell to be related to SHINGRIX. Additional information was reported as follows: The patient experienced a sore arm, stomach hurting and general feeling of unwell. The events experienced by the patient were slightly improving at the time of reporting. The patient had denied permission to contact their physician. At the time of reporting the event experienced by the patient was slightly improving. This case was linked with US2018167128 (1st dose), reported by the same reporter for the same patient.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 10th September 2018, the patient received the 2nd dose of SHINGRIX. On 10th September 2018, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm, weakness, headache, stomach pain, influenza-like symptoms, chills and feeling unwell. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, weakness, headache, stomach pain, influenza-like symptoms, chills and feeling unwell were recovering/resolving. It was unknown if the reporter considered the pain in arm, weakness, headache, stomach pain, influenza-like symptoms, chills and feeling unwell to be related to SHINGRIX. Additional information was reported as follows: The patient experienced a sore arm, stomach hurting and general feeling of unwell. The events experienced by the patient were slightly improving at the time of reporting. The patient had denied permission to contact their physician. At the time of reporting the event experienced by the patient was slightly improving. This case was linked with US2018167128 (1st dose), reported by the same reporter for the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain 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, 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: This case was reported by pharmacist who himself was the patient. The age at vaccination was not reported. After vaccination only reaction the patient experienced was mild pain at the injection site. The reporter was agreed to be follow up from GlaxoSmithKline For tolerance to next dose, refer case US2018GSK174738.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Hyperaesthesia, Pruritus, Skin ulcer, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus aggravated in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pruritus (1st dose received on 13th April 2018, for tolerance see case US2018171057). Concurrent medical conditions included itchy skin and hypersensation skin (started in April after 1st dose vaccination). In June 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than 4 months after receiving SHINGRIX, the patient experienced pruritus aggravated, skin ulcer, hypersensation skin and condition aggravated. The patient was treated with Cortisone Topical Cream and Over The Counter Medication (Unknown). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pruritus aggravated was not recovered/not resolved and the outcome of the skin ulcer, hypersensation skin and condition aggravated were unknown. It was unknown if the reporter considered the pruritus aggravated, skin ulcer, hypersensation skin and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient experienced terrible itchy skin and sores in her ears, arms and on her neck. The itching was incessant and she had tried cortisone creams, OTC products and the only relief she could get was with scolding hot water which provided her temporary relief. The patient reported a sensitivity to her skin after the vaccination, which included her chest was still itching from April where the electrocardiogram monitor electrodes were placed. The back of her shoulders are itching as well. The itching is worse on the reporting date than it was in April. The contact details of the physician was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received in 2018, refer case US2018GSK171374). In August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced fever, chills, general body pain and myalgia. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the chills, general body pain and myalgia were unknown. It was unknown if the reporter considered the fever, chills, general body pain and myalgia to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the pharmacist who himself was the patient. The age at vaccination was not reported. Day after vaccination the patient experienced fever, chills, shivering, body aches and myalgia. The events lasted for 6 hours. The patient stated if he had experienced these symptoms after the first dose he might not had wanted to receive the second dose. The reporter was agreed to be follow up from GlaxoSmithKline.
Sex: F
Vaccine: HIBV, IPV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from nurse in the on 19-Sep-2018. This case involves about 15 female patients who were vaccinated with a 0.5 ml dose of ADACEL (Batch number: C5228AA, expiration date: 26-Jan-2019, route and site of administration was not reported) and MENACTRA on an unknown date which had a cold chain break including dose of a vaccine IPOL, ACT-HIB, (Batch number, expiration date, dose, route and site of administration was not reported). The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (Vaccines were moved to a break room refrigerator that was un-monitored). It was unknown whether patient experienced 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: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 months old male patient who was vaccinated with a 0.5 ml fourth dose of PENTACEL Lot #C5409AA (DTap-IPV), lot:C5550AA (carton); lot:C550AA (HIB) via intramuscular route in the left thigh on 19-Sep-2018. The patient's past medical history, medical treatment(s) and family history were not provided. The patient had no other vaccinations. It was a case of actual medication error due to inappropriate reconstitution technique. On 19-Sep-2018, the patient had a visit to the doctor. 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: F
Vaccine: RAB
Symptoms: Product container issue, Syringe issue
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an adult female patient who was subjected to receive a 0.5 ml dose of vaccine IMOVAX RABIES (Lot number: N1B051M (IMOVAX) and Lot M0308 (diluent); expiry date: 26-Feb-2019) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of syringe issue since some pressure built up in the syringe and the vial exploded. Glass was in her hand. The syringe blew off of the needle which occurred during preparation. It was reported that the patient couldn't able to get administered with the dose. List of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA266375 (Same Reporter). This case involves a 6 months old patient of an unknown gender who received a dose of PENTACEL which was mixed with wrong diluent. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunization; and PNEUMOCOCCAL VACCINE for Immunization. On 26-Jun-2018, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot C5422AA expiry date: 15-Sep-2019 via intramuscular route in the right thigh. It was case of actual medication error due to wrong solution used in drug reconstitution as PENTACEL was mixed with sterile water. No adverse event was experienced. 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: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 years old male patient who was vaccinated with 0.5 ml (once) dose of FLUBLOK QIV (Batch number: QFAA1819 and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on 21-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because the following vaccine should be used for 18 years age or older. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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 the sender: none.
Sex: M
Vaccine: MEN, MNQ
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 18 years old male patient who received 0.5 mL dose of vaccines MENACTRA lot U6142AA, expiry date: 17-FEB-2020 via intramuscular route in the left deltoid on 21-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Wrong vaccine administered. It was reported that a patient received MENACTRA instead of MenB vaccine. It was unknown whether patient experienced any adverse reaction after the vaccination. 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. Documents held by sender: none.
Sex: F
Vaccine: FLU4, HIBV, MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who received 0.5 mL dose of vaccines ACTHIB lot UI903AAA, expiry date: 14-Sep-2019 via subcutaneous route in the left arm on an unknown date. Concomitant vaccinations included FLUARIX via intramuscular route in the left thigh and MMR via subcutaneous route in the left arm not produced by Sanofi Pasteur (dose and expiry date not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to inappropriate route of vaccination (ACT HIB given SubQ instead of IM). It was unknown whether patient experienced any adverse event after vaccination. 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: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 10 patients (demographics unknown) who received vaccines FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medication not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was a case of actual medication error due to product storage error. Vaccine shipped greater than 2 days to deliver and reported that it was also administered to patients. It was unknown whether adverse event occurred 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 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.