chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Confusional state
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of confusion in a 85-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE HIGH-DOSE for prophylaxis. On 14th September 2018, the patient received the 1st dose of SHINGRIX and FLUZONE HIGH-DOSE. On 14th September 2018, less than a day after receiving SHINGRIX and FLUZONE HIGH-DOSE, the patient experienced confusion. On 15th September 2018, the outcome of the confusion was recovered/resolved. It was unknown if the reporter considered the confusion to be related to SHINGRIX. Additional details were received as follows: This case was reported by a Certified Medical Assistant (CMA). The patient was in clinic and received a dose of SHINGRIX and high dose flu vaccine during the same visit. Later that day, the patient's daughter reported that her mother showed signs of confusion and wanted to call her deceased husband. The reporter said that the patient was not confused the next day and was normal since. On 20th November 2018, the patient was in clinic for regular checkup and showed no signs of confusion and acted normal. The CMA was made aware of the initial patient response at her visit today. The patient and healthcare professional (HCP) wondered if the patient should get the second SHINGRIX dose. The reporter agreed to receive follow up from GlaxoSmithKline. It was unknown if the reporter considered the confusion to be related to FLUZONE HIGH-DOSE.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Neuralgia, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of nerve pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced nerve pain, fever, chills, headache and pain. On an unknown date, the outcome of the nerve pain, fever, chills, headache and pain were unknown. The reporter considered the nerve pain, fever, chills, headache and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter believes related to product. Initially had fever, chills day after 2nd dose the patient had pain, headache that had persisted for almost 2 weeks, pain spreads across top of head along a dermatome, got worse throughout the day and overnight. The reporter believes it to be nerve pain.
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Syncope
Clinical narrative: This case was reported by a nurse and described the occurrence of fainting 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 fainting (serious criteria GSK medically significant) and chest pain. On an unknown date, the outcome of the fainting and chest pain were unknown. It was unknown if the reporter considered the fainting and chest pain to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not applicable. Two weeks after the reporter had stress test, in a meeting, the reporting nurse and nurses were discussing SHINGRIX vaccine when a coworker reported to the group of nurses that she saw many patients come to the emergency room (she worked in emergency department), with symptoms of heart attack and fainting days after getting the SHINGRIX vaccine. The reporting nurse was asking, had GlaxoSmithKline (GSK) had any reports of chest pain or fainting symptoms after receiving SHINGRIX vaccine. This case was linked with case US2018GSK219276, reported by the same reporter (master case).
Sex: F
Vaccine: DTP
Symptoms: Adverse event, Death, Vaccination complication
Clinical narrative: This case was reported by a consumer via interactive digital media Facebook post and described the occurrence of adverse event in a female patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced adverse event (serious criteria death). On an unknown date, the outcome of the adverse event was fatal. The reported cause of death was adverse event. It was unknown if the reporter considered the adverse event to be related to DTP (A or W not known). Additional details were provided as follows: This case was received via social media post contents by the patient's mother.  The patient's family had no issues in the past with the shot and thought by getting it could protect the daughter from getting it from him but unfortunately that's the very thing that caused her granddaughter to have hospitalized. It was not fun but she was alive and happy with no brain damage. The age at vaccination was not reported. The reporter stated that the patient died from a reaction to the DPT vaccine. It was unknown if an autopsy was performed or not. This case was linked with case US2018GSK219962, reported by the same reporter.; Reported Cause(s) of Death: adverse event.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included tingling sensation (got prior to appearance of the fever blisters). Concurrent medical conditions included fever blister (breaking out on face, in mouth, on eyebrows almost weekly). Concomitant products included SHINGRIX. In September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional information received as follows: After receiving SHINGRIX, the fever blisters on the patient's face, inside her mouth, and on the eyebrows went away almost immediately. The patient reported that the tingle she used to got prior to the appearance of the fever blisters went away. The current physician was unknown. Lot numbers of SHINGRIX were unknown. The patient did not give consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On 20th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient experienced a sore arm due to which she could not sleep. No further details were provided by the pharmacist.
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly female patient who received HAVRIX (batch number 3C7ZG, expiry date 29th January 2022) for prophylaxis. On an unknown date, the patient received the 2nd dose of HAVRIX. On an unknown date, immediately after receiving HAVRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient experienced pain during administration of HAVRIX. Pain spreads down the hand and then subsided. The patient did not experience same symptoms during the 1st dose. The reporter gave consent to follow up. This case was 1 of the 3 linked cases, reported by same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Irritability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 27th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and nausea. On 28th September 2018, the patient experienced tiredness, headache, irritability and influenza like illness. On 3rd October 2018, the outcome of the injection site pain, tiredness, headache, nausea, irritability and influenza like illness were recovered/resolved. It was unknown if the reporter considered the injection site pain, tiredness, headache, nausea, irritability and influenza like illness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. On 28th September 2018, 1 day after receiving SHINGRIX, the patient experienced tiredness, headache, irritability and influenza like illness. The patient planned to continue follow up with his physician on an unknown date. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 27th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and nausea. On 28th September 2018, the patient experienced tiredness, headache, irritability and influenza like illness. On 3rd October 2018, the outcome of the injection site pain, tiredness, headache, nausea, irritability and influenza like illness were recovered/resolved. It was unknown if the reporter considered the injection site pain, tiredness, headache, nausea, irritability and influenza like illness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. On 28th September 2018, 1 day after receiving SHINGRIX, the patient experienced tiredness, headache, irritability and influenza like illness. The patient planned to continue follow up with his physician on an unknown date. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Note from office visit 12/06/18 MD: 4 yo here today with parents to follow up after local reaction 1 week ago he had his vaccination given (VZV, KINRIX) in the left thigh; next morning the area was red, painful, swollen and hot to touch w/o fever; mom took him to the walk in clinic next day as Sx were getting worse; he was started on BENADRYL and Amoxicillin PO but the local Sx cont' to worsen for which parent took him to to Hospital and family was told it was a local reaction then the next day Sx started to get better, now Sx resolved, no more swelling and redness just little dark at the area of redness. He can walk well no joint involvement no Hx of fever.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Heart rate increased, Nausea, Pain in extremity
Clinical narrative: Severe pain in right arm starting about 1.7 hours after injection and lasting for approximately 36 hours, although the very worst of the arm pain was about 12 hours. Symptoms progressed so that by 3:00 pm on day of vaccine I was also experiencing nausea, weakness, fast heartbeat and felt like I was going to faint. Called husband home from work in case I fainted. Called Nurse Care Line and they advised me to call 911. Did NOT do that as I felt symptoms were very significant but not life threatening as I could still breathe and didn't have hives. l started to take ibuprofen and that helped immensely. As soon as ibuprofen wore off the symptoms would reappear exactly as described above. Continued with ibuprofen for 48 hours and by then symptoms were almost completely gone.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt reports pain in left upper arm which started after she got the shot. Also has decreased ROM in the left shoulder. Pain has not gone away as of today 12/10/18. Have ordered physical therapy. Not a candidate for NSAIDS.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site induration, Pain, Pyrexia, Rash
Clinical narrative: Pt reports severe shaking, slight temp for 1st day hard area under injection site, bruising, slight rash, feeling achy x 2-3 days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Pt reports severe shaking, slight temp for 1st day hard area under injection site, bruising, slight rash, feeling achy x 2-3 days.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site inflammation, Injection site warmth, Nausea
Clinical narrative: REDNESS, INFLAMMATION, HOT TO TOUCH OF LEFT DELTOID. FEVER, NAUSEA AND DIARRHEA. RESULTED TO TRIP TO URGENT CARE. RX GIVEN TO PATIENT FOR ANTIBIOTIC, MUSCLE RELAXER AND STEROID DOSE PACK.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: REDNESS, INFLAMMATION, HOT TO TOUCH OF LEFT DELTOID. FEVER, NAUSEA AND DIARRHEA. RESULTED TO TRIP TO URGENT CARE. RX GIVEN TO PATIENT FOR ANTIBIOTIC, MUSCLE RELAXER AND STEROID DOSE PACK.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Dizziness, Headache, Nuclear magnetic resonance imaging brain, Presyncope
Clinical narrative: Near syncope, severe dizziness, headache reported.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Vaccine was administered unusually high into the shoulder. Intense left shoulder pain started within hours of vaccine administration and continues as of 12/10/18. Pain has been improving with heat, ice, light stretching, and ibuprofen.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-DEC-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 14-JAN-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-MAY-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 04-AUG-2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site pain, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received SHINGRIX for prophylaxis. On 29th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced headache, injection site pain, loss of energy and sleepiness. On an unknown date, the outcome of the headache, injection site pain, loss of energy and sleepiness were unknown. It was unknown if the reporter considered the headache, injection site pain, loss of energy and sleepiness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX a day before the date of reporting and experienced severe headache, sore at location site. The patient had slept all day and had no energy.
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 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 provided as follows: The age at vaccination was not reported. For tolerance to the 2nd dose of SHINGRIX refer case US2018GSK220435, reported for the same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 61-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the adverse reaction and product supply issue were unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose. After receiving 1st dose of SHINGRIX, the patient experienced very bad reaction. The patient called his provider and said that he thought that he had an allergic reaction but the provider said that it was not an allergic reaction but just a bad reaction. On the day of reporting, the patient went to his physician office to get the second dose but they did not have it and said it was on back order since several months. The patient asked where would he get the vaccine. The call center representative replied that individual medical guidance for patients like yourself should be provided by medical professionals and was not something GlaxoSmithKline provides to the patients. As you may know the FDA approved dosing schedule for SHINGRIX was the first dose at month 0, followed by a second dose 2 to 6 month after the first dose. The Centers for Disease Control and Prevention (CDC) has provided guidance that if it has been more than 6 months since you got the first dose, you should get the second dose a soon as possible; you do not need to restart the vaccine series. Advised to the patient that he should talk to his physician or pharmacist about this guidance and the patient's individual situation.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles 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 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 received the new shingles vaccine approximately two months ago before the date of reporting. The patient was about to receive the 2nd those when he contracted shingles. The patient was apparently had a mild case with no serious outbreak or pain. The patient wanted to know could he receive the 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (experienced after 1st dose, refer case US2018GSK219175). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, fever, shivering, headache and upset stomach. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, fever, shivering, headache and upset stomach were unknown. It was unknown if the reporter considered the injection site pain, fever, shivering, headache and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced all the known side effects, fever, shivering, headache, upset stomach and pain at the injection site. The patient asked if there are any foods that should be avoided when receiving the SHINGRIX vaccine as the side effects intensified after receiving 2nd dose as compared to the 1st dose.
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 pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (experienced after 1st dose, refer case US2018GSK219175). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, fever, shivering, headache and upset stomach. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, fever, shivering, headache and upset stomach were unknown. It was unknown if the reporter considered the injection site pain, fever, shivering, headache and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced all the known side effects, fever, shivering, headache, upset stomach and pain at the injection site. The patient asked if there are any foods that should be avoided when receiving the SHINGRIX vaccine as the side effects intensified after receiving 2nd dose as compared to the 1st dose.
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Hypersensitivity, Rash pustular, Swelling of eyelid
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced eye swelling (serious criteria hospitalization), pustule (serious criteria hospitalization) and allergic reaction (serious criteria hospitalization). On an unknown date, the outcome of the eye swelling and allergic reaction were unknown and the outcome of the pustule was recovering/resolving. It was unknown if the reporter considered the eye swelling, pustule and allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The reporter was patient's daughter. The age at vaccination was not reported. The patient received 2nd booster of SHINGRIX just a few weeks ago before the date of reporting. On 30th November 2018, the patient was hospitalized for pussy lesions on one side of his face and his eyes swelling shut. On 4th December 2018, the patient was released from hospital. The lesions has cleared up but not fully resolved.
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 16-year-old male patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. Co-suspect products included Meningitis ACWY vaccine (potential MENVEO)for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose and Meningitis ACWY vaccine (potential MENVEO) at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season and Meningitis ACWY vaccine (potential MENVEO), the patient experienced fatigue, headache and joint pain. On an unknown date, the outcome of the fatigue, headache and joint pain were unknown. It was unknown if the reporter considered the fatigue, headache and joint pain to be related to Influenza vaccine Quadrivalent 2018-2019 season and Meningitis ACWY vaccine (potential MENVEO). Additional details were reported as follows: This case was reported by the patient's mother. The age at vaccination was not reported but, it could be 15 or 16 years. The patient received unknown manufacturer's meningitis vaccine and a flu shot at the same time. The reporter did not remember any of the manufacturer name. No other details or timelines were known. The reporter was distraught because the representative could not provide medical advice on how to treat the symptoms.
Sex: F
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received HAVRIX (batch number 3C7ZG, expiry date 29th January 2021) for prophylaxis. On an unknown date, the patient received the 2nd dose of HAVRIX. On an unknown date, immediately after receiving HAVRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient experienced pain during administration of HAVRIX. Pain spreads down the hand and then subsided. The patient did not experience same symptoms during the 1st dose. The reporter gave consent to follow up. This case was 1 of the 3 linked cases, reported by same reporter.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received HAVRIX (batch number 3C7ZG, expiry date 29th January 2021) for prophylaxis. On 30th November 2018, the patient received the 2nd dose of HAVRIX. On 30th November 2018, immediately after receiving HAVRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient experienced pain during administration of HAVRIX. Pain spreads down the hand and then subsided. The patient did not experience same symptoms during the 1st dose. The reporter gave consent to follow up. This case was 1 of the 3 linked cases, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a elderly female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) 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 itchy rash. On an unknown date, the outcome of the itchy rash was recovered/resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a rash and itching on her stomach which lasted 2 days. The healthcare professional (HCP) not comfortable providing patient initials.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Exposure during pregnancy, Nausea, Vomiting
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case is linked to case 2018SA328295 (same reporter). This case involves a 28 years old female patient who experienced dizziness, felt nausea, vomiting and exposure during pregnancy, while she received vaccine ADACEL. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported dizziness, felt nausea, vomiting and exposure during pregnancy occurred at unknown gestation period and the patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at -8 weeks of pregnancy, during third pregnancy trimester for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The date of last menstrual period was reported as 24-Apr-2018. The estimated due date is 29-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 13-Feb-2017, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in the left deltoid. On 26-Nov-2018 she also received a dose  of the same vaccine (lot number: U5979AA) via intramuscular route in the left deltoid. On an unspecified date, the patient developed a non-serious dizziness following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unspecified date, the patient developed a non-serious felt nausea following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unspecified date, the patient developed a non-serious vomiting following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was a case of exposure during pregnancy. Relevant prenatal testing after exposure not reported. Other relevant tests included No Lab data was reported. Final diagnosis was exposure during pregnancy, vomiting, felt nausea and dizziness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for felt nausea, as Unknown for vomiting, as Unknown for dizziness and as Not Applicable for exposure during pregnancy. Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as Unknown and fetal outcome was reported as Unknown. Documents held by the sender: none.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Underdose
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a health professional. This case involves a four years old patient (gender not reported) who supposed to vaccinated with a 0.5 ml dose of QUADRACEL lot number-C5497AA Exp. Date- 17-Jul-2020 via intramuscular route in unknown administration site on 27-Nov-2018. It was reported that, we were giving a patient QUADRACEL and a fifth of the dose didn't go in. The patient's medical history were not reported. Concomitant medication included MMR. It was an actual medication error due to vaccine underdose. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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. Follow up information received from healthcare professional on 30-Nov-2018. Vaccine details including batch number, site, expiration date, concomitant added, outcome updated. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (unknown age) who was vaccinated with ACT-HIB which was reconstituted with sterile water vs. the supplied 0.4% NaCl diluent on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was unknown whether 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 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. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Expired product administered
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two-months old female patient who was vaccinated with a 0.5 ml first dose of ACT-HIB lot UI820AAA; expiry date: 18-Nov-2018 in the left thigh on 29-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included DAPTACEL for Immunisation; HEPATITIS B VACCINE for Immunisation; and PREVNAR for Immunisation. It was a case of actual medication error due to expired vaccine used. It was unknown whether the patient experienced any adverse reactions 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 Practices. The classification as a medical error is in no way intended, nor should it be 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: FLUX, TDAP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 53 years old male patient who experienced numbing pain in the right arm, specifically small fingers and ring fingers, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Flu Vaccine for Immunization in the left arm. On an unknown date, the patient received a dose of suspect ADACEL lot number not reported via unknown route in the right arm. On 08-Oct-2018, the patient developed a non-serious numbing pain in the right arm, specifically small fingers and ring fingers (Pain in extremity) following the administration of ADACEL. No lab data was reported. Final diagnosis was numbing pain in the right arm, specifically small fingers and ring fingers. It was not reported if the patient received a corrective treatment. The event outcome was Unknown for numbing pain in the right arm, specifically small fingers and ring fingers. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV, FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 4 years old patient who received vaccine FLUZONE QUADRIVALENT injection lot no 3E5SX, expiry date: 30-Jun-2019 via intramuscular route on 15-Nov-2018. The patient received FLUZONE QUADRIVALENT also on 11-DEC-2015, 21-OCT-2016 and 13-OCT-2017. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included QUADRACEL for Immunisation. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was reported that the patient who is currently 4 years old has never received the second FLUZONE QUADRIVALENT injection. No AE was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2.5 months old female patient who received 0.25 mL dose of vaccine PENTACEL lot 05401AA via intramuscular route in the right thigh on 29-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Expired vaccine used and vaccine underdose. It was reported that the patient received 0.25 ml of an expired dose of PENTACEL yesterday. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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 sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Expired product administered
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a two-months old female patient who received an expired dose of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR, ROTATEQ and HEPATITIS B VACCINE for Immunisation. It was actual medication error due to expired vaccine used. It was not reported that the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA331476, 2018SA331477 and 2018SA331478 (same reporter). This case involves 38 year- years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (formulation Suspension for injection in pre-filled syringe) (lot number, was reported as unknown, dose, dose in series, route and site of administration was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was not reported if the patient experienced any adverse events 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 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.
Age: 14.0
Sex: M
Vaccine: FLUR4, HPV4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 years old male patient who received FLUBLOK QIV instead of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL for Immunisation in the right deltoid. On 30-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1824, expiry date: 30-Jun-2019, dose in series not reported) via unknown route in the left deltoid. This was a case of actual medication error due to wrong vaccine administered because FLUBLOK QUADRIVALENT was given instead of FLUZONE QUADRIVALENT and inappropriate age at vaccine administration because 14 years old patient was given FLUBLOK QUADRIVALENT. It was not reported if any 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 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: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA331166, 2018SA331477 and 2018SA331478. This case involves a five-years old patient of an unknown gender who had received vaccine FLUZONE HIGH DOSE (lot number, expiry date, dose, dose in series, route, site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. This was a case of actual medication error due to Inappropriate age at vaccine administration and overdose. It was not reported 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 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: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA331476, 2018SA331166 and 2018SA331478. This case involves a seven years old patient (age not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (formulation Suspension for injection in pre-filled syringe) lot number, Exp. Date, route and administration site not reported. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration and overdose. It was unknown whether the 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 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.