chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Myalgia
Clinical narrative: Fever up to 102, myalgia, headache, fatigue, nausea, diarrhea, vomiting. These systemic symptoms lasted 2-3 days. Red spot on arm where vaccine was given - still present today on Day 4 after vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever up to 102, myalgia, headache, fatigue, nausea, diarrhea, vomiting. These systemic symptoms lasted 2-3 days. Red spot on arm where vaccine was given - still present today on Day 4 after vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Erythema, Headache, Local reaction, Myalgia
Clinical narrative: Fever up to 102, myalgia, headache, fatigue, nausea, diarrhea, vomiting. These systemic symptoms lasted 2-3 days. Red spot on arm where vaccine was given - still present today on Day 4 after vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Fever up to 102, myalgia, headache, fatigue, nausea, diarrhea, vomiting. These systemic symptoms lasted 2-3 days. Red spot on arm where vaccine was given - still present today on Day 4 after vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PT reported contracting the Shingles virus a couple of days after receiving the vaccine.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Loss of personal independence in daily activities, Malaise, Mobility decreased
Clinical narrative: Patient's arm was swollen, red and warm to touch from the top of the deltoid muscle to the elbow. Pt was unable to lift her arm. Patient reported having difficulty with dressing herself the day after getting the vaccine and that lasted for about 7 days. Patient stated she had a fever and body chills and feeling unwell.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient's arm was swollen, red and warm to touch from the top of the deltoid muscle to the elbow. Pt was unable to lift her arm. Patient reported having difficulty with dressing herself the day after getting the vaccine and that lasted for about 7 days. Patient stated she had a fever and body chills and feeling unwell.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Encephalitis, Screaming
Clinical narrative: High pitched screaming greater than 4 hours. Indicative of Encephalitis.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS GIVEN A STATE VACCINE WHICH IS MEANT FOR CHILDREN 18 YRS OLD AND UNDER.  PATIENT HAS NO SYMPTOMS OR REACTIONS TO THE VACCINATION. PATIENT HAS BEEN NOTIFIED OF THE ERROR. PATIENT DOES NOT NEED TO BE RE-VACCINATED.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Cheilitis, Headache, Lip swelling, Ocular hyperaemia
Clinical narrative: Lips swelling and rash around the lips, Eye redness and  Headache.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Musculoskeletal disorder, Pain, Pain in extremity, X-ray
Clinical narrative: Left arm hurt as soon it was received. The next day it got worse. Limited use of arm, constant and shooting pain. Pain never resided and had to make a doctors appointment.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: I have had a continuous headache every single day since March 2014.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Asthenia, Axillary pain, Back pain, Chills
Clinical narrative: I did not start to feel negative effects until a few hours after the shot. That afternoon and evening is when the arm pain began along with the redness. Hot and hard lump formed on arm where shot was given. For the next 4 days, I was incapacitated with weakness and fatigue. Severe body aches and pains in every muscle and joint of my body. Arm where shot was given was immobile with shooting pains all the way into the shoulder and arm pit and down to the fingers. My lower back was particularly painful. Severe headaches and sensitivity to light. No appetite. Severe nausea. Back and forth from chills with rigors to being hot and feverish. I did not check my temperature during this time. I would suspect I had a fever though, but I was taking NSAIDs around the clock so that may have prevented a high fever. The medication helped mildly but did not take away the symptoms. It is now 3/5/2019, five days after my shot was administered. I am still weak and fatigued. I have headaches and constant arm pain. The severity of the arm redness, hardness, hotness and pain have reduced considerably but still makes it difficult to use the arm. It gets very tired quickly and hurts more with engagement of the biceps and triceps. I still cannot sleep on that side.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Decreased appetite, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: I did not start to feel negative effects until a few hours after the shot. That afternoon and evening is when the arm pain began along with the redness. Hot and hard lump formed on arm where shot was given. For the next 4 days, I was incapacitated with weakness and fatigue. Severe body aches and pains in every muscle and joint of my body. Arm where shot was given was immobile with shooting pains all the way into the shoulder and arm pit and down to the fingers. My lower back was particularly painful. Severe headaches and sensitivity to light. No appetite. Severe nausea. Back and forth from chills with rigors to being hot and feverish. I did not check my temperature during this time. I would suspect I had a fever though, but I was taking NSAIDs around the clock so that may have prevented a high fever. The medication helped mildly but did not take away the symptoms. It is now 3/5/2019, five days after my shot was administered. I am still weak and fatigued. I have headaches and constant arm pain. The severity of the arm redness, hardness, hotness and pain have reduced considerably but still makes it difficult to use the arm. It gets very tired quickly and hurts more with engagement of the biceps and triceps. I still cannot sleep on that side.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: I did not start to feel negative effects until a few hours after the shot. That afternoon and evening is when the arm pain began along with the redness. Hot and hard lump formed on arm where shot was given. For the next 4 days, I was incapacitated with weakness and fatigue. Severe body aches and pains in every muscle and joint of my body. Arm where shot was given was immobile with shooting pains all the way into the shoulder and arm pit and down to the fingers. My lower back was particularly painful. Severe headaches and sensitivity to light. No appetite. Severe nausea. Back and forth from chills with rigors to being hot and feverish. I did not check my temperature during this time. I would suspect I had a fever though, but I was taking NSAIDs around the clock so that may have prevented a high fever. The medication helped mildly but did not take away the symptoms. It is now 3/5/2019, five days after my shot was administered. I am still weak and fatigued. I have headaches and constant arm pain. The severity of the arm redness, hardness, hotness and pain have reduced considerably but still makes it difficult to use the arm. It gets very tired quickly and hurts more with engagement of the biceps and triceps. I still cannot sleep on that side.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Photophobia
Clinical narrative: I did not start to feel negative effects until a few hours after the shot. That afternoon and evening is when the arm pain began along with the redness. Hot and hard lump formed on arm where shot was given. For the next 4 days, I was incapacitated with weakness and fatigue. Severe body aches and pains in every muscle and joint of my body. Arm where shot was given was immobile with shooting pains all the way into the shoulder and arm pit and down to the fingers. My lower back was particularly painful. Severe headaches and sensitivity to light. No appetite. Severe nausea. Back and forth from chills with rigors to being hot and feverish. I did not check my temperature during this time. I would suspect I had a fever though, but I was taking NSAIDs around the clock so that may have prevented a high fever. The medication helped mildly but did not take away the symptoms. It is now 3/5/2019, five days after my shot was administered. I am still weak and fatigued. I have headaches and constant arm pain. The severity of the arm redness, hardness, hotness and pain have reduced considerably but still makes it difficult to use the arm. It gets very tired quickly and hurts more with engagement of the biceps and triceps. I still cannot sleep on that side.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: I did not start to feel negative effects until a few hours after the shot. That afternoon and evening is when the arm pain began along with the redness. Hot and hard lump formed on arm where shot was given. For the next 4 days, I was incapacitated with weakness and fatigue. Severe body aches and pains in every muscle and joint of my body. Arm where shot was given was immobile with shooting pains all the way into the shoulder and arm pit and down to the fingers. My lower back was particularly painful. Severe headaches and sensitivity to light. No appetite. Severe nausea. Back and forth from chills with rigors to being hot and feverish. I did not check my temperature during this time. I would suspect I had a fever though, but I was taking NSAIDs around the clock so that may have prevented a high fever. The medication helped mildly but did not take away the symptoms. It is now 3/5/2019, five days after my shot was administered. I am still weak and fatigued. I have headaches and constant arm pain. The severity of the arm redness, hardness, hotness and pain have reduced considerably but still makes it difficult to use the arm. It gets very tired quickly and hurts more with engagement of the biceps and triceps. I still cannot sleep on that side.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Loss of consciousness
Clinical narrative: Intense pain at injection site and surrounding area, chills at bedtime, shivering, passed out in kitchen as a result. Recovered and no chills as of 2-22-19.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Varicella
Clinical narrative: The patient received SHINGRIX on 2/23/19, came back 2/27/19 with rash. Instructed to see medical doctor. The patient went to emergency department. Emergency room Dr. diagnosed rash as chicken pox 2/28/19.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash papular, Varicella
Clinical narrative: The patient received SHINGRIX on 2/23/19, came back 2/27/19 with rash. Instructed to see medical doctor. The patient went to emergency department. Emergency room Dr. diagnosed rash as chicken pox 2/28/19.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 20-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided. On 27-JAN-2012, the 13-year-old patient was vaccinated with the first dose of GARDASIL or GARDASIL 9 injection (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On 31-JAN-2019, the patient was vaccinated with the second dose of GARDASIL 9 injection, lot number M030380, expiration date 01-FEB-2019 (dose and route of administration were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 69 year old patient of unknown gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 28-JAN-2019, the patient was vaccinated with a pediatric dose of VAQTA lot # R010369, expiration date: 25-MAR-2019 (dose, frequency, route of administration and anatomical location were not provided) as prophylaxis. No adverse effects were reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a 70 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The female patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In NOVEMBER 2016, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). In MARCH 2017, the patient was treated by a healthcare provider at a hospital for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAR-2019, the patient was vaccinated with the first dose of improperly stored VARIVAX injection, subcutaneously, lot # R026715, expiration date: 18-SEP-2020 (exact dose was not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion of minus 10.5 degrees Celsius for 1 hour and 11 minutes. There was no previous temperature excursion. The digital data logger was involved in recording excursion details. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA001668: Original Case: 1903USA001655.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAR-2019, the patient was vaccinated with the first dose of improperly stored VARIVAX injection, subcutaneously, lot # R026715, expiration date:18-SEP-2020 (exact dose was not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion of minus 10.5 degrees Celsius for 1 hour and 11 minutes. There was no previous temperature excursion. The digital data logger was involved in recording excursion details. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1903USA001655: Original Case : 1903USA001655.
Age: 57.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Paraesthesia, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in a 57-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number FH9NA, expiry date unknown) for prophylaxis. Co-suspect products included BOOSTRIX (batch number K5F5R, expiry date unknown) for prophylaxis. Concurrent medical conditions included meat allergy (Allergy to pork). On 18th February 2019, the patient received FLUARIX QUADRIVALENT 2018-2019 season and BOOSTRIX. On 18th February 2019, less than a day after receiving FLUARIX QUADRIVALENT 2018-2019 season and BOOSTRIX, the patient experienced rash and tingling. On 18th February 2019, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the tingling was unknown. It was unknown if the reporter considered the rash and tingling to be related to FLUARIX QUADRIVALENT 2018-2019 season and BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received one vaccine in the right deltoid and the other in the left deltoid. Withinn about 15 min , patient stated feeling a tingly feeling all over. The reporter stated she saw nothing visual (no hives etc.), however. Provider assessed the patient, there was a slight rash, no hives, and provider considered her fine, no other side effects. The patient rubbed area and rash went away quickly. Then the patient was released. No follow-up issues at the time of reporting. The reporter agreed to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever 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, unknown after receiving SHINGRIX, the patient experienced fever, fatigue and weakness generalized. On an unknown date, the outcome of the fever, fatigue and weakness generalized were unknown. It was unknown if the reporter considered the fever, fatigue and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not agree to follow up from GlaxoSmithKline (GSK).
Sex: U
Vaccine: HEP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a child patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Vitamin K for an unknown indication. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and Vitamin K at an unknown dose and frequency. On an unknown date, 2 hrs after receiving Hepatitis B vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. In the study done for 673 infants with half PEDIARIX (combo vaccine) and half infants were given the hep B, INFANRIX and IPV separately as in not a combo vaccine. The reporter believed that, a patients who had an adverse reaction 2 hours after the Hepatitis B and Vitamin K vaccine. The reporter pediatrician carried multiple manufacturers for vaccines and from the research the reporter had read on the inserts provided from GSK. It was recommended to not mix manufacturers because there was not testing, for example GSK and MERCK. The reporter wanted to make sure understand this properly so the reporter could make the best decision for his child. The reporter wanted to know, were they ever re-tested for new reactions since the number of administered vaccines had been increased over the past 15 years and when were clinical trials performed. Also because many pediatrician gave multiple doses in one visit but were there safety studies done for multiple vaccines given, for example DTap, rotavirus, Hepatitis B, IPV at the same time. It was unknown if the reporter considered the adverse reaction to be related to Vitamin K.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 20th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd shingles shot and the site was red and hot to touch like a sunburn. The reporter wanted to know how long it will last.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: The patient was due for the 2nd dose of SHINGRIX and wondered if the 2nd dose of SHINGRIX could be administered. This case was reported by a other health professional via sales rep and described the occurrence of tinnitus in a 51-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced tinnitus and partial hearing loss. On an unknown date, the outcome of the tinnitus and partial hearing loss were unknown. It was unknown if the reporter considered the tinnitus and partial hearing loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was 51 year old at the time of reporting. The patient experienced tapping in ear several days after receiving SHINGRIX. Followed up to check the symptom with ent doctor, it was indicated that the patient had some partial hearing loss in ear. The reporter was not sure tapping in ear or hearing loss has any correlation to administration of SHINGRIX. The patient was due for the 2nd dose of SHINGRIX and wondered if the 2nd dose of SHINGRIX could be administered.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Suspected vaccination failure in a 58-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (since the age of 30 experienced shingles at the base of spine and or just about the buttocks). On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 57 or 58 years. The patient took 2 rounds of the SHINGRIX vaccine and it helped a lot at the first but at the time of reporting it was not as much about half a year later. Initially the patient thought he was cured but of recent they seem to return almost as much as before receiving the vaccine, but with a shortened time to heal. The shingles popped out after long drives or lots of bending while working. The patient asked whether there was any need for a 3rd round of SHINGRIX that might boost the first two doses or would it be a waste of time and money and or cause a possible reaction. This case was considered as suspected vaccination failure as laboratory confirmation for shingles was not provided at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hair loss in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included stem cell transplant (underwent 14 years before the date of reporting, for multiple myeloma) and multiple myeloma. In January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown. It was unknown if the reporter considered the hair loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX 5 weeks before the date of reporting and experienced hair loss within 1 week. The patient asked if hair loss was a side effect of the vaccine and if the hair loss was permanent. The patient wanted to know before she would receive 2nd dose of SHINGRIX, which was due on 13th March 2019. The patient's oncologist advised her to receive SHINGRIX.
Age: 10.0
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Influenza virus test positive, Vaccination failure
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On 14th February 2019, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. The patient was treated with ibuprofen and TAMIFLU. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was reported as follows: On an unspecified date, within this past flu season, the patient received a dose of unspecified influenza vaccine. On 14th February 2019, the patient was tested positive for flu. No additional information was provided. This case was considered, as suspected vaccination failure as details regarding time to onset of event was unknown.
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received ENGERIX B for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (received on an unknown date, refer case US2019GSK037462). On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, unknown after receiving ENGERIX B, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to ENGERIX B. Additional details were reported as follows: The age at vaccination was not reported. The nurse reported the patient received a past ENGERIX B vaccine, details unknown, and experienced a high fever for over one year. She stated there was a September 2011 date in the patient's profile related to the ENGERIX B, but she did not know if that was the date the patient received the vaccine, or if that was the date the patient reported the reaction. The nurse stated, at the time of initial report, she was unable to find other details related to patient's ENGERIX B vaccine details, including where she received vaccine, injection site location, lot number, expiration date, and doctor details.
Age: 61.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Chills, Cold sweat, Fatigue, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 61-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included FLUCELVAX. On 13th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th October 2018, immediately after receiving SHINGRIX, the patient experienced tiredness, cold sweat, nausea, fever and shivering. On 14th October 2018, the outcome of the tiredness, cold sweat, nausea, fever and shivering were recovered/resolved. It was unknown if the reporter considered the tiredness, cold sweat, nausea, fever and shivering to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's spouse. The patient received SHINGRIX on the right deltoid. Right after receiving SHINGRIX, the patient felt tired, cold sweat, nausea, fever and was shivering. The symptoms were lasted 24 hours. On the same day of SHINGRIX vaccination, the patient also received FLUCELVAX on the left deltoid.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (over 50 times prior to getting the Shingles vaccine after the 1st dose) and foot surgery. On 1st October 2018, the patient received the 1st dose of SHINGRIX. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. In October 2018, 21 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On 24th February 2019, the patient experienced headache. On 25th February 2019, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and vesicle. On an unknown date, the outcome of the vaccination failure, shingles, headache, shingles and vesicle were unknown. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, headache, shingles and vesicle to be related to SHINGRIX. Additional details were reported as follows: The reporter did not have batch number or expiry date for the suspect vaccine doses. The patient stated she had broke out in a shingles rash about 3 weeks later receiving 1st of SHINGRIX vaccine. The patient stated the rash occurred on her sacral area on the right side. The patient stated it always shows up in the same spot. The patient also mentioned that she had to have foot surgery after the 1st dose but did not gave any further information. The patient stated twice she did have the shingles rash on the sacral area on the left side. The patient stated yesterday on 24th February 2019 she developed a headache and today on 25th February 2019 a new vesicle appeared on the sacral area on the right side again. The reporter consented to follow up. This case was considered as suspected vaccination failure laboratory confirmation for shingles was not provided at the time of reporting.
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Based on additional information received and internal review on 28-Feb-2019, it was found that the report (previously processed as non-valid) is considered as valid as the patient identifier was available in initial report and observed in follow-up. Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15-months old female patient who was vaccinated with dose of PENTACEL batch number Lyophilized powder (Lot: C5594AA, expiry date: 27-Oct-2019), Liquid vial (Lot: C5444AA, expiry date: 27-Oct-2019) Package: Lot: C5594AA), expiry date: 27-Oct-2019) via unknown route in left leg on an unknown date. The concomitant vaccine included PREVNAR 13. It was an actual medication error due to inappropriate reconstitution technique. PENTACEL was not mixed with the correct diluent. Medical assistant took the Lyophilized powder vial from out of the PENTACEL box and gave a separate Diluent but the liquid portion was not given. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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. Follow-up report received from a nurse on 27-Feb-2019. No new information was updated. Follow-up report received from a nurse on 28-Feb-2019. The patient details and concomitant vaccine was added. Case became valid. Narrative updated accordingly. List of documents held by sender: none.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff). This case involves a 16 months old female patient who received a single dose of vaccine PENTACEL (lot C5324AC (expiry date: 05-Sep-2019) via intramuscular route in unknown administration site) without ACTHIB component on 12-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was stated that the dry lyophilized component of in the Hib vaccine vial in the PENTACEL packaging should only be reconstituted with the liquid DTaP-IPV component of PENTACEL. If any other liquid was used (except for 0.4% NaCl saline solution) the dose of such Hib vaccine administered would not be considered valid. It was not reported whether adverse reaction 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: done.
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 years old female patient who received a 0.5 mL dose of suspect vaccine FLUBLOK QIV lot QFAA1818, expiry date- 30-Jun-2019 via unknown route in the left deltoid on 20-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications. It was a case of actual medication error due to Inappropriate age at vaccine administration. No side effects or reaction 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.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 40 years old male patient who was vaccinated with 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UJ052AB and expiry date: 09-Jun-2019) (dose in series and route was not reported) in the right deltoid instead of age appropriate annual influenza vaccine (Flu Vaccine) on 27-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to inappropriate age at vaccine administration, overdose and wrong vaccine administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLUX, HEP, HIBV, PNC13, RVX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a six-months-old female patient who received a 0.5ml dose of vaccines ACT-HIB (batch number: C5447AA, expiry date: 21-Nov-2019 via unknown route in unknown administration site) and PENTACEL batch number, expiry date, route and administration site was not reported on 28-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccinations included was ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), INFLUENZA VACCINE (INFLUENZA VACCINE), PREVNAR 13 and HEPATITIS B VACCINE (HEPATITIS B VACCINE). It was an actual medication error due to extra dose administered. A patient was administered ACTHIB and PENTACEL today, ACTHIB was not ordered but given inadvertently. No symptoms reported following 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. List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 16 years old female patient who received first and second dose of vaccine IMOVAX RABIES lot number not reported via unknown route in unknown administration site on an unknown date and missed third dose of IMOVAX RABIES. The patient's past medical history included patient was bitten in another country and did not come to the clinic till a month after the bite. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was reported that the office staff had ordered IMOVAX online to be overnighted to be at the office by noon today but they did not receive it. It was sent by regular mail. The patient was coming in at 4 PM to get her 3rd shot today. Caller said it is Pasteur's fault that they did not ship it overnight even though she paid for it. She was given the first 2 shots in the ER as their office did not have it in stock. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.75
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Rash generalised, Wrong product administered
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional by phone. This case involves a 9 months old female patient (reported as 9 months and 30 days) who experienced all over body rash while she received a dose of ADACEL instead of PREVENAR 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 04-Feb-2019, the patient received a 0.5 single dose of ADACEL (batch number: C5566AA and expiry date: 13-Feb-2021) via intramuscular route in the left thigh. The ADACEL was in a pre-filled syringe. On an unspecified date, the patient developed a non-serious all over body rash (rash generalised), following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was also a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that patient was not supposed to receive ADACEL at that time. The patient was supposed to have received PREVNAR 13. No lab data was reported. Final diagnosis was all over body rash. It was not reported if the patient received a corrective treatment. The outcome of event all over body rash was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Wrong product administered
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 55-years-old female patient who reported that the pain in her left arm from the injection is so severe that when she lifts that arm it takes her breath away, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient described herself as healthy and a person who exercises with lifting weights daily. No other vaccine was given on that day. On 18-Jan-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number C5585BA (Expiry date 06-Mar-2021) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious pain in her left arm (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This is also a case of actual medication error due to wrong vaccine administered. It was reported that the patient did not want a Tdap vaccine and had visited the office for a Td vaccine. The office did not have any Td on hand and insisted on giving her Tdap. The consumer worried that she received the correct vaccine. Event details: Caller stated she was not able to use her arm for 2 months after receiving TDAP. The caller stated her arm still hurts when she is trying to use it. There was no visible bruise, but the pain has been so bad that she was very close to visiting the ER. (Other relevant tests included no lab data). Final diagnosis was severe pain in her left arm. It was not reported if the patient received a corrective treatment. The outcome of the event was considered not recovered at the time of report. 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: U
Vaccine: DTAPIPV, FLUX
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information and additional information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 18-months-old patient (gender unknown) who received a dose of QUADRACEL batch number, dose and expiry date not reported via intramuscular route in the left thigh on 01-Feb-2019. The patient's past vaccination(s) included was PEDIARIX on 08-JAN-2018. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant vaccination included a dose of INFLUENZA VACCINE (QUADRIVALENT) (batch number, dose and expiry date not reported via unknown route in unknown administration site) on 01-Feb-2019. It was an actual medication error due to inappropriate age at vaccine administration. A 18 months old patient was inadvertently administered QUADRACEL by a physician PA. It was unknown whether patient experienced any adverse event following 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. List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient of unknown demographics who was vaccinated with an expired dose of IPOL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 28-Feb-2019, the patient received a dose of suspect IPV (VERO) (lot number: N1A45 and expiry date: 05-Feb-2019) (dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to expired vaccine used. 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. List of documents held by sender: none.