chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a improperly stored PEDVAXHIB (which had a lot # of M006710 and an expiration date of 06-DEC-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursions on an unknown date: 9°C to 25°C (21.9°C) for 6 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one were identified due to a data logger. Furthermore, no product quality complaint was involved.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Neck pain
Clinical narrative: This spontaneous report as received from a healthcare worker who was also the patient: a 65 year old female with allergy to penicillin and sulfa drugs. The patient had no pertinent medical history. Her concomitant medication included an unspecified blood pressure, cholesterol and thyroid medication, and metformin. On 09-OCT-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, lot number and expiration date were not reported). At that time, the patient experienced no adverse effect. On 24-JUL-2018, the patient was vaccinated with the second dose of PNEUMOVAX 23 lot # N030987, expiry date: 15-MAY-2019, for prophylaxis. On the same date, the patient experienced pain on injection site, headache and pain in the back of the neck. The patient sought medical attention by calling the physician. She received unspecified treatment for the events. The outcome of the events was reported as not recovered. The causality assessment was not provided.
Age: 1.42
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine and the 2nd dose of Hepatitis B vaccine. In August 1998, the patient received the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The health care professional was the father of the patient, a cardiologist. The health care professional shared adverse event information to Regulatory Authority via health care professional chat. The age at vaccination was not reported. The health care professional stated that a patient was vaccinated with Hepatitis B vaccine series that was completed in August 1998 and was recently tittered for Hepatitis B surface antibody and the results were shown as not detectable. The health care professional did not have information on which Hepatitis vaccine was administered for the three dose series, and wanted to know how to dose ENGERIX B to provide a booster. The health care professional did not respond to the question if that was the initial contact with Glaxosmithkline.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 45-year-old female patient who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B (batch number B39CM, expiry date 3rd February 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B and the 2nd dose of ENGERIX B. On 3rd May 2018, the patient received the 3rd dose of ENGERIX B. On 8th June 2018, unknown after receiving ENGERIX B and ENGERIX B and 36 days after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. On 3rd May 2018, the patient received 3rd dose of ENGERIX-B series. On 8th June 2018, the patient underwent for serology test for hepatitis B antibody and found no immunity.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Hepatitis A vaccine, Hepatitis B vaccine and ARMOUR THYROID. On 25th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th June 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue. On 26th June 2018, the patient experienced headache and general body pain. On an unknown date, the outcome of the fatigue was recovering/resolving and the outcome of the headache and general body pain were recovered/resolved. The reporter considered the fatigue, headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient received 1st dose of Hepatitis A vaccine intramuscularly on the left arm, 4 weeks prior to receiving SHINGRIX and 1st dose of Hepatitis B vaccine intramuscularly on the right arm, 3 weeks prior to receiving SHINGRIX. The manufacturer of Hepatitis A and Hepatitis B vaccines were unknown. The patient received SHINGRIX on the left arm. The patient stated that the following day after receiving SHINGRIX, she experienced a headache and body aches. On the reporting date, she felt a bit better, however, she was still quite tired. The patient gave the contact details of the physician. She did not have physician's phone number at the time of the reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Incomplete course of vaccination, Medication error, Pain in extremity, Product availability issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In December 2017, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, circumstance or information capable of leading to medication error, incomplete course of vaccination and product availability issue. On an unknown date, the outcome of the pain in arm, circumstance or information capable of leading to medication error, incomplete course of vaccination and product availability issue were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The patient stated that, she received her 1st dose of SHINGRIX and experienced a sore arm. The patient also reported that her 2nd dose would be due on 3rd July 2018, but her pharmacy was unable to get it due to the backorder, which was the circumstance or information capable of leading to medication error of incomplete course of vaccination. No follow-up information was requested from the patient. No further information was provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX (batch number T5242, expiry date unknown) and (batch number 5223C, expiry date unknown) for prophylaxis. Concomitant products included simvastatin. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, joint pain and fatigue. On 14th April 2018, the outcome of the injection site pain, joint pain and fatigue were recovered/resolved. It was not reported if the reporter considered the injection site pain, joint pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported 2 batch numbers 1 of adjuvant and other of lyophilized powder. The patient received SHINGRIX in left arm. The health care professional reported that the patient received SHINGRIX and developed pain at the injection site, fatigue and achy joints within 6 hours of vaccination. This case has been linked with US2018116408, reported by the same reporter.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Skin burning sensation, Skin weeping, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 56-year-old male patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis. On 7th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. In May 2018, 2 days after receiving SHINGRIX, the patient experienced itchy rash, rash, burning skin, hives and skin weeping. On an unknown date, the outcome of the itchy rash, rash, burning skin and hives were recovered/resolved and the outcome of the skin weeping was unknown. It was unknown if the reporter considered the itchy rash, rash, burning skin, hives and skin weeping to be related to SHINGRIX. Additional details were provided as follow: The patient received SHINGRIX on right deltoid. The patient developed hives/rash on right thigh. The rash was itchy, burning, weeping and it was lasted for 3 to 4 days. The patient was positive for hives 12 hours later and rash longer than 3 days. The hives broke open and were draining. The patient reported no complaints at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old female patient who received SHINGRIX (batch number 75GJ5, expiry date 2nd February 2021) and (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 28th June 2018 01:00, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist administered SHINGRIX to a co-worker and the patient experienced shingles 5 days after the SHINGRIX vaccine. The patient received a SHINGRIX vaccine around 1 to 2:00 PM and the shingles presented in her buttock's crack. The patient was prescribed acyclovir 800 mg 5 times per day for 7 days on 6th July 2018.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Generalised erythema, Headache, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 62-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020) and (batch number X3M27, expiry date 20th August 2020) for prophylaxis. On 16th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 16th April 2018, less than a day after receiving SHINGRIX, the patient experienced headache, shivering, generalized erythema and fever. On 17th April 2018, the outcome of the headache, shivering, generalized erythema and fever were recovered/resolved. The reporter considered the headache, shivering and fever to be probably related to SHINGRIX. The reporter considered the generalized erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine in left deltoid. The patient's whole body turned red.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Therapy non-responder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a neonate female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis. On 12th November 1996, the patient received the 1st dose of Hepatitis B vaccine. On 26th December 1996, the patient received the 2nd dose of Hepatitis B vaccine. On 6th June 1997, the patient received the 3rd dose of Hepatitis B vaccine. On 17th January 2018, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced therapy non-responder, hepatitis b antibody negative, therapy non-responder, hepatitis b antibody negative, drug dose administration interval too long and drug dose administration interval too long. On an unknown date, the outcome of the therapy non-responder, hepatitis b antibody negative, therapy non-responder, hepatitis b antibody negative, drug dose administration interval too long and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapy non-responder, hepatitis b antibody negative, therapy non-responder and hepatitis b antibody negative to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. It was unknown if the reporter considered the therapy non-responder and hepatitis b antibody negative to be related to Hepatitis B vaccine. Additional details were provided as follows: The caller stated that the patient received Hepatitis B vaccine on her date of birth. The patient was mentioned that she was going into a medical program. The patient was completed the 3 doses of Hepatitis B vaccine.The patient received 2nd dose and 3rd dose later than the recommended interval, which led to lengthening of vaccination schedule. The patient underwent for serology test and titer come back negative (therapy non-responder and hepatitis b antibody negative), therefore the patient was recommeded to get the booster dose. On 17th January 2018, the patient received another dose of Hepatitis B vaccine on left deltoid and less than a year after receiving booster dose of Hepatitis B vaccine, the serology titer was found negative (therapy non-responder and hepatitis b antibody negative). Lab Comments: On an unknown date, lab test was performed.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Poor quality sleep, Pruritus, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 2nd July 2018, the patient received the 2nd dose of SHINGRIX. On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced headache. On 10th July 2018, the patient experienced rash, pruritus and erythematous rash. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the rash and pruritus were not recovered/not resolved and the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the headache, rash, pruritus and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient reported that he experienced a headache. The patient was unsure in the beginning because he had just gotten new eye glasses on 5th July 2018 and thought they were the cause. The patient soon realized that the glasses did not cause the headache and now believed the vaccine caused it. Around 10 July 2018, 8 days after receiving SHINGRIX, the patient noticed a rash on the inner bicep of the right arm and on the right side of the body. The rash looked like a small patch of little red bumps with itching. The patch of small bumps was about 5 inches in diameter and had not gotten any smaller. The itching has become more pronounced. The patient said that he had been using over the counter powder to help with the itching. Less than a month after receiving SHINGRIX, the patient still had trouble not sleeping well since the second dose. For tolerance of 1st dose of SHINGRIX, refer linked case US2018GSK128826.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a month after receiving SHINGRIX, the patient experienced shingles. The patient was treated with Antiviral for systemic use. 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. In mid-May, the patient received 2nd dose of SHINGRIX, 2 months after 1st dose. During 2nd week of June, the patient experienced shingles. The physician of the patient stated that she did not think it was related to the receipt of SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 1st June 2018, the patient received the 2nd dose of SHINGRIX. On 2nd June 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On 3rd June 2018, the patient experienced chills. On 4th June 2018, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the fever, chills, injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the fever, chills, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On an unspecified date in 2018, two months before the date of reporting, the patient received 1st dose of SHINGRIX. Two days after receiving SHINGRIX, the patient experienced chills. Three days after receiving SHINGRIX, the patient experienced soreness and redness at the injection site. The patient refused to provide their full contact information and their physician's contact information. No further information was reported.
Age: 47.0
Sex: M
Vaccine: HEPAB
Symptoms: Diarrhoea, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 47-year-old male patient who received TWINRIX adult (batch number Z75Y2, expiry date unknown) for prophylaxis. Concomitant products included TWINRIX adult. On 9th January 2018, the patient received the 2nd dose of TWINRIX adult 1 ml. On 10th January 2018, 1 days after receiving TWINRIX adult, the patient experienced injection site pain (serious criteria disability), fatigue (serious criteria disability), nausea (serious criteria disability), headache (serious criteria disability) and diarrhea (serious criteria disability). On an unknown date, the outcome of the injection site pain, fatigue, nausea, headache and diarrhea were recovered/resolved. The reporter considered the injection site pain, fatigue, nausea, headache and diarrhea to be related to TWINRIX adult. Additional details were provided as follows: The patient received TWINRIX 2nd dose on the left deltoid. The next day he experienced soreness at injection site, headache, fatigue, nausea and diarrhea. The healthcare professional described the patient's symptoms after the 2nd dose as a general systemic reaction. The registered nurse made note that the patient was a very muscular man. The reporter did not have the expiry date of the lot number. The reported TWINRIX adult batch number (SKBZ75Y2) did not exist and was updated to Z75Y2 as per sales database. For tolerance to next dose, refer case US2018GSK113363.
Age: 19.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site lump in a 19-year-old male patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019) for prophylaxis. On 30th May 2018, the patient received BEXSERO .5 ml. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site lump, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site lump, injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site lump, injection site pain and injection site erythema to be related to BEXSERO. Additional details were provided as follows: The patient also received a Hepatitis A vaccine the day of vaccination but in a different arm. The patient came in 2 days later for an unrelated follow up appointment and it was noticed that he had a painful lump and it was still red where he had gotten the BEXSERO shot 2 days earlier. They had not seen him back since so not sure if it resolved. The patient would be gone on a vacation after.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 14th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, incomplete course of vaccination and product availability issue. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination and product availability issue were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient hurt like heck and arm was sore for 3 days. She put the reminder on phone for 1st June 2018 following her monthly hike only to discover the back order she was told to check on 1st July 2018. She was told to call daily to find out if it was in. And after calling several sources and researching online, that was the only answer available, which could lead to incomplete course of vaccination and product availability issue. The patient realized that she was fortunate to be an active over 50 year old which she meant she had better things to do with time than investing in the anxiety-producing process of call daily to be told no. The patient felt it far worse for older people who do not have where with all to even do the daily process, much less endure the daily slog through phone calls and rejections.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 2nd February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, feeling unwell, incomplete course of vaccination and product availability issue. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved and the outcome of the feeling unwell, incomplete course of vaccination and product availability issue were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad reaction to the first dose of SHINGRIX that was extreme, painful swelling at the injection site that lasted 2 weeks. The patient felt ill the day after injection, and so felt strongly that she should receive the injection at least one week before departing for travel. On 16th July 2018, the patient had a scheduled and appointment for and showed up for her second dose. And she called only to be informed that there was no available product. SHINGRIX on backorder, which led to incomplete course of vaccination and product availability issue. The patient was traveling soon and need to get the second dose as soon as possible, before the 6-month window closed. The patient was very upset that there was a shortage of the product, and she was worried that by not getting the second dose within the 2 to 6 month window of the first dose, her immunity and health would be put at risk. The patient requested that; please send a dose of SHINGRIX for her and any other patients in urgent need as soon as possible and no later than 20th July 2018.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 17th July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The reporter was receptionist and called to report her own personal experience. The age at vaccination was not reported. The patient did not experience any side effects with her 1st dose 2 months before the 2nd dose. The patient experienced increased swelling larger than a quarter size and fever to the touch at the injection site. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer (medical assistant). This report was received via a Pfizer sales representative. A male patient of an unspecified age received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) and right away he was light-headed and had been experiencing vertigo for the last month. He was starting to get better. The information on the batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer-sales representative. A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced numbness, dizziness, and tingling on an unspecified date. The outcome of all events was unknown. Information on batch number has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Incorrect route of drug administration, Wrong drug administered
Clinical narrative: Initial unsolicited report received from other health care professional on 24-JUL-2018. This case involves a five-year-old child patient, who was vaccinated with 0.5 ml dose of MENACTRA (frequency once, batch number: U5984AB, expiration date, dose and site of administration was not reported) via subcutaneous route instead of MMR vaccine on 23 Jul 2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate route of vaccination and wrong vaccine administered. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a, eight years old female patient who received a dose of QUADRACEL (batch number, expiry date, route and site of administration were not reported). 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 inappropriate age at vaccine administration. It was reported that patient received a dose of QUADRACEL at 8 years old. It was accidentally administered by the physician. It was not reported if the patient experienced 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. Documents held by sender: none.
Age: 35.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA207505, 2018SA207528, 2018SA207544. This case involves a 35 years old patient who received 0.5 ml expired dose of vaccine TENIVAC lot U5280AA, expiry date- 16-Mar-2018 via intramuscular route in the left deltoid on 02-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of actual medication error due to expired vaccine used. It was unknown if patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
Age: 1.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Injection site abscess sterile, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 months old patient who experienced tender, 1 cm sterile abscess and warm red at the injection site, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Jul-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5437AA via intramuscular route in the thigh NOS. The patient developed a non-serious tenderness following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The patient developed a non-serious 1 cm sterile abscess following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The patient developed a non-serious warm red at the injection site following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. (Other relevant tests included No lab data). Final diagnosis was warm red at the injection site, 1 cm sterile abscess and tender. An unknown corrective treatment was received. The patient outcome is reported as Unknown for warm red at the injection site, as Unknown for 1 cm sterile abscess and as Unknown for tender.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a nurses. This case is linked with case 2018SA206713 for same patient. This case involves a 17 years old female patient who was exposed to vaccine ADACEL while pregnant, patient was seven weeks pregnant. The date of last menstrual period was reported as 26-May-2018. The estimated due date is 02-Mar-2019. The patient's past medical history and family history were not provided. No concomitant vaccines given. On 24-Jun-2018, the patient received a 0.5ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, lot U5852AA, expiry date 16 Jan 2020 via unknown route in the left deltoid. It was an actual medication error due to vaccine exposure during pregnancy. It was reported that received ADACEL following a foot injury and the patient was seven weeks pregnant at time vaccine given. Lab data was not provided. It was unknown whether patient experienced any adverse reaction after the injection. 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.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from other health care professional (Nurse Manager). This case involves a 11 years old female patient who received DAPTACEL instead of ADACEL vaccine. The patient's past medical history and family history were not provided. Concomitant medications included MENACTRA on 20-Jul-2018, Lot number, expiry date and route, site of administration was not provided. On 20-Jul-2018, the patient received a fifth dose in series, 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5171AA, expiry date not provided via intramuscular route in the right deltoid instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was an actual medication error due to wrong vaccine and inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse reaction after the injection. 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.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (office staff) on 25-Jul-2018. This case involves a four-month-old patient (gender not reported) who was inadvertently vaccinated with an expired dose of 0.5 mL PENTACEL batch number: C5402AA, expiry date: 24-Jun-2018 via intramuscular route in left leg on 02-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 for and ROTATEQ for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any harm or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a two months old female patient who received a 0.5 mL dose of QUADRACEL (lot number: C5325BA, expiry date: 14-Nov-2019) in left thigh in error instead of PENTACEL (lot number and expiry date not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was reported that QUADRACEL given to 2 months old patient in left thigh today in error and also received MMR and Varicella vaccines (right thigh). Intended vaccines to be given today were: PENTACEL, PCV 13, ROTATEQ, Hep B and none of those were given. It was not reported if the patient experienced 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. Documents held by sender: none.
Sex: U
Vaccine: HEP, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an adult patient (age reported as 40's) who was vaccinated once with an 0.5 ml expired dose of MENACTRA (Batch number: U5539AB, expiration date: 25-Apr-2018 via intramuscular route in the right deltoid on 25-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS (TDAP) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. It was a case of actual medication error due to expired product administered. It was not reported if 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 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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from other healthcare professional on 26 Jun 2018. This case involves 11-year-old female patient (patient was not pregnant, but did not have date of last menstrual period) who was vaccinated with 0.5 ml second dose of MENACTRA (Batch number: U5917AA, expiration date: 30-Jun-2019, dose was not reported) via intramuscular route in left deltoid on an unspecified date. The patients medical history was not reported. It was reported that no other vaccines were administered concomitantly. It was an actual medication error due to incorrect product storage as it was reported that inadvertently given dose of MENACTRA that had been improperly shipped from Vaccine Shop and extra dose administered as 2nd dose was given to 11 years old. It was reported that no signs of adverse reaction were observed. 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.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2017SA019528. This case involves a 39 years old female patient who was exposed to vaccine ADACEL in context of maternal vaccine exposure. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal vaccine exposure occurred at unknown gestation period and the patient was exposed to Diphtheria-2/Tetanus/5 AC Pertussis Vaccine at 31 weeks of pregnancy, during third pregnancy trimester for Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. The date of last menstrual period was reported as 07-Dec-2017. The estimated due date is 19-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Jul-2018, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, lot U5829AB, via intramuscular route. The patient developed a non-serious maternal vaccine exposure (exposure during pregnancy). Final diagnosis was maternal vaccine exposure. Mother did not experienced any adverse event. Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Oropharyngeal pain, Rash
Clinical narrative: Rash and Sore Throat. Prednisone given for the rash.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 4 days after vaccine I developed spots all over my feet. They were not raised, nor itchy or hot. I have photos if you need them.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warm to touch, and sore at site of injection leading up to shoulder.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Hypoaesthesia, Presyncope, Tinnitus, Vomiting
Clinical narrative: Vasovagal presyncope -Patient was given the HPV injection first dose. Patient was starting to hold breath before receiving injection. Patient was told to relax and take a deep breath and relax the arm. Within a few seconds of the injection she started to complain of trouble breathing, numbness in the arm and hands, and ears ringing. I was then called into the room to re-evaluate the patient. Vitals remained excellent with HR 70-80, normal breath sounds, no evidence of angioedema, O2 sats at 100%. She did vomit once. Patient was reclined on the exam table, given cold water and a bag of ice. She felt back to normal within 10 minutes. She did not lose consciousness. during this entire episode.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Hypoacusis, Malaise, No reaction on previous exposure to drug
Clinical narrative: Within 15 minutes of receiving the shot I began to tremble and feel hot and dizzy. I ached all over and my ears began to ring. I was ill for at least 2 weeks but slowly recovered except for the tinnitus, which I still have. The tinnitus has grown progressively worse to the point that it's hard to hear over it. I've gotten a seasonal flu shot every year all my adult life and had never had any reaction before 2017.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Tinnitus, Tremor
Clinical narrative: Within 15 minutes of receiving the shot I began to tremble and feel hot and dizzy. I ached all over and my ears began to ring. I was ill for at least 2 weeks but slowly recovered except for the tinnitus, which I still have. The tinnitus has grown progressively worse to the point that it's hard to hear over it. I've gotten a seasonal flu shot every year all my adult life and had never had any reaction before 2017.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Disorientation, Loss of consciousness, Seizure
Clinical narrative: Pt. had seizure and passed out less than a minute. Pt. was very disoriented. Pt. doesn't remember what happened.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Lethargy
Clinical narrative: Feeling very lethargic at the end of the day; didn't even have the strength to make it to planned dinner with family and friends. Was ok after a couple of days.