chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm and dizziness. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the dizziness was not recovered/not resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. The reporter considered the dizziness to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. Less than a week after vaccination, the patient experienced dizziness. Till the time of reporting, the patient was still experiencing dizziness two weeks after vaccination with SHINGRIX. The patient had denied permission to contact their physician.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Angular cheilitis, Lymphadenopathy, Nasal crusting, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling arm in a 80-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced swelling arm, pimples, nasal crusting, axillary lymph nodes enlarged and angular cheilitis. On an unknown date, the outcome of the swelling arm, pimples, nasal crusting and angular cheilitis were unknown and the outcome of the axillary lymph nodes enlarged was recovered/resolved. It was not reported if the reporter considered the swelling arm, pimples, nasal crusting, axillary lymph nodes enlarged and angular cheilitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported via webform email. The patient received SHINGRIX on arm and her arm became swollen, not at the injection site; she had a swollen axillary lymph node. Three days after vaccination, the patient had sores at the corners of her mouth, bloody crusts in her nostrils, and a pimple on her nose. The caller did not speak with the HCP. This case has been linked to the US2018115892, reported by the same reporter for the same patient.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized urticaria in a 56-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2019) for prophylaxis. On 10th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 10 days after receiving SHINGRIX, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was not recovered/not resolved. The reporter considered the generalized urticaria to be possibly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that, the patient developed hives all over her body, about 10 days after vaccination. At the time of this report, two months later, the patient had the hives.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (body aches and chills after receiving 1st dose on 3rd February 2018, see case US2018GSK118703). On 24th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, 2 days after receiving SHINGRIX, the patient experienced headache, general body pain and chills. On an unknown date, the outcome of the headache, general body pain and chills were recovered/resolved. It was unknown if the reporter considered the headache, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient experienced the same symptoms which he experienced after 1st dose of SHINGRIX. All his symptoms lasted for about a week. He did not know the specific dose given. The patient reported the contact details of the physician. This case has been linked with US2018115928 (patient's sister-in-law), reported by the same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Ocular hyperaemia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye red in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 27th June 2018 13:00, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced eye red. On an unknown date, the outcome of the eye red was unchanged. It was unknown if the reporter considered the eye red to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that he noticed that white part on his left eye ball was red and it had gotten worse since. The patient had denied permission to contact their physician. No further details were provided. The patient would follow up with their health care provider.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Impaired work ability, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient had received the SHINGRIX vaccine 8 days ago. Since that time, the patient had had fevers, arm pain, headaches, general flu type symptoms and at the time of reporting full blown head colds. The patient had missed several days of work, cancelled a hiking trip, and basically felt lousy since the SHINGRIX vaccine was administered with no end in sight. The patient was not sure about that second shot and asked what in the world was in this stuff. This case has been linked with case US2018GSK112843, reported for the patient's husband.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient had received the SHINGRIX vaccine 8 days ago. Since that time, the patient had had fevers, arm pain, headaches, general flu type symptoms and at the time of reporting full blown head colds. The patient had missed several days of work, cancelled a hiking trip, and basically felt lousy since the SHINGRIX vaccine was administered with no end in sight. The patient was not sure about that second shot and asked what in the world was in this stuff. This case has been linked with case US2018GSK112843, reported for the patient's husband.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several hours after receiving SHINGRIX, the patient experienced fever, chills, nausea and pain in arm. On an unknown date, the outcome of the fever, chills, nausea and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, nausea and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine late Saturday afternoon and since late Saturday evening the patient had a fever ranging from 99 to 101.5 with chills and nausea and lots of arm pain. The patient knew these are typical side effects of the vaccine, but queried if how long do these symptoms usually last on average, it had been more than 24 hours and they were not getting the slightest bit better.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of herpes zoster in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included lymphoma (remission after lymphoma treatment which ended 6 months ago). Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The physician had a patient who had reactions after SHINGRIX. The patient developed Herpes Zoster 2 weeks after her 2nd dose of SHINGRIX. This case was linked with US2018GSK113823, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pruritus, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia (on no prescription). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pruritus and fatigue. On an unknown date, the outcome of the fever, pruritus and fatigue were recovering/resolving. It was unknown if the reporter considered the fever, pruritus and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed daily fever of 102 plus degree F after dose of SHINGRIX. The patient had no rash but was pruritic and had fatigue. The patient was improving slowly. This case was linked with US2018GSK113820, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of blister in a female patient who received SHINGRIX for prophylaxis. On 21st June 2018, the patient received the 2nd dose of SHINGRIX. On 23rd June 2018, 2 days after receiving SHINGRIX, the patient experienced blister. On an unknown date, the outcome of the blister was recovering/resolving. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Thursday, the patient received the SHINGRIX vaccine. The patient noticed on Saturday 23rd June 2018, 3 small blisters vessels on her ankle. The patient did not have pain, fever or chills. The patient had a follow up visit on 25th June 2018 with the provider and that was when she reported her blisters to the provider. However, the blisters on the day of reporting had improved. The nurse agreed for follow-up contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: This case was reported by medical assistant. The age at vaccination was not reported. The patient brought SHINGRIX in from pharmacy and in office the patient received only adjuvant only because they thought box had both doses inside, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter agreed to follow up from GlaxoSmithKline.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cold sores in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown. It was unknown if the reporter considered the cold sores to be related to SHINGRIX. Additional details were provided as follows: The patient developed cold sores after vaccination, which she had usually gets 1 to 2 times per year. Hence, the registered nurse was not sure if the event was related to SHINGRIX. The office was notified regarding the event approximately on 22nd June 2018. The reporter agreed to receive follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, 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 SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and feeling unwell were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient experienced extreme fever, chills, and flu like symptoms for 3 days. The patient felt too sick to get out of bed for the 3 days. The reporter did not agree to follow up
Sex: F
Vaccine: DTAP
Symptoms: Rash, Skin discolouration, Skin warm
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a female patient who received INFANRIX (batch number AC7AG, expiry date 17th October 2016) for prophylaxis. On 14th May 2015, the patient received INFANRIX. On 14th May 2015, less than a day after receiving INFANRIX, the patient experienced rash (serious criteria hospitalization). On an unknown date, the patient experienced skin warm (serious criteria hospitalization) and skin discoloration (serious criteria hospitalization). On an unknown date, the outcome of the rash, skin warm and skin discoloration were recovered/resolved. It was unknown if the reporter considered the rash, skin warm and skin discoloration to be related to INFANRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was taken to hospital on 15th May 2015. Less than a month after vaccination, the patient experienced warm spots that became bright. It took almost a month for spots to go away and every time she was outside or got real warm spots became bright. The photos of spots were taken on the day and on the next day of vaccination were provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got hives after the 1st dose. The patient was advised not to get the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient experienced fever and aches on the next day of vaccination. The patient asked, if he/she should expect same reaction with the second dose or it was less likely to have that reaction with the 2nd dose.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 3rd February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 2 days after receiving SHINGRIX, the patient experienced headache, general body pain and chills. In February 2018, the outcome of the headache, general body pain and chills were recovered/resolved. It was unknown if the reporter considered the headache, general body pain and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. All his symptoms lasted for about a week. He did not know the specific dose given. The patient reported the contact details of the physician. For tolerance to next dose, refer case US2018115927. This case has also been linked with US2018115928 (patient's sister-in-law), reported by the same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involve an adult patient ADACEL (expiry date 20 May 2018, batch number, route and site of administration were not reported). It was a case of actual medication error due to Expired vaccine used patient received the ADACEL today and then realized it expired 20May2018. It was unknown if any adverse event 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.
Sex: M
Vaccine: MENB, MNQ, VARCEL
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Initial information received on 18-May-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old male patient who experienced lower body weakness and fever, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TRUMENBA for Product used for unknown indication; and VARICELLA VACCINE for Product used for unknown indication. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported. The patient developed a non-serious lower body weakness <<Unknown latency>> following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient developed a non-serious fever <<Unknown latency>> following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Final diagnosis was fever and lower body weakness. An unknown corrective treatment was received. The patient outcome is reported as Recovered/Resolved on an unknown date for lower body weakness and as Recovered/Resolved on an unknown date for fever.
Sex: F
Vaccine: FLUR4
Symptoms: Chromaturia, Fatigue, Rash, Renal function test normal, Skin discolouration
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (patient itself). This case is linked to cases 2018SA175572, 2018SA164901 and 2018SA175612. This case involves adult female patient who experienced purple rash on her thigh, more tired and urine changed color, while she received vaccine FLUBLOK QIV. It was also reported that in late 2015 she was premedicated with 50 mg BENADRYL and her renal functions normal but on the low side. It was reported that years ago she took the flu vaccine which was a standard seasonal one but not sure which one. States that night she became hypertensive, tachy, panicy, short of breath, swollen face and was covered in hives. Her husband took her to the ER and they gave her a SOLUMEDROL dose pack.States she has an allergy to latex and they were wondering if the reaction may have been due to the stopper. In 2015, the patient received a first dose of suspect FLUBLOK QIV lot number not reported in unknown administration site. In 2015, the patient developed a non-serious purple rash on her thigh, more tired and urine changed color (chromaturia) few months later administration of FLUBLOK QIV. The reporter reported that purple rash it could have been an immunological rash. Other relevant tests included No lab data Final diagnosis was urine changed color, more tired and purple rash on her thigh. An unknown corrective treatment was received. The patient outcome is reported as Unknown for purple rash on her thigh, more tired and urine changed color. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves child female patient who was vaccinated with an expired dose of [PENTACEL] (batch number, Expiration date: 24-Jun-2018, dose, dose in series, route and site of administration were not reported) on 25-Jun-2018. It was a case of an actual medication error due to expired vaccine used. It was not known whether the patient experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be 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: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old male patient who experienced gave PENTACEL today which expired, while he received vaccine PENTACEL. The patients past medical history, medical treatment, vaccination and family history were not provided. On 25-Jun-2018, the patient received a expire dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5401AA, Exp date 24 Jun 2018. It was a case of an actual medication error due to expired vaccine used. It was not known whether the patient experienced any adverse events 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 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.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a six-month-old female patient who was inadvertently vaccinated with an expired dose (third) of 0.5 ml PENTACEL (batch number: C5400AA, expiration date: 24-Jun-2018) via intramuscular in the left thigh on 25-Jun-2018. The patient's past vaccination(s) included PENTACEL on 07-FEB-2018 with at the age of 2 months and PENTACEL on 09-APR-2018 with at the age of 4 months. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; ROTAVIRUS VACCINE for Immunisation; and HEPATITIS B VACCINE for Immunisation (Batch number, expiry date, route and site of administration were not reported) on 25-Jun-2018. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves an 18-year-old patient (gender not reported) who was inadvertently vaccinated with an expired dose of MENACTRA (batch number: U5523AA, expiration date: 05-Apr-2018 dose, route and site of administration was not reported) on 25-Jun-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 64.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 64-year-old patient (gender not reported), who was vaccinated with a dose of DAPTACEL (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because a 64-year-old patient received pediatric Daptacel. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA177770, 2018SA177771 and 2018SA177772. This case involves a 36-years old patient (gender not reported) who experienced redness, swelling and lump at injection site, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the patient did not receive any other vaccine on the date of administration. On 19-Jun-2018, the patient received a dose of ADACEL (lot C5541AA, expiry date: 13-Nov-2020) via intramuscular route in the deltoid NOS. On an unknown date, the patient developed a non-serious redness, swelling and lump at injection site, following the administration of ADACEL. Relevant tests were not reported. Final diagnosis was lump at injection site and redness, swelling at injection site. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA177766, 2018SA177771 and 2018SA177772. This case involves a female patient (age reported as 16-20 years) who experienced redness, swelling and lump at injection site, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the patient did not receive any other vaccine on the date of administration. On 25-Jun-2018, the patient received a dose of ADACEL lot C5541AA, expiry date: 13-Nov-2020) via intramuscular route in the deltoid NOS. On an unknown date, the patient developed a non-serious redness, swelling and lump at injection site, following the administration of ADACEL. Relevant tests were not reported. Final diagnosis was lump at injection site and redness, swelling at injection site. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA177770, 2018SA177766 and 2018SA177772. This case involves a patient (age reported as 16-20 years, gender not reported) who experienced redness, swelling and lump at injection site, while she received vaccine [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the patient did not receive any other vaccine on the date of administration. On 18-Jun-2018, the patient received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5541AA, expiry date: 13-Nov-2020) via intramuscular route in the deltoid nos. On an unknown date, the patient developed a non-serious redness, swelling and lump at injection site, following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Relevant tests were not reported. Final diagnosis was lump at injection site and redness, swelling at injection site. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA177770, 2018SA177766 and 2018SA177771. This case involves a patient (age reported as 16-20 years, gender not reported) who experienced redness, swelling and lump at injection site, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the patient did not receive any other vaccine on the date of administration. On 18-Jun-2018, the patient received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5541AA, expiry date: 13-Nov-2020) via intramuscular route in the deltoid NOS. On an unknown date, the patient developed a non-serious redness, swelling and lump at injection site, following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Relevant tests were not reported. Final diagnosis was lump at injection site and redness, swelling at injection site. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Musculoskeletal pain
Clinical narrative: Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult patient who experienced extended soreness in my shoulder after receiving a typhoid vaccination, while he/she received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a non-serious extended soreness in my shoulder after receiving a typhoid vaccination following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. (Other relevant tests included no lab data). Final diagnosis was extended soreness in my shoulder after receiving a typhoid vaccination. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for extended soreness in my shoulder after receiving a typhoid vaccination.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old male patient who was received an expired dose vaccine PENTACEL (lot C5382AA, expiry date: 22-Jun-2018, dose and route of administration were not reported) in the thigh NOS on 26-Jun-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was also a case of actual medication error due to expired vaccine used. 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 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: MNQ
Symptoms: Hypersensitivity
Clinical narrative: Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult female patient who experienced had severe allergic reaction to MENACTRA, while he/she received vaccines MENACTRA. The patient's past medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect MENACTRA (lot number, expiry date not reported) and her college was required MENINGOCOCCAL VACCINE B. On an unknown date, following the vaccination patient developed a non-serious severe allergic reaction to MENACTRA (and her college is requiring Men B). No lab data provided. Final diagnosis was had severe allergic reaction to MENACTRA. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for had severe allergic reaction to MENACTRA.
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Discomfort, Expired product administered
Clinical narrative: Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves female patient (age not reported) who experienced she did not feel comfortable, while she received vaccine MENACTRA. The patients past medical history, medical treatment, vaccination and family history were not provided. On 26-Jun-2018, the patient received 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5415AA, expiry date: 16-Oct-2017, via intramuscular route in the right arm along with TDAP. On an unknown date, the patient developed a non-serious she did not feel comfortable, following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was also a case of actual medication error due to expired vaccine used. Relevant tests were not reported. Final diagnosis was she did not feel comfortable. It was not reported if the patient received a corrective treatment. The outcome was reported as unknown for the 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. Documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from an other non-health care professional. This case involves a six months old female patient who received ACT-HIB with expiry 03 Jun 2018. The patients past medical history and concomitant medication were not provided. It was an actual medication error due to Expired vaccine used. On 26-Jun-2018, the patient received a 0.5 ml dose, 3rd in series of suspect HIB (PRP/T) VACCINE lot UI796AA, expiry date 03 Jun 2018 via unknown route in the left thigh. 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves Infant patient who received ACT-HIB with expiry date of 01 Jun 2018. The patients past medical history and concomitant medication were not provided. It was an actual medication error due to Expired vaccine used. On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot U1795AA, expiry date 01 Jun 2018 via unknown route in the left thigh. 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: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RVX
Symptoms: Rash generalised
Clinical narrative: Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 4 months old male patient who experienced generalized rash all over, while he received vaccines IPOL and ACT-HIB. The patients past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included DTAP for Immunisation, PREVNAR for Immunisation, and ROTAVIRUS VACCINE for Immunisation, Lot number, dose, site, route of administration not reported for all vaccines. On 12-Jun-2018 date, the patient received injection of suspect IPV (VERO) lot N1G51, expiry date 02 Aug 2019, dose not reported via intramuscular route in the right thigh. On 12-Jun-2018, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot UI917AA via intramuscular route in the right thigh. The patient developed a non-serious generalized rash all over fourteen days following the administration of HIB (PRP/T) VACCINE and following the administration of IPV (VERO). Final diagnosis was generalized rash all over. Lab data was not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for generalized rash all over. List of documents held by sender - none.
Age: 8.0
Sex: F
Vaccine: TYP
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 8 years old female patient who about to inject the vaccine injection of suspect TYPHIM VI, lot N1K801M, expiry date 15 Oct 2019, dose not reported via unknown route in unknown administration site on 27-Jun-2019 and it sprayed out everywhere and was not injected into the patient. Caller states that she is certain that she screwed the needle on tightly, she did not reinject the patient. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to accidental exposure to product and syringe issue. 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.
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 months old patient (gender unknown) who was inadvertently given vaccine ADACEL, lot number, expiry date, dose not reported via unknown route in unknown administration site on an unknown date. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to 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.