chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative 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, less than a year after receiving SHINGRIX, the patient experienced fever, malaise and chills. On an unknown date, the outcome of the fever, malaise and chills were unknown. It was unknown if the reporter considered the fever, malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The pharmacist reported that she had administered 26 doses of SHINGRIX since May 2018. This case has been linked with the cases US2018125495 and US2018125497, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 61-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 19th June 2018, the patient received SHINGRIX. On 20th June 2018, 1 days after receiving SHINGRIX, the patient experienced malaise, headache, fever, dizziness, nausea and vomiting. On an unknown date, the outcome of the malaise, headache, fever, dizziness, nausea and vomiting were recovered/resolved. It was unknown if the reporter considered the malaise, headache, fever, dizziness, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: This case was reported to the physician. The patient was administered SHINGRIX in the left arm. The patient reported that the next day after a SHINGRIX dose, she experienced malaise, fever, nausea, vomiting, dizziness, and headache. The symptoms lasted about 72 hours and then improved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 61-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 19th June 2018, the patient received SHINGRIX. On 20th June 2018, 1 days after receiving SHINGRIX, the patient experienced malaise, headache, fever, dizziness, nausea and vomiting. On an unknown date, the outcome of the malaise, headache, fever, dizziness, nausea and vomiting were recovered/resolved. It was unknown if the reporter considered the malaise, headache, fever, dizziness, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: This case was reported to the physician. The patient was administered SHINGRIX in the left arm. The patient reported that the next day after a SHINGRIX dose, she experienced malaise, fever, nausea, vomiting, dizziness, and headache. The symptoms lasted about 72 hours and then improved.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Fatigue, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis (in spring 2017, had surgery on wrist to cut the nerves to his hand to control severe arthritis pain). Previously administered products included steroid injections (got 5 injections in his hands prior to the surgery where the nerves were cut). Concurrent medical conditions included injury at work (had caused a lot of physician problems and led to 8 surgeries), multiple allergies and biceps tendon rupture. On 5th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 6th July 2018, the patient experienced stomach cramps and bloating. On 7th July 2018, the patient experienced swelling arm and pain in arm. On 13th July 2018, the patient experienced erythromacular rash. In July 2018, the patient experienced localized itching and fatigue. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, swelling arm and pain in arm were recovering/resolving and the outcome of the stomach cramps and bloating were recovered/resolved and the outcome of the localized itching was unknown and the outcome of the fatigue and erythromacular rash were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, stomach cramps, bloating, swelling arm, localized itching, fatigue, erythromacular rash and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had many allergies. The patient reported that he got SHINGRIX on 5th July 2018 (Thursday) in the muscle of his left arm, about 2 inches below his shoulder (left deltoid).  On the same day, in the evening the patient started experiencing pain at the injection site, at the time of reporting the pain was minimal but initially he could not touch it, it was so painful. On 6th July 2018 (Friday), in the evening, the experienced cramping in his stomach muscles. Not the intestines, but on the surface and also felt bloated. On 7th July 2018 (Saturday) morning, the patient woke up at 4 AM and his right hand was swollen to twice the size of his left hand and was very painful. Since then the patient has had some episodes of swelling, but it usually resolves after a short period of time but this time he had been compressing and icing his hand and taking ibuprofen, but his hand was still swollen at the and it was getting better, at the time of reporting. The patient could see his knuckles again, but this was longer than usual, but he feels like he was itching more than usual, and he had also been more tired than usual. On the day of reporting, the patient noticed a red dot on his left arm, below where his bicep would be. The patient did not had a bicep because it was ruptured.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis (in spring 2017, had surgery on wrist to cut the nerves to his hand to control severe arthritis pain). Previously administered products included steroid injections (got 5 injections in his hands prior to the surgery where the nerves were cut). Concurrent medical conditions included injury at work (had caused a lot of physician problems and led to 8 surgeries), multiple allergies and biceps tendon rupture. On 5th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 6th July 2018, the patient experienced stomach cramps and bloating. On 7th July 2018, the patient experienced swelling arm and pain in arm. On 13th July 2018, the patient experienced erythromacular rash. In July 2018, the patient experienced localized itching and fatigue. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, swelling arm and pain in arm were recovering/resolving and the outcome of the stomach cramps and bloating were recovered/resolved and the outcome of the localized itching was unknown and the outcome of the fatigue and erythromacular rash were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, stomach cramps, bloating, swelling arm, localized itching, fatigue, erythromacular rash and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had many allergies. The patient reported that he got SHINGRIX on 5th July 2018 (Thursday) in the muscle of his left arm, about 2 inches below his shoulder (left deltoid).  On the same day, in the evening the patient started experiencing pain at the injection site, at the time of reporting the pain was minimal but initially he could not touch it, it was so painful. On 6th July 2018 (Friday), in the evening, the experienced cramping in his stomach muscles. Not the intestines, but on the surface and also felt bloated. On 7th July 2018 (Saturday) morning, the patient woke up at 4 AM and his right hand was swollen to twice the size of his left hand and was very painful. Since then the patient has had some episodes of swelling, but it usually resolves after a short period of time but this time he had been compressing and icing his hand and taking ibuprofen, but his hand was still swollen at the and it was getting better, at the time of reporting. The patient could see his knuckles again, but this was longer than usual, but he feels like he was itching more than usual, and he had also been more tired than usual. On the day of reporting, the patient noticed a red dot on his left arm, below where his bicep would be. The patient did not had a bicep because it was ruptured.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in 2007). On 15th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the injection site pain and feeling unwell were recovered/resolved. It was unknown if the reporter considered the injection site pain and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced soreness at the injection site that started on the same day that she received the injection and lasted for a couple of days. The patient stated that she could not lie on her arm due to the soreness. The patient also did not feel well after receiving the vaccine, however, she was not sure when that started or how long it lasted. The patient was not sure if she would receive the 2nd dose.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 83-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced mild shingles 5 years before the date of reporting). On 14th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 2 days after receiving SHINGRIX, the patient experienced allergic reaction and erythematous rash. On an unknown date, the outcome of the allergic reaction and erythematous rash were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction and erythematous rash to be related to SHINGRIX. Additional details were received as follows: This case was reported by the patient's daughter. The patient received the SHINGRIX vaccine on the left arm. The reporter stated that initially the patient thought that she had Shingles. However, after physician visit, the physician told that she had an allergic reaction to the SHINGRIX. The patient had red lines on her skin that came and went. The red lines are located on her left armpit, on her right shoulder, the upper right arm, and half way down her back. The reporter stated that when the lines first appeared, the patient had them all over her abdomen as well. The lines on her abdomen have gone away. However, the red lines in the other locations continue to come and go. The physician's contact details were provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a 55-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 3 days after receiving SHINGRIX the patient experienced rash and shingles. On an unknown date, the outcome of the rash and shingles were recovered/resolved. It was unknown if the reporter considered the rash and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she had a dot on her chest three days after she received the SHINGRIX vaccine. The patient stated the rash had gone away. The patient did not provide the date or any additional information about her symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included Tetanus booster with an associated reaction of injection site pain (received on an unknown date) and ZOSTAVAX (received on an unknown date). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were unknown. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient stated that, the SHINGRIX immunization hurt like a tetanus booster. The patient also felt tired (less than a year after vaccination), but did not had fever. The reporter did not agree to be followed up. This case was linked to case US2018GSK124675, reported by same reporter.
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Injection site pain, Migraine
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 33-year-old female patient who received Rabies Vaccine for prophylaxis. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced injection site pain, joint pain and migraine. On an unknown date, the outcome of the injection site pain, joint pain and migraine were unknown. It was unknown if the reporter considered the injection site pain, joint pain and migraine to be related to Rabies Vaccine. Additional details were provided as follows: The reporter reported this case for someone she knew. The age at vaccination was not reported. The reporter was not sure of the brand of the rabies vaccine that the patient received, so she was not sure whether it was definitely GlaxoSmithKline's vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood blister, Blood glucose increased, Blood urea increased, Metabolic function test normal, Rash generalised
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of itchy rash in a 61-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included asthma (uncontrolled) and allergic reaction to antibiotics (doxycycline allergy). Concomitant products included XOLAIR. On 2nd July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 6th July 2018, 4 days after receiving SHINGRIX, the patient experienced itchy rash, urticarial rash and widespread rash. In July 2018, the patient experienced blood blister. The patient was treated with Steroids. On an unknown date, the outcome of the itchy rash, urticarial rash, blood blister and widespread rash were unknown. It was unknown if the reporter considered the itchy rash, urticarial rash, blood blister and widespread rash to be related to SHINGRIX. Additional details were provided as follows: On Friday, the patient presented with an urticaric and pruritic rash which started on his butt, spread to his side, groin and thighs. It spread to wrists and hands. When physician saw the patient on Monday 9th July 2018, the patient's wrists and hands were covered in blood blisters, as well as the widespread rash on the patient's torso. The physician prescribed steroids to the patient and had a follow up next week. A metabolic panel was essentially normal except for slightly elevated blood urea nitrogen and blood glucose. The physician was not 100 percent convinced that reaction was from SHINGRIX. Lab Comments: In July 2018, the metabolic panel was essentially normal.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of itchy rash in a 61-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included asthma (uncontrolled) and allergic reaction to antibiotics (doxycycline allergy). Concomitant products included XOLAIR. On 2nd July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 6th July 2018, 4 days after receiving SHINGRIX, the patient experienced itchy rash, urticarial rash and widespread rash. In July 2018, the patient experienced blood blister. The patient was treated with Steroids. On an unknown date, the outcome of the itchy rash, urticarial rash, blood blister and widespread rash were unknown. It was unknown if the reporter considered the itchy rash, urticarial rash, blood blister and widespread rash to be related to SHINGRIX. Additional details were provided as follows: On Friday, the patient presented with an urticaric and pruritic rash which started on his butt, spread to his side, groin and thighs. It spread to wrists and hands. When physician saw the patient on Monday 9th July 2018, the patient's wrists and hands were covered in blood blisters, as well as the widespread rash on the patient's torso. The physician prescribed steroids to the patient and had a follow up next week. A metabolic panel was essentially normal except for slightly elevated blood urea nitrogen and blood glucose. The physician was not 100 percent convinced that reaction was from SHINGRIX. Lab Comments: In July 2018, the metabolic panel was essentially normal.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, erythema and pruritus. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the erythema was recovering/resolving and the outcome of the pruritus was unknown. It was unknown if the reporter considered the pain, erythema and pruritus to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had a large red mark that was fading slightly after seven days still was sore, also itchy sometimes and I felt should be gone.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. In February 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient stated that, he was vaccinated with the 1st dose of SHINGRIX in February, 2018 and got shingles at the end of June, 2018. The patient inquired, why was he not protected and should he get the second shot. The patient also inquired that, his wife when she was young had Guillain-Barre was it safe for her to get SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Discomfort, Dizziness, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced dizziness and energy decreased. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the headache, dizziness and energy decreased were not recovered/not resolved. It was unknown if the reporter considered the headache, dizziness and energy decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the expected reaction for a few days, but about 6 weeks later the patient continued to have the reported 1% reaction of mild headache and slight dizziness, and low energy. The patient finally had an office visit with his primary care physician to review the situation, she felt that his discomfort seemed to line up with the 1% he reported having this problem, she or we found no information on 1, and the patient queried if how long this might continue and how to gauge if or when he should take the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by an other health professional via call center representative and described the occurrence of Bell's palsy in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter mentioned that in a very casual conversation with her sister, her sister mentioned to her that one of her friend was going through the same identical situation experiencing Facial Bell's Palsy. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided. This case was linked with US2018082822 and US2018082823, reported by the same reporter.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Deafness, Dysstasia, Feeling abnormal, Nausea, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old female patient received the first dose of TRUMENBA at 0.5 ml, single for immunisation and meningococcal vaccine a/c/y/w (reported as MCV4) at unknown dose, both via unspecified route of administration on an unspecified date for immunisation. The patient's medical history included allergies. Concomitant medication included loratadine for allergies. On an unspecified date, the patient experienced loss of hearing- felt like she was underwater, nausea, and blurred vision. She required support to remain standing. It was reported that the patient was an otherwise healthy patient. Outcome of the events loss of hearing- felt like she was underwater, nausea, and blurred vision was unknown. Information on batch and lot numbers has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced soreness at injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about lot number cannot be obtained.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal discomfort
Clinical narrative: Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient (age and gender not reported) who experienced adverse outcome to her shoulder, while patient received vaccine INFLUENZA VACCINE. 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 INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a non-serious adverse outcome to her shoulder (musculoskeletal discomfort), following the administration of INFLUENZA VACCINE. Relevant tests were not reported. Final diagnosis was adverse outcome to her shoulder. It was not reported if the patient received a corrective treatment. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from a nurse on 10-Jul-2018. This case involves a 12-year-old male patient who was inadvertently vaccinated with an expired first dose of 0.5 ml MENACTRA (batch number: not reported, expiration date: 28-Jun-2018, frequency once) via intramuscular in right deltoid on 09-Jul-2018. The patient's medical history was not reported. The patient's concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any harm. 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: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial unsolicited report received from an other health professional on 10-Jul-2018. This case involves a two-month-old male patient who was vaccinated with a dose of 0.5 ml PENTACEL (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) via subcutaneously instead of intramuscularly in leg on 09-Jul-2018. On 09-Jul-2018, the patient concomitantly received a dose of suspect ROTATEQ not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site and a dose of suspect PREVENAR not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. The patient's medical history were not reported. It was an actual medication error due to Inappropriate route of vaccination. It was reported that parents haven't reported any side effects at this time. 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: DTAPIPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult patient who experienced redness of entire thigh and swelling of entire thigh, while he/she received vaccine QUADRACEL. 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 Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious redness of entire thigh (erythema), following the administration of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine. On an unknown date, the patient developed a non-serious swelling of entire thigh (swelling), following the administration of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine. Other relevant tests included No Lab data was reported. Final diagnosis was swelling of entire thigh and redness of entire thigh. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for redness of entire thigh and as Unknown for swelling of entire thigh. List of documents held by the sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Initial information received on 11-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (age and gender unknown) who experienced hives, while received vaccine ADACEL. The patients past medical history, medical treatment, concomitant medication and family history were not provided. On an unknown date in the year 2012, the patient received injection of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. Patient had all CDC recommended vaccines in 2012 during the same timeframe. On an unknown date, the patient developed a non-serious hives (urticaria) with unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Lab data was not provided. Final diagnosis was hives. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for hives. List of documents held by sender- none.
Age: 1.25
Sex: U
Vaccine: HIBV, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 11-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 15 months old patient receive expired one dosage form (a single dose vial) of vaccine ACTHIB (lot number: UI802AA, expiry date: 01-Jul-2018) via intramuscular route on 06-Jul-2018 (Diluent- lot number UI802AAA exp date: 01-Jul-2018, Powder- expires 08-Jul-2018). The patient's past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation. It was a case of actual medication error due to expired product administered. It was reported that the parents haven't reported any side effects at this time. 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.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional, nurse. This case involves a 18 years old female patient who received the imovax first two injections on time but is late for her next injection, while she received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 29-May-2018, the patient received 0.5 ml single dose of suspect RABIES (HDC) VACCINE (M14921M) and received another 0.5 ml single dose on 05-Jun-2018 (M14921M). It was a case of actual medication error due to Drug dose administration interval too long. No symptoms occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive  and Module VI of the 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.
Sex: F
Vaccine: TDAP
Symptoms: Laceration, Syringe issue
Clinical narrative: Initial information received on 11-Jul-2018 regarding an unsolicited valid non-serious case received from a Non health care professional. This case involves female patient (age unknown) (medical office assistant) who experienced flange on the syringe broke while the vaccine was being given, when the flange broke it cut her unknown finger, while she received vaccine ADACEL. The patients past medical history, concomitant medication and family history were not provided. On 06-Jul-2018, the patient received a 0.5ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, lot U5875AA, expiry date not provided via unknown route in unknown administration site. On 06-Jul-2018, the flange on the syringe broke while the vaccine was being given, when the flange broke it cut the patients unknown finger (laceration) and (syringe issue) same day following the administration of Diphtheria -2/Tetanus/5 AC Pertussis Vaccine. Final diagnosis was flange on the syringe broke while the vaccine was being given, when the flange broke it cut the medical office assistants unknown finger. Lab data was not provided. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown. List of documents held by sender- none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a physician via phone. This case seven month old patient (gender not reported) who was vaccinated with an expired one dose of PENTACEL (batch number not reported, expiry date 24-JUN-2018, route and site of administration were not reported) on 09 July 2018. It was a case of actual medication error due to expired vaccine used as PENTACEL was administered to a 7-month old patient on 09Jul2018 and the product was out of date with an expiration date of 24Jun2018. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial unsolicited report received from a nurse on 11-Jul-2018. This case involves a child patient (age and gender were not reported) who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, route and site of administration was not reported) an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to Inappropriate reconstitution technique. It was reported that patient was inadvertently given the DTAP and Polio part of the PENTACEL and did not mix it with the HIB portion. It was not known whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a patient received third dose of PENTACEL (batch number, expiry date 13 June 2018, route and site of administration was not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two months old patient (gender not reported) who did not receive ACTHIB, while patient received a 0.5 mL 1 dose of PENTACEL in left leg on 03 July 2018. The patient's past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included Pneumococcal Conjugate Vaccine for Immunisation; and Rotavirus Vaccine for Immunisation (on 03 July 2018). It was a case of actual medication error due to Inappropriate reconstitution technique. It was reported that Vial 1 had DTAP/TPA and Vial 2 had the ACTHIB. The nurse only gave the Diluent and did not constitute the medicine. 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.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial unsolicited report received from a nurse on 13-Jul-2018. This case involves a four-month-old patient (gender not reported) who was vaccinated with a first and second dose of PENTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on 11-May-2018 and 16-May-2018 respectively (unknown batch number via unknown route in unknown administration site). The patient's medical history and concomitant medications were not reported. It was an actual medication error due drug dose administration interval too short. It was reported that the patient had no side effect. 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: 58.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 58 years old male patient who was one week late for the second dose in the series, while he received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Jul-2018, the patient received a 0.5 mL dose of suspect RABIES (HDC) VACCINE lot number not reported. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was reported that the patient who received IMOVAX, 2 weeks ago and was one week late for the second dose in the series which was due on 09-Jul-2018. The patient had not been seen since first injection, but was expected to come in to continue his series today. 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 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: IPV
Symptoms: Nausea, Overdose
Clinical narrative: Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who experienced nausea while he received vaccine IPV (VERO) [IPOL]. The patients past medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was also a case of an actual medication error due to overdose as medical assistant on 26-Jun-2018 gave ipol 3ml, or 6 times recommended 0.5ml dose, due to thinking it was single dose vial instead of mdv. On 26-Jun-2018, the patient received a 0.5ml dose of suspect IPV (VERO) lot number, expiry date not reported via unknown route in unknown administration site. On 26-Jun-2018, the patient developed a non-serious nausea with unknown latency following the administration of IPV (VERO). Patient was treated in emergency room. Final diagnosis was nausea and overdose. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for nausea. 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 Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 6 months old patient (gender unknown) who was given pentacel dilutent part but not the acthib portion, while received vaccine PENTACEL. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. On 10-Jul-2018, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, expiry date and site of administration not reported in the left thigh. It was reported that patient was given Pentacel dilutent part but not the ActHib portion. 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  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: DTAPIPVHIB, PNC13, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional via phone. This case involves a 4 months old male patient received 0.5 ml expired PENTACEL (frequency once, batch number C5391AB, expiry date 24-JUN-2018) in right thigh on 16 July 2018. Concomitant medication included PREVENAR and Rotavirus. It was a case of actual medication error due to expired vaccine used. ER/Dr visit and date16 July 2018 (also reported as 16 July 1988). It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.