chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Dizziness, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Per patient: heads up on my reaction to the Flu/pneumococcal vaccines. I know the flu vaccines vary year to year and the reactions are sometimes recorded. My arm felt like it had been punched by 4pm the day of, not uncommon, I know. Within an hour feeling it coming on: light headed, leg aches, and arm increasingly sore. By 10 pm chills. Next day, still not feeling top notch, arm still in poor shape. In fact soreness spreading to inner bicep area. That night still getting chills. Barely lift my arm above shoulder level. Finally, next day I felt fine except for the arm. Bicep swollen and hives from inner bicep down to elbow. Yesterday, inner elbow was swollen. Some itching on upper arm as well. Good news, this morning arm is greatly improved and betting I am past this. I realize these may be common results of this years vaccine, but I also read there is a reporting agency that tracks this. So mainly this is a heads up to you.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Per patient: heads up on my reaction to the Flu/pneumococcal vaccines. I know the flu vaccines vary year to year and the reactions are sometimes recorded. My arm felt like it had been punched by 4pm the day of, not uncommon, I know. Within an hour feeling it coming on: light headed, leg aches, and arm increasingly sore. By 10 pm chills. Next day, still not feeling top notch, arm still in poor shape. In fact soreness spreading to inner bicep area. That night still getting chills. Barely lift my arm above shoulder level. Finally, next day I felt fine except for the arm. Bicep swollen and hives from inner bicep down to elbow. Yesterday, inner elbow was swollen. Some itching on upper arm as well. Good news, this morning arm is greatly improved and betting I am past this. I realize these may be common results of this years vaccine, but I also read there is a reporting agency that tracks this. So mainly this is a heads up to you.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reported soreness in arm radiating down towards hand.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Head injury, Insomnia, Loss of consciousness
Clinical narrative: 09/08/2018  Woke with left arm pain and large red spot about 4" X 6". Felt feverish and weak. Had difficulty falling asleep at night due to the arm pain. 09/09/2018 got out of bed at 4:00 a.m. to get an ice pack for the painful arm. Passed out on the kitchen floor. Came to and went back to the bedroom. Later that morning I had a large goose egg on the upper back right side of my head where I must have hit when I fainted. Continued to have pain and redness in the arm for a week. The red spot faded to pink and remained for another 2 weeks.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 09/08/2018  Woke with left arm pain and large red spot about 4" X 6". Felt feverish and weak. Had difficulty falling asleep at night due to the arm pain. 09/09/2018 got out of bed at 4:00 a.m. to get an ice pack for the painful arm. Passed out on the kitchen floor. Came to and went back to the bedroom. Later that morning I had a large goose egg on the upper back right side of my head where I must have hit when I fainted. Continued to have pain and redness in the arm for a week. The red spot faded to pink and remained for another 2 weeks.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Injection site was red, painful, edematous, hot to the touch in a circle approximately three inches in diameter approximately 24 hours after administration.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Injected high on arm and placed intra-articularly into shoulder joint (left arm). Immediately felt in shoulder and within an hour started to have shoulder pain and limited range of motion. Significant pain has continued and limited ROM. No e/o septic shoulder noted with no erythema and no systemic e/o infection.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pain, Swelling
Clinical narrative: The patient received the Vaccine on 10/11. On 10/12 the patient took her Band-Aid off and noticed her arm was red around the area. On 10/13 the patient noticed the area was red and raised below the injection site. On 10/12 the patient took some TYLENOL but if did not help so she took MOTRIN. On 10/13 the patient tried to use Hydrocortisone cream but it did not help and also by mouth BENADRYL to help. She experienced soreness around the injection site and area under injection site. On 10/15 the patient noticed the swelling had gone down and redness. On 10/16 the patient called the pharmacy to inform us and she is still experiencing some soreness with a pain level of 2 or 3.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Blood lactic acid normal, Blood pressure increased, Chest X-ray normal, Chills, Computerised tomogram head normal
Clinical narrative: Around 7:00 p.m., I became feverish, had chills with shaking. Covered up and fell asleep. When awoken at 11:30p.m., was feverish and confused. Temperature was 107.0 but as soon as cover was removed, temperature began to decrease. Was unable to stand without the help of two people and continued to be confused. Called 911 who found my blood pressure was elevated (150's), temp was 102.0. Was taken to emergency room by ambulance.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Culture urine negative, Differential white blood cell count normal, Dysstasia, Electrocardiogram normal
Clinical narrative: Around 7:00 p.m., I became feverish, had chills with shaking. Covered up and fell asleep. When awoken at 11:30p.m., was feverish and confused. Temperature was 107.0 but as soon as cover was removed, temperature began to decrease. Was unable to stand without the help of two people and continued to be confused. Called 911 who found my blood pressure was elevated (150's), temp was 102.0. Was taken to emergency room by ambulance.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Laboratory test normal, Lipase normal, Metabolic function test normal, N-terminal prohormone brain natriuretic peptide normal
Clinical narrative: Around 7:00 p.m., I became feverish, had chills with shaking. Covered up and fell asleep. When awoken at 11:30p.m., was feverish and confused. Temperature was 107.0 but as soon as cover was removed, temperature began to decrease. Was unable to stand without the help of two people and continued to be confused. Called 911 who found my blood pressure was elevated (150's), temp was 102.0. Was taken to emergency room by ambulance.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Streptococcus test negative, Tremor, Troponin I normal, Urine analysis normal
Clinical narrative: Around 7:00 p.m., I became feverish, had chills with shaking. Covered up and fell asleep. When awoken at 11:30p.m., was feverish and confused. Temperature was 107.0 but as soon as cover was removed, temperature began to decrease. Was unable to stand without the help of two people and continued to be confused. Called 911 who found my blood pressure was elevated (150's), temp was 102.0. Was taken to emergency room by ambulance.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: A rash started 12 hour after dose on inside of both bicepts, then next morning a rash under both arm pits, then following day a rash on both hips and butt. follow by a rash behind both knee's. Used  benadryl liquid, and cream. Rash now going on 4 days.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. In 2013, the patient was treated in a clinic for the onset of rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-OCT-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. On or about 20-FEB-2015, the patient was treated by a physician for the onset of rash, which was diagnosed as shingles. The patient was prescribed VALTREX (valacyclovir hydrochloride) for management of his painful symptoms and chronic pain. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On 24-OCT-2007, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. On or about 23-FEB-2013, the patient was treated for the onset of a vesicular rash which was diagnosed as severe herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 31-OCT-2012, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 17-FEB-2015, the patient was treated at the same physician's office for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-JUN-2008, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-Sep-2015, the patient was treated bya physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 06-SEP-2015, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-AUG-2016, the patient was treated at an urgent care for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2013, the patient was inoculated with ZOSTAVAX at a health clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-SEP-2014, the patient was treated at a health clinic for herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from the patient's mother referring to a female patient of unknown age. The patient's concurrent conditions included sulfa based medications allergy. The patient had not concomitant medications and no pertinent medical history. In July 2018, the patient was vaccinated with GARDASIL 9 "1 x 0.5-mL dose at 0, 2 and 6 months", intramuscularly, for prophylaxis (lot # and expiration date were not reported). On an unspecified date in 2018 (reported as "about two weeks after receiving her first dose"), the patient experienced warts on her fingers. At the time of reporting, the outcome of the event was reported as not recovered on an unspecified date. The causality assessment between warts on her fingers with GARDASIL 9 was not provided. This one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA006350: US-009507513-1810USA006397.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 04Oct2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable certified medical assistant calling on behalf of a physician and of the patient. A 69-year-old female patient received PREVNAR 13 (lot W11306) on 28Sep2018, at 0.5 ml single dose, intramuscular, in arm, for pneumonia prevention. Medical history and concomitant medications were not reported. On 28Sep2018 the patient experienced redness from shoulder to right above the elbow and shoulder warm to touch. The patient iced her arm over the weekend but the redness did not go away. The patient had no fever and everything else was normal. The events had not yet resolved at the time of report. The reporter considered there was a reasonable possibility that redness was related to PREVNAR 13. Causality for the event shoulder being warm to touch was not provided.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction to a pneumococcal vaccine and stated that it may be PREVNAR 13 on an unspecified date 10 years ago. Pharmacist wanted to know if there have been any ingredient changes in the past 10 years in pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The outcome of the event was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Haemolytic uraemic syndrome, Pneumococcal infection, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is 3rd of four reports. A patient of unspecified age and gender received PREVNAR 13 at single dose for immunization on unknown date. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced pneumococcal infection and then a hemolytic uremic syndrome. The outcome of the events was unknown. Information on the batch number 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 and Investigators as appropriate. Linked Report(s): US-PFIZER INC-2018410904 Same reporter/drug/event, different patient.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two female patients (one 70 and one 90-year-old). This is the 1st of two reports. An elderly female patient received PREVNAR 13; (lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization, and FLUZONE; (reported as HD flu (pending clarification)), via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that the patients received both HD flu vaccine and pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), and both experienced significant systemic reactions. This patient was out sick for a few days. The outcome of the event sick was unknown. Information on the batch/lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018414481 same reporter/drug, same event and different patient.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two female patients (one 70 and one 90-year-old). This is the second of two reports. A female patient of an unspecified age received PREVNAR 13; lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization, and influenza vaccine (FLUZONE; reported as HD flu (pending clarification)), via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that the patients received both HD flu vaccine and pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), and both experienced significant systemic reactions. This patient felt ill enough to seek medical attention for her physician. The outcome of the event felt ill was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018414465 same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Application site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness on the application site on an unspecified date. The outcome of the event was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling and excessive pain at the injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A 65-year-old female patient received PREVNAR 13, on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced sore arm and limited movement for about a month after receiving pneumococcal 13-val conj vaccines. Events resolved in about a month after seeing a massage therapist. Information on the batch number has been requested.
Sex: F
Vaccine: PNC
Symptoms: Asthenia, Fatigue, Malaise, Pain, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable consumer (acquaintance of patient). A female patient of an unspecified age received PREVNAR, via an unspecified route of administration on an unspecified date as single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced malaise, body pain, exhausted and feeling weak on an unspecified date. Details were as follows: the patient posted on the internet that she had a serve reaction to pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein). Her symptoms were reported as malaise, body pain, and she was exhausted. She described these symptoms as similar to influenza or pneumonia. She felt weak and "blah". The patient said that her doctor told her that she could never have the vaccine again. The outcome of malaise, body pain, exhausted and feeling weak was unknown. No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three years eight months old female patient who received 0.25 mL dose of vaccine FLUZONE QUADRIVALENT lot UT6259KA, expiry date: 30-Jun-19 via unknown route in the right deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccinations were given. It was an actual medication error due to vaccine underdose. It was reported that three-years-old female got the 0.25 mL dose. No side effects were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Extra dose administered, Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a health professional. This case involves a four-months old patient of unknown gender who received a dose of PENTACEL instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient also received a dose of IPOL and a dose of ACT-HIB. Patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccinations given. On 24-Sep-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot C5518AA expiry date: 15-Sep-2018 via intramuscular route in the left thigh. On 01-Oct-2018, the patient received a third 0.5 ml dose of ACT-HIB batch number: UI863AAA, exp date: 18-Feb-2019, intramuscularly in left thigh. On 08-Oct-2018, the patient received a third dose of 0.5 ml dose of IPOL batch number: N1G511M, exp date: 02-Aug-2019, intramuscularly in left thigh. It was reported that it was too early per schedule. Caller reported that the patient's parents did not want combination vaccines for the child. It was a case of actual medication error due to Wrong vaccine administered, inappropriate schedule of vaccine administered, expired vaccine used and extra dose administered. It was not reported that if any adverse event was experienced 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: DTAP, HIBV, VARCEL
Symptoms: Crying, Diarrhoea, Gastroenteritis, Inappropriate schedule of product administration, Injection site erythema
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 09-Oct-2018 from a consumer. This case involves an unknown gender four months old patient who experienced diarrhea, gastroenteritis, vomiting, very irritable, inconsolable crying, abdominal rash, fever, hard nodule at the injection site in the left thigh, redness and swelling, while he/she received vaccine DAPTACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was ACT-HIB, lot UI944AA, expiration date: 14-Nov-2019 and VARIPOX. On 18-Sep-2018, 24-Sep-2018 and 08-Oct-2018 respectively the patient received a dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, lot C5180AA, expiration date: 06-Apr-2019 via intramuscular route in the left thigh. On an unknown date, the patient developed a non-serious diarrhea (diarrhoea), gastroenteritis, vomiting, irritable (irritability), inconsolable crying (crying),abdominal rash (rash), fever (pyrexia), hard nodule at the injection site in the left thigh (injection site nodule) and redness and swelling (vaccination site inflammation) following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine. It was also reported that was diagnosed with gastroenteritis and HCP encouraged oral hydration. It was an actual medication error due to inappropriate schedule of drug administration (was administered before the interval of 6 to 8 weeks doses). Other relevant tests included no lab data. Final diagnosis was redness and swelling, hard nodule at the injection site in the left thigh, fever, abdominal rash, inconsolable crying, very irritable, vomiting, gastroenteritis and diarrhea. It was not reported if the patient received a corrective treatment. The patient outcome was Recovered / Resolved for event redness and swelling, hard nodule at the injection site in the left thigh, fever, abdominal rash, inconsolable crying, very irritable and the outcome for other event (vomiting, gastroenteritis and diarrhea) was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site induration, Injection site nodule, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 09-Oct-2018 from a consumer. This case involves an unknown gender four months old patient who experienced diarrhea, gastroenteritis, vomiting, very irritable, inconsolable crying, abdominal rash, fever, hard nodule at the injection site in the left thigh, redness and swelling, while he/she received vaccine DAPTACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was ACT-HIB, lot UI944AA, expiration date: 14-Nov-2019 and VARIPOX. On 18-Sep-2018, 24-Sep-2018 and 08-Oct-2018 respectively the patient received a dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, lot C5180AA, expiration date: 06-Apr-2019 via intramuscular route in the left thigh. On an unknown date, the patient developed a non-serious diarrhea (diarrhoea), gastroenteritis, vomiting, irritable (irritability), inconsolable crying (crying),abdominal rash (rash), fever (pyrexia), hard nodule at the injection site in the left thigh (injection site nodule) and redness and swelling (vaccination site inflammation) following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine. It was also reported that was diagnosed with gastroenteritis and HCP encouraged oral hydration. It was an actual medication error due to inappropriate schedule of drug administration (was administered before the interval of 6 to 8 weeks doses). Other relevant tests included no lab data. Final diagnosis was redness and swelling, hard nodule at the injection site in the left thigh, fever, abdominal rash, inconsolable crying, very irritable, vomiting, gastroenteritis and diarrhea. It was not reported if the patient received a corrective treatment. The patient outcome was Recovered / Resolved for event redness and swelling, hard nodule at the injection site in the left thigh, fever, abdominal rash, inconsolable crying, very irritable and the outcome for other event (vomiting, gastroenteritis and diarrhea) was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 09-Oct-2018 from a consumer. This case involves an unknown gender four months old patient who experienced diarrhea, gastroenteritis, vomiting, very irritable, inconsolable crying, abdominal rash, fever, hard nodule at the injection site in the left thigh, redness and swelling, while he/she received vaccine DAPTACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was ACT-HIB, lot UI944AA, expiration date: 14-Nov-2019 and VARIPOX. On 18-Sep-2018, 24-Sep-2018 and 08-Oct-2018 respectively the patient received a dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, lot C5180AA, expiration date: 06-Apr-2019 via intramuscular route in the left thigh. On an unknown date, the patient developed a non-serious diarrhea (diarrhoea), gastroenteritis, vomiting, irritable (irritability), inconsolable crying (crying),abdominal rash (rash), fever (pyrexia), hard nodule at the injection site in the left thigh (injection site nodule) and redness and swelling (vaccination site inflammation) following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine. It was also reported that was diagnosed with gastroenteritis and HCP encouraged oral hydration. It was an actual medication error due to inappropriate schedule of drug administration (was administered before the interval of 6 to 8 weeks doses). Other relevant tests included no lab data. Final diagnosis was redness and swelling, hard nodule at the injection site in the left thigh, fever, abdominal rash, inconsolable crying, very irritable, vomiting, gastroenteritis and diarrhea. It was not reported if the patient received a corrective treatment. The patient outcome was Recovered / Resolved for event redness and swelling, hard nodule at the injection site in the left thigh, fever, abdominal rash, inconsolable crying, very irritable and the outcome for other event (vomiting, gastroenteritis and diarrhea) was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves an 81 years old male patient who received vaccine FLUZONE HIGH DOSE (lot UJ039AA, expiration date 15-May-2019) via unknown route in the left deltoid on an unknown date. Medical history and concomitant therapies not reported. It was actual medication error due to vaccine underdose, exposure via skin contact and product issue due to syringe leak. It was reported that FLUZONE high dose leaked from had Leaked from the syringe during administration and patient had received a less than recommended dose. During administration the patient noticed that there was a leakage down his arm to his elbow, may be the whole dose had leaked. Reporter was unsure if it leaked from patients arm or from the tip of syringe where needle screws onto. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 66 years old male patient who received vaccine FLUZONE HIGH DOSE which was leaked from the needle hub (syringe tip). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ023AA expiry date: 25-Apr-2019 via unknown route in the left deltoid. It was a case of actual medication error due to vaccine underdose. It is also a case of Syringe issue (it was reported that leakage from the needle hub (syringe tip)). It was not reported that if any adverse event was not reported 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: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a non health care professional (manager). This case involves a 78 years old male patient who was vaccinated with a dose of ADACEL (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 6.0
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a six-years old patient who received an expired 0.5 ml dose of vaccine ADACEL (lot C5065AA, expiration date 08-Oct-2018) via intramuscular route in the left deltoid on 09-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration. No Adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 29.0
Sex: U
Vaccine: TYP
Symptoms: Manufacturing product shipping issue, Product storage error
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 29 years old patient who received vaccine TYPHIM VI (lot N1K121M, expiration date 10-Oct-2019) via intramuscular route in the left deltoid on 09-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Deteriorated drug administered and Product storage error. It was reported that vaccine was not good due to taking to long during shipping and we gave 2 doses. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 26.0
Sex: U
Vaccine: TYP
Symptoms: Manufacturing product shipping issue, Poor quality product administered, Product storage error
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case was linked with 2018SA284352 (Same reporter). This case involves a 26 years old patient (gender was not reported) who received 0.5 ml dose of vaccine TYPHIM VI (lot N1K121M, expiration date 10-Oct-2019) via intramuscular route in the left deltoid on 09-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Deteriorated drug administered and Product storage error. It was reported that received vaccine was not good due to taking to long during shipping and we gave 2 doses. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Extra dose administered, Fatigue
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old female patient who complained of feeling tired after she received vaccine FLUZONE HIGH DOSE twice by mistake. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation on an unknown date. On 26-Sep-2018, the patient received 0.5 ml dose and on 09-Sep-2018 again received 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AA (expiry date: 05-May-2019, via intramuscular route in the left deltoid for both injections. On an unknown date, the patient complaints of feeling tired following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No other symptoms were noted. It was also a case of actual medication error due to Extra dose administered. Final diagnosis was fatigue. Details of lab date was not provided. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for fatigue. 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.