chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Extra dose administered, Injection site reaction, Local reaction
Clinical narrative: Initial information received on 19-Jan-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a five years old female patient who did cry and pull her arm away after the second dose of vaccine QUADRACEL instead of MMR, on 18-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Jan-2019, the patient received a fifth 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AB via intramuscular route in the left arm and also received a 0.5 ml dose of the same vaccine lot C5532AB via intramuscular route in the left arm on same day. On 18-Jan-2019, the patient crying same day following the administration of second dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was reported that somehow there was a misunderstanding that the first vaccine give had been an MMR vaccine, and so a second dose of QUADRACEL was administered IM to the patient by the nurse. (Other relevant tests included no lab data). Final diagnosis was cry, extra dose administered and wrong product administered. No specific treatment had been given, other than monitoring the patient for any adverse reactions. The outcome of the event cry was unknown at the time of report. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Crying, Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 19-Jan-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a five years old female patient who did cry and pull her arm away after the second dose of vaccine QUADRACEL instead of MMR, on 18-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Jan-2019, the patient received a fifth 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AB via intramuscular route in the left arm and also received a 0.5 ml dose of the same vaccine lot C5532AB via intramuscular route in the left arm on same day. On 18-Jan-2019, the patient crying same day following the administration of second dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was reported that somehow there was a misunderstanding that the first vaccine give had been an MMR vaccine, and so a second dose of QUADRACEL was administered IM to the patient by the nurse. (Other relevant tests included no lab data). Final diagnosis was cry, extra dose administered and wrong product administered. No specific treatment had been given, other than monitoring the patient for any adverse reactions. The outcome of the event cry was unknown at the time of report. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Severe red rash which lasted for 4 days and is now fading. Slight body temperature which did not exceed 100.4 F. Baby was uncomfortable and itched on her face and head during the second day of the rash. The doctor recommended TYLENOL if she became uncomfortable, and children's CLARITIN once per day until relieved.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Body temperature, Discomfort, Pruritus, Rash erythematous
Clinical narrative: Severe red rash which lasted for 4 days and is now fading. Slight body temperature which did not exceed 100.4 F. Baby was uncomfortable and itched on her face and head during the second day of the rash. The doctor recommended TYLENOL if she became uncomfortable, and children's CLARITIN once per day until relieved.
Age: 1.58
Sex: F
Vaccine: HIBV, MEN, TDAP, UNK, UNK
Symptoms: Respiration abnormal, Wheezing
Clinical narrative: While napping, patient was breathing really oddly. It sounded like wheezing almost. Patient has had a respiratory virus for a few weeks, but has not had breathing like this until after her appoimtment. I called the pediatrician's office, they described what concerning breathing would look like, and it did not fit the description. They told me to monitor her breathing, and tonight she sounds the same as well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients. The patients historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patients were vaccinated with an unspecified number of doses of PROQUAD subcutaneously, reported lot number R011217, expiry date 15-OCT-2019, reported lot number R011802, expiry date 21-OCT-2019, (laterality, strength, dose and frequency were not reported) and VARIVAX reported lot number R009411, expiry date 29-MAR-2020, reported lot number R003300, expiry date 01-FEB-2020, reported lot number N035940, expiry date 18-DEC-2019 and reported lot number N034551, expiry date 05-DEC-2019 (laterality, strength, dose, route and frequency were not reported) both vaccines for prophylaxis, following a temperature excursion.  The administered doses of the vaccines experienced a temperature excursion of 6°F to 14°F (-14°C to -10°C) for 14 hours 30 minutes and of 15°F to 46°F (-9°C to 8°C) (-6.1°C) for 20 minutes, with multiple excursions, as recorded by a data logger. No previous temperature excursion was reported and there was no adverse effect reported. No product quality complaint was filed. This case was considered non-valid due to lack of patient identifiers. As of 09-NOV-2018, all telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received from the registered nurse on 08-JAN-2019, referring to a 4-year-old male patient. It was reported that the patient had two brothers/sisters. Concomitant therapies included albuterol (VENTOLIN) and beclomethasone dipropionate (QVAR) (also reported as suspect therapies, discrepant information), and his concurrent conditions included asthma and developmental delay. On 18-SEP-2018, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (strength and dose were not provided), lot number R011217 (lot number R011217 was an invalid lot number for M-M-R II(expiration date not provided), subcutaneously, in the left thigh, for prophylaxis; and with diphtheria toxoid, pertussis acellular 1-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV)(strength and dose were not provided), lot number reported as C5497AA (expiration date not provided), intramuscularly, in the left thigh. There was no adverse effect reported . It was also reported that the patient received an unspecified treatment for the event. This is one of several reports received from the same reporter.; Sender's Comments: US-09507513-1809USA010598: US-09507513-1901USA002753: US-09507513-1901USA002754: US-09507513-1901USA002755: US-09507513-1901USA002764: US-09507513-1901USA002763: US-09507513-1901USA002762: US-09507513-1901USA002761: US-09507513-1901USA002760: US-09507513-1901USA002759: US-09507513-1901USA002758: US-09507513-1901USA002765: US-09507513-1901USA002756:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring a patient of unknown age and unknown gender. The patient's concurrent condition, historical drugs, medical history and concomitant therapy were not reported. On 09-JAN-2019, the patient was administered a dose of GARDASIL 9 (lot#: R008164, expiration date: 12-NOV-2020; strength, route and frequency were not reported; for prophylaxis) that may have been improperly stored. No adverse effects were reported.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report has been received from a 67 years old female patient referring to herself. Information about medical history, and concurrent conditions was not provided. The patient's concomitant therapy included PROLIA. On 30-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 (1 x 0.5 mL dose, route of administration and anatomical location were not reported) for prophylaxis. On 01-DEC-2018, 2 days after onset of therapy the patient experienced "soreness at injection site and in the front and back of her left shoulder and the pain ran down to her fingers". The patient's also turned bright red, like a sunburn, she also had a fever. Unspecified treatment was given for the events. No laboratory studies performed. At the time of this report, the outcome of all the event was recovered on unspecified dates. The causality between the events and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered improperly stored GARDASIL 9 for prophylaxis lot #1586751 and expiration date 16-FEB-2021 (strength, dose, frequency and route of administration were not reported).  No adverse effects were reported. The lowest temperature of excursion was below 36°F / 2°C (34.9°F) for 28 minutes including below 32°F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-09507513-1901USA010543: US-09507513-1901USA010542: US-09507513-1901USA010541: US-09507513-1901USA010539: US-09507513-1901USA010540.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 21-JAN-2019, the patient was inadvertently vaccinated with M-M-R II (therapy type: rHA, lot # M045394, expiration date 14-NOV-2018, one injection, strength and frequency were not reported) subcutaneously for prophylaxis. The patient did not experience any reaction. The outcome of the event was unknown.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a 12-month-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 24-JAN-2019, the patient was vaccinated with a dose of VARIVAX (lot # R020652 and expiration date 18-JUL-2020), subcutaneously for prophylaxis. The administered dose experienced a temperature excursion of -2.3 degree Celsius for 1 hour. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1901USA010788: US-009507513-1901USA010789: US-009507513-1901USA010790.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a 4-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 24-JAN-2019, the patient was vaccinated with a dose of VARIVAX (lot # R020652 and expiration date 18-JUL-2020), subcutaneously for prophylaxis. The administered dose experienced a temperature excursion of -2.3 degree Celsius for 1 hour. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1901USA010637: US-009507513-1901USA010789: US-009507513-1901USA010790.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a 4-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 24-JAN-2019, the patient was vaccinated with a dose of VARIVAX (lot # R020652 and expiration date 18-JUL-2020), subcutaneously for prophylaxis. The administered dose experienced a temperature excursion of -2.3 degree Celsius for 1 hour. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1901USA010637: US-009507513-1901USA010788: US-009507513-1901USA010790.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a 2-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 24-JAN-2019, the patient was vaccinated with a dose of VARIVAX (lot # R020652 and expiration date 18-JUL-2020), subcutaneously for prophylaxis. The administered dose experienced a temperature excursion of -2.3 degree Celsius for 1 hour. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1901USA010637: US-009507513-1901USA010788: US-009507513-1901USA010789.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Dyspnoea, Feeling abnormal, Influenza like illness, Injection site injury
Clinical narrative: Initial information received on 16-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves 59-year-old female patient who experienced blister, feeling abnormal, localised infection, influenza like illness, oropharyngeal pain, dyspnoea, injection site injury, peripheral swelling, pruritus and pyrexia, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE for 25 years without reaction. The patient's medical treatment, past medical history and family history were not provided. On 11-Jan-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) in the left arm. On 11-Jan-2019, the patient developed a non-serious five fluid-filled blisters in left arm (first 3, then 2 more, then yesterday 1 more), sores (blister), on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 16-Jan-2019, the patient developed a non-serious flu (influenza like illness), 5 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient felt bad and laid around (feeling abnormal), her left arm burst open with infection (localised infection), raw throat (oropharyngeal pain), difficulty breathing intermittently during Sunday night, Monday and Tuesday (dyspnoea), like a big hole in arm (injection site injury), arm in which she received the injection (left) has swollen (peripheral swelling), blisters left arm they hurt and itch (pruritus) and she has been running a fever of 101 (pyrexia), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient also stated that she may end up with scarring on her left arm. The patient went to Emergency room (ER visit) over the weekend due to her left arm infection. It was reported that the patient was seeking compensation for her reaction. Other relevant tests were not reported. Final diagnosis was blister, feeling abnormal, localised infection, influenza like illness, oropharyngeal pain, dyspnoea, injection site injury, peripheral swelling, pruritus and pyrexia. Patient received Benadryl, Augmentin (strength: 875 mg) and mupirocin ointment to put on her arm as a corrective treatment. The outcome of the events feeling abnormal and fever was not reported. The patient was not recovered from the other events. Follow-up information was received from a consumer or non-healthcare professional by phone on 17-Jan-2019. Date of birth, patient age, site of administration of suspect vaccine, additional events and corrective treatment was updated and changes made in the field and narrative accordingly. Follow-up information was received from a consumer or non-healthcare professional by phone on 22-Jan-2019. Additional events localised infection and fever added. Event details, emergency room visit and corrective treatment were updated and changes made in the field and narrative accordingly. List of document held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Localised infection, Oropharyngeal pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Initial information received on 16-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves 59-year-old female patient who experienced blister, feeling abnormal, localised infection, influenza like illness, oropharyngeal pain, dyspnoea, injection site injury, peripheral swelling, pruritus and pyrexia, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE for 25 years without reaction. The patient's medical treatment, past medical history and family history were not provided. On 11-Jan-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) in the left arm. On 11-Jan-2019, the patient developed a non-serious five fluid-filled blisters in left arm (first 3, then 2 more, then yesterday 1 more), sores (blister), on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 16-Jan-2019, the patient developed a non-serious flu (influenza like illness), 5 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient felt bad and laid around (feeling abnormal), her left arm burst open with infection (localised infection), raw throat (oropharyngeal pain), difficulty breathing intermittently during Sunday night, Monday and Tuesday (dyspnoea), like a big hole in arm (injection site injury), arm in which she received the injection (left) has swollen (peripheral swelling), blisters left arm they hurt and itch (pruritus) and she has been running a fever of 101 (pyrexia), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient also stated that she may end up with scarring on her left arm. The patient went to Emergency room (ER visit) over the weekend due to her left arm infection. It was reported that the patient was seeking compensation for her reaction. Other relevant tests were not reported. Final diagnosis was blister, feeling abnormal, localised infection, influenza like illness, oropharyngeal pain, dyspnoea, injection site injury, peripheral swelling, pruritus and pyrexia. Patient received Benadryl, Augmentin (strength: 875 mg) and mupirocin ointment to put on her arm as a corrective treatment. The outcome of the events feeling abnormal and fever was not reported. The patient was not recovered from the other events. Follow-up information was received from a consumer or non-healthcare professional by phone on 17-Jan-2019. Date of birth, patient age, site of administration of suspect vaccine, additional events and corrective treatment was updated and changes made in the field and narrative accordingly. Follow-up information was received from a consumer or non-healthcare professional by phone on 22-Jan-2019. Additional events localised infection and fever added. Event details, emergency room visit and corrective treatment were updated and changes made in the field and narrative accordingly. List of document held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Initial information received on 16-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves 59-year-old female patient who experienced blister, feeling abnormal, localised infection, influenza like illness, oropharyngeal pain, dyspnoea, injection site injury, peripheral swelling, pruritus and pyrexia, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE for 25 years without reaction. The patient's medical treatment, past medical history and family history were not provided. On 11-Jan-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) in the left arm. On 11-Jan-2019, the patient developed a non-serious five fluid-filled blisters in left arm (first 3, then 2 more, then yesterday 1 more), sores (blister), on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 16-Jan-2019, the patient developed a non-serious flu (influenza like illness), 5 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient felt bad and laid around (feeling abnormal), her left arm burst open with infection (localised infection), raw throat (oropharyngeal pain), difficulty breathing intermittently during Sunday night, Monday and Tuesday (dyspnoea), like a big hole in arm (injection site injury), arm in which she received the injection (left) has swollen (peripheral swelling), blisters left arm they hurt and itch (pruritus) and she has been running a fever of 101 (pyrexia), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient also stated that she may end up with scarring on her left arm. The patient went to Emergency room (ER visit) over the weekend due to her left arm infection. It was reported that the patient was seeking compensation for her reaction. Other relevant tests were not reported. Final diagnosis was blister, feeling abnormal, localised infection, influenza like illness, oropharyngeal pain, dyspnoea, injection site injury, peripheral swelling, pruritus and pyrexia. Patient received Benadryl, Augmentin (strength: 875 mg) and mupirocin ointment to put on her arm as a corrective treatment. The outcome of the events feeling abnormal and fever was not reported. The patient was not recovered from the other events. Follow-up information was received from a consumer or non-healthcare professional by phone on 17-Jan-2019. Date of birth, patient age, site of administration of suspect vaccine, additional events and corrective treatment was updated and changes made in the field and narrative accordingly. Follow-up information was received from a consumer or non-healthcare professional by phone on 22-Jan-2019. Additional events localised infection and fever added. Event details, emergency room visit and corrective treatment were updated and changes made in the field and narrative accordingly. List of document held by sender: none.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 18-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 18 years old patient who was inadvertently administered an extra 0.5 ml dose of ADACEL lot C5243AA via unknown route in the right arm, on 18-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunisation. It was an actual medication error case due extra dose administered. It was reported that ADACEL was inadvertently administered to a patient who received ADACEL two weeks ago. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 18-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves 24 Months old female patient who received 0.5 ml fourth dose of vaccine PENTACEL without the powder ACTHIB portion (lot number and Expiry date unknown) via unknown route in unknown administration site. The patients' medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported that if any adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 18-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 44 years old female patient who received 0.5 ml dose of FLUZONE QUADRIVALENT on 10-Jan-2019,which was expired last year (lot UI876AB expiry date: 20-Jun-2018 via intramuscular route in the left deltoid). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to expired vaccine used. No side effects 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: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Injection site reaction, Local reaction
Clinical narrative: Initial information received on 19-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse (mother of the patient). This case involves female patient of an unknown age who experienced local injection site reaction at each injection site, while she received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Jan-2019, the patient received two doses of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via intramuscular route in unknown administration site and same vaccine with an unknown batch number via subcutaneous route in the left arm. On an unknown date, the patient developed a non-serious local injection site reaction at each injection site following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. It was also the case of actual medication error due to extra dose administered and incorrect route of product administration. Inadvertently administered two doses of QUADRACEL yesterday (18 Jan 2019) by a nurse in the practice. Reporter stated that one of the QUADRACEL doses was given Intramuscular, but the other one may have been given Subcutaneous. (Other relevant tests included no lab data). Final diagnosis was QUADRACEL doses was given intramuscular, but the other one may have been given subcutaneous, inadvertently administered two doses of QUADRACEL and local injection site reaction at each injection site. It was not reported if the patient received a corrective treatment. The patient got recovered from local injection site reaction at each injection site. 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: F
Vaccine: TDAP
Symptoms: Wrong technique in product usage process
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves female patient (age not reported) who was vaccinated with a dose of vaccine ADACEL (lot number, Exp. Date, dose, route of administration were not reported) in the deltoid region. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to wrong injection technique. It was reported that, vaccine given in the deltoid with a 1-inch needle and was not sure whether it was truly IM or SC because of the patient's body size. No any adverse event observed. 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: 4.0
Sex: M
Vaccine: DTAP, FLU4, MMR
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old male patient who received a 0.25ml dose of FLUZONE QUADRIVALENT batch number: UT6262NA, expiration date: 21-Jun-2019  via intramuscular route in the left thigh on 09-Jan-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) on 09-Jan-2019. It was an actual medication error due to vaccine underdose. A 4 years old male patient was administered 0.25 ml FLUZONE QUADRIVALENT. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Alopecia, Asthenia, Diarrhoea, Dizziness, Weight decreased
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a over 65 years old female patient who experienced weight loss of 10 pounds, dizziness, weakness, hair loss and diarrhea, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Sep-2018, the patient received a 0.5 ml dose  of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot: UJ004AB, expiry date: 30-MAR-2019) via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious weight loss of 10 pounds, dizziness, weakness, hair loss and diarrhea (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was diarrhea, weakness, dizziness, hair loss and weight loss of 10 pounds. The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea. On an unknown date, the patient outcome was not reported. List of document held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Headache, Injection site erythema, Muscle spasms, Musculoskeletal pain
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from a Pharmacist via phone. This case is linked to case 2019SA021433. This case involves an 85 years old female patient who experienced pain moved to her shoulder, then her neck into her ear and head, soreness and a knot in arm, muscle spasms and redness in her arm at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Aug-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number UI993AB and Exp. Date 18-MAR-2019) not reported via intramuscular route in the arm nos. On an unknown date, the patient experienced non-serious pain moved to her shoulder, then her neck into her ear and head, soreness and a knot in arm (radiating pain), muscle spasms and redness in her arm at the injection site (vaccination site erythema) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Details of lab data not provided. Final diagnosis was redness in her arm at the injection site, muscle spasms and pain moved to her shoulder, then her neck into her ear and head, soreness and a knot in arm. The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Muscle spasms. The patient had not recovered from the events. List of documents held by sender: none. Follow up information received from non healthcare professional on 22-Jan-2019. Vaccine details added (lot number and Exp. date). List of documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Pain in extremity
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from a Pharmacist via phone. This case is linked to case 2019SA021433. This case involves an 85 years old female patient who experienced pain moved to her shoulder, then her neck into her ear and head, soreness and a knot in arm, muscle spasms and redness in her arm at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Aug-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number UI993AB and Exp. Date 18-MAR-2019) not reported via intramuscular route in the arm nos. On an unknown date, the patient experienced non-serious pain moved to her shoulder, then her neck into her ear and head, soreness and a knot in arm (radiating pain), muscle spasms and redness in her arm at the injection site (vaccination site erythema) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Details of lab data not provided. Final diagnosis was redness in her arm at the injection site, muscle spasms and pain moved to her shoulder, then her neck into her ear and head, soreness and a knot in arm. The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Muscle spasms. The patient had not recovered from the events. List of documents held by sender: none. Follow up information received from non healthcare professional on 22-Jan-2019. Vaccine details added (lot number and Exp. date). List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid non-serious case received from a Pharmacist via phone. This case is linked to case 2019SA020397. This case involves an 90 years old male patient who had sore arm, while she received vaccine FLUZONE HIGH DOSE. The patients 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 USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown, site and route not reported). On an unknown date, the patient experienced non-serious  sore arm (Pain in extremity) (Other relevant tests included No lab data.) Final diagnosis was sore arm. It was not reported if any corrective treatment was recieved. The patient had recovered from the event. List of documents held by sender: none.
Age: 1.5
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Crying, Extra dose administered
Clinical narrative: Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 months old female patient who received fourth dose of KINRIX via intramuscular route in the right thigh as well as a separate dose of vaccine IPOL (batch number: P1A171M, expiry date: APR-2020) via Subcutaneous route in the left thigh on 22-Jan-2018 and had crying during the injections. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Jan-2019 during injection patient was crying. Concomitant medication was not reported. It was a case of actual medication error due to Extra dose administered. The outcome of event crying during the injections was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a seven months old female patient who received a 0.5 ml expired dose of ACT-HIB batch number: UI860AAA, expiration date: 09-Jan-2019 via unknown route in the left thigh on 22-Jan-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was PREVNAR 13, FLULAVAL and PEDIARIX. It was an actual medication error due to expired vaccine used. A 7 month old received expired ACT-HIB vaccine. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 3 years old female patient who was vaccinated with 0.5 ml dose of QUADRACEL (lot C5497AA, expiry date: 17-Jul-2020, route of administration was not reported) in left deltoid instead of IPOL, DAPTACEL on 28-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation. It was a case of actual medication error due to wrong vaccine administered as physician ordered DAPTACEL and IPOL, but QUADRACEL was given in error by a medical assistant who was new to the office and inappropriate age at vaccine administration as QUADRACEL was administered at less than 4 years of age. It was reported that QUADRACEL vaccine was given in the left deltoid for the second polio vaccine and the third DTaP vaccine in the patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old female patient who was administered an expired 0.5 ml third dose of PENTACEL (Powder lot C5439AA, expiry date: 29-Oct-2018, Liquid lot C5264AA, expiry date: 26-Oct-2018) via intramuscular route in the left thigh on 21-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; ROTATEQ for Immunisation; and INFLUENZA for Immunisation. It was a case of actual medication error due to expired vaccine used. No adverse reactions reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Wrong product administered
Clinical narrative: Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA022342.(same reporter). This case involves a 70 years old male patient who got FLUZONE QUADRIVALENT instead of FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 14-Sep-2018, the patient received 0.5 ml single first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot 25228 expiry date: 01-May-2019 via intramuscular route in the right deltoid. On an unknown date, patient presented with flu post vaccination with INFLUENZA QUADRIVAL A-B VACCINE. It was also a case of actual medication error due to wrong vaccine administered. No lab test was reported. As corrective treatment, patient received Tamiflu. Outcome of the event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Adenovirus infection, Malaise, Meningitis
Clinical narrative: Pt contracted the Adenovirus/ Meningitis within 24 hrs of receiving the routine 6 month vaccinations. PT was hospitalized for 4 days. Treatment included sodium chloride and ROBAXIN while hospitalized. Pt has fully recovered from sickness.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted yet.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Twenty minutes after administration, patient experienced itching all over. Patient took 50 mg BENADRYL and within 60 minutes itching subsided and no further itchiness occurred. Two hours after administration, patient started having redness at the site, swelling, pain, high fever and fatigue. Today raised, warm, red erythematous areas are noted at right deltoid one is 4 inches by 3 inches with a second medial to the first that just started this morning, measuring 1 1/2 " x 1 ".  Patient states this second one is getting bigger.