chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: U
Vaccine: FLU4
Symptoms: Allergy test negative, Cough, Eye pruritus, Sneezing
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 6 years old patient (gender not reported), who experienced sneezing, began to have itchy eyes, cough, erythema at the injection site and the patient was tested for egg allergy and that was negative/unsure if this reaction is a contraindication to her receiving the flu vaccine again, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine lot number not reported. On an unknown date, the patient developed a non-serious sneezing 30 minutes following the administration of Influenza Quadrival A-B Vaccine. On an unknown date, the patient developed a non-serious began to have itchy eyes (eye pruritus) 30 minutes following the administration of Influenza Quadrival A-B Vaccine. On an unknown date, the patient developed a non-serious cough 30 minutes following the administration of Influenza Quadrival A-B Vaccine. On an unknown date, the patient developed a non-serious erythema at the injection site (vaccination site erythema) 30 minutes following the administration of Influenza Quadrival A-B Vaccine. It was a case of contraindication to vaccination as the patient had tested for egg allergy and that was negative. It was reported that the reporter was unsure if there are other components of the vaccine that may have caused her to have localized reaction. Other relevant tests included On an unknown date, the patient was tested for egg allergy and that was negative. Final diagnosis was the patient was tested for egg allergy and that was negative/unsure if this reaction is a contraindication to her receiving the flu vaccine again, erythema at the injection site, cough, began to have itchy eyes and sneezing. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for sneezing, as Unknown for began to have itchy eyes, as Unknown for cough, as Unknown for erythema at the injection site and as Not Applicable for the patient was tested for egg allergy and that was negative/unsure if this reaction is a contraindication to her receiving the flu vaccine again. Documents held by the sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven- years old patient (gender was not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (lot: UJ034AB in the left deltoid) on an unknown date. 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 vaccine underdose and exposure via skin contact. There was not any cracks in the syringe. It was unsure if the patient received a complete dose because it looked like most of it was on the patient's arm..No adverse events reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298512, 2018SA298593, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298695, 2018SA298701 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a 5 ml dose of FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 (frequency once, Suspension for injection in pre-filled syringe) via intramuscular route in unknown site on an unknown date (reported as during the period 01Oct2018 to 08Oct2018). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was given. It is an actual medication error case due to incorrect product storage and overdose. It was reported that temperature report of the refrigerator showed that the FLUZONE HD was frozen at some time and were injected to 15 patients. It was unknown whether the patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 68 years old male patient who experienced nausea and headache, while he received FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was reported. On 25-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported in the left arm. On an unknown date, the patient developed a non-serious nausea following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious headache following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was headache and nausea. Lab tests not reported. The patient was treated with TYLENOL for Headache and IBUPROFEN for Headache. The patient outcome is reported as Recovered/Resolved on an unknown date for nausea and as Recovered/Resolved on an unknown date for headache.
Sex: U
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (pharmacy student). This case involves an 80 years old patient (gender was not reported) who experienced bruising at the injection site, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient didn't have any other vaccines administered. On 20-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported in the deltoid NOS. On an unknown date, the patient developed a non-serious bruising at the injection site following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No lab data reported. Final diagnosis was bruising at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for bruising at the injection site.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an elderly patient (age was reported as 95) who was vaccinated with doses of FLUZONE HIGH DOSE (lot number: UJ039AA and expiry date: 15-May-2019) on 11-Oct-2018 and 25-Oct-2018 respectively. 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 extra dose administered and inappropriate schedule of drug administration. It was not reported whether the patient experienced any adverse event was reported following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Skin exfoliation
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 74 years old male patient who developed top layer of skin surrounding at the injection site on the left upper arm peeled off in a six inch by four inch area and it stings a little, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported the patient has no known drug allergies. Concomitant medication was none. Reported as no other vaccines. On 24-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI986AB expiry date: 30-Jun-2019 via intramuscular route in the left upper arm. On an unknown date (reported as noticed on 30-Oct-2018) the patient developed a non-serious the top layer of skin surrounding the injection site on the patient's left upper arm peeled off in a six inch by four inch area following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also reported that on 29-Oct-2018 patient had a heating pad on his neck that may have also affected that area. On an unknown date, the patient developed a non-serious it stings a little (arthropod sting) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was it stings a little and the top layer of skin surrounding the injection site on the patient's left upper arm peeled off in a six inch by four inch area. Patient received NEOSPORIN and bandage as a corrective treatment. The patient outcome is reported as Unknown for the top layer of skin surrounding the injection site on the patient's left upper arm peeled off in a six inch by four inch area and as Unknown for it stings a little. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Fatigue, Feeling hot, Flushing, Local reaction
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves Adult female patient who experienced localized reaction, feels sluggish, flushing and redness in her face and felt warm but no fever, and achiness in her legs, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical treatment included ACYCLOVIR [ACICLOVIR] and PREDNISONE with for 4 days for another problem but is not sure which year.. It was also reported that she had Shingles twice this year in May and July. The patient's past medical history, vaccination(s) and family history were not provided. Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious localized reaction (local reaction) four hour following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious feels sluggish (sluggishness) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious flushing and redness in her face and felt warm but no fever (flushing) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious flushing and redness in her face and felt warm but no fever (erythema) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious achiness in her legs (pain in extremity) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also reported she has never felt this tired. Her husband got the same type of injection and he had no problems but weighs more than she does. States the pharmacist told her they only had one other person with this type of reaction. (Other relevant tests included No lab data.) Final diagnosis was achiness in her legs, flushing and redness in her face and felt warm but no fever, feels sluggish and localized reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for flushing and redness in her face and felt warm but no fever, as Unknown for feels sluggish, as Unknown for achiness in her legs and as Unknown for localized reaction. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Sluggishness
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves Adult female patient who experienced localized reaction, feels sluggish, flushing and redness in her face and felt warm but no fever, and achiness in her legs, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical treatment included ACYCLOVIR [ACICLOVIR] and PREDNISONE with for 4 days for another problem but is not sure which year.. It was also reported that she had Shingles twice this year in May and July. The patient's past medical history, vaccination(s) and family history were not provided. Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious localized reaction (local reaction) four hour following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious feels sluggish (sluggishness) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious flushing and redness in her face and felt warm but no fever (flushing) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious flushing and redness in her face and felt warm but no fever (erythema) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious achiness in her legs (pain in extremity) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also reported she has never felt this tired. Her husband got the same type of injection and he had no problems but weighs more than she does. States the pharmacist told her they only had one other person with this type of reaction. (Other relevant tests included No lab data.) Final diagnosis was achiness in her legs, flushing and redness in her face and felt warm but no fever, feels sluggish and localized reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for flushing and redness in her face and felt warm but no fever, as Unknown for feels sluggish, as Unknown for achiness in her legs and as Unknown for localized reaction. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Furuncle, Injection site reaction
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA304598 (same reporter). This case involves a 31 patients (gender was not reported) who developed a boil at the injection site, while he/she received vaccine FLUZONE QUADRIVALENT. The patients' past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported. On an unknown date, the patients received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UI998AE and expiry date: 30-Jun-2019) via intramuscular route in unknown administration site. On an unknown date, the patients developed a non-serious boil at the injection site following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that one patient had the boil cultured and there were no bacterial growth. (Other relevant tests included No lab data). Final diagnosis was developed a boil at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for developed a boil at the injection site. Follow up information was received from a pharmacist on 05-Nov-2018. Vaccination details of the suspect product was updated. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Chest pain, Muscle spasms, Throat tightness
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (reported as staff). This case involves a 49 years old patient of unknown age who experienced chest pain, throat tightness and muscle spasms, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On 17-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260BA expiry date: 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious chest pain 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious throat tightness 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious muscle spasms 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was muscle spasms, throat tightness and chest pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered / resolved on an unknown date for chest pain, as Recovered / Resolved on an unknown date for throat tightness and as Recovered / Resolved on an unknown date for muscle spasms. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 76 years old female patient who experienced muscle soreness is at the injection site and discomfort is at the injection site, 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 21-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ038AB, expiry date - 03-May-2019 in the left deltoid. On an unknown date patient developed a non-serious muscle soreness is at the injection site following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date patient developed a non-serious discomfort is at the injection site following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab test). Final diagnosis was discomfort is at the injection site and muscle soreness is at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for muscle soreness is at the injection site and as Unknown for discomfort is at the injection site.
Sex: U
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves patient who experienced inject reactions, while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. The patient developed a non-serious inject reactions (injection site reaction) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab test.) Final diagnosis was inject reactions. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for inject reactions.
Age: 60.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 60 years old male patient who experienced he had problem lifting his left arm, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PNEUMOVAX 23 for Immunisation on an unspecified date (reported as same-day). On 02-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6310NA; expiry date: 20-Jun-2019 via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious he had problem lifting his left arm, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No lab data reported. Final diagnosis was he had problem lifting his left arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for he had problem lifting his left arm.
Sex: U
Vaccine: FLU4, TD
Symptoms: Product storage error
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 10 patients who had vaccine stored at temperature outside the recommended range standard/in a refrigerator since Sept 2018 with unrecorded temperature, while he/she received vaccines FLUZONE QUADRIVALENT and TENIVAC and while treated with TUBERSOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking TUBERSOL dosage unknown route unknown (with an unknown batch number) for Tuberculin test. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5526AA, expiry date - 15-Dec-2018 via unknown route. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred 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.
Sex: M
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old male patient who had fluzone HD while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AB, expiry date- 31-May-2019 in the right deltoid. It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves male patient who gets violently ill, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route. The patient developed a non-serious gets violently ill, has even had a couple ambulance rides (malaise) following the administration of INFLUENZA VACCINE. Patient had even had a couple ambulance rides. (Other relevant tests included No lab test.) Final diagnosis was gets violently ill, has even had a couple ambulance rides. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for gets violently ill, has even had a couple ambulance rides.
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2018SA312352 and 2018SA308949 (same reporter). This case involves adult female patient (nurse) (age not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6258MA and expiry date: 30-Jun-2019, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of Occupational exposure to product because the nurse pushed the thing up and then felt wetness on my hand. No Lab data was reported. It was unknown whether the patient received any corrective treatment or not. Documents held by the sender: none.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU4, PPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 78 years old male patient who received vaccines FLUZONE HIGH DOSE and FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines was given. On 19-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ069AB via unknown route instead of PNEUMOCOCCAL VACCINE. On 16-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AB via unknown route in unknown administration site. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was not reported if 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.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 55 years old female patient for whom incorrect product storage happened while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medication. On 19-Nov-2018, the patient received a dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine lot lot number: U6103AA; EXP date: 25-oct-2018 via intramuscular route in the left deltoid. It was reported that the ADACEL shipment received was not viable as it was too long in transit and One ADACEL immunization was already given to a patient with the vaccine that was determined to be not viable. It was a case of actual medication error due to incorrect product storage issue.  Final diagnosis was vaccine that was determined to be not viable as it was too long in transit. 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.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Mobility decreased, Pain
Clinical narrative: I had a SHINGRIX (shingles vaccine yesterday). 2 hours later I developed a little fever (100 degrees) and my arm was swollen and in pain. I could barely move my arm. I took ALEVE to relieve it. Woke up fine, though my stomach was a little upset. As the day progresses, I started to feel worse, sharping body pain (back, legs, arms, neck) shivering, headache, minor fever, arm pain.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: I had a SHINGRIX (shingles vaccine yesterday). 2 hours later I developed a little fever (100 degrees) and my arm was swollen and in pain. I could barely move my arm. I took ALEVE to relieve it. Woke up fine, though my stomach was a little upset. As the day progresses, I started to feel worse, sharping body pain (back, legs, arms, neck) shivering, headache, minor fever, arm pain.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: IM PREVNAR immunization, given under aseptic technique on 10/31/18. Patient reported on 11/7/18 that she experiencing redness and swelling at injection site. She was seen in the office 11/08/18. On examination the patient had erythema, swelling and tenderness in a circular area (approximately 9 cm in diameter) surrounding the injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and feels awful. On an unknown date, the outcome of the fever and feels awful were recovered/resolved. It was unknown if the reporter considered the fever and feels awful to be related to SHINGRIX. Additional information received as follows: The patient felt horrible and had a fever (body temperature 102 degree F) for one day after her SHINGRIX injection. Lab Comments: In 2018, the patient's body temperature was recorded as 102 degree F.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Pruritus, Rash macular, Skin discolouration, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 49-year-old female patient who received SHINGRIX (batch number 77PL3, expiry date 18th April 2021) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 10th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) 50 µg. On an unknown date, the patient received the 1st dose of SHINGRIX. On 10th November 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 12th November 2018, the patient experienced swelling, skin blotches and skin discoloration. On 13th November 2018, the patient experienced pruritus. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the swelling, skin blotches, skin discoloration and pruritus were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the swelling, skin blotches, skin discoloration and pruritus to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX in the left deltoid. The patient developed 2 large blotches on her right arm those were swollen and had some white dots on them and they itched. The patient received 1st dose and 2nd dose of SHINGRIX at the age of 49 years, which led to inappropriate age at vaccine administration. The reporter gave consent to follow up. Unable to confirm if the patient's date of birth was correctly reported.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 15th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's husband. The patient received SHINGRIX on left arm. The patient experienced sore arm and a half-dollar sized red spot for 2 days and then they resolved. The reporter did not give consent to follow-up.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is 2nd of two reports. A 64-year-old female patient received PREVNAR 13 (Lot Number: S13847, Expire Date: 01Ju2020) via an unspecified route of administration at 0.5 ml, single in the right deltoid on 15Nov2018 for immunisation. Medical history none. There were no concomitant medications. On 15Nov2018, the patient experienced fever, swollen, red, and pain at injection site, chills. The  outcome of the events was recovered on an unspecified date in Nov2018.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018482600 same reporter same drug similar events different patients.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 82-years old patient of an unspecified gender received PREVNAR 13 (batch/lot number and expiration date were not reported), via an unspecified route of administration on 19Nov2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness at the injection site on an unspecified date. The outcome of the event was unknown.
Sex: F
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old female patient who received vaccines MENACTRA instead of the provided diluent and ACT-HIB. At the time of the event, the patient had ongoing Asplenia. Concomitant medication not reported. On 05-Oct-2018, the patient received 0.5 ml single dose of suspect HIB (PRP/T) VACCINE lot UI957AA via unknown route. On 05-Oct-2018, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5833AA. It was a case of actual medication error due to Inappropriate reconstitution technique. It was reported that medical assistant went to administer an ACTHIB vaccine to an adult, who is asplenic, but used MENACTRA to reconstitute it instead of the provided diluent. No adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB, TYP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA304535. This case involves a 10 years old female patient who was received expired dose of IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Oct-2018, the patient received a 0.5 ml once dose of suspect RABIES (HDC) VACCINE lot M15651M via intramuscular route, expiry date- 24-October-2018 in Left arm. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves male patient of unknown age of who experienced tingling in his arm, back, neck, all left sided only, numbness, muscle pain and weakness, while he received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunization. On 12-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI982AB via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious tingling in his arm, back, neck, all left sided only following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On an unknown date, the patient developed a non-serious numbness following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On an unknown date, the patient developed a non-serious muscle pain following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On an unknown date, the patient developed a non-serious weakness following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. (Other relevant tests included No lab data.) Final diagnosis was weakness, muscle pain, numbness and tingling in his arm, back, neck, all left sided only. The patient was treated with TRAMADOL. The patient outcome is reported as Unknown for muscle pain, as Unknown for weakness, as Unknown for numbness and as Unknown for tingling in his arm, back, neck, all left sided only. List of documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 37 years old female patient who was exposed to vaccine FLUZONE QUADRIVALENT in context of FLUZONE QUADRIVALENT was administered to a pregnant patient with her permission. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported FLUZONE QUADRIVALENT was administered to a pregnant patient with her permission occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6310LA and expiration date 30-Jun-2019) via unknown route in the left deltoid. It was not reported that the patient had no adverse event. (Other relevant tests included No lab data.) Final diagnosis was FLUZONE QUADRIVALENT was administered to a pregnant patient with her permission. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for FLUZONE QUADRIVALENT was administered to a pregnant patient with her permission. Additionally, at time of reporting, the outcome of the pregnancy is unknown. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves male patient who had an expired 0.5 ml dose of MENACTRA IM in the left arm today to a patient, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Nov-2018, the patient received a 0.5 ml  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5746AC, expiry date- 14-Oct-2018 Intramuscularly in left arm. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for an expired 0.5 ml dose of menactra im in the left arm today to a patient. 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.
Sex: F
Vaccine: FLU3
Symptoms: Needle issue, No adverse event
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 70 years old female patient who received vaccine FLUZONE HIGH DOSE (batch number: UJ044AA, expiry date: 04-Jun-2019, dose, dose in series and site of administration were not reported) via unknown route (reported as intramuscular or subcutaneous) on 08-Nov-2018 with a 5/8 inch needle instead of a 1 inch needle. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccine. It was a case of medication error due to Needle issue. No adverse event 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
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 4 months old female patient who received 0.25 ml pre-filled syringe dose today in left thigh, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.25 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6315PA, expiry date- 30-Jun-2019 via unknown route in the left thigh. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.