chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site discolouration, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 2nd October 2018, the patient received the 1st dose of SHINGRIX. On 2nd October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 3rd October 2018, the patient experienced fever. On 4th October 2018, the patient experienced numbness of upper extremities. In October 2018, the patient experienced injection site discoloration. In October 2018, the outcome of the injection site discoloration was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever and numbness of upper extremities were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site discoloration, fever and numbness of upper extremities to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness and swelling at the injection site the same day that she had the injection and it lasted about a week. Then the site of injection was discolored from red to brown. That discoloration was gone at the reporting time, but it tooked a long time to go away. The patient experienced fever the day after the injection and it lasted a half a day. The patient experienced numbness in her whole arm where she received the injection and it lasted over a week and then it went away. The patient had denied permission to contact their physician.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain and pain in arm. On an unknown date, the outcome of the muscle pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the muscle pain and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The healthcare professional (HCP) reported that the patient developed muscle pain and arm pain for about 2 weeks after receiving the SHINGRIX. The patient received SHINGRIX from a different HCP than the one reporting it. The healthcare professional did not have patient information or vaccine details to share.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a 6-month-old female patient who received PEDIARIX for prophylaxis. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, less than a year after receiving PEDIARIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to PEDIARIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received PEDIARIX and other 6-month vaccines. It was unknown if the reporter considered the fever to be related to other 6-month vaccines. The reporter agreed to be follow up.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of pruritus in a patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In October 2018, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced pruritus, swelling and erythema. On an unknown date, the outcome of the pruritus, swelling and erythema were unknown. It was unknown if the reporter considered the pruritus, swelling and erythema to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The reporter was the Corporate Negotiator of the pharmacy. The age at vaccination was not applicable for this report. The patient demographic details were unknown. The reporter stated that they began giving flu vaccine a day before reporting and since then they had several staff members who had reactions such as redness, swelling and itching. All other information regarding vaccination was unknown. The reporter agreed to be followed up.
Sex: U
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a child patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. The reporter considered the pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided a follows: The age at the vaccination was not reported. The physician said her older children were experiencing more pain with GlaxoSmithKline flu vaccine than with non-GSK flu. The physician felt it was related to the product.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 16-year-old male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a week after receiving BEXSERO, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. After receiving BEXSERO, the patient experienced swollen and red arm, returned to doctor after one day with arm. Then returned 3 days later and it was fine. This was reported many weeks later and reporter did not have any further information. The patient initials were not known. The reporter did not agree to receive follow up from GSK.
Age: 45.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 45-year-old male patient who received MENVEO (batch number M17035, expiry date March 2019) for prophylaxis. On 27th September 2018, the patient received MENVEO. On an unknown date, less than a week after receiving MENVEO, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm was unknown and the outcome of the erythema of extremities was not recovered/not resolved. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to MENVEO. Additional details were reported as follows: The patient was administered the vaccine MENVEO and subsequently the patient's arm became red and swollen from the elbow to the shoulder. The patient called the next day complaining about redness. The reporter told the patient to call back if it still persisted in 2 days. The patient did not call back but was seen for something else a week later. The reporter noticed that the patient's upper arm was still somewhat red.
Sex: F
Vaccine: DTAP
Symptoms: Cough, Pertussis, Pyrexia, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), fever and cough. On an unknown date, the outcome of the vaccination failure, whooping cough, fever and cough were unknown. It was unknown if the reporter considered the vaccination failure, whooping cough, fever and cough to be related to DTaP vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported high fevers for weeks and intractable coughing and whooping. At the time, the patient did not know what the whoop was and kept going back to the physician and they never told her what was wrong with her, but one physician yelled at her because she had assumed she had pneumonia. The patient reported that do not forget to quarantine yourself for several weeks after you get the vaccine, as you might become an asymptomatic carrier. This case was considered as a suspected vaccination failure case as the time to onset of the event and lab confirmation for whooping cough were unknown.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Malaise, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Flu unspecified for prophylaxis. Previously administered products included ZOSTAVAX (dose received on an unknown date). On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza and sickness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Flu vaccine. Additional information received as follows: This was reported previously to the doctor. The age at vaccination was not reported. The patient mentioned that she no longer received the flu vaccine because whenever she received the flu vaccine (unknown manufacturer) in the past, she would get sick or experienced the flu. This case was considered as a suspected vaccination failure case as the time to onset and the lab test confirmation for influenza were unknown. The patient did not wish to provide her physical address. This has been linked to the case US2018183633, reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 50-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included belimumab (Benlysta) unknown for an unknown indication. On an unknown date, the patient received SHINGRIX at an unknown dose and Benlysta at an unknown dose and frequency. On an unknown date, less than a year after receiving SHINGRIX and unknown after starting Benlysta, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and Benlysta. Additional details were reported as follows: The age at vaccination was not reported. Since two years patient was receiving Benylsta and about three months before the date of reporting, the patient received SHINGRIX. The patient broke out with Shingles. This case was considered as suspected vaccination failure case since the primary vaccination schedule was unknown at the time reporting.  The reporter agreed to follow up from GlaxoSmithKline.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Chills, Diarrhoea, Lethargy, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 22-year-old male patient who received BEXSERO (batch number 1514101A, expiry date unknown) for prophylaxis. On 28th July 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced fever, lethargy, diarrhea, myalgia, chills and back pain. The patient was treated with MOTRIN and TYLENOL. BEXSERO was discontinued. On an unknown date, the outcome of the fever, lethargy, diarrhea, myalgia, chills and back pain were recovered/resolved. It was unknown if the reporter considered the fever, lethargy, diarrhea, myalgia, chills and back pain to be related to BEXSERO. Additional details were provided as follows: The patient refused to received 2nd dose due side effects of 1st dose. This case has been linked with case US2018117629, reported by same reporter.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 22-year-old male patient who received BEXSERO (batch number 1514101A, expiry date unknown) for prophylaxis. On 28th July 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced fever, lethargy, diarrhea, myalgia, chills and back pain. The patient was treated with MOTRIN and TYLENOL. BEXSERO was discontinued. On an unknown date, the outcome of the fever, lethargy, diarrhea, myalgia, chills and back pain were recovered/resolved. It was unknown if the reporter considered the fever, lethargy, diarrhea, myalgia, chills and back pain to be related to BEXSERO. Additional details were provided as follows: The patient refused to received 2nd dose due side effects of 1st dose. This case has been linked with case US2018117629, reported by same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This Pharmacist reported similar events for 3 patients. This is 2nd of three reports. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness, swollen and feels warm at the injection site after pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) administration. The outcome of the events was recovered on an unspecified date. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018424190 same reporter, event and suspect drug; different patient; US-PFIZER INC-2018424204 same reporter, event and suspect drug; different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from contactable pharmacist via Pfizer sales representative. This Pharmacist reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness, swollen and feels warm at the injection site after pneumococcal 13-valent conjugate vaccine administration on an unspecified date. Outcome of the events was recovered. Information on the lot/batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018424190 same reporter/event/drug, different patients; US-PFIZER INC-2018424203 same reporter/event/drug, different patients.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old female patient who received unknown volume (reported as 0.5 ml) of vaccine FLUZONE QUADRIVALENT (lot UJ035AB and expiration date 30-Jun-2019) via intramuscular route in the left arm on 16-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Underdose and Syringe issue. It was also reported that some of the medication came out through a crack or where the needle attaches, unknown exactly how it came out. "It squirted out" was the term used for description. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. Follow up information received from nurse on 16 Oct 2018. No new information reported.
Age: 17.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: No adverse event, Underdose
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves 17 year old male patient who was vaccinated with a dose of 0.25 ml of FLUZONE QUADRIVALENT (batch number: UT6259LA, expiration date, was not reported) via intramuscular route in right deltoid or arm, on 01-Oct-2018. The patient's medical history was not reported. In Concomitant therapy the patient received a dose of MENACTRA on 01-Oct-2018. It was an actual medication error due to underdose (gave 0.25 ml instead of 0.5 ml to adult). Patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 63.5-year-old patient who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number: UJ039AA, expiration date: 15-May-2019) 0.5 ml, via intramuscular route in left deltoid, on 16-Oct-2018. The patient's medical history was not reported. No other vaccine was given. It was an actual medication error due to inappropriate age at vaccination. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from consumer (Office Staff). This case involves six-months-old patient who was vaccinated with 0.5 ml of FLUZONE QUADRIVALENT (batch number, expiration date, route and site of administration was not reported), on 11-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to overdose (six month old patient received 0.5 ml FLUZONE QUADRIVALENT. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 71.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from nurse. This case involves 71-year-old male patient who was vaccinated with dose of FLUZONE HD (0.5 ml) (batch number: UJ024AC, expiration date: 29-Apr-2019, route and site of administration was not reported) on 17 Oct 2018. The patient's medical history was not reported. Concomitant vaccinations included SHINGRIX and PNEUMOCOCCAL VACCINE CONJ (PCV). It was an actual medication error due to extra dose administered as it was reported that patient had already received the dose of FLUZONE HD it 2 weeks ago at a Pharmacy with no adverse reaction then. Patient had no complaints or adverse reaction today and has not had treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked with 2018SA290496 (same reporter). This case involves a 29 months old male patient who received a fourth dose on 19-May-2017 and fifth dose on 24-Aug-2017 of DAPTACEL (Batch number, expiration date, route and site of administration was not reported). The patient's medical history and concomitant medications were not reported. The patient also received a third dose of ACT-HIB on 19-May-2017 and 4th dose on 24-Aug-2017 as concomitant therapy. It was an actual medication error due to inappropriate schedule of vaccine administered (given fourth dose of DAPTACEL on 19-May-2017 and fifth dose on 24-Aug-2017). 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: 2.42
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 29 months old male patient who received a third dose on 19-May-2017 and fourth dose on 24-Aug-2017 of ACTHIB and a fourth dose on 19-May-2017 and fifth dose on 24-Aug-2017 of DAPTACEL (Batch number, expiration date, route and site of administration was not reported). The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate schedule of vaccine administered (given fourth dose of DAPTACEL on 19-May-2017 and fifth dose on 24-Aug-2017 and given third dose of ACTHIB on 19-May-2017 and fourth dose on 24-Aug-2017). 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 and Module VI of the 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: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 54 years old female patient who experienced a generalized papular/macular, itchy, rash while she received vaccine FLUBLOK QIV. The patient's past medical history included Parotid abscess with 3-4 week prior to the immunization. Received antibiotics and steroids to treat. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was also reported that she had no known drug allergies. Concomitant medication was none. Reported as no other medications at the time of the immunizations. On 11-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot LQFAA1825 expiry date: 16-Jun-2019 via intramuscular route in the right deltoid. On an unknown date, the patient developed a non-serious a generalized papular/macular, itchy, rash 2 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious a generalized papular/macular, itchy, rash 2 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included No lab data). Final diagnosis was a generalized papular/macular, itchy, rash and a generalized papular/macular, itchy, rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for a generalized papular/macular, itchy, rash and as Unknown for a generalized papular/macular, itchy, rash. List of documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site rash, Throat tightness
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a Nurse. This case involves a 47 years old female patient who experienced itching at the injection site that developed into a rash, throat was closing and redness at the site, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was reported. On 16-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ035AA and Exp. Date 30-JUN-2019) via intramuscular route in the right deltoid. On 16-Oct-2018, the patient developed a serious itching at the injection site that developed into a rash, throat was closing and redness at the site immediately after the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were considered medically significant. Details of lab data not provided. Final diagnosis was redness at the site, throat was closing and itching at the injection site that developed into a rash. On an unknown date, the patient was treated with DEPO-MEDROL and SALBUTAMOL, BENADRYL 15 ml was administered and ice was applied to injection site as corrective treatment. The patient was transported via ambulance to the nearest hospital where she was kept for observation in ER. On an unknown date, the patient recovered from events. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who presented with itchy rash, throat tightness and vaccination site redness after use of FLUZONE QUADRIVALENT vaccine. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient (greater than 65 years of an unknown gender) who received an expired dose of vaccine FLUZONE HD lot number not reported (dose, expiry date, route and site of administration were not reported) on an unknown date. 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. It was reported that gave High dose vaccine to a patient greater than 65 but then realized it was from last year's stock (expired date High Dose vaccine from last year). Did not report any adverse event with the vaccine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a seven-months old female patient who received a second dose of 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot number UT6262MA, exp date: 30-Jun-2019) via intramuscular route in the left thigh on 17-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was given. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was reported  that the patient received second dose 1 day earlier than the recommended 4 weeks apart. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a non-hcp. This case involves a 71 years old female patient who experienced left arm pain, burning, warmth, swelling and raised site, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 15-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UL030AA and Exp. Date 05-May-2019) via unknown route in the left arm. On an unknown date, the patient developed a non-serious left arm pain, burning, warmth, swelling and raised site (vaccination site inflammation) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that, on 17OCT2018 after receiving FLUZONE HD 2 days prior patient complaint for event. Details of lab data not provided. Final diagnosis was left arm pain, burning, warmth, swelling and raised site. The patient was treated with steroid shot, KEFLEX (oral 500 mg BID for 10 days) and OTC topical Cortisone cream. The event outcome was unknown. List of documents held by sender: none.
Sex: F
Vaccine: DTAP, FLUX, HEP, IPV, PPV, RVX
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a six months old female patient who was vaccinated with a 0.5 ml dose of DAPTACEL (lot C5519BA and Exp. Date: 12-Sep-2020) via unknown route in the left thigh on an unspecified date, instead of intended 3rd dose of ADACEL. The patient's medical history was not reported. Concomitant medications included INFLUENZA; POLIO VACCINE; ROTAVIRUS VACCINE; HEPATITIS B VACCINE and PNEUMOCOCCAL VACCINE for Immunisation. It was an actual medication error due to wrong vaccine administered. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Extrasystoles, Injection site erythema, Injection site warmth, Oropharyngeal pain
Clinical narrative: Upper left arm red - warm - 21 Sept 2018 cough, AM fever, sore throat 2 days later heart -skip beat face - from nose down feels swollen and prickly-still at times on upper back - patch of pimple like 2" x 2" welts over trunk, upper legs, very itchy" side, tummy, back. Still have welts that come and go about 1" x 1/4" - hard; last train of thought. 15 Oct 2018, gain back Praise! Most of the welts are all by themselves not in clusters like this photo shows and they are individually larger. These are very small welts - most, the size of three together and itchy.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Pyrexia, Swelling face, Urticaria
Clinical narrative: Upper left arm red - warm - 21 Sept 2018 cough, AM fever, sore throat 2 days later heart -skip beat face - from nose down feels swollen and prickly-still at times on upper back - patch of pimple like 2" x 2" welts over trunk, upper legs, very itchy" side, tummy, back. Still have welts that come and go about 1" x 1/4" - hard; last train of thought. 15 Oct 2018, gain back Praise! Most of the welts are all by themselves not in clusters like this photo shows and they are individually larger. These are very small welts - most, the size of three together and itchy.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient was given 3 vaccines on 9/27/18. He came in today with a raised red rash around FLUAD injection site. Still ongoing.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dyspnoea, Eye pain, Headache, Nasopharyngitis
Clinical narrative: Severe headache, eye pain, noise like raindrops on tin roof, sore joints, trouble breathing, couldn't get full breath, sore throat, flashing white light when moving eyes side to side, 5 days. I thought I was getting a cold or flu but the reactions came on so fast and colds and headaches are something I don't usually get.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Photopsia, Tinnitus
Clinical narrative: Severe headache, eye pain, noise like raindrops on tin roof, sore joints, trouble breathing, couldn't get full breath, sore throat, flashing white light when moving eyes side to side, 5 days. I thought I was getting a cold or flu but the reactions came on so fast and colds and headaches are something I don't usually get.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient received flu vaccine late PM on 10/19. Redness, swelling noted a little over 24 hrs later though may have occurred sooner due to patient being fully dressed and not visualizing area until that point. Swelling/Redness first measured 6"x2" and was measured again. On 10/22 at 8"x3.5". Area was warm to touch but not painful per patient report. Patient did received BENADRYL Sunday night (10/21/18) but slept through the night so was unsure if it was helpful. Mom reports on 10/23/18 that area is less red but still measures 8"x3.5"
Age: 0.42
Sex: M
Vaccine: HEP
Symptoms: Acne, Rash
Clinical narrative: My son started having raised bumps on his skin. Some appeared pimple like others just raised. No redness.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt  had swelling and pain from injection site to her elbow. Pt reports the pain was there for the next 5 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Full blood count, Laboratory test
Clinical narrative: Child presented to the ER in status epilepticus and had bloodwork CT and IV ATIVAN that stopped seizures and then child was transferred to hospital where EEG and MRI were done and neuro consult was done and child was discharged the next day.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Nuclear magnetic resonance imaging, Seizure, Status epilepticus
Clinical narrative: Child presented to the ER in status epilepticus and had bloodwork CT and IV ATIVAN that stopped seizures and then child was transferred to hospital where EEG and MRI were done and neuro consult was done and child was discharged the next day.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Cough, Insomnia, Irritability, Nasal congestion, Pyrexia
Clinical narrative: Irritability, nasal congestion, and cough began 9am 10/23/2018; Fever 12/12:30 10/23/2018; Difficulty sleeping 1pm 10/23/2018.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Nurse reports patient has red, swollen right arm that is warm to the touch. The reaction has been unresponsive to oral BENADRYL nor hydrocortisone cream. The nurse will be sending the patient to her doctor.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PPV
Symptoms: Erythema, Irritability, Oral herpes, Pyrexia, Rash macular
Clinical narrative: Cold sores on bottom lip. Red spots on both legs and genitals as well as a few on head. Irritability. Low grade fever.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Injection site pain
Clinical narrative: Employee states that about 30 minutes after receiving a flu shot he began to have difficulty breathing, dizziness and chest tightness. He reports the symptoms got worse for about an hour, then stayed the same. After about three hours the employee sought care at an urgent care facility. He states he was told that he had a "mild allergic reaction" and was given an inhaler and told to continue to take BENADRYL. He used the inhaler twice. By 8:00 pm the symptoms had resolved.  He reports that he did have some itching at injection site on 10/22/2018 and soreness today, 10/23/2018 but did not notice hives, rash, swelling or redness at the injection site. He did not report an egg allergy, being unwell or having had a reaction to a previous flu shot or any other vaccine.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus
Clinical narrative: Employee states that about 30 minutes after receiving a flu shot he began to have difficulty breathing, dizziness and chest tightness. He reports the symptoms got worse for about an hour, then stayed the same. After about three hours the employee sought care at an urgent care facility. He states he was told that he had a "mild allergic reaction" and was given an inhaler and told to continue to take BENADRYL. He used the inhaler twice. By 8:00 pm the symptoms had resolved.  He reports that he did have some itching at injection site on 10/22/2018 and soreness today, 10/23/2018 but did not notice hives, rash, swelling or redness at the injection site. He did not report an egg allergy, being unwell or having had a reaction to a previous flu shot or any other vaccine.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine on 10-16 and by the afternoon of 10-17 his site of injection was red, warm to the touch, and swollen. His wife had a similar reaction including fever and pain in the eyes so they both went to the ER (mainly for her). The doctor recommended diphenhydramine, ZYRTEC, and TYLENOL. They have been taking the medication daily and on 10-22 he reported that the swelling had subsided and that the injection site had a pink tint.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: No reaction when shots were given, but over the next day became swollen, red, and warm to touch. No fever reported.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Persistent shoulder pain near injection site, scheduled to see his medical provider today.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: PATIENT CALLED TO SAY THAT HE HAD AN ADVERSE EFFECT TO FLU SHOT. I ASKED PATIENT TO COME TO SHOW ME. HE SAID THAT HE COULD NOT DRESS OR MOVE HIS ARM. HIS ARM WAS NOT RED, NO RAISED BUMP AND PATIENT WAS ABLE TO PUT ARM BEHIND HIS BACK AND RAISE AND LOWER HIS ARM. I THANKED HIM AND TOLD HIM TO CONTINUE TO USE HIS ARM AND IF NO BETTER IN A COUPLE OF DAYS TO SEE HIS PHYSICIAN.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 3 doses of SHINGRIX but only 2 are required. Patient did not report any syptoms.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: Soreness/tenderness at injection site. Vomiting and diarrhea, chills, fever, headache, body ache, fatigue.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain, Pyrexia, Vomiting
Clinical narrative: Soreness/tenderness at injection site. Vomiting and diarrhea, chills, fever, headache, body ache, fatigue.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Pain
Clinical narrative: I received the vaccine in the left upper arm within 2 finger breaths of the shoulder. Noticed discomfort in the shoulder within one hour following the vaccine. The discomfort continued to worsen extending down the arm. It became extremely painful to move the arm and specifically certain pulling or pushing motions such as pulling a shirt off  over my head. The discomfort continued to worsen for 3 days and then began to subside after the third day. Today is day 5 following the vaccine. I continue to have discomfort with pulling and pushing motion however much improved overall.
Age: 69.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Asthenia, Blister, Chest X-ray normal, Erythema
Clinical narrative: Red, swollen (L) arm with blistering skin feels weak and diffuse arthralgias x 2weeks. Flu and Pneumo shots given in same arm. 10/15/18 Presents today w/ h/o going to the ER On 10/3. Had throbbing in his joints and HA and labs and CXR were normal. He noted Sxs for about a week or two prior to going to the ER. He feels much better now. Wife notes he is red in the face at times. He feels weak at times. He has not taken his temperature. He had his flu and pneumonia shots last of Sept given in the same at (left) at Pharmacy and then his arm he says b/c very swollen and red and had fever in it w/blistering on the skin. Went back in an they were not able to identify what shot caused the issues and told him 'he would live'. Knees, hands and feet have felt stiff in the AM for about 10 min. No lupus or RA in his family. No tick bites, no travel. Notes spider bite in July.
Age: 69.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Headache, Joint stiffness, Laboratory test normal, Peripheral swelling, Skin warm
Clinical narrative: Red, swollen (L) arm with blistering skin feels weak and diffuse arthralgias x 2weeks. Flu and Pneumo shots given in same arm. 10/15/18 Presents today w/ h/o going to the ER On 10/3. Had throbbing in his joints and HA and labs and CXR were normal. He noted Sxs for about a week or two prior to going to the ER. He feels much better now. Wife notes he is red in the face at times. He feels weak at times. He has not taken his temperature. He had his flu and pneumonia shots last of Sept given in the same at (left) at Pharmacy and then his arm he says b/c very swollen and red and had fever in it w/blistering on the skin. Went back in an they were not able to identify what shot caused the issues and told him 'he would live'. Knees, hands and feet have felt stiff in the AM for about 10 min. No lupus or RA in his family. No tick bites, no travel. Notes spider bite in July.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Mobility decreased, Pain
Clinical narrative: Pt's left deltoid is following immunization of PNEUMOVAX 23 next day was hot, red, inflamed about size of orange. Also developed fever of 100F for a day. Took TYLENOL, BENADRYL, and hydroxyzine for 5 days. Sore for 13 days and swollen for 1 week. For 3 days she was unable to move her arm. Symptoms started 9/26/18 fully recovered 10/13/18.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Pt's left deltoid is following immunization of PNEUMOVAX 23 next day was hot, red, inflamed about size of orange. Also developed fever of 100F for a day. Took TYLENOL, BENADRYL, and hydroxyzine for 5 days. Sore for 13 days and swollen for 1 week. For 3 days she was unable to move her arm. Symptoms started 9/26/18 fully recovered 10/13/18.