chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 26-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 14-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020353 and expiration date 28-APR-2020) for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018  was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 18-OCT-2018, the patient was vaccinated with an expired VARIVAX lot # M038857, expiration date 14-SEP-2018 (dose, route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. Sterile diluent used was lot # M037018, expiration date 01-MAY-2019.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 26-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II (strength was unknown) (lot# M034856 and expiration date 27-JUL-2018) subcutaneously for prophylaxis. The MERCK STERILE DILUENT was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017; 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 07-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RAB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in an unspecified number of the patients who received RABAVERT for prophylaxis. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to RABAVERT. Additional details were provided as follows: It was unknown whether the patient received RABAVERT for pre or post exposure prophylaxis. The age at vaccination was not applicable for this report. The healthcare professional made a general statement about how most patients did not report many adverse events after receiving RABAVERT except soreness at the injection site.
Sex: M
Vaccine: FLU3
Symptoms: Cough, Guillain-Barre syndrome, Pertussis, Pyrexia
Clinical narrative: This case was reported by a nurse via interactive digital media and described the occurrence of Guillain Barre syndrome in a male patient who received Flu Seasonal TIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine unspecified 2011-12 season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine unspecified 2011-12 season, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine unspecified 2011-12 season. 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.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received PREVNAR 13 (Lot W51762, Exp. Date 30Jun2020, NDC number: 00005197102), intramuscular in left arm on 05Oct2018 17:09 at 0.5 ml, single for immunisation, and influenza vaccine (Seqirus, Lot 250796, Exp. Date 31May2019, NDC number: 70461001803), intramuscular in left arm on 05Oct2018 at 0.5 ml, single for immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced severe shoulder pain that limited the use of the arm/severe pain in her left shoulder (non-serious) on 06Oct2018. The outcome of the events was not recovered.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age (reported as Age: 17; Unit: Unknown) received TRUMENBA, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site on an unspecified date. Outcome of the event was unknown.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site ulcer, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 71 years old female patient who was vaccinated with a 0.5 ml dose of ADACEL (expiration date 12-SEP-2019 and batch number C5519BAQ) via intramuscular route in the left deltoid on 12-Sep-2018. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient developed a non-serious sore and feels like punched in the arm following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was an actual medication error due to inappropriate age at vaccine administration. The patient was given recommendations by the pharmacy to ice it and the HCP wants to do an x-ray. No other information about a corrective treatment reported for sore and punched in the arm. The event outcome was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a syringe of 0.5 ml FLUZONE QUADRIVALENT (lot UJ041AA and Exp. Date 30 JUN 2019) which was cracked by where the bar code would be and vaccine squirted from the side while a seven years old male patient was receiving vaccine. The patients medical history and concomitant medications were not reported. It is an actual medication error case due to vaccine underdose. Also it was a case of syringe issue. It was reported that, the syringe was cracked by where the bar code would be. as she was administering the vaccine, the vaccine squirted from the side she is unsure if the consumer received any or just part of the vaccine. No information reported 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 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 11-Oct-2018. Events added. List of documents held by sender: none.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 10 months old male patient and reported that asking the side effects are and what do to regarding 4th dose, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Oct-2018, the patient received a 4th dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number for Hib: C5576AB and for Dtap-IPV: C5447AA and expiry date: 18-Oct-2019) via intramuscular route in left thigh. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was unknown if 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: 42.0
Sex: U
Vaccine: FLUR4
Symptoms: Injection site bruising, Injection site pain, Lymphadenopathy
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA279494 (Same reporter). This case involves a 42 years old patient who experienced swelling of the lymph nodes, pain at the injection site and and bruising at the injection site 2 inches long and 1.5 inches wide from the injection site to the inner arm, while he/she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was given. On 04-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1805, expiry date 30 June 2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious swelling of the lymph node, pain at the injection site, bruising at the injection site 2 inches long and 1.5 inches wide from the injection site to the inner arm following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that reaction was really bad for the first 3 days after receiving the injection but more prominent on the Left Side. (Other relevant tests included no lab test reported). Final diagnosis was bruising at the injection site 2 inches long and 1.5, pain at the injection site and swelling of the lymph nodes and swelling of the lymph nodes. Corrective treatment not reported. The patient outcome was Unknown for pain at the injection site and swelling, swelling of the lymph nodes and bruising at the injection site 2 inches long and 1. 5 inches wide from the injection site to the inner arm. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Product preparation error
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 56 years old female patient who received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Details of concomitant medication was not provided. On 20-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5829AB via unknown route in the left deltoid. It was a case of actual medication error due to Product preparation error. It was reported that Pharmacist stated that an ADACEL pre-filled syringe was not shaken prior to administering to a patient. Question came to the forefront on Friday 12-Oct-2018, when he was preparing another dose of ADACEL for another patient when he realized that he did not shake the syringe on 20-Sep-2018. It was unknown if patient experienced any adverse events post 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. List of documents held by the sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 65 year female patient who received 0.5 mL an expired dose of FLUZONE HIGH DOSE (batch number UI840AC, expiry date 06-APR-2018) in left deltoid on 27 Sep 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 as expired vaccine used. No known reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 years old female patient who received a booster dose of MENACTRA lot U6151AA Expiry date 16-MAR-2020 via unknown route in the right arm on 15-Oct-2018 but she had already had her booster dose in 2017. The patient's past medical history, medical treatments, vaccinations and family history were not provided. It was a case of actual medication error due to extra dose administered. After dose had been given the Nurse realized on review of the health record that the patient had already received a booster of MENACTRA at age 16 in 2017. The patient was not aware of the prior dose. The nurse will notify her that she has had 2 boosters of MENACTRA in 2017 and 2018. It was not reported 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. List of documents held by sender: none.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 14 years old patient who reported medication error, while he/she received vaccine FLUBLOK QIV. (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to Inappropriate age at vaccine administration. 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: F
Vaccine: FLUR4
Symptoms: Rash pruritic
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves female patient of an unknown age who experienced pruritic medication rash, while she received vaccine FLUBLOK QIV. 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 QUADRIVALENT RECOMBINANT VACCINE (lot number, dose, expiry date, route and site of administration were not reported). On an unknown date, patient developed a non-serious pruritic medication rash within two-hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. She has had the rash and recurrent pruritus for 4 days now. No lab data was reported. Final diagnosis was pruritic medication rash. It was not reported if the patient received a corrective treatment. The event was ongoing at the time of report. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves four year patient who received vaccination with FLUZONE QUADRIVALENT (batch number UT6259KA, expiry date 30-JUN-2019) intramuscular in left arm on 13 Oct 2018. It was a case of actual medication error due to vaccine underdose as children ages 4 years and up were inadvertently given the 0.25mL of FLUZONE QUADRIVALENT. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a non-hcp. This case involves a two months old female patient who was vaccinated with a dose of FLUBLOK QIV (Lot number: QFAA1831, Exp. Date not reported) via intramuscular route in the right thigh on 15-Oct-2018. Concomitant medications included PENTACEL for Immunisation. Lot number was reported as qfaa1831. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case is cross linked to case 2018SA286322, 2018SA286331, 2018SA288492, 2018SA288492 (same reporter). This case involves a 75 year old female patient who experienced swollen about 10-15 cm at the injection site with redness, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medications were not provided. On 10-Oct-2018, the patient received a single dose of suspect FLUZONE HIGH DOSE lot UI985AC, expiry date 22-MAR-2019. On an unknown date, the patient developed a non-serious swollen about 10-15 cm at the injection site with redness, following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was swelling at the site about 10-15 cm in size with redness. Corrective treatment with ice and alcohol compresses. The outcome of the event was not reported. List of documents held by sender- none.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 52 years old female patient who was vaccinated with a dose of DIPHTHERIA AND TETANUS TOXOIDS On 11-Oct-2018 instead of ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was not vaccinated with any other vaccines on that time. It was a case of actual medication error due to wrong vaccine administered. It was unknown whether the patient experienced any adverse events. 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 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: Product storage error
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves six patients (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot UJ045AC; expiry date: 30-Jun-2019) on an unknown date. The patients' past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. Caller reported that they received a shipment of FLUZONE QUADRIVALENT and started using them right away. They received an e-mail later that the product had been in transit too long, it was shipped on 10-Oct-2018. Six Patients were already vaccinated. It was not reported whether the patients experienced any adverse events. 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 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: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 12 years old male patient who was vaccinated with a suspect vaccine IPOL lot number N1K931M, via unknown route and administration on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that an opened vial of IPOL reached 32 F were given to patient. It was not reported that 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: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to cases 2018SA289594, 2018SA289611, 2018SA289640, 2018SA289651, 2018SA289666, 2018SA289688 and 2018SA289702 (same reporter). This case involves a 20 months old male/female patient who was vaccinated with a dose of IPOL (Batch number: N1K931M, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (given opened multidose vial of IPOL after the temperature excursion reached 32.76 F for 19 hours 44 minutes). 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: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 33 years old male patient who received a dose of FLUZONE HIGH DOSE lot UJ024AC via intramuscular route in the right deltoid, by accident on 16-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was not reported 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 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: 66.0
Sex: F
Vaccine: FLUX, PNC13, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient came in today for a flu shot and said when she got the SHINGRIX vaccine, her arm was immobile and extremely sore afterward, but it later resolved without any additional care.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever of 103.1, body aches, headache for x1 day, symptoms resolved after 1 day course of OTC Tyelnol prn.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Sinus congestion
Clinical narrative: Sinus congestion, poss fever (unknown temp), body aches for x1 day, resolved after 1 day of resting.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Received work place flu injection into L arm. Immediately on administration I said it was very high. The RN advised that it was in the deltoid and that pushing in the vaccine was harder and she had only had about 2 single doses be this way. I took picture of injection site - looks about 2 cm below shoulder. I had pain with injection and then within 2 h noted loss of range of motion with being unable to reach back to get toilet paper off back toilet, more pain with crossing my arms to remove shirt and unable to raise arm up completed. This continued to next day so I saw a provider at Sat clinic and advised what happened. I showed her where injection went in and she said shoulder higher so did not think it went into shoulder. I had about 50% improvement in initial pain by Mon but have continue to have a burning sensation all around my rotator cuff. Achy and dull pain with using arm and this pain has interrupted my sleep. Pain and weakness from underarm/back arm. I have flu injection yearly and have never had this reaction. I have never had a shoulder issue or pain such as this. I plan to see my own primary care provider next week if it is not resolving.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Received work place flu injection into L arm. Immediately on administration I said it was very high. The RN advised that it was in the deltoid and that pushing in the vaccine was harder and she had only had about 2 single doses be this way. I took picture of injection site - looks about 2 cm below shoulder. I had pain with injection and then within 2 h noted loss of range of motion with being unable to reach back to get toilet paper off back toilet, more pain with crossing my arms to remove shirt and unable to raise arm up completed. This continued to next day so I saw a provider at Sat clinic and advised what happened. I showed her where injection went in and she said shoulder higher so did not think it went into shoulder. I had about 50% improvement in initial pain by Mon but have continue to have a burning sensation all around my rotator cuff. Achy and dull pain with using arm and this pain has interrupted my sleep. Pain and weakness from underarm/back arm. I have flu injection yearly and have never had this reaction. I have never had a shoulder issue or pain such as this. I plan to see my own primary care provider next week if it is not resolving.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: I broke out in large, red hives all over my arms. By the next morning the hives were also all over my upper thighs. They lasted three days. I did not get any hives on my torso.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Patient's arm became developed mild pain, redness, and itching. Patient declined to be seen and opted for OTC medications (BNEADRYL and Hydrocortisone).
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site rash, Injection site warmth
Clinical narrative: LEFT UPPER ARM - RED, WARM, EDEMATOUS ALMOST ENTIRE ANTERIOR AND LATERAL HUMERUS, NO LYMPHADENOPATHY, NONTENDER, NO FLUCTUANCE, NO EXCORIATIONS, NO DISCHARGE OR CRUSTING NOTED. PRESCRIBED ANTIBIOTICS IF RASH SPREADING.
Age: 82.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient noticed a mildly painful red rash down her arm beginning the day after vaccination that resolved after 4 days.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Hyperhidrosis, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Stephen's Johnson Syndrome (blisters on arm and tongue); Swelling arm; Pain in body (left side); Fever; Sweats.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stevens-Johnson syndrome, Tongue blistering
Clinical narrative: Stephen's Johnson Syndrome (blisters on arm and tongue); Swelling arm; Pain in body (left side); Fever; Sweats.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Blister, Dyspnoea, Eye swelling, Fall
Clinical narrative: Stephen's Johnson Syndrome (blisters on arm and tongue); Swelling arm; Pain in body (left side); Fever; Sweats.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeding disorder, Head injury, Hyperhidrosis, Injection site pain
Clinical narrative: Stephen's Johnson Syndrome (blisters on arm and tongue); Swelling arm; Pain in body (left side); Fever; Sweats.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Stephen's Johnson Syndrome (blisters on arm and tongue); Swelling arm; Pain in body (left side); Fever; Sweats.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stevens-Johnson syndrome, Swelling, Swollen tongue, Tenderness, Tongue blistering
Clinical narrative: Stephen's Johnson Syndrome (blisters on arm and tongue); Swelling arm; Pain in body (left side); Fever; Sweats.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: CSF protein increased, CSF white blood cell count negative, Electromyogram abnormal, Guillain-Barre syndrome, Nerve conduction studies abnormal
Clinical narrative: Developed Guillain Barre syndrome.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dysstasia, Exercise tolerance decreased, Gait inability, Guillain-Barre syndrome
Clinical narrative: Developed Guillain Barre syndrome.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immunoglobulin therapy, Intensive care, Lumbar puncture, Neuralgia
Clinical narrative: Developed Guillain Barre syndrome.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Dysstasia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain in both legs, unable to walk easily. Beginning an hour post injection: Swelling in left thigh with hard, tight skin. Skin hot to touch, expanding redness around site. Fluid filled blister size about 1/4 inch near site. Still presenting symptoms 48 hours post injection.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site vesicles, Injection site warmth, Skin tightness
Clinical narrative: Pain in both legs, unable to walk easily. Beginning an hour post injection: Swelling in left thigh with hard, tight skin. Skin hot to touch, expanding redness around site. Fluid filled blister size about 1/4 inch near site. Still presenting symptoms 48 hours post injection.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood glucose normal, Blood pressure measurement, Cardiac monitoring normal, Chills, Loss of consciousness
Clinical narrative: Patient got both shots at 2:10 on 10/16/18. Said she had fever and chills night of 10/16/18. She went to town morning of 10/17/18. She passed out at 9:30 AM morning of 10/17/18. Paramedics evaluated patient. Blood pressure, blood sugar, heart moniter and temperature was all perfect patient said.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient got both shots at 2:10 on 10/16/18. Said she had fever and chills night of 10/16/18. She went to town morning of 10/17/18. She passed out at 9:30 AM morning of 10/17/18. Paramedics evaluated patient. Blood pressure, blood sugar, heart moniter and temperature was all perfect patient said.
Age: 27.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Disorientation, Erythema, Extensive swelling of vaccinated limb, Lymphadenopathy, Pyrexia
Clinical narrative: Fever of 102 on 10-8-2018 for 2 days. Patient sought medical treatment at that time. On 10-10-2018 went to physicians office stating huge, red, swollen left arm, lymph nodes under the arm swollen, and disoriented. Was then sent to ER had ultrasound of arm to verify no abscess and no abscess was found. Patient was released with BENADRYL, famotidine, and steroids. Patient has since fully recovered.
Age: 27.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Ultrasound scan normal
Clinical narrative: Fever of 102 on 10-8-2018 for 2 days. Patient sought medical treatment at that time. On 10-10-2018 went to physicians office stating huge, red, swollen left arm, lymph nodes under the arm swollen, and disoriented. Was then sent to ER had ultrasound of arm to verify no abscess and no abscess was found. Patient was released with BENADRYL, famotidine, and steroids. Patient has since fully recovered.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disturbance in attention, Fatigue, Incorrect route of product administration, Injection site erythema
Clinical narrative: Fever and chills x 48 hrs, severe body aches not relieved by TYLENOL x 36 hrs, injection site red, hard and hot - started 10/19 AM and continues, very fatigued, cloudy thinking and difficulty concentrating continues. INJECTION WAS GIVEN SC RATHER THAN IM.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site warmth, Pain, Pyrexia, Thinking abnormal
Clinical narrative: Fever and chills x 48 hrs, severe body aches not relieved by TYLENOL x 36 hrs, injection site red, hard and hot - started 10/19 AM and continues, very fatigued, cloudy thinking and difficulty concentrating continues. INJECTION WAS GIVEN SC RATHER THAN IM.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Fatigue, flu-like symptoms.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Bone pain, Chills, Decreased appetite, Dizziness
Clinical narrative: I received the shot as described at about 0800 Wednesday morning. At about 1400 I began experiencing some minor chills. These chills increased until the point at about 1800 when they became severe, uncontrollable, and unaffected by my being dressed in multiple layers, under blankets, and using heating pads. This is also about the time that I began to experience increasingly severe pain in my spine, neck, skull, and face. It felt like pain was coming from the bones themselves, not the surrounding tissue, and it became very, very intense, so much so that I strongly considered coming in to the ER for it. I also experienced some mild lightheadedness, lack of appetite, and nausea. These symptoms continued for several hours, well into the night, and prevented me from being able to fall asleep. They eased somewhat after I soaked in a warm bath with some Epsom salts and baking soda added at about 0200 the next day. The bath ended the chills, but the bone pain persisted, though subsiding, throughout the morning. I was unable to come into work on Thursday due to this. Today I still feel a bit weak and achy.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Sleep disorder
Clinical narrative: I received the shot as described at about 0800 Wednesday morning. At about 1400 I began experiencing some minor chills. These chills increased until the point at about 1800 when they became severe, uncontrollable, and unaffected by my being dressed in multiple layers, under blankets, and using heating pads. This is also about the time that I began to experience increasingly severe pain in my spine, neck, skull, and face. It felt like pain was coming from the bones themselves, not the surrounding tissue, and it became very, very intense, so much so that I strongly considered coming in to the ER for it. I also experienced some mild lightheadedness, lack of appetite, and nausea. These symptoms continued for several hours, well into the night, and prevented me from being able to fall asleep. They eased somewhat after I soaked in a warm bath with some Epsom salts and baking soda added at about 0200 the next day. The bath ended the chills, but the bone pain persisted, though subsiding, throughout the morning. I was unable to come into work on Thursday due to this. Today I still feel a bit weak and achy.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt. had reaction in left arm after PNEUMOVAX-23 immunization was administered. Pt. reports that left arm was very red and painful from shoulder all the way to elbow for 3 days after the immunization was administered. Pt. was advised to seek medical attention after he reported reaction but decided not to seek treatment as he thought it was improving. Pt. reported taking benadryl and ibuprofen for the pain.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: The patient presents with left upper arm swelling. Pt presents with swelling to her left upper arm after flu vaccine on 10/9. D/C home with BENADRYL prescription.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Headache, Hyperhidrosis, Muscular weakness
Clinical narrative: Severe bone and muscle pain, headache, muscle weakness. Chills and fever with diaphoresis, eye blurriness.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Vision blurred
Clinical narrative: Severe bone and muscle pain, headache, muscle weakness. Chills and fever with diaphoresis, eye blurriness.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Retching, Syncope
Clinical narrative: Arm pain in the beginning. At midnight I got up to go to the bathroom and fainted in the bathroom. When I woke up I started having uncontrollable dry heaves. Everytime I tried to stand up I felt like I was going to faint again. I took some TYLENOL and tried to get to sleep. I have had severe body aches all day today and needed to take pain reliever.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Gait disturbance
Clinical narrative: Received flu shot at approx. 1115 AM on 10-5-2018. At approx. 815 PM that evening, I got shaking chills, my "skin hurt", achy all over body and low grade temp of 100.0. I took ibuprofen 600 mg and fell asleep. I woke up at 215 AM with fever of 104.6. Could hardly walk, severe headache, dizzy and my fingers felt numb. Took TYLENOL 1000 mg and laid on couch. Boyfriend checked on me at 530 AM and fever was down to 103.8. Took additional 600 mg of ibuprofen and stood in a cold shower. I did not want to go to ER, so I went back and laid in bed. Woke up at 9 AM completely drenched and fever down to normal at 98.3. Felt fatigued and weak x 24 hours, but no further elevated temperature. Should have went to ER, but I honestly felt too ill and they would have told me to take the ADVIL and TYLENOL.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Pain, Pain of skin
Clinical narrative: Received flu shot at approx. 1115 AM on 10-5-2018. At approx. 815 PM that evening, I got shaking chills, my "skin hurt", achy all over body and low grade temp of 100.0. I took ibuprofen 600 mg and fell asleep. I woke up at 215 AM with fever of 104.6. Could hardly walk, severe headache, dizzy and my fingers felt numb. Took TYLENOL 1000 mg and laid on couch. Boyfriend checked on me at 530 AM and fever was down to 103.8. Took additional 600 mg of ibuprofen and stood in a cold shower. I did not want to go to ER, so I went back and laid in bed. Woke up at 9 AM completely drenched and fever down to normal at 98.3. Felt fatigued and weak x 24 hours, but no further elevated temperature. Should have went to ER, but I honestly felt too ill and they would have told me to take the ADVIL and TYLENOL.