chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer (patient's wife). This case involves a 62-year-old male patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number, expiry date and dose not reported) via unknown route in unknown administration site. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that by consumer that- her husband is 62 years and his doctor's office gave him the FLUZONE HIGH DOSE vaccine. It was unknown whether the patient experienced any adverse reaction after the injection. 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.
Sex: F
Vaccine: FLUX, MMR, PPV, TDAP
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 12 months old female patient who was vaccinated with a 0.5 ml dose of ADACEL (lot U5829BA and Exp. Date 24-NOV-2019) via unknown route in the left deltoid on 02-OCT-2018 instead of DAPTACEL. Concomitant medications included Pneumococcal Vaccine Conj 13V (CRM197); MMR and Influenza Vaccine for Immunisation. The patient's medical history not reported. It was an actual medication error due to wrong vaccine was administered and 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 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, HEPA
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24-month old male patient who received FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. Notes: The child had 2 pediatric doses of FLUZONE QUAD in 2017 previously. Concomitant medications included Hepatitis A Vaccine second dose (Lot number not provided) on 01-Oct-2018. On 01-Oct-2018, the patient received a 0.5ml dose of suspect Influenza Quadrival A-B Vaccine, lot number UI986AB, expiry date 30-Jun-2018 via intramuscular route in the right thigh. It was an actual medication error due overdose. It was reported that staff gave a 2 yr. old an adult dose 0.5ml of FLUZONE QUAD. The patient did not experience any adverse reaction after the injection. 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 hypoaesthesia, Injection site induration, Injection site mass, Injection site paraesthesia
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 66 years old female patient who experienced continued to experience numbness and tingling, and have a hard lump (hardness) where the FLUZONE HIGH DOSE was injected, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were reported. On 22-Aug-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI993AB and expiry date: 18-Mar-2018) in the left arm. On an unknown date, the patient developed a non-serious continued to experience numbness and tingling, and have a hard lump (hardness) where the FLUZONE HIGH DOSE was injected (injection site hypoaesthesia, injection site paraesthesia and vaccination site mass) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient raise her arm over her head to get the numbness to go away. No Lab data was reported. Final diagnosis was have a hard lump where the FLUZONE HIGH DOSE was injected, experienced tingling and continued to experience numbness. It was not reported if the patient received a corrective treatment. The patient did not recover from reported events at the time of report. (taken as not recovered due to event reported as continued to experienced). Documents held by the sender: none.
Age: 1.67
Sex: M
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a non-Healthcare Professional. This case involves a 20 months old male patient who was vaccinated with a 0.5 ml dose of IPOL (lot N020620 and Exp. Date 30-JAN-2019) via intramuscular route in the right thigh on 17-Sep-2018 that proper stability was not maintained. The patients medical history and concomitant medications were not reported. It was an actual medication error due product storage error and poor quality drug administered. It was reported that, IPOL (opened) with out of range from May to Aug 2018 with lowest temp of 8.06 C to 8.89 C for total time of 2 hours and 30 min. Then from April to Sept 2018 they had a low temp of 1.65 C for a total of 8 hours and 30 min. 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.25
Sex: U
Vaccine: FLU4, HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 15 months old patient who was vaccinated with an 0.5 ml expired dose of ACT-HIB (lot number: UI807AAA and expiry date: 01-Oct-2018) via intramuscular route in the right thigh on 03-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 for Immunisation; and FLULAVAL for Immunisation. It was a case of actual medication error due to expired vaccine used. No adverse symptoms have been reported at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a four-years old male patient who was vaccinated with a 0.5 ml once dose of vaccine FLUBLOK QIV (Batch number: QFAA1814 and expiry date: 30-Jun-2019) via intramuscular route in the left arm on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccine was administered. It was a case of actual medication error due to inappropriate age at vaccine administration because the vaccine was inadvertently administered to a 4 year old male. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB, FLU4, MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 30 patients who was given vaccines that were outside of the recommended temp range below 32f, while he/she received vaccines PENTACEL, MENACTRA, FLUZONE QUADRIVALENT and QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. The patient outcome is reported as Not Applicable for given vaccines that were outside of the recommended temp range below 32F. 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.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 56 years old female patient and reported that most of the vaccine leaked out on the patient and on the floor patient received only a partial dose of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 04-Oct-2018, the patient received a partial 0.5 ml one time dose suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number-UT6301NA, expiry date-30-Jun-2019 and dose in series was not reported) via intramuscular route in the left deltoid. It was a case of actual medication error due to underdose. It was also a case of syringe issue. 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 and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a three years old female patient who received 0.25 ml dose of vaccine FLUZONE QUADRIVALENT inadvertently. The patient's past medical history was not reported. No other concomitant vaccine was administered. On 02-OCT-2018, the patient received a 0.25 ml dose of suspect Influenza Quadrival A-B Vaccine (lot number: UT6259KA and expiry date: 30-Jun-2019) via intramuscular route in the left leg. It was a case of actual medication error due to vaccine underdose. No 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277419 and 2018SA277420 (same reporter). This case involves a female patient (age unknown) who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6301NA and expiry date: 30-Jun-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to  vaccine underdose. It was reported that 3 of the 0.5 ml prefilled syringes leaked around the hub during administration. Two different nurses found that when they were going to give vaccine with needle already attached,it leaked from base of the hub with 3 different prefilled syringes and were unable to deliver full dose (syringe issue). It was unknown whether product technical complaint was registered or not for the syringes. 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 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: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277418 and 2018SA277420 (same reporter). This case involves a female patient (age unknown) who received vaccine INFLUENZA FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6301NA and expiry date: 30-Jun-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to underdose. It was reported that 3 of the 0.5 ml prefilled syringes leaked around the hub during administration. Two different nurses found that when they were going to give vaccine with needle already attached,it leaked from base of the hub with 3 different prefilled syringes and were unable to deliver full dose (syringe issue). It was unknown whether product technical complaint was registered or not for the syringes. 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 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.
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277419 and 2018SA277418 (same reporter). This case involves a female patient (age unknown) who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a single 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine (lot number: UT6301NA and expiry date: 30-Jun-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to vaccine underdose. It was reported that 3 of the 0.5 ml prefilled syringes leaked around the hub during administration. Two different nurses found that when they were going to give vaccine with needle already attached, it leaked from base of the hub with 3 different prefilled syringes and were unable to deliver full dose (syringe issue). It was unknown whether product technical complaint was registered or not for the syringes. 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.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient (age not reported) who inadvertently received two injections of vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medications were not provided. On an unknown date, the patient received two doses of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Suspension for injection in pre-filled syringe) lot number not reported (dose, dose in series, route and site of administration were not reported). It was a case of actual medication error due to extra dose administered. It was reported that there was some confusion with the medical assistants if the patient actually received a dose or not, and she was inadvertently given a second dose of FLUZONE HD before they saw her paperwork from her first dose. No adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.        .
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 34 years old female patient who supposed to vaccinated with TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Oct-2018, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot N1K811M and Exp. Date 19-Oct-2019) via intramuscular route in the left arm. This is a PTC case as it involves syringe issue and hence patient experienced underdose. It was reported that, the coupling that the needle attaches to blew out. Caller clarified the Luer Lok with the needle still attached snapped off, and the needle was stuck in the patient's arm, and the vaccine "squirted everywhere. Patient was concerned, but needed no treatment following this. Caller states he thinks he twisted off the tip cap on this syringe, but does not recall. Caller states he screwed on the needle, and tightened it on like other vaccines that he gives. The needle didn't feel like it screwed in as tightly as it normally would, but I don't give a lot of typhoid injections so I thought it was normal. Vaccine given IM, left arm. No information about relevant tests reported. Final diagnosis was the vaccine squirted everywhere and snapped off and the needle was stuck in the patient's arm. No information about a corrective treatment reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB, FLU4, MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves over 30 patients (age and gender not reported) who were vaccinated with dose of PENTACEL, QUADRACEL, FLUZONE QUADRIVALENT and MENACTRA (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. (patients were given vaccines that were outside of the recommended temp range (below 32F). 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 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.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, TTOX
Symptoms: Anaphylactic shock
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid serious case received from a non-healthcare professional. This case involves a 65 years old female patient who experienced anaphylactic shock, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation; and TETANUS VACCINE (TETANUS VACCINE) for Immunisation on 02-Oct-2018. On 02-Oct-2018, the patient received a single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. On an unknown date, the patient developed a serious anaphylactic shock, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. Patient was taken by an ambulance to the emergency room at hospital but was not admitted over night. Lab test not reported. Final diagnosis was anaphylactic shock. The patient was treated with Prednisone, Loratadine and Famotidine. The patient was recovering from the event. List of documents held by sender: none.; Sender's Comments: Patient presented with anaphylactic shock after vaccination. Time to onset is unknown. Moreover, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB, FLU4, MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult patient who experienced patients were given vaccines that were outside of the recommended temp range, while he/she received vaccines PENTACEL, QUADRACEL, MENACTRA and FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to incorrect product storage. The patient outcome is reported as Not Applicable for patients were given vaccines that were outside of the recommended temp range. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA277831 (same reporter). This case involves a 32 months old male patient who experienced received 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (lot UI975AA) once via unknown route in the left deltoid instead of indicated 0.25 ml dose on 03-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to overdose. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA277809 (same reporter). This case involves a 32 months old male patient who experienced received 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (lot UI975AA, expiration date 30-Jun-2019) once via unknown route in the left deltoid instead of indicated 0.25 ml dose on 03 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to overdose. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Mobility decreased, Skin warm
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 44 years old female patient who experienced swelling, redness at injection site, joint pain and limited mobility and hot to touch, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (lot number not reported) via unknown route in the right arm. On 04-Oct-2018, the patient developed a non-serious swelling, redness at injection site (injection site erythema), joint pain (arthralgia) and limited mobility and hot to touch (mobility decreased) (latency unknown) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. (Other relevant tests included No lab data.) Final diagnosis was limited mobility and hot to touch, joint pain, redness at injection site and swelling. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for swelling, as Unknown for redness at injection site, as Unknown for joint pain and as Unknown for limited mobility and hot to touch.
Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277148, 2018SA278726 and 2018SA278731 (same reporter). This case involves 16 years male patient who received vaccine IPOL (lot number: P1A171M, expiry date: 20-Apr-2014) via unknown route in the right Deltoid (expiry date and dose not reported) on 02-Oct-2018, which was stored incorrectly. 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 IPOL was exposed to temperature elevation for 3 days to 46.6 Fahrenheit and 48 Fahrenheit. It was reported that no reactions were 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.
Age: 31.0
Sex: F
Vaccine: FLUR4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279742, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279740 and 2018SA279743 (same suspect). This case involves a 31 years old female patient was vaccinated with a 0.5 ml dose of FLUBLOK QIV, lot QFAA1829; expiry date; 30-Jun-2019 via intramuscular route in the left deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was not pregnant. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was not provided any information confirming whether 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 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: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain
Clinical narrative: A rash the size of my open hand at site for about 7 days, body aches (both my husband and I were out of it for 4-5 days). We are retired, never had a reaction from any shots like this. My husband and I both had reactions. Got over them in several days. Our concern is we are suppose to take 2nd shot 10/17 or later or it does not help. My hx I had chicken pox as child, shingles in my 30's. I am the one that got a larger rash where the injection was given. Do we get the 2nd shot?
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Lethargy
Clinical narrative: Resident stated she woke up the next morning after receiving vaccines feeling exhausted. Slept approximately 8 hours during he day, in 4 hours intervals, feeling "extreme lethargy". Also C/O slight redness and warmth at injection site of the left arm where Pneumococcal vaccine administered. Felt better the following day, not quite herself. Was never given high dose flu shot in the past. Stated she is a woman of small stature. Fully recovered.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness spreading swelling fever aches not at site per employee states "no fever".
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: Patient called 10/10/18 at 9:15 to describe an increasingly sore rt arm. "I can now not lift my arm above my head and my hand feels like it is going to sleep". States she received her vaccine in her right arm at a flu shot clinic here on 10/4/18 and symptoms of arm discomfort started by Friday 10/5/18, but were most significant on 10/6/18 when she started not being able to move her arm fully. It has now progressed to not being able to lift her arm, feeling weak just in her right arm. Has used a heating pad with little relief with TYLENOL.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Erythema, Skin warm
Clinical narrative: Large red area, hot to the touch.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Injected limb mobility decreased, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Went to gym was doing stuff in water,working on bar bells, started rt shoulder pain soerness. Rt shoulder not able to lift, swelling deltoid area, triceps demarcation, no neusens deficit, elbow, hand rom nl 10/01/2018 11:47:22 AM PDT > rt shoulder/upper arm pain r/o hematoma, muscle repture Ordered CT scan and labs, recommended to keep arm in sling
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dysgeusia, Erythema, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: The next morning after the vaccination the patient woke up with an extremely painful arm, with redness and swelling of the entire upper left arm. Patient reported she had a low-grade fever, night  sweats, was nauseous, and had a metallic taste for 2 days after the immunization. The third day after immunization patient reported a headache and sweats. The fourth day patient just had night sweats. Patient reported to the pharmacy on the 5th day and is feeling better. Her upper left arm is still slightly swollen and red 5 days after immunization.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site swelling, Nausea, Night sweats, Pain in extremity, Peripheral swelling
Clinical narrative: The next morning after the vaccination the patient woke up with an extremely painful arm, with redness and swelling of the entire upper left arm. Patient reported she had a low-grade fever, night  sweats, was nauseous, and had a metallic taste for 2 days after the immunization. The third day after immunization patient reported a headache and sweats. The fourth day patient just had night sweats. Patient reported to the pharmacy on the 5th day and is feeling better. Her upper left arm is still slightly swollen and red 5 days after immunization.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pyrexia
Clinical narrative: The next morning after the vaccination the patient woke up with an extremely painful arm, with redness and swelling of the entire upper left arm. Patient reported she had a low-grade fever, night  sweats, was nauseous, and had a metallic taste for 2 days after the immunization. The third day after immunization patient reported a headache and sweats. The fourth day patient just had night sweats. Patient reported to the pharmacy on the 5th day and is feeling better. Her upper left arm is still slightly swollen and red 5 days after immunization.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Breaking out with small hives on right arm (inside elbow) one on hand (thumb).
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Hep A was given at 6 mos of age INSTEAD of using Hep B. Dr called and spoke to mom. No signs of adverse reactions.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Epilepsy, Seizure
Clinical narrative: Patient stated she had a seizure the day after receiving the vaccine and 4 more the following day. Previously her epilepsy had been under control with no seizure activity during a 6 day observation at the hospital.
Age: 18.0
Sex: M
Vaccine: DTAP, FLUC4, HEPA, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: DTaP given to 18 year old by accident .
Age: 61.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Asthenia, Blood glucose increased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Patient was admitted to hospital from 08/2018-09/18/2018 for rehab due to Guillain Barre Syndrome. Was initial seen at ER on 08/16/2018 with vomiting, and elevated B/S in 500's, 1 week after receiving vaccines, and was transferred to community hospital 08/16/2018 where he spent 4 days, he then went to another hospital due to progressive weakness, and was admitted for 2 weeks, and started on IVIG which improved symptoms. Had pain all over with numbness.
Age: 61.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pain, Vomiting
Clinical narrative: Patient was admitted to hospital from 08/2018-09/18/2018 for rehab due to Guillain Barre Syndrome. Was initial seen at ER on 08/16/2018 with vomiting, and elevated B/S in 500's, 1 week after receiving vaccines, and was transferred to community hospital 08/16/2018 where he spent 4 days, he then went to another hospital due to progressive weakness, and was admitted for 2 weeks, and started on IVIG which improved symptoms. Had pain all over with numbness.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, HEP, HIBV, PNC13
Symptoms: Death
Clinical narrative: Passing.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles in genital area. Famciclovir 1500 mg daily for 10 days was prescribed.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Disturbance in attention, Headache, Malaise, Nausea
Clinical narrative: Client reports nausea, abdominal pain, headache, difficulty concentrating, malaise 5 hours after receiving flu vaccine. No local reaction. Pt also reports fasting for 16 hours prior to receiving vaccine as part of diet routine. All symptoms resolved by midnight on 10/9/18.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Blood glucose normal, Feeling abnormal, Immediate post-injection reaction, Neurological examination normal, Pallor
Clinical narrative: Immediately following GARDASIL vaccine, nurse noted that he was pale. Immediately laid down on exam table where he fainted then clenched both arms Lt leg shook. Event lasted 1-2 sec.Responsive after that but C/O feeling terrible. Sats and glucose were fine. Neuro. exam normal. Patient report after he had not had any breakfast or liquids prior to visit.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Posture abnormal, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Immediately following GARDASIL vaccine, nurse noted that he was pale. Immediately laid down on exam table where he fainted then clenched both arms Lt leg shook. Event lasted 1-2 sec.Responsive after that but C/O feeling terrible. Sats and glucose were fine. Neuro. exam normal. Patient report after he had not had any breakfast or liquids prior to visit.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: 4inx2in red, raised, warm, painful to touch - approx. 2 inches below injection site.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Received flu shot in AM on 9/25/18- developed rash with itching to hand/arms/chest. Required treatment in ED at 12PM 9/25/18. Received PEPCID/DECADRON/Prednisone.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pain in extremity
Clinical narrative: Patient reported that she experienced an injection site reaction after the first dose of SHINGRIX. Her symptoms included extreme redness and soreness/pain radiating down to her forearm. Patient described this reaction as severe but not anaphylaxis. She stated that her symptoms resolved in approximately one week. It was recommended that she still receive the second dose today but in the other arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Feeling cold, Headache, Myalgia
Clinical narrative: Reaction began with chills, then fever as high as 102.6, progressed to nausea with episodes of vomiting for approximately 8 hours; severe muscle aches and headache; fatigue and weakness. Fever continued for 24 hours; muscle aches and headache persisted for 72 hours; malaise continued for 72 hours. No treatment other than BRAT diet was used. I did not contact my primary care physician, as this was over a weekend. By 84 hours post injection I felt normal.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Reaction began with chills, then fever as high as 102.6, progressed to nausea with episodes of vomiting for approximately 8 hours; severe muscle aches and headache; fatigue and weakness. Fever continued for 24 hours; muscle aches and headache persisted for 72 hours; malaise continued for 72 hours. No treatment other than BRAT diet was used. I did not contact my primary care physician, as this was over a weekend. By 84 hours post injection I felt normal.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: High Fever, Chills, Shortness of Breath, Extreme Sweating, Dizziness, Headache, Severe Muscle Aches.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: High Fever, Chills, Shortness of Breath, Extreme Sweating, Dizziness, Headache, Severe Muscle Aches.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Pruritus, Swelling face, Throat irritation
Clinical narrative: Patient developed throat itching and facial redness, swelling, and itching within one hour after receiving vaccine. Patient sent to urgent care and given IM steroid and course of antihistamines. Told to list FLUZONE as an allergy.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: I broke out in hives about 24 hours after the shot. I took BENADRYL and used hydrocortisone. The hives remained for about three days. I called the Tele-Doc and sent pictures. He said to only get the nasal vaccine with no eggs going forward and that I am now fully allergic to eggs. The hives went away by day four.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Tongue disorder
Clinical narrative: Tongue was raw X 3 days, back of throat swelled.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Dizziness, Exposure during pregnancy
Clinical narrative: I am pregnant and due Dec 23, 2018. I received the flu shot at my OBGYN yesterday. This morning I woke up at 6 AM feeling week and sick with my left arm where the shot was given significantly sore. I rallied and got ready and went to work despite feeling very ill and extremely thirsty.  I drank two bottles of water. At 11 AM I decided I didn't feel well enough to stay and would go home. As I got to the car I had uncontrollable explosive diarrhea. I have had it two additional times in the next three hours. I am resting now but extremely nauseated and feel lightheaded and not well at all. My stomach is still very upset.