chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Adverse event, Mobility decreased
Clinical narrative: patient whose arm had to be kept in a sling for 2 weeks due to an unspecified reason; This spontaneous report was received from a medical assistant via company representative referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot# and expiry date were not reported) for prophylaxis.         It was reported that the patient's arm had to be kept in a sling for 2 weeks due to an unspecified reason (adverse event) after receiving with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient recovered from the event, 2 weeks after with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was received. No further information was reported. No product quality complaint was reported. Causality assessment was not provided.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Redness about 1 inch from the injection site; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 2nd August 2019 and experienced injection site pain,refer case US2019187941).   On 14th October 2019, the patient received the 2nd dose of Shingrix. On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th October 2019, the patient experienced injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The patient received Shingrix on left arm. On the same day after receiving Shingrix, the patient experienced injection site pain. On the day of reporting, the patient noticed redness about 1 inch from the injection site with diameter of about 3-4 inches. The reporter consented to follow up. This case is 1 of the 4 cases reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Injection site pain, Rash pustular
Clinical narrative: Shingles; Intense pain at the injection site; Pus filled blisters that spread from the arm to the shoulder and neck; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, immediately after receiving Shingrix, the patient experienced shingles, injection site pain and vesiculopustular rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, injection site pain and vesiculopustular rash were recovered/resolved.   It was unknown if the reporter considered the shingles, injection site pain and vesiculopustular rash to be related to Shingrix.  Additional details were provided as follows: The patient was approximately 70 years old. The patient received the first dose of Shingrix two months ago.  Immediately after, he started intense pain at the injection site and a breakout of shingles with pus filled blisters that spread from the arm to the shoulder and neck. The next day the doctor treated him with an anti viral and it disappeared within a couple of days.  The patient was hesitant and afraid to take the second dose based on this experience.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: red; warm site reactions; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included hepatitis B (received 1st dose on an unknown date), hepatitis B (received 2nd  dose on an unknown date) and hepatitis B with an associated reaction of erythema (received 3rd dose on an unknown date).   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Flu vaccine.  Additional details were provided as follows: The patient received Flu vaccine and had erythema and feeling of warmth. This case linked with US2019186993 and US2019AMR192366, reported by same reporter for the same patient.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Feeling hot, Pruritus, Reaction to excipient
Clinical narrative: red; warm site reactions; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included hepatitis B (received 1st dose on an unknown date), hepatitis B (received 2nd  dose on an unknown date) and hepatitis B with an associated reaction of erythema (received 3rd dose on an unknown date).   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Flu vaccine.  Additional details were provided as follows: The patient received Flu vaccine and had erythema and feeling of warmth. This case linked with US2019186993 and US2019AMR192366, reported by same reporter for the same patient.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: red; warm; itching; Reaction to thimerasol; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 75-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included hepatitis B (received 1st dose on an unknown date), hepatitis B (received 2nd dose on an unknown date), hepatitis B with an associated reaction of erythema (received 3rd dose on an unknown date refer case US2019AMR192366) and Flu vaccine with an associated reaction of injection site erythema (received flu shot on an unknown date refer case US2019AMR192365).   In September 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, couple of days after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced erythema, feeling of warmth, pruritus and reaction to excipient. On an unknown date, the outcome of the erythema, feeling of warmth, pruritus and reaction to excipient were unknown.   The reporter considered the erythema, feeling of warmth, pruritus and reaction to excipient to be possibly related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient stated about three weeks ago and received a high dose flu vaccine.  The patient had a red, warm and itching after a couple of days of receiving the flu vaccine.     She believed it was related to products that have thimerasol in them.   She notes that was what the common denominator was years ago. She stated that with the recent flu vaccine of three weeks ago, she asked for non thimerosal containing products. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Feeling hot, Pruritus, Reaction to excipient
Clinical narrative: red; warm; itching; Reaction to thimerasol; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 75-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included hepatitis B (received 1st dose on an unknown date), hepatitis B (received 2nd dose on an unknown date), hepatitis B with an associated reaction of erythema (received 3rd dose on an unknown date refer case US2019AMR192366) and Flu vaccine with an associated reaction of injection site erythema (received flu shot on an unknown date refer case US2019AMR192365).   In September 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, couple of days after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced erythema, feeling of warmth, pruritus and reaction to excipient. On an unknown date, the outcome of the erythema, feeling of warmth, pruritus and reaction to excipient were unknown.   The reporter considered the erythema, feeling of warmth, pruritus and reaction to excipient to be possibly related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient stated about three weeks ago and received a high dose flu vaccine.  The patient had a red, warm and itching after a couple of days of receiving the flu vaccine.     She believed it was related to products that have thimerasol in them.   She notes that was what the common denominator was years ago. She stated that with the recent flu vaccine of three weeks ago, she asked for non thimerosal containing products. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: patient received an invalid dose of 0.25 mL instead of 0.5 mL of Fluzone QIV/no AT; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case was linked to 2019SA293392.  This case involves a 14 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2019, the patient received a 0.25 ml instead of 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6653BD via intramuscular route in the right deltoid.  It was of actual medication error due to vaccine underdose..  It was unknown whether adverse event was noted or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Device leakage, Exposure via skin contact
Clinical narrative: the metal part of the vial started leaking all over her hand, because it leaked out so much, the Pentacel vaccine was not able to be administered to the patient with no Ae; the metal part of the vial started leaking all over her hand, because it leaked out so much, the Pentacel vaccine was not able to be administered to the patient with no Ae; the metal part of the vial started leaking all over her hand, because it leaked out so much, the Pentacel vaccine was not able to be administered to the patient with no Ae; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient with an unknown demographic for whom it was reported that the metal part of the vial started leaking all over her hand, because it leaked out so much, the pentacel vaccine was not able to be administered to the patient (exposure via skin contact) (underdose) (syringe issue), while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received at an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6257AA via unknown route in unknown administration site.  On an unknown date, it was reported that Nurse states that one of the Medical Assistants went to combine the ActHIB into the DTAP/Ipol vial and once they were combined and mixed together, the metal part of the vial started leaking all over her hand, because it leaked out so much, the Pentacel vaccine was not able to be administered to the patient (exposure via skin contact) (underdose) (syringe issue). The medical assistant had a gloved hand and was able to take off her gloves and wash her hands. According to the caller, she did not have any injuries as a result of this.  No lab data was provided.  Final diagnosis was not applicable the metal part of the vial started leaking all over her hand, because it leaked out so much, the pentacel vaccine was not able to be administered to the patient.   It was not reported if the patient received a corrective treatment.  It was not reported if patient had any adverse event.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: administered the Diluent and not the HIB lyophilzed with no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient who was administered the diluent and not the HIB lyophilzed (product preparation issue), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 15-Oct-2019, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ124AAA via intramuscular route in the right vastus lateralis.  On an unknown date, it was reported that they were busy and in a hurry and did not grab both vials when preparing the Pentacel. They administered the diluent and not the HIB lyophilized (product preparation issue) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was an actual medication error due to product preparation issue.  No lab data was provided.  Final diagnosis was not applicable administered the diluent and not the hib lyophilzed with no ae.   It was not reported if the patient received a corrective treatment.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: don't think the patient got much of it, no AE; vaccine squirted out underneath the skin, no AE; vaccine squirted out underneath where the needle was attached to the shot, no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient who was vaccinated with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number UJ251AD expiry date:01-May-2020 via unknown route in unknown administration site, patient didn't got much of it, and vaccine squirted out underneath where the needle was attached to the shot on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to vaccine underdose and also a case of syringe leak. It was reported that,  the vaccine squirted out underneath where the needle was attached to the shot, don't think the patient got much of it. The vaccine was leaking where the needle was attached.   At the time of the report, 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.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: a 26 years old female patient received a dose of Fluzone High Dose vaccine/No AE; a 26 years old female patient received a dose of Fluzone High Dose vaccine/No AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (medical assistant).  This case involves a 26 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UT668110A via unknown route in the left arm on an unknown 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 inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  Doctor visit and date 16Oct2019.  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.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was given ActHIB after it had reached temperatures of 29C for up to 3 days in error, no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA290256 (same reporter).  This case involves a 15 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UJ161AA, expiry date: 02-May-2021, via intramuscular route in the left thigh on 23-Sep-2019 which had reached temperatures of 29C for up to 3 days in error.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was a case of actual medication error due to incorrect product storage.  At the time of reporting, 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 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.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was given ActHIB after it had reached temperatures of 29C for up to 3 days in error, no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA290230 (same reporter).  This case involves a 4 years old female patient who received a dose (4th in series) of vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UJ161AA, expiry date: 02-May-2021, via intramuscular route in the left thigh which had reached temperatures of 29C for up to 3 days in error on 23-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  It was a case of actual medication error due to incorrect product storage.  At the time of reporting, 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 holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: nurse only administered the DTAP and Ipol portions of the vaccine. She did not mix in the ActHIB powder into the vaccine / no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21 months old male patient who received only third dose of 0.5 ml DTap/IPV portions of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) Lot UJ115AAA, DTAP/IPV vial: U6396AB (Expiry date 23-Oct-2020) via intramuscular route in the right thigh on 15-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that nurse only administered the DTAP and Ipol portions of the vaccine. She did not mix in the ActHIB powder into the vaccine)  At a time of reporting no adverse event 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.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Fluzone Quadrivalent 0.5ml from a multiuse vial on Tuesday evening (15Oct2019) and administrated the vaccines to 66 patients on Wednesday morning (16Oct2019) starting at 9am/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves 66 patients who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] from a multiuse vial which was prepared on Tuesday evening (15-Oct-2019) and administrated the vaccines to on Wednesday morning (16-Oct-2019) starting at 9am lot UJ255AA, expiry date: 30-Jun-2020 via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong technique in product usage process.  At the time of report 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 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.
Age: 4.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: a four years old patient received a dose of Fluzone Quadrivalent, facility received their shipment this vaccine which were not viable shipment was delayed and took longer than 2 days/No AE; a four years old patient received a dose of Fluzone Quadrivalent, facility received their shipment this vaccine which were not viable shipment was delayed and took longer than 2 days/No AE; Initial information received on 17-Oct-2019 and additional information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves four years old patient (gender unknown) who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled facility received their shipment this vaccine which were not viable shipment was delayed and took longer than 2 days lot UT6686LA, expiry date: 30-JUN-2020 via intramuscular route in the right thigh on 17-Oct-2019.  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 a case of product shipment delay.  At the time of report 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 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.
Age: 4.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered at inappropriate site
Clinical narrative: 4 year old child received Fluzone 0.25ml rather than indicated 0.5ml as a medication error/No AE; 4 year old child received Fluzone in in the left vastus lateralis/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old patient who received 0.25 mL dose instead of 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6647JA, expiry date 30-06-2020 via intramuscular route in the left vastus lateralis on 09-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to vaccine underdose and vaccine administered at inappropriate site.  At the time of report 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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: gave an over weight patient the Fluzone Quad but 2 drops came out when she pulled the needle out, no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from  pharmacist.  This case involves patient of an unknown demographics who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported via unknown route in unknown administration site on an unknown date but 2 drops came out when she pulled the needle out.  The patient's medical history included Overweight. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to vaccine underdose.  At the time of report 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 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.  Information on batch number was requested.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 64 year old patient receivced a dose of Fluzone HD, no AE; a 64 year old patient receivced a dose of Fluzone HD, no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (other).  This case involves a 64 years old patient who received a dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported).  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 inappropriate age at vaccine administration and overdose.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  Information on the batch number was requested.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: They gave the expired Fluzone High Dose injection from this basket to the patient, no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 87 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ052AB, expiry date: 09-Jun-2019) via unknown route in the left deltoid.  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 expired vaccine used.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Local reaction, Skin warm, Swelling
Clinical narrative: localized reaction that were red, raised, warm, and about the size of a sand dollar; localized reaction that were warm, and about the size of a sand dollar; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 49 years old female patient who experienced localized reaction that were red, raised, warm, and about the size of a sand dollar (vaccination site reaction and inflammation), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ269AB and lot UJ255AB via unknown route in unknown administration site.  On an unknown date, the patient had a non-serious localized reaction that were red, raised, warm, and about the size of a sand dollar (vaccination site reaction and inflammation) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site reaction and inflammation.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site reaction and inflammation.
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site reaction
Clinical narrative: localized reaction that were red, raised, warm, and about the size of a sand dollar; localized reaction that were warm, and about the size of a sand dollar; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 49 years old female patient who experienced localized reaction that were red, raised, warm, and about the size of a sand dollar (vaccination site reaction and inflammation), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ269AB and lot UJ255AB via unknown route in unknown administration site.  On an unknown date, the patient had a non-serious localized reaction that were red, raised, warm, and about the size of a sand dollar (vaccination site reaction and inflammation) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site reaction and inflammation.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site reaction and inflammation.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: diluent portion only of Pentacel in the right thigh/no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old male patient who recieved diluent portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without HIB in the right thigh, Lot number- UJ104AA, expiration date- 13-Oct-2020 on 01-Oct-2019    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  It was a case of actual medication error due to Active ingredient not added to diluent.  It was unknown if patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Malaise, Nasopharyngitis, Pain
Clinical narrative: achy and off; cold will put her down; very sick, did not feel well, when she gets sick, she gets really sick, feels bad for 2-3 days; felt tired; felt run down for 2 months like she had a sub-clinical flu; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 70 years old female patient who experienced achy and off (pain), cold will put her down (nasopharyngitis), very sick, did not feel well, when she gets sick, she gets really sick, feels bad for 2-3 days (malaise), felt tired (fatigue) and felt run down for 2 months like she had a sub-clinical flu (influenza like illness), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In Sep-Oct 2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious achy and off (pain), cold will put her down (nasopharyngitis), very sick, did not feel well, when she gets sick, she gets really sick, feels bad for 2-3 days (malaise), felt tired (fatigue) and felt run down for 2 months like she had a sub-clinical flu (influenza like illness) 2-3 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests not reported.   Final diagnosis was pain, nasopharyngitis, malaise, fatigue and influenza like illness.  It was not reported if the patient received a corrective treatment.  The patient was recovering from all events.  Information on the batch number was requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Fluzone High Dose was inadvertently given to a 62 year old patient, no AE; Fluzone High Dose was inadvertently given to a 62 year old patient, no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 years old female patient who received 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ251AD, Exp. Date 01-May-2020) via unknown route in the left deltoid on 16-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications administered.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, patient did not had any reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4, VARZOS
Symptoms: Mesenteritis
Clinical narrative: Mesenteritis; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who experienced mesenteritis, while patient received vaccines SHINGRIX and INFLUENZA QUADRIVALENT RECOMBINANT 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 not reported via unknown route in unknown administration site.  On an unknown date, the patient received a dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious mesenteritis 48 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and SHINGRIX.  (Other relevant tests included no lab data.)  Final diagnosis was mesenteritis.   It was not reported if the patient received a corrective treatment.  The outcome of the event was Unknown for mesenteritis.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: injection site was still bleeding; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 69 years old female patient whose injection site was still bleeding ((vaccination site haemorrhage), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation; and HEPATITIS A VACCINE INACT (HAVRIX) in left arm on 15-Oct-2019.  On 15-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AA, 20-May-2020 via unknown route in the right arm.  On 15-Oct-2019, the patient had a non-serious injection site was still bleeding (vaccination site haemorrhage) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site haemorrhage.   The patient was treated with clopidogrel for Vaccination site haemorrhage.  The patient outcome is reported as unknown for vaccination site haemorrhage.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site reaction
Clinical narrative: itching like a mosquito bite; injection site reaction; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient of unknown age who experienced injection site reaction (injection site reaction) and itching like a mosquito bite (injection site itching), while she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE injection lot number not reported  via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious injection site reaction (injection site reaction) and itching like a mosquito bite (injection site itching) unknown latency following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Other lab data was not reported.  Final diagnosis was injection site reaction (injection site reaction) and itching like a mosquito bite (injection site itching).  It was not reported if the patient received a corrective treatment.  Outcome of event was unknown.  Information on the batch number was requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itching at site and on upper arm
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Erythema, Paraesthesia oral, Peripheral swelling, Pruritus
Clinical narrative: Swelling, redness and itching spread down the arm (spanned the space between the deltoid and elbow, them spread across the back to the other arm.  Patient's lips were tingling and she was coughing
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: Within 24 hours, pain in right arm at injection site. Next 24-48 hours injection site on right arm had swollen to approximately 3X4 inches, red, painful, hot to touch. This continued through 10/21 when the swelling started to go down.  Today, 10/24 there is a clear discoloration on my right arm.   At day 4, experienced pain in right leg and glute area. Pain spread from buttock area to back of thigh.  painful to touch. Pain continues today.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin discolouration, Tenderness
Clinical narrative: Within 24 hours, pain in right arm at injection site. Next 24-48 hours injection site on right arm had swollen to approximately 3X4 inches, red, painful, hot to touch. This continued through 10/21 when the swelling started to go down.  Today, 10/24 there is a clear discoloration on my right arm.   At day 4, experienced pain in right leg and glute area. Pain spread from buttock area to back of thigh.  painful to touch. Pain continues today.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Site of injection and  surrounding area extremely sore and tender,  partial loss of arm mobility, fatigue
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: 5 inch rash below injection site, red slightly bumpy and warm to touch. Very tender
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Migraine, Muscle fatigue, Pyrexia
Clinical narrative: 1:30AM - Fever and Chills 5:00AM - Fever and Chills + Muscle Fatigue 7:00AM - Muscle Fatigue and Severe Headache 10:00AM  - Muscle Fatigue and Severe Headache 12PM - Muscle Fatigue and Headache diminished after taking (3) Ibuprofen and (3) Excedrin Migraine at 10:00AM
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site oedema
Clinical narrative: redness edema at site. headache. and general achiness flu like ache for about 48  hours