chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; The patient received the first dose of GARDASIL 9 on 01-AUG-2018 and the second dose of GARDASIL 9 on 07-AUG-2019; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant mediations and drug reactions or allergies were not provided.  On 01-AUG-2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml (route, lot number: N028567 and expiration date: 17-MAY-2020) for prophylaxis. On 07-AUG-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml (route, lot number: R008165 and expiration date: 12-NOV-2020) for prophylaxis. The second dose was a late dose (inappropriate schedule of vaccine administered). No adverse effects reported. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: The rash at site of injection was about 5 inches top to bottom; This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but was between 50 to 60 years. The patient experienced a very large rash in 2 areas on the arm where injection was given. The patient experienced injection site rash about 5 inches top to bottom and 2nd lower rash was about half dollar size. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: The rash at injection site was about 5 inches top to bottom; This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but was between 50 to 60 years. The patient experienced a very large rash in 2 areas on the arm where injection was given. The patient experienced injection site rash about 5 inches top to bottom and 2nd lower rash was about half dollar size. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: small rashes, itchy; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of rash (received shingle shot 5 years ago from time of reporting and received several rashes slightly bigger).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but as per indication of the vaccine age group was captured as adult. The patient developed 3 small rashes, itchy, but did not spread. The patient inquired of everything was normal or not and asked if the patient should get the second dose or not.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Headache, Influenza like illness, Injection site pain, Nausea
Clinical narrative: Pain at Injection Site; Low-grade fever; Nausea; Headache; Generalized Aches and Pain; Redness; pain down neck; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old 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 1st April 2019, refer case US2019127814).   On 12th July 2019, the patient received the 2nd dose of Shingrix .5 ml. In July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms. The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The caller reported that she received 1st and 2nd dose of Shingrix doses over a period of 3 months. Within about 6 to 8 hours following vaccination the patient experienced pain at injection site, redness, low grade fever, nausea, headache, generalized aches and pain down neck (flu-like symptoms). The patient reported that the current symptoms were not bad as 1st dose. The reporter consented to follow up reports taking Tylenol and Advil intermittently . This was 1 of the 2 cases reported by same reporter.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Pain at Injection Site; Low-grade fever; Nausea; Headache; Generalized Aches and Pain; Redness; pain down neck; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old 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 1st April 2019, refer case US2019127814).   On 12th July 2019, the patient received the 2nd dose of Shingrix .5 ml. In July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms. The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The caller reported that she received 1st and 2nd dose of Shingrix doses over a period of 3 months. Within about 6 to 8 hours following vaccination the patient experienced pain at injection site, redness, low grade fever, nausea, headache, generalized aches and pain down neck (flu-like symptoms). The patient reported that the current symptoms were not bad as 1st dose. The reporter consented to follow up reports taking Tylenol and Advil intermittently . This was 1 of the 2 cases reported by same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue, Pyrexia
Clinical narrative: Extra Dose; Fever; did not want to move/Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 24th January 2019) and Shingrix (2nd dose received in 24th May 2019).   In August 2019, the patient received the 3rd dose of Shingrix (intramuscular). In August 2019, not applicable after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever and fatigue were resolved with sequelae and the outcome of the extra dose administered was unknown.   The reporter considered the fever to be related to Shingrix. It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were reported as follows: The reporter was the daughter and patient was the mother.  The patient lives with the reporter. The reporter states that her mother did not speak English very well and that she received a third dose of Shingrix, which led to extra dose administered.  The reporter did not know the exact. The reporter did not have the lot number for any of the doses.  The reporter said all three doses were given at the same pharmacy.  The reporter states that all three were given intramuscularly.  The reporter also stated that after the 3rd shot of Shingrix her mother had a fever and was fatigued for 2 days.  She said she did not want to move.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Feeling sick; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in an  unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patients experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. A pharmacist reports that she had had a number of patient complain that they feel sick for at least a day after receiving the Shingrix vaccine.  The reporter consented to follow up.  The pharmacist estimated 50 plus patients. When asked to elaborate on feeling sick she stated it was all the symptoms listed in the prescribing information.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Hearing Loss; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 5th July 2021) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd July 2019, 2 hrs 30 min after receiving Shingrix and 61 days after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On 22nd July 2019, the outcome of the hearing loss was recovered/resolved.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine on left arm. The patient and her husband were watching TV and she noticed she had trouble hearing a show. Hearing loss reportedly lasted 2.5 hours. The patient had supporting documentation of hearing loss. The reporter consented to follow up.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: arms start swelling was red, and right below the reaction site and very sore; arm was red right below the reaction site; arms start swelling right below the reaction site; arm was very sore right below the reaction site; Hard time sleep due to every time she rolled over it hurt; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves female patient of an unknown age who experienced arms start swelling was red, and right below the reaction site and very sore (inflammation), (erythema), (swelling), (pain in extremity) and hard time sleep due to every time she rolled over it hurt (sleep disorder), 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.   On an unknown date in morning at 11:30 AM, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ245AA via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious arms start swelling was red, and right below the reaction site and very sore (inflammation), (erythema), (swelling), (pain in extremity) and hard time sleep due to every time she rolled over it hurt (sleep disorder) on same day by that afternoon following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was hard time sleep due to every time she rolled over it hurt and arms start swelling was red, and right below the reaction site and very sore.  It was not reported if the patient received a corrective treatment.  The patient was Recovering from inflammation, erythema, swelling and outcome of the other events was unknown.  Documents held by sender: none.
Age: 1.17
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: received Ipol from a MDV that was opened and deemed not safe to use / no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.   This case is linked to case 2019SA264011 (same reporter).  This case involves a 14 years old female patient who received 0.5 ml dose of IPV (VERO) lot PIE70 via intramuscular route in the right arm on 11-Nov-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, TETANUS VACCINE TOXOID (TDAP), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) and HEPATITIS B VACCINE (HEPATITIS-B).  It was a actual medication error case due to incorrect product storage.  It was reported that 2 patient's that received Ipol from a MDV that was opened and deemed not safe to use. The physician mentioned that she thinks that she should be able to use her clinical judgment as to whether or not to reinjection her patient's and she did not believe that this situation warrented it.  At a 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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: I was giving the injection, it leaked onto my hand, no AE; pharmacist was giving a patient a Fluzone High Dose and almost half of the dose came off on my shot and shirt, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  The case is linked with 2019SA268222 (same reporter).  This case involves a 65 years old male patient who received almost half of the dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ236AA, expiry date: 04-Apr-2019, via intramuscular route in the right arm) and half of the dose was came off on my shot and shirt on 19-Sep-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of vaccine underdose and syringe issue.  At the time of reporting the patient had no adverse event.  It was also reported that screwing the needle on tight for injecting the dose her gloved hand was suddenly wet from the vaccine leaking. She stated the leaking must have come from the barrel of the syringe on the side or perhaps the orange part of the needle because that is where her finger was resting. Rph mentioned the other doses in the carton were fine to administer. She asked if the dose should be repeated, she will call the patient back to the pharmacy.  Needle type: Safety, BD safety glide, 25g by 1 inch.  List of document held by sender: none.
Age: 10.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 10 year old received Flublok accidentally, no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 years old patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA1914, expiry date: 30-Jun-2020) accidentally, via intramuscular route in the right arm on 21-Sep-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 the inappropriate age at vaccine administration.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: UNK
Symptoms: Adverse reaction
Clinical narrative: patient had a reaction; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient of an unknown age who had a reaction (adverse event), while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious patient had a reaction (adverse event) (Unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was patient had a reaction.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown.  The caller has three children, ages 7, 9, and 11. One of the children received DTaP in the past and had a reaction. After that, the mom and physician decided to delay DTP immunization of the three children until the youngest is age 7. All three children received Sanofi Tdap about 4 weeks ago. It was the first dose for two of the children. It was the second dose of one of the children. Lot --C5609AA expiry 04-Apr-2021 and concomitant medication MMR.  Information on the batch number was requested.  Documents held by sender: none.
Age: 13.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13 year old patient was accidentally administered Flublok, no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old patient who received a 0.5 mL dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1914, expiry date: 30-Jun-2020,  via intramuscular route in the left deltoid on 21-Sep-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 age at vaccine administration.  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.  Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, Needle issue, Underdose
Clinical narrative: gave the Fluzone HD, all of the vaccine didn't enter the Left Deltoid/ No AE; Pharmacist stated after giving the consumer their Fluzone HD injection the vaccine began to drip down their arm/ No AE; The vaccine liquid came out between the hub of the needle and the syringe on injection, It was the needle and not the syringe/ No AE; Initial information received on 23-Sep-2019 and additional information received on 24-SEP-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 74 years old male patient who did not received full dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ232AB via unknown route in the left deltoid on 23-Sep-2019, the vaccine liquid came out between the hub of the needle and the syringe on injection, it was the needle and not the syringe.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of vaccine underdose, Exposure via skin contact and Needle leak.  At the time of report no adverse event was reported.  The leakage occurred during the injection of the Fluzone HD. Caller stated she placed the needle with the syringe in the arm and pushed the plunger. The vaccine liquid came out between the hub of the needle and the syringe on injection. Caller stated, "When she took the needle off of the syringe the needle looked wobbly and loosey goosey. Caller stated the needle didn't look right." 'It was the needle and not the syringe.  Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: patient received dose of Fluzone HD on 20Sep2019 in which there was a needle malfunction and some of the dose leaked out, no AE; the leakage was not from the tip of the needle, but further up the syringe and some of the dose leaked out, no AE; Initial information received on 23-Sep-2019 and additional information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 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 UJ242AA, expiry date: 04-May-2020) via intramuscular route in the right deltoid on 20-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and syringe leak.   Pharmacist reported that patient received dose of Fluzone HD in which there was a needle malfunction and some of the dose leaked out. It was reported that the leakage was not from the tip of the needle, but further up the syringe. Leakage did occur during administration and it was believed the needle might not have been attached properly/screwed in tight.  At the time of reporting, no adverse event was reported.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Tremor
Clinical narrative: body shaking; trouble breathing; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 90 years old female patient who experienced body shaking (tremor) and trouble breathing (dyspnea), 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.   On 23-Sep-2019, the patient received a single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ251AB via unknown route in the arm nos.  On an unknown date, The patient developed a non-serious body shaking (tremor) and trouble breathing (dyspnea) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab test reported.  Final diagnosis was trouble breathing and body shaking.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for body shaking and as Unknown for trouble breathing.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient only e liquid DTAP- IPV portion of Pentacel without mixing it with the powder Hib portion; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who recieved only e liquid dtap- ipv portion of pentacel without mixing it with the powder hib portion, 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.   On 20-Sep-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number - U6138AB in left Vastus Lateralis.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  It was a case of actual medication error due to Inappropriate reconstitution technique.  No adverse event reported as none symptoms 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: M
Vaccine: FLU3, FLUX
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 64 year old patient was inadvertently given the Fluzone High Dose vaccine instead of an influenza vaccine/ no AE; 64 year old patient was inadvertently given the Fluzone High Dose vaccine instead of an influenza vaccine/ no AE; 64 year old patient was inadvertently given the Fluzone High Dose vaccine instead of an influenza vaccine/ no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 64 years old male patient who vaccines INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ251AB, expiry- 01-05-2020 via unknown route in the left arm instead of INFLUENZA VACCINE.  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 vaccine administered, inappropriate age at vaccine administration and overdose.  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.  Information on the batch number was requested.  Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD administered to 63 year old patient/no AE; Fluzone HD administered to 63 year old patient/no AE; Fluzone HD administered to 63 year old patient/no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 63 years old female patient 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.   On 21-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ251AB via intramuscular route in the left deltoid.  It was of actual medication error due to inappropriate age at vaccine administration, off label use and overdose.  It was unknown where adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: large amount of swelling at the side, redness, and heat; large amount of swelling at the side, redness, and heat; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (reported as 1) who experienced large amount of swelling at the side, redness, and heat (Inflammation  and vaccination site reaction), while he/she received vaccine INFLUENZA VACCINE  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date (09/17), the patient received a dose of suspect INFLUENZA VACCINE lot number not reported via unknown route and unknown site.  On an unknown date, the patient had experienced large amount of swelling at the side, redness, and heat (Inflammation and vaccination site reaction) (Unknown latency) following the administration of INFLUENZA VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site inflammation, vaccination site swelling, vaccination site erythema and vaccination site warmth.   Office recommended ice to site of injection, motrin, and benedryl. Seen in office 9/19 (flu shot administered 9/17), oral steroids if not improved with OTC recommendations  The patient outcome was reported as unknown for experienced large amount of swelling at the side, redness, and heat (Inflammation  and vaccination site reaction).  Information on batch number was requested.  List of document held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: large amount of swelling at injection site, redness, and heat.; large amount of swelling at injection site, redness, and heat.; large amount of swelling at injection site, redness, and heat.; large amount of swelling at injection site, redness, and heat.; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional in via Sales Representative.  This case involves a 10 years old patient who experienced large amount of swelling at injection site, redness, and heat (vaccination site inflammation), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 17-Sep-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  On an unknown date, The patient developed a non-serious large amount of swelling at injection site, redness, and heat. (vaccination site inflammation) (vaccination site swelling) (vaccination site erythema) (vaccination site warmth) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No lab test reported.  Final diagnosis was large amount of swelling at injection site, redness, and heat..   The patient was treated with ice the site, NAPROXEN (MOTRIN [NAPROXEN]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient outcome is reported as Unknown for the events.  Information on the batch number was requested.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Large amount of swelling at the injection site; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18  old patient who experienced large amount of swelling at the injection site (vaccination site swelling), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, concomitant therapy, 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 developed a non-serious large amount of swelling at the injection site (vaccination site swelling) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No lab test reported.  Final diagnosis was large amount of swelling at the injection site.   The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]), ice to the site and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient outcome is reported as Unknown for large amount of swelling at the injection site.  Information on the batch number was requested.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: swelling and itching at injection site; swelling and itching at injection site; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (reported as 4) who experienced swelling and itching at injection site (vaccination site pruritus and vaccination site swelling), while he/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 an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route and unknown site.  On an unknown date, the patient had swelling and itching at injection site (vaccination site pruritus and vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site pruritus and vaccination site swelling.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site pruritus and vaccination site swelling.  Information on the batch number is requested.  List of document held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Headache, Influenza like illness, Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: fever; flu like symptoms; sniffles; headache; sick like a dog; feeling like they were dying for a day; Initial and Additional information received on 23-Sep-2019 and 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacy other/non-hcp.  This case is linked to cases 2019SA267183 and 2019SA267181 (same reporter).  This case involves a 67 years old male patient who experienced flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), fever (pyrexia) and feeling like they were dying for a day (unevaluable event), while he 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.   On 06-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Lot: UJ232AA and expiry date: 10-Apr-2020) via intramuscular route in the left deltoid.  On an unknown date, the patient had flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), sick like a dog (malaise), fever (pyrexia) and feeling like they were dying for a day (unevaluable event) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  Final diagnosis was influenza like illness, rhinorrhoea, headache, malaise, pyrexia and unevaluable event.   It was not reported if the patient received a corrective treatment and Spent the whole day in bed.  The patient outcome was reported as unknown for all the events.  List of document held by sender:  none.
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Influenza like illness, Malaise, Pyrexia
Clinical narrative: feeling like they were dying for a day; fever; flu like symptoms; sniffles,; headache; sick like a dog; Initial and Additional information received on 23-Sep-2019 and 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacy other/non-hcp.  This case is linked to cases 2019SA267183 and 2019SA267182 (same reporter).  This case involves a 66 years old male patient who experienced flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), sick like a dog (malaise), fever (pyrexia) and feeling like they were dying for a day (unevaluable event), while he 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.   On 06-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Lot: UJ232AA and expiry date: 10-Apr-2020) via intramuscular route in the left deltoid.  On an unknown date, the patient had flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), sick like a dog (malaise), fever (pyrexia) and feeling like they were dying for a day (unevaluable event) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  Final diagnosis was influenza like illness, rhinorrhoea, headache, malaise, pyrexia and unevaluable event.   It was not reported if the patient received a corrective treatment and Spent the whole day in bed.  The patient outcome was reported as unknown for all the events.  List of document held by sender:  none.
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: feeling like they were dying for a day; fever; flu like symptoms; sniffles,; headache; sick like a dog; Initial and Additional information received on 23-Sep-2019 and 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacy other/non-hcp.  This case is linked to cases 2019SA267183 and 2019SA267182 (same reporter).  This case involves a 66 years old male patient who experienced flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), sick like a dog (malaise), fever (pyrexia) and feeling like they were dying for a day (unevaluable event), while he 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.   On 06-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Lot: UJ232AA and expiry date: 10-Apr-2020) via intramuscular route in the left deltoid.  On an unknown date, the patient had flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), sick like a dog (malaise), fever (pyrexia) and feeling like they were dying for a day (unevaluable event) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  Final diagnosis was influenza like illness, rhinorrhoea, headache, malaise, pyrexia and unevaluable event.   It was not reported if the patient received a corrective treatment and Spent the whole day in bed.  The patient outcome was reported as unknown for all the events.  List of document held by sender:  none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193;   This case involves (an adult) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  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.  Documents held by sender: none.
Age: 10.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 10 years old patient was administered Flublok instead of Fluzone Quad/no AE; 10 years old patient was administered Flublok instead of Fluzone Quad/no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.   This case is linked to case 2019SA267184 (same reporter).  This case involves a 10 years old patient of unknown gender who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT).  The patient's past medical history, concomitant therapy, 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.  It was of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown where adverse event was experienced or not.  Information on the batch number was requested.  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: FLUX
Symptoms: Arthritis, Neck pain, Pain in extremity
Clinical narrative: possibly Parsonage Turner Syndrome; Severe pain in the shoulder, and arm; random neck pain or a flare; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 33 years old female patient who experienced possible parsonage turner syndrome (neuralgic amyotrophy), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis and Sjogren's syndrome.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route.  On an unknown date, The patient developed a non-serious possible parsonage turner syndrome (neuralgic amyotrophy) severe pain in the shoulder, and arm (pain in extremity) and random neck pain or a flare (neck pain) one or two days following the administration of INFLUENZA VACCINE.  No lab test was reported.  Final diagnosis was possible parsonage turner syndrome.   Several physical therapy sessions, and unsuccessful steroid attempts to ease the pain corrective treatment was received.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for the events.  Information on the batch number will be requested.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was not given at our facility. Unsure of Manufacturer and/or Lot numbers etc.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Patient developed rash starting on torso and spreading to back and legs and became itchy.