chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.92
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient was administered Pentacel instead of Diphtheria, Tetanus and Acellular Pertussis (DTAP), No AE; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 23 months and 4 days old male patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination instead of just DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) on an unknown date (wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to wrong vaccine administered.  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.  There will be no information available on lot number.
Sex: U
Vaccine: MNQ
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: The patient received first dose of Menactra in early 2019 and never received the second dose, no AE; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist .  This case involves a patient who received first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported) via an unknown route at an unknown administration site, in early 2019 as prophylactic vaccination and never received the second dose of the same.  The patient's past medical history included Splenectomy. The patient's past medical treatment, vaccination and family history were not provided.   It was an actual medication error due to missed dose. (latency unknown)  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.  There will be no information available on batch number for this case.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: three year patient received Fluzone High-Dose Quadrivalent vaccine/ NO AE; three year patient received Fluzone High-Dose Quadrivalent vaccine/ NO AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case ID 2020SA243060, 2020SA242187, 2020SA242315, 2020SA242186 and 2020SA242184.  This case involves a 3-year-old male patient who received once 0.7 mL INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, batch number: UJ450AB, expiry date: 30-Jun-2021, via an intramuscular route in left thigh) (overdose and product administered to patient of inappropriate age) on 31-Aug-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, family history were not provided.  No vaccination and concomitant medications were given.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency : same day).  Reported wanted to know possible side effects.  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.
Age: 7.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 7 year old patient was administered Flublok, no AE; Initial information was received on 04-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.   This case involves a 7 year old male patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, past medical treatment, vaccination and family history were not provided.  The patient did not receive any concomitant vaccines.   On 01-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2003, expiry date: 19-May-2021) once via unknown route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  Reporter wanted information regarding this occurrence due vaccine not being approved for this age  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: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: the diluent that came in the box with the ACTHIB, was not used, they used another diluent instead/No AE; Initial information was received on 08-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient with unknown demographics who was vaccinated on an unknown date, with using another diluent instead of the diluent that came in the box with the HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination (product preparation error).   Medical history, past medical treatment, vaccination and family history were not provided. Concomitant medication if any, not reported.  It was a case of actual medication error due to wrong solution used in drug reconstitution (latency: same day)   Reporter wanted to know if this is safe for the patient?  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.  There will be no information available on the batch number for this case.
Age: 73.0
Sex: M
Vaccine: FLUR4, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: nurse mistakenly gave him Flublok, when he intended to have Fluzone High-Dose Quadrivalent, no AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 73-year-old male patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2003, Expiry date 19-May-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 03-Aug-2020, instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency same day).   Reporter asked if it is possible for him to take the Fluzone vaccine maybe in October 2020  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: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was accidentally given without the liquid component, just the HIB part with sterile water/No AE; Initial information was received on 09-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to 2020SA246864.  This case involves a 2 months old male patient who received a  0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] accidentally without the liquid component, just the hib part with sterile water (lot UJ195AAA, expiry date- 12-Mar-21) via unknown route in the left thigh for prophylactic vaccination on 09-Sep-2020.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL CONJUGATE VACCINE (PCV) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination..  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  The caller stated that staff person administered 0.5ml of Pentacel in the patient's left thigh today. She used sterile water to dilute the Hib component of the vaccine and that was injected.  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.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was accidentally given without the liquid component, just the HIB part with sterile water, No AE; Initial information was received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a two-months-old male patient who was administered a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ195AAA, Expiry date 12-Mar-2021) without the liquid component, just the Hib part was given with sterile water (product preparation issue), via an unknown route in the right thigh on 09-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL CONJUGATE VACCINE (PCV) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  This was an actual medication error case due to inappropriate reconstitution technique (latency same day).  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: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel vaccine was administered to 32 months old female patient/ NO AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 32 months old female patient received a 0.5 mL first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5656AA, expiry date: 13-Aug-2021 via an intramuscular route in left deltoid) which was intended for patient of four year old and above on 29-Jul-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration(latency: same day).  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.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received ACTHIB with expired diluent /no AE; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case from a health care professional.  This case is linked to case 2020SA256170. (same reporter, age, gender and initial reported for two patients).  This case involves a 15-month-old male patient who received a dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACTHIB], with expired diluent (expired product administered).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  On 10-Sep-2020, the patient received a fourth dose of 0.5 ml of suspect HAEMOPHILUS TYPE B (HIB) VACCINE [Vaccine Powder: lot UJ125AGA, expiry date: 02-Nov-2020 and for Diluent: U6337AA, 12-Aug-2020] via an intramuscular route at the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.   HCP wanted to known harm associated with receiving a 5th dose of ACTHIB, and how soon the dose with non expired product can be given.  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.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 49-year-old female patient was given Fluzone-HD quadrivalent instead of the Fluzone Quad, no AE; 49-year-old patient was given Fluzone-HD quadrivalent, no AE; 49-year-old female patient was given Fluzone-HD quadrivalent instead of the Fluzone Quad, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case is linked to cases 2020SA253357, 2020SA252226, 2020SA253258 and 2020SA253258.  This case involves a 49 year old female patient who received 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ453AB and expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination, on 10-Sep-2020 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered, product administered to patient of inappropriate age and overdose).  Medical history, past medical treatments, vaccination and family history were not provided. No other vaccine was given concomitantly.  It is an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and overdose (latency same day). The caller reported that the error occurred due to grabbing the wrong box, not paying attention, and not looking at the box carefully. It was unknown if the patient was pregnant due to the information not obtained.  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: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: medical assistance gave out Fluzone-HD quadrivalent instead of the Fluzone Quad, no AE; 37-year-old patient was given Fluzone-HD quadrivalent, no AE; 37-year-old patient was given Fluzone-HD quadrivalent instead of the Fluzone Quad, no AE; Initial information was received on 15-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves a 37-year-old female patient who received 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ453AB, expiry date 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination, on 10-Sep-2020 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered, product administered to patient of inappropriate age and overdose).  Medical history, past medical treatments, vaccination and family history were not provided. Patient did not have any other vaccines.   It is an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and overdose (latency same day).  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: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 64-years-old female patient was given Fluzone High Dose instead of the Fluzone quadrivalent, no AE; a 64-years-old patient was given Fluzone High Dose quadrivalent, no AE; a 64-years-old patient was given Fluzone High Dose quadrivalent, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case is linked to cases 2020SA252226, 2020SA252621 and 2020SA253258.  This case involves a 64 years old female patient who received 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE []FLUZONE HIGH-DOSE QUADRIVALENT (lot UJ453AB and expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination, on 10-Sep-2020 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered, product administered to patient of inappropriate age and overdose).  Medical history, past medical treatments, vaccination and family history were not provided. Patient did not have any other vaccines.  It is an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and it was a case of overdose (latency same day).  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: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient received Fluzone High Dose instead of the Fluzone Quadrivalent, no AE; A 60-years-old patient was given Fluzone High Dose, no AE; A 60-years-old patient was given Fluzone High Dose, no AE; Initial information was received on 15-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case is linked to cases 2020SA253357, 2020SA253258 and 2020SA252226 (same reporter).  This case involves a 60-years-old female patient who received 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ453AB, expiry date 30-Jun-2021) once via an intramuscular route in the left deltoid for prophylactic vaccination, on 10-Sep-2020 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered, product administered to patient of inappropriate age and overdose).  Medical history, past medical treatments, vaccination and family history were not provided. Patient did not receive any concomitant medications. It was unknown if the patient was pregnant as the information was not obtained.   It is an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and it was a case of overdose (latency same day).  It was reported that the error occurred due to grabbing the wrong box, not paying attention and not looking at the box carefully. The facility contacted the patient on the day after the injection and is planning to follow up today after reaching out to the manufacturer.  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: 80.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Monoplegia
Clinical narrative: paralysis in the arm receiving the flu shot; Initial information was received on 15-Sep-2020 regarding an unsolicited valid serious case from a consumer or other non-professional (patient).  This case involves an 80-year-old female patient (age at the time of report was 81 years) who experienced paralysis in the arm receiving the flu shot (monoplegia), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR].  Patient had history of peripheral neuropathy and brittle bone disease (5 fractures in 4 years).  The patient had been vaccinated from last 4-5 year by Fluzone HD vaccine.  Past medical treatment, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route at the arm and a dose of suspect PREVNAR (not produced by Sanofi Pasteur) [lot number and expiry date not reported] via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious paralysis in the arm receiving the flu shot (monoplegia), either the evening of or the following day after receiving the flu shot as well as after receiving Prevnar. This event was assessed as medically significant.   The patient reported the most severe reaction last year with the flu shot for the elderly and Prevnar. Patient reported that she could not even put key in the door lock. Patient wanted to ask whether or not regular flu shot would be better for her than the HD.  Caller requested PIs (product information) for FLUZONE HD, FLUBLOK QUADRIVALENT, and FLUZONE QUADRIVALENT.    Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from arm paralysis (it was reported that symptoms lasting approximately 2 days).  Information on batch number has been requested.; Sender's Comments: This case involves an 80-year-old female patient who presented with monoplegia of the vaccinated limb after vaccination with FLUZONE HIGH DOSE and PREVNAR. The time to onset is compatible with the role of the vaccines. Patient had a history of vaccination with same suspect Influenza vaccine from last 4-5 years and experienced similar event. Patient also had history of peripheral neuropathy and brittle bone disease (5 fractures in 4 years). However, information regarding patient's condition at time of vaccination, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be individually assessed.
Age: 28.0
Sex: M
Vaccine: ANTH, MNQ, YF
Symptoms: Immediate post-injection reaction, Loss of consciousness, Presyncope
Clinical narrative: Vasovagal reaction immediately following vaccine administration. Patient lost consciousness for approximately 10 seconds after receiving vaccines and regained consciousness. Patient was sitting in chair while having shots administered and did not obtain any secondary injuries. Patient was monitored in clinic for 30 minutes with vital signs being taken. Patient recovered well and did not report any pain, dizziness or lightheadedness.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; Nurse calling to report expired DILUENT used with PROQUAD to vaccinate a child on 9/21/20.; Nurse calling to report expired DILUENT used with PROQUAD to vaccinate a child on 9/21/20.; This spontaneous report was received from a nurse, referring to a child of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 21-SEP-2020, the patient received an expired dose of sterile diluent (MERCK STERILE DILUENT), administered at a dose of 0.5 milliliters (ml) (formulation, strength, route of administration and frequency were not reported, lot number S018824, which has been verified to be valid, expiration date reported and validated as 20-AUG-2020), that was used with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5ml (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T013536, which has been verified to be valid, expiration date reported and validated as 17-OCT-2021) as prophylaxis (product preparation issue). There was no temperature excursion reported with any of the suspects therapies. No additional adverse events were reported.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Oropharyngeal pain
Clinical narrative: Upset stomach; Slight sore throat; This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2020, the patient received the 1st dose of Shingrix. On 16th September 2020, less than a day after receiving Shingrix, the patient experienced upset stomach and sore throat. On an unknown date, the outcome of the upset stomach and sore throat were unknown.   It was unknown if the reporter considered the upset stomach and sore throat to be related to Shingrix.  Additional details were provided as follows: The reporter who was a patient stated that Shingrix was received about 3 hours ago. The patient experienced upset stomach and slight sore throat. The patient drank iced coca cola and felt pretty good then. The reporter had also questioned if they should be concerned. The follow-up was not required.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Tetanus vaccine.   On 17th September 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 19th September 2020, 2 days after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient said that got flu shot last Thursday (17th September 2020), sick as a dog since Saturday (19th September 2020). Tetanus shot was good for 10 years, got that with my last visit with my primary. No further information was available.
Age: 15.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was given to a 15-year-old patient, no AE; Initial information received on 18-Sep-2020 regarding an unsolicited valid non-serious case from pharmacist.  This case involves a 15 years old patient (gender unknown) who was given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unspecified date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration (same day latency) and it was reported that the if the patient should be administered the FLUZONE after receiving FLUBLOK.   No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin exfoliation
Clinical narrative: Patient claims her arm swelled 2 times the normal size. She said it was red all the way around arm and was very sore. She also stated her skin was peeling off from where the Band-Aid was.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis in the Right thigh
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Chills, Feeling hot, Headache, Micturition urgency
Clinical narrative: Urge to urinate while in bed, fever, chills, shaking, all muscles tensed up, pain in head, neck, back, and legs, followed by urination roughly every hour for nine hours.  Feeling of being very hot while in bed, but no sweating.  Low-grade fever, headache, and muscle aches through 10 AM (present time).
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle tightness, Myalgia, Neck pain, Pain in extremity, Pollakiuria
Clinical narrative: Urge to urinate while in bed, fever, chills, shaking, all muscles tensed up, pain in head, neck, back, and legs, followed by urination roughly every hour for nine hours.  Feeling of being very hot while in bed, but no sweating.  Low-grade fever, headache, and muscle aches through 10 AM (present time).
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Tremor
Clinical narrative: Urge to urinate while in bed, fever, chills, shaking, all muscles tensed up, pain in head, neck, back, and legs, followed by urination roughly every hour for nine hours.  Feeling of being very hot while in bed, but no sweating.  Low-grade fever, headache, and muscle aches through 10 AM (present time).
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Use of accessory respiratory muscles, Wheezing
Clinical narrative: 09/24/2020 @5:30pm mom called reporting patient was wheezing, and retracting. Patient referred to the ED.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arteriospasm coronary, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest pain, Dyspnoea
Clinical narrative: Pt who received both anthrax #2 and primary SPV on the same day (11/7/05). Approximately 12 days later, he noticed he was having chest pain while out on the town with friends. He decided to go home and go to bed, thinking he had over exerted himself in the previous days. He woke up during the night with increasing chest pain (10/10) and SOB secondary to chest pain and was sent to be seen at the local hospital. A complete work up was done and he was diagnosed as having coronary artery spasm. He was hospitalized for 4 days and placed on quarters for 4 more days after discharge. He was sent home on nifedipine and isosorbide. He was then placed on a profile and returned to the states in March of 2006 for follow up. Since the original episode he has had 2 more episodes of CP which he did not seek attention for the first time, but on 5/20/06 he got evaluated at the cardiac work up was normal. He was evaluated by a cardiologist on 5/06 and all test results normal. The nifedipine and isosorbide were stopped at that time.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Laboratory test normal, Troponin I increased, Troponin T normal
Clinical narrative: Pt who received both anthrax #2 and primary SPV on the same day (11/7/05). Approximately 12 days later, he noticed he was having chest pain while out on the town with friends. He decided to go home and go to bed, thinking he had over exerted himself in the previous days. He woke up during the night with increasing chest pain (10/10) and SOB secondary to chest pain and was sent to be seen at the local hospital. A complete work up was done and he was diagnosed as having coronary artery spasm. He was hospitalized for 4 days and placed on quarters for 4 more days after discharge. He was sent home on nifedipine and isosorbide. He was then placed on a profile and returned to the states in March of 2006 for follow up. Since the original episode he has had 2 more episodes of CP which he did not seek attention for the first time, but on 5/20/06 he got evaluated at the cardiac work up was normal. He was evaluated by a cardiologist on 5/06 and all test results normal. The nifedipine and isosorbide were stopped at that time.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: patient complains of rash (pinpoint macules) on chest by Thursday evening (9/24/25) this morning it spread to both shoulders.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Fatigue started on 7/16/20, chills and fever on 7/17/20 and 7/18/20, diarrhea started on 7/19/20 that last up to two weeks.  Also had poor appetite for approx 3 weeks after vaccine was given.  No aching noted.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Needle issue, No adverse event
Clinical narrative: No other AE reported; Employee on training used a 30gauge 1/2 needle instead of 25gauge 5/8 to given the injection. It may have been given subcutaneous instead of intramuscular; Employee on training used a 30gauge 1/2 needle instead of 25gauge 5/8 to given the injection. It may have been given subcutaneous instead of intramuscular; This spontaneous report was received from a nurse concerning a 4 month old patient, gender unknown by reporter. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 15-SEP-2020, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB)  for prophylaxis (lot # T011167 has been determined to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and established as 27-MAY-2022) (strength and dose were not provided). The nurse reported that the employee on training used a 30gauge 1/2 needle instead of 25gauge 5/8 to given the injection and it may have been given subcutaneous instead of intramuscular (incorrect route of product administration and circumstance or information capable of leading to medication error).   No adverse event reported.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took two doses of Vivotif on two consecutive days; Spontaneous report received on 10AUG2020.  A healthcare professional reported that an 18-year-old male consumer "took two doses of Vivotif on two consecutive days" (PT: Inappropriate schedule of product administration). He was receiving Vivotif for immunisation. The consumer took his first two doses of Vivotif on two consecutive days instead of alternative days. On 07AUG2020, he took his first dose of Vivotif and on 08AUG2020, took his second dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first two doses of Vivotif on two consecutive days (inappropriate schedule of product administered) instead of taking it on every other day. The causality of inappropriate schedule of product administered is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: A consumer took first two doses of Vivotif on two consecutive days (inappropriate schedule of product administered) instead of taking it on every other day. The causality of inappropriate schedule of product administered is assessed as not applicable to Vivotif due to the nature of the event.
Age: 61.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Myalgia, Pruritus
Clinical narrative: muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included covid-19 (both she and her husband suffered with Covid 19 this year.).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the muscle soreness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not applicable for this report. After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced muscle soreness without any kind of other reaction. On 13th September 2020, the patient had Fluarix Quadrivalent 2020-2021 and experienced itch on her chest near her left shoulder and it went body wide including her scalp, legs, feet, and back. The reporter consented to follow up. This case has been linked with US2020186260 reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020186260:same patient
Age: 61.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Myalgia, Pruritus, Reaction to previous exposure to any vaccine
Clinical narrative: muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included covid-19 (both she and her husband suffered with Covid 19 this year.).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the muscle soreness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not applicable for this report. After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced muscle soreness without any kind of other reaction. On 13th September 2020, the patient had Fluarix Quadrivalent 2020-2021 and experienced itch on her chest near her left shoulder and it went body wide including her scalp, legs, feet, and back. The reporter consented to follow up. This case has been linked with US2020186260 reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020186260:same patient
Sex: U
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable physician.   A 16/17 year old adolescent patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced dizziness on an unspecified date with outcome of unknown. Physician specified the adolescent didn't eat anything in the AM/PM.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Skin reaction
Clinical narrative: mild redness, tenderness, and swelling to the injection site; mild redness, tenderness, and swelling to the injection site; mild redness, tenderness, and swelling to the injection site; Mild tenderness and induration, 2cm in diameter, was noted; This is a spontaneous report from a contactable nurse. A patient received first dose of meningococcal group b rlp2086 (TRUMENBA) on 18Sep2020 single dose at left upper arm for immunisation. Medical history and concomitant drugs were not provided. The patient had local skin reaction to the vaccine: mild redness, tenderness, and swelling to the injection site on 19Sep2020. The subject was seen on 23Sep2020 and the injection site was assessed. Mild tenderness and induration, 2cm in diameter, was noted to the injection site. No erythema was seen. The outcome of redness was resolved in Sep2020, outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: Rash, warm to the touch, minor swelling
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: tender and swollen lymph node in armpit, on the same side as injection
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Left Upper arm is red, warm to the touch, small rash No pain or no fever
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Joint range of motion decreased, Mobility decreased
Clinical narrative: extreme pain from shoulder to elbow, can't lift arm up. can move arm elbow down but not shoulder area
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: FLU; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced flu (preferred term: Influenza).     The outcome of the event was unknown.    The event was considered non-serious.