chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of PENTACEL was administered to a patient with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient of unknown age and unknown gender and it was reported an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant and family history were not provided.  On 08-Mar-2023, an expired dose of 0.5 mL of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] suspension for injection (1X; batch/lot number: UJ658AAA and expiry date: 31-Jan-2023; strength, route: unknown) in unknown administration site for immunization was administered to a patient with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 0.58
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: menquadfi vaccine was given to a patient under the age of 2 with no reported AE; Initial information received  on 10-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old of an unknown gender and reporter reported Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] vaccine was given to a patient under the age of 2 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) For Immunisation; Hib Vaccine Conj (Tet Tox) (Acthib) for Immunisation; and Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix) for Immunisation.  On 09-Mar-2023, the patient received 0.25 ml of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot number: U7447AC, Expiry date: 20-Sep-2024, Strength: Standard, Frequency: Once) via intramuscular route in the right thigh for Immunization.  On 09-Mar-2023, the patient was given Meningococcal A-C-Y-W135 (T Conj) Vaccine was given to a patient under the age of 2 with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, MENQUADFI vaccine was given to a patient under the age of 2. They are wondering what to look for as far as any adverse reactions.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (menquadfi vaccine was given to a patient under the age of 2 with no reported AE).  At time of reporting, the outcome was Unknown for the event menquadfi vaccine was given to a patient under the age of 2 with no reported ae.  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 the 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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient being administered only the DTAP-IPV component of PENTACEL without being reconstituted with the lyophilized ACTHIB component with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old male patient who being administered only the dtap-ipv component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without being reconstituted with the lyophilized acthib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine and Pneumococcal Vaccine CONJ (Pneumococcal Conjugate Vaccine) for Immunisation.  On 09-Mar-2023, the patient received dose 1 at 0.5mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (strength: standard) (lot number: UJ876AA; expiry date: 19-MAR-2024) via unknown route in unknown administration site for immunisation.  On 09-Mar-2023 the patient being administered only the dtap-ipv component of pentacel without being reconstituted with the lyophilized acthib component with no reported adverse event (product preparation issue) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  It was reported as Caller states that a medical assistant administered the liquid component (DTAP-IPV) of vaccine without reconstituting it with the powder component (lyophilized ACTHIB vaccine).   No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 15.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administration of menquadfi post excursion with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA082363(CLUSTER) and 2023SA082367(CLUSTER).  This case involves a 15 years old male patient and it was reported administration of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 10-Jan-2023, it was reported administration of 0.5 mL of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] solution for injection (batch/lot number: U7449AB and expiry date: 23-SEP-2024; strength, route: unknown) in unknown administration site for Immunization post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.; Sender's Comments:  US-SA-2023SA082418:
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: Administration of MENQUADFI post excursion with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who was administrated with vaccine Meningococcal a-c-y-w135 (t conj) vaccine [MENQUADFI].post excursion with no reported adverse event    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 16-Dec-2022, the patient received suspect Meningococcal a-c-y-w135 (t conj) vaccine Solution for injection at dose of 0.5 ml total (strength were not reported) (lot U7449AB and expiry date-23-sep-2024) via intramuscular route in unknown administration site for immunization after post excursion with no reported adverse event (poor quality product administered) (latency-same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.; Sender's Comments:  US-SA-2023SA082418:
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Poor quality product administered
Clinical narrative: administration of Menquadfi post excursion without adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received via health professional. Number: 01527689.  This case involves 11 years old male patient to whom Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] post excursion without adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2023SA082367, 2023SA082373, 2023SA082418, 2023SA082416, 2023SA082675, 2023SA082382, 2023SA082953 and 2023SA081681.   On 11-Jan-2023, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) vaccine Solution for injection at dose 0.5ml once (lot: U7449AB, expiry date: 23-Sep-2024) via intramuscular route in unknown administration site for immunization after the excursion, with no reported adverse event (poor quality product administered) at same day latency.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event poor quality product administered.  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 the 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: 16.0
Sex: F
Vaccine: MEN
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: administration of menquadfi post excursion with no adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA082416, 2023SA082675 and 2023SA082363.  This case involves a 16-year-old female patient who had administration of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 11-Jan-2023, the patient received suspect meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection at a dose of 0.5 ml total (lot U7449AB, expiry date: 23-Sep-2024) via intramuscular route in unknown administration site for immunization.  On 11-Jan-2023 the patient had administration of menquadfi post excursion with no adverse event (poor quality product administered, same day latency).  Action taken: Not applicable.  Outcome: Unknown.   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 the 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: 11.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: menquadfi administered post excursion with no reported adverse events; Initial information received on 10-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA082418.  This case involves a 11 years old male patient and reporter reported Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] was administered post excursion with no reported adverse events.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On 10-Jan-2023, the patient received 0.5 mL  dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (frequency- once (1x), lot U7449AB, expiry date - 23-Sep-2024, strength - unknown) via intramuscular route in unknown administration site for immunization post excursion with no reported adverse event (poor quality product administered) (Latency: same day).  Action taken: not applicable.  Outcome: Unknown for the reported event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 17.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: Menquadfi was administered after the excursion, with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received via health professional. Number: 01527753.  This case involves 17 years old female patient to whom MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] was administered after the excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2023SA082418, 2023SA082416, 2023SA081681, 2023SA082363, 2023SA082367, 2023SA082373, 2023SA082953 and 2023SA082675.   On 20-Dec-2022, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) vaccine Solution for injection at dose 0.5ml once (lot: U7449AB, expiry date: 23-Sep-2029) via intramuscular route in unknown administration site for immunization after the excursion, with no reported adverse event (poor quality product administered) at same day latency.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event poor quality product administered.  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 the 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: 14.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Menquadfi administered after the excursion with no reported event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA082363 and 2023SA082367.  This case involves a 14-year-old female patient to whom meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] administered after the excursion with no reported event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 16-Dec-2022, the patient received suspect meningococcal A-C-Y-W135 (T CONJ) Vaccine solution for injection at a dose of 0.5 ml total (lot U7449AB, expiry date: 23-Sep-2024) via intramuscular route in unknown administration site for immunization.  On 16-Dec-2022, menquadfi administered after the excursion with no reported event (poor quality product administered, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   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 the 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.; Sender's Comments:  US-SA-2023SA082418:
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: MENQUADFI was in a previous excursion and was administered after the excursion with no reported adverse event; MENQUADFI was in a previous excursion and was administered after the excursion with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case 2023SA082363(CLUSTER).  This case involves an 18-year-old male patient, to whom MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] was in a previous excursion and was administered after the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Dec-2022, the patient received 0.5ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength: standard) (lot number: U7449AB, expiry date: 23-Sep-2024) via intramuscular route in unknown administration site for Immunization on the same day menquadfi was in a previous excursion and was administered after the excursion with no reported adverse event (poor quality product administered), (product storage error).  It was reported, caller originally stated that it was not administered post excursion. Caller is requesting revaccination information. No additional information available. This situation is reported as a medication error due to administration of MENQUADFI post excursion.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 16.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: IPOL at a low of 1.6C out of range for 26 minutes with no adverse event; IPOL at a low of 1.6C out of range for 26 minutes and administered post excursion with no adverse event; Initial information received on 13-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA082834.  This case involves a 16-year-old male patient to whom IPV (VERO) [IPOL] at a low of 1.6c out of range for 26 minutes and administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and meningitis.  On an unknown date IPOL was at a low of 1.6c out of range for 26 minutes with no adverse event (product storage error).  On 14-Feb-2023, the patient received a suspect IPV (VERO) suspension for injection at a dose of 0.5 ml once (lot V1A121M, expiry date: 15-Feb-2024) via intramuscular route in the right deltoid for immunization.  On 14-Feb-2023 the patient developed a non-serious ipol at a low of 1.6c out of range for 26 minutes and administered post excursion with no adverse event (poor quality product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 0.58
Sex: F
Vaccine: HIBV, UNK
Symptoms: Single component of a two-component product administered, Wrong technique in product usage process
Clinical narrative: administered pentacel to a 7 month old patient of only the liquid dtap/ipv portion and not the acthib component of pentacel with no reported adverse event; DTAP-IPV and ACTHIB components given as 2 separate injections with no reported adverse event.; Initial information received on 14-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient to whom administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] of only the liquid dtap/ipv portion and not the haemophilus type B (HIB) vaccine (HIB (PRP/T) vaccine) [ACT-HIB] component of pentacel with no reported adverse event and dtap-ipv and acthib components given as 2 separate injections with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 01-Mar-2023, the patient received a dose 3 at 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, (strength and lot number: not reported) (expiry date: 09-Sep-2023) via intramuscular route in right leg and unknown dose of suspect HIB (PRP/T) vaccine , powder and solvent for solution for injection, (lot number: UJ680AA) (strength and expiry date: not reported) via unknown route in unknown administration site for immunization.  On 01-Mar-2023, to the patient administered pentacel to a 7 month old patient of only the liquid dtap/ipv portion and not the acthib component of pentacel with no reported adverse event (single component of a two-component product administered) and dtap-ipv and acthib components given as 2 separate injections with no reported adverse event (wrong technique in product usage process) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine and HIB (PRP/T) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of DAPTACEL was administered today with no reported adverse event; Initial information received on 14-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown age and gender and it was reported an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered today with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 14-Mar-2023, an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] suspension for injection (batch/lot number: C5829BA and expiry date: 01-Mar-2023; strength, route, dose: unknown) in unknown administration site for immunization was administered today with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: Condition aggravated, Neuromyelitis optica spectrum disorder
Clinical narrative: One with Neuromyelitis Optica Spectrum Disorder (NMOSD) experienced worsening of pre-existing symptoms after influenza vaccine /deemed to have experienced vaccine-related pseudo-relapses; This literature case was received on 14-Mar-2023, reported by other healthcare professional and concerned a patient of an unreported age and gender.   This study objective was to evaluate the prevalence and clinical characteristics of iatrogenic central nervous system (CNS) inflammation in a tertiary neuroimmunology clinic since various vaccines, tumor-necrosis-factor-alpha inhibitors (TNFAIs), immune-checkpoint inhibitors (ICIs), and other immunomodulators had been linked to inflammatory CNS events. However, the prevalence of iatrogenic events in the neuroimmunology clinic is unknown.  The patient's concurrent conditions included neuromyelitis optica spectrum disorder (NMOSD). The patient's concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient experienced worsening of pre-existing symptoms of NMOSD with no objective evidence of a new relapse deemed as pseudo-relapse.  The outcome for the event was not reported.   The reporter assessed the event to be related to influenza vaccine. As reported, the patient was deemed to have experienced vaccine-related pseudo-relapse.  The event of 'neuromyelitis optica pseudo relapse' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The literature citation is of iatrogenic CNS inflammation at a tertiary neuroimmunology clinic. This case is linked with cases 202301976, 202301977 and 202301978 (the same literature article).  Company comment: A patient of an unreported age and gender was vaccinated with influenza vaccine. On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient experienced worsening of pre-existing symptoms of neuromyelitis optica spectrum disorder (NMOSD) with no objective evidence of a new relapse deemed as pseudo-relapse. Causal role of the vaccine is unassessable, due to insufficient information regarding diagnostic findings and temporal relationship with the vaccine.; Reporter's Comments: As reported, the patient was deemed to have experienced vaccine-related pseudo-relapse.; Sender's Comments: A patient of an unreported age and gender was vaccinated with influenza vaccine. On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient experienced worsening of pre-existing symptoms of neuromyelitis optica spectrum disorder (NMOSD) with no objective evidence of a new relapse deemed as pseudo-relapse. Causal role of the vaccine is unassessable, due to insufficient information regarding diagnostic findings and temporal relationship with the vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue
Clinical narrative: she feels tired; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (she feels tired) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (one was before getting any of vaccines). Previously administered products included for Product used for unknown indication: Flu Shot (had the flu vaccine sometime Sep or Oct2022 and batch number unknown) in 2022. Past adverse reactions to the above products included No adverse event with Flu Shot. Concurrent medical conditions included Hypertension, Asthma (from time to time) and High cholesterol.    On 02-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (she feels tired). At the time of the report, FATIGUE (she feels tired) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient took 1st dose on 24-Feb-202 with lot number 023M20A, 2nd dose on 24-Mar-2021 with lot number 007B21A, 3rd dose on 25-Nov-2021 with lot number 011F21A and 4th dose on 21-Apr-2022 with lot number 005M21A.  She does not has shortness of breath but think she still has Covid symptoms. She had 4 Covid episodes one was before getting any of vaccines and 3 in between the 2nd and other succeeding dose (she cannot remember exact dates). No treatment drug details was reported.   This case was linked to MOD-2023-715603.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Glucose tolerance impaired, Hepatic steatosis, Myalgia, Pain
Clinical narrative: I had periacardytis,  and muscle aches. Then my legs started swelling and I have had chronic pain in all my joints. I had blood work the previous year and everything was great. I lived a very healthy year. Now I have a fatty liver , I am pre diabetic and I have chronic pain, heart palpitations, swollen legs.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pericarditis, Peripheral swelling
Clinical narrative: I had periacardytis,  and muscle aches. Then my legs started swelling and I have had chronic pain in all my joints. I had blood work the previous year and everything was great. I lived a very healthy year. Now I have a fatty liver , I am pre diabetic and I have chronic pain, heart palpitations, swollen legs.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Confusional state, Fatigue, Headache
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Lethargy, Lymphadenopathy, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: C-reactive protein increased, Peripheral swelling, Red blood cell sedimentation rate increased, Rheumatoid factor positive
Clinical narrative: Bilateral hand swelling
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Loss of consciousness, Visual impairment
Clinical narrative: The donor was vaccinated with Anthrax(P6) in the Nursing office ,after  with a full donation . Injection time was 11:00 am and five minutes after be vaccinated when the donor was still in the nursing office ,  the donor passing out  . The LOC was less than 40 seconds a the donor recovered with in 10 minutes . Other symptoms was visual disturbances  . Cold compress was applied, legs elevated and vitals signs were taken . Oral electrolytes was given to the donor (GATORADE)  The donor improved and left the Center in a very good condition . Two hours later the donor was called to follow up and the donor stated that was feeling fine.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second bivalent booster , no adverse effects were reported
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain operation, Cerebral haemorrhage, Syncope, Unresponsive to stimuli
Clinical narrative: Collapsed and found unresponsive, Brain bleeds, emergency brain surgery
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported. Patient got an extra (3rd Shingrix shot)
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Injection site erythema
Clinical narrative: Swollen injection site, large red painful area around injection site (6 inches across), headache, tender not just at injection site- but tender armpit of that arm, chills, fatigue lasting one week. At this time skin around injection site is still slightly red and itchy. My husband who was vaccinated at the same time had a different reaction. Besides a painful injection site, he experienced fever, chills, headache, and threw-up the morning after his vaccination, but got over everything quicker than I did.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pruritus, Tenderness
Clinical narrative: Swollen injection site, large red painful area around injection site (6 inches across), headache, tender not just at injection site- but tender armpit of that arm, chills, fatigue lasting one week. At this time skin around injection site is still slightly red and itchy. My husband who was vaccinated at the same time had a different reaction. Besides a painful injection site, he experienced fever, chills, headache, and threw-up the morning after his vaccination, but got over everything quicker than I did.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Injection site erythema, Injection site swelling, Nervousness
Clinical narrative: Fever, chills, body pain, arm red at injection site and swollen. Not warm to the touch. Fever broke after 2 days. Patient feels like she is shaking from the inside of her body. Arm is still red and swollen on day 5.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, body pain, arm red at injection site and swollen. Not warm to the touch. Fever broke after 2 days. Patient feels like she is shaking from the inside of her body. Arm is still red and swollen on day 5.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Dermatitis acneiform, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: ACCORDING TO PATIENT, SHE DEVELOPED A RED-RAISED SPOT AT THE SITE OF INJECTION A DAY AFTER THE VACCINATION AND AFTER THE NEXT FEW DAYS IT STARTED ITCHING AND LITTLE BUMPS STARTED TO DEVELOP. ACCORDING TO HER, SHE CALLED AND SPOKE WITH HER NEPHROLOGIST AND WAS ADVISED TO USE SOME HYDROCORTISONE CREAM WHICH HELPS THE ITCHING BUT THE LITTLE PUMPS ARE STILL THERE. PATIENT SHOWED ME A PICTURE OF HER ARM THAT SHE TOOK AS OF MORNING OF 3/18/2023 AND SHE ALSO SHOWED ME HER ARM ON THE SAME DAY 3/18/23 EVENING AND IT LOOKED JUST LIKE WHAT SHE DESCRIBED; RAISED RED SPOT WITH PUMPS/BIG PIMPLES-LIKE.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Dizziness, Dizziness postural
Clinical narrative: About three hours later maybe dozing or lying down I got up quickly...was dizzy . felt faint but did not faint. I had a 6 minute afib pause. as recorded on a linq.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Cold sweat, Heart rate increased, Pyrexia
Clinical narrative: Rapid heart beat, fever like symptoms, heart pain. Cold sweats throughout the night
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Discomfort, Gait disturbance, Headache
Clinical narrative: Starting at approximately 6:00 am on 03/18/2023 I began to have muscle pain throughout my body that continued to intensify throughout the day.  At some point I began having a jabbing type headache in the back of my head that continued to get more intense.  I was shivering but did not take my temperature. I became very weak, having to leave my job at which time I went home having a difficult time walking into the house. I laid down in extreme discomfort and took some Advil gel caps, finally falling asleep at approximately 12:00 pm and sleeping until the next morning. I still am very weak and am still feeling the jabbing pains in the back of my head , nowhere near as intense,  and the muscle aches  are improving.   I have never experienced any reaction other than sore arm after a vaccination and wasn?t certain if it was worth reporting so I did it anyway.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Myalgia
Clinical narrative: Starting at approximately 6:00 am on 03/18/2023 I began to have muscle pain throughout my body that continued to intensify throughout the day.  At some point I began having a jabbing type headache in the back of my head that continued to get more intense.  I was shivering but did not take my temperature. I became very weak, having to leave my job at which time I went home having a difficult time walking into the house. I laid down in extreme discomfort and took some Advil gel caps, finally falling asleep at approximately 12:00 pm and sleeping until the next morning. I still am very weak and am still feeling the jabbing pains in the back of my head , nowhere near as intense,  and the muscle aches  are improving.   I have never experienced any reaction other than sore arm after a vaccination and wasn?t certain if it was worth reporting so I did it anyway.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, fatigue, headache, muscle soreness, pain at vaccine site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Fever, chills, fatigue, headache, muscle soreness, pain at vaccine site.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine registry was pulled and reviewed prior to administration. No bivalent was on patients record. After administration the registry was verified again to see if reporting for vaccine was successful. Upon the second time it was pulled a bivalent dose appeared.   Patient was notified of the event while he was still waiting at the pharmacy. He has had no adverse reaction and was not concerned about receiving the extra/unneeded dose.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Herpes simplex, Injection site pain, Oral herpes
Clinical narrative: Strong chills and high body temperature lasting 48 hours; strong body aches lasting for 3 days; soar arm on injection location lasting 4 days; Herpes simplex (cold soar) on the left side corner of lower lip starting within 18 hours of vaccine (patient hadn't had a cold soar for at least 6-8 years before the vaccine); very itchy, slightly raised, pinkish skin rash on both sides of the thighs that went away with antihistamine (Loratadine) and appeared again every 24 hours (this side effect is persisting several weeks after the vaccine).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Strong chills and high body temperature lasting 48 hours; strong body aches lasting for 3 days; soar arm on injection location lasting 4 days; Herpes simplex (cold soar) on the left side corner of lower lip starting within 18 hours of vaccine (patient hadn't had a cold soar for at least 6-8 years before the vaccine); very itchy, slightly raised, pinkish skin rash on both sides of the thighs that went away with antihistamine (Loratadine) and appeared again every 24 hours (this side effect is persisting several weeks after the vaccine).
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine that was expired. Product was put in fridge on 1/3/23 and should have been discarded 3/14/23.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine that was expired. Product was placed in fridge 1/3/23 and should have been discarded 3/14/23.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: developed COVID symptoms (dry cough, fever) early AM of Jan 1, tested + on home test, took Paxlovid starting that day, asymptomatic within 48 hours, tested negative by day 5, developed rebound symptoms (sniffles only) 5 days after finishing Paxlovid and retested +, no treatment given, tested negative again 5 days after the rebound
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: developed COVID symptoms (dry cough, fever) early AM of Jan 1, tested + on home test, took Paxlovid starting that day, asymptomatic within 48 hours, tested negative by day 5, developed rebound symptoms (sniffles only) 5 days after finishing Paxlovid and retested +, no treatment given, tested negative again 5 days after the rebound
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, Asthenia, Bacterial infection, Blood creatinine normal
Clinical narrative: Patient is a 69 y.o. male with h/o- HTN, CKD, prostate cancer, who presented from home on 1/31/2023 with fever, generalized weakness, hypoxia, found to have COVID-19 pneumonia with possible superimposed bacterial pneumonia.  Pulmonology was consulted, patient completed course of remdesivir, started on Decadron and will complete 10-day course outpatient.  He was given Rocephin and azithromycin to cover for possible bacterial pneumonia.  He has been weaned to room air.  He will follow-up with PCP for imaging to ensure resolution of pneumonia.   COVID infection Acute hypoxic respiratory failure - Presented with: fever, generalized weakness - Symptom onset: 1/30/23 - Positive COVID-19: RMH ER on 1/31/23 - Vaccination status: vaccinated and boosted with Pfizer - CXR on admission showed left basal infiltrate - Oxygen status: Increasing oxygen, required non-rebreather then weaned to Oxymizer and now on room air - Decadron: Yes, started 2/1, will complete 10 days - Remdesivir: Yes, started 2/2 after seen by Pulm with renal function at baseline, can be stopped on day - Ceftriaxone, Azithro added 2/2 per Pulm for suspected secondary bacterial infection; sputum culture with gram-positive cocci, no growth, they state okay to discontinue 2/6 - DVT prophylaxis: - Serial COVID labs ordered: Yes- CRP is down trending  - supportive care with limited IV hydration, PRN antipyretics, PRN antitussives, IS - PT/OT and mobility encouraged - Pulmonology signed off   Throat pain, laryngitis - FEES by ST performed 2/3 with pharyngeal and laryngeal structures appearing edematous-see separate procedure images - Suspect this is related to acute COVID infection, treatment as above  - Continue supportive care   Essential HTN - BP acceptable; resumed home med Nifedipine - initially held hydralazine given soft blood pressures, now resumed   Hyperlipidemia - stable, resume statin   CKD- Stage 3 - follows with Dr. - Cr stable range, avoid nephrotoxins as able   Prostate cancer in remission BPH - follows with Urology/Dr. - s/p radiation, now on Xtandi - resumed Flomax